CBP and Trade Automated Interface Requirements

Participating Government Agencies - FDA Supplemental Guide Release 2 4 1 Final.pdf

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CBP and Trade Automated Interface Requirements

OMB: 0910-0046

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FDA Supplemental Guidance

CBP and Trade Automated
Interface Requirements
FDA Supplemental Guidance for the Automated
Commercial Environment/International Trade Data
System (ACE/ITDS) Version 2.4.1
March 31, 2016

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance

Contents
Change Log ................................................................................................................................................................7
General Introduction ................................................................................................................................................ 18
FDA Overview ..................................................................................................................................................... 18
Legends ................................................................................................................................................................... 20
Field Requirements ............................................................................................................................................. 20
Field Data Types ................................................................................................................................................. 20
Required (Mandatory and/or Conditional)Data Elements for all FDA Commodities ............................................... 21
FDA Commodities and Commodity Sub-Types ....................................................................................................... 22
Biologics Commodity Data Elements and Values ................................................................................................... 23
Biologics Example ............................................................................................................................................... 25
Record Identifier OI (Record Identifier) ............................................................................................................... 26
Record Identifier PG01 (Record Identifier) .......................................................................................................... 27
Record Identifier PG02 (Product Identifier) ......................................................................................................... 29
Record Identifier PG04 (Product Constituent Element) ...................................................................................... 30
Record Identifier PG05 (Scientific Genus Names) .............................................................................................. 31
Record Identifier PG06 (Product Origin) ............................................................................................................. 32
Record Identifier PG07 (Product Trade Names) ................................................................................................. 33
Record Identifier PG10 (Product Characteristics) ............................................................................................... 34
Record Identifier PG19 (Entity Data) ................................................................................................................... 35
Record Identifier PG20 (Entity Address) ............................................................................................................. 37
Record Identifier PG21 (Point of Contact) ........................................................................................................... 38
Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 39
Record Identifier PG24 (Remarks) ...................................................................................................................... 44
Record Identifier PG25 (Product Condition)........................................................................................................ 45
Record Identifier PG26 (Product Packaging) ...................................................................................................... 47
Record Identifier PG27 (Container Information) ................................................................................................. 50
Record Identifier PG29 (Unit of Measure) ........................................................................................................... 51
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) .......................................... 53
Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 54
Record Identifier PG60 (Additional Information) ................................................................................................. 55
Record Identifier PG00 (Data Substitution) ......................................................................................................... 56
Cosmetics Commodity Data Elements and Values ................................................................................................. 57
Cosmetics Example............................................................................................................................................. 58
Record Identifier OI (Record Identifier) ............................................................................................................... 59
Record Identifier PG01 (PGA Identifier) .............................................................................................................. 60
Record Identifier PG02 (Product Identifier) ......................................................................................................... 61
Record Identifier PG06 (Product Origin) ............................................................................................................. 62
Record Identifier PG07 (Product Trade Names) ................................................................................................. 63
Record Identifier PG10 (Product Characteristics) ............................................................................................... 64
Record Identifier PG19 (Entity Data) ................................................................................................................... 65
Record Identifier PG20 (Entity Address) ............................................................................................................. 67
Record Identifier PG21 (Point of Contact) ........................................................................................................... 68
Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 69
Record Identifier PG24 (Remarks) ...................................................................................................................... 70
Record Identifier PG25 (Product Condition)........................................................................................................ 71
Record Identifier PG26 (Product Packaging) ...................................................................................................... 73
Record Identifier PG27 (Container Information) ................................................................................................. 76
Record Identifier PG29 (Unit of Measure) ........................................................................................................... 77
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) .......................................... 79

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 80
Record Identifier PG60 (Additional Information) ................................................................................................. 81
Record Identifier PG00 (Data Substitution) ......................................................................................................... 82
Drug Commodity Data Elements and Values .......................................................................................................... 83
Drug Example ...................................................................................................................................................... 85
Record Identifier OI (Record Identifier) ............................................................................................................... 86
Record Identifier PG01 (PGA Identifier) .............................................................................................................. 87
Record Identifier PG02 (Product Identifier) ......................................................................................................... 90
Record Identifier PG04 (Product Constituent Element) ...................................................................................... 92
Record Identifier PG06 (Product Origin) ............................................................................................................. 95
Record Identifier PG07 (Product Trade Names) ................................................................................................. 96
Record Identifier PG10 (Product Characteristics) ............................................................................................... 97
Record Identifier PG19 (Entity Data) ................................................................................................................... 98
Record Identifier PG20 (Entity Address) ........................................................................................................... 100
Record Identifier PG21 (Point of Contact) ......................................................................................................... 101
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 102
Record Identifier PG24 (Remarks) .................................................................................................................... 105
Record Identifier PG25 (Product Condition)...................................................................................................... 106
Record Identifier PG26 (Product Packaging) .................................................................................................... 108
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 111
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 113
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 114
Record Identifier PG60 (Additional Information) ............................................................................................... 115
Record Identifier PG00 (Data Substitution) ....................................................................................................... 116
Stand Alone Prior Notice Submission Data Elements and Values ........................................................................ 117
Prior Notice Non-PGA Data Elements by Mode of Transportation (See Note) ................................................. 117
Food Commodity Data Elements and Values ................................................................................................... 119
Prior Notice Example ......................................................................................................................................... 121
Record Identifier OI (Record Identifier) ............................................................................................................. 122
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 123
Record Identifier PG02 (Product Identifier) ....................................................................................................... 124
Record Identifier PG06 (Product Origin) ........................................................................................................... 125
Record Identifier PG10 (Product Characteristics) ............................................................................................. 127
Record Identifier PG13 (License Plate Issuer) .................................................................................................. 128
Record Identifier PG14 (License Plate Number) ............................................................................................... 129
Record Identifier PG19 (Entity Data) ................................................................................................................. 130
Record Identifier PG20 (Entity Address) ........................................................................................................... 134
Record Identifier PG21 (Point of Contact) ......................................................................................................... 135
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 137
Record Identifier PG24 (Remarks) .................................................................................................................... 140
Record Identifier PG25 (Product Condition)...................................................................................................... 141
Record Identifier PG26 (Product Packaging) .................................................................................................... 142
Record Identifier PG27 (Container Information) ............................................................................................... 148
Record Identifier PG28 (Express Courier Tracking Number)............................................................................ 149
Record Identifier PG30 (Anticipated Arrival Info and Port of Arrival / Entry) ..................................................... 150
Record Identifier PG55 (Additional Roles) ........................................................................................................ 152
Record Identifier PG60 (Additional Information) ............................................................................................... 153
Record Identifier PG00 (Data Substitution) ....................................................................................................... 154
Food Commodity Combined Entry Submission - Data Elements and Values....................................................... 155
Prior Notice Non-PGA Data Elements by Mode of Transportation (See Note) ................................................. 157
Prior Notice Combined Entry Example .............................................................................................................. 158
Record Identifier OI (Record Identifier) ............................................................................................................. 159
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 160
Record Identifier PG02 (Product Identifier) ....................................................................................................... 161
Record Identifier PG05 (Scientific Genus Names) ............................................................................................ 162

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Record Identifier PG06 (Product Origin) ........................................................................................................... 163
Record Identifier PG07 (Product Trade Names) ............................................................................................... 164
Record Identifier PG10 (Product Characteristics) ............................................................................................. 165
Record Identifier PG13 (License Plate Issuer) .................................................................................................. 166
Record Identifier PG14 (License Plate Number) ............................................................................................... 167
Record Identifier PG19 (Entity Data) ................................................................................................................. 168
Record Identifier PG20 (Entity Address) ........................................................................................................... 172
Record Identifier PG21 (Point of Contact) ......................................................................................................... 173
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 174
Record Identifier PG24 (Remarks) .................................................................................................................... 178
Record Identifier PG25 (Product Condition)...................................................................................................... 179
Record Identifier PG26 (Product Packaging) .................................................................................................... 181
Record Identifier PG27 (Container Information) ............................................................................................... 186
Record Identifier PG28 Express Courier Tracking and Can Dimensions (Acidified and LACF) ....................... 187
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 189
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 191
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 192
Record Identifier PG60 (Additional Information) ............................................................................................... 193
Record Identifier PG00 (Data Substitution) ....................................................................................................... 194
Food Commodity including PN Requirement Previously Met - Data Elements and Values ................................. 195
Food Example ................................................................................................................................................... 197
Record Identifier OI (Record Identifier) ............................................................................................................. 198
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 199
Record Identifier PG02 (Product Identifier) ....................................................................................................... 200
Record Identifier PG05 (Scientific Genus Names) ............................................................................................ 201
Record Identifier PG06 (Product Origin) ........................................................................................................... 202
Record Identifier PG07 (Product Trade Names) ............................................................................................... 203
Record Identifier PG10 (Product Characteristics) ............................................................................................. 204
Record Identifier PG14 (PN Confirmation Number) .......................................................................................... 205
Record Identifier PG19 (Entity Data) ................................................................................................................. 206
Record Identifier PG20 (Entity Address) ........................................................................................................... 208
Record Identifier PG21 (Point of Contact) ......................................................................................................... 209
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 210
Record Identifier PG24 (Remarks) .................................................................................................................... 213
Record Identifier PG25 (Product Condition)...................................................................................................... 214
Record Identifier PG26 (Product Packaging) .................................................................................................... 216
Record Identifier PG27 (Container Information) ............................................................................................... 221
Record Identifier PG28 (Can Dimensions – Acidified and LACF only) ............................................................. 222
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 223
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 225
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 227
Record Identifier PG60 (Additional Information) ............................................................................................... 228
Record Identifier PG00 (Data Substitution) ....................................................................................................... 229
Medical Devices Commodity Data Elements and Values ..................................................................................... 230
Medical Devices Example ................................................................................................................................. 232
Record Identifier OI (Record Identifier) ............................................................................................................. 233
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 234
Record Identifier PG02 (Product Identifier) ....................................................................................................... 237
Record Identifier PG06 (Product Origin) ........................................................................................................... 238
Record Identifier PG07 (Product Trade Names) ............................................................................................... 239
Record Identifier PG10 (Product Characteristics) ............................................................................................. 240
Record Identifier PG19 (Entity Data) ................................................................................................................. 241
Record Identifier PG20 (Entity Address) ........................................................................................................... 243
Record Identifier PG21 (Point of Contact) ......................................................................................................... 244
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 245

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Record Identifier PG24 (Remarks) .................................................................................................................... 248
Record Identifier PG25 (Product Condition)...................................................................................................... 249
Record Identifier PG26 (Product Packaging) .................................................................................................... 251
Record Identifier PG27 (Container Information) ............................................................................................... 253
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 254
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 257
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 258
Record Identifier PG60 (Additional Information) ............................................................................................... 259
Record Identifier PG00 (Data Substitution) ....................................................................................................... 260
Tobacco Commodity Data Elements and Values .................................................................................................. 261
Tobacco Example.............................................................................................................................................. 263
Record Identifier OI (Record Identifier) ............................................................................................................. 264
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 265
Record Identifier PG02 (Product Identifier) ....................................................................................................... 267
Record Identifier PG06 (Product Origin) ........................................................................................................... 268
Record Identifier PG07 (Product Trade Names) ............................................................................................... 269
Record Identifier PG10 (Product Characteristics) ............................................................................................. 270
Record Identifier PG19 (Entity Data) ................................................................................................................. 271
Record Identifier PG20 (Entity Address) ........................................................................................................... 273
Record Identifier PG21 (Point of Contact) ......................................................................................................... 274
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 275
Record Identifier PG24 (Remarks) .................................................................................................................... 277
Record Identifier PG25 (Product Condition)...................................................................................................... 278
Record Identifier PG26 (Product Packaging) .................................................................................................... 280
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 282
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 284
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 285
Record Identifier PG60 (Additional Information) ............................................................................................... 286
Record Identifier PG00 (Data Substitution) ....................................................................................................... 287
Radiation Emitting Products Commodity Data Elements and Values ................................................................... 288
Radiation Emitting Products Example ............................................................................................................... 292
Record Identifier OI (Record Identifier) ............................................................................................................. 293
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 294
Record Identifier PG02 (Product Identifier) ....................................................................................................... 296
Record Identifier PG06 (Product Origin) ........................................................................................................... 297
Record Identifier PG07 (Product Trade Names) ............................................................................................... 298
Record Identifier PG10 (Product Characteristics) ............................................................................................. 299
Record Identifier PG19 (Entity Data) ................................................................................................................. 300
Record Identifier PG20 (Entity Address) ........................................................................................................... 302
Record Identifier PG21 (Point of Contact) ......................................................................................................... 303
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 304
Record Identifier PG24 (Remarks) .................................................................................................................... 308
Record Identifier PG25 (Product Condition)...................................................................................................... 309
Record Identifier PG26 (Product Packaging) .................................................................................................... 311
Record Identifier PG27 (Container Information) ............................................................................................... 313
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 314
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 316
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 317
Record Identifier PG60 (Additional Information) ............................................................................................... 318
Record Identifier PG00 (Data Substitution) ....................................................................................................... 319
Animal Drugs and Devices Commodity Data Elements and Values ..................................................................... 320
Animal Drugs and Devices Example ................................................................................................................. 322
Record Identifier OI (Record Identifier) ............................................................................................................. 323
Record Identifier PG01 (PGA Identifier) ............................................................................................................ 324
Record Identifier PG02 (Product Identifier) ....................................................................................................... 325

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Record Identifier PG04 (Product Constituent Element) .................................................................................... 326
Record Identifier PG06 (Product Origin) ........................................................................................................... 328
Record Identifier PG07 (Product Trade Names) ............................................................................................... 329
Record Identifier PG10 (Product Characteristics) ............................................................................................. 330
Record Identifier PG19 (Entity Data) ................................................................................................................. 331
Record Identifier PG20 (Entity Address) ........................................................................................................... 333
Record Identifier PG21 (Point of Contact) ......................................................................................................... 334
Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 335
Record Identifier PG24 (Remarks) .................................................................................................................... 337
Record Identifier PG25 (Product Condition)...................................................................................................... 338
Record Identifier PG26 (Product Packaging) .................................................................................................... 340
Record Identifier PG27 (Container Information) ............................................................................................... 343
Record Identifier PG29 (Unit of Measure) ......................................................................................................... 344
Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 346
Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 347
Record Identifier PG60 (Additional Information) ............................................................................................... 348
Record Identifier PG00 (Data Substitution) ....................................................................................................... 349
Appendix A: Use of PG10 Record ......................................................................................................................... 350
Appendix B: Food Facility Registration Exemption (FME) .................................................................................... 351
Appendix C: Sample use of PG04 – Product Constituent Element ....................................................................... 352
Appendix D: Unit of Measurement Codes; See Base Units below ........................................................................ 353

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Change Log
Date

Version
No.

11/25/2014

1/02/2015

1.2

1/22/2015

1.3

2/9/2015

1.4

3/5/2015

Description

Page Number

Author

129

FDA

Updated all mandatory record types to match
FDA business rules for CBP processing

Multiple pages

FDA

Updates based on feedback from Trade in the
1/6 and 1/13 meetings; based on feedback
from FDA’s review of draft. Added Commodity
type to Commodity sub-type mapping table.

Multiple pages

FDA

Updates based on feedback from CDRH on
Medical Devices and from CBP on all
chapters; enforced consistence of same PG
record types across commodities where there
is no special handling from one commodity to
another (example, PG06, PG20, PG21);
updates based on feedback from Trade in the
1/20, 1/27 and 2/3 meeting.

Multiple pages

FDA

1.6

Updates to Drugs chapter based on CBP’s
feedback; removed references to MID as the
identifier for Trade; re-aligned the Processing
Codes for Medical Devices

Multiple pages

FDA

3/19/2015

1.7

Removed references to ESS, SSN & TIN in
PG19; Added ‘DP’ to PG19; the mandatory
LOT# related fields in PG25 are now
conditional; Improved rules for Item Type in
PG02 record; Updates to Drugs chapter based
on meeting with Philadelphia District Office;
PG06 Notes are made consistent across all
the commodities; added new Processing
Codes for Radiation Emitting Products

Multiple pages

FDA

4/2/2015

1.8

For VME, PG07 is conditional; for Cosmetics,
Cosmetic Registration Number (COS) is
optional; for FOO, PG23 AoC Codes FCE/SID
requirements are updated; for DRU PG23,
REG is not required for PHN; updated the
processing codes for drugs; PG25 – all values
except PGA Line value are now optional for all
commodities; PG27 record is now mandatory
for PN but is optional for all commodities;
PG26 is optional and PG29 is conditional for
Drugs; added Appendix C for DRU;

Multiple pages

FDA

Initial Version

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Date

Version
No.

Description

Page Number

Author

4/11/2015

1.9

Additional text added for PG30 record
description based on the March 25th release of
CATAIR; adjusted list of intended use codes
for PG01 in Radiation Emitting Products
chapter per Amy Gomez, CDRH; changes to
Drugs chapter PG01, PH02, PG04, PG19 and
PG23 based on feedback from John Verbeten
CDER; updates to Biologics chapter based on
feedback from CBER;

Multiple pages

FDA

4/27/2015

2.0

Updated PG19 Entity identification criteria
across all commodities; added subtypes to
Tobacco; added PG04 to Tobacco and
included feedback from CTP; includes CBER
feedback in Biologics; added the new chapter
on Device and Drug Combination Products
chapter; added the new chapter for Prior
Notice; included additional text to Food chapter
to connect PN and Food chapters; updated the
context of the PN and Food chapters to describe a

Multiple pages

FDA

Updated Drugs chapter using 4/30/2015 &
5/8/2015 feedback from CDER; updated
Tobacco chapter using 5/1/2015, 5/2/2015 &
5/7/2015 feedback from CTP; updated
Veterinary Medicine chapter using 5/5/2015 &
5/8/2015 feedback from CVM; updated the
Biologics chapter using 5/6/2015 feedback
from CBER; updated Disclaimer in PG01
consistently across all the commodities;
updated Medical Devices chapter using ACE
ITDS Import Scenario Mapping19.xlsx from
CDRH; updated Cosmetics chapter using
feedback from CFSAN; updated Radiation
Emitting Products chapter based on 5/7/2015
feedback from CDRH; updated Prior Notice
chapter using 5/7/2015 feedback from DFDT;

Multiple pages

FDA

Updates to PG30 to make mandatory for
anticipated arrival time. Updated Prior Notice
section to include data elements in the PE
records. Various cosmetic and formatting
updates

Multiple pages

FDA

stand-alone PN entry in the PN chapter and a
combination entry (801a and 801m) in the Food
chapter.

5/12/2015

2.1

5/18/2015

2.1.1

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Date

Version
No.

6/12/2015

2.2

8/18/2015

2.3.1

Description

Page Number

Author

PG55 is not supported at this time for all FDA
commodities; CBER AoC codes & business
rules updated; PG25 - line value is required in
all the PG25 records (repeated for multiple lot
#); FDA product code = 7 characters; Added
references to a new entity role code: FDC =
FDA Consolidator; Valid list of port codes link
added to PG30; Medical Devices - PG01
Intended Use codes and sub-codes – updated;
Radiation Emitting Products - PG01 Intended
Use codes and sub-codes – updated; PG20 is
mandatory with additional notes for all
commodities; dropped Remarks Code and
clarified the Note in PG24 for all commodities;
added Prior Notice Non-PGA Data Elements
by Mode of Transportation to PN chapters;
external sample file is referenced to provide
samples for all commodities; included
additional rules for entering PG19 entity role
codes;
Updated PN-related chapters based on
feedback from DFDT’s FDA Supplemental
Guide Release 2 2 DFDT Edits 07-02-15.docx,
FDA Supplemental Guide Release 2 3 draft
DFDT Edits 7-13-15.docx, FDA Supplemental
Guide Release 2 3 with tracking DFDT Edits 720-15.docx and FDA Supplemental Guide
Release 2 3 with tracking DFDT Edits 7-2415.docx; updated Medical Devices and
Radiation Editing Products chapters based
on feedback from CDRH’s FDA Supplemental
Guide Release 2.2 abg.docx and final - FDA
Supplemental Guide Release 2 3 with tracking
- Device Chapter_abg + ja 150814abg.docx;
changed the use of FD1 entity role code to DII
for CDRH use; updated PG26 across all
commodities based on CBP’s new descriptions
of product packaging; updated PG05-06-07-10
throughout the document to reference the most
recent PG02; re-arranged the appendices and
updated their references throughout the
document; updated the validation criteria for
FEI numbers across all commodities based on
its current range of values in FDA’s databases;
clarified the text for PG21 and PG30 record
across all commodities; clarified the references
to PE10 and SE15 in conjunction with the PG
Message Set in the PN-related chapters; in
the Drugs chapter, added BLA to the scope of
the AoC code DA (formerly NDA and AND);
removed the use of Intended Use Codes for
Food-related commodities and added logic

Multiple pages

FDA

Multiple pages

FDA

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Date

10/26/2015

Version
No.

2.3.2

Description
depending on parts of product codes at group
level; PG01 is not repeatable for different
Intended Use Codes; added the FDA Product
Code structure to all commodities and included
logic based on product codes in Food-related
chapters; renamed veterinary medicine
chapter to Animal Drugs and Devices per
feedback from CVM and replaced references
to veterinary medications by animal drugs in
the entire document; updated Tobacco
chapter based on feedback in Tobacco Data
Elements - June 2015 exw jw jma.doc;
updated Biologics chapter using feedback
from FDA Supplemental Guide Release 2 3
CBER Edits.docx; updated Devices and Drug
chapters in lieu of the Device+Drug
Combination chapter before removing it;
updated Devices and Biologics chapters in lieu
of the Device+Biologics Combination
chapter before removing it; added business
rules for PG24; added Appendix E showing the
use of PG04 both at Product-level and at
Constituent Element-level and updated all
commodities accordingly; added new AoC
codes in the Tobacco chapter; added new
UoM codes for Drugs;
For all commodities:
Intended Use Description is optional;
added Appendix F for the list of Unit of
Measurement codes and included its reference
in PG26 and PG29;
PG29 is not supported by the FDA at this time;
clarified the use of PG04 for multiple
constituent elements under PG02 and
corrected Appendix E accordingly;
Line value in PG25 must be greater than zero;
Quantity in PG26 must be greater than zero;
PG19:Entity Number is optional; PG19:Entity
Identification Code is Mandatory if PG19:Entity
Number is entered;
PG21:Telephone Number is 15X (alphanumeric) to include global telephone numbers;
added a national and an international
telephone number as examples in PG21;

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

Multiple pages

FDA

FDA Supplemental Guidance
Date

Version
No.

Description
At least one PG21 record is required;
For specific commodities:
Government Agency Processing codes have
changed for VME;
reviewed and corrected the Intended Use
Codes for BIO, DRU, DEV and VME – these
changes will be in line with the next release of
Schedule R by the CBP;
corrected a typo in DRU:PG07;
corrected Note3 text for Radiation Emitting
Products:PG01;
PG23:AoC codes are adjusted for BIO, DRU,
DEV and VME;
updated the mapping between the AoC codes
and import scenarios for BIO and DRU
chapters;
PG01:Note3 for Cosmetics is deleted;
PG04 is required for all DRU messages except
PHN;
Note5 is new in DRU:PG04;
added the new AoC code PLR for drugs;
added references to Carrier Name to PNrelated chapters – the new AoC code CAN is
added to PG23 for PN;
Bulk (230.005) is not a valid IUC code for
Food;
all references to the AoC code PND are
deleted in the Food chapters;
clarified the rules for PG06, PG13 and PG14
for Food chapters;
PG21:PK reference is added to all Food
chapters;
Food UoM tables are added to FOO chapters;
PG28 is conditional for non-PN chapters –
Note1 includes additional clarifications;

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

FDA Supplemental Guidance
Date

Version
No.

Description

Page Number

Author

Multiple pages

FDA

Multiple pages

FDA

for TOB:PG26, it is not required to enter 20
cigarettes in a pack – it may be entered if
desired by the filer;
IUC codes are optional for VME; the AoC code
VMS is deleted from VME chapter;
Clarified that ONE of MF/DFI/FDC is required
for PN and only one of them is allowed;
PG30 is used to collect Foreign Trade Zone
(FTZ) information for the FOO+PNC chapter.
10/29/2015

2.4

3/31/2016

2.4.1

Corrected the footnotes in PG19 for Prior
Notice chapters; clarified the percentage of
constituent element in PG04 and added
examples for DRU and VME chapters; AofC
code is conditional for RAD chapter; new IUC
codes are ordered to match the next release of
Schedule R by CBP. Updated PG30 record for
FOO+PNC chapter;
For all commodities:
AoC Qualifier is 30 characters long;
Sum of all PGA Line Value in PG25 cannot
exceed CBP’s entry value – this business rule
is validated by CBP;
In case of multiple PG25 records to enter
different lot numbers, the line value must be
entered in only the first PG25 record;
Clarified that Quantity in PG26 is always
entered with 2 implied decimals;
Clarified the description of the Packaging
Qualifier for PG26;
Introduced the use of the new PG Message
Record PG60 and the use of PG07, PG19,
PG20 and PG21 records is affected by PG60;
Deleted the Note for PG24 to include the effect
of PG60 and removed PG24:NAM construct;
Synchronized the Intended Use Codes to the
Appendix R -DRAFT 2015-12-01H.docx;

FDA Supplemental Guidance - Release 2.4.1

FDA Supplemental Guidance
Date

Version
No.

Description
PG30:Inspection or Arrival Location Code is
set to '2' and the valid port code is entered in
the PG30:Arrival Location;
The Entity role code UC is interpreted to be
synonymous to DP for Prior Notice –
Combined Entry; for all other chapters, text for
this interpretation is removed;
The disclaimer code ‘B’ is removed;
PG06:Country Code should match the Country
Code in PG19-PG20 record set depending on
PG06:Source Type Code and PG19:Entity
Role Code;
Entity role code ‘LG’ is removed from the
applicable roles list for all non-PN chapters; LG
is used only for PN purposes;
AoC codes CCN, UFC and HTS are removed;
PG01: record layout changed to reflect CBP
inclusion of ‘Correction Indicator’ in position
79;
Clarified the title of PG30 to include Port of
Arrival / Entry; adjusted the field names in
PG30 accordingly; added the port of Entry
data requirements to PG30 across all
chapters;
All the other applicable entity roles for PG19,
except PK, are removed from all chapters;
Removed all references to Fax Number for a
POC in PG21;
Biologics:
Removed the requirement for lot# in PG25;
Removed PG05 / PG07 notes not needed
anymore;
Added clarification to Note1 for PG07
regarding HCT products;
Clarified that FEI is preferred over DUNS in
PG19 similar to CDRH rules;
Replaced the IUC codes table for PG01 based
on CBER feedback dated 2/23/2016;

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

FDA Supplemental Guidance
Date

Version
No.

Description

Replaced the AoC codes table for PG23 based
on CBER feedback dated 2/18/2016;
Replaced the Import Scenario table for PG23
based on CBER feedback dated 2/23/2016;
PG04 is optional;
Tobacco:
Added ‘PCS’ as a valid Unit of Measure base
unit; made PGA Unit Value optional;
All AoC Codes are optional in PG23 based on
CTP feedback;
Correction: FEI is not required in PG19;
Medical Devices:
Added BD+6N to AoC code PM# in PG23
based on CBER feedback;
Source Type Code of 30 is for components
and 39 for finished devices in PG06;
Brand Name is conditional for PG07 and
added the condition in a note;
Food (non-PN):
Clarified AoC code FCE can be from 5 to 10
digits;
Clarified PNC# should be a 12 digits number;
Clarified the use of Source Type Code in
PG06;
Clarified the format of AoC Code SID in PG23
as CCYYMMDDnnn for 11 digits;
AoC Cods FCE and SID are required for LACF
and AF; additionally, either the AoC code VOL
or PG28 is required; this clarifies the use of
AoC Codes SID, FCE and VOL to be in line
with the most recent NPRM;
Prior Notice (PN):
Program Code CCW is removed from the
combined entry chapter;
PG28 is edited to allow for the SCAC to be
submitted;

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

FDA Supplemental Guidance
Date

Version
No.

Description

PE10: Ref.Qual.Code changed from BIL to
BOL based on recent CBP changes;
Clarified the use of Source Type Code in
PG06;
Clarified the rule for PG13:LPCO;
Clarified the choice of Grower or Consolidator
in PG19;
Added the AoC code LFR for Location of
Foods (Holding Facility);
Govt. Agency Processing Code ‘CCW’ is not
applicable to the Combined Entry chapter;
Entity Role Code ‘LG’ was included in both the
PN Stand-Alone chapter and the Combined
Entry chapter but with inconsistent condition;
corrected this inconsistency to use the same
description / condition in both these chapters;
AoC code VFT is required when it exists.
‘Does Not Exist’ can be entered if Trip # is not
known;
AoC Code FME should be followed by a 1letter code based on the newly named
Appendix B;
AoC Code RNO in PG23 can be repeated for
multiple rail car numbers; if rail car number is
not known, then ‘Does Not Exist’ can be
entered;
PG27 record is repeatable with 3 container
numbers per record;
Animal Drugs & Devices:
PG04 is not required for VME/ADE; it can be
entered for VME/ADR;
Clarified the description to include multiple GD
records in PG19 for multiple API producers;
GD is optional;
AoC codes are conditional if the Government
Agency Program Code = VME and
Government Agency Processing Code = ADR;
there are currently no AoC codes for ADE;

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

FDA Supplemental Guidance
Date

Version
No.

Description

AoC Code REG is conditional;
AoC Code NDC is optional;
AoC Code DLS is optional;
AoC Code VFL is optional;
AoC Code VFD (=Veterinary Feed Directive) is
optional;
Added UoM CAP (Capsules) and CTR
(Cartridge) to PG26/PG29 and Appendix D;
Radiation Emitting Products:
Clarified the rules for entering the AoC codes
ACC and ANC in PG23;
Brand Name is conditional for PG07 and
added the condition in a note;
Clarified AoC Codes ‘ACC’ and ‘ANC’: added
the syntax and format; required if RB1 is
entered;
Clarified AoC Code RB1: required if either
ACC or ANC is entered; no qualifier
Added an optional AoC Code ‘MDL’ where the
filer can enter the model number of the
product;
Added an optional AoC Code ‘CCM’ for
Certified Component Manufacturer;
Drugs:
Removed Appendix B and Appendix C and renamed the rest of the appendices; this affects
the references to appendices in other chapters
as well;
Clarified that PG04 is not required for
DRU/PHN but is optional for other processing
codes within DRU;
Clarified the description to include multiple GD
records in PG19 for multiple API producers;
GD is optional;
Expanded the definition of the processing code
‘PHN’ to include Pharmaceutical Necessities,

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

FDA Supplemental Guidance
Date

Version
No.

Description
Inactive Pharmaceutical Ingredients and
Excipients;
Clarified the use of PG04 for APIs and deleted
the 2nd example for API; clarified the rules in
Note2 and Note3 for PG04;
Added UoM CAP (Capsules) and CTR
(Cartridge) to PG26/PG29 and Appendix D;
Restated the rule when PG23 will not be
required; added notes to the AoC code ‘DLS’
in the case of a Private Label Distributor
(PLD);
Added syntax to the AoC code LST in PG23;
Included the missing Intended Use Codes in
the AoC code rules due to changes in CBP’s
Schedule R;
Added a new editing rule for the PIC in the
FDA product code based on government
agency processing code (in PG01) and
intended use code (in PG01);
Added capsules (CAP) and cartridges(CTR) as
unit of measurement values in PG26/PG29;
Cosmetics:
Clarified the text for Government Agency
Processing Code in PG01;
Only 39 is allowed as a valid source type code
in PG06; Country of Source is not applicable to
PG06;

FDA Supplemental Guidance - Release 2.4.1

Page Number

Author

FDA Supplemental Guidance

General Introduction
This document is intended as a supplemental guide to the CBP Customs and Trade Automated Interface
Requirements (CATAIR), PGA Message Set chapter (also referred to as an implementation guide).
The PGA Message Set chapter/implementation guide and its related Appendix PGA can be found on CBP.gov at:
http://www.cbp.gov/document/guidance/appendix-pga
The ACE ABI CATAIR – Custom and Trade Automated Interface Requirements:
http://www.cbp.gov/document/guidance/pga-message-set
Appendix V Government Agency Codes:
http://www.cbp.gov/document/guidance/appendix-v-government-agency-codes
Appendix R Intended Use Codes for ACE:
http://www.cbp.gov/document/guidance/appendix-r-intended-use-codes-ace
Appendix B Valid Codes:
http://www.cbp.gov/document/guidance/appendix-b-valid-codes
Appendix C:
http://www.cbp.gov/document/guidance/appendix-c-tariff-abbreviations

There are times when FDA and CBP reporting may require the same data. In those instances, FDA will not ask
for the data to be provided again in the PGA Message Set, if it is already collected by CBP. That is, the PGA
Message Set data requirements for FDA will not duplicate those common data elements. Instead, the PGA
Message Set is used to provide specific data elements required for FDA reporting

FDA Overview
FDA is responsible for:
Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg
products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and
properly labeled; ensuring that human and animal drugs, and vaccines and other biological products and
medical devices intended for human use are safe and effective,
Protecting the public from electronic product radiation,
Assuring cosmetics and dietary supplements are safe and properly labeled,
Regulating tobacco products, and
Advancing the public health by helping to speed product innovations.
Primary responsibility for administering the nation’s laws relating to import, export, and the collection of duties is
given to the United States Customs and Border Protection (CBP). FDA, however, is responsible for determining
whether or not an article offered for importation is in compliance with or in violation of the acts enforced by the
FDA. This includes the responsibility of determining whether or not a violative article may be brought into
compliance with the appropriate statute and/or regulations, and authorizing reconditioning in order to bring an
article into compliance.
In order to fulfill their respective responsibilities, CBP and FDA must work in close cooperation.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
Points of Contact
If you have technical questions about the content of this Supplemental Guide, please email FDA at
[email protected].
If you have other questions about this Guide or its data examples, please contact:
Sandy Abbott
Director Division of Compliance Systems
Office of Enforcement and Import Operations
Food and Drug Administration
301-796-3240
[email protected]
Jessica Aranda
Communications & Program Analyst
Food and Drug Administration
240-402-9914
[email protected]

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Legends
Field Requirements
Abbreviation

Name

Mandatory

Conditional

Optional

Description
This data element is required under all
circumstances
This data element is required under certain
circumstances based on business rules
This data element is not compulsory under all
circumstances

Field Data Types
Abbreviation

Name

Description

Alpha

Letters A-Z

Numeric

Numbers 0-9

Alphanumeric

Letters A-Z and Numbers 0-9

Alphanumeric and
Special Characters

Letters A-Z, Numbers 0-9, special characters
(*,!,@, etc.)

AN
X

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Required (Mandatory and/or Conditional)Data Elements for all FDA Commodities
Level
of Data
Entry

Record
ID
OI

Record Identifier

Line

PG01

PGA Line Number

Line

PG01

Government Agency Code

Line

PG01

Line

PG01

Government Agency Program
Code*
Government Agency Processing
Code*

Line

PG02

Item Type

Line

PG02

Line

PG02

Line

Length/
Class

Position

Field Type

5-7

incremental

3AN

8-10

code

11-13

code

3AN

14-16

code

Product Code Qualifier

4AN

6-9

code

Product Code Number

19X

10-28

PG06

Source Type Code

3AN

5-7

text
code

Line

PG06

Country Code

8-9

code

Line

PG10

Product Description

57X

24-80

text

Line

PG19

Entity Role Code

3AN

5-7

code

Line

PG19

Entity Name

32X

26-57

text

Line

PG19

Entity Address 1

23X

58-80

text

Line

PG20

Entity City

21X

42-62

text

Line

PG20

Entity Country

66-67

code

Line

PG21

Individual Name

23X

8-30

text

Line

PG21

15X

31-45

text

Line

PG21

Telephone Number of the
Individual
Email Address for the Individual

35X

46-80

text

Line

PG26

Packaging Qualifier

code

Line

PG26

Quantity

12N

6-17

number

Line

PG26

Unit of Measure (Packaging Level)

18-22

code

Line

PG30

code

Line

PG30

Inspection/
Laboratory Testing Status
Anticipated Arrival date

6-13

date

Line

PG30

Anticipated Arrival time

14-17

time

Data Element

*Not Required for a Disclaimed entry

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

FDA Commodities and Commodity Sub-Types
Govt.
Agen
cy
Code

Commodity Type

Govt.
Agency
Program
Code

Commodity Sub-Type

Govt.
Agency
Processing
Code

FDA
FDA

Biologics
Biologics

BIO
BIO

Allergens
Blood and Blood Products

ALG
BLO

FDA
FDA
FDA
FDA
FDA
FDA

Biologics
Biologics
Biologics
Biologics
Biologics
Biologics

BIO
BIO
BIO
BIO
BIO
BIO

FDA
FDA

Biologics
Biologics

BIO
BIO

Cell & Gene Therapy
Human Cells & Tissue
Vaccines
Xenotransplant
Blood Derivatives
Licensed Devices
Blood Bag with Anti-coagulant

CGT
HCT
VAC
XEN
BDP
BLD
BBA
PVE
BRD

FDA
FDA
FDA
FDA
FDA
FDA

Biologics
Cosmetics
Medical Devices
Medical Devices
Drugs
Drugs

BIO
COS
DEV
DEV
DRU
DRU

FDA
FDA
FDA

Drugs
Drugs
Drugs

DRU
DRU
DRU

Plasma Volume Expanders
Biologics Regulated Devices (Not
subject to licensure)
All Products
Radiation Emitting Devices
Non-Radiation Emitting Devices
Investigational
Research and Development
Pharmaceutical Necessities, Containers,
Inactive Pharmaceutical Ingredients and
Excipients
Over the Counter
Prescription

FDA
FDA

Foods
Foods

FOO
FOO

FDA

Foods

FOO

FDA
FDA
FDA
FDA
FDA
FDA

Foods
Foods
Foods
Radiation Emitting Products
Tobacco
Tobacco

FDA
FDA
FDA

Tobacco
Animal Drugs and Devices
Animal Drugs and Devices

FDA Supplemental Guidance 2.4.1

RED
NED
INV
RND
PHN
OTC
PRE

Additives and Colors
Dietary Supplements
Animal Food

ADD
DSU

FOO
FOO
FOO
RAD
TOB
TOB

(includes pet food, medicated feed and
feeds)
Ceramic ware and other food contact
substances
Natural State Food
Processed Food
Non-Medical Radiation Emitting Products
Consumer Use
For Further Manufacturing

CCW
NSF
PRO
REP

TOB
VME
VME

Investigational
Animal Drugs
Animal Devices

INV
ADR
ADE

FEE

CSU
FFM

FDA Supplemental Guidance

Biologics Commodity Data Elements and Values
Biologics commodities can be broken down into the following categories using the existing Government Agency
data elements available in the PG01 message
PG01 Government
Agency Code

Commodity
Type

PG01 - Government
Agency Program
Code

Commodity SubType

PG01 - Government
Agency Processing
Code

FDA

Biologics

BIO

Allergens

ALG

FDA

Biologics

BIO

Vaccines

VAC

FDA

Biologics

BIO

Human Cells &
Tissue

HCT

FDA

Biologics

BIO

Xenotransplant

XEN

FDA

Biologics

BIO

Cell & Gene
Therapy

CGT

FDA

Biologics

BIO

Blood and Blood
Products

BLO

FDA

Biologics

BIO

Licensed Devices

BLD

FDA

Biologics

BIO

Blood Derivatives

BDP

FDA

Biologics

BIO

Blood Bag with Anticoagulant

BBA

FDA

Biologics

BIO

Plasma Volume
Expanders

PVE

FDA

Biologics

BIO

Biologics Regulated
Devices (Not subject
to licensure)

BRD

Table 1 – Biologics commodity hierarchy
The following are the potential PGA records associated with submitting Biologics data:
PG Record

Description

The commercial description of the shipment is provided.

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.
The item type and Product Code detail are provided.
Product Constituent Active Ingredient
Scientific Genus Names
Product Source information is provided
Trade/Brand Name
Description of items in the lot number
Entity Role (manufacturer, consignee, shipper, etc.) Entity Identification, Entity Name, and Entity
Address 1 are provided.

PG02
PG04
PG05
PG06
PG07
PG10
PG19

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
PG Record
PG20
PG21

Description

PG23
PG24
PG25
PG26
PG27

Additional address data on the entity in PG19 is provided
The entity (manufacturer, consignee, shipper, etc.) of Record’s individual point of contact, phone
number and email is given.
FDA affirmation of Compliance criteria is provided
Remarks
Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are provided
Packaging qualifier and quantity of the shipment are provided
Additional data on Container number

PG29

Weight of lot number

PG30

Inspection location, date and time

PG55

Additional roles performed by entity or individual

PG60

Additional Information

PG00

Data Substitution

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Biologics Example
Biologic Message Set Layout for Sample
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Biologics
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier OI (Record Identifier)
This is a mandatory PGA line item description input record that provides the description of the item. This record
precedes the Record Identifiers for the PGA Message set.
Record Identifier OI (Record Identifier)
Data Element

Length/
Class

Position

Status

Description

Control Identifier

1-2

Must be “OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product. This
can be the importer’s product description used in
ACS currently. For example, BLOOD
DERIVATIVES

FDA Supplemental Guidance 2.4.1

Note

FDA Supplemental Guidance

Record Identifier PG01 (Record Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government Agency
Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use Code,
Intended Use Description, and Disclaimer.
Record Identifier PG01 (Record Identifier)
Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government Agency
Code
Government Agency
Program Code

3AN

8-10

11-13

Government Agency
Processing Code

3AN

Intended Use Code

16X

42-57

Intended Use
Description
Correction Indicator

21X

58-78

Disclaimer

Data Element

14-16

Description/Required Value

Note

“FDA”
“BIO”

1, 2

Allowed values for Biologics sub-types:
ALG, VAC, HCT, XEN, CGT, BLO, BLD,
BDP, BBA, PVE and BRD.
Refer to the table below for valid values
Refer to the table below for valid values

1, 2
3, 4
3, 4

For future Use
A code of A (= product is not regulated by
this agency) indicating there is no agency
declaration requirement. Or this field is
left blank for no disclaimer. No other code
is accepted

Note 1
See Table 1 above for the commodity hierarchy for Biologic commodities
Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. Otherwise the Government
Agency Program Code and Government Agency Processing Code are mandatory.
Note 3
If the Disclaimer is ‘A’ then these data elements are optional; otherwise the Intended Use Code is required.

Note 4:
CBER Regulated Products
Import Scenario
CBER-regulated
Final
Product
(includes licensed biological products,
drugs or devices) ; ready for use

FDA Supplemental Guidance 2.4.1

Intended Use Code
080.000

CBP Intended Use Name
For Human Medical Use as a NonFood Product under Controlled
Distribution

FDA Supplemental Guidance
CBER Regulated Products
Intended Use Code
Import Scenario
082.000
Human Cells, tissues, and cellular and
tissue based products (HCT/Ps) for implant,
transplant, infusion, or transfer into a human
recipient
081.000
CBER-regulated product- for processing into
a medical device
970.000
CBER-Import for Export (IFE) under
the import for export provisions 801(d)
(3), & 801(d) (4) of the FD&C Act.
CBER Product Sample for testing or lot
release

180.016

Bulk Drug Substance or CBER product for
processing into a
pharmaceutical product.
CBER product For further manufacture of a
licensed biological product under a short
supply agreement (21 CFR 601.22)*

150.007

155.000

Importation for Personal Use

100.000

Standard import of a biological drug or
device for non-commercial distribution in
government and non-government
organization support program
Import of a biological or chemical for
research and development into a
pharmaceutical product
Import of a biological or chemical for
research and development into a medical
device
Import of biologic for nonclinical research use only, bench testing,
etc.. These entries could be disclaimed if
the HTS code allows it.

140.000

Import of biological drug or device for trade
show
import of a biological product, drug or device
that is US goods returned (to manufacturer)
Importation of a drug (including a biological
product) or device for compassionate
use/emergency use

110.000

FDA Supplemental Guidance 2.4.1

180.009

180.010

180.000

170.000
940.000

CBP Intended Use Name
For Immediate use by authorized
medical officials in the medical
treatment of humans
For processing into a medical
device
Import for Export

For processing samples
submitted to CBER for lot release
testing.
For commercial processing as a
Non Food product; for processing
into a pharmaceutical product.
For processing into a
pharmaceutical product
For private non-commercial use
under the FDA personal
importation policy (PIP)
For improving living conditions
during a natural disaster.
For Research and Development
of a pharmaceutical product
including investigational products
For Research and Development
of a medical device including
investigational products
For Research and Development
as a Non-Food Product

For Public Exhibition or Display
as a Non-Food Product
For reconditioning or repair of a
Non-Food Product
Import of a Compassionate
Use/Emergency Use Device

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
This mandatory PGA input record is used to indicate whether or not the information being provided relates to a
product (P) or a component (C) of a product.

Record Identifier PG02 (Product Identifier)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to the product.
Enter P for product. No other values are allowed.
Only one ‘P’ record is allowed for the same PGA
Line # in PG01.

Product Code
Qualifier
Product Code
Number

4AN

6-9

“FDP” (FDA Product)

19X

10-28

FDA Product Code Must be equal 7 characters

Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For FDA, this is currently always ‘FDP’ for all FDA products.
Only one FDA Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“04”.

Constituent Active
Ingredient Qualifier
Name of the Constituent
Element
Quantity of Constituent
Element
Unit of Measure
(Constituent Element)
Percent of Constituent
Element

Active ingredient = “Y” if yes, blank if
no.

51X

6-56

12N

57-68

5AN

69-73

74-80

1
2 decimal places are implied

4 decimal places are implied. 18.2%
is entered as 0182000.

Note 2
Examples of Percentages:
=
=
=
=
=
=
=

100%
99%
9%
.9%
.09%
.009%
.0009%

FDA Supplemental Guidance 2.4.1

1
1

Note 1
Some of the Biologics products may not have a defined active ingredient. Even when an active ingredient is
known, it may be in a descriptive form. For example, the multiple active ingredients in the MMR Vaccine are
expressed in detail in the Prescribing information.

1000000
0990000
0090000
0009000
0000900
0000090
0000009

1, 2

FDA Supplemental Guidance

Record Identifier PG05 (Scientific Genus Names)
This is an optional PGA input record that provides data pertaining to Scientific Genus Names, Scientific Species,
Scientific Sub Species Name, Scientific Species Code, and FWS Description Code for the product identified by
Product Code Number in PG02.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when
they are under a PG02) at this time.
Record Identifier PG05 (Scientific Genus Names)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“05”.

Scientific Genus
Name
Scientific Species
Name
Scientific Sub
Species Name

22X

5-26

22X

27-48

18X

49-66

Scientific Genus Name of the merchandise
being entered.
Scientific Species Name of the merchandise
being entered.
Scientific Sub Species Name of the
merchandise being entered.

FDA Supplemental Guidance 2.4.1

Description

Note

1
1
1

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is a mandatory PGA input record that provides data pertaining to Source Type (Origin) - other than the CBP
Country of Origin - for the product identified by Product Code Number in PG02 in addition to Processing dates,
Processing Type and Processing Description.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they
are under a PG02) at this time.
For the Lacey Act, the filer must submit a corresponding genus/species (PG05/PG06) for each Country of Harvest.
Record Identifier PG06 (Product Origin)
Data Element
Control Identifier
Record Type
Source Type
Code

Country Code

Note

Length/
Class

Position

Status

1-2

“PG”.

2N
3AN

3-4
5-7

M
M

“06”.
Mandatory valid value is 39 (Country of
Production) or 30 (Country of Source).
294 (Country of Refusal) is MANDATORY if
previously refused.

8-9

Description

Note

There would be at least one PG06 with source
type code of 30 or 39. If previously refused, then
trade would also provide another PG06 with
source type code 294.
Country of production or source is required for
Biologics. Should match the country code in PG19PG20 record set for the Entity Role Code ‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.
Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
For Biologics, this is a conditional PGA input record that provides data pertaining to Trade or Brand Name of the
product identified by Product Code Number in PG02.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when
they are under a PG02) at this time.
Record Identifier PG07 (Product Trade Names)
Data Element
Length Position Status
/Class
Control Identifier
2A
1-2
M
Record Type
2N
3-4
M
Trade Name/Brand
C
35X
5-39
Name

Note

Description

Note

“PG”.
“07”.
The make of the product (or component) by
manufacturer or distributor from the label or
invoice. If Trade/Brand Name requires
additional space, continue in a PG60 record
with Qualifier Code ‘TBN’.

If a product is licensed, Trade Name or Proper Name is mandatory. Vaccines (VAC), Blood Derivatives (BDP) and
Licensed Devices (BLD) are required to include Trade/Brand Name if it exists. If no Trade Name is available then
its Proper Name should be provided.
Per 21CFR600.3 (k), Proper name is defined as the name designated in the product license, for use upon each
package of the product.
Most Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) do not have a trade name or
proper name but only have product description (PG01 - Government Agency Processing Code =HCT).

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
For Biologics this is a mandatory PGA input record that allows for importer to report the description of the product
identified by Product Code Number in PG02 at the line level to capture the information currently collected in
multiple OI records. This record can be repeated if there are more Commodity Characteristic Descriptions.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when
they are under a PG02) at this time.
Record Identifier PG10 (Product Characteristics)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Include proper name (if applicable) OR
invoice description here - NOT product code
description.
See Appendix A for the use of PG10 to
capture the information currently collected in
multiple OI records.

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Biologics, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role and
conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element

Length
/Class

Position

Status

1-2

“PG”

Control Identifier
Record Type

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example, IM.
Code identifying the Entity Identification is
entered. For example: 16, 47. Mandatory, if
Entity Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘ENA’. See
validation criteria below.
The address of the entity is required. If Entity
Address1 requires additional space, continue
in a PG60 record with Qualifier Code ‘AD1’.
See validation criteria below.

1
2
2
2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes mandatory to FDA Biologics Message Sets is below. One of
each of these is mandatory for EACH LINE:
Data Element
Entity Role Codes§

Code
MF
DEQ
FD1
DP

Description
Manufacturer of goods
Shipper
FDA Importer (Importer of Record)
Delivered To Party

Same Role Code cannot be entered more than once.

List of Entity Role codes also applicable to FDA Biologics Message Sets is below:
Data Element
Entity Role Codes

Code
PK

Description
Point of Contact

Note 2

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
Entity Identification Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Identification
Codes) of the ACE ABI CATAIR publication. List of Entity Identification codes applicable to FDA Biologics
Message Sets is below:
Data Element
Entity Identification
Codes

Code
16
47

Description

Length/
Class

D&B-assigned (DUNS number); must be 9 digits
FDA-assigned (FEI number); must be from 4 to 10 digits

9N
4-10N

FDA ENTITY IDENTIFICATION CODE AND ENTITY NUMBER SELECTION AND VALIDATION CRITERIA
FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use FEI numbers for identifying the
Entity; IF FEI is not available THEN may provide DUNS.
Entity Name <>NULL AND Entity Address 1 <>NULL AND
IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length = from 4 to 10 and Type = N
ELSE IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
This is a mandatory PGA input record that provides additional data pertaining to Entity identification such as Entity
Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This record is used when additional address
information for the entity needs to be entered.
Record Identifier PG20 (Entity Address)
Data Element
Control Identifier

Length
/Class

Position

Status

1-2

“PG”.

Description

Note

Record Type

3-4

“20”.

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite
Number
Entity City

37-41

Address Line 2 for the Entity. If Entity Address2
requires additional space, continue in a PG60
record with Qualifier Code ‘AD2’.
Apartment/Suite number of the entity.

21X

42-62

3AN

63-65

66-67

68-76

City of the entity. If Entity City requires
additional space, continue in a PG60 record
with Qualifier Code ‘ECI’.
State/Province of the entity. See Appendix B in
the ACS ABI CATAIR for valid codes.
ISO Country Code. See Appendix B in the ACS
ABI CATAIR for valid codes.
Zip/Postal Code of the entity.

77-80

Space fill

Entity
State/Province
Entity Country
Entity Zip/Postal
Code
Filler

Note 1: If the Entity requires more than 2 address lines, use the optional PG60 records with Qualifier Codes
‘AD3’, ‘AD4’ and ‘AD5’ immediately under the PG20 record for the same Entity.
Note 2: Populated if US or Canada based entities

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG21 (Point of Contact)
This is a mandatory PGA input record that provides data about an Individual and may also be related to an entity
(the party) in the preceding PG19 record. Included in this record are the Individual Name, Telephone Number
and Email address. If multiple Individuals related to a single entity are required by an agency, this record can be
repeated and should follow each entity designated in the PG19 record. A typical example is a POC for the Filer.
At least one PG21 record is required.
Record Identifier PG21 (Point of Contact)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“21”.

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Telephone Number
of the Individual

15X

31-45

Email Address for
the Individual

35X

46-80

Identify the type of party or facility the
Individual represents. For example, person is
associated to the grower, producer, I-house
or filer, etc. For valid codes, use the Entity
Role Codes from PG19 (See Appendix PGA
of this publication.)
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’. .
Telephone number of the Individual.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore
Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
For Biologics, it is a conditional PGA input record that provides data pertaining to Food and Drug Administration
Affirmation of Compliance Criteria. This record is typically only used by FDA. This record is repeatable.
Record Identifier PG23 (Affirmation of Compliance)
Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

30AN

10-39

A code used to affirm compliance with
FDA requirements. See Appendix PGA
(Food & Drug Affirmation of
Compliance Codes) of this publication
for valid codes.
Text describing the information required
by the FDA. This could include a
number or a country code, etc. Also,
see Appendix PGA (Food & Drug
Affirmation of Compliance Qualifier
Codes) of this publication for valid
codes related to certain specific
Affirmation of Compliance codes.
Space fill

Data Element

Affirmation of
Compliance
Qualifier

Filler

Description

Note

Note 1
Below is the list of Affirmation of Compliance codes for FDA-Biologics Message Sets, followed by the scenarios
when the AofCs are provided:
Data
Element

Syntax

Code

Description

Biologics New Drug Application Number or Abbreviated
New Drug Application Number (NDA or ANDA)

PM#

Biologics Pre-Market Approval Number
(This includes PMA and PMN)

HRN

Biologics Human Cells, Tissues/ Cellular and TissueBased Product Establishment Registration Number
(HCT/P Registration Numbers)

10N

IND
IDE
HCT
BLN

Biologics Investigation New Drug Application Number
Biologics Investigational Device Exemption
Human Cells & Tissue
Biologics License Number

4-6N
4-5N
Indicator only
4N

FDA Supplemental Guidance 2.4.1

BA+4-6N or
BN + 5-6 N
or 6N
Any of the following:
BP + 4-6N; BK +
6N;
BH+6N; BR+6N;
DK+6N; P+6N;
D+6N; K+6N
DEN+6N; BM+6N;
BD+6N

FDA Supplemental Guidance
Data
Element

Syntax

Code

Description

STN
CPT
IFE
REG

Biologics Submission Tracking Number
Component Identifier
Import For Export
Drug Registration Number

DEV
LST

Device Foreign Manufacturer Registration Number
Device Listing Number

DLS

Drug Listing Number

6N
indicator only
4-10N
1-10N
A+6N; B+6N; C+6N;
D+6N; E+6N; L+6N;
Q+6N; R+6N
10N

Scenario based use of the above AoC codes
#

Government
Agency
Processing
codes for
BIO
ALG, BBA,
BDP, CGT,
PVE, VAC, or
XEN

CBER Regulated Products
Import Scenario

Intended
Use
Codes

CBP Intended
Use Name

Mandatory/
Conditional

Optional

Import of a biological or chemical
for research and development
into a pharmaceutical product

180.009

IND

REG

ALG, BDP,
BLD, BLO,
CGT, VAC, or
XEN

080.000

BLN and/or
STN

REG,
DLS

BBA, PVE

CBER-regulated Final product;
ready for use.
Importation of a licensed
biological product. The Biologics
License number (BLN) is the
U.S. License Number. The
Submission Tracking Number
(STN) is associated with the
manufacturer and a specific
product and the first six digits
represent the original submission
tracking number.
CBER-regulated Final product;
ready for use.
Importation of drug regulated by
CBER.

For Research
and
Development of
a
pharmaceutical
product
For Human
Medical Use as
a Non-Food
Product under
Controlled
Distribution

DA, REG,
(DA includes
NDA and
ANDAs
only)

DLS

BRD

CBER-regulated Final product;
ready for use.
Importation of a device regulated
by CBER.

FDA Supplemental Guidance 2.4.1

080.000

For Human
Medical Use as
a Non-Food
Product under
Controlled
Distribution
For Human
Medical Use as
a Non-Food
Product under
Controlled
Distribution

PM#, DEV,
LST
(PM#
includes
PMA and
PMN)

FDA Supplemental Guidance
#

Government
Agency
Processing
codes for
BIO
BRD

CBER Regulated Products
Import Scenario

Intended
Use
Codes

CBP Intended
Use Name

Mandatory/
Conditional

CBER-regulated product- for
processing into a medical device

081.000

For processing
into a medical
device

For Research
and
Development of
a medical device
For Immediate
use by
authorized
medical officials
in the medical
treatment of
humans

PM#, DEV,
LST, CPT
(PM#
includes
PMA and
PMN)
IDE

BRD

Import of a biological or chemical
for research and development
into a medical device

180.010

HCT

082.000

HCT

ALG, BDP,
BLD, BLO,
CGT, VAC, or
XEN

Human Cells, tissues, and
cellular and tissue based
products (HCT/Ps) for implant,
transplant, infusion, or transfer
into a human recipient.
The HCT affirmation should be
used to indicate the HCT/Ps
being importer or offered for
import are in compliance with all
applicable requirements of 21
CFR 1271.
Human Cells, tissues, and
cellular and tissue based
products (HCT/Ps) for implant,
transplant, infusion, or transfer
into a human recipient. The HRN
Affirmation should be used for
Importation of human cells,
tissues and cellular and tissuebased product where the
establishment is registered with
the FDA.
CBER Product sample for testing
or lot release

ALG, BLO,
BLD, BDP,
BBA, VAC,
XEN, CGT, or
PVE.

CBER product For further
manufacture of a licensed
biological product under a short
supply agreement (21 CFR
601.22)*

155.000

ALG, BBA,
BDP, BLD,
BLO, BRD,
CGT, PVE,
VAC, or XEN

Importation for personal use

100.000

FDA Supplemental Guidance 2.4.1

Optional

DEV,
LST
CPT

HCT
(No Qualifier
Needed for
HCT)

082.000

For Immediate
use by
authorized
medical officials
in the medical
treatment of
humans

HRN

HCT

180.016

For processing
samples
submitted to
CBER for lot
release testing.
For processing
into a
pharmaceutical
product

BLN and/or
STN

REG,
DLS

BLN and/or
STN

REG,
DLS

For private noncommercial use
under the FDA
Personal
importation
policy (PIP)

FDA Supplemental Guidance
#

Government
Agency
Processing
codes for
BIO
ALG, BBA,
BDP, BLD,
BLO, CGT,
PVE, VAC, or
XEN

CBER Regulated Products
Import Scenario

Intended
Use
Codes

CBP Intended
Use Name

Mandatory/
Conditional

Optional

Bulk drug substance for
processing into a pharmaceutical
product

150.007

For commercial
processing as a
non- food
product; for
processing into
a
pharmaceutical
product.

BLN and/or
STN

IND,
REG,
DLS

ALG, BBA,
BRD, BDP,
BLD, BLO,
CGT, PVE,
VAC, or XEN

Standard import of a biological
drug of device for noncommercial distribution in
government and nongovernment support program.

140.000*

For improving
living conditions
during a natural
disaster.

BLN,
STN,
PM#, DA,
IND, IDE

ALG, BBA,
BRD, BDP,
BLD, BLO,
CGT, PVE,
VAC, or XEN

Import of a biological drug or
device for trade show

110.000*

For public
exhibition or
display as a
non-food
product.

BLN,
STN,
PM#, DA,
IND, IDE,

ALG, BBA,
BRD, BDP,
BLD, BLO,
CGT, HCT,
PVE, VAC, or
XEN

Import of a biological product,
drug, or device that is US Goods
Returned (to manufacturer)

170.000*

For
reconditioning or
repair of a nonfood product.

BLN,
STN,
PM#, DA,
IND, IDE,
HCT,
HRN,

ALG, BBA,
BRD, BDP,
BLD, BLO,
CGT, PVE,
VAC, or XEN

Importation of non-compliant
articles (including blood, blood
components, Source plasma and
source leukocytes) under the
import for export provisions
801(d) (3), & 801(d) (4) of the
FD&C Act.
Import of a biologic for nonclinical research use only, bench
testing, etc. These entries could
be disclaimed if the HTS code
allows it.

970.000*

Import for Export

IFE
(No qualifier
required)

180.000
BLO, ALG,
For Research
BBA, BRD,
and
BDP, BLD,
Development as
CGT,
a Non-food
product.
HCT, PVE,
VAC, or XEN
Importation of a drug (including a 940.000* Compassionate
18 ALG, BLO,
biological product) or device for
CGT, HCT,
Use/Emergency
VAC, XEN,
compassionate use/emergency
Device
BDP, BLD,
use
BBA, PVE,
BRD
*Annotates that additional information may be needed at time of entry in order for FDA to make a final
admissibility decision.
17
.

FDA Supplemental Guidance 2.4.1

BLN,
STN,
PM#, DA,
IND, IDE,
HCT,
HRN

FDA Supplemental Guidance
The list of AoC codes optional to FDA Biologics Message Sets is below:
Data
Element

Syntax

Business Rules

Entry Review Requested

indicator only

FTZ Admission Number

ERR is just used as an indicator,
no data will follow
A maximum of 7 characters.
Note: May be used when the
E214 is deployed automating the
existing FTZ processes.

Code

Description

ERR
FTZ

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG24 (Remarks)
This is an optional PGA input record that provides data pertaining to Remarks Codes, and Text of Remarks.
Remark Type Code should be GEN.
If GEN, the PG24 is applicable to the preceding PG02. Only one GEN:PG24 is allowed per PG02 (this is to avoid
multiple GEN:PG24 records without a guaranteed sequencing as intended by the filer). This may be expanded in
future with sufficient sequencing control to receive multiple GEN:PG24 records in the same order in which the
Filer entered remarks.

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

A code indicating the type of remarks.
Valid codes are listed in Appendix PGA
(Remarks Type Code) of this publication.
FDA uses GEN as its valid value.
Free form text relevant to the shipment or
the commodity.

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
For Biologics, it is a conditional PGA input record that provides data pertaining to: Temperature Qualifier, Degree
Type, Actual Temperature, Lot Number, Production, Date, Range of the Lot, PGA Line Value, and PGA Unit Value.
This record is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value MUST be included
on the first PG25 record. There must be at least one PG25 record for each FDA line.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature Qualifier

Temperature Category being reported for
quality control or preservation purposes.

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording

Lot Number Qualifier

1AN

Lot Number

25X

16-40

Production Start date
of the Lot

41-48

Production End Date
of the Lot

49-56

PGA Line Value

12N

57-68

FDA Supplemental Guidance 2.4.1

A= Ambient, F=Frozen
R=Refrigerated/Chilled, D=Dry Ice
H=Fresh, U=Uncontrolled
P=Flashpoint
F = Fahrenheit, C = Celsius , K = Kelvin
If the actual temperature is in the negative
numbers use an “X”.
Reported temperature. Two decimals
places are implied.
Identifies recorded temperature is for
A = product
B = container
C = conveyance
Code of the entity that assigned the Lot
number. For Biologics the only valid value
is: 1 = Manufacturer
Should not be entered if more than one
PG25 record is entered
The lot number that the manufacturer/
producer/grower assigned to the product.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format.
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
The value associated with the PGA line
number in whole dollars. Must be entered in
the first PG25 record in the case of multiple
PG25 records. When entered, it must be
right-justified with preceding zeros and
must be greater than zero.

FDA Supplemental Guidance
PGA Unit Value

12N

69-80

The value of the lowest unit of measure
reported in PG26. Two decimal places are
implied.

Note 1
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
For Biologics, this is a mandatory PGA Record that provides data pertaining to Packaging Qualifier, Quantity and
Unit of Measure. This record can be repeated up to six times per unique package size. The first record is used to
describe the largest container (outermost container) and the number of containers. The second record is used to
describe the contents of the next smallest container. If needed, records 2-6 are used in a similar manner (largest
to smallest container). The last quantity record used must describe the actual amount of the product in the
smallest container.
When reporting a different package size of the same product, repeat this record using the method described
above.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.
Record Identifier PG26 (Packaging Data)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“26”.

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging for
the product. Outermost (largest=1) packages to
the innermost (smallest=6) packages. There
can be up to 6 levels of packaging. If reporting
only one level, show the total quantity for the
item and report that as level 1.
The total quantity for the packaging level. Must
be greater than zero. Two decimal places are
implied. The base quantity must always be the
last quantity transmitted.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among the
PG26 records.

Unit of Measure
(Packaging Level)

1,4

2,4

3,4

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging.
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Biologics Message Sets
For a full list of applicable Unit of Measure codes, please refer to the Appendix D in this document or to Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Below are FDA valid units of measure for Biologics:

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Code
AE
AM
AP
AT
BA
BC
BO
BQ
BS
BV
BX
CA
CG
CI
CON
CS
CT
CX
CY
DR
EN
FD
FOZ
G
GAL
GB
KG
L
LB
MB
MG
ML
NO
OZ
PAL
PCS
PK
PTL
QTL

Code Name
Aerosol
Ampoule, Nonprotected
Ampoule, Protected
Atomizer
Barrel
Bottle crate, Bottle rack
Bottle, Non-Protected, Cyl
Bottle, Protected, Cylindrical
Bottle, Nonprotected, Bulbous
Bottle, Protected Bulbous
Box
Can, Rectangular
Centigrams (Weight)
Canister
Container
Case
Carton
Can, Cylindrical
Cylinder
Drum
Envelope
Framed Crate
Ounces, fluid (Volume)
Grams (Weight)
Gallons (US) (Volume)
Gas Bottle
Kilograms (Weight)
Liters (Volume)
Pounds (avdp) (Weight)
Bag, Multi-ply
Milligrams (Weight)
Milliliters (Volume)
Number (Count)
Ounces, weight (avdp) (Weight)
Pallet
Pieces (Count)
Package
Pints, liquid (US) (Volume)
Quarts, liquid (US) (Volume)

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
SY
VI
TU

Syringe
Vial
Tube

Note 4
Quantity Data provides additional information to FDA about the product and how it is packaged. The basic format
for Quantity Data is in multiple pairs of data – quantity and unit of measure, i.e., 500 cases, 12 ounces, fluid, 1000
cartons, etc. Up to 6 data pairs may be submitted, beginning with the 1st pair for the outermost packaging when
Packaging Qualifier = 1. The first pairs may describe the largest container and the last pair must describe the
amount of product in the smallest container.
For example: Blood Derivatives: 25 boxes, 8 bottles/box, 1pint each bottle:
Units 1-Quantity= 25
Units 1-Measure =BX
Units 2-Quantity=8
Units 2-Measure=BO
Units 3-Quantity=1
Units 3-Measure=PTL

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG27 (Container Information)
This is an optional PGA input record that provides data pertaining to issued Container Number. The Number of the
shipping container is included in the Bill of Lading. Hence this record is not needed. This record may be repeated.
Record Identifier PG27 (Container Information)
Data Element
Control Identifier
Record Type
Container Number
(Equipment ID)
Container Number
(Equipment ID)
Container Number
(Equipment ID)
Filler

Length
/Class

Position

Status

1-2

“PG”.

Description

Note

3-4

“27”.

20AN

5-24

20AN

28-47

20AN

51-70

74-80

The number of the shipping container as
entered in the Bill of Lading.
The number of the shipping container as
entered in the Bill of Lading.
The number of the shipping container as
entered in the Bill of Lading.
Space fill

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is an optional PGA input record that provides data pertaining to the net or gross unit of measure of the
commodity. This can be provided at the overall PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length Position
/Class
Control Identifier
2A
1-2
Record Type
2N
3-4
3AN
Unit of Measure
5-7
(PGA line - net)

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix C in the
ACS ABI CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net Quantity
(PGA line - net)” is required when “Unit of
Measure (PGA line - net)” is reported in
positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line - gross)”
and is required when “Commodity Gross
Quantity (PGA line - gross)” is reported. Valid
Unit of Measure codes are listed in Appendix D
in this document or in Appendix C in the ACS
ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA line
- gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length Position
/Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Pertaining to the Individual unit (net), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - net)” in this position is
associated with “Commodity Net Quantity
(Individual unit - net)” and is required when
“Commodity Net Quantity (Individual unit - net)”
is reported. Valid Unit of Measure codes are
listed in Appendix D in this document or in
Appendix C in the ACS ABI CATAIR.
Pertaining to the Individual unit, excluding all
packing and packaging. Two decimals are
implied. “Commodity Net Quantity (Individual
unit - net)” is required when “Unit of Measure
(Individual unit - net)” is reported in positions
35-37 of this record.
Pertaining to the Individual unit (gross), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - gross)” in this position is
associated with “Commodity Gross Quantity
(Individual unit - gross)” and is required when
“Commodity Gross Quantity (Individual unit gross)” is reported. Valid Unit of Measure
codes are listed in Appendix D in this document
or in Appendix C in the ACS ABI CATAIR.
Pertaining to the Individual unit, including any
packaging, but excluding weight of the carrier's
equipment. Two decimals are implied.
“Commodity Gross Quantity (Individual unit gross)” is required when “Unit of Measure
(Individual unit - gross)” is reported in positions
50-52 of this record.
Space fill

Record not supported
by FDA at this time

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry)
This is a mandatory PGA input record that provides data pertaining to the date, time and location of the
anticipated arrival/entry information for all FDA products. While other PGAs may use PG30 to Collect Inspection
and Lab information, currently FDA will utilize this record to collect Anticipated Arrival/Entry Information at this
time.
For each line a PG30 record with an "A" (Anticipated arrival information) status code, date and time of arrival is
Mandatory.
Record Identifier PG30 (Port of Arrival / Entry Information)
Data Element

Length/
Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival/
Entry date
Anticipated Arrival/
Entry time

Note

1
A = Anticipated arrival information

6-13

14-17

Arrival / Entry
Location Code

4AN

18-21

Port of Arrival /
Entry
Filler

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes
) is allowed.
For valid port codes, refer to note 1.

72-80

Space fill

1
1

Note 1:
For PN shipments, A = Anticipated Arrival Date and Time at the Port of Arrival.
For Non-PN shipments, A= Anticipated Arrival Date and Time at the Port of Entry.
Port of Arrival:
21 CFR 1.276 (b)
(11) Port of arrival means the water, air, or land port at which the article of food is imported or offered for import into the United States. For an
article of food arriving by water or air, this is the port of unloading. For an article of food arriving by land, this is the port where the article of
food first crosses the border into the United States. The port of arrival may be different than the port where consumption or warehouse entry or
foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).

Port of Entry:
19 CFR 101.1.
Port and port of entry. The terms “port” and “port of entry” refer to any place designated by Executive Order of the President, by order of the
Secretary of the Treasury, or by Act of Congress, at which a Customs officer is authorized to accept entries of merchandise to collect duties,
and to enforce the various provisions of the Customs and navigation laws. The terms “port” and “port of entry” incorporate the geographical
area under the jurisdiction of a port director. (The Customs ports in the Virgin Islands, although under the jurisdiction of the Secretary of the
Treasury, have their own Customs laws (48 U.S.C. 1406(i)). These ports, therefore, are outside the Customs territory of the United States and
the ports thereof are not “ports of entry” within the meaning of these regulations).

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Length
/Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
8X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
72-80

O
O
O
O
O
O
O
O
O
O
M

Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Additional role of the entity.
Space fill

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG60 (Additional Information)
This is an optional PGA input record used to provide additional information about data in the PG record that
precedes it during the submission of a PGA record set.
This record can follow a PG07, PG19, PG20 or PG21 record, and can only be used to provide the additional
information noted by the Additional Information Qualifier Code list.
This record may be repeated.

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

Entity Name for PG19
Entity address Line 1 for PG19
Entity address Line 2 for PG20
Entity address Line 3 for PG20
Entity address Line 4 for PG20
Entity address Line 5 for PG20
Entity City for PG20
Individual Name for PG21
Email Address for PG21
Trade/Brand Name for PG07

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG00 (Data Substitution)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of
where to place the substitute data within
the PGA Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the
substitution group indicated by the
Substitution Number
Sequential number assigned to, or
referring to, a specific substitution group
of data provided at the header level.
This data element is mandatory when
using the S or R substitution indicator.
Space fills.

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Cosmetics Commodity Data Elements and Values
Cosmetic commodities can be broken down into the following categories using the existing Government Agency
data elements available in the PG01 message
PG01 Government
Agency Code

Commodity
Type

PG01 - Government
Agency Program
Code

Commodity SubType

PG01 - Government
Agency Processing Code

FDA

Cosmetics

COS

None

Table 2 – Cosmetics commodity hierarchy
The following are the potential PGA records associated with submitting Cosmetics:
PG Record

Description

The commercial description of the shipment is provided.

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.

PG02

The item type and Product Code detail are provided.

PG06

Source Type(origin) other than the CBP country of origin is provided

PG07

The Trade/Brand Name, Model and Year of Manufacture are provided

PG10

Description of items in the lot number

PG19

The entity (manufacturer, consignee, shipper, etc.) of Record’s identification information is
provided.

PG20

Additional address data on the entity in PG19 is provided

PG21

The entity (manufacturer, consignee, shipper, etc.) of Record’s individual point of contact,
phone number and email is given.

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are
provided

PG26

Packaging qualifier and quantity of the shipment are provided

PG27

Additional data on Container number

PG29

Weight of lot number

PG30

Inspection location, date and time

PG55

Additional roles performed by entity or individual

PG60

Additional Information

PG00

Data Substitution

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Cosmetics Example
Cosmetics Message Set Layout for Sample
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Cosmetics
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Length
/Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product. For
example, FINE EYELINER

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government
Agency Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use
Code, Intended Use Description, and Disclaimer.
Record Identifier PG01 (PGA Identifier)
Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government
Agency Code
Government
Agency Program
Code
Government
Agency Processing
Code
Intended Use Code

3AN

8-10

11-13

Data Element

Description/Required Value

Note

“FDA”
“COS”

16AN

14-16

1, 2

1, 2
No Processing Code applies for Cosmetics.

16X

42-57

Intended Use
Description
Correction Indicator

21X

58-78

Disclaimer

For future Use
A code of A (= product is not regulated by
this agency) indicating there is no agency
declaration requirement. Or this field is left
blank for no disclaimer. No other code is
accepted

Note 1
See Table 2 above for the commodity hierarchy for Cosmetic commodity.

Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. Otherwise, the Government
Agency Program Code is mandatory.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
This mandatory PGA input record is used to indicate whether or not the information being provided relates to a
product (P) or a component (C) of a product.
Record Identifier PG02 (Product Identifier)
Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.

Data Element

Description

Note

Only one ‘P’ record is allowed for the
same PGA Line # in PG01.
Product Code
Qualifier
Product Code
Number

4AN

6-9

“FDP”

19X

10-28

FDA Product Code Must be equal to 7
characters

Note 1
Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For FDA, this is currently always ‘FDP’ for all FDA products.
Only one FDA Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is a mandatory PGA input record that provides data pertaining to Source Type (Origin) other than the CBP
Country of Origin, in addition to Processing dates, Processing Type and Processing Description.
Record Identifier PG06 (Product Origin)
Data Element
Control Identifier
Record Type
Source Type Code

Country Code

Note

Length/
Class

Position

Status

Description

Note

1-2

“PG”.

2N
3AN

3-4
5-7

M
M

“06”.
Mandatory valid value is 39 (Country
of Production). 294 (Country of
Refusal) if previously refused.

8-9

Country of production or source is
required for Cosmetics. Should
match the country code in PG19PG20 record set for the Entity Role
Code ‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.
Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is an optional PGA input record that provides data pertaining to Trade or Brand Name, Model, Manufacture
Year, Item Identity Number Qualifier and Item Identity Numbers.
Record Identifier PG07 (Product Trade Names)
Data Element
Control Identifier

Length/
Class

Position

Status

1-2

“PG”

Description

Note

Record Type

3-4

“07”

Trade Name/Brand
Name

35X

5-39

Trade or Brand name of the Cosmetic product
is entered. If Trade/Brand Name requires
additional space, continue in a PG60 record
with Qualifier Code ‘TBN’.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
This is a mandatory PGA input record that allows for reporting codes that provide additional characteristics of a
product or component, not reported elsewhere in the PG Message Set. For example, this record can be used to
provide the model year of an automobile, which can be different from the year of manufacture provided in the
PG07. This record can be repeated if there are more qualifiers or categories.
Record Identifier PG10 (Product Characteristics)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Free form description (invoice description NOT
product code description) of the item. See
Appendix A for the use of PG10 to capture the
information currently collected in multiple OI
records.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Cosmetics, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role and
conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element

Length
/Class

Position

Status

1-2

“PG”

Control Identifier
Record Type

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example: MF, UC
Code identifying the Entity Identification is
entered. For example: 16, 47. Mandatory, if
Entity Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘ENA’. See
validation criteria below.
Must be entered. If Entity Address1 requires
additional space, continue in a PG60 record
with Qualifier Code ‘AD1’. See validation criteria
below.

1, 3
2
2
2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes mandatory to FDA Cosmetics Message Sets is below:
Data Element
Entity Role Codes§

Code
MF
DEQ
FD1
DP

Description
Manufacturer of goods
Shipper
FDA Importer (Importer of Record)
Delivered To Party

Same Role Code cannot be entered more than once.

List of Entity Role codes also applicable to FDA Cosmetics Message Sets is below:
Data Element
Entity Role Codes

Code
PK

Description
Point of Contact

Note 2

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
Entity Identification Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Identification
Codes) of the ACE ABI CATAIR publication. List of Entity Identification codes applicable to FDA Drug Message
Sets is below:
Data Element
Entity Identification
Codes

Code
16
47

Description
D&B-assigned (DUNS number)
FDA-assigned

Length/
Class
9N
4-10N

FDA ENTITY IDENTIFICATION CODE AND ENTITY NUMBER SELECTION AND VALIDATION CRITERIA
FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the
Entity; IF DUNS is not available THEN FEI.
Entity Name <>NULL AND Entity Address 1 <>NULL AND
IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N
ELSE IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to 10 and Type = N
.
.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
This is a mandatory PGA input record that provides additional data pertaining to Entity identification such as Entity
Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This record is used when additional address
for the entity needs to be entered.
Record Identifier PG20 (Entity Address)
Data Element
Control Identifier

Length
/Class

Position

Status

Description

1-2

“PG”.

Note

Record Type

3-4

“20”.

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite
Number
Entity City

37-41

Address Line 2 for the Entity. If Entity Address2
requires additional space, continue in a PG60
record with Qualifier Code ‘AD2’.
Apartment/Suite number of the entity.

21X

42-62

3AN

63-65

66-67

68-76

77-80

Space fill

Entity
State/Province
Entity Country
Entity Zip/Postal
Code
Filler

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG21 (Point of Contact)
This is a mandatory PGA input record that provides data about an Individual and may also be related to an entity
(the party) in the preceding PG19 or record. Included in this record are the Individual Name, Telephone Number
and Email address. If multiple Individuals related to a single entity are required by an agency, this record can be
repeated and should follow each entity designated in the PG19 record. A typical example is a POC for the Filer.
At least one PG21 record is required.
Record Identifier PG21 (Point of Contact)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“21”.

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Telephone Number
of the Individual

15X

31-45

Email Address for
the Individual

35X

46-80

Identify the type of party or facility the
Individual represents. For example, person is
associated to the grower, producer, I-house
or filer, etc. For valid codes, use the Entity
Role Codes from PG19 (See Appendix PGA
of this publication.)
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’.
Telephone number of the Individual.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore
Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
For Cosmetics, this is an optional PGA input record that provides data pertaining to Food and Drug Administration
Affirmation of Compliance Criteria. This record is repeatable.
Record Identifier PG23 (Affirmation of Compliance)
Length/
Class

Position

Status

Control Identifier

1-2

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

30AN

10-39

A code used to affirm compliance with FDA
requirements. . See Appendix PGA (Food &
Drug Affirmation of Compliance Codes) of this
publication for valid codes.
Text describing the information required by the
PGA. This could include a number or a country
code, etc. Also, see Appendix PGA (Food &
Drug Affirmation of Compliance Qualifier
Codes) of this publication for valid codes
related to certain specific Affirmation of
Compliance codes.
Space fill

Data Element

Affirmation of
Compliance
Qualifier

Filler

Description

Note

“PG”.
1

Note 1
The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication. List of
Affirmation of Compliance codes CONDITIONALLY MANDATORY (see note 1.1) to FDA-Cosmetics Message
Sets:
The list of AoC codes optional to FDA Cosmetic Message Sets is below:
Data Element

Affirmation of
Compliance Code

Description

Syntax

Business Rules

COS

Cosmetic
Registration Number

7N or 10N

ERR

Entry Review
Requested
Import For Export

indicator only

IF Government Agency Program
Code = COS THEN COS IS Optional
(voluntarily entered)
ERR is just used as an indicator, no
data will follow

Code

IFE

FDA Supplemental Guidance 2.4.1

indicator only

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
For Cosmetics, it is a conditional PGA input record that provides data pertaining to: Temperature Qualifier,
Degree Type, Actual Temperature, Lot Number, Production Date, Range of the Lot, PGA Line Value, and PGA
Unit Value. This record is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value
MUST be included on the first PG25 record. There must be at least one PG25 record for each FDA line.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording

Lot Number
Qualifier

1AN

Temperature Category being reported
for quality control or preservation
purposes.
A= Ambient, F=Frozen, D=Dry Ice,
R=Refrigerated/Chilled, H=Fresh,
U=Uncontrolled, P=Flashpoint
Optional
F = Fahrenheit, C = Celsius , K = Kelvin
Optional. If the actual temperature is in
the negative numbers use an “X”.
Optional. Required if Degree Type is
entered. Reported temperature. Two
decimals places are implied.
Optional.
Identifies recorded temperature is for
A=product, B=container and C=
conveyance
Includes Lots and/or Batches
Lot Number Qualifier = 1

Lot Number

25X

16-40

Production Start
date of the Lot

41-48

Production End
Date of the Lot

49-56

PGA Line Value

12N

57-68

FDA Supplemental Guidance 2.4.1

Should not be entered if more than one
PG25 record is entered
The lot number that the manufacturer
assigned to the product.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format.
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
The value associated with the PGA line
number in whole dollars. Must be
entered in the first PG25 record in the
case of multiple PG25 records. When
entered, it must be right-justified with
preceding zeros and be greater than
zero.

FDA Supplemental Guidance
PGA Unit Value

12N

FDA Supplemental Guidance 2.4.1

69-80

The value of the lowest unit of measure
reported in PG26. Two decimal places
are implied.

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
This is a mandatory PGA input record that provides FDA with data pertaining to Packaging Qualifier, Quantity,
Unit of Measure, Package Identifier, Packaging Method, Package Material, and Packaging Filler. This record can
be repeated up to six (6) times, once for each unique packaging level. The first record is used to describe the
largest (outermost) container and the number of containers at this packaging level. The second record is used to
describe the contents of the next smallest container. If needed, qualifiers 2-6 are used in a similar manner
(largest to smallest container). The final record must describe the actual amount of the product in the smallest
container.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.

Record Identifier PG26 (Product Packaging)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging for
the product. Outermost (largest=1) packages
to the innermost (smallest=6) packages.
There can be up to 6 levels of packaging. If
reporting only one level, show the total quantity
for the item and report that as level 1.
“Quantity of the packaging level, For example,
000000000400. Two decimal places are
implied. Must be greater than zero.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among the
PG26 records.

Unit of Measure
(Packaging Level)

Description

Note

2
3

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging.
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Cosmetics Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Valid FDA Units of Measure for Packaging Containers

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
Code
AE
AT
BA
BC
BO
BQ
BS
BV
BX
CA
CG
CI
CON
CS
CT
CX
CY
DR
EN
FD
FOZ
G
GAL
KG
L
LB
MB
MG
ML
NO
OZ
PAL
PCS
PK
PTL
QTL

Name
Aerosol
Atomizer
Barrel
Bottle crate, Bottle rack
Bottle, Nonprotected, Cylindrical
Bottle, Protected, Cylindrical
Bottle, Nonprotected, Bulbous
Bottle, Protected Bulbous
Box
Can, Rectangular
Centigrams (Weight)
Canister
Container
Case
Carton
Can, Cylindrical
Cylinder
Drum
Envelope
Framed Crate
Ounces, fluid (Volume)
Grams (Weight)
Gallons (US) (Volume)
Kilograms (Weight)
Liters (Volume)
Pounds (avdp) (Weight)
Bag, Multi-ply
Milligrams (Weight)
Milliliters (Volume)
Number (Count)
Ounces, weight (avdp) (Weight)
Pallet
Pieces (Count)
Package
Pints, liquid (US) (Volume)
Quarts, liquid (US) (Volume)

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
cartons, etc. Up to 6 data pairs may be submitted, beginning with the 1 st pair for the outermost packaging when
Packaging Qualifier = 1. The first pairs may describe the largest container and the last pair must describe the
amount of product in the smallest container.
For example: Bubble bath: 25 boxes, 4 bottles/box, 28 fluid oz. each bottle:
Units 1-Quantity= 25
Units 1-Measure =BX
Units 2-Quantity=4
Units 2-Measure=BO
Units 3-Quantity=28
Units 3-Measure=FOZ

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Length
/Class

Position

Status

1-2

“PG”.

Description

Note

3-4

“27”.

20AN

5-24

20AN

28-47

20AN

51-70

74-80

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net Quantity
(PGA line - net)” is required when “Unit of
Measure (PGA line - net)” is reported in
positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line - gross)”
and is required when “Commodity Gross
Quantity (PGA line - gross)” is reported. Valid
Unit of Measure codes are listed in Appendix D
in this document or in Appendix C in the ACS
ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA line
- gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length Position
/Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG30 (Port of Arrival / Entry Information)
Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival/
Entry date
Anticipated Arrival /
Entry time

A = Anticipated arrival information

6-13

14-17

4AN

18-21

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes) is allowed.
For valid port codes, refer to note 1.

72-80

Space fill

Data Element

Arrival / Entry
Location Code
Port of Arrival /
Entry
Filler

Description

Note

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG55 (Additional Entity Roles)
This is an optional PGA input record used to provide additional roles performed by an entity or individual.
The PG55 record is not supported by FDA at this time. Multiple PG19 records should be used to input more than
one Entity-Role combination. Refer to the PG19 section for details.
Record Identifier PG55 (Additional Entity Roles)
Data Element
Control Identifier
Record Type
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Length
/Class
2A

Position

Status

Description

1-2

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
46X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
35-80

O
O
O
O
O
O
O
O
O
O
M

Note

“PG”.

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Length
/Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of where to
place the substitute data within the PGA
Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the substitution
group indicated by the Substitution Number
Sequential number assigned to, or referring
to, a specific substitution group of data
provided at the header level.
This data element is mandatory when using
the S or R substitution indicator.
Space fills.

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Drug Commodity Data Elements and Values
Drug commodities can be broken down into the following categories using the existing Government Agency data
elements available in the PG01 message
PG01 Government
Agency Code

Commodity
Type

PG01 Government
Agency
Program
Code

FDA

Drugs

DRU

Prescription

PRE

FDA

Drugs

DRU

Over the Counter

OTC

Drugs

DRU

Pharmaceutical Necessities, Containers,
Inactive Pharmaceutical Ingredients and
Excipients

PHN

FDA

Drugs

DRU

Research and Development

RND

FDA

Drugs

DRU

Investigational

INV

FDA

PG01 Government
Agency
Processing
Code

Commodity Sub-Type

Table 3 – Drug commodity hierarchy
The following are the potential PGA records associated with submitting Drug:
PG Record

Description

The commercial description of the shipment

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.

PG02

Product Identifier; the item type and Product Code detail are provided.

PG04

Product Constituent Active Ingredient

PG06

Product Source information is provided

PG07

The Trade/Brand Name

PG10

Product/Component Reporting Code

PG19

Entity Role (manufacturer, consignee, shipper, etc.) Entity Identification, Entity Name, and Entity
Address 1 are provided.

PG20

Additional Entity Identification (Address line 2, Apartment/Suite, City, State, and Zip/Postal Code).

PG21

Additional Entity Role

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are provided

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
PG Record

Description

PG26

Packaging qualifier and quantity of the shipment are provided

PG29

Data pertaining to the net or gross unit of measure of the commodity

PG30

Product pertaining to the pertaining to the date, time and location of inspection; previous
laboratory testing; inspection location; and anticipated arrival information for FDA

PG55

Additional roles performed by an entity or individual

PG60

Additional Information

PG00

Data Substitution

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Drug Example
Drug message set layout sample below:
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Drugs
Drugs Message Set Description
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product.
For example, Amoxicillin

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government
Agency Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use
Code, Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the
imported commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Description/Required Value

Control Identifier

1-2

“PG”

Record Type

3-4

“01”.

PGA Line Number

5-7

“001”

Government Agency
Code
Government Agency
Program Code
Government Agency
Processing Code
Intended Use Code

3AN

8-10

11-13

3AN

14-16

16X

42-57

Intended Use
Description
Correction Indicator

21X

58-78

Disclaimer

Note

“FDA”
1, 2, 4

“DRU”
Allowed values: PRE, OTC, INV, PHN,
RND
Refer to the table below for valid values
Refer to the table below for valid values
For future Use
A code of A (= product is not regulated
by this agency) indicating there is no
agency declaration requirement. Or this
field is left blank for no disclaimer. No
other code is accepted

1, 2, 4
3, 4
3, 4

Note 1
Refer to Table 3 above for commodity type and sub-type for Drugs
Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. Otherwise the Government
Agency Program Code and Government Agency Processing Code are mandatory.
Note 3
If the Disclaimer is ‘A’ then these data elements are optional; otherwise the Intended Use Code is required.
Note 4
This is the list of intended use codes available for Government Agency Program Code = “DRU”.
Intended Use Intended Use Description
Code
080.000
For Human Medical Use as a Non-Food Product under Controlled Distribution –
Prescription (PRE)
130.000
For Consumer Use as a Non- Food Product – Over the Counter (OTC)

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
Intended Use Intended Use Description
Code
150.007
Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a
pharmaceutical product
180.009
Chemical for research and development in a pharmaceutical product – Investigational
New Drugs; clinical trials or other human/animal use
180.017
970.000
100.000
155.009
150.017
150.013

Chemical for research and development in a pharmaceutical product – laboratory
testing only, no human/animal use
Import for Export
Importation for Personal Use
Importation of a drug constituent part (drug product) for use in a medical product
regulated under a device (CDRH) application type (e.g., for use in a PMA/510(k) drugdevice combination product).
Importation of a drug component (API) for use in a medical product regulated under a
device (CDRH) application type (e.g., for use in a PMA/510(k) drug-device
combination product)
Active Pharmaceutical Ingredient / Bulk Drug Substance to be used for Pharmacy
Compounding

Please see the Intended Use codes applicable for Forms and Types:
Prescription (PRE)
Finished Form:
080.000
970.000
100.000
155.009

For Human Medical Use as a Non-Food Product under Controlled Distribution –
Prescription (PRE)
Import for Export
Importation for Personal Use
Drug to be used as a constituent part in a Medical Device (Finished Dosage Form
Drug)

Not Finished Form Active Pharmaceutical Ingredient / Bulk Drug Substance:
150.007
Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a
pharmaceutical product
150.013
Active Pharmaceutical Ingredient to be used in pharmacy compounding
970.000
Import for Export
150.017
Drug to be used as a component in a Medical Device (Active Pharmaceutical
Ingredient / Bulk Drug Substance)
Over the Counter (OTC)
Finished Form:
130.000
970.000
100.000
155.009

For Consumer Use as a Non-Food Product – Over the Counter (OTC)
Import for Export
Importation for Personal Use
Drug to be used as a constituent part in a Medical Device (Finished Dosage Form
Drug)

Not finished form: Active Pharmaceutical Ingredient / Bulk Drug Substance:

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance
150.007
150.013
970.000
150.017

Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a
pharmaceutical product
Active Pharmaceutical Ingredient to be used in pharmacy compounding
Import for Export
Drug to be used as a component in a Medical Device (Active Pharmaceutical
Ingredient / Bulk Drug Substance)

Pharmaceutical Necessities, Containers, Inactive Pharmaceutical Ingredients and Excipients (PHN)
No intended use codes for this Commodity Sub-Type
Investigational New Drug (INV)
180.009 Chemical for research and development in a pharmaceutical product – clinical trial
or other human/animal use
Research and Development (RND)
180.017 Chemical for research and development in a pharmaceutical product – laboratory
testing only, no human/animal use
.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
This mandatory PGA input record is used to indicate whether or not the information being provided relates to a
product (P) or a component (C) of a product. For Drugs entries, the Product Code Number is provided within this
record.
Record Identifier PG02 (Product Identifier)
Data Element

Length/
Class

Position

Status

Control Identifier

“PG”.

Record Type

3-4

“02”.

Item Type

Code identifying the following records as
pertaining to P=Product. No other values are
allowed.

Product Code
Qualifier
Product Code
Number

4AN

6-9

19X

10-28

Description

Note

Only one ‘P’ record is allowed for the same
PGA Line # in PG01.
“FDP”.
FDA Product Code Must be equal to 7
characters

Only one FDA Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

*** Edit to limit Industry Codes, dependent upon the Commodity Sub-Type ***
IF Commodity Sub-Type = PRE, OTC, INV or RND
THEN PRODUCT.CODE.INDUSTRY = 56, 60, 61, 62, 63, 64, 65, or 66
IF Commodity Sub-Type = PHN
THEN PRODUCT.CODE.INDUSTRY = 55
*** Edit to limit Subclass, dependent upon the Commodity Sub-Type:
C & D are the Subclasses for Rx products;
A & B are the Subclasses for OTC products;
I is the Subclass for Investigational New Drug products ***
IF Commodity Sub-Type = PRE or OTC or INV
AND PG01 Intended Use Code INCLUDES 180.009
THEN PRODUCT.CODE.SUBCLASS = “I”

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

IF Commodity Sub-Type = PRE
AND PG01 Intended Use Code DOES NOT INCLUDE 180.009
THEN PRODUCT.CODE.SUBCLASS = ‘C’ or ‘D’
IF Commodity Sub-Type = OTC
AND PG01 Intended Use Code DOES NOT INCLUDE 180.009
THEN PRODUCT.CODE.SUBCLASS = ‘A’ or ‘B’
*** Edit to limit Process Indicator Code (PIC) for Active Pharmaceutical Ingredients ***
IF Commodity Sub-Type = PRE or OTC
AND PG01 Intended Use Code = 150.007 or PG01 Intended Use Code = 150.017 Drug to be used as a
component in a Medical Device (Active Pharmaceutical Ingredient / Bulk Drug Substance)
THEN PRODUCT.CODE.PIC = ‘S’
IF Commodity Sub-Type = PRE or OTC
AND PG01 Intended Use Code = 150.013 (Active Pharmaceutical Ingredient to be used in pharmacy
compounding)
THEN PRODUCT.CODE.PIC = ‘T’

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG04 (Product Constituent Element)
For Drugs, this PGA input record is optional and it provides data pertaining to Constituent Active Ingredient Qualifier,
Name of the Constituent Element, Quantity of Constituent Element, Unit of Measure, and Percent of Constituent
Element for the product identified by Product Code Number in PG02. This record can be repeated.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they are
under a PG02) at this time.

Record Identifier PG04 (Product Constituent Element)
Length/
Class

Position

Status

Control Identifier

“PG”.

Record Type

3-4

“04”.

Constituent Active
Ingredient Qualifier

If commodity sub-type = PRE, OTC, INV
or RND then YES = “Y” if yes, blank (=
NO)

Name of the
Constituent Element

51X

6-56

IF FINISHED: Name of Active Ingredient
contained in the dosage form

1, 2

IF
ACTIVE
PHARMACEUTICAL
INGREDIENT/BULK
DRUG
SUBSTANCE: name of the Active
Pharmaceutical Ingredient (API)
IF FINISHED – amount of active
ingredient per dose

Data Element

Quantity of
Constituent Element

12N

57-68

Description

Note

IF API/BULK DRUG SUBSTANCE: total
volume of API
Unit of Measure
(Constituent
Element)

Percent of
Constituent Element

Note

5AN

69-73

74-80

2 decimal places are implied
IF FINISHED: Unit of measure for
Quantity of Constituent Element
IF API/BULK DRUG SUBSTANCE: Unit
of measure for Quantity of Constituent
Element
Only
applicable
for
Active
Pharmaceutical Ingredients otherwise left
blank. 4 decimal places are implied.

IF Government Agency Program Code = DRU
AND If Government Agency Processing Code = PRE or OTC or INV or RND
THEN Constituent Active Ingredient Qualifier and Name of the Constituent Element are entered.

Note 2

FDA Supplemental Guidance 2.4.1

1, 2
3

1, 2
3
1, 3, 4,

FDA Supplemental Guidance
*** Rules for Finished Dosage Form Drugs ***
IF PG01 Intended Use Code =
080 For Human Medical Use as a Non-Food Product under Controlled Distribution – Prescription (PRE)
OR
130 For Consumer Use as a Non- Food Product – Over the Counter (OTC)
OR
155.009 Drug to be used as a constituent part in a Medical Device (Finished Dosage Form Drug)
OR
180.009 Chemical for research and development in a pharmaceutical product – clinical trials or other
human/animal use - Investigational New Drug (INV)
OR
180.017 Chemical for research and development in a pharmaceutical product – laboratory testing only, no
human/animal use – Research and Development (RND)
THEN:
Either the quantity and Unit of Measurement are entered OR the Percent Constituent Element is entered.
MAY REPEAT PG04 for EACH Active Pharmaceutical Ingredient in the Finished Dosage form
Example1: Ibuprofen, 200mg tablets
Name of the Constituent Element = Ibuprofen
Quantity of Constituent Element = 200 and Unit of Measure = milligrams
Example2: Anti-perspirant Deodorant
Name of the Constituent Element = aluminum zirconium tetrachlorohydrex
Percent of Constituent Element 18.2% (entered as 0182000)
Note 3
*** Rules for Active Pharmaceutical Ingredients (API) ***
IF PG01 Intended Use Code =
150.007 Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a pharmaceutical
product
OR
150.013 Active Pharmaceutical Ingredient to be used in drug compounding
OR
150.017 Drug to be used as a component in a Medical Device (Active Pharmaceutical Ingredient / Bulk
Drug Substance)
OR
180.009 Chemical for research and development in a pharmaceutical product – clinical trials or other
human/animal use - Investigational New Drug (INV)
OR
180.017 Chemical for research and development in a pharmaceutical product – laboratory testing only, no
human/animal use – Research and Development (RND)
THEN
The quantity, Unit of Measurement and the Percent Constituent Element are entered.
Name of the Constituent Element = Active Pharmaceutical Ingredient name
Quantity of Constituent Element = Total Amount (by Unit of Measure) of the Active Pharmaceutical
Ingredient
Unit of Measure = base unit of measure weight/volume
Percent of Constituent Element = percent identification of the Active Pharmaceutical Ingredient.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Example: Ephedrine Hydrochloride 99%, USP, 2 – 25 KG drums
Name of the Constituent Element = Ephedrine HCl
Quantity of Constituent Element = 50 and Unit of Measure = KG

Note

Examples of Percentages:
1000000
0990000
0090000
0009000
0000900
0000090
0000009

=
=
=
=
=
=
=

100%
99%
9%
.9%
.09%
.009%
.0009%

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is a mandatory PGA input record that provides data pertaining to Source Type (Origin) -other than the CBP
Country of Origin – for the product identified by Product Code Number in PG02.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they
are under a PG02) at this time.
Record Identifier PG06 (Product Origin)
Data Element

Length/
Class

Position

Status

Control Identifier

“PG”.

Record Type

3-4

“06”.

3AN

5-7

Mandatory valid values are 30 (Country of
Source) or 39 (Country of Production).
294 (Country of Refusal) if previously
refused.

Source Type Code

Country Code

Note

8-9

Description

Note

There would be at least one PG06 with
source type code of 30 or 39. If previously
refused, then provide another PG06 with
source type code 294.
Country of production or source is
required for Drugs. Should match the
country code in PG19-PG20 record set
for the Entity Role Code ‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.
Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is a conditional PGA input record that provides data pertaining to Trade or Brand Name for the product
identified by Product Code Number in PG02.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when
they are under a PG02) at this time.
Record Identifier PG07 (Product Trade Names)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

“PG”

Record Type

3-4

“07”

Trade Name/Brand
Name

35X

5-39

If Government Agency Program Code =
‘DRU’ and [ if PG01 Intended use code =
150.007 (indicates API/Bulk) or Agency
Processing Code = ‘PHN’ OR ‘RND’ ] then
Trade/Brand Name of the Drug is optional;
otherwise, the Trade/Brand Name of the Drug
is MANDATORY. If Trade/Brand Name
requires additional space, continue in a
PG60 record with Qualifier Code ‘TBN’.

Finished – Mandatory (PRE, OTC)
Investigation (intended use code – 180.009 – Mandatory (if no trade name then provide the existing compound
name)
API/Bulk - Optional
RND – Optional
PHN – Optional

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
This is a mandatory PGA input record that allows for reporting codes that provide additional characteristics of a
product or component identified by Product Code Number in PG02, not reported elsewhere in the PG Message
Set.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when
they are under a PG02) at this time.
Record Identifier PG10 (Product Characteristics)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

This should be Invoice Description NOT
product code description. See Appendix A for
the use of PG10 to capture the information
currently collected in multiple OI records.

FDA Supplemental Guidance 2.4.1

Description

Note

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Drugs, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role and
conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example, MF.
Code identifying the Entity Identification is
entered. For example, 16. Mandatory, if
Entity Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘ENA’. See
validation criteria below.
The address of the entity is required. See
validation criteria below.

1,2,
3
3
3

If Entity Address1 requires additional space,
continue in a PG60 record with Qualifier Code
‘AD1’.
Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes mandatory to FDA Drugs Message Sets is below:
Data Element

Code
MF

Entity Role Codes§
DEQ
FD1
DP
§

Description
Manufacturer of goods (Final producer for the final drug
product). If the product is a bulk API, use “MF” as the Entity
Role Code (rather than “GD” – Producer of API); If the
product is in finished form, provide MF of final product .
Shipper
FDA Importer (Importer of Record)
Delivered To Party

Same Role Code cannot be entered more than once.

Note 2
List of Entity Role codes conditional to FDA Drugs Message Sets is below:
Data Element
Entity Role Codes

FDA Supplemental Guidance 2.4.1

Code
SPO

Description
Sponsor (New) – if different then MF or FD1

FDA Supplemental Guidance

List of Entity Role codes optional to FDA Drugs Message Sets is below:
Data Element

Code

Entity Role Codes

Description
Producer (Producer of the API*)

*API – Active Pharmaceutical Ingredient
*** Rules for Finished Dosage Form Drugs ***
IF PG01 Intended Use Code =
080 For Human Medical Use as a Non-Food Product under Controlled Distribution – Prescription (PRE)
OR
130 For Consumer Use as a Non- Food Product – Over the Counter (OTC)
THEN: must include one MF and may include one or more GD
REPEAT GD for EACH Active Pharmaceutical Ingredient in the dosage form
List of Entity Role codes also applicable to FDA Drugs Message Sets is below:
Data Element

Code

Entity Role Codes

Description
Point of Contact

Note 3
Entity Identification Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Identification
Codes) of the ACE ABI CATAIR publication. List of Entity Identification codes applicable to FDA Drug Message
Sets is below:
Data Element

Code

Entity Identification
Codes

Description

D&B-assigned (DUNS number); must be 9 digits

FDA-assigned (FEI number); must be from 4 to 10
digits

Length/
Class
9N
4-10N

FDA SELECTION CRITERIA
FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the
Entity; IF DUNS is not available THEN FEI.
Entity Name <>NULL AND Entity Address 1 <>NULL AND
IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N
ELSE IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to10 and Type = N

FDA Supplemental Guidance 2.4.1

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
This is a mandatory PGA input record that provides additional data pertaining to Entity identification such as Entity
Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This record is used when additional address for
the entity needs to be entered.
Record Identifier PG20 (Entity Address)
Data Element
Control Identifier

Length/
Class

Position

Status

Description

1-2

“PG”

Note

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Address Line 2 for the Entity.
If Entity Address2 requires additional
space, continue in a PG60 record with
Qualifier Code ‘AD2’.

Entity Apartment
Number/Suite Number

37-41

Apartment/Suite number of the entity.

Entity City

21X

42-62

City of the entity. If Entity City requires
additional space, continue in a PG60
record with Qualifier Code ‘ECI’.

Entity State/Province

3AN

63-65

State/Province of the entity.

Entity Country

66-67

ISO Country Code.

Entity Zip/Postal Code

68-76

Zip/Postal Code of the entity.

FDA Supplemental Guidance 2.4.1

100

FDA Supplemental Guidance

Record Identifier PG21 (Point of Contact)
This is a mandatory PGA input record that provides data about an Individual and may also be related to an entity
(the party) in the preceding PG19 record. Included in this record are the Individual Name, Telephone Number
and Email address. A typical example is a POC for the Filer.
At least one PG21 record is required.
Record Identifier PG21 (Point of Contact)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“21”.

3AN

5-7

23X

8-30

Telephone Number
of the Individual

15X

31-45

Email Address for
the Individual

35X

46-80

Identify the type of party or facility the
Individual represents.
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’.
Telephone number of the Individual.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore
Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

Individual Qualifier
Individual Name

FDA Supplemental Guidance 2.4.1

Description

Note

101

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
This is a conditional PGA input record that provides data pertaining to Food and Drug Administration Affirmation
of Compliance Criteria. This record is typically only used by FDA. This record is repeatable.
Record Identifier PG23 (Affirmation of Compliance)
Data Element

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

Control Identifier

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

A code used to affirm compliance with FDA
requirements. See Appendix PGA PG23 –
Food & Drug Affirmation of Compliance,
FDA Affirmation of Compliance Codes of
ACE ABI CATAIR publication.

30AN

10-39

Text describing the information required by
the PGA. This could include a number or a
country code, etc. Also, see Appendix PGA
(Food & Drug Affirmation of Compliance
Qualifier Codes) of this publication for valid
codes related to certain specific Affirmation
of Compliance codes.

Space fill

Affirmation of
Compliance
Qualifier

Filler
Note

The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication. The list of
AoC codes applicable to FDA Drugs Message Sets is below:
*** Exemptions from providing Affirmations of Compliance ***
*** Pharmaceutical Necessities & Containers and Research & Development products do not need AofCs ***
For Government Program Code = DRU AND Government Processing Code =
PHN: Pharmaceutical Necessities, Containers, Inactive Pharmaceutical Ingredients and Excipients; or
RND: Research and Development
THEN PG23 is not required
*** Import For Export entries, and Personal Importations do not require AofCs ***
For Government Program Code = DRU AND Intended Use code =
100.000: Importation for Personal Use; OR
970.000: Import For Export
THEN PG23 is not required
When several PG23 records are included in the Message Set, the same AoC Code can be entered only once.

The list of AoC codes conditional to FDA Drugs Message Sets is below:
Data Element

Code

Description

FDA Supplemental Guidance 2.4.1

Syntax

Business Rules

102

FDA Supplemental Guidance
DA

New Drug
Application Number
or Abbreviated New
Drug Application
Number or
Therapeutic Biologic
Application Number

IF Government Agency Program Code =
DRU AND Government Agency
Processing Code = ‘PRE’ AND Intended
Use Code NOT = 100.000, 130.000,
180.009, 180.017, or 970.00 THEN DA IS
MANDATORY
IF Government Agency Program Code =
DRU AND Government Agency
Processing Code = ‘ ‘OTC’ THEN DA IS
OPTIONAL

REG

Drug Registration
Number

DLS

Drug Listing Number

10N

IND

Investigational New
Drug Number

Affirmation of
Compliance Code

The DA AofC includes all the previous AoC
codes, NDA, ANDA and BLA.
IF Government Agency Program Code =
DRU and IF Government Agency
Processing Code is PRE or OTC AND
Intended Use Code NOT = 100.000,
180.009, 180.017, or 970.000 THEN REG
IS MANDATORY
IF Government Agency Program Code =
DRU and IF Government Agency
Processing Code is PRE or OTC,AND
Intended Use Code NOT = 100.000,
180.009, 180.017, or 970.000 THEN DLS
IS MANDATORY unless affirmation “PLR”
is declared. The DLS AofC includes both
the previous NDC and DLS AofC codes.
See Note 1 below
IF Government Agency Program Code =
DRU and IF Government Agency
Processing Code is PRE or OTC or INV
AND Intended Use Code = 180.009 THEN
IND is MANDATORY

Note 1:
Importing finished dosage drugs that are imported by a Private Label Distributor (PLD). The Manufacturer in
PG19 should be the actual manufacturer of the product being imported. The DLS should be the listing of the
product by the Manufacturer not the Private Label Distributor.
The list of AoC codes optional to FDA Drugs Message Sets is below:
Data Element

Affirmation of
Compliance Code

Code

Description

Syntax

Business Rules

ERR

Entry Review
Requested

Indicator only

ERR is just used as an indicator,
no data will follow

PLR

Used to identify the
shipment as a
PLAIR import
shipment
Device Listing
Number

Indicator only

Used as an indicator, no data will
follow.

Any of the
following:

IF Government Agency Program
Code = DRU AND Intended Use

LST

FDA Supplemental Guidance 2.4.1

103

FDA Supplemental Guidance

PM#

Device Premarket
Number

IDE

Investigational
Device Exemption
Number

FDA Supplemental Guidance 2.4.1

A+6N; B+6N;
C+6N;
D+6N; E+6N;
L+6N;
Q+6N; R+6N

Code = 150. 017 or 155.009
[Component/Constituent Part of a
Medical Device] THEN Device
Listing is Optional

Any of the
following:
P+6N;
N+4N, 5N, or
6N;
D+6N;
H+6N;
K+6N;
DEN+6N;
G+6N OR
"NSR"

IF Government Agency Program
Code = DRU AND Intended Use
Code = 150. 017 or 155.009
[Component/Constituent Part of a
Medical Device] THEN Device
Premarket Application is Optional

104

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

105

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
This is a conditional PGA input record that provides data pertaining to: Temperature Qualifier, Degree Type, Actual
Temperature, Lot Number, Production Date Range of the Lot, PGA Line Value, and PGA Unit Value. This record
is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value MUST be included on the first
PG25 record. There must be at least one PG25 record for each FDA line.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Degree Type

Temperature Category being reported for quality
control or preservation purposes.
A= Ambient, F=Frozen
R=Refrigerated/Chilled, D=Dry Ice
H=Fresh, U=Uncontrolled
P=Flashpoint
F = Fahrenheit, C = Celsius , K = Kelvin

Negative Number

Actual
Temperature
Location of
Temperature
Recording

8-13

Lot Number
Qualifier

1AN

Lot Number

25X

16-40

Production Start
date of the Lot

41-48

Production End
Date of the Lot

49-56

PGA Line Value

12N

57-68

PGA Unit Value

12N

69-80

If the actual temperature is in the negative
numbers use an “X”.
Reported temperature. Two decimals places are
implied.
Identifies recorded temperature is for
A = product
B = container
C = conveyance
Code of the entity that assigned the Lot number.
For Drugs the only valid value is:
1 = Manufacturer
Should not be entered if more than one PG25
record is entered
The lot number that the manufacturer/
producer/grower assigned to the product.
The date when the production for the Lot started.
A numeric date in MMDDCCYY (month, day,
century, year) format.
The date when the production for the Lot ended.
A numeric date in MMDDCCYY (month, day,
century, year) format.
The value associated with the PGA line number
in whole dollars. Must be entered in the first
PG25 record in the case of multiple PG25
records. When entered, it must be right-justified
with preceding zeros and be greater than zero.
The value of the lowest unit of measure reported
in PG26. Two decimal places are implied.

Note 1

FDA Supplemental Guidance 2.4.1

106

FDA Supplemental Guidance
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

107

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
For Drugs, this is a Mandatory PGA input record that provides FDA with data pertaining to Packaging Qualifier,
Quantity and Unit of Measure.
This record can be repeated up to six (6) times, once for each unique packaging level. The first record is used to
describe the largest (outermost) container and the number of containers at this packaging level. The second
record is used to describe the contents of the next smallest container. If needed, qualifiers 2-6 are used in a
similar manner (largest to smallest container). The final record must describe the actual amount of the product in
the smallest container.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.
Record Identifier PG26 (Product Packaging)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging
for the product. Outermost (largest=1)
packages to the innermost (smallest=6)
packages. There can be up to 6 levels of
packaging. If reporting only one level,
show the total quantity for the item and
report that as level 1.
“Quantity of the packaging level, For
example, 000000000400. Two decimal
places are implied. Must be greater than
zero.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among
the PG26 records.

Unit of Measure
(Packaging Level)

Description

Note

1,4,5

2,4,5

3,4,5

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Drug Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)

FDA Supplemental Guidance 2.4.1

108

FDA Supplemental Guidance

Code
AE
AM
AP
AT
BG
BA
BC
BO
BQ
BS
BV
BX
CA

Code Name
Aerosol
Ampoule, Nonprotected
Ampoule, Protected
Atomizer
Bag
Barrel
Bottle crate, Bottle rack
Bottle, Nonprotected, Cylindrical
Bottle, Protected, Cylindrical
Bottle, Nonprotected, Bulbous
Bottle, Protected Bulbous
Box
Can, Rectangular

CAP

Capsules (Dosage)

CG
CI
CON
CS
CT
CTR
CX
CY
DR
EN
FD
FOZ
G
GAL
GB
KG
L
LB
MB
MG
MCG
ML
NO
OZ
PAL
PCS
PK
PTL
QTL
SUP
SY
TAB

Centigrams (Weight)
Canister
Container
Case
Carton
Cartridge
Can, Cylindrical
Cylinder
Drum
Envelope
Framed Crate
Ounces, fluid (Volume)
Grams (Weight)
Gallons (US) (Volume)
Gas Bottle
Kilograms (Weight)
Liters (Volume)
Pounds (avdp) (Weight)
Bag, Multi-ply
Milligrams (Weight)
Micrograms (Weight)
Milliliters (Volume)
Number (Count)
Ounces, weight (avdp) (Weight)
Pallet
Pieces (Count)
Package
Pints, liquid (US) (Volume)
Quarts, liquid (US) (Volume)
Suppositories (Dosage)
Syringe
Tablets (Dosage)

FDA Supplemental Guidance 2.4.1

109

FDA Supplemental Guidance
Code
TU

Code Name
Tube

24 Aspirin 100 tablets 325 mg

Units 1-Quantity
Units 1-Measure

100
CT

Units 2-Quantity
Units 2-Measure

24
BO

Units 3-Quantity
Units 3-Measure

100
TAB

In this case, the invoice description contains the strength of the aspirin tablets. The product quantity is listed
using the "Tablets" quantity unit code.

FDA Supplemental Guidance 2.4.1

110

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is a conditional PGA input record that provides data pertaining to the net or gross unit of measure of the
commodity. This can be provided at the overall PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length/
Position
Class
Control Identifier
2A
1-2
Record Type
2N
3-4
3AN
Unit of Measure (PGA
20-22
line - gross)

Status
M
M
O

Commodity Gross
Quantity (PGA line gross)

12N

23-34

Unit of Measure
(Individual Unit - gross)

3AN

50-52

Commodity Gross
Quantity (Individual Unit
- gross)

12N

53-64

Filler

16X

65-80

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line
Number, the indication of the unit of
measurement in which weight, capacity,
length, area, volume or other quantity is
expressed. “Unit of Measure (PGA line
- gross)” in this position is associated
with “Commodity Gross Quantity (PGA
line - gross)” and is required when
“Commodity Gross Quantity (PGA line gross)” is reported. Valid Unit of
Measure codes are listed in Appendix D
in this document or in Appendix C in the
ACS ABI CATAIR.
Pertaining to the overall PGA Line
Number, including any packaging, but
excluding weight of the carrier's
equipment. Two decimals are implied.
“Commodity Gross Quantity (PGA line gross)” is required when “Unit of
Measure (PGA line - gross)” is reported
in positions 20-22 of this record.
Pertaining to the Individual unit (gross),
the indication of the unit of
measurement in which weight, capacity,
length, area, volume or other quantity is
expressed. “Unit of Measure (Individual
unit - gross)” in this position is
associated with “Commodity Gross
Quantity (Individual unit - gross)” and is
required when “Commodity Gross
Quantity (Individual unit - gross)” is
reported. Valid Unit of Measure codes
are listed in Appendix D in this
document or in Appendix C in the ACS
ABI CATAIR.
Pertaining to the Individual unit,
including any packaging, but excluding
weight of the carrier's equipment. Two
decimals are implied. “Commodity
Gross Quantity (Individual unit - gross)”
is required when “Unit of Measure
(Individual unit - gross)” is reported in
positions 50-52 of this record.
Space fill

111

FDA Supplemental Guidance

Valid FDA Units of Measure for Packaging Containers
Code
BX
CS
CT
CX
DR
MB
PK
PO

Description
Box
Case
Carton
Can, Cylindrical
Drum
Bag, Multi-ply
Package
Pouch

Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)
Code
DOZ
DPC
NO
PCS
CAP
CTR
SUP
TAB
BBL
FOZ
GAL
L
ML
PTL
QTL
CG
G
KG
LB
MG
MCG
OZ
TU

Description
Dozen (Count)
Dozen Pieces (Count)
Number (Count)
Pieces (Count)
Capsules (Dosage)
Cartridge
Suppositories (Dosage)
Tablets (Dosage)
Barrels (42 Gallons ea.) (Volume)
Ounces, fluid (Volume)
Gallons (US) (Volume)
Liters (Volume)
Milliliters (Volume)
Pints, liquid (US) (Volume)
Quarts, liquid (US) (Volume)
Centigrams (Weight)
Grams (Weight)
Kilograms (Weight)
Pounds (avdp) (Weight)
Milligrams (Weight)
Micrograms (Weight)
Ounces, weight (avdp) (Weight)
Tube

Record not supported
by FDA at this time
FDA Supplemental Guidance 2.4.1

112

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival/
Entry time

Arrival / Entry
Location Code
Port of Arrival /
Entry
Filler

Description

Note

1
A = Anticipated arrival information

6-13

14-17

4AN

18-21

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes) is allowed.
For valid port codes, refer to note 1.

72-80

Space fill

1
1

Port of Entry:
19 CFR 101.1.

Port and port of entry. The terms “port” and “port of entry” refer to any place designated by Executive Order of the President, by order of the
Secretary of the Treasury, or by Act of Congress, at which a Customs officer is authorized to accept entries of merchandise to collect duties,
and to enforce the various provisions of the Customs and navigation laws. The terms “port” and “port of entry” incorporate the geographical
area under the jurisdiction of a port director. (The Customs ports in the Virgin Islands, although under the jurisdiction of the Secretary of the
Treasury, have their own Customs laws (48 U.S.C. 1406(i)). These ports, therefore, are outside the Customs territory of the United States and
the ports thereof are not “ports of entry” within the meaning of these regulations).

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

113

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
8X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
72-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

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FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

115

FDA Supplemental Guidance

Position

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of where to
place the substitute data within the PGA
Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the substitution
group indicated by the Substitution Number
Sequential number assigned to, or referring
to, a specific substitution group of data
provided at the header level.
This data element is mandatory when using
the S or R substitution indicator.
Space fills.

Data Element

FDA Supplemental Guidance 2.4.1

Status

Description

Note

116

FDA Supplemental Guidance

Stand Alone Prior Notice Submission Data Elements and Values
This chapter describes the data elements and their business rules for a stand-alone Prior Notice submission. This
chapter is consisting of Prior Notice Submission (801m) requirements and the PE record requirements.

Prior Notice Non-PGA Data Elements by Mode of Transportation (See Note)
MOT

AIR

OCEAN

LAND - Bus,
Truck

LAND - Rail

Express
Consignment
Carrier

Required Data Elements

Mapping

Mapping - Data Elements

IATA

PE10

Carrier

Airway Bill Number

PE10

Flight Number

PG23

Container Number

PG27

Ref Qual Code = AWB, Ref ID Num
AofC - VFT - Voyage/Flight/Trip
Number
Container Number

Carrier Name

PG23

Bill of Lading

PE10

Vessel Name

PG23

Voyage Number

PG23

Container Number

PG27

Carrier Name

PG23

Bill of Lading

PE10

Trip Number

PG23

SCAC

PE10

AofC - CAN – Carrier Name
Ref. Qual. Code ‘BOL,’ Bill Type
Indicator ‘R,’ and report the Simple Bill
of Lading Number in the Reference
Identifier Number field
AofC - VFT - Voyage/Flight/Trip
Number
Carrier

Container Number *

PG27

Container Number

Carrier Name

PG23

AofC - CAN – Carrier Name

Bill of Lading

PE10

Trip Number

PG23

SCAC

PE10

Ref Qual Code = BOL, Ref ID Num
AofC - VFT - Voyage/Flight/Trip
Number
Filer/SCAC Code, Ref ID Num

Rail Car Number

PG23

AofC – RNO - Rail Car Number

Container Number *

PG27

Tracking Number

PG28

Carrier Name

PG28 or
PG23

Container Number
Report Express Consignment
Carrier/Courier tracking number for the
shipment as applicable.
SCAC may be entered in PG28
otherwise use PG23 AofC - CAN –
Carrier Name

AofC - CAN – Carrier Name
Ref. Qual. Code ‘BOL,’ Bill Type
Indicator ‘R,’ and report the Simple Bill
of Lading Number in the Reference
Identifier Number field
AofC – VES – Vessel Name
AofC - VFT - Voyage/Flight/Trip
Number
Container Number

* if applicable

FDA Supplemental Guidance 2.4.1

117

FDA Supplemental Guidance
Note: The above table makes references to select entry-level data elements from the PE10 to provide the
context and to identify from which data source FDA expects to receive a number of the required prior notice data
elements for the specific modes of transportation. For additional information on the data elements found within
the PE10 record, please refer to the relevant CBP documentation. This supplemental guidance document
describes only line-level data within the structure of the FDA PG Message Set.

FDA Supplemental Guidance 2.4.1

118

FDA Supplemental Guidance

Food Commodity Data Elements and Values
Food commodities can be broken down into the following categories using the existing Government Agency data
elements available in the PG01 message
PG01 Government
Agency Code

Commodity
Type

PG01 Government
Agency Program
Code

Commodity Sub-Type

PG01 Government
Agency
Processing Code

FDA

Food

FOO

Natural State Food

NSF

FDA

Food

FOO

Processed Food

PRO

Animal Food

FDA
Food

FOO

(includes pet food, medicated
feed and feeds)

FEE

FDA

Food

FOO

Additives and Colors

ADD

FDA

Food

FOO

Dietary Supplements

DSU

Table 4a – Food commodity hierarchy
The following are the potential PGA records associated with submitting Prior Notice:
PG
Record

Description

Record Identifier (The general product description)

PG01

PGA Identifier (The shipment is regulated by the FDA program office within FDA and the
Intended Use)

PG02

Product Identifier (FDA Product Code Information)

PG06

Product Origin (FDA Country of Production, Shipment, and Refusal)

PG10

Product Characteristics (Line level Item Common/Usual/Market Name Description)

PG13

License Plate Issuer [Privately Owned Vehicle (POV) Information]

PG14

License Plate Number [Privately Owned Vehicle (POV) Information]

PG19

Entity Data (Trade Entity’s Transaction Role, Identification Type, Identification Number, and
1st Line of Address)

PG20

Entity Address (Continuation of Entity information including Address Line 2, City,
State/Province, Country for entities provided in PG19)

PG21

Point of Contact [Individual (POC) Information, including Name, Phone Number, Email
Address for trade entities]

PG23

Affirmation of Compliance [FDA’s Affirmation of Compliance (AofC) Criteria including food
facility registration and other Prior Notice information]

FDA Supplemental Guidance 2.4.1

119

FDA Supplemental Guidance
PG
Record

Description

PG24

Remarks (Continuation of POC name as necessary)

PG25

Product Condition (Lot # of product as required by specific commodities)

PG26

Product Packaging (Packaging Qualifier And Quantity per line)

PG27

Container Information

PG28

Express Courier Tracking (Number)§

PG30

Anticipated Arrival Information

PG55

Additional Role(s) (for future use)

PG60

Additional Information

PG00

Data Substitution

§ CBP confirmed that the PE header can only be used to submit express courier tracking numbers in the air
environment. Therefore, all express courier tracking numbers for PNs in the air environment should be submitted
in the PE. Express courier tracking numbers for PNs for food shipments in the ground environment are to be
reported in the PG28.

FDA Supplemental Guidance 2.4.1

120

FDA Supplemental Guidance

Prior Notice Example
Prior Notice message set layout sample below:
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: PN Only
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

121

FDA Supplemental Guidance

Record Identifier OI (Record Identifier)
For Prior Notice, this is a mandatory record that provides the general description of the item. This record precedes
the Record Identifiers for the PGA Message set.
Record Identifier OI (Input)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the
product. For example, Fruit Juice

FDA Supplemental Guidance 2.4.1

Description

Note

122

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
For Prior Notice, this is a mandatory input record that provides data pertaining to the PGA Line Number, Government
Agency Code, Government Agency Program and Processing Codes, Intended Use Code, and Disclaim information.
Record Identifier PG01 (Input)
Data Element

Length
/Class

Position

Status

Description

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government
Agency Code
Government
Agency Program
Code
Government
Agency Processing
Code
Intended Use Code

8-10

11-13

Note

“FDA”
“FOO”

14-16

16X

42-57

Intended Use
Description

21X

58-78

Correction Indicator

For allowed values Codes for Food see
Note 1 below.

For future Use

Note 1
See Table 4a above for the commodity hierarchy for Human Food and Animal Food commodities applicable for
Prior Notice.
Note2
Choose one of these intended use codes, if applicable based on the product requirements. The submission of an
Intended use code is not a requirement for prior notice.
CFSAN Regulated Products
Import Scenario
For Research Use as Human Food
For Research Use as an Animal Food
Personal Importation

FDA Supplemental Guidance 2.4.1

Intended Use Code

CBP Intended Use Name

260.000
015.000
210.000

For Research Use as Human Food
For Research Use as an Animal Food
For Personal Use as Human Food

123

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
For Prior Notice, this mandatory input record is used to indicate whether or not the information being provided
relates to a product (P) or a component (C) of a product. The Product Code Qualifier and Number can be used to
provide FDA Product Code.
Record Identifier PG02 (Input)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.

Product Code
Qualifier
Product Code
Number

6-9

19X

10-28

Description

Note

Only one ‘P’ record is allowed for the
same PGA Line # in PG01
“FDP”

The FDA Product Code Must be equal to
7 characters

Note 1
Product Code Qualifier is currently always ‘FDP’ for all FDA products.
Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication.
Only one Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Group
Code
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

A product is subject to Prior Notice requirements if the following condition is satisfied.

if industry_code IN ('48','49', '69', '70', '71', '72')
OR if industry_code BETWEEN '01' and '46'
OR if (industry_code+class_code+group_code) in ('52D01','52D99')
OR if (industry_code+class_code+group_code) in ('50A01','50B01')
OR if (industry code ='50' and class_code in ('C', 'D', 'E', 'F', 'G', 'L')
OR if (industry_code = '54' and subclass_code in ('A','B','C','L','M','Y'))

FDA Supplemental Guidance 2.4.1

124

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
For Prior Notice, this is a mandatory input record that provides data pertaining to Source Type (FDA country of
production/growth and country from which the article was shipped) for the article of food. This record also provides
the conditional PN data concerning the Country or Countries) who previously refused entry of the article of food.
This record can be repeated to submit the countries required for PN as described in Note 1.
Record Identifier PG06 (Input)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

Must always equal PG.

Record Type
Source Type
Code

2N
3X

3-4
5-7

M
M

Must always be 06.
Source Type Code must be selected using
the following logic.
Source Type Code must be selected using
the following logic:

IF Government Agency Program Code =
FOO and natural state food
THEN use 262 (Place of growth)
ELSE use 39 (Country of Production).
IF Government Agency Program Code =
FOO, THEN requires CSH (Country of
Shipment).

Country Code

8-9

If refused from other country(s), use 294.
1)
ISO country codes are allowed. Should
match the country code in PG19-PG20
record set based on the value entered for
Source Type Code:
Source Type Code
39
262

Entity Role Code
MF
DFI or FDC

Note 1
Source Type Code from Appendix PGA, PG06 – Source Type Codes may be entered.
Prior Notice requires the following data elements:
1. Country of Shipment, Source Type Code = CSH
2. All Natural State Human Food and Animal Food requires the
Country of Growth, Source Type Code = 262 –the country where the article of food was grown for fish/seafood caught outside the waters of the US = country in which the vessel who caught the
fish/seafood is registered.
3. Non-Natural State Human Food and Animal Food requires the
Country of Production, Source Type Code = 39- the country where the article of food was made
- if made from fish/seafood aboard a vessel = country in which the vessel is registered.
4. Country of Entry Refusal, if the article of food has been refused by other country(ies), provide the ISO
country code(s) as a part of the Prior Notice submission. (Source Code Type = 294)

FDA Supplemental Guidance 2.4.1

125

FDA Supplemental Guidance

Note 2
ISO Country codes from Appendix D (ISO Country and Currency Codes) in the ACS ABI CATAIR must be
entered.

FDA Supplemental Guidance 2.4.1

126

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
For Prior Notice, this is a mandatory input record that provides common or usual name description of a product or
component, not reported elsewhere in the PG Message Set.

Record Identifier PG10 (Input)
Data Element

Control Identifier
Record Type
Commodity
Characteristic
Description

Length
/Class

Position

Status

2A
2N
57X

1-2
3-4
24-80

M
M
M

Description

Note

Must always equal PG.
Must always be 10.
Common, market or usual name or
description, NOT product code
description of the product. Free form
description of the item.

An example of the use of PG10 record is included in Appendix A.
Note 1
For PN at least one common, market or usual name in PG10 MUST be provided.

FDA Supplemental Guidance 2.4.1

127

FDA Supplemental Guidance

Record Identifier PG13 (License Plate Issuer)
For Prior Notice, this is a conditional input record that provides data pertaining to Licenses, Permits,
Certificates or Other (LPCO). For Prior Notice submission, this PG record is only required when the
carrier is a privately owned vehicle and does not have a SCAC or IATA. For this situation, this PG
record allows for the submission of some of the license plate informati on for the subject privately
owned vehicle. The data elements included in this record are Issuer and location of issuer of the
LPCO. If using this record, a PG14 and PG23 (Carrier Name – CAN) are mandatory.

Record Identifier PG13 (Input)
Data Element

Length/
Class

Position Status Description

Note

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 13.

35X

5-39

Identifies the entity that issued the LPCO.
Leave blank - not required (reserved for future
use)

LPCO Issuer Government
Geographic Code
Qualifier

40-42

The code relating to the location of the
issuer of the POV license plate. Select one:
Canadian Province = PR
Country Code = ISO
Mexican State = MS
US State = US

Location
(Country/State/Pro
vince) of Issuer of
the LPCO

43-45

Identifies the location of the issuer of the
POV license plate (ex: the US, Mexico or
Canadian Province/State code or Foreign
Country Code). Enter the appropriate
code from Appendix B in the ACS ABI
CATAIR.

Regional
description of
location of Agency
Issuing the LPCO

25X

46-70

This description allows for the submission of
a L ic e ns e P l at e Is s uer location when the
Issuer is reported as an ISO and State or
Province other than those from the US,
Canada, or Mexico.

Filler

10X

71-80

Space fill

Issuer of LPCO

Note 1
When the Carrier or the Transport Means Owner does not have SCAC or IATA, the following data requirements
Prior Notice’s privately owned vehicle (POV) license plate information should be submitted using PG13 and
PG14.
License Plate Number

PG14 – LPCO Number

License State (US)

PG13 - LPCO Issuer - Location (Country/State/Province) of Issuer of the LPCO

License Province

PG13 - LPCO Issuer - Location (Country/State/Province) of Issuer of the LPCO

License Country

PG13 - LPCO Issuer - Government Geographic Code Qualifier

FDA Supplemental Guidance 2.4.1

128

FDA Supplemental Guidance

Record Identifier PG14 (License Plate Number)
Applicable for Prior Notice where the carrier is a privately owned vehicle, provide the Privately Owned Vehicle
license plate information.
Record Identifier PG14 (Input)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 14.

LPCO Transaction
Type
LPCO Type

3AN

6-8

Leave blank - not required (reserved for
future use)
Identifies Type Code for Privately Owned
Vehicle license plate number as
applicable.

Use “POV” for Type
LPCO Number (or
Name)

33X

9-41

Identifies the number that corresponds to
the PN Confirmation number or Privately
Owned Vehicle license plate number.

Note 1
This information is only required in cases where the carrier is a privately owned vehicle, and PG 13 is used to
report the issuer of the license plate, provide the Privately Owned Vehicle license plate information.
.

FDA Supplemental Guidance 2.4.1

129

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Prior Notice, this is a mandatory input record that provides FDA with data pertaining to Entity Role, Entity
Identification Code, Entity Identification Number, Entity Name, and Entity Address 1, specifying various trade
entities involved in this transaction.
Record Identifier PG19 (Input)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“19”

Entity Role Code

5-7

Entity Identification
Code

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity
being provided. For example: MF, UC
Code identifying the Entity Type is
entered. For example: 16 (DUNS), 47
(FEI) . Mandatory, if Entity Number is
entered.
The Entity Number of the entity based
on the above Entity Identification Code is
entered; must conform to the
descriptions in Note 2
The name of the entity is entered. If Entity
Name requires additional space, continue
in a PG60 record with Qualifier Code
‘ENA’. See validation criteria below
Conditional only for the Manufacturer,
PN Transmitter, and/or PN Submitter
entities if a Food Facility Registration
number is included in PG23 . Mandatory
for all other required entities. If Entity
Address1 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD1’. See Note 1 and validation
criteria below.

1
2

1, 2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes MANDATORY to FDA Prior Notice Message Sets is below:
Data
Element

Code

Description

PNS

PN Submitter1, 5

PNT

PN Transmitter1, 5

Entity Role
Codes§

FDA Supplemental Guidance 2.4.1

Condition
Provide DUNS, FEI number and/or full address in PG19
and PG20 or if the facility is registered you may provide
the Submitter’s FDA Food Facility Registration number in
PG23, with the Name, City, and Country in lieu of the full
address in PG19 and PG20.
POC person’s name, phone, email address information is
required for all PN in PG21.
PN Transmitter is required if the PN is not transmitted by
the PN Submitter.
Provide DUNS, FEI number and/or full address in
PG19 and PG20 or if the facility is registered you
may provide the Transmitter’s FDA Food Facility

130

FDA Supplemental Guidance
Data
Element

Code

Condition

Description

MF4

Manufacturer3, 5

-orFDC4

FDA Consolidator3, 5

-orDFI4
Grower3, 5

DEQ

Shipper5

Registration number in PG23, with the Name, City,
and Country in lieu of the full address in PG19 and
PG20
POC person’s name, phone, email address information is
required in PG21.
Provide DUNS, FEI number and/or full address in PG19
and PG20 of the manufacturer or person (if individual) as
required when the food /feed is NOT in its natural state.
Otherwise if you provide the AoC code PFR (
manufacturer’s Food Facility Registration number) in
PG23, you may provide the manufacturer’s Name, City,
and Country in PG19 and PG20 in lieu of the full address
Full address of the firm or person (if individual) who
consolidated the articles of food from the grower(s) is
required when the food/feed is in its natural state and the
grower(s) is/are unknown. If registered you may provide
the AoC Code CFR (FDA Consolidator’s Food Facility
Registration number) if available in PG23
Full address of the growing location of the grower or
person (if individual) is required when the food/feed IS in
its natural state. If registered you may provide the AoC
code GFR (Grower’s Food Facility Registration number) if
available in PG23
Full address of Shipper is required for all PN.
Provide DUNS, FEI number with full address in PG19 and
PG20, and if registered you may provide the Shipper’s
Food Facility Registration number if available in PG23

§ Same Role Code cannot be entered more than once.
List of Entity Role codes that are CONDITIONALLY REQUIRED to FDA Prior Notice Message Sets is below:

Data Element

Code

Description

Condition

Location of
Goods (Secure
Holding Facility
for PN
Purposes)
FDA Importer

This entity is only required for PN when the article of food/feed was
refused for inadequate PN and moved under CBP Supervision. This
entity is the location and address where the refused food is held.

FD1

(Importer of
Record)
UC

Ultimate
Consignee
(Delivered to
Party)2, 3

DFP

Owner2, 3

FDA Supplemental Guidance 2.4.1

Except for T & E entries, full address of the Importer is required for all
PN.
Provide DUNS, FEI number with full address in PG19 and PG20, and
if registered you may provide the Importer’s Food Facility Registration
number if available in PG23.
Except for T & E entries, full address of the UC is required for all PN.
Provide DUNS, FEI number with full address in PG19 and PG20, and
if registered you may provide the Ultimate Consignee’s Food Facility
Registration number if available in PG23.
Except for T & E entries, full address of the Owner is required by all
PN.
Provide DUNS, FEI number with full address in PG19 and PG20 and
if registered you may provide the Owner’s Food Facility Registration
number in PG23.

131

FDA Supplemental Guidance
The Entity Role of Submitter and Transmitter requires the Firm/Entity info as well as a Point of Contact
info which includes the Individual’s Full Name, Phone Number(s), and Email Address in PG21.
1

Ultimate Consignee (Deliver To Party – reference guidance), Importer and Owner info is not required IF
the entry line product is imported for transportation and exportation, i.e. T&E entry type.
2

3 The PN regulation requires ONE of the following:
IF the food/feed is NOT in natural state THEN Manufacturer (MF)
IF the food/feed is in natural state THEN Grower (DFI)
IF the food/feed is in natural state, and Grower is unknown THEN Consolidator (FDC)

Grower or Consolidator. For an article of food that is in its natural state, enter the name and growing
location address of the grower, if known. If the submitter does not know the identity of the grower or, if the
article has been consolidated and the submitter does not know the identity of any of the growers, you may
provide the name and address of the firm that has consolidated the articles of food from different growers
or different growing locations.
Only one of the Entity Role Codes MF/FDC/DFI is permitted. When AoC codes are entered along with
one of these PG19 entity role codes, then only a PFR or FME shall be used along with MF; only a GFR
may be used in conjunction with DFI; and only a CFR may be used in conjunction with FDC.
4

Full address means the facility's street name and number; suite/unit number, as appropriate; city;
Province or State as appropriate; mail code as appropriate; and country

List of Entity Role codes MAY BE APPLICABLE to FDA Prior Notice Message Sets is below. These codes may
not be used as a substitute for the mandatory or conditional entities listed above.
Data Element
Entity Role
Codes

Code

Description

PK1

Point of Contact

Any other additional POC’s information may be provided using the
Role Code PK

For role code PK, PG20 and 21 would be required in order to submit the complete address (PG19,
PG20) and name (PG21) of the individual. Also, Phone, Email address (PG21) may be additionally
required depending on the individual’s role in the Entry process.
1

Note 2
Entity Identification Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Identification
Codes) of the ACE ABI CATAIR publication. List of Entity Identification codes applicable to FDA Prior Notice
Message Sets is below:
Data Element
Entity Identification Codes1

Code
16
47

Description
D&B-assigned (DUNS number)
FDA-assigned (FEI number)

Length/
Class
9N
4- 10N

For PN purposes, FDA always requires Entity Name but the Entity Address 1 is optional for the Manufacturer, PN
Submitter, and/or PN Transmitter entities if an associated Food Facility Registration number is included in PG23.
Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI.
IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N
ELSE IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to 10 and Type = N

FDA Supplemental Guidance 2.4.1

132

FDA Supplemental Guidance

FDA Supplemental Guidance 2.4.1

133

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
For Prior Notice, this is a mandatory PGA input record that provides additional data pertaining to Entity identification
such as Entity Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This record is used with the PG19
and may be repeated if PG19 is repeated.

Record Identifier PG20 (Input)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 20.

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite
Number
Entity City

37-41

Address Line 2 for the Entity. If Entity
Address2 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD2’.
Apartment/Suite number of the entity.

21X

42-62

Entity
State/Province
Entity Country

63-65

66-67

Entity Zip/Postal
Code
Filler

68-76

City of the entity. If Entity City requires
additional space, continue in a PG60
record with Qualifier Code ‘ECI’.
State/Province of the entity. See Appendix
B in the ACS ABI CATAIR for valid codes.
ISO Country Code. See Appendix B in the
ACS ABI CATAIR for valid codes.
Zip/Postal Code of the entity.

77-80

Space fill

FDA Supplemental Guidance 2.4.1

134

FDA Supplemental Guidance

Record Identifier PG21 (Point of Contact)
For Prior Notice, this is a mandatory PG input record that provide2 data about an Individual POC’s information.
The contact may also be related to an entity (the party) in the preceding PG19 record. Included in this record are
the Individual Name, Telephone Number and Email address.

Record Identifier PG21 (Input)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 21.

Individual Qualifier

5-7

Individual Name

23X

8-30

Telephone Number
of the Individual

15X

31-45

Email Address for
the Individual

35X

46-80

Identify the type of party or facility the
Individual represents. For example,
person is associated to the PN
Submitter and PN Transmitter. For valid
codes, use the Entity Role Codes from
PG19 (See Appendix PGA of this
publication.)
Name of the Individual. If the name will
not fit, continue in a PG60 record with
Qualifier Code ‘INA’.
Telephone number of the Individual.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore
Email Address of the individual. If the
Email Address needs more space,
continue in a PG60 record with Qualifier
Code ‘EMA’.

1, 2, 3
1
1

Note 1
Prior Notice regulation requires PG21 data for the Entity Roles of PN Submitter, and PN Transmitter. Other
condition where PG21 information is required for Prior Notice is specified in PG19 mandatory and conditional data
sections.

Data Element
Entity Role Codes

FDA Supplemental Guidance 2.4.1

Code

Description

Point of Contact

135

FDA Supplemental Guidance
Note 2
Individual’s Name should have the following format:
Last Name, First Name

Middle Name

Note 3
If the individual’s Name is longer than 23 characters, then the PG24 Remarks records should be used to indicate
the full name of the individual. Individual’s Name should still follow the same format when using PG24:
Last Name, First Name

Middle Name

FDA Supplemental Guidance 2.4.1

136

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
For Prior Notice, these are conditional or optional PGA input records that provide data pertaining to Food and
Drug Administration Affirmation of Compliance Criteria. This record is typically only used by FDA. This record is
repeatable.
Record Identifier PG23 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Record Type

3-4

Must always be 23.

Affirmation of
Compliance Code

5-9

30AN

10-39

A code used to affirm compliance
with FDA requirements. If the
merchandise is subject to BTA, use
this field to report the appropriate
affirmation of compliance information,
not reported elsewhere. See
Appendix PGA (Food & Drug
Affirmation of Compliance Codes) of
this publication for valid codes.
Text describing the information
required by the PGA. This could
include a number or a country code,
etc. Also, see Appendix PGA (Food &
Drug Affirmation of Compliance
Qualifier Codes) of this publication for
valid codes related to certain specific
Affirmation of Compliance codes.
Space fill

Affirmation of
Compliance
Qualifier

Filler

Description

Note

Must always equal PG.
1,2

Note 1
The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication.
The list of CONDITIONAL AoC codes for the FDA Prior Notice Message Set is below:
Data
Element

Code

Description

Syntax

Business Rules
See Appendix B at the end of this document for
valid codes
When food or feed is in a natural state and the
entity role code DFI(Grower) or FDC
(Consolidator) is entered in lieu of manufacturer,
FME and food facility registration number are
NOT required.
Either FME or PFR is required when the
Manufacturer is transmitted. If both FME and
PFR are submitted, FDA will review the
registration.

Affirmation
of
Compliance
Code

FME

Food Processing
Facility Registration
Exemption

FDA Supplemental Guidance 2.4.1

137

FDA Supplemental Guidance
Data
Element

Code

Description

Syntax

Business Rules
Required If MOT = Rail or MOT = Containerized
Rail. For multiple Rail Car Numbers, repeat
PG23 as needed.

RNO

Rail Car Number

CAN
VFT

Carrier Name
Voyage, Trip, Flight
Number

If the Rail Car Number is not available, enter
‘Does Not Exist’.
If using a PG13 record OR if the SCAC or IATA
are not provided this AoC value is required.
If the article of food is arriving by express
consignment operator or carrier and neither the
PN submitter or PN transmitter is the express
consignment operator or carrier, the express
consignment operator or carrier tracking number
may be submitted in lieu of the flight number.
Otherwise, VFT is required if MOT = Air,
Rail, Truck or Ocean, if it exists.
If the Trip Number is not available, enter ‘Does
Not Exist’.

VES

Vessel Name

PFR

Manufacturers food
facility registration
number

Required If MOT = Ocean
11N

Manufacturer registration number is required
unless FME and Reason code is submitted or
consolidator / grower role code is submitted in
lieu of manufacturer for food in its natural state.
If both FME and PFR are submitted, FME is not
used by the FDA.

Note 2
The list of OPTIONAL AoC codes for the FDA Prior Notice Message Set is below:
Data
Element

Code

Description

SFR

Shippers food facility
registration number
Ultimate consignee
food facility
registration number
Importers food facility
registration number
Transmitter food
facility registration
number
Owners food facility
registration numberSubmitters food
facility registration
number

UFR
IFR
TFR
ORN
SRN

FDA Supplemental Guidance 2.4.1

Syntax

Business Rules

11N

optional

11N

optional

11N

optional

11N

optional

11N

optional

11N

optional

138

FDA Supplemental Guidance
CFR
GFR

LFR

FDA Consolidator
food facility
registration number
Growers food facility
registration number
Location of Goods
(Holding Facility
Registration Number)

FDA Supplemental Guidance 2.4.1

11N

optional

11N

optional

11N

optional

139

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

A code indicating the type of remarks.
Valid codes are listed in Appendix PGA
(Remarks
Type
Code)
of
this
publication. FDA uses GEN as its valid
value.
Free form text relevant to the shipment
or the commodity.

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

140

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
For Prior Notice, this is a conditional input record that provides data pertaining to: Lot Number required by FDA
regulations for Infant formula, Acidified Foods, and LACF products. This record is repeatable for multiple Lot
Number Qualifiers and Lot Numbers.
Record Identifier PG25 (Temperature Qualifier)
Data Element

Length/
Class

Position

Status

1-2

Must always equal PG.

Record Type

3-4

Must always be 25.

Lot Number
Qualifier

1AN

Includes Lots and/or Batches.
Mandatory for Infant formula, Acidified
Foods, and LACF/AF products. Should
not be entered if more than one PG25
record is entered.

Lot Number

25X

16-40

Control Identifier

Description

Note

1 = Manufacturer
The lot number that the manufacturer
assigned to the product. Mandatory for
Infant formula, Acidified Foods, and
LACF products.

Required, if more than one PG25
record is entered.
Note 1:
Using the FDA Product Code in PG02, the following classifications are made where specific imported food/feed
products require the submission of lot or code numbers or other identifier with prior notice. These include:
LACF and Acidified:
Industry Codes: 02-39, 41, 71, & 72
With Process Indicator Code (PIC): Acidified-I, Aseptic-F, Commercially Sterile-E
Infant Formula:
Industry Code: 40
With Class:
C-Formula Prod (Baby)
N-Ready to Feed Formula Product
O-Liquid Concentrate Formula Product
P-Powder Formula Products
R-Infant Formula for Sample Testing (not for sale)

FDA Supplemental Guidance 2.4.1

141

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
For Prior Notice, this is a mandatory input record that provides FDA with estimated quantity of food to be shipped
by describing the Packaging Qualifier, Quantity, Unit of Measure, Package Identifier, Packaging Method, Package
Material, and Packaging Filler. This record can be repeated up to six (6) times, once for each unique packaging
level. The first record is used to describe the largest (outermost) container and the number of containers at this
packaging level. The second record is used to describe the contents of the next smallest container. If needed,
qualifiers 2-6 are used in a similar manner (largest to smallest container). The final record must describe the
actual amount of the product in the smallest container.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.
Record Identifier PG26 (Input)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging
for the product. Outermost (largest=1)
packages to the innermost (smallest=6)
packages. There can be up to 6 levels of
packaging. If reporting only one level,
show the total quantity for the item and
report that as level 1.
“Quantity of the packaging level, For
example, 000000000400. Two decimal
places are implied. Must be greater than
zero.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among
the PG26 records.

Unit of Measure
(Packaging Level)

Description

Note

1, 4

2, 4

3, 4

Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Prior Notice Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.

Valid FDA Food Units of Measure for Packaging Containers
FDA Supplemental Guidance 2.4.1

142

FDA Supplemental Guidance

Code
AE
AM
AP
AT
BA
BB
BC
BE
BF
BG
BH
BI
BJ
BK
BL
BN
BO
BP
BQ
BR
BS
BU
BV
BX
BZ
CA
CAG
CB
CC
CE
CF
CH
CI
CJ
CK
CL
CO
CON
CP
CR

FDA Supplemental Guidance 2.4.1

Description
Aerosol
Ampoule, Non-Protected
Ampoule, Protected
Atomizer
Barrel (Container)
Bobbin
Bottle crate, Bottle rack
Bundle
Balloon, Non-Protected
Bag
Bunch
Bin
Bucket
Basket
Bale, Compressed
Bale, Non-Compressed
Bottle, Non-Protected, Cyl
Balloon, Protected
Bottle, Protected, Cylnd
Bar
Bottle, Non-Prot Bulbous
Butt
Bottle, Protected Bulbous
Box
Bars in Bundle/Bunch/Trus
Can, Rectangular
Cage
Crate, Beer
Churn
Creel
Coffer
Chest
Canister
Coffin
Cask
Coil
Carboy, Non-Protected
Container
Carboy, Protected
Crate

143

FDA Supplemental Guidance

CS
CT
CU
CV
CX
CY
CZ
DJ
DP
DR
EN
FC
FD
FI
FL
FO
FR
GB
HG
HR
JC
JG
JR
JT
JY
KEG
KIT
MB
MC
MS
MT
NE
NS
NT
PA
PAL
PC
PH
PK
PL
PO
PT

FDA Supplemental Guidance 2.4.1

Case
Carton
Cup
Cover
Can, Cylindrical
Cylinder
Canvas
Demijohn, Non-Protected
Demijohn, Protected
Drum
Envelope
Crate, Fruit
Crate, Framed
Firkin
Flask
Footlocker
Frame
Bottle, Gas
Hogshead
Hamper
Jerri can, Rectangular
Jug
Jar
Jute bag
Jerri can, Cylindrical
Keg
Kit
Bag, Multi-ply
Crate, Milk
Sack, Multiwall
Mat
Unpacked Or Unpackaged
Nest
Net
Packet
Pallet
Parcel
Pitcher
Package
Pail
Pouch
Pot

144

FDA Supplemental Guidance

PU
PY
RG
RO
SA
SC
SD
SE
SH
SK
SL
SU
SW
SZ
TB
TC
TD
TK
TN
TO
TR
TS
TU
TY
TZ
VA
VG
VI
VL
VO
VP
VQ
VR
VY
WB

Tray or Tray Pack
Plates in Bndl/Bnch/Truss
Ring
Roll
Sack
Crate, Shallow
Spindle
Sea-chest
Sachet
Case, Skeleton
Slipsheet
Suitcase
Shrinkwrapped
Sheets in Bndl/Bnch/Truss
Tub
Tea-Chest
Tube, Collapsible
Tank, Rectangular
Tin
Ton
Trunk
Truss
Tube
Tank, Cylindrical
Tubes in Bndl/Bnch/Truss
Vat
Bulk Gas at 1031 MBAR
Vial
Bulk Liquid
Bulk,Solid,Lg Particles
Vacuum-packed
Bulk Liquified Gas
Bulk,Solid,Granular Parti
Bulk,Solid,Fine Particle
Wickerbottle

Valid FDA Food Units of Measure for the Base Unit (Last Quantity Transmitted)
Code
BBL
BOL
FDA Supplemental Guidance 2.4.1

Description
Barrels (42 Gallons Ea)
Boluses

Measure Type
Volume
Dosage
145

FDA Supplemental Guidance

CAR
CAP
CFT
CG
CM3
CYD
DOZ
DPC
DPR
FOZ
G
GAL
GR
KG
KM3
L
LB
M3
MCG
MG
ML
NO
OZ
PCS
PRS
PTL
QTL
STN
T
Tab
TON
TOZ

Carats
Capsules
Cubic Feet
Centigrams
Cubic Centimeters
Cubic Yards
Dozen
Dozen Pieces
Dozen Pairs
Ounces, fluid
Grams
Gallons (US)
Gross
Kilograms
1,000 Cubic Meters
Liters
Pounds (avdp)
Cubic Meters
Micrograms
Milligrams
Milliliters
Number
Ounces, weight (avdp)
Pieces
Pairs
Pints, liquid (US)
Quarts, liquid (US)
Short ton (2000 LB)
Metric Ton
Tablets
Long Ton (2240 LB)
Ounces, Troy or Apoth

Weight
Dosage
Volume
Weight
Volume
Volume
Count
Count
Count
Volume
Weight
Volume
Count
Weight
Volume
Volume
Weight
Volume
Weight
Weight
Volume
Count
Weight
Count
Count
Volume
Volume
Weight
Weight
Dosage
Weight
Weight

Note 4
Quantity Data provides additional information to FDA about the product and how it is packaged. The basic format
for Quantity Data is in multiple pairs of data – quantity and unit of measure, i.e., 500 cases, 12 ounces, fluid, 1000
cartons, etc. Up to 6 data pairs may be submitted, beginning with the 1st pair for the outermost packaging when
Packaging Qualifier = 1. The first pair may describe the largest container and the last pair must describe the
amount of product in the smallest container. For example:
Product: 1000 cases of mineral water, 24/12 ounce bottles in each case
Packaging Qualifier =1: 1000 CS (Case)
Packaging Qualifier =2: 24 BO (Bottle, Non-protected, Cyl)
Packaging Qualifier =3: 12 FOZ (Ounces, fluid)

FDA Supplemental Guidance 2.4.1

146

FDA Supplemental Guidance

FDA Supplemental Guidance 2.4.1

147

FDA Supplemental Guidance

Record Identifier PG27 (Container Information)
For Prior Notice, this is a conditional PGA input record that provides data pertaining to the Container Number.
Data provided should match the Container number info included in the Bill of Lading. This record is repeatable.
Record Identifier PG27 (Container Information)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“27”.

Container Number
(Equipment ID)

20AN

5-24

Container Number
(Equipment ID)

20AN

28-47

Container Number
(Equipment ID)

20AN

51-70

74-80

The number of the shipping container (CNO)
as entered in the Bill of Lading based on the
Mode of Transportation (MOT). This is
applicable for food arriving as containerized
cargo by water, air, rail, or land, the container
number(s) is required for prior notice.
The number of the shipping container (CNO)
as entered in the Bill of Lading based on the
Mode of Transportation (MOT). This is
applicable for food arriving as containerized
cargo by water, air, rail, or land, the container
number(s) is required for prior notice.
The number of the shipping container (CNO)
as entered in the Bill of Lading based on the
Mode of Transportation (MOT). This is
applicable for food arriving as containerized
cargo by water, air, rail, or land, the container
number(s) is required for prior notice.
Space fill

Filler

FDA Supplemental Guidance 2.4.1

148

FDA Supplemental Guidance

Record Identifier PG28 (Express Courier Tracking Number)
For Prior Notice if the Mode of Transportation is mail or express courier then Package Tracking Number Code
and Package Tracking Number are conditionally required, i.e. may be submitted in PG28 in lieu of the airway bill
or bill of lading and in lieu of the flight number in PG23.
Record Identifier PG28 (Input)
Data Element
Length/
Class
Control Identifier
2A
Record Type
2N
Package Tracking
4AN
Number Code
Package Tracking
Number

50AN

Position

Status

1-2
3-4
17-20

M
M
C

21-70

Description

Note

“PG”.
“28”.
Enter SCAC for Express Consignment
Carrier/Courier. For those express
consignment carriers without a SCAC,
leave blank & enter carrier name in PG23
Tracking numbers used by Express
Consignment Carrier

Note 1:
If the article of food is arriving by express consignment operator or carrier and neither the PN submitter or PN
transmitter is the express consignment operator or carrier, the express consignment operator or carrier tracking
number may be submitted in lieu of the Airway Bill number(s) or Bill of Lading number(s), and in lieu of the flight
number in PG23.

FDA Supplemental Guidance 2.4.1

149

FDA Supplemental Guidance

Record Identifier PG30 (Anticipated Arrival Info and Port of Arrival / Entry)
This is a mandatory PGA input record that provides data pertaining to the date, time and location of the
anticipated arrival/entry information for all FDA products. While other PGAs may use PG30 to Collect Inspection
and Lab information, currently FDA will utilize this record to collect Anticipated Arrival/Entry Information at this
time.
For Prior Notice, this is a mandatory PGA input record, with status code A in position 5, that provides data
pertaining to the date, time and location of anticipated arrival information for FDA BTA.
Record Identifier PG30 (Port of Arrival / Entry Information)
Data Element

Length
/Class

Position

Status

Description

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 30.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival/
Entry time

Note

1
A = Anticipated arrival information

6-13

A numeric date in MMDDCCYY (month,
day, century, year) format.
Military time HHMM in (hour, minute)
format. (Example: 1015, this represents
10:15 a.m.). For midnight, use 2400 (0000
is invalid).
Location type code from Appendix PGA;
only the value of 2 (= Schedule D Port
codes) is allowed

14-17

Arrival / Entry
Location Code

4AN

18-21

Port of Arrival /
Entry
Filler

50X

22-71

For valid port codes, refer to note 3.

72-80

Space fill

Note 2:

FDA Supplemental Guidance 2.4.1

150

FDA Supplemental Guidance
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

151

FDA Supplemental Guidance

Record Identifier PG55 (Additional Roles)
For Prior Notice, this is an optional input record used to provide additional roles performed by an entity or
individual identified in PG19.
The PG55 record is not supported by FDA at this time. Multiple PG19 records should be used to input more than
one Entity-Role combination. Refer to the PG19 section for details.
Record Identifier PG55 (Input)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 55.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
46X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
35-80

C
C
C
C
C
C
C
C
C
C
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Description

Note

Record not supported
by FDA at this time

FDA Supplemental Guidance 2.4.1

152

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

153

FDA Supplemental Guidance

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

FDA Supplemental Guidance 2.4.1

Sequential number assigned to, or
referring to, a specific substitution group
of data provided at the header level.
This data element is mandatory when
using the S or R substitution indicator.
Space fills.

154

FDA Supplemental Guidance

Food Commodity Combined Entry Submission - Data Elements and Values
In this scenario both 801a and 801m data elements will be submitted as a single message for an Entry.
Food commodities can be broken down into the following categories using the existing Government Agency data
elements available in the PG01 message
PG01 Government
Agency Code

Commodity
Type

PG01 Government
Agency
Program Code

Commodity Sub-Type

PG01 Government
Agency
Processing Code

FDA

Food

FOO

Natural State Food

NSF

FDA

Food

FOO

Processed Food

PRO

FDA

Animal Food
Food

FOO

(includes pet food, medicated feed
and feeds)

FEE

FDA

Food

FOO

Additives and Colors

ADD

FDA

Food

FOO

Dietary Supplements

DSU

Table 4b – Food commodity hierarchy
This chapter describes the data elements and their business rules for a 801A entry, with the Government Agency
Program Code = ‘FOO’, which may be subject to PN regulations. To satisfy the PN requirements in a combined
entry (801a and 801m), a PG14 record may be included in the combined entry in addition to all applicable PG
records described in this chapter.

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The following are the potential PGA records associated with submitting Foods with PN processing:
PG Record

Description

Record Identifier (The commercial description of the shipment is provided)

PG01

PGA Identifier (The shipment is regulated by the FDA program office within FDA and the
intended use is provided)

PG02

Product Identifier (The item type and the FDA Product Code details are provided)

PG05

Scientific Genus Name (Optional information related to the scientific species name and code)

PG06

Product Origin (FDA Country of Production, Shipment, and Refusal)

PG07

Product Trade Name (Conditional submission of product market name)

PG10

Product Characteristics (Line level item common/usual name)

PG13

License Plate Issuer [Privately Owned Vehicle (POV) Information]

PG14

License Plate Number [Privately Owned Vehicle (POV) Information]

PG19

Entity Data (Trade entity’s Transaction Role, Identification Type, Identification Number, and 1 st
line of address)

PG20

Entity Address (Continuation of Entity information including Address line 2, City, State/Province,
Country for entities provided in PG19)

PG21

Point of Contact [Individual (POC) Information including Name, Phone Number, Email address
for trade entities]

PG23

Affirmation of Compliance [FDA’s Affirmation of Compliance (AofC) Criteria including food
facility registration, specific PN information, and other food related codes]

PG24

Remarks (Continuation of POC name as necessary)

PG25

Product Condition (Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA
Unit Value are provided)

PG26

Product Packaging (Packaging qualifier and quantity of the shipment are provided)

PG27

Container Number

PG28

Express Courier Tracking (Number) and Can Dimensions(LACF Only) §

PG29

Unit of Measure (Data pertaining to the net or gross unit of measure of the commodity)

PG30

Anticipated Arrival Information

PG55

Additional roles performed by entity or individual (future use)

PG60

Additional Information

PG00

Data Substitution

§ CBP confirmed that the SE header can only be used to submit express courier tracking numbers in the air
environment. Therefore, all express courier tracking numbers for PNs in the air environment should be submitted
in the SE. Express courier tracking numbers for PNs for food shipments in the ground environment are to be
reported in the PG28.

FDA Supplemental Guidance 2.4.1

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FDA Supplemental Guidance

Prior Notice Non-PGA Data Elements by Mode of Transportation (See Note)
MOT

AIR

OCEAN

LAND - Bus,
Truck

LAND - Rail

Express
Consignment
Carrier

Required Data Elements

Mapping

Mapping - Data Elements

IATA

SE15

Carrier

Airway Bill Number

SE15

Flight Number

PG23

Container Number

PG27

Ref Qual Code = AWB, Ref ID Num
AofC - VFT - Voyage/Flight/Trip
Number
Container Number

Carrier Name

PG23

Bill of Lading

SE15

Vessel Name

PG23

Voyage Number

PG23

Container Number

PG27

Carrier Name

PG23

Bill of Lading

SE15

Trip Number

PG23

SCAC

SE15

AofC - CAN - Carrier Name
Ref. Qual. Code ‘BIL,’ Bill Type
Indicator ‘R,’ and report the Simple Bill
of Lading Number in the Reference
Identifier Number field
AofC - VFT - Voyage/Flight/Trip
Number
Carrier

Container Number *

PG27

Container Number

Carrier Name

PG23

AofC - CAN - Carrier Name

Bill of Lading

SE15

Trip Number

PG23

SCAC

SE15

Ref Qual Code = BIL, Ref ID Num
AofC - VFT - Voyage/Flight/Trip
Number
Filer/SCAC Code, Ref ID Num

Rail Car Number

PG23

AofC – RNO - Rail Car Number

Container Number *
Tracking Number

PG27

Container Number
Report Express Consignment
Carrier/Courier tracking number for the
shipment as applicable.
SCAC may be entered in PG28
otherwise use PG23 AofC - CAN –
Carrier Name

PG28
Carrier Name

PG28 or
PG23

AofC - CAN - Carrier Name
Ref. Qual. Code ‘BIL,’ Bill Type
Indicator ‘R,’ and report the Simple Bill
of Lading Number in the Reference
Identifier Number field
AofC – VES – Vessel Name
AofC - VFT - Voyage/Flight/Trip
Number
Container Number

* if applicable

Note: The above table makes references to select entry-level data elements from the SE15 to provide the context
and to identify from which data source FDA expects to receive a number of the required prior notice data
elements for the specific modes of transportation. For additional information on the data elements found within
the SE15 record, please refer to the relevant CBP documentation. This supplemental guidance document
describes only line-level data within the structure of the FDA PG Message Set.

FDA Supplemental Guidance 2.4.1

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FDA Supplemental Guidance

Prior Notice Combined Entry Example
Prior Notice Combined Entry message set layout sample below:
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: FOO+PN
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

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FDA Supplemental Guidance

Record Identifier OI (Record Identifier)
This is a mandatory PGA line item description input record that provides the general commercial description of the
item. This record precedes the Record Identifiers for the PGA Message set.
Record Identifier OI
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product.
For example, NATURE’S FINEST REAL
FRUIT JUICE, 12 OUNCE BOTTLES

FDA Supplemental Guidance 2.4.1

Description

Note

159

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government Agency
Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use Code,
Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the imported
commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Description/Required Value

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government Agency
Code

3AN

8-10

Government Agency
Program Code

11-13

Government Agency
Processing Code

3AN

14-16

Intended Use Code

16X

42-57

Intended Use
Description
Correction Indicator

21X

58-78

Disclaimer

“FDA”
“FOO”

Allowed values: NSF, PRO, FEE, ADD, DSU

For future Use

Note 1
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. otherwise the Government
Agency Program Code, Government Agency Processing are mandatory.
Note 2
Choose one of these intended use codes based on the product requirements. The submission of an Intended use
code is not a requirement for prior notice.
CFSAN Regulated Products
Intended Use Code CBP Intended Use Name
Import Scenario
260.000
For Research Use as Human Food
For Research Use as Human Food
015.000
For Research Use as an Animal Food
For Research Use as an Animal Food
210.000
Personal Importation
For Personal Use as Human Food

FDA Supplemental Guidance 2.4.1

160

FDA Supplemental Guidance

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.

Data Element

Product Code
Qualifier
Product Code
Number

4AN

6-9

19X

10-28

Description

Note

Only one ‘P’ record is allowed for the same PGA
Line # in PG01.
“FDP”

FDA Product Code Must be equal to 7
characters

Note 1
Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For Food commodity, this is currently always ‘FDP’ for all FDA products.
Only one Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Group
Code
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

A product is subject to Prior Notice requirements if the following condition is satisfied.

FDA Supplemental Guidance 2.4.1

161

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

Record Type

3-4

“05”.

Scientific Genus
Name
Scientific Species
Name
Scientific Sub
Species Name

22X

5-26

22X

27-48

18X

49-66

Scientific Genus Name of the merchandise
being entered.
Scientific Species Name of the merchandise
being entered.
Scientific Sub Species Name of the
merchandise being entered.

FDA Supplemental Guidance 2.4.1

162

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

1-2

“PG”.

2N
3AN

3-4
5-7

M
M

“06”.
Source Type Code must be selected using
the following logic:
IF Government Agency Program Code =
FOO and natural state food
THEN use 262 (Place of growth)
ELSE use 39 (Country of Production).

IF Government Agency Program Code =
FOO, THEN requires CSH (Country of
Shipment).
Country Code

8-9

IF refused from other country(s), use 294.
Foods require the harvesting or production
location of the product. Should match the
country code in PG19-PG20 record set
based on the value entered for Source Type
Code:
Source Type Code
39
262

Entity Role Code
MF
DFI or FDC

Note 1
Source Type Code from Appendix PGA, PG06 – Source Type Codes may be entered.
Prior Notice requires the following data elements:
Country of Shipment, Source Type Code = CSH (required for Prior Notice)
All Natural State Human Food and Animal Food requires the
Country of Growth, Source Type Code = 262 - if made from fish/seafood aboard a vessel =
country in which the vessel is registered.
Non-Natural State Human Food and Animal Food requires the
Country of Production, Source Type Code = 39- if made from fish/seafood aboard a vessel =
country in which the vessel is registered.
Country of Entry Refusal, if the article of food has been refused by other country(ies), provide the ISO country
code(s) and. (Source Code Type = 294)
Note 2
ISO Country codes from Appendix D (ISO Country and Currency Codes) in the ACS ABI CATAIR must be
entered.

FDA Supplemental Guidance 2.4.1

163

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is an optional PGA input record that provides data pertaining to Trade or Brand Name.
Record Identifier PG07 (Product Trade Names)
Data Element

Length/
Class

Position

Status

Description

Control Identifier

1-2

“PG”

Record Type

3-4

“07”

Trade Name/Brand
Name

35X

5-39

Note

Market, Trade, or Brand Name that
describes the food or feed product at each
line level. If Trade/Brand Name requires
additional space, continue in a PG60 record
with Qualifier Code ‘TBN’.

FDA Supplemental Guidance 2.4.1

164

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
For Food, this is a mandatory PGA input record that allows for importer to report the description of the product at
the line level to capture the information currently collected in multiple OI records. This record can be repeated if
there are more Commodity Characteristic Descriptions.
Record Identifier PG10 (Product Characteristics)
Data Element
Control Identifier

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Common, market or usual name or
description, NOT product code description of
the product. Free form description of the
item.

FDA Supplemental Guidance 2.4.1

165

FDA Supplemental Guidance

Record Identifier PG13 (Input)
Data Element

Position Status Description

Length/
Class

Note

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 13.

5-39

Identifies the entity that issued the LPCO.

Issuer of LPCO

35X

LPCO Issuer Government
Geographic Code
Qualifier

40-42

The code relating to the location of the
issuer of the POV license plate. Select one:
Canadian Province = PR
Country Code = ISO
Mexican State = MS
US State = US

Location
(Country/State/Pr
ovince) of Issuer
of
the LPCO

43-45

25X

46-70

10X

71-80

This description allows for the submission of
a L ic e ns e P l at e Is s uer location when the
Issuer is reported as an ISO and State or
Province other than those from the US,
Canada, or Mexico.
Space fill

Regional
description of
location of
Agency
Issuing the LPCO
Filler

Note 1
When the Carrier or the Transport Means Owner does not have SCAC or IATA, the following data requirements Prior Notice’s
privately owned vehicle (POV) license plate information should be submitted using PG13 and PG14.
License Plate Number

PG14 – LPCO Number

License State (US)

PG13 - LPCO Issuer - Location (Country/State/Province) of Issuer of the LPCO

License Province
License Country

PG13 - LPCO Issuer - Location (Country/State/Province) of Issuer of the LPCO
PG13 - LPCO Issuer - Government Geographic Code Qualifier

FDA Supplemental Guidance 2.4.1

166

FDA Supplemental Guidance

Record Identifier PG14 (License Plate Number)
As applicable for Prior Notice where the carrier is a privately owned vehicle, provide the Privately Owned Vehicle
license plate information.
Record Identifier PG14 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 14.

LPCO Transaction
Type

Leave blank - not required (reserved for
future use)

3AN

6-8

Identifies Type Code for Privately Owned
Vehicle license plate number as
applicable.

Data Element

LPCO Type

Description

Note

Use “POV” for Type
LPCO Number (or
Name)

33X

9-41

Privately Owned Vehicle license plate
number.

FDA Supplemental Guidance 2.4.1

167

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Foods, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role and
conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“19”

Entity Role Code

5-7

Entity Identification
Code

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity
being provided. For example: MF, UC
Code identifying the Entity Type is
entered. For example: 16 (DUNS), 47
(FEI) . Mandatory, if Entity Number is
entered.
The Entity Number of the entity based
on the above Entity Identification Code is
entered; must conform to the
descriptions in Note 2
The name of the entity is entered. If Entity
Name requires additional space, continue
in a PG60 record with Qualifier Code
‘ENA’. See validation criteria below.
Conditional only for the PN Transmitter
and PN Submitter entities if a Food
Facility Registration number is included
in PG23. Mandatory for all other
required entities. If Entity Address1
requires additional space, continue in a
PG60 record with Qualifier Code ‘AD1’.
See Note 1 for validation criteria below.

Data Element

Description

Note

1
2

1, 2

Code

Description

PNS

PN Submitter1, 5

PNT

PN Transmitter1, 5

Entity Role
Codes§

FDA Supplemental Guidance 2.4.1

Condition
Provide DUNS, FEI number and/or full address in
PG19 and PG20 or if the facility is registered you
may provide the Submitter’s FDA Food Facility
Registration number in PG23, with the Name, City,
and Country in lieu of the full address in PG19 and
PG20.
POC person’s name, phone, email address
information is required for all PN in PG21.
PN Transmitter is required if the PN is not
transmitted by the PN Submitter.
Provide DUNS, FEI number and/or full address
in PG19 and PG20 or if the facility is registered
you may provide the Transmitter’s FDA Food

168

FDA Supplemental Guidance
Data
Element

Code

Description

MF4

Manufacturer3, 5

-orFDC4

FDA Consolidator3, 5

-orDFI4
Grower3, 5

DEQ

Shipper5

Condition
Facility Registration number in PG23, with the
Name, City, and Country in lieu of the full
address in PG19 and PG20
POC person’s name, phone, email address
information is required in PG21.
Provide DUNS, FEI number and/or full address in
PG19 and PG20 of the manufacturer or person (if
individual) as required when the food /feed is NOT in
its natural state. Although the PN submission allows
you to provide the manufacturer’s Food Facility
Registration number in PG23, and the
manufacturer’s Name, City, and Country in PG19
and PG20 in lieu of the full address, the full address
is required to satisfy FDA 801(a) requirements.
Full address of the firm or person (if individual) who
consolidated the articles of food from the grower(s)
is required when the food/feed is in its natural state
and the grower(s) is/are unknown. If registered you
may provide the FDA Consolidator’s Food Facility
Registration number if available in PG23
Full address of the growing location of the grower or
person (if individual) is required when the food/feed
IS in its natural state. If registered you may provide
the Grower’s Food Facility Registration number if
available in PG23
Full address of Shipper is required for all PN.
Provide DUNS, FEI number with full address in
PG19 and PG20, and if registered you may provide
the Shipper’s Food Facility Registration number if
available in PG23

FD1

DFP

FDA Importer 1
(Importer of Record)

Owner2,

FDA Supplemental Guidance 2.4.1

Full address of the Importer is required for all PN
and entries.
Provide DUNS, FEI number with full address in
PG19 and PG20, and if registered you may provide
the Importer’s Food Facility Registration number if
available in PG23
Full address of the Owner is required for all PN.
Provide DUNS, FEI number with full address in
PG19 and PG20 and if registered you may provide
the Owner’s Food Facility Registration number in
PG23.

169

FDA Supplemental Guidance
Data
Element

Condition

Code

Description

Ultimate Consignee
(Delivered to Party)2,

Full address of the UC is required for all PN and
entries.
Provide DUNS, FEI number with full address in
PG19 and PG20, and if registered you may provide
the Ultimate Consignee’s Food Facility Registration
number if available in PG23

§ Same Role Code cannot be entered more than once.
The Entity Role of Submitter and Transmitter require the Firm/Entity info as well as a Point of Contact
info which includes the Individual’s Full Name, Phone Number(s), and Email Address in PG21.
1

Ultimate Consignee (Deliver To Party – reference guidance) and Owner info is not required IF the entry
line product is imported for transportation and exportation, i.e. T&E entry type.
2

Even though Title 19 141.19 (CBP) addresses - Consignee -, Title 21, Requires Prior Notice information
about the - Ultimate Consignee - and Title 19 (CBP) defines - Ultimate Consignee -, FDA acknowledges
that these terms cause confusion and would like to simplify and harmonize said data elements under the
ACE environment.
Hence, the FDA has elected to utilize the data element --- “Deliver to Party” ---, U.S party that physically
receives the good(s). The FDA’s PG Message Set will, therefore, incorporate the deliver to party as
issued in the ITDS Standard Data Set under the auspices of the ITDS Board of Directors. FDA interprets
the Prior Notice requirement for ultimate consignee to be synonymous with the deliver to party.
The PN regulation requires ONE of the following:
IF the food/feed is NOT in natural state THEN Manufacturer
IF the food/feed is in natural state THEN Grower
IF the food/feed is in natural state, and grower is unknown THEN Consolidator
3

Grower or Consolidator. For an article of food that is in its natural state, enter the name and growing
location address of the grower, if known. If the submitter does not know the identity of the grower or, if the
article has been consolidated and the submitter does not know the identity of any of the growers, you may
provide the name and address of the firm that has consolidated the articles of food from different growers
or different growing locations.
Only one of the Entity Role Codes MF/FDC/DFI is permitted. If AoC codes are entered along with one of
these PG19 entity role codes, then only a PFR or FME shall be used along with MF; only a GFR may be
used in conjunction with DFI; and only a CFR may be used in conjunction with FDC.
4

5 Full address means the facility's street name and number; suite/unit number, as appropriate; city; Province or
State as appropriate; mail code as appropriate; and country
List of Entity Role codes that are CONDITIONALLY REQUIRED to FDA Prior Notice Message Sets is below:

Data Element

Code

Description

FDA Supplemental Guidance 2.4.1

Condition

170

FDA Supplemental Guidance
Entity Role
Codes

Location of
Goods (Secure
Holding Facility
for PN
Purposes)

This entity is only required for PN when the article of food/feed
was refused for inadequate PN and moved under CBP
Supervision. This entity is the location and address where the
refused food is held.

Code

Description

PK1

Point of Contact

Any other additional POC’s information may be provided using the
Role Code PK. This is in lieu of IATA or SCAC information.

For role code PK, PG20 and PG21 would be required in order to submit the complete address (PG19,
PG20) and name (PG21) of the individual. Also, Phone, Email address (PG21) may be additionally
required depending on the individual’s role in the Entry process.
1

Code
16
47

Description
D&B-assigned (DUNS number)
FDA-assigned (FEI number)

Length/
Class
9N
4- 10N

For PN (801m) purposes, FDA always requires Entity Name but the Entity Address 1 for Manufacturer, PN
Submitter and PN Transmitter is optional if an Food Facility Registration number is included in PG23. However,
for Manufacturer, Entity Address 1 is required to satisfy 801a regulations. Additionally, FDA prefers to use DUNS
numbers for identifying the Entity; IF DUNS is not available THEN FEI.
Entity Name <>NULL AND Entity Address 1 <>NULL AND
IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N
ELSE IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to 10 and Type = N

FDA Supplemental Guidance 2.4.1

171

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
This is a mandatory PGA input record that provides additional data pertaining to the Entity identified in the preceding
PG19 record; such as Entity Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This record is used
when additional address for the entity needs to be entered.
Record Identifier PG20 (Entity Address)
Data Element
Control Identifier

Length/
Class

Position

Status

1-2

“PG”

Description

Note

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite Number
Entity City

37-41

Address Line 2 for the Entity. If Entity
Address2 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD2’.
For example, 102 A.

21X

42-62

Entity State/Province

3AN

63-65

For example, SUGARLAND. If Entity
City requires additional space, continue
in a PG60 record with Qualifier Code
‘ECI’.
For example, TX.

Entity Country

66-67

For example, US.

Entity Zip/Postal Code

68-76

For example, 77004.

Filler

77-80

Space fill

2
2

FDA Supplemental Guidance 2.4.1

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FDA Supplemental Guidance

Record Identifier PG21 (Point of Contact)
This is a mandatory PGA input record that provides FDA with data about an Individual Point of Contact (POC)
related to the Entity (the party) in the preceding PG19 record. Included in this record are the Individual Name,
Telephone Number and Email address. A typical example is a POC for the Filer.
At least one PG21 record is required.
Record Identifier PG21 (Point of Contact)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“21”

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Code identifying which entity the Point of
Contact is related to. Use PK
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’.

Telephone Number
of the Individual

15X

31-45

For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore

Email Address for
the Individual

35X

46-80

Email Address of the Individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

1
1,2

Code

Description

Point of Contact

Note 2
Individual’s Name should have the following format:
Last Name, First Name

Middle Name

FDA Supplemental Guidance 2.4.1

173

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
These are conditional or optional PGA input records that provide data pertaining to Food and Drug Administration
Affirmation of Compliance Criteria. This record is typically only used by FDA. This record is repeatable.
Record Identifier PG23 (Affirmation of Compliance)
Length/
Class

Position

Status

Control Identifier

1-2

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

30AN

10-39

A code used to affirm compliance with
FDA requirements. See Appendix PGA
(Food & Drug Affirmation of Compliance
Codes) of this publication for valid codes.
Text describing the information required by
the PGA. This could include a number or
a country code, etc. Also, see Appendix
PGA (Food & Drug Affirmation of
Compliance Qualifier Codes) of this
publication for valid codes related to
certain specific Affirmation of Compliance
codes.
Space fill

Data Element

Affirmation of
Compliance Qualifier

Filler

Description

Note

“PG”.
1, 2,
3, 4,
5
1

Note 1
The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication. The list of
conditional AoC codes for the FDA food Prior Notice Message Set is below:
Data Element

Code

Description

Syntax

Business Rules
See Appendix B at the end of this
document for valid codes

Affirmation of
Compliance
Code

When food or feed is in a natural state and
the entity role code DFI(Grower) or FDC
(Consolidator) is entered in lieu of
manufacturer, FME and food facility
registration number are NOT required.
Either FME or PFR is required when the
Manufacturer is transmitted. If both FME
and PFR are submitted, FDA will review
the registration.

FME

Food Processing
Facility Registration
Exemption

FDA Supplemental Guidance 2.4.1

174

FDA Supplemental Guidance
Data Element

Code

Description

Syntax

Business Rules
Required If MOT = Rail or MOT =
Containerized Rail. For multiple Rail Car
Numbers, repeat PG23 as needed.

RNO

CAN
VFT

VES

If the Rail Car Number is not available,
enter ‘Does Not Exist’.

Rail Car Number

If using a PG13 record OR if the SCAC or
IATA are not provided this AoC value is
required.
If the article of food is arriving by express
consignment operator or carrier and neither
the PN submitter or PN transmitter is the
express consignment operator or carrier,
the express consignment operator or
carrier tracking number may be submitted
in lieu of the flight number. Otherwise, VFT
is required if MOT = Air, Rail, Truck or
Ocean if it exists.

Carrier Name
Voyage, Trip, Flight
Number

If the Trip Number is not available, enter
‘Does Not Exist’.
Required If MOT = Ocean

Vessel Name
Manufacturers food
facility registration
number

11N

Manufacturer registration number is
required unless FME and Reason code is
submitted or consolidator / grower role
code is submitted in lieu of manufacturer
for food in its natural state.
See Appendix B of this document for valid
codes
If both FME and PFR are submitted, FME
is not used by the FDA.

PFR
Note 2

.
The list of optional AoC codes for the FDA food Prior Notice Message Set is below:
Data Element

Code
SFR
UFR
IFR
TFR
ORN

Description
Shippers food facility registration
number
Ultimate consignee food facility
registration number
Importers food facility
registration number
Transmitter food facility
registration number
Owners food facility registration
number-

FDA Supplemental Guidance 2.4.1

Syntax

Business Rules

11N

Optional

11N

Optional

11N

Optional

11N

Optional

11N

Optional

175

FDA Supplemental Guidance
Data Element

Code
SRN
CFR
GFR
LFR

Syntax

Description
Submitters food facility
registration number
FDA Consolidator food facility
registration number
Growers food facility registration
number
Location of Goods (Holding
Facility Registration Number)

Business Rules

11N

Optional

11N

optional

11N

optional

11N

optional

Note 3
The list of conditional AoC codes for the FDA Food (Non-PN) Message Set is below:
Data Element

Description

Syntax

Business Rules

FCE

Food Canning
Establishment
Number

5N- 10N

SID

Schedule
Identifier
Number

11N

VOL

LACF/AF
Volume

IF Government Agency Program
Code = FOO AND the product is
either LACF or AF THEN FCE must
be entered. See Note 5 for details.
IF Government Agency Program
Code = FOO AND the product is
LACF or AF THEN AoC Code ‘SID’
must be entered. Format:
CCYYMMDDnnn. See Note 5 for
details.
IF Government Agency Program
Code = FOO AND the product is AF
THEN VOL must be entered. See
Note 5 for exceptions.

Code

Note
5

Note 4
The list of optional AoC codes for the FDA Food (Non-PN) Message Set is below:
Data Element

Description

Syntax

Business Rules

CIN

Color
Identification
Number

Text
(30X max.)

ERR

Entry Review
Requested
Food Additive
Petition
Approval
Number
French Cheese
Facility
Certification
Number

indicator only

IF Government Agency Program
Code = FOO AND Government
Agency Processing Code = ADD
THEN CIN IS ALLOWED
ERR is just used as an indicator, no
data will follow
IF Government Agency Program
Code = FOO AND Government
Agency Processing Code = ADD
THEN FAP IS ALLOWED
IF Government Agency Program
Code = FOO AND Government
Agency Processing Code = PRO
THEN FCC IS ALLOWED.

Code

FAP

FCC

FDA Supplemental Guidance 2.4.1

9X or 10X

Note

176

FDA Supplemental Guidance
Data Element

Code

Description

Syntax

Business Rules
If length = 9, then the format should
be ‘NN NNN NN’; if length = 10, then
the format should be ‘NN NNN NNN’.
IF Government Agency Program
Code = FOO AND Government
Agency Processing Code = NSF
THEN IBP IS ALLOWED

IBP

Indian Black
Pepper
Certificate

text

IFE

Import For
Export
Package/Can
Code

indicator
only

AIN

Food Additive
Identification
Number

6N or 8N or
E+7N

JIF

Juice HACCP
Importer Firm

7N or 10N

SIF

Seafood
HACCP
Importer Firm

7N or 10N

PKC

Note

IF Government Agency Program
Code = FOO THEN PKC IS
ALLOWED
IF Government Agency Program
Code = FOO AND Government
Agency Processing Code = ADD
THEN AIN IS ALLOWED
IF Government Agency Program
Code = FOO AND the product is
HACCP THEN JIF IS ALLOWED
IF Government Agency Program
Code = FOO AND the product is
HACCP THEN SIF IS ALLOWED

Note 5:
Using the FDA Product Code in PG02, the following classifications are made where specific imported food/feed
products require the submission of lot or code numbers or other identifier with prior notice. These include:
LACF and Acidified:
LACF: Industry Codes: 02-39, 41, 71, & 72 with PIC: F (Aseptic) and E (Commercially Sterile)
AF: Industry Codes: 02-39, 41, 71, & 72 with PIC: I (Acidified)
If the product is Low-Acid Canned Food (LACF) or Acidified Food (AF), both the AoC codes, FCE and SID must
be provided; additionally, one of the following must be provided:
1. Container Measurements in PG28 OR
2. Container Volume AoC code VOL

FDA Supplemental Guidance 2.4.1

177

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

178

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
For Food, it is a conditional PGA input record that provides data pertaining to: Temperature Qualifier, Degree Type,
Actual Temperature, Lot Number, Production Date, Range of the Lot, PGA Line Value, and PGA Unit Value. This
record is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value MUST be included on
the first PG25 record. There must be at least one PG25 record for each FDA line.
For Prior Notice, this is a conditional input record that provides data pertaining to: Lot Number required by FDA
regulations for Infant formula, Acidified Foods, and LACF products.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording
Lot Number
Qualifier

1AN

Lot Number

25X

16-40

Production Start
date of the Lot

41-48

Production End
Date of the Lot

49-56

PGA Line Value

12N

57-68

FDA Supplemental Guidance 2.4.1

Description

Note

If the actual temperature is in the negative
numbers use an “X”.
Required if Degree Type is entered.
Reported temperature. Two decimals places
are implied.
Identifies recorded temperature is for
A=product, B=container and C= conveyance
Code of the entity that assigned the Lot
number. 1 = Manufacturer and 3 = Grower .
IF Government Agency Program Code =
FOO and Government Agency Processing
Code = NSF THEN Lot Number Qualifier = 3
ELSE Lot Number Qualifier = 1
Should not be entered, if more than one
PG25 record is entered.
The lot number that the manufacturer
assigned to the product. Mandatory for Infant
formula, Acidified Foods, and LACF
products.
Required, if more than one PG25 record is
entered.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
The value associated with the PGA line
number in whole dollars. Must be entered in

179

FDA Supplemental Guidance

PGA Unit Value

12N

69-80

the first PG25 record in the case of multiple
PG25 records. When entered, it must be
right-justified with preceding zeros and be
greater than zero.
The value of the lowest unit of measure
reported in PG26. Two decimal places are
implied. IF Government Agency Program
Code = ‘FOO’ AND IF AoC Code = ‘IFE’
THEN this is MANDATORY

Note 1:
Using the FDA Product Code in PG02, the following classifications are made where specific imported food/feed
products require the submission of lot or code numbers or other identifier with prior notice. These include:
LACF and Acidified:
Industry Codes: 02-39, 41, 71, & 72
With Process Indicator Code (PIC): Acidified-I, Aseptic-F, Commercially Sterile-E
Infant Formula:
Industry Code: 40
With Class:
C-Formula Prod (Baby)
N-Ready to Feed Formula Product
O-Liquid Concentrate Formula Product
P-Powder Formula Products
R-Infant Formula for Sample Testing (not for sale)
Note 2
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

180

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
For Food, this is a mandatory PGA input record that provides FDA with data pertaining to Packaging Qualifier,
Quantity and Unit of Measure. This record can be repeated up to six (6) times, once for each unique packaging
level. The first record is used to describe the largest (outermost) container and the number of containers at this
packaging level. The second record is used to describe the contents of the next smallest container. If needed,
qualifiers 2-6 are used in a similar manner (largest to smallest container). The final record must describe the
actual amount of the product in the smallest container.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.
Record Identifier PG26 (Product Packaging)
Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging for
the product. Outermost (largest=1) packages
to the innermost (smallest=6) packages.
There can be up to 6 levels of packaging. If
reporting only one level, show the total quantity
for the item and report that as level 1.
“Quantity of the packaging level, For example,
000000000400. Two decimal places are
implied. Must be greater than zero.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among the
PG26 records.

Data Element

Unit of Measure
(Packaging Level)

Description

Note

1, 4

2, 4
3, 4

Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Food Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.

Valid FDA Food Units of Measure for Packaging Containers
Code
AE

FDA Supplemental Guidance 2.4.1

Description
Aerosol

181

FDA Supplemental Guidance

AM
AP
AT
BA
BB
BC
BE
BF
BG
BH
BI
BJ
BK
BL
BN
BO
BP
BQ
BR
BS
BU
BV
BX
BZ
CA
CAG
CB
CC
CE
CF
CH
CI
CJ
CK
CL
CO
CON
CP
CR
CS
CT
CU

FDA Supplemental Guidance 2.4.1

Ampoule, Non-Protected
Ampoule, Protected
Atomizer
Barrel (Container)
Bobbin
Bottle crate, Bottle rack
Bundle
Balloon, Non-Protected
Bag
Bunch
Bin
Bucket
Basket
Bale, Compressed
Bale, Non-Compressed
Bottle, Non-Protected, Cyl
Balloon, Protected
Bottle, Protected, Cylnd
Bar
Bottle, Non-Prot Bulbous
Butt
Bottle, Protected Bulbous
Box
Bars in Bundle/Bunch/Trus
Can, Rectangular
Cage
Crate, Beer
Churn
Creel
Coffer
Chest
Canister
Coffin
Cask
Coil
Carboy, Non-Protected
Container
Carboy, Protected
Crate
Case
Carton
Cup

182

FDA Supplemental Guidance

CV
CX
CY
CZ
DJ
DP
DR
EN
FC
FD
FI
FL
FO
FR
GB
HG
HR
JC
JG
JR
JT
JY
KEG
KIT
MB
MC
MS
MT
NE
NS
NT
PA
PAL
PC
PH
PK
PL
PO
PT
PU
PY
RG

FDA Supplemental Guidance 2.4.1

Cover
Can, Cylindrical
Cylinder
Canvas
Demijohn, Non-Protected
Demijohn, Protected
Drum
Envelope
Crate, Fruit
Crate, Framed
Firkin
Flask
Footlocker
Frame
Bottle, Gas
Hogshead
Hamper
Jerri can, Rectangular
Jug
Jar
Jute bag
Jerri can, Cylindrical
Keg
Kit
Bag, Multi-ply
Crate, Milk
Sack, Multiwall
Mat
Unpacked Or Unpackaged
Nest
Net
Packet
Pallet
Parcel
Pitcher
Package
Pail
Pouch
Pot
Tray or Tray Pack
Plates in Bndl/Bnch/Truss
Ring

183

FDA Supplemental Guidance

RO
SA
SC
SD
SE
SH
SK
SL
SU
SW
SZ
TB
TC
TD
TK
TN
TO
TR
TS
TU
TY
TZ
VA
VG
VI
VL
VO
VP
VQ
VR
VY
WB

Roll
Sack
Crate, Shallow
Spindle
Sea-chest
Sachet
Case, Skeleton
Slipsheet
Suitcase
Shrinkwrapped
Sheets in Bndl/Bnch/Truss
Tub
Tea-Chest
Tube, Collapsible
Tank, Rectangular
Tin
Ton
Trunk
Truss
Tube
Tank, Cylindrical
Tubes in Bndl/Bnch/Truss
Vat
Bulk Gas at 1031 MBAR
Vial
Bulk Liquid
Bulk,Solid,Lg Particles
Vacuum-packed
Bulk Liquified Gas
Bulk,Solid,Granular Parti
Bulk,Solid,Fine Particle
Wickerbottle

Valid FDA Food Units of Measure for the Base Unit (Last Quantity Transmitted)
Code
BBL
BOL
CAR
CAP
CFT
FDA Supplemental Guidance 2.4.1

Description
Barrels (42 Gallons Ea)
Boluses
Carats
Capsules
Cubic Feet

Measure Type
Volume
Dosage
Weight
Dosage
Volume
184

FDA Supplemental Guidance

Centigrams
Cubic Centimeters
Cubic Yards
Dozen
Dozen Pieces
Dozen Pairs
Ounces, fluid
Grams
Gallons (US)
Gross
Kilograms
1,000 Cubic Meters
Liters
Pounds (avdp)
Cubic Meters
Micrograms
Milligrams
Milliliters
Number
Ounces, weight (avdp)
Pieces
Pairs
Pints, liquid (US)
Quarts, liquid (US)
Short ton (2000 LB)
Metric Ton
Tablets
Long Ton (2240 LB)
Ounces, Troy or Apoth

CG
CM3
CYD
DOZ
DPC
DPR
FOZ
G
GAL
GR
KG
KM3
L
LB
M3
MCG
MG
ML
NO
OZ
PCS
PRS
PTL
QTL
STN
T
Tab
TON
TOZ

Weight
Volume
Volume
Count
Count
Count
Volume
Weight
Volume
Count
Weight
Volume
Volume
Weight
Volume
Weight
Weight
Volume
Count
Weight
Count
Count
Volume
Volume
Weight
Weight
Dosage
Weight
Weight

Note 4
Quantity Data provides additional information to FDA about the product and how it is packaged. The basic format
for Quantity Data is in multiple pairs of data – quantity and unit of measure, i.e., 500 cases, 12 ounces, fluid, 1000
cartons, etc. Up to 6 data pairs may be submitted, beginning with the 1st pair for the outermost packaging when
Packaging Qualifier = 1. The first pair may describe the largest container and the last pair must describe the
amount of product in the smallest container. For example:
Product: 1000 cases of mineral water, 24/12 ounce bottles in each case
Units 1-Quantity
Units 1-Measure
Units 2-Quantity
Units 2-Measure
Units 3-Quantity
Units 3-Measure

1000
CS
24
BO
12
FOZ

FDA Supplemental Guidance 2.4.1

185

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

3-4

“27”.

Container Number
(Equipment ID)

20AN

5-24

Container Number
(Equipment ID)

20AN

28-47

Container Number
(Equipment ID)

20AN

51-70

74-80

The number of the shipping container (CNO)
as entered in the Bill of Lading based on the
Mode of Transportation (MOT). This is
applicable for food arriving as containerized
cargo by water, air, rail, or land; the container
number(s) is required for prior notice.
The number of the shipping container (CNO)
as entered in the Bill of Lading based on the
Mode of Transportation (MOT). This is
applicable for food arriving as containerized
cargo by water, air, rail, or land, the container
number(s) is required for prior notice.
The number of the shipping container (CNO)
as entered in the Bill of Lading based on the
Mode of Transportation (MOT). This is
applicable for food arriving as containerized
cargo by water, air, rail, or land, the container
number(s) is required for prior notice.
Space fill

Filler

FDA Supplemental Guidance 2.4.1

186

FDA Supplemental Guidance

Record Identifier PG28 Express Courier Tracking and Can Dimensions (Acidified and
LACF)
For Acidified and Low Acid Canned Food (LACF) this is a conditional PGA input record that provides data
pertaining to reporting Container Dimensions for the Food and Drug. For Prior Notice if the Mode of
Transportation is mail or express courier then Package Tracking Number Code and Package Tracking Number
are conditionally required, i.e. may be submitted in PG28 in lieu of the airway bill or bill of lading and in lieu of the
flight number in PG23.
.
Record Identifier PG28 (Tracking and/or Can Dimensions – LACF only)
Data Element
Length/ Position Status Description
Class
Control Identifier
2A
1-2
M
“PG”.
Record Type
2N
3-4
M
“28”.
Can Dimensions #1
4N
5-8
C
The first dimension of the container. If the
container is rectangle, the dimension is in
width, height, and length order. If the
container is cylindrical, the dimensions are in
diameter and height order. Container
dimension information is restricted to use with
acidified and low acid canned foods. The first
two spaces are inches. The second two
positions are in 16ths.
Can Dimensions #2
4N
9-12
C
The second dimension of the container. If the
container is rectangle, the dimension is in
width, height, and length order. If the
container is cylindrical, the dimensions are in
diameter and height order. The first two
spaces are inches. The second two positions
are in 16ths.
Can Dimension #3
4N
13-16
C
The third dimension. If the container is
rectangle, the dimension is in width, height,
and length order. The first two spaces are
inches. The second two positions are in 16ths.
Package Tracking
17-20
C
4AN
Enter SCAC for Express Consignment
Number Code
Carrier/Courier. For those express
consignment carriers without a SCAC,
leave blank & enter carrier name in PG23
Package Tracking
21-70
C
Tracking numbers used by Express
50AN
Number
Consignment Carrier

Note

1, 2

FDA Supplemental Guidance 2.4.1

187

FDA Supplemental Guidance

E.g. 1404 x 0800 x 0608 represents 14 4/16” width, 8” height and 6 8/16” length.
If the container is cylindrical the dimensions are in diameter & height order. Each dimension is expressed as a
three-digit number. The first digit gives the number of whole inches. The next two digits give the additional fraction
of the dimension expressed as sixteenths of an inch.
E.g. 300 x 108 represents 3” diameter & 1 8/16” height.
Note 3:
If the article of food is arriving by express consignment operator or carrier and neither the PN submitter or PN
transmitter is the express consignment operator or carrier, the express consignment operator or carrier tracking
number may be submitted in lieu of the Airway Bill number(s) or Bill of Lading number(s), and in lieu of the flight
number in PG23.

FDA Supplemental Guidance 2.4.1

188

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is an optional PGA input record that provides data pertaining to the net or gross unit of measure of the
commodity. This can be provided at the overall PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
Control Identifier
2A
1-2
Record Type
2N
3-4
3AN
Unit of Measure
5-7
(PGA line - net)

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net
Quantity (PGA line - net)” is required when
“Unit of Measure (PGA line - net)” is reported
in positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line gross)” and is required when “Commodity
Gross Quantity (PGA line - gross)” is reported.
Valid Unit of Measure codes are listed in
Appendix D in this document or in Appendix C
in the ACS ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA
line - gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

189

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Pertaining to the Individual unit (net), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - net)” in this position is
associated with “Commodity Net Quantity
(Individual unit - net)” and is required when
“Commodity Net Quantity (Individual unit net)” is reported. Valid Unit of Measure codes
are listed in Appendix C in the ACS ABI
CATAIR.
Pertaining to the Individual unit, excluding all
packing and packaging. Two decimals are
implied. “Commodity Net Quantity (Individual
unit - net)” is required when “Unit of Measure
(Individual unit - net)” is reported in positions
35-37 of this record.
Pertaining to the Individual unit (gross), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - gross)” in this position is
associated with “Commodity Gross Quantity
(Individual unit - gross)” and is required when
“Commodity Gross Quantity (Individual unit gross)” is reported. Valid Unit of Measure
codes are listed in Appendix C in the ACS ABI
CATAIR.
Pertaining to the Individual unit, including any
packaging, but excluding weight of the carrier's
equipment. Two decimals are implied.
“Commodity Gross Quantity (Individual unit gross)” is required when “Unit of Measure
(Individual unit - gross)” is reported in positions
50-52 of this record.
Space fill

Record not supported
by FDA at this time

FDA Supplemental Guidance 2.4.1

190

FDA Supplemental Guidance

Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry)
This is a mandatory PGA input record that provides data pertaining to the date, time and location of the
anticipated arrival/entry information for all FDA products. While other PGAs may use PG30 to Collect Inspection
and Lab information, currently FDA will utilize this record to collect Anticipated Arrival/Entry Information at this
time.
For each line a PG30 record with an "A" (Anticipated arrival information) status code, date, time and location of
arrival is Mandatory.
Record Identifier PG30 (Port of Arrival / Entry Information)
Data Element

Length/
Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival /
Entry time

Note

1
A = Anticipated arrival information

6-13

14-17

Anticipated Arrival /
Entry Location Code

4AN

18-21

Port of Arrival /
Entry
Filler

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Location type code from Appendix PGA; only
the value of 2 (= Schedule D Port codes) is
allowed.
For valid port codes, refer to note 3.

72-80

Space fill

1
1

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

191

FDA Supplemental Guidance

Length/
Class

Position

Statu
s

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
46X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
35-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

192

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

193

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of where to
place the substitute data within the PGA
Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the substitution
group indicated by the Substitution Number
Sequential number assigned to, or referring
to, a specific substitution group of data
provided at the header level.
This data element is mandatory when using
the S or R substitution indicator.
Space fills.

FDA Supplemental Guidance 2.4.1

Description

Note

194

FDA Supplemental Guidance

Food Commodity including PN Requirement Previously Met - Data
Elements and Values
In this scenario 801(a) data elements may be submitted with a PG14 record including the Prior Notice Confirmation
Number. or if the Government Processing Code is CCW or if food is withdrawn from a Foreign Trade Zone (FTZ).
Prior Notice Confirmation Number in PG 14 is NOT always required. Food commodities can be broken down into
the following categories using the existing Government Agency data elements available in the PG01 message
PG01 Government
Agency Code

Commodity
Type

PG01 Government
Agency Program
Code

Commodity Sub-Type

PG01 Government
Agency
Processing Code

FDA

Food

FOO

Natural State Food

NSF

FDA

Food

FOO

Processed Food

PRO

Food

FOO

(includes pet food, medicated feed and
feeds)

FEE

FDA

Food

FOO

Additives and Colors

ADD

FDA

Food

FOO

Dietary Supplements

DSU

Food

FOO

Ceramicware and other food
contact substances

CCW

Animal Food

FDA

Table 4b – Food commodity hierarchy
This chapter describes the data elements and their business rules for a 801A entry, with the Government Agency
Program Code = ‘FOO’, which may have been subject to PN regulations. To show that the PN requirements were
already satisfied, a PG14 record with the PN Conformation Number) may be included in the PG Message Set in
addition to all applicable PG records described in this chapter.
The following are the potential PGA records associated with submitting Foods:
PG Record

Description

The commercial description of the shipment is provided.

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.

PG02

The item type and Product Code detail are provided.

PG05

The scientific species name and code

PG06

Source Type(origin) other than the CBP country of origin is provided

PG07

The Trade/Brand Name

PG10

Category Code

PG14

PN Confirmation Number

FDA Supplemental Guidance 2.4.1

195

FDA Supplemental Guidance
PG Record

Description

PG19

The entity (manufacturer, consignee, shipper, etc.) of Record’s identification information is
provided.

PG20

Additional address data on the entity in PG19 is provided

PG21

The entity (manufacturer, consignee, shipper, etc.) of Record’s individual point of contact,
phone number and email is given.

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are
provided

PG26

Packaging qualifier and quantity of the shipment are provided

PG27

Container Number

PG28

Can Dimensions (LACF Only)

PG29

Data pertaining to the net or gross unit of measure of the commodity

PG30

Anticipated Arrival Information

PG55

Additional roles performed by entity or individual (future use)

PG60

Additional Information

PG00

Data Substitution

FDA Supplemental Guidance 2.4.1

196

FDA Supplemental Guidance

Food Example
Food message set layout sample below:
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: FOO+PNC
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

197

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product.
For example, NATURE’S FINEST REAL
FRUIT JUICE, 12 OUNCE BOTTLES

FDA Supplemental Guidance 2.4.1

Description

Note

198

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government Agency
Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use Code,
Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the imported
commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Description/Required Value

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government Agency
Code

3AN

8-10

Government Agency
Program Code

11-13

Government Agency
Processing Code

3AN

14-16

Intended Use Code

16X

42-57

Intended Use
Description
Correction Indicator

21X

58-78

Disclaimer

“FDA”
“FOO”

Allowed values: NSF, PRO, FEE, ADD,
DSU,CCW

For future Use

A code of A (= product is not regulated by
this agency) indicating there is no agency
declaration requirement. Or this field is left
blank for no disclaimer. No other code is
accepted
Refer to Table 4b above for commodity type and sub-type for Food
Note 1
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. otherwise the Government
Agency Program Code, Government Agency Processing are mandatory.
Note 2
One of these intended use codes may be chosen, based on the product requirements.
CFSAN Regulated Products
Import Scenario
For Research Use as Human Food
For Research Use as an Animal Food
Personal Importation

FDA Supplemental Guidance 2.4.1

Intended Use Code

CBP Intended Use Name

260.000
015.000
210.000

For Research Use as Human Food
For Research Use as an Animal Food
For Personal Use as Human Food

199

FDA Supplemental Guidance

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.

Data Element

Description

Note

Only one ‘P’ record is allowed for the same PGA
Line # in PG01 record.
Product Code
Qualifier
Product Code
Number

4AN

6-9

FDP

19X

10-28

Product Code Must be equal to 7 characters

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Group
Code
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

200

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

Record Type

3-4

“05”.

Scientific Genus
Name
Scientific Species
Name
Scientific Sub
Species Name

22X

5-26

22X

27-48

18X

49-66

Scientific Genus Name of the merchandise
being entered.
Scientific Species Name of the merchandise
being entered.
Scientific Sub Species Name of the
merchandise being entered.

FDA Supplemental Guidance 2.4.1

201

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is A Mandatory PGA input record that provides data pertaining to Source Type (Origin) other than the CBP
Country of Origin, in addition to Processing dates, Processing Type and Processing Description.
Record Identifier PG06 (Product Origin)
Data Element
Control Identifier
Record Type
Source Type Code

Length/
Class

Position

Status

1-2

“PG”.

2N
3AN

3-4
5-7

M
M

“06”.
IF Government Agency Program Code =
FOO and Government Agency Processing
Code = NSF THEN Source Type Code
MUST BE 262 (Place of growth)
ELSE Source Type Code must be 39
(Country of Production).

Description

Note

294 (Country of Refusal) is Allowed.

Country Code

Note

8-9

There would be one PG06 with source type
code of 39. If previously refused, then trade
would also provide another PG06 with
source type code 294.
Foods require the harvesting or production
location of the product. Should match the
country code in PG19-PG20 record set for
the Entity Role Code ‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.
Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

202

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is an optional PGA input record that provides data pertaining to Trade or Brand Name.
Record Identifier PG07 (Product Trade Names)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“07”

Trade Name/Brand
Name

35X

5-39

Market, Trade, or Brand Name that
describes the food or feed product at each
line level. If Trade/Brand Name requires
additional space, continue in a PG60 record
with Qualifier Code ‘TBN’.

FDA Supplemental Guidance 2.4.1

Description

Note

203

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Free form description, NOT product code
description, of the item, either to supplement
the above data elements or in place of the
above. See Appendix A for the use of PG10
to capture the information currently collected
in multiple OI records.

FDA Supplemental Guidance 2.4.1

204

FDA Supplemental Guidance

Record Identifier PG14 (PN Confirmation Number)
For Foods with a previously submitted prior notice, the Prior Notice Confirmation Number information is required.
If declaring FTZ in PG30 for Entry Type 21 OR the Government Processing Code is CCW, this record is not
needed.
Record Identifier PG14 (Input)
Data Element

Length
/Class

Position

Status

Description

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 14.

Transaction Type

Identifies the transaction type.

Note

1 = single use
Code Type

3AN

6-8

Identifies Type Codes for PN
Confirmation Number
PN Confirmation Number = PNC

PNC Number

33X

9-41

Identifies the number that corresponds to
the PN Confirmation number

This should be a 12 digit number.

Note 1
Prior notice must be submitted before arrival and admission into a FTZ, prior notice is not required when
the food is withdrawn from the FTZ, either as an export or for use within the U.S. However, if the food is
withdrawn from the FTZ for consumption entry into the U.S., FDA must be notified and will make the
admissibility decision about the consumption entry at that time.

FDA Supplemental Guidance 2.4.1

205

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”

Control Identifier
Record Type

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example: MF, UC
Code identifying the Entity Identification is
entered. For example: 16, 47. Mandatory, if
Entity Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in
a PG60 record with Qualifier Code ‘ENA’.
See validation criteria below.
The address of the entity is required. If Entity
Address1 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD1’. See validation criteria below.

1
2
2
2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes mandatory to FDA Food Message Sets is below:
Data Element

Code
MF
DEQ
FD1
DP

Entity Role Codes§

Description
Manufacturer of goods
Shipper
FDA Importer (Importer of Record)
Delivered To Party

Same Role Code cannot be entered more than once.

Note 2
Data Element

Code

Entity Identification
Codes

16
47

Description
D&B-assigned (DUNS number)
FDA-assigned

Length/
Class
9N
4-10N

FDA Supplemental Guidance 2.4.1

206

FDA Supplemental Guidance
IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N
ELSE IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to 10 and Type = N
List of Entity Role codes also applicable to FDA Drugs Message Sets is below:
Data Element
Entity Role Codes

FDA Supplemental Guidance 2.4.1

Code
PK

Description
Point of Contact

207

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”

Description

Note

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite Number
Entity City

37-41

Address Line 2 for the Entity. If Entity
Address2 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD2’.
For example, 102 A.

21X

42-62

Entity State/Province

3AN

63-65

For example, SUGARLAND. If Entity
City requires additional space, continue
in a PG60 record with Qualifier Code
‘ECI’.
For example, TX.

Entity Country

66-67

For example, US.

Entity Zip/Postal Code

68-76

For example, 77004.

Filler

77-80

Space fill

2
2

FDA Supplemental Guidance 2.4.1

208

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“21”

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Telephone Number
of the Individual

15X

31-45

Code identifying which entity the Point of
Contact is related to. Use PK
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore

Email Address for
the Individual

35X

46-80

Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes applicable is below:
Data Element
Entity Role Codes

FDA Supplemental Guidance 2.4.1

Code

Description

Point of Contact

209

FDA Supplemental Guidance

Position

Status

Control Identifier

1-2

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

30AN

10-39

A code used to affirm compliance with
FDA requirements. See Appendix PGA
(Food & Drug Affirmation of Compliance
Codes) of this publication for valid codes.
Text describing the information required by
the PGA. This could include a number or
a country code, etc. Also, see Appendix
PGA (Food & Drug Affirmation of
Compliance Qualifier Codes) of this
publication for valid codes related to
certain specific Affirmation of Compliance
codes.
Space fill

Data Element

Affirmation of
Compliance Qualifier

Filler

Description

Note

“PG”.
1, 2

1, 2

Note 1
The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication. T
The list of AoC codes conditional to FDA Food Message Sets is below:
Data Element

Description

Syntax

Business Rules

Note

FCE

Food Canning
Establishment
Number

5N10N

SID

Schedule Identifier
Number

IF Government Agency Program Code =
FOO and the product is either LACF or
AF THEN FCE must be entered. See
Note 2 for details.
IF Government Agency Program Code =
FOO AND the product is either LACF or
AF THEN AoC Code ‘SID’ must be
entered. Format: CCYYMMDDnnn. See
Note 2 for details.
IF Government Agency Program Code =
FOO AND the product is AF THEN VOL
must be entered. See Note 2 for
exceptions.

Code

VOL

LACF/AF Volume

11N

The list of AoC codes optional to FDA Food Message Sets is below:

FDA Supplemental Guidance 2.4.1

210

FDA Supplemental Guidance
Data Element

Description

Syntax

Business Rules

CCC

Chinese Ceramic
Ware Factory Code

6AN

CIN

Color Identification
Number

text

ERR

Entry Review
Requested
Food Additive
Petition Approval
Number

indicator
only
6N

FCC

French Cheese
Facility Certification
Number

9X or
10X

AIN

Food Additive
Identification
Number

6N or 8N
or E+7N

JIF

Juice HACCP
Importer Firm

7N or
10N

SIF

Seafood HACCP
Importer Firm

7N or
10N

IBP

Indian Black
Pepper Certificate

text

FTZ

IFE

FTZ Admission
Number
Import For Export

IF Government Agency Program Code
= FOO AND Government Agency
Processing Code = CCW THEN CCC IS
ALLOWED
IF Government Agency Program Code
= FOO AND Government Agency
Processing Code = ADD THEN CIN IS
ALLOWED
ERR is just used as an indicator, no
data will follow
IF Government Agency Program Code
= FOO AND Government Agency
Processing Code = ADD THEN FAP IS
ALLOWED
IF Government Agency Program Code
= FOO AND Government Agency
Processing Code = PRO THEN FCC IS
ALLOWED. If length = 9, then the
format should be ‘NN NNN NN’; if
length = 10, then the format should be
‘NN NNN NNN’.
IF Government Agency Program Code
= FOO AND Government Agency
Processing Code = ADD THEN AIN IS
ALLOWED
IF Government Agency Program Code
= FOO AND the product is HACCP
THEN JIF IS ALLOWED
IF Government Agency Program Code
= FOO AND the product is HACCP
THEN SIF IS ALLOWED
IF Government Agency Program Code
= FOO AND Government Agency
Processing Code = NSF THEN IBP IS
ALLOWED
A maximum of 7 characters.

PKC

Package/Can Code

Code

FAP

Affirmation of
Compliance
Code

Note

indicator
only
IF Government Agency Program Code
= FOO THEN PKC IS ALLOWED

Note 2:
Using the FDA Product Code in PG02, the following classifications are made where specific imported food/feed
products require the submission of lot or code numbers or other identifier with prior notice. These include:
LACF and Acidified:
LACF: Industry Codes: 02-39, 41, 71, & 72 with PIC: F (Aseptic) and E (Commercially Sterile)
AF: Industry Codes: 02-39, 41, 71, & 72 with PIC: I (Acidified)

FDA Supplemental Guidance 2.4.1

211

FDA Supplemental Guidance
If the product is Low-Acid Canned Food (LACF) or Acidified Food (AF), both the FCE and SID must be provided;
additionally one of the following must be provided:
1. Container Measurements in PG28 OR
2. Container Volume AoC Code VOL

FDA Supplemental Guidance 2.4.1

212

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

213

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
For Food, it is a conditional PGA input record that provides data pertaining to: Temperature Qualifier, Degree Type,
Actual Temperature, Lot Number, Production Date, Range of the Lot, PGA Line Value, and PGA Unit Value. This
record is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value MUST be included on
the first PG25 record. There must be at least one PG25 record for each FDA line.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording
Lot Number
Qualifier

1AN

Lot Number

25X

16-40

Production Start
date of the Lot

41-48

Production End
Date of the Lot

49-56

PGA Line Value

12N

57-68

PGA Unit Value

12N

69-80

FDA Supplemental Guidance 2.4.1

If the actual temperature is in the negative
numbers use an “X”.
Required if Degree Type is entered.
Reported temperature. Two decimals places
are implied.
Identifies recorded temperature is for
A=product, B=container and C= conveyance
Code of the entity that assigned the Lot
number. 1 = Manufacturer and 3 = Grower.
IF Government Agency Program Code =
FOO and Government Agency Processing
Code = NSF THEN Lot Number Qualifier = 3
ELSE Lot Number Qualifier = 1
Should not be entered if more than one
PG25 record is entered
The lot number that the manufacturer /
Grower assigned to the product.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format.
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format
The value associated with the PGA line
number in whole dollars. Must be entered in
the first PG25 record in the case of multiple
PG25 records. When entered, it must be
right-justified with preceding zeros and be
greater than zero.
The value of the lowest unit of measure
reported in PG26. Two decimal places are

214

FDA Supplemental Guidance
implied. IF Government Agency Program
Code = ‘FOO’ AND IF AoC Code = ‘IFE’
THEN this is MANDATORY

Note 1
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

215

FDA Supplemental Guidance

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging for
the product. Outermost (largest=1) packages
to the innermost (smallest=6) packages.
There can be up to 6 levels of packaging. If
reporting only one level, show the total quantity
for the item and report that as level 1.
“Quantity of the packaging level, For example,
000000000400. Two decimal places are
implied. Must be greater than zero.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among the
PG26 records.

Data Element

Unit of Measure
(Packaging Level)

Description

Note

1, 4

2, 4
3, 4

Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Food Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.

Valid FDA Food Units of Measure for Packaging Containers
Code
AE

FDA Supplemental Guidance 2.4.1

Description
Aerosol

216

FDA Supplemental Guidance

AM
AP
AT
BA
BB
BC
BE
BF
BG
BH
BI
BJ
BK
BL
BN
BO
BP
BQ
BR
BS
BU
BV
BX
BZ
CA
CAG
CB
CC
CE
CF
CH
CI
CJ
CK
CL
CO
CON
CP
CR
CS
CT
CU

FDA Supplemental Guidance 2.4.1

217

FDA Supplemental Guidance

CV
CX
CY
CZ
DJ
DP
DR
EN
FC
FD
FI
FL
FO
FR
GB
HG
HR
JC
JG
JR
JT
JY
KEG
KIT
MB
MC
MS
MT
NE
NS
NT
PA
PAL
PC
PH
PK
PL
PO
PT
PU
PY
RG

FDA Supplemental Guidance 2.4.1

218

FDA Supplemental Guidance

RO
SA
SC
SD
SE
SH
SK
SL
SU
SW
SZ
TB
TC
TD
TK
TN
TO
TR
TS
TU
TY
TZ
VA
VG
VI
VL
VO
VP
VQ
VR
VY
WB

Valid FDA Food Units of Measure for the Base Unit (Last Quantity Transmitted)
Code
BBL
BOL
CAR
CAP
CFT
FDA Supplemental Guidance 2.4.1

Description
Barrels (42 Gallons Ea)
Boluses
Carats
Capsules
Cubic Feet

Measure Type
Volume
Dosage
Weight
Dosage
Volume
219

FDA Supplemental Guidance

CG
CM3
CYD
DOZ
DPC
DPR
FOZ
G
GAL
GR
KG
KM3
L
LB
M3
MCG
MG
ML
NO
OZ
PCS
PRS
PTL
QTL
STN
T
Tab
TON
TOZ

Weight
Volume
Volume
Count
Count
Count
Volume
Weight
Volume
Count
Weight
Volume
Volume
Weight
Volume
Weight
Weight
Volume
Count
Weight
Count
Count
Volume
Volume
Weight
Weight
Dosage
Weight
Weight

Note 4
Quantity Data provides additional information to FDA about the product and how it is packaged. The basic format
for Quantity Data is in multiple pairs of data – quantity and unit of measure, i.e., 500 cases, 12 ounces, fluid, 1000
cartons, etc. Up to 6 data pairs may be submitted, beginning with the 1 st pair for the outermost packaging when
Packaging Qualifier = 1. The first pair may describe the largest container and the last pair must describe the
amount of product in the smallest container. For example:
Product: 1000 cases of mineral water, 24/12 ounce bottles in each case
Units 1-Quantity
Units 1-Measure
Units 2-Quantity
Units 2-Measure
Units 3-Quantity
Units 3-Measure

1000
CS
24
BO
12
FOZ

FDA Supplemental Guidance 2.4.1

220

FDA Supplemental Guidance

Record Identifier PG27 (Container Information)
This is an optional PGA input record that provides data pertaining to issued Container Number. The number of the
shipping container is included in the Bill of Lading. Hence this record is not needed. This record may be repeated.
Record Identifier PG26 (Container Information)
Data Element
Control Identifier
Record Type
Container Number
(Equipment ID)
Container Number
(Equipment ID)
Container Number
(Equipment ID)
Filler

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

3-4

“27”.

20AN

5-24

20AN

28-47

20AN

51-70

74-80

FDA Supplemental Guidance 2.4.1

221

FDA Supplemental Guidance

Record Identifier PG28 (Can Dimensions – Acidified and LACF only)
For Acidified and Low Acid Canned Food (LACF) this is a conditional PGA input record that provides data
pertaining to reporting Container Dimensions for the Food and Drug.
Record Identifier PG28 (Can Dimensions – LACF only)
Data Element
Length/ Position Status Description
Class
Control Identifier
2A
1-2
C
“PG”.
Record Type
2N
3-4
C
“28”.
Can Dimensions #1
4N
5-8
C
The first dimension of the container. If the
container is rectangle, the dimension is in
width, height, and length order. If the
container is cylindrical, the dimensions are in
diameter and height order. Container
dimension information is restricted to use with
acidified and low acid canned foods. The first
two spaces are inches. The second two
positions are in 16ths.
Can Dimensions #2
4N
9-12
C
The second dimension of the container. If the
container is rectangle, the dimension is in
width, height, and length order. If the
container is cylindrical, the dimensions are in
diameter and height order. The first two
spaces are inches. The second two positions
are in 16ths.
Can Dimension #3
4N
13-16
C
The third dimension. If the container is
rectangle, the dimension is in width, height,
and length order. The first two spaces are
inches. The second two positions are in 16ths.

Note

1, 2

Note 1:
IF Government Agency Program Code = FOO and
If the product is Low-Acid Canned Food (LACF) or Acidified Food (AF), one of the following must be provided:
1. Container Measurements in PG28 (either height and diameter or height/length, width and thickness OR
2. Container Volume (VOL) in PG23
Note 2:
If the container is rectangular, the dimensions are in width, height & length order. Each dimension is expressed as
a four-digit number. The first 2 digits give the number of whole inches. The next two digits give the additional
fraction of the dimension expressed as sixteenths of an inch.
E.g. 1404 x 0800 x 0608 represents 14 4/16” width, 8” height and 6 8/16” length.
If the container is cylindrical the dimensions are in diameter & height order. Each dimension is expressed as a
three-digit number. The first digit gives the number of whole inches. The next two digits give the additional fraction
of the dimension expressed as sixteenths of an inch.
E.g. 300 x 108 represents 3” diameter & 1 8/16” height.

FDA Supplemental Guidance 2.4.1

222

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is an optional PGA input record that provides data pertaining to the net or gross unit of measure of the
commodity. This can be provided at the overall PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
Control Identifier
2A
1-2
Record Type
2N
3-4
3AN
Unit of Measure
5-7
(PGA line - net)

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net
Quantity (PGA line - net)” is required when
“Unit of Measure (PGA line - net)” is reported
in positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line gross)” and is required when “Commodity
Gross Quantity (PGA line - gross)” is reported.
Valid Unit of Measure codes are listed in
Appendix D in this document or in Appendix C
in the ACS ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA
line - gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

223

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Description

Note

Pertaining to the Individual unit (net), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - net)” in this position is
associated with “Commodity Net Quantity
(Individual unit - net)” and is required when
“Commodity Net Quantity (Individual unit net)” is reported. Valid Unit of Measure codes
are listed in Appendix C in the ACS ABI
CATAIR.
Pertaining to the Individual unit, excluding all
packing and packaging. Two decimals are
implied. “Commodity Net Quantity (Individual
unit - net)” is required when “Unit of Measure
(Individual unit - net)” is reported in positions
35-37 of this record.
Pertaining to the Individual unit (gross), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - gross)” in this position is
associated with “Commodity Gross Quantity
(Individual unit - gross)” and is required when
“Commodity Gross Quantity (Individual unit gross)” is reported. Valid Unit of Measure
codes are listed in Appendix C in the ACS ABI
CATAIR.
Pertaining to the Individual unit, including any
packaging, but excluding weight of the carrier's
equipment. Two decimals are implied.
“Commodity Gross Quantity (Individual unit gross)” is required when “Unit of Measure
(Individual unit - gross)” is reported in positions
50-52 of this record.

Record not supported
by FDA at this time

FDA Supplemental Guidance 2.4.1

224

FDA Supplemental Guidance

Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry)
This is a mandatory PGA input record that provides data pertaining to the date, time and location of the
anticipated arrival/entry information for all FDA products and the Foreign Trade Zone facility that the goods are
being withdrawn from, if applicable.
For each line a PG30 record with an "A" (Anticipated arrival information) code, date, time and location of arrival is
Mandatory..
For entry type 21 coming from a Foreign Trade Zone, a PG30 record with an "F" (Foreign Trade Zone) code and
FIRMS code for the FTZ location is required to exempt the shipment from prior notice because the requirements
were previously met entering the Foreign Trade Zone.

Record Identifier PG30 (Port of Arrival / Entry Information)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Status

A = Anticipated arrival informationIf entry type
= 21, then repeat PG30 and enter F = Foreign
Trade Zone.

Anticipated Arrival/
Entry date

6-13

Anticipated Arrival /
Entry time

14-17

Arrival / Entry
Location Code (or
Foreign Trade Zone
Firm Code if
repeating the record
for entry type 21)
Port of Arrival /
Entry

4AN

18-21

A numeric date in MMDDCCYY (month, day,
century, year) format. Not Mandatory for
Status = ’F’.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid). Not
Mandatory for Status = ‘F’.
Either a value of ‘2’ (= Census Schedule D
representing the CBP port codes) OR 4
(=FIRMS Codes) is allowed.

50X

22-71

72-80

Filler

Description

Note

For valid port codes, Refer to Note 1.
For valid Firms Codes, Refer to ACS/ACE
query.
Space fill

Port of Entry:
19 CFR 101.1.

FDA Supplemental Guidance 2.4.1

225

FDA Supplemental Guidance
Port and port of entry. The terms “port” and “port of entry” refer to any place designated by Executive Order of the President, by order of the
Secretary of the Treasury, or by Act of Congress, at which a Customs officer is authorized to accept entries of merchandise to collect duties,
and to enforce the various provisions of the Customs and navigation laws. The terms “port” and “port of entry” incorporate the geographical
area under the jurisdiction of a port director. (The Customs ports in the Virgin Islands, although under the jurisdiction of the Secretary of the
Treasury, have their own Customs laws (48 U.S.C. 1406(i)). These ports, therefore, are outside the Customs territory of the United States and
the ports thereof are not “ports of entry” within the meaning of these regulations).

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

226

FDA Supplemental Guidance

Length/
Class

Position

Statu
s

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
46X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
35-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

227

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

228

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of where to
place the substitute data within the PGA
Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the substitution
group indicated by the Substitution Number
Sequential number assigned to, or referring
to, a specific substitution group of data
provided at the header level.
This data element is mandatory when using
the S or R substitution indicator.
Space fills.

FDA Supplemental Guidance 2.4.1

Description

Note

229

FDA Supplemental Guidance

Medical Devices Commodity Data Elements and Values
Medical Device commodities can be broken down into the following categories using the existing Government
Agency data elements available in the PG01 message
PG01 Government
Agency Code
FDA

Commodity
Type

PG01 - Government
Agency Program
Code

Medical Devices

DEV

Medical Devices

DEV

Commodity SubType
Radiation Emitting
Devices *

FDA

Non-Radiation
Emitting Devices

PG01 - Government
Agency Processing
Code
RED

NED

Table 5 – Medical Devices commodity hierarchy
* If Radiation Emitting Devices then all Medical Device data is required in addition to all applicable PG23 data
elements for radiation-emitting products. See also PG23 for Radiation Emitting Products.
In submitting a Medical Device PGA Message Set to FDA, Importers are identifying themselves, the commodity,
the intended use, the quantity of the commodity and valid FDA Affirmation of Compliance code values.
The following are the potential PGA records associated with submitting Medical Devices:
PG Record

Description

The commercial description of the shipment

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.

PG02

Product Identifier; the item type and Product Code detail are provided.

PG06

Source Type(origin) other than the CBP country of origin is provided

PG07

The Trade/Brand Name, Model and Year of Manufacture are provided

PG10

Product Characteristics and other optional product information are provided

PG19

Entity Role (manufacturer, FDA importer, shipper, etc.) Entity Identification, Entity Name, and
Entity Address 1 are provided.

PG20

Additional address data on the entity in PG19 is provided

PG21

Individual Name, Telephone Number, and Email address are provided

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are provided

PG26

Packaging qualifier and quantity of the shipment are provided

PG27

Data pertaining to issued Container Number is provided

PG29

Data pertaining to the net/gross unit of measure and quantity are provided

FDA Supplemental Guidance 2.4.1

230

FDA Supplemental Guidance
PG Record

Description

PG30

Data pertaining to date, time and location of inspection are provided

PG55

Identifies Entity from the previous PG19, PG20 and PG21 group as having additional roles.

PG60

Additional Information

PG00

Data substitution

FDA Supplemental Guidance 2.4.1

231

FDA Supplemental Guidance

Medical Devices Example
A shipment of Pediatric Tourniquet Cuff Set, is imported into the United States for domestic consumption.
Medical Device Message Set Layout for Sample
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Medical Devices
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

232

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product.
For example, PEDIATRIC TOURNIQUET
CUFF SET.

FDA Supplemental Guidance 2.4.1

Description

Note

233

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government
Agency Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use
Code, Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the
imported commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government
Agency Code
Government
Agency Program
Code
Government
Agency
Processing Code
Intended Use
Code

3AN

8-10

11-13

Intended Use
Description
Correction
Indicator
Disclaimer

3AN

14-16

Description/Required Value

Note

“FDA”
“DEV”

1, 2

Allowed values are ‘RED’ and ‘NED’

1, 2

16X

42-57

Code identifying the intended use for the
commodity after importation. For example,
081.001 (For Human Medical Use as a Medical
Device).

21X

58-78

This field is used to describe the Intended Use
such as ‘Sample devices’, ‘Return shipment’, etc.

For future Use
A code of A (= product is not regulated by this
agency) indicating there is no agency declaration
requirement. Or this field is left blank for no
disclaimer. No other code is accepted

Refer to Table 5 above for commodity type and sub-type for Medical Devices
Note 1
See Table 5 above for the commodity hierarchy for Medical Devices commodities.
Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. Otherwise the Government
Agency Program Code, Government Agency Processing Code and Intended Use Code are mandatory.
Note 3
Intended Use Codes and their descriptions can be found in Appendix R (Intended Use Codes for ACE) of the
ACE ABI CATAIR publication. For Medical Devices, only one of the following Intended Use Codes may be
entered:

FDA Supplemental Guidance 2.4.1

234

FDA Supplemental Guidance
Intended
Use Code

Intended Use Definition

081.001

For Human Medical Use as a Medical Device

081.002

For Human Medical Use as a Medical Device for Domestic
Refurbishing
For Human Medical Use as Medical Device–domestically
manufactured device that is part of a medical device
convenience kit
For Human Medical Use as a Medical Device –foreign
manufactured device that is part of a medical device
convenience kit
Importation of a device constituent part (finished device) for
use in a medical product regulated under a drug (CDER)
application type (e.g., for use in an NDA/ANDA/BLA drugdevice combination product).

081.003

081.004

081.005

081.006

100.000
110.000
140.000
081.007
081.008

170.000
180.010
180.014

180.015
920.001

920.002
940.000
950.001
950.002
970.000

Relevant Medical Device Import
Scenarios
Standard import of a medical device,
accessories, or components regulated as a
finished device
Import of refurbished device
Import of a reprocessed device

Import of a medical device under enforcement discretion
provisions per final guidance:
http://www.fda.gov/ucm/groups/fdagov-public/@fdagovmeddev-gen/documents/document/ucm401996.pdf
For Personal Use as a Non-Food Product – for personal use
as a medical device
For Public Exhibition or Display as a Non-Food Product
For Charitable Organization Use as a Non-Food Product
Component for further manufacturing into a finished medical
device
Importation of a device component for use in a medical
product regulated under a drug (CDER) application type (e.g.,
for use in an NDA/ANDA/BLA drug-device combination
product).

Applicable product codes for CBP business rule:
80O - - UG; 86N - - FF
86N - - FG; 80N - - XQ
90L - - MB; 90L - - MD

For Repair of a Non-Food Product
For Research and Development as a Non-Food Product - For
research and development as a medical device
For Research and Development as a Non-Food Product – for
bench testing or nonclinical research use

Repair of medical device and re-exportation
Import of research or investigational use in
vitro diagnostic device

For Research and Development as a Non-Food Product –
import of a medical device for clinical investigational use
Import of a device that is US goods returned for
refund/overstock (to manufacturer)

Import of a device that is US goods returned for sale to a third
party
Import of a Compassionate Use/Emergency Use Device
Import of a single-use device for domestic reprocessing
Import of a multi-use device for domestic reprocessing
Import for Export

FDA Supplemental Guidance 2.4.1

Includes import of device for trade show

Import of a device for non-clinical use/bench
testing
Import of device sample for customer
evaluation

Refund/overstock
Bench Testing
Corrective Action Prevention Action (CAPA)
Plan Investigation
Recall

Import of a medical device for further
processing and re-exportation
Import of medical device or accessory for
further manufacturing into an export only
medical device

235

FDA Supplemental Guidance
Intended
Use Code

Intended Use Definition

970.001

Import for Export

FDA Supplemental Guidance 2.4.1

Relevant Medical Device Import
Scenarios
Import of a medical device component for
further manufacturing into an export only
medical device

236

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
This mandatory PGA input record is used to indicate if the following records relate to a product (P) or a component
(C) of a product by specifying the Item Type.
For Medical Device entries, the Product Code Number is provided within this record.
Record Identifier PG02 (Product Identifier)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.
Only one ‘P’ record is allowed for the same
PGA Line # in PG01 record.

Product Code Qualifier

4AN

6-9

“FDP”.

Product Code Number

19X

10-28

Product Code Must be equal to 7
characters

Note 1
Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For Medical Devices, this is currently always ‘FDP’ for all FDA products.
Only one Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

237

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is a mandatory PGA input record that provides data pertaining to Source Type (Origin) other than the CBP
Country of Origin.
Record Identifier PG06 (Product Origin)
Data Element
Control Identifier
Record Type
Source Type
Code

Country Code

Note

Length/
Class

Position

Status

1-2

“PG”.

2N
3AN

3-4
5-7

M
M

“06”.
Mandatory valid values are 30 (Country of
Source) for a component or 39 (Country of
Production) for a finished product. 294 (Country
of Refusal) is MANDATORY if previously refused.

8-9

Description

Note

There would be one PG06 with source type code
of either 30 or 39. If previously refused, then trade
would also provide another PG06 with source
type code 294.
Country of production or source is required for
Medical Devices. Should match the country code
in PG19-PG20 record set for the Entity Role Code
‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.

Note 2
Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

238

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
For Medical Device, this is a conditional PGA input record that provides FDA with data pertaining to Name.
Record Identifier PG07 (Product Trade Names)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“07”

Trade Name/Brand
Name

35X

5-39

Trade/Brand Name of the Medical
Device. For example, Zimmer
Reusable Tourniquet Cuff. Please
see Note 1 below. If Trade/Brand
Name requires additional space,
continue in a PG60 record with
Qualifier Code ‘TBN’.

Note

Description

Note

DEV/NED: optional. Encouraged, if provided on the invoice or otherwise available to the filer.
DEV/RED: conditional. See radiation-emitting products chapter

FDA Supplemental Guidance 2.4.1

239

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
This is a mandatory PGA input record that allows for reporting codes that provide additional characteristics of a
product or component, not reported elsewhere in the PG Message Set. For example, this record can be used to
provide the model year of a product, which can be different from the year of manufacture provided in the PG07.
This record can be repeated if there are more qualifiers or categories.
Record Identifier PG10 (Product Characteristics)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

”10”.

Commodity
Characteristic
Description

57X

24-80

Free form description, NOT product code
description, of the item, either to supplement the
above data elements or in place of the above.
See Appendix A for the use of PG10 to capture
the information currently collected in multiple OI
records.

FDA Supplemental Guidance 2.4.1

240

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Medical Devices, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role
and conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element
Control Identifier
Record Type

Length
/Class

Position

Status

1-2

“PG”

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example, MF.
Code identifying the Entity Identification is
entered. For example, 16. Mandatory, if Entity
Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2.
Conditional, based on the roles and if they have
been supplied at the entry and line
The name of the entity is required. If Entity
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘ENA’. See
validation criteria below.
The address of the entity is required. If Entity
Address1 requires additional space, continue in
a PG60 record with Qualifier Code ‘AD1’. See
validation criteria below.

1
2
2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes mandatory to FDA Device Message Sets is below:
Data Element

Code

Description

MF
Manufacturer of goods
DEQ
Shipper
Entity Role Codes§
FD1
FDA Importer 1 (Importer of Record)
DII
Device Initial Importer
DP
Delivered To Party
Same Role Code cannot be entered more than once.

List of Entity Role codes also applicable to FDA Medical Device Message Sets is below:
Data Element
Entity Role Codes

Code
PK

Description
Point of Contact

FDA Supplemental Guidance 2.4.1

241

FDA Supplemental Guidance
Data Element
Entity Identification
Codes

Code
16
47

Description
D&B-assigned (DUNS number)
FDA-assigned

Length/
Class
9N
4-10N

FDA ENTITY IDENTIFICATION CODE AND ENTITY NUMBER SELECTION AND VALIDATION CRITERIA
FDA requires Entity Name and Entity Address. Additionally, FDA/CDRH prefers to use FEI numbers for identifying
the Entity; IF FEI is not available THEN DUNS.
For devices the vast majority of registration numbers are FEIs
Entity Name <>NULL AND Entity Address 1 <>NULL AND
IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to 10 and Type = N
ELSE IF Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N

FDA Supplemental Guidance 2.4.1

242

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”

Description

Note

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite Number
Entity City

37-41

Address Line 2 for the Entity. If Entity
Address2 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD2’.
For example, 102 A.

21X

42-62

Entity State/Province

3AN

63-65

For example, SAN DIEGO. If Entity City
requires additional space, continue in a
PG60 record with Qualifier Code ‘ECI’.
For example, CA.

Entity Country

66-67

For example, US.

Entity Zip/Postal Code

68-76

For example, 92169.

Filler

77-80

Space fill

2
2

FDA Supplemental Guidance 2.4.1

243

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“21”

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Telephone Number
of the Individual

15X

31-45

Code identifying which entity the Point of
Contact is related to. For example, PK.
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore

Email Address for
the Individual

35X

46-80

Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes applicable to FDA Medical Device Message Sets is below:
Data Element
Entity Role Codes

FDA Supplemental Guidance 2.4.1

Code

Description

Point of Contact

244

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
For Medical Device, this is a conditional PGA input record that provides data pertaining to Food and Drug
Administration Affirmation of Compliance Criteria. This record is typically only used by FDA. This record is
repeatable.
Record Identifier PG23 (Affirmation of Compliance)
Data Element
Control Identifier
Record Type
Affirmation of
Compliance Code
Affirmation of
Compliance
Qualifier

Filler

Length/
Class

Position

Status

2A
2N
5X

1-2
3-4
5-9

M
M
M

30AN

10-39

Description

Note

“PG”
“23”
A code used to affirm compliance with FDA
requirements. .
Text describing the information required by the
PGA. This could include a combination of
letters and digits, specific text, etc. Follow the
Entered value of AoC Description / Business
Rule column in the table below in the Note
section.
Space fill

1
1

Note 1
The list of Affirmation of Compliance codes for FDA-Medical Devices Message Sets is below followed by the
scenarios when the AofCs should be provided: : N=Numeric digits; X=Alphanumeric.
Code

Description

Syntax

PM#

Device Premarket Number

DDM
DEV

Device Domestic Manufacturer
Device Foreign Manufacturer Registration
Number
Device Foreign Exporter Registration Number
Device Identifier
Component Identifier
Import For Export
Investigational Device Exemption Number
Device Impact Resistance Lens Certification
Device Imported Kit of Finished Device
Device Listing Number

Any of the following:
P+6N; N+4N, 5N, or 6N;
D+6N; H+6N; K+6N;
DEN+6N; BP + 4-6N;
BK + 6N; BH + 6N; BM + 6N; BR + 6N;
DK + 6N; BD+6N
1 - 10N
1 - 10N

DFE
DI
CPT
IFE
IDE
IRC
KIT
LST
DA
IND
LWC

New Drug Application Number or Abbreviated
New Drug Application Number or Therapeutic
Biologic Application Number
Investigation New Drug Application Number
Electrode Lead Wire Or Patient Cable

1 - 10N
6-23X
Indicator only
Indicator only
G+6N OR "NSR"
Indicator only
Indicator only
A+6N; B+6N; C+6N; D+6N; E+6N; L+6N;
Q+6N; R+6N
BA+4-6N or
BN + 5-6 N
or 6N
4-6N
Indicator Only

The table below shows which Affirmations of Compliance are Mandatory (M), Conditional (C) or Optional
(O) based on the Intended Use Code/Import Scenario:

FDA Supplemental Guidance 2.4.1

245

FDA Supplemental Guidance
Mandatory
Affirmations

Conditional1
Affirmations

Optional
Affirmations

DEV, DFE, LST

IRC, LWC, PM#

Import of a device for domestic refurbishing

DEV, DFE, LST

IRC, LWC, PM#

081.003

domestically manufactured device that is part of a
medical device convenience kit

IRC, LWC, PM#

081.004

foreign manufactured device that is Part of a
medical device convenience kit

PM#, LWC;IRC

081.005

Device constituent part for drug-device combination
product

DDM, DFE, KIT,
LST
KIT, DEV, DFE,
LST
DEV, DFE, LST

140.000

Import of a device for charity

DEV, DFE, LST

IRC, LWC, PM#

081.007

Component for further manufacturing into a finished
medical device

CPT

081.008

Device component for use in a drug-device
combination product

CPT

DA, IND

170.000

Repair of medical device and re-exportation

DDM, IFE

DFE, LST, IRC,
LWC, PM#

180.010

Import of research or investigational use in vitro
diagnostic device

180.014*

Import of a device for non-clinical use/bench
testing
Import of device sample for customer
evaluation
Import of a medical device for clinical
investigational use
Import of a device that is US goods returned for
refund/overstock (to manufacturer)

DDM, LST

DFE, IRC, LWC,
PM#

Intended
Use (see
PG01 for
definitions)
081.001

Import Scenarios

081.002*

180.015*
920.001

Standard import of device, accessories, or
components regulated as a finished device
Import of refurbished device
Import of a reprocessed device

DA, IND
DI
LST, PM#

IDE

920.002

Import of device that is US goods returned for sale
to a third party

DFE, DDM, LST

IRC, LWC, PM#

950.001*

Import of a single-use device for domestic
reprocessing

DDM, LST

950.002*

Import of a multi-use device for domestic
reprocessing

DFE, IRC, LWC,
PM#
DDM, DFE, IRC,
LST, LWC, PM#

970.000

Import for Export:
Import of a medical device for further
processing and re-exportation
Importation of a medical device or accessory
for further manufacturing into an export-only
medical device
Import for Export:
Importation of a medical device component
for further manufacturing into an export-only
medical device

970.001

100.000*

Device For Personal Use

110.000*

Public Exhibition/Trade Show

940.000*

Compassionate Use/Emergency
device

081.006

Import under enforcement
discretion provisions per final
guidance

FDA Supplemental Guidance 2.4.1

DEV, DFE, IFE,
LST

IFE, CPT, DDM,
LST

246

FDA Supplemental Guidance
: The conditional affirmations are required if applicable to the product being declared.
For example, if the product requires premarket clearance (510(k)), then PM# must be provided.

*Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision.

The list of Optional Affirmation of Compliance codes for FDA-Medical Devices Message Sets is below.
Code

Description

Syntax

Device Identifier (part of the Unique Device
Identifier, UDI)

6-23X

FDA Supplemental Guidance 2.4.1

247

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

248

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
For Medical Device, it is a conditional PGA input record that provides data pertaining to: Temperature Qualifier,
Degree Type, Actual Temperature, Lot Number, Production Date, Range of the Lot, PGA Line Value, and PGA
Unit Value. This record is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value
MUST be included on the first PG25 record. There must be at least one PG25 record for each FDA line.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“25”

Temperature Qualifier

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording
Lot Number Qualifier

1AN

Lot Number

25X

16-40

Production Start date
of the Lot

41-48

Production End Date
of the Lot

49-56

PGA Line Value

12N

57-68

PGA Unit Value

12N

69-80

If the actual temperature is in the negative
numbers use an “X”. This is left blank for a
positive value.
Required if Degree Type is entered.
Reported temperature. Two decimals
places are implied.
Identifies recorded temperature is for
A=product, B=container and C=
conveyance
Code of the entity that assigned the Lot
number. 1 = Manufacturer
Should not be entered if more than one
PG25 record is entered
The lot number that the manufacturer
assigned to the product.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format.
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
The value associated with the PGA line
number in whole dollars. Must be entered
in the first PG25 record in the case of
multiple PG25 records. When entered, it
must be right-justified with preceding zeros
and be greater than zero.
The value of the lowest unit of measure
reported in PG26. Two decimal places are
implied.

Note 1

FDA Supplemental Guidance 2.4.1

249

FDA Supplemental Guidance
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

250

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
For Medical Device, this is a mandatory PGA input record that provides FDA with data pertaining to Packaging
Qualifier, Quantity and Unit of Measure. This record can be repeated up to six (6) times, once for each unique
packaging level. The first record is used to describe the largest (outermost) container and the number of
containers at this packaging level. The second record is used to describe the contents of the next smallest
container. If needed, qualifiers 2-6 are used in a similar manner (largest to smallest container). The final record
must describe the actual amount of the product in the smallest container.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.
Record Identifier PG26 (Product Packaging)
Length
/Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging for
the product. Outermost (largest=1) packages
to the innermost (smallest=6) packages.
There can be up to 6 levels of packaging. If
reporting only one level, show the total
quantity for the item and report that as level 1.
“Quantity of the packaging level, For example,
000000000400. Two decimal places are
implied. Must be greater than zero.
Type of packaging / packaging level. For
example, BX. At least, ‘Pieces’ must be
selected. Cannot be repeated among the
PG26 records.

Data Element

Unit of Measure
(Packaging Level)

Description

Note

1,4

2,4
3,4

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging.
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Medical Devices Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Valid FDA Units of Measure for Packaging Containers
Code
CS

Description
Case

FDA Supplemental Guidance 2.4.1

251

FDA Supplemental Guidance
Code

Description

CT
BX
PK

Carton
Box
Package

Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)
Code

Description

PCS

Pieces (Count)

200
CT

Units 2-Quantity
Units 2-Measure

6
BX

Units 3-Quantity
Units 3-Measure

8
PCS

For Medical Devices, the lowest unit of measure must be PCS (Pieces – Count).

FDA Supplemental Guidance 2.4.1

252

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

3-4

“27”.

20AN

5-24

20AN

28-47

20AN

51-70

FDA Supplemental Guidance 2.4.1

253

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is an optional PGA input record that provides data pertaining to the net or gross unit of measure of the
commodity. This can be provided at the overall PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
Control Identifier
2A
1-2
Record Type
2N
3-4
3AN
Unit of Measure
5-7
(PGA line - net)

Status
M
M
O

Commodity Net
Quantity (PGA line
- net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line
- gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net Quantity
(PGA line - net)” is required when “Unit of
Measure (PGA line - net)” is reported in
positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line - gross)”
and is required when “Commodity Gross
Quantity (PGA line - gross)” is reported. Valid
Unit of Measure codes are listed in Appendix D
in this document or in Appendix C in the ACS
ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA line
- gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

254

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Note 1
Each pair of Unit of Measure and Quantity of commodity is entered at Net and Gross Level and PGA Line and
Individual Unit level for 4 distinct pairs of data.
All the four pairs of data are optional and for each pair, if the Quantity is entered, its corresponding Units of
Measure value is required. The valid values of Units of Measure for Medical Devices are below:
HTS Units of Measure
Code
CC
CFT

Description
Cubic Centimeter
Cubic Feet (Volume)

FDA Supplemental Guidance 2.4.1

255

FDA Supplemental Guidance
HTS Units of Measure
Code
CM3
CYD
DOZ
DPC
DPR
G
HUN
K
KG
KM3
LB
M3
NO
OZ
PCS
PK
PRS
STN
T

Description
Cubic Centimeters
Cubic Yards (Volume)
Dozen
Dozen Pieces
Dozen Pairs
Gram
Hundreds
1,000
1,000 Grams
1,000 Cubic Meters
Pounds, (weight) avdp)
Cubic Meters
Number
Ounces, (weight) (avdp)
Pieces
Pack
Pairs
Short Ton (2000 LB) (Weight)
Metric Ton

Record not supported
by FDA at this time

FDA Supplemental Guidance 2.4.1

256

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival /
Entry time

Anticipated Arrival /
Entry Location Code
Port of Arrival /
Entry
Filler

Description

Note

1
A = Anticipated arrival information

6-13

14-17

4AN

18-21

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes) is allowed.
For valid port codes, refer to Note 1.

72-80

Space fill

1
1

Port of Entry:
19 CFR 101.1.

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

257

FDA Supplemental Guidance

Length
/Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
8X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
72-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

258

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

259

FDA Supplemental Guidance

Record Identifier PG00 (Data Substitution)
This is an optional record used at the CBP entry (or entry summary) header, CBP entry (or entry summary) line
and/or PGA message set levels to indicate data substitution.
Currently, the PG00 record is implemented only at the CBP entry header level. Future implementation will allow
for submission at the CBP entry line and PGA Message Set level.
PG00 Substitution Grouping
In situations where the trade finds it would be supplying identical information more than once within the PGA
Message Set, a PG00 substitution grouping can be used, instead of repeating that information multiple times. See
the ‘usage notes’ in the ACE ABI CATAIR - Customs and Trade Automated Interface Requirements publication
for more detailed information.
Record Identifier PG00 (Data Substitution)
Data Element

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of where to
place the substitute data within the PGA
Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the substitution
group indicated by the Substitution Number
Sequential number assigned to, or referring to,
a specific substitution group of data provided at
the header level.
This data element is mandatory when using the
S or R substitution indicator.
Space fills.

FDA Supplemental Guidance 2.4.1

260

FDA Supplemental Guidance

Tobacco Commodity Data Elements and Values
Tobacco commodities can be broken down into the following categories using the existing Government Agency
data elements available in the PG01 message
PG01 Government
Agency Code
FDA

Commodity
Type

PG01 - Government
Agency Program
Code

PG01 - Government
Agency Processing
Code±

Tobacco

TOB

Consumer Use

CSU

Tobacco

TOB

For Further
Manufacturing

FFM

Tobacco

TOB

Investigational

INV

FDA
FDA

Commodity SubType

Table 6 – Tobacco commodity hierarchy
±

Required to identify a tobacco product as “for further manufacturing (FFM)”, for “consumer use” (CSU), or
for “investigational use” (INV). This information is needed to determine the marketing status of the
product. Ref: Sections 905, 910, and 911 of the FD&C Act.

The following are the potential PGA records associated with submitting Tobacco Products:
PG Record

Description

The commercial description of the shipment is provided.

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is provided.

PG02

The item type and Product Code detail are provided.

PG06

Source Type(origin) other than the CBP country of origin is provided

PG07

The Trade/Brand Name, Model and Year of Manufacture are provided

PG10

Product Characteristics and other optional product information are provided

PG19

The entity (manufacturer, consignee, shipper, etc.) of Record’s identification information is
provided.

PG20

Additional address data on the entity in PG19 is provided

PG21

The entity (manufacturer, consignee, shipper, etc.) of Record’s individual point of contact, phone
number and email is given.

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are provided

PG26

Packaging qualifier and quantity of the shipment are provided

PG29

Data pertaining to the net or gross unit of measure of the commodity

PG30

Inspection/Laboratory Testing

FDA Supplemental Guidance 2.4.1

261

FDA Supplemental Guidance
PG Record

Description

PG55

Additional roles performed by entity or individual

PG60

Additional Information

PG00

Data Substitution

FDA Supplemental Guidance 2.4.1

262

FDA Supplemental Guidance

Tobacco Example
Tobacco Message Set Layout for Sample
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Tobacco
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may vary
both from program to program and within a single program. For a more expansive set of examples of FDA PGA
Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

263

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product. For
example, Tobacco leaves - unprocessed

FDA Supplemental Guidance 2.4.1

Description

Note

264

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government Agency
Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use Code,
Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the imported
commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Description/Required Value

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

3AN

8-10

“FDA”

Government Agency
Program Code

11-13

Government Agency
Processing Code
Intended Use Code

3AN

14-16

16X

42-57

Government Agency Code

“TOB”

Note

1, 2

Allowed values: CSU, FFM, INV

1, 2
3,4

The Government Agency Processing
Code and the Product Code should
provide all the information the FDA
need to know about the intended
use.
Intended Use Description

21X

58-78

Correction Indicator

Disclaimer

3,4
For future Use
A code of A (= product is not
regulated by this agency) indicating
there is no agency declaration
requirement. Or this field is left blank
for no disclaimer. No other code is
accepted

Note 1
See Table 6 above for the commodity hierarchy for Tobacco commodities.
Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. Otherwise the Government
Agency Program Code, Government Agency Processing Code are mandatory.
Note 3
If the Disclaimer is ‘A’ then these data elements are optional; otherwise the Intended Use Code is conditional. If
Government Agency Program Code = TOB and Government Agency Processing Code = INV then one of the 180
Base Code intended use codes must be supplied.

Note 4

FDA Supplemental Guidance 2.4.1

265

FDA Supplemental Guidance
Intended Use Code
150.000
155.000
180.001
180.000
110.000
130.000
140.000
130.037
**

Intended Use Description
for commercial process as non-food
For Commercial Assembly as a Non-Food Product to be consumed
For Research and Development as a non-Food Product - Animal or plant for
biomedical research
For Research and Development as a non-Food Product – All other Uses
For Public Exhibition or Display as a Non-Food Product
For Consumer Use as a Non- Food Product
For Charitable Organization Use as Non-Food Product
For re-packaging and re-labelling**

Although Section 905 of the FD&C Act only applies to domestic manufacturers, it’s important for
enforcement purposes to know when products are being imported for repackaging or relabeling because
the re-packagers / re-labelers will need to register with FDA. Under Section 905, the term “manufacture,
preparation, compounding, or processing” includes repackaging or otherwise changing the container,
wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco
product from the original place of manufacture to the person who makes final delivery or sale to the
ultimate consumer or user. Ref: 701(b); Section 905 of the FD&C Act (21 U.S.C. §387e)

FDA Supplemental Guidance 2.4.1

266

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
This mandatory PGA input record is used to indicate whether or not the information being provided relates to a
product (P) or a component (C) of a product.

Record Identifier PG02 (Product Identifier)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.
Only one ‘P’ record is allowed for the same
PGA Line # in PG01 record.

Product Code
Qualifier
Product Code
Number

4AN

6-9

“FDP”

19X

10-28

FDA Product Code Must be equal to 7
characters

Note 1
Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For Tobacco, this is currently always ‘FDP’ for all FDA products.
Only one FDA Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

267

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is a conditional PGA input record that provides data pertaining to Source Type (Origin) other than the CBP
Country of Origin, in addition to Processing dates, Processing Type and Processing Description.
Record Identifier PG06 (Product Origin)
Data Element
Control Identifier
Record Type
Source Type Code

Length/
Class

Position

Status

1-2

“PG”.

2N
3AN

3-4
5-7

M
C

“06”.
For Tobacco, Source Type Code 39 (Country
of Production) is required. Other Source Type
Codes, 262 (Place of Growth) or HRV
(Harvested) or
30 (Country of Source) may be entered, if
available.

Description

Note

There would be at least one PG06 with
source type code of 39. More PG06 records
may be repeated for the optional Source Type
Codes, 262, HRV or 30..

Country Code

Note

8-9

Additionally, if previously refused, then trade
would also provide another PG06 with source
type code 294 (Country of Refusal).
Country of production or source is required for
Tobacco. Should match the country code in
PG19-PG20 record set for the Entity Role
Code ‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.
Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

268

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is a conditional PGA input record that provides data pertaining to Trade or Brand Name, Model, Manufacture
Year, Item Identity Number Qualifier and Item Identity Numbers.
Record Identifier PG07 (Product Trade Names)
Data Element
Control Identifier

Length/
Class

Position

Status

1-2

“PG”

Description

Note

Record Type

3-4

“07”

Trade Name/Brand
Name**

35X

5-39

If Government Agency Processing Code is
INV (Investigational) or CSU (Consumer Use)
then trade or brand name is mandatory.
If Government Agency Processing Code is
FFM (For Further Manufacturing), then trade
name/brand name is optional.
If Trade/Brand Name requires additional
space, continue in a PG60 record with
Qualifier Code ‘TBN’.

This field is only required for products intended for consumer use and for investigational use, not for
products intended for further manufacturing. Brand name is required in order to help identify if the
product meets FDA’s pre-market authorization requirements under Section 910 of the FD&C Act.

FDA Supplemental Guidance 2.4.1

269

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
For Tobacco, this is a mandatory PGA input record that allows for importer to report the description of the product
at the line level to capture the information currently collected in multiple OI records. This record can be repeated if
there are more Commodity Characteristic Descriptions.
Record Identifier PG10 (Product Characteristics)
Data Element
Control Identifier

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Free form invoice description, NOT product
code description.
This field will capture such information as
length, color, and pack count. Under 21
1140.16(b), cigarette packages are required
to contain a minimum of 20 cigarettes.
See Appendix A for the use of PG10 to
capture the information such as length, color
and pack count.

FDA Supplemental Guidance 2.4.1

270

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Tobacco, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role and
conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element

Length
/Class

Position

Status

1-2

“PG”

Control Identifier
Record Type

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example: MF, UC
Code identifying the Entity Identification is
entered. For example: 16, 47. Mandatory, if
Entity Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘ENA’. See
validation criteria below.
The address of the entity is required. If Entity
Address1 requires additional space, continue
in a PG60 record with Qualifier Code ‘AD1’.
See validation criteria below.

1
2
2
2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes mandatory to FDA Tobacco Message Sets is below:
Data Element

Entity Role Codes§

Code
MF
DEQ
FD1
TB
DP

Description
Manufacturer of goods
Shipper
FDA Importer (Importer of Record)
Submitter
Delivered to Party

Same Role Code cannot be entered more than once.

List of Entity Role codes conditional to FDA Tobacco Message Sets is below:
(If Government Agency Processing Code is INV then either ITL or LAB is mandatory.
Data Element
Entity Identification Codes

FDA Supplemental Guidance 2.4.1

Code
ITL
LAB

Description
Independent Third Party Laboratory
Laboratory or Clinical Site

271

FDA Supplemental Guidance
List of Entity Role codes also applicable to FDA Tobacco Message Sets is below:
Data Element

Code

Entity Role Codes

RD
PK

Description
Retailer/Distributor
Point of Contact

Note 2
Entity Identification Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Identification
Codes) of the ACE ABI CATAIR publication. List of Entity Identification codes applicable to FDA Tobacco
Message Sets is below:
Data Element
Entity Identification
Codes

Code
16
47

Description
D&B-assigned (DUNS number)
FDA-assigned

Length/
Class
9N
4-10N

FDA ENTITY IDENTIFICATION CODE AND ENTITY NUMBER SELECTION AND VALIDATION CRITERIA
FDA requires Entity Name and Entity Address. Additionally, an FEI number is preferred to import into the U.S.
Entity Name <>NULL AND Entity Address 1 <>NULL AND
IF Entity Identification Code =47 (FEI) THEN Entity Number MUST BE Length from 4 to 10 and Type = N
ELSE Entity Identification Code =16 (DUNS) THEN Entity Number MUST BE Length = 9 and Type = N
.

FDA Supplemental Guidance 2.4.1

272

FDA Supplemental Guidance

Length/
Class

Position

Status

1-2

“PG”

Description

Note

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite Number
Entity City

37-41

Address Line 2 for the Entity. If Entity
Address2 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD2’.
For example, 102 A.

21X

42-62

Entity State/Province

3AN

63-65

For example, SUGARLAND. If Entity City
requires additional space, continue in a
PG60 record with Qualifier Code ‘ECI’.
For example, TX.

Entity Country

66-67

For example, US.

Entity Zip/Postal Code

68-76

For example, 77004.

Filler

77-80

Space fill

2
2

FDA Supplemental Guidance 2.4.1

273

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“21”

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Telephone Number
of the Individual

15X

31-45

Code identifying which entity the Point of
Contact is related to. For example, PK
Name of the Individual. If the name will not fit,
continue in a PG60 record with Qualifier Code
‘INA’.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore

Email Address for
the Individual

35X

46-80

Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

FDA Supplemental Guidance 2.4.1

Code

Description

Point of Contact

274

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
For Tobacco, this is an optional PGA input record that provides data pertaining to Food and Drug Administration
Affirmation of Compliance Criteria. This record is typically only used by FDA. This record is repeatable.
Record Identifier PG23 (Affirmation of Compliance)
Length/
Class

Position

Status

Control Identifier

1-2

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

A code used to affirm compliance with FDA
requirements. See table below for valid
affirmation codes.

30AN

10-39

Text describing the information required by the
PGA. This could include a number or a
country code, etc. Also, see Appendix PGA
(Food & Drug Affirmation of Compliance
Qualifier Codes) of this publication for valid
codes related to certain specific Affirmation of
Compliance codes.

Space fill

Data Element

Affirmation of
Compliance
Qualifier

Filler

Description

Note

“PG”.
1

Note 1
The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication. The list of
AoC codes optional to FDA Tobacco Message Sets is below:
Data Element

Code
ILS

HPC
Affirmation of
Compliance Code

CMT

Description
Confirmation of Ingredient Listings
Submission to FDA: Manufacturers
and importers of tobacco products to
the U.S. must provide a list of
ingredients to FDA. Code of “ILS”
affirms Ingredients Listings was
previously submitted.
Harmful or Potentially Harmful
Constituents (HPHC) Report: All
manufacturers and importers of
tobacco products to the U.S. must
provide HPHC information to
FDA. Code of “HPC” confirms HPHC
information was previously submitted.
Commercially Marketed Tobacco.
Code of “CMT” indicates that the
product was commercially marketed
in the U.S. as of February 15, 2007

FDA Supplemental Guidance 2.4.1

Syntax

Business Rules

Indicator
only

If Government Agency
Processing Code is “CSU”,
then “ILS” may be entered.

Indicator
only

If Government Agency
Processing Code is “CSU”,
then “HPC” may be entered.

Indicator
only

If Government Agency
Processing Code is “CSU”
and the product was
commercially marketed in the
U.S. as of February 15,
2007, then “CMT” may be
entered.

275

FDA Supplemental Guidance
Data Element

Code
SE or
PMT or
EXE

Description

Syntax

If the product was not commercially
marketed in the U.S. as of February
15, 2007, then

Indicator
only

SE = Substantially Equivalent
or
PMT= Premarket Tobacco Application,
or
EXE= Exemption from Substantial
Equivalence

Business Rules
If Government Agency
Processing Code is “CSU”
and the product was not
commercially marketed in the
U.S. as of February 15, 2007
(CMT was not declared),
then either SE, PMT, or EXE
may be entered.

may be affirmed.
TST

Tobacco Submission Tracking

ERR

Entry Review Requested

FTZ

FTZ Admission Number

FDA Supplemental Guidance 2.4.1

7X or 7X24X

indicator
only
7X

If Government Agency
Processing Code is “CSU”
and affirmations “SE”, “PMT”,
or “EXE” were declared, then
“TST” is entered.
(i.e. “TST may be entered if
product was not
commercially marketed in the
U.S. as of February 15,
2007)
If declaring CMT, then TST is
optional.
ERR is just used as an
indicator, no data will follow
A maximum of 7 characters

276

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Data Element

Length
/Class

Position

Status

Control Identifier

1-2

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

FDA Supplemental Guidance 2.4.1

Description

Note

Must always equal PG.

277

FDA Supplemental Guidance

Record Identifier PG25 (Product Condition)
It is a conditional PGA input record that provides data pertaining to: Temperature Qualifier, Degree Type, Actual
Temperature, Lot Number, Production Date, Range of the Lot, PGA Line Value, and PGA Unit Value. This record
is repeatable for multiple Lot Number Qualifiers and Lot Numbers and the line value MUST be included on the first
PG25 record. There must be at least one PG25 record for each FDA line.
Record Identifier PG25 (Product Condition)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording
Lot Number
Qualifier**

1AN

Lot Number**

25X

16-40

Production Start date
of the Lot**

41-48

Production End Date
of the Lot**

49-56

PGA Line Value

12N

57-68

If the actual temperature is in the negative
numbers use an “X”.
Required if Degree Type is entered.
Reported temperature. Two decimals places
are implied.
Identifies recorded temperature is for
A=product, B=container and C= conveyance
Includes Lots and/or Batches
IF Government Agency Program Code =
TOB THEN Lot Number Qualifier = 3
Should not be entered if more than one
PG25 record is entered
The lot number that the manufacturer
assigned to the product.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format.
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
Line Value is needed for enforcement of
User Fee Regulations. Failure to pay user
fees makes a product adulterated under
Section 902 of the FD&C Act in accordance
with Section 919.
The value associated with the PGA line
number in whole dollars. Must be entered in
the first PG25 record in the case of multiple
PG25 records. When entered, it must be

FDA Supplemental Guidance 2.4.1

278

FDA Supplemental Guidance

PGA Unit Value

12N

69-80

right-justified with preceding zeros and be
greater than zero.
The value of the lowest unit of measure
reported in PG26. Two decimal places are
implied.

Not currently required for importing tobacco products, but may be required in future CTP regulations. Ref:
21 CFR 7; 701(b)

Note 1
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

279

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
For Tobacco, this is a mandatory PGA input record that provides FDA with data pertaining to Packaging Qualifier,
Quantity and Unit of Measure. This record can be repeated up to six (6) times, once for each unique packaging
level. The first record is used to describe the largest (outermost) container and the number of containers at this
packaging level. The second record is used to describe the contents of the next smallest container. If needed,
qualifiers 2-6 are used in a similar manner (largest to smallest container). The final record must describe the
actual amount of the product in the smallest container.
The appearance of any ‘Packaging Qualifier’ number level requires all levels under it to be represented. For
instance, level 3 can’t be present unless levels 1 and 2 are present.

Record Identifier PG26 (Product Packaging)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Used to determine the quantity of tobacco
products being imported, such as the
number of cigarettes, cartons, cartons per
pack, etc. Under 21 1140.16(b), cigarette
packages are required to contain a minimum
of 20 cigarettes.

Quantity
Unit of Measure
(Packaging Level)

12N

6-17

18-22

Description

Note

This code identifies the level of packaging
for the product. Outermost (largest=1)
packages to the innermost (smallest=6)
packages. There can be up to 6 levels of
packaging. If reporting only one level, show
the total quantity for the item and report that
as level 1.
“Quantity of the packaging level, For
example, 000000000400. Two decimal
places are implied. Must be greater than zero.
Type of packaging / packaging level. For
example, BX. Cannot be repeated among the
PG26 records.

1, 4

2, 4
3, 4

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging.
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Tobacco Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA

FDA Supplemental Guidance 2.4.1

280

FDA Supplemental Guidance
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Valid FDA Units of Measure for Packaging Containers
Code

Description

CS
CT
BX
PK

Case
Carton
Box
Package

Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)
Code
DOZ
DPC
NO
PK
PCS

Description
Dozen (Count)
Dozen Pieces (Count)
Number (Count)
Package
Pieces (Count)

Note 4
Quantity Data provides additional information to FDA about the product and how it is packaged. The basic format
for Quantity Data is in multiple pairs of data – quantity and unit of measure, i.e., 500 cases, 12 ounces, fluid, 1000
cartons, etc. Up to 6 data pairs may be submitted, beginning with the 1st pair for the outermost packaging when
Packaging Qualifier = 1. The first pair may describe the largest container and the last pair must describe the
amount of product in the smallest container. For example:
For example:
Product: 1000 cartons of cigarettes, 10 packs in each carton, 20 cigarettes in each pack
Units 1-Quantity= 1000
Units 1-Measure =CT
Units 2-Quantity=10
Units 2-Measure=PK
*Units 3-Quantity=20 (optional)
*Units 3-Measure=PCS (optional)
*The last level of packaging is optional to describe the shipment if the product labeling already
Includes the fact that each pack contains 20 individual cigarettes.

FDA Supplemental Guidance 2.4.1

281

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is an optional PGA record for Government Agency Program Code = ‘TOB’, PGA input record that
provides data pertaining to the net or gross unit of measure of the commodity. This can be provided at the overall
PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
Control Identifier
2A
1-2
Record Type
2N
3-4
Unit of Measure
5-7
3AN
(PGA line - net)

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net
Quantity (PGA line - net)” is required when
“Unit of Measure (PGA line - net)” is reported
in positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line gross)” and is required when “Commodity
Gross Quantity (PGA line - gross)” is reported.
Valid Unit of Measure codes are listed in
Appendix D in this document or in Appendix C
in the ACS ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA
line - gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

282

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length/ Position
Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Pertaining to the Individual unit (net), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - net)” in this position is
associated with “Commodity Net Quantity
(Individual unit - net)” and is required when
“Commodity Net Quantity (Individual unit net)” is reported. Valid Unit of Measure codes
are listed in Appendix D in this document or in
Appendix C in the ACS ABI CATAIR.
Pertaining to the Individual unit, excluding all
packing and packaging. Two decimals are
implied. “Commodity Net Quantity (Individual
unit - net)” is required when “Unit of Measure
(Individual unit - net)” is reported in positions
35-37 of this record.
Pertaining to the Individual unit (gross), the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure
(Individual unit - gross)” in this position is
associated with “Commodity Gross Quantity
(Individual unit - gross)” and is required when
“Commodity Gross Quantity (Individual unit gross)” is reported. Valid Unit of Measure
codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the Individual unit, including any
packaging, but excluding weight of the carrier's
equipment. Two decimals are implied.
“Commodity Gross Quantity (Individual unit gross)” is required when “Unit of Measure
(Individual unit - gross)” is reported in positions
50-52 of this record.
Space fill

Record not supported
by FDA at this time

FDA Supplemental Guidance 2.4.1

283

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival/
Entry time

A = Anticipated arrival information

6-13

14-17

4AN

18-21

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes) is allowed.
For valid port codes, refer to Note 1.

72-80

Space fill

Arrival / Entry
Location Code
Port of Arrival /
Entry
Filler

Description

Note

Port of Entry:
19 CFR 101.1.

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

284

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
46X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
35-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

285

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

286

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

FDA Supplemental Guidance 2.4.1

Sequential number assigned to, or referring
to, a specific substitution group of data
provided at the header level.
This data element is mandatory when using
the S or R substitution indicator.
Space fills.

287

FDA Supplemental Guidance

Radiation Emitting Products Commodity Data Elements and Values
Radiation Emitting Product commodities can be broken down into the following categories using the existing
Government Agency data elements available in the PG01 message.

PG01 Government
Agency Code
FDA

Commodity
Type

Radiation
Emitting
Products

PG01 - Government
Agency Program
Code

RAD

Commodity SubType

Non-Medical
Radiation
Emitting
Products

PG01 - Government
Agency Processing
Code

REP

Table 7 – Radiation Emitting Products commodity hierarchy
For informational purposes, the following table describes the Radiation Emitting Categories and whether the
product requires a 2877 and whether the product is a medical device. The Radiation Emitting Product
Classification website provides information on radiation emitting products.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm
Radiation Emitting Product Category

2877
Required

Medical Device*

Diagnostic Ultrasound Devices

Sonic Medical Products

Sonic Non-Medical Products

Therapeutic Ultrasonic Devices (Certified)

Ultrasonic Medical Devices (Miscellaneous)

Ultrasound Non-Medical Devices

Veterinary Diagnostic Ultrasonic Products

Veterinary Therapy Ultrasonic Products

Analytical X-Ray Systems, Non-Medical

Cabinet X-Ray Systems, Medical

Cabinet X-Ray Systems, Non-Medical

Cargo Non-Intrusive Security Systems

Cathode Ray Tube (without Electronics Chassis)

Cold-Cathode Gas Discharge Tubes

Dental Diagnostic X-Ray Equipment

Diagnostic Nuclear Medicine Devices

FDA Supplemental Guidance 2.4.1

288

FDA Supplemental Guidance
Radiation Emitting Product Category

2877
Required

Medical Device*

Diagnostic X-Ray Equipment (Non-Certified)

High Voltage Vacuum Switches

High Voltage Vacuum Tubes

Industrial Particle Beam Systems

Industrial X-Ray Systems (Excluding Cabinet)

Medical Accelerators

Medical Diagnostic X-Ray Equipment

Non-Medical Accelerators

Y, except product codes
RCA, RCB, RBZ, RCD
N

Personnel Security Systems

Radioisotope Therapy Devices

Therapeutic X-Ray Systems

TV Receivers & Products Containing Same

Veterinary X-Ray Systems

ONLY the following product
codes are medical devices:
FET, FWB, FWC, FWD,
FWE, FWF, FWG, HJG, and
ODA. All other product
codes in this category are
not medical devices.
N

X-Ray Bone Densitometers

X-Ray Film and Film Processing Materials

Household ELF Products

ONLY the following product
codes are medical devices:
LQA and JAC. All other
product codes in this
category are not medical
devices.
N

Industrial Dielectric Heaters

Microwave Communication, Data Transmit, and Measurement
Products
Microwave Diathermy Machines

Microwave Heating and Drying Products

Microwave Hyperthermia Therapy Devices

Microwave Identification, Safety, Security, and Surveillance Products

Microwave Medical Products

Y, except product code RDG

Microwave Ovens (Food Prep)

Nuclear Magnetic Resonance Devices

FDA Supplemental Guidance 2.4.1

289

FDA Supplemental Guidance
Radiation Emitting Product Category

2877
Required

Medical Device*

Other Microwave Products

Data Measurement, Transmit, Control Laser Products

General Optical Products, Medical

General Optical Products, Non-Medical

Y, except product code
RGV, RGU
N

In Vitro and Other Medical Laser Products

Y, except product code RGB

Laser Light Show/Display Products

Laser Products (Pre-Standard)

Material Processing Laser Products

Medical Laser Products

Y, except product code RGC

Mercury Vapor Lamps

Other Demonstration Laser Products

Other Laser Products

Positioning Medical Laser Products

Y, except product code RGC

Research, Scientific, Laboratory Laser Products

Safety, Security, Surveillance Laser Products

Sunlamp Products (Certified)

Sunlamp Products (Pre-Standard)

Surveying, Leveling, Alignment Laser Products

Toy, Novelty, Play Laser Products

Ultraviolet Commercial/Consumer Products

Ultraviolet Hygiene Products

Ultraviolet Medical Products

ONLY the following product
codes are medical devices:
LYL, MCF, NOB. All other
product codes in this
category are not medical
devices.
Y

Ultraviolet Surveillance & Detection Products

Utility/Peripheral Laser Products

Table 7a – Radiation Emitting Device Categories
*If Medical Device then all Medical Device data is required, in addition to applicable PG23 message set for
radiation-emitting products. See the chapter for Medical Devices.
The following are the potential PGA records associated with submitting Radiation-Emitting Products.

FDA Supplemental Guidance 2.4.1

290

FDA Supplemental Guidance

PG Record

Description

The commercial description of the shipment

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.

PG02

Product Identifier; the item type and Product Code detail are provided.

PG06

Source Type(origin) other than the CBP country of origin is provided

PG07

The Trade/Brand Name, Model and Year of Manufacture are provided

PG10

Product Characteristics and other optional product information are provided

PG19

Entity Role (manufacturer, consignee, shipper, etc.) Entity Identification, Entity Name, and Entity
Address 1 are provided.

PG20

Additional address data on the entity in PG19 is provided

PG21

Individual Name, Telephone Number, and Email address are provided

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are provided

PG26

Packaging qualifier and quantity of the shipment are provided

PG27

Data pertaining to issued Container Number is provided

PG29

Data pertaining to the net/gross unit of measure and quantity are provided

PG30

Data pertaining to date, time and location of inspection are provided

PG55

Identifies Entity from the previous PG19, PG20, and PG21 group as having additional roles.

PG60

Additional Information

PG00

Data substitution

FDA Supplemental Guidance 2.4.1

291

FDA Supplemental Guidance

Radiation Emitting Products Example
Radiation Emitting Products Message Set Layout for Sample
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Radiation Emitting
Products
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

292

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product. For
example, FDR D-EVO Suite FS by Fujifilm.

FDA Supplemental Guidance 2.4.1

Description

Note

293

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government
Agency Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use
Code, Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the
imported commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“01”

PGA Line Number

5-7

“001”

Government
Agency Code
Government
Agency Program
Code
Government
Agency
Processing Code
Intended Use
Code
Intended Use
Description

3AN

8-10

11-13

Correction
Indicator
Disclaimer

Description/Required Value

Note

“FDA”
“RAD”

3AN

14-16

1, 2

1, 2
“REP”

16X

42-57

21X

58-78

Code identifying the intended use for the
commodity after importation.
If the Intended Use code used is 980.000, this
field is used to describe the Intended Use such
as ‘Sample devices’, ‘Return shipment’, etc.

2,3
2,3

For future Use
A code of A (= product is not regulated by this
agency) indicating there is no agency declaration
requirement. Or this field is left blank for no
disclaimer. No other code is accepted

Note 1
See Table 7 above for the commodity hierarchy for Radiation Emitting Products commodities.
Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. otherwise the Government
Agency Program Code, Government Agency Processing Code and Intended Use Code are mandatory.

Note 3
Intended Use Codes and their descriptions can be found in Appendix R (Intended Use Codes for ACE) of the
ACE ABI CATAIR publication. For Radiation-Emitting Products, only one of the following Intended Use Codes
may be entered:

FDA Supplemental Guidance 2.4.1

294

FDA Supplemental Guidance
085.000
090.000
100.000
110.000
120.000
130.000
140.000
150.000
155.000
170.000
180.000
970.000
980.000

For Veterinary Medical Use as a Non-Food Product under Controlled Distribution
For Military Use as a Non- Food Product
For Personal Use as a Non- Food Product
For Public Exhibition or Display as a Non-Food Product
For Public Safety Use as a Non-Food Product
For Consumer Use as a Non- Food Product
For Charitable Organization Use as Non-Food Product
For Commercial Processing as a Non-Food Product
For Commercial Assembly as a Non-Food Product
For Repair of a Non-Food Product
For Research and Development as a Non-Food Product
For Import For Export
For Other Use

FDA Supplemental Guidance 2.4.1

295

FDA Supplemental Guidance

Record Identifier PG02 (Product Identifier)
This mandatory PGA input record is used to indicate whether or not the information being provided relates to a
product (P) or a component (C) of a product.
For Radiation-Emitting Product entries, the Product Code Number is provided within this record.
Record Identifier PG02 (Product Identifier)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“02”

Item Type

Code identifying the following records as
pertaining to P=Product.
Only one ‘P’ record is allowed for the same PGA
Line # in PG01

Product Code
Qualifier
Product Code
Number

4AN

6-9

“FDP”.

19X

10-28

FDA Product Code Must be equal to 7
characters

Note 1
Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For Radiation-Emitting Products, this is currently always ‘FDP’ for all FDA
products.
Only one FDA Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

296

FDA Supplemental Guidance

Position

Status

1-2

Must always equal PG.

Record Type
Source Type
Code

2N
3AN

3-4
5-7

M
M

Country Code

8-9

Must always be 06.
Mandatory valid values are 30 (Country of
Source) or 39 (Country of Production). 294 is
MANDATORY (Country of Refusal) if previously
refused
There would be one PG06 with source type code
of 30 or 39. If previously refused, then trade would
also provide another PG06 with source type code
294.
A two-letter code that identifies the country from
where the product was produced, packed or
shipped. Valid International Organization for
Standardization (ISO) Country and Currency
Code codes are in Appendix B in the ACS ABI
CATAIR. Should match the country code in PG19PG20 record set for the Entity Role Code ‘MF’.

Data Element
Control Identifier

Note

Description

Note

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.

Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

297

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is a conditional PGA input record that provides FDA with data pertaining to Name, Model, Manufacture Year,
and Item Identity Number.

Record Identifier PG06 (Product Trade Names)
Data Element
Control Identifier

Length/
Class

Position

Status

Description

1-2

“PG”

Note

Record Type

3-4

“07”

Trade Name/Brand
Name

35X

5-39

Trade/Brand Name of the Radiation-Emitting
Device. For example, Sony Laser scanner
RM2. Please see Note 1 below. If
Trade/Brand Name requires additional space,
continue in a PG60 record with Qualifier
Code ‘TBN’.

Note

If product requires 2877, then brand name is mandatory.

FDA Supplemental Guidance 2.4.1

298

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
This is a mandatory PGA input record that allows for reporting codes that provide additional characteristics of a
product or component, not reported elsewhere in the PG Message Set. For example, this record can be used to
provide the model year of a product, which can be different from the year of manufacture provided in the PG07.
This record can be repeated if there are more qualifiers or categories.
Record Identifier PG10 (Product Characteristics)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Free form description (invoice
description NOT product code
description) of the item. See Appendix A
for the use of PG10 to capture the
information currently collected in multiple
OI records.

FDA Supplemental Guidance 2.4.1

299

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Radiation Emitting Products, this is a mandatory PGA input record that provides FDA with data pertaining to
Entity Role and conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element

Length/
Class

Position

Status

1-2

“PG”

Control Identifier
Record Type

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example, MF.
Code identifying the Entity Identification is
entered. For example, 16. Mandatory, if Entity
Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘ENA’. See
validation criteria below.
The address of the entity is required. If Entity
Address1 requires additional space, continue
in a PG60 record with Qualifier Code ‘AD1’.
See validation criteria below.

1
2
2
2

Note 1
Entity Role Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Role Codes) of the ACE
ABI CATAIR publication. List of Entity Role codes applicable to FDA Radiation-Emitting Products Message Sets is
below:
Data Element
Entity Role Codes§

Code
MF
DEQ
FD1
DP

Description
Manufacturer of goods
Shipper
FDA Importer (Importer of Record)
Delivered To Party

Same Role Code cannot be entered more than once.

List of Entity Role codes also applicable to FDA Radiation Emitting Device Message Sets is below:
Data Element
Entity Role Codes

Code
PK

Description
Point of Contact

Note 2

FDA Supplemental Guidance 2.4.1

300

Data Element
Entity Identification
Codes

Code

Description

D&B-assigned (DUNS number); must be 9
digits
FDA-assigned (FEI number); must be from 4
to 10 digits

Length/
Class
9N
4-10N

FDA Supplemental Guidance 2.4.1

301

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
This is a mandatory PGA input record that provides additional data pertaining to the Entity identified in the
preceding PG19 record; such as Entity Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This
record is used when additional address for the entity needs to be entered.
Record Identifier PG20 (Entity Address)
Data Element
Control Identifier

Length/
Class

Position

Status

Description

1-2

“PG”

Note

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Entity Apartment
Number/Suite Number
Entity City

37-41

Address Line 2 for the Entity. If Entity
Address2 requires additional space,
continue in a PG60 record with
Qualifier Code ‘AD2’.
For example, 102 A.

21X

42-62

Entity State/Province

3AN

63-65

For example, SAN DIEGO. If Entity City
requires additional space, continue in a
PG60 record with Qualifier Code ‘ECI’.
For example, CA.

Entity Country

66-67

For example, US.

Entity Zip/Postal Code

68-76

For example, 92169.

Filler

77-80

Space fill

2
2

FDA Supplemental Guidance 2.4.1

302

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“21”

Individual Qualifier

3AN

5-7

Individual Name

23X

8-30

Code identifying which entity the Point of
Contact is related to. For example, PK.
Name of the Individual. If the name will not
fit, continue in a PG60 record with Qualifier
Code ‘INA’.

Telephone Number
of the Individual

15X

31-45

For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore

Email Address for
the Individual

35X

46-80

Email address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

FDA Supplemental Guidance 2.4.1

Code

Description

Point of Contact

303

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance)
This is a conditional PGA input record that provides data pertaining to Food and Drug Administration Affirmation
of Compliance Criteria. This record is typically only used by FDA. This record is repeatable.
If Medical Device then all Medical Device data is required, in addition to relevant radiation emitting product data
elements.. See also PG23 for Medical Devices.

Record Identifier PG23 (Affirmation of Compliance)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“23”.

Affirmation of
Compliance Code

5-9

30AN

10-39

A code used to affirm compliance
with FDA requirements. . See
Appendix PGA, PG23 – Food &
Drug Affirmation of Compliance,
FDA Affirmation of Compliance
Codes of ACE ABI CATAIR
publication.
Text describing the information
required by the PGA. This could
include a combination of letters and
digits, specific text, etc. Follow the
Entered value of AoC Description /
Business Rule column in the table
below in the Note section.
Space fill

Affirmation of
Compliance
Qualifier

Filler
Note

Description

Note

List of Affirmation of Compliance codes CONDITIONAL to FDA Radiation Emitting Product Message Sets
If 2877 is required:
Affirmation Qualifier Examples and
additional
information

RA1

date

format MM/YYYY

RA2

text

text is reason for
exclusion. Example:
DOD exemption

RA3

none

FDA Supplemental Guidance 2.4.1

Additional
Affirmations
Required

Text on 2877

1.Were manufactured prior to the effective date
of any applicable standard. Date of
Manufacture:____________________________
2. Are excluded by the applicability clause or
definition in the standard or by FDA written
guidance. Specify reason for
exclusion:______________
3. Are personal household goods of an individual
entering the U.S. or being returned to a U.S.
resident (Limit: 3 of each product type)

304

FDA Supplemental Guidance
Affirmation Qualifier Examples and
additional
information

RA4

text

RA6

none

RA7

text

RB1

text is description of
the end product.
Example: Laser
Diode

text is description of
the end product

text

RC1±

none

RC2

text

RD1±

none

5. Are components or subassemblies to be used
in manufacturing or as replacement parts
6. Are prototypes intended for ongoing product
development by the importing firms, are labeled
"FOR TEST/EVALUATION ONLY" and will be
exported, destroyed, or held for future testing.there is a quantity limit for this option-stated on
the back of the 2877 (page 2)
7.Are being reprocessed in accordance with P.L.
104-134 or other FDA guidance, are labeled
"FOR EXPORT ONLY" and will not be sold,
distributed or transferred without FDA approval.
If RB1 is
entered then
either ACC or
ANC is
B1.Comply with the performance standards1.Last annual report or Product/Initial Report
required.

none

RB2

Text on 2877

4. Are property of a party residing outside the
U.S. and will be returned to the owner after repair
or servicing.

none

RA5

Additional
Affirmations
Required

text is reason the
product complies

text is dates and use
restriction

FDA Supplemental Guidance 2.4.1

B2.Comply with the performance standards-2.
Unknown manufacturer/report number. State
reason:
C1.Do not comply with performance standards;
are being held under a temporary import bond;
will not be introduced into commerce, will be
used under a radiation protection plan, and will
be destroyed or exported under U.S. Customs
Supervision when the mission is complete - 1.
Research , Investigations/Studies, or Training
(Attach Form FDA 766)
C2.Do not comply with performance standards;
are being held under a temporary import bond;
will not be introduced into commerce, will be
used under a radiation protection plan, and will
be destroyed or exported under U.S. Customs
Supervision when the mission is complete - 1.
Trade Show/Demonstration; List dates and use
restrictions
D1. Do not comply with performance standards;
are held and will remain under bond; and will not
be introduced into commerce until notification is
received from FDA that products have been
brought into compliance in accordance with an

305

FDA Supplemental Guidance
Affirmation Qualifier Examples and
additional
information

Additional
Affirmations
Required

Text on 2877

FDA approved petition.(See Form FDA 766) -1.
Approved Petition is attached.

RD2±

RD3

ACC

ANC

none

date is the date form
766 will be provided,
due within 60 days of
date
submission.
Syntax: 7 or 11
characters long
Format: nnXnnnn-nnn
where n is a 1-digit
number and X is
either a letter or a 1If ACC is
Product digit number;
Report
‘-nnn’ is the optional entered then
accession Supplement Number. RB1 is
number
required
Syntax: 7 or 11
characters long
Format: nnXnnnn-nnn
where n is a 1-digit
number and X is
either a letter or a 1- If ANC is
Annual
entered then
Report
digit number;
accession ‘-nnn’ is the optional RB1 is
number Supplement Number. required

D2. Do not comply with performance standards;
are held and will remain under bond; and will not
be introduced into commerce until notification is
received from FDA that products have been
brought into compliance in accordance with an
FDA approved petition.(See Form FDA 766) 2.Petition request is attached.
D3. Do not comply with performance standards;
are held and will remain under bond; and will not
be introduced into commerce until notification is
received from FDA that products have been
brought into compliance in accordance with an
FDA approved petition.(See Form FDA 766) 3.Request will be submitted within 60 days.

±Annotates that additional information may be needed at time of entry in order for FDA to make a final
admissibility decision.

List of Affirmation of Compliance codes OPTIONAL to FDA Radiation Emitting Product Message Sets

FDA Supplemental Guidance 2.4.1

306

FDA Supplemental Guidance
Affirmation Qualifier Examples and Additional
additional
Affirmations
information
Required

MDL

CCM

Text

Remarks

Model Number
of the Product

Name of the
Certified
Component
Manufacturer

FDA Supplemental Guidance 2.4.1

EPRC Certified Component Manufacturer - in the
diagnostic x-ray systems and their major
components performance standard, manufacturers
of major components are required to certify such
components, which can be assembled by others
into the finished x-ray system. In cases where the
certifying component manufacturer is different from
the manufacturer who is shipping the entire system
to the U.S., this Affirmation of Compliance may be
used to provide additional identifying information
about that component manufacturer.

307

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

308

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Degree Type

Negative Number

Actual Temperature

8-13

Location of
Temperature
Recording
Lot Number
Qualifier

1AN

Temperature Category being reported for
quality control or preservation purposes.
A= Ambient, F=Frozen, D=Dry Ice,
R=Refrigerated/Chilled, H=Fresh,
U=Uncontrolled, P=Flashpoint
Optional
F = Fahrenheit, C = Celsius , K = Kelvin
Optional. If the actual temperature is in the
negative numbers use an “X”.
Optional. Required if Degree Type is entered.
Reported temperature. Two decimals places
are implied.
Optional.
Identifies recorded temperature is for
A=product, B=container and C= conveyance
Code of the entity that assigned the Lot
number. 1 = Manufacturer

Lot Number

25X

16-40

Production Start
date of the Lot

41-48

Production End
Date of the Lot

49-56

PGA Line Value

12N

57-68

PGA Unit Value

12N

69-80

FDA Supplemental Guidance 2.4.1

Should not be entered if more than one PG25
record is entered
The lot number that the manufacturer assigned
to the product.
Optional. The date when the production for the
Lot started. A numeric date in MMDDCCYY
(month, day, century, year) format.
Optional. The date when the production for the
Lot ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
The value associated with the PGA line
number in whole dollars. Must be entered in
the first PG25 record in the case of multiple
PG25 records. When entered, it must be rightjustified with preceding zeros and be greater
than zero.
The value of the lowest unit of measure
reported in PG26.
Two decimal places are implied.
IF Import For Export (PG01) submitted THEN
PG25 Value is MANDATORY

309

FDA Supplemental Guidance

Note 1
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

310

FDA Supplemental Guidance

Record Identifier PG26 (Product Packaging)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of packaging
for the product. Outermost (largest=1)
packages to the innermost (smallest=6)
packages. There can be up to 6 levels of
packaging. If reporting only one level, show
the total quantity for the item and report that
as level 1.
Quantity is MANDATORY.
Quantity of the packaging level, For
example, 000000000400. Two decimal
places are implied. Must be greater than
zero.
Type of packaging / packaging level. For
example, BX. At least, ‘Pieces’ must be
selected. Cannot be repeated among the
PG26 records.

Unit of Measure
(Packaging Level)

Description

Note

1,4

2,4

3,4

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging.
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA-Radiation-Emitting Products Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA

FDA Supplemental Guidance 2.4.1

311

FDA Supplemental Guidance
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Valid FDA Units of Measure for Packaging Containers
Code

Description

CS
CT
BX
PK

Case
Carton
Box
Package

Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)
Code
PCS

Description
Pieces (Count)

Microwave Ovens
Units 1-Quantity
Units 1-Measure

24,935.00 POUNDS
950
PCS

FDA Supplemental Guidance 2.4.1

312

FDA Supplemental Guidance

Record Identifier PG27 (Container Information)
This is an optionalPGA input record that provides data pertaining to issued Container Number. The number of the
shipping container is included in the Bill of Lading. Hence this record is not needed. This record may be repeated.
Record Identifier PG27 (Container Information)
Data Element
Control Identifier
Record Type
Container Number
(Equipment ID)
Container Number
(Equipment ID)
Container Number
(Equipment ID)

Length/
Class

Position

Status

1-2

“PG”.

Description

Note

3-4

“27”.

20AN

5-24

20AN

28-47

20AN

51-70

FDA Supplemental Guidance 2.4.1

313

FDA Supplemental Guidance

Record Identifier PG29 (Unit of Measure)
This is an optional PGA input record that provides data pertaining to the net or gross unit of measure of the
commodity. This can be provided at the overall PGA Line Number and/or the Individual Unit level.
Record Identifier PG29 (Unit of Measure)
Data Element
Length/
Position
Class
Control Identifier
2A
1-2
Record Type
2N
3-4
3AN
Unit of Measure
5-7
(PGA line - net)

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number,
the indication of the unit of measurement in
which weight, capacity, length, area, volume
or other quantity is expressed. “Unit of
Measure (PGA line - net)” in this position is
associated with “Commodity Net Quantity
(PGA line - net)” and is required when
“Commodity Net Quantity (PGA line - net)” is
reported. Valid Unit of Measure codes are
listed in Appendix D in this document or in
Appendix C in the ACS ABI CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net
Quantity (PGA line - net)” is required when
“Unit of Measure (PGA line - net)” is reported
in positions 5-7 of this record.
Pertaining to the overall PGA Line Number,
the indication of the unit of measurement in
which weight, capacity, length, area, volume
or other quantity is expressed. “Unit of
Measure (PGA line - gross)” in this position
is associated with “Commodity Gross
Quantity (PGA line - gross)” and is required
when “Commodity Gross Quantity (PGA line
- gross)” is reported. Valid Unit of Measure
codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding
weight of the carrier's equipment. Two
decimals are implied. “Commodity Gross
Quantity (PGA line - gross)” is required when
“Unit of Measure (PGA line - gross)” is
reported in positions 20-22 of this record.

314

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length/
Position
Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Pertaining to the Individual unit (net), the
indication of the unit of measurement in
which weight, capacity, length, area, volume
or other quantity is expressed. “Unit of
Measure (Individual unit - net)” in this
position is associated with “Commodity Net
Quantity (Individual unit - net)” and is
required when “Commodity Net Quantity
(Individual unit - net)” is reported. Valid Unit
of Measure codes are listed in Appendix D in
this document or in Appendix C in the ACS
ABI CATAIR.
Pertaining to the Individual unit, excluding all
packing and packaging. Two decimals are
implied. “Commodity Net Quantity
(Individual unit - net)” is required when “Unit
of Measure (Individual unit - net)” is reported
in positions 35-37 of this record.
Pertaining to the Individual unit (gross), the
indication of the unit of measurement in
which weight, capacity, length, area, volume
or other quantity is expressed. “Unit of
Measure (Individual unit - gross)” in this
position is associated with “Commodity
Gross Quantity (Individual unit - gross)” and
is required when “Commodity Gross
Quantity (Individual unit - gross)” is reported.
Valid Unit of Measure codes are listed in
Appendix D in this document or in Appendix
C in the ACS ABI CATAIR.
Pertaining to the Individual unit, including
any packaging, but excluding weight of the
carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity
(Individual unit - gross)” is required when
“Unit of Measure (Individual unit - gross)” is
reported in positions 50-52 of this record.
Space fill

Not supported by FDA
at this time
FDA Supplemental Guidance 2.4.1

315

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival/
Entry time

A = Anticipated arrival information

6-13

14-17

4AN

18-21

50X

22-71

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes) is allowed.
For valid port codes, refer to Note 1.

72-80

Space fill

Arrival / Entry
Location Code
Port of Arrival /
Entry
Filler

Description

Note

Port of Entry:
19 CFR 101.1.

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

316

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
8X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
72-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

317

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

318

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

Identifies either the start or end of the
substitution group, or the location of where to
place the substitute data within the PGA
Message Set.
The following codes are allowed:
S=Start of the substitution group
E=End of the substitution group
R=Replace this record with the substitution
group indicated by the Substitution Number
Sequential number assigned to, or referring to,
a specific substitution group of data provided
at the header level.
This data element is mandatory when using
the S or R substitution indicator.
Space fills.

FDA Supplemental Guidance 2.4.1

Description

Note

319

FDA Supplemental Guidance

Animal Drugs and Devices Commodity Data Elements and Values
Animal Drugs and Devices commodities can be broken down into the following categories using the existing
Government Agency data elements available in the PG01 message
PG01 Government
Agency Code

Commodity Type

PG01 Government
Agency Program
Code

Animal Drugs and
Devices
VME
Drugs
and
Animal
FDA
Devices
VME
Table 8 – Animal Drugs and Devices commodity hierarchy
FDA

Commodity SubType

PG01 - Government
Agency Processing Code

Animal Drugs

ADR

Animal Devices

ADE

The following are the potential PGA records associated with submitting Animal Drugs and Devices:
PG
Record

Description

The commercial description of the shipment

PG01

The shipment is regulated by the FDA program office within FDA and the intended use is
provided.

PG02

Product Identifier; the item type and Product Code detail are provided.

PG04

Product Constituent Active Ingredient

PG06

Product Source information is provided

PG07

The Trade/Brand Name

PG10

Product/Component Reporting Code

PG19

Entity Role (manufacturer, consignee, shipper, etc.) Entity Identification, Entity Name, and
Entity Address 1 are provided.

PG20

Additional Entity Identification (Address line 2, Apartment/Suite, City, State, and Zip/Postal
Code).

PG21

Additional Entity Role

PG23

FDA’s Affirmation of Compliance Criteria is provided.

PG24

Remarks

PG25

Temperature qualifier, Lot#, Production dates, PGA Line Value and PGA Unit Value are
provided

PG26

Packaging qualifier and quantity of the shipment are provided

PG27

Container Number

FDA Supplemental Guidance 2.4.1

320

FDA Supplemental Guidance
PG
Record

Description

PG29

Data pertaining to the net or gross unit of measure of the commodity

PG30

Product pertaining to the pertaining to the date, time and location of inspection; previous
laboratory testing; inspection location; and anticipated arrival information for FDA

PG55

Additional roles performed by an entity or individual

PG60

Additional Information

PG00

Data Substitution

FDA Supplemental Guidance 2.4.1

321

FDA Supplemental Guidance

Animal Drugs and Devices Example
Animal Drugs and Devices Message Set Layout for Sample
Please refer to the external file: FDA SG 2.4.1 Example PG Message Sets.xlsx Tab: Animal Drugs & Devices
Because of the flexibility of the PGA Message set, the PGA Records and Data Elements that are required may
vary both from program to program and within a single program. For a more expansive set of examples of FDA
PGA Message Sets, please refer to the above document.

FDA Supplemental Guidance 2.4.1

322

FDA Supplemental Guidance

Length/
Class

Position

Status

Control Identifier

1-2

“OI”

Filler

3-10

Space filled.

Commercial
Description

70X

11-80

The commercial description of the product.
For example, Amoxicillin

FDA Supplemental Guidance 2.4.1

Description

Note

323

FDA Supplemental Guidance

Record Identifier PG01 (PGA Identifier)
This is a mandatory PGA input record that provides data pertaining to the PGA Line Number, Government
Agency Code, Government Agency Program Code, Globally Unique Product Identification Code, Intended Use
Code, Intended Use Description, and Disclaimer. The Intended Use Code allows FDA to identify whether the
imported commodity is restricted by a consumption allowance or not.
Record Identifier PG01 (PGA Identifier)
Data Element

Length/
Class

Position

Status

Description/Required Value

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“01”.

PGA Line Number

5-7

Government Agency
Code
Government Agency
Program Code
Government Agency
Processing Code
Intended Use Code

3AN

8-10

“001”
“FDA”

11-13

3AN

14-16

Codes allowed: ADR , ADE

16X

42-57

See below for the list of New Intended Use
Codes

Intended Use
Description
Correction Indicator

21X

58-78

Disclaimer

1, 2

“VME”

1, 2
3
3

For future Use
A code of A (= product is not regulated by
this agency) indicating there is no agency
declaration requirement. Or this field is left
blank for no disclaimer. No other code is
accepted

Note 1:
Refer to Table 8 above for commodity type and sub-type for Animal Drugs and Devices.

Note 2
If the Disclaimer is ‘A’ then these data elements should both be populated with ‘FDA’. otherwise the Government
Agency Program Code, Government Agency Processing Code are mandatory.
Note 3
180.018
100.000

For Research and Development as a Non-Food Product – Investigational use on Animals
Importation for Personal Use

FDA Supplemental Guidance 2.4.1

324

FDA Supplemental Guidance

Position

Status

Control Identifier

“PG”.

Record Type

3-4

“02”.

Item Type

Code identifying the following records as
pertaining to P=Product. No other values
accepted.

Data Element

Description

Note

Only one ‘P’ record is allowed for the
same PGA Line # in PG01 record.
Product Code
Qualifier
Product Code Number

4AN

6-9

“FDP”.

19X

10-28

FDA Product Code Must be equal to 7
characters

Product Code Qualifiers and their descriptions can be found in Appendix PGA (PG02 – Product Code Qualifiers)
of the ACE ABI CATAIR publication. For Animal Drugs, this is currently always ‘FDP’ for all FDA products.
Only one FDA Product Code Number per product is allowed.
FDA Product Code Structure:

Position

1-2

6-7

Name

Industry
Code
(N)

Class
Code
(A)

Sub
Class
Code
(A or '-')

Process
Identification
Code - PIC
(A or '-')

Product
(AN)

Legend - N: Numeric; A: Alphabetic; AN: Alphanumeric

FDA Supplemental Guidance 2.4.1

325

FDA Supplemental Guidance

Record Identifier PG04 (Product Constituent Element)
This is an optional PGA input record that provides data pertaining to Constituent Active Ingredient Qualifier, Name
of the Constituent Element, Quantity of Constituent Element, Unit of Measure, and Percent of Constituent Element
for the product identified by Product Code Number in PG02. This record can be repeated.
The PG04 record is not required IF Government Agency Program Code = VME AND Government Agency
Processing Code = ADE; may be entered if Government Agency Program Code = VME AND Government Agency
Processing Code = ADR.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they are
under a PG02) at this time.
Record Identifier PG04 (Product Constituent Element)
Data Element

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”

Record Type

3-4

“04”

Constituent Active
Ingredient Qualifier

Active ingredient = “Y” if yes, blank if no.

Name of the
Constituent Element
Quantity of
Constituent Element
Unit of Measure
(Constituent
Element)
Percent of
Constituent Element

51X

6-56

12N

57-68

5AN

69-73

74-80

1
2 decimal places are implied

1
1

4 decimal places are implied

1, 2

Note 1
IF Government Agency Program Code = VME AND Government Agency Processing Code = ADR
THEN Constituent Active Ingredient Qualifier and Name of the Constituent Element are entered.
Either the quantity and Unit of Measurement are entered OR the Percent Constituent Element is entered.
May REPEAT PG04 for EACH Active Pharmaceutical Ingredient
Example1: Ibuprofen, 200mg tablets
Name of the Constituent Element = Ibuprofen
Quantity of Constituent Element = 200 and Unit of Measure = milligrams
Example2: Aluminum zirconium tetrachlorohydrex
Name of the Constituent Element = aluminum zirconium tetrachlorohydrex
Percent of Constituent Element 18.2% (entered as 0182000)
Note

Examples of Percentages:
1000000
0990000

=
=

100%
99%

FDA Supplemental Guidance 2.4.1

326

FDA Supplemental Guidance
0090000
0009000
0000900
0000090
0000009

=
=
=
=
=

9%
.9%
.09%
.009%
.0009%

FDA Supplemental Guidance 2.4.1

327

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin)
This is a mandatory PGA input record that provides data pertaining to Source Type (Origin) - other than the CBP
Country of Origin - for the product identified by Product Code Number in PG02.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they
are under a PG02) at this time.
Record Identifier PG06 (Product Origin)
Data Element

Length/
Class

Position

Status

Control Identifier

“PG”.

Record Type

3-4

“06”.

Source Type
Code

3AN

5-7

Mandatory valid values are 30 (Country of
Source) or 39 (Country of Production) is
MANDATORY. 294 (Country of Refusal) if
previously refused.

Country Code

Note

8-9

Description

Note

There would be one PG06 with source
type code of 30 or 39. If previously
refused, then trade would also provide
another PG06 with source type code 294.
Country of production or source is required
for Animal Drugs. Should match the country
code in PG19-PG20 record set for the
Entity Role Code ‘MF’.

Source Type Codes and their descriptions can be found in Appendix PGA (PG06 – Source Type Codes) of the
ACE ABI CATAIR publication.
Note

Any of the country codes from Appendix B (ISO Country and Currency Codes) in the ACS ABI CATAIR can be
entered.

FDA Supplemental Guidance 2.4.1

328

FDA Supplemental Guidance

Record Identifier PG07 (Product Trade Names)
This is a conditional PGA input record that provides FDA with data pertaining to Trade Name for the product
identified by Product Code Number in PG02.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements. The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when
they are under a PG02) at this time.

Record Identifier PG06 (Product Trade Names)
Data Element

Length
/Class

Position

Status

Control Identifier

“PG”.

Record Type

3-4

“07”.

Trade Name/Brand
Name

35X

5-39

If Government Agency Program Code =
‘VME’ and Government Agency Processing
Code = ‘ADR’ the Trade/Brand Name of the
Animal Drug is MANDATORY. If Trade/Brand
Name requires additional space, continue in a
PG60 record with Qualifier Code ‘TBN’.

FDA Supplemental Guidance 2.4.1

Description

Note

329

FDA Supplemental Guidance

Record Identifier PG10 (Product Characteristics)
For Animal Drugs, this is a mandatory PGA input record that allows for importer to report the description of the
product for the product identified by Product Code Number in PG02 at the line level to capture the information
currently collected in multiple OI records. This record can be repeated if there are more Commodity Characteristic
Descriptions.
Using a Drug example, Appendix C shows how PG04 can be used at the Product-level for multiple Constituent
Elements The FDA will process PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they
are under a PG02) at this time.
Record Identifier PG10 (Product Characteristics)
Length/
Class

Position

Status

Control Identifier

1-2

“PG”.

Record Type

3-4

“10”.

Commodity
Characteristic
Description

57X

24-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

330

FDA Supplemental Guidance

Record Identifier PG19 (Entity Data)
For Animal Drugs, this is a mandatory PGA input record that provides FDA with data pertaining to Entity Role and
conditionally the following data elements; Entity Identification, Entity Name, and Entity Address 1.
Record Identifier PG19 (Entity Data)
Data Element

Length/
Class

Position

Status

1-2

“PG”

Control Identifier
Record Type

Description

Note

3-4

“19”

Entity Role Code

3AN

5-7

Entity Identification
Code

3AN

8-10

Entity Number

15X

11-25

Entity Name

32X

26-57

Entity Address 1

23X

58-80

Code identifying the role of the entity being
provided. For example, MF.
Code identifying the Entity Identification is
entered. For example, 16. Mandatory, if
Entity Number is entered.
The Entity Number of the entity based on the
above Entity Identification Code is entered;
must conform to the descriptions in Note 2
The name of the entity is required. If Entity
Name requires additional space, continue in
a PG60 record with Qualifier Code ‘ENA’.
See validation criteria below.
The address of the entity is required. If
Entity Address1 requires additional space,
continue in a PG60 record with Qualifier
Code ‘AD1’. See validation criteria below.

1
2
2
2

Code
MF

Entity Role Codes§
DEQ
FD1
DP
§

Description
Manufacturer of goods (Final producer for the final drug
product). If the product is a bulk API, use “MF” as the Entity
Role Code (rather than “GD – Producer of API); If the product
is in finished form, provide MF of final product.
Shipper
FDA Importer (Importer of Record)
Delivered To Party

Same Role Code cannot be entered more than once.

List of Entity Role codes optional to FDA Animal Drugs Message Sets is below:
Data Element

Code

Entity Role Codes

Description
Producer (Producer of the API*)

*API – Active Pharmaceutical Ingredient

FDA Supplemental Guidance 2.4.1

331

FDA Supplemental Guidance
REPEAT GD for EACH Active Pharmaceutical Ingredient in the dosage form
List of Entity Role codes also applicable to FDA Animal Drugs Message Sets is below:
Data Element

Code

Entity Role Codes

Description
Point of Contact

Note 2
Entity Identification Codes and their descriptions can be found in Appendix PGA (PG19 – Entity Identification
Codes) of the ACE ABI CATAIR publication. List of Entity Identification codes applicable to FDA Animal Drugs
Message Sets is below:
Data Element
Entity Identification
Codes

Code
16
47

Description
D&B-assigned (DUNS number)
FDA-assigned

Length/
Class
9N
4-10N

FDA Supplemental Guidance 2.4.1

332

FDA Supplemental Guidance

Record Identifier PG20 (Entity Address)
This is a mandatory PGA input record that provides additional data pertaining to Entity identification such as Entity
Address line 2, Apartment/Suite, City, State, and Zip/Postal Code. This record is used when additional address for
the entity needs to be entered.
Record Identifier PG20 (Entity Address)
Data Element
Control Identifier

Length/
Class

Position

Status

1-2

Description

Note

“PG”

Record Type

3-4

“20”

Entity Address 2

32X

5-36

Address Line 2 for the Entity. If Entity
Address2 requires additional space, continue
in a PG60 record with Qualifier Code ‘AD2’.

Entity Apartment
Number/Suite Number
Entity City

37-41

Apartment/Suite number of the entity.

21X

42-62

Entity State/Province

3AN

63-65

City of the entity. If Entity City requires
additional space, continue in a PG60 record
with Qualifier Code ‘ECI’.
State/Province of the entity.

Entity Country

66-67

ISO Country Code.

Entity Zip/Postal Code

68-76

Zip/Postal Code of the entity.

Filler

77-80

Space fills.

2
2

FDA Supplemental Guidance 2.4.1

333

FDA Supplemental Guidance

Record Identifier PG21 (Point of Contact)
This is a mandatory PGA input record that provides data about an Individual and may also be related to an entity
(the party) in the preceding PG19 record. Included in this record are the Individual Name, Telephone Number
and Email address. A typical example is a POC for the Filer.
At least one PG21 record is required.
Record Identifier PG21 (Point of Contact)
Data Element

Length/
Class

Control Identifier

Record Type

Position

Status

Description

Note

1 2

“PG”.

3-4

“21”.

3AN

5-7

23X

8-30

Telephone Number
of the Individual

15X

31-45

Email Address for
the Individual

35X

46-80

Identify the type of party or facility the
Individual represents.
Name of the Individual. If the name will not
fit, continue in a PG60 record with Qualifier
Code ‘INA’.
Telephone number of the Individual.
For example, (713)555-8765 in US or
(+65)9052-3529 in Singapore
Email Address of the individual. If the Email
Address needs more space, continue in a
PG60 record with Qualifier Code ‘EMA’.

Individual Qualifier
Individual Name

FDA Supplemental Guidance 2.4.1

334

FDA Supplemental Guidance

Length/
Class

Control Identifier

Record Type
Affirmation of
Compliance Code

Position

Status

Description

Note

1-2

“PG”.

3-4

“23”.

5-9

A code used to affirm compliance with
FDA requirements. There must be at least
one PG23 record with the AoC code of
REG when filing animal drug. See
Appendix PGA PG23 – Food & Drug
Affirmation
of
Compliance,
FDA
Affirmation of Compliance Codes of ACE
ABI CATAIR publication.

Affirmation of
Compliance
Qualifier

30AN

10-39

Text describing the information required
by the PGA. This could include a number
or a country code, etc. Also, see Appendix
PGA (Food & Drug Affirmation of
Compliance Qualifier Codes) of this
publication for valid codes related to
certain specific Affirmation of Compliance
codes.

Filler

Space fill

Note

The FDA Affirmation of Compliance Codes and their descriptions are listed in the Appendix PGA (Food & Drug
Affirmation of Compliance, FDA Affirmation of Compliance Codes) of ACE ABI CATAIR publication.
No Affirmation of Compliances are mandatory for Animal Devices.
The list of AoC codes conditional to FDA Animal Drugs Message Sets is below:
Data
Element

Code

Description

Syntax

Business Rules
IF Government Agency Program Code =
VME and Government Agency
Processing Code = ‘ADR’ THEN REG
IS MANDATORY.
IF Government Agency Program Code =
VME AND PROCESSING CODE IS
ADR THEN EITHER VNA, VIN or VAN
is MANDATORY
IF Government Agency Program Code =
VME AND PROCESSING CODE IS
ADR THEN EITHER VNA, VIN or VAN
is MANDATORY

REG

Animal Drug Registration
Number

VAN

Abbreviated New Animal
Drug Number (ANADA)

VIN

Investigational New Animal
Drug Number (INAD) and
JINDA

FDA Supplemental Guidance 2.4.1

335

FDA Supplemental Guidance
Data
Element

Code

Description

Syntax

Business Rules

VNA

New Animal Drug Application 4N or 6N IF Government Agency Program Code =
VME AND PROCESSING CODE IS
Number (NADA) [also
includes conditionally
ADR THEN EITHER VNA, VIN or VAN
approved animal drugs
is MANDATORY
(CNADA), )], Type A
Medicated Articles], Legally
Marketed Unapproved New
Animal Indexed Drugs for
Minor Species (MSIF)
The list of AoC codes optional to FDA Animal Drugs Message Sets is below:
Data
Element

Affirmation of
Compliance
Code

Code

Description

Syntax

Business Rules
IF Government Agency Program Code =
VME AND Government Agency
Processing Code = ADR THEN DLS may
be entered.
IF Government Agency Program Code =
VME AND Government Agency
Processing Code = ADR THEN NDC
may be entered.
ERR is just used as an indicator, no data
will follow
IF Government Agency Program Code =
VME AND Government Agency
Processing Code = ADR THEN VFL may
be entered.

DLS

Animal Drug Listing Number

10N

NDC

National Drug Code

10N

ERR

Entry Review Requested

VFL

Medicated Feed License
(MFL)

indicator
only
6N
(5NNNN
N)

IFE

Import For Export

VFD

Veterinary Feed Directive

FDA Supplemental Guidance 2.4.1

indicator
only
6N

IF Government Agency Program Code =
VME AND Government Agency
Processing Code = ADR THEN VFD
may be entered.

336

FDA Supplemental Guidance

Record Identifier PG24 (Input)
Length
/Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 24.

Remarks Type
Code

5-7

Remarks Text

68X

13-80

Data Element

FDA Supplemental Guidance 2.4.1

Description

Note

337

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“25”.

Temperature
Qualifier

Temperature Category being reported. for
quality control or preservation purposes.

Degree Type

Negative Number

Actual
Temperature
Location of
Temperature
Recording

8-13

Lot Number
Qualifier

1AN

Lot Number

25X

16-40

Production Start
date of the Lot

41-48

Production End
Date of the Lot

49-56

PGA Line Value

12N

57-68

FDA Supplemental Guidance 2.4.1

A= Ambient, F=Frozen
R=Refrigerated/Chilled, D=Dry Ice
H=Fresh, U=Uncontrolled
P=Flashpoint
F = Fahrenheit, C = Celsius , K = Kelvin
If the actual temperature is in the negative
numbers use an “X”.
Reported temperature.
Two decimals
places are implied.
Identifies recorded temperature is for
A = product
B = container
C = conveyance
Code of the entity that assigned the Lot
number. For Animal Drugs the only valid
value is: 1 = Manufacturer
Should not be entered if more than one
PG25 record is entered
The lot number that the manufacturer/
producer/grower assigned to the product.
The date when the production for the Lot
started. A numeric date in MMDDCCYY
(month, day, century, year) format.
The date when the production for the Lot
ended. A numeric date in MMDDCCYY
(month, day, century, year) format.
The value associated with the PGA line
number in whole dollars. Must be entered
in the first PG25 record in the case of
multiple PG25 records. When entered, it
must be right-justified with preceding
zeros and be greater than zero.

338

FDA Supplemental Guidance
PGA Unit Value

12N

69-80

The value of the lowest unit of measure
reported in PG26. Two decimal places are
implied.

Note 1
The sum of PGA Line Value in PG25 across all FDA Line Numbers (PG01) cannot exceed the CBP entry value.
This business rule is enforced by CBP as a bucket-1 validation.

FDA Supplemental Guidance 2.4.1

339

FDA Supplemental Guidance

Position

Status

Control Identifier

1-2

“PG”

Record Type

3-4

“26”

Packaging Qualifier

Quantity

12N

6-17

18-22

This code identifies the level of
packaging for the product. Outermost
(largest=1) packages to the innermost
(smallest=6) packages. There can be
up to 6 levels of packaging. If
reporting only one level, show the total
quantity for the item and report that as
level 1.
“Quantity of the packaging level, For
example, 000000000400.
Two
decimal places are implied. Must be
greater than zero.
Type of packaging / packaging level.
For example, BX. Cannot be repeated
among the PG26 records.

Data Element

Unit of Measure
(Packaging Level)

Description

Note

1,4

2,4

3,4

Note 1
This code identifies the level of packaging for the product. Valid values are 1, 2, 3, 4, 5 and 6: Outermost
(largest=1) packages to the innermost (smallest=6) packages. There can be up to 6 levels of packaging
Note 2
There are two implied decimal points when writing the quantity in Units of Measure for the Base Unit (Last
Quantity Transmitted). In this example, 4 pieces are represented as 000000000400, with the nine leading zeroes
as “fill” and two decimal places following the value. The sample shows 1 carton containing 10 boxes and each box
containing 4 pieces.
Note 3
List of Unit of Measure codes applicable to FDA- Animal Drugs and Devices Message Sets
For a full list of applicable Unit of Measure codes, please refer to Appendix D in this document or to the Appendix
PGA (PG26 – Unit of Measure - Valid FDA Units of Measure for Packaging Containers) and Appendix PGA
(PG26 – Unit of Measure -Valid FDA Units of Measure for the Base Unit (Last Quantity Transmitted)) of the
CATAIR.
Valid FDA Units of Measure for Packaging Containers

FDA Supplemental Guidance 2.4.1

340

FDA Supplemental Guidance

Code
BG
BI
BJ
BK
AE
AM
AP
AT
BA
BC
BO
BQ
BS
BV
BX
CA
CAP
CG
CI
CON
CS
CT
CTR
CX
CY
DR
EN
FD
FOZ
G
GAL
KG
L
LB
MB
MG
ML
NO
OZ
PAL

Name
Bag
Bin
Bucket
Basket
Aerosol
Ampoule, Nonprotected
Ampoule, Protected
Atomizer
Barrel
Bottle crate, Bottle rack
Bottle, Nonprotected, Cylindrical
Bottle, Protected, Cylindrical
Bottle, Nonprotected, Bulbous
Bottle, Protected Bulbous
Box
Can, Rectangular
Capsules (Dosage)
Centigrams (Weight)
Canister
Container
Case
Carton
Cartridge
Can, Cylindrical
Cylinder
Drum
Envelope
Framed Crate
Ounces, fluid (Volume)
Grams (Weight)
Gallons (US) (Volume)
Kilograms (Weight)
Liters (Volume)
Pounds (avdp) (Weight)
Bag, Multi-ply
Milligrams (Weight)
Milliliters (Volume)
Number (Count)
Ounces, weight (avdp) (Weight)
Pallet

FDA Supplemental Guidance 2.4.1

341

FDA Supplemental Guidance
Code
PCS
PK
PTL
QTL
SUP
TAB

Name
Pieces (Count)
Package
Pints, liquid (US) (Volume)
Quarts, liquid (US) (Volume)
Suppositories (Dosage)
Tablets (Dosage)

24
BO

Units 3-Quantity
Units 3-Measure

100
TAB

In this case, the invoice description contains the strength of the aspirin tablets. The product quantity is listed
using the "Tablets" quantity unit code.

FDA Supplemental Guidance 2.4.1

342

FDA Supplemental Guidance

Record Identifier PG27 (Container Information)
This is an optional PGA input record that provides data pertaining to issued Container Number. The number of the
shipping container is included in the Bill of Lading. Hence this record is not needed. This record may be repeated.
Record Identifier PG27 (Container Information)
Data Element
Control Identifier
Record Type

Length/
Class

Position

Status

1-2

“PG”

Description

Note

3-4

“27”

Container Number
(Equipment ID)

20AN

5-24

The number of the shipping container
as entered in the Bill of Lading.

Container Number
(Equipment ID)

20AN

28-47

The number of the shipping container
as entered in the Bill of Lading.

Container Number
(Equipment ID)

20AN

51-70

The number of the shipping container
as entered in the Bill of Lading.

74-80

Filer

FDA Supplemental Guidance 2.4.1

343

FDA Supplemental Guidance

Status
M
M
O

Commodity Net
Quantity (PGA line net)

12N

8-19

Unit of Measure
(PGA line - gross)

3AN

20-22

Commodity Gross
Quantity (PGA line gross)

12N

23-34

FDA Supplemental Guidance 2.4.1

Description

Note

“PG”.
“29”.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - net)” in this position is associated with
“Commodity Net Quantity (PGA line - net)” and
is required when “Commodity Net Quantity
(PGA line - net)” is reported. Valid Unit of
Measure codes are listed in Appendix D in this
document or in Appendix C in the ACS ABI
CATAIR.
Pertaining to the overall PGA Line Number,
excluding all packing and packaging. Two
decimals are implied. “Commodity Net Quantity
(PGA line - net)” is required when “Unit of
Measure (PGA line - net)” is reported in
positions 5-7 of this record.
Pertaining to the overall PGA Line Number, the
indication of the unit of measurement in which
weight, capacity, length, area, volume or other
quantity is expressed. “Unit of Measure (PGA
line - gross)” in this position is associated with
“Commodity Gross Quantity (PGA line - gross)”
and is required when “Commodity Gross
Quantity (PGA line - gross)” is reported. Valid
Unit of Measure codes are listed in Appendix D
in this document or in Appendix C in the ACS
ABI CATAIR.
Pertaining to the overall PGA Line Number,
including any packaging, but excluding weight
of the carrier's equipment. Two decimals are
implied. “Commodity Gross Quantity (PGA line
- gross)” is required when “Unit of Measure
(PGA line - gross)” is reported in positions 2022 of this record.

344

FDA Supplemental Guidance
Record Identifier PG29 (Unit of Measure)
Data Element
Length Position
/Class
3AN
Unit of Measure
35-37
(Individual Unit net)

Status
O

Commodity Net
Quantity (Individual
Unit - net)

12N

38-49

Unit of Measure
(Individual Unit gross)

3AN

50-52

Commodity Gross
Quantity (Individual
Unit - gross)

12N

53-64

Filler

16X

65-80

Description

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

345

FDA Supplemental Guidance

Length/
Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“30”.

Inspection/
Laboratory Testing
Status
Anticipated Arrival /
Entry date
Anticipated Arrival /
Entry time

A = Anticipated arrival information

6-13

14-17

A numeric date in MMDDCCYY (month, day,
century, year) format.
Military time HHMM in (hour, minute) format.
(Example: 1015, this represents 10:15 a.m.).
For midnight, use 2400 (0000 is invalid).
Only a value of ‘2’ (= Census Schedule D
representing the CBP port codes) is allowed.
For valid port codes, refer to Note 1.

4AN
Arrival / Entry
18-21
O
Location Code
50X
22-71
Port of Arrival /
O
Entry
Filler
8X
72-80
M
Space fill
Note 1:
For PN shipments, A = Anticipated Arrival Date and Time at the Port of Arrival.
For Non-PN shipments, A= Anticipated Arrival Date and Time at the Port of Entry.

Port of Arrival:
21 CFR 1.276 (b)

(11) Port of arrival means the water, air, or land port at which the article of food is imported or offered for import into the United States. For an
article of food arriving by water or air, this is the port of unloading. For an article of food arriving by land, this is the port where the article of
food first crosses the border into the United States. The port of arrival may be different than the port where consumption or warehouse entry or
foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).

Note 2:
Refer to List of Valid Port Codes:
http://www.cbp.gov/sites/default/files/documents/CBP%20Port%20Codes%20041014_1.pdf

FDA Supplemental Guidance 2.4.1

346

FDA Supplemental Guidance

Length
/Class

Position

Status

Description

Control Identifier

1-2

“PG”.

Record Type

3-4

“55”.

3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
3AN
8X

5-7
8-10
11-13
14-16
17-19
20-22
23-25
26-28
29-31
32-34
72-80

O
O
O
O
O
O
O
O
O
O
M

Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Entity Role Code
Filler

Note

Not supported by FDA
at this time

FDA Supplemental Guidance 2.4.1

347

FDA Supplemental Guidance

Record Identifier PG60 (Input)
Data Element

Length/
Class

Position

Status

Control Identifier

1-2

Must always equal PG.

Record Type

3-4

Must always be 60.

3AN

5-7

Code indicating the type of additional
information being provided

72X

8-80

Text of the additional information related
to the additional reference qualifier code

Additional
information qualifier
code
Additional
Information

Note

Description

Note

Valid Additional Information Qualifier Codes applicable to FDA Message Set are:
Code

Description

ENA
AD1
AD2
AD3
AD4
AD5
ECI
INA
EMA
TBN

PG60 record should follow immediately after its parent. For example, a PG60:ENA record should follow PG19 and
a PG60:TBN record should follow PG07.

FDA Supplemental Guidance 2.4.1

348

FDA Supplemental Guidance

Length
/Class

Position

Status

Description

Note

Control Identifier

1-2

“PG”.

Record Type

3-4

“00”.

Substitution
Indicator

Substitution Number

4AN

6-9

Filler

71X

10-80

FDA Supplemental Guidance 2.4.1

349

FDA Supplemental Guidance

Appendix A: Use of PG10 Record
Here is an example of how the PG10 record is used to capture the information currently collected in multiple OI
records. A group of PG10...PG26 data can provide information on multiple variation of the product that was
generally identified in the OI record along with specific packaging information using PG26 within the same group.
Without using PG10:
OI
SOFT CANDY KR CHERRY SOURS 6/8 OZ
PG01001FDAFDA
PG02PFDP 33LGT07A
...
OI
SOFT CANDY CB GUMMI BEARS 24/6 OZ PEG
PG01001FDAFDA
PG02PFDP 33LGT07A
...
OI
SOFT CANDY KR GUMMI BEARS 6/9 OZ
PG01001FDAFDA
PG02PFDP 33LGT07A
...
With the use of PG10:
OI
VARIOUS SOFT AND HARD CANDIES
PG01001FDAFDA
PG02PFDP 33LGT07A
...
PG10
SOFT CANDY KR CHERRY SOURS 6/8 OZ
...
PG01002FDAFDA
PG02PFDP 33LGT07A
...
PG10
SOFT CANDY CB GUMMI BEARS 24/6 OZ PEG
...
PG01003FDAFDA
PG02PFDP 33LGT07A
...
PG10
SOFT CANDY KR GUMMI BEARS 6/9 OZ
...

FDA Supplemental Guidance 2.4.1

350

FDA Supplemental Guidance

Appendix B: Food Facility Registration Exemption (FME)
Code

Description

Facility is out of business

Facility is a private residence (21 CFR 1.227(b)(2))

Facility is a restaurant (21 CFR 1.226(d); 1.227(b)(10))

Facility is a retail food establishment (21 CFR 1.226(c); 1.227(b)(11))

Facility is a non-processing fishing vessel (21 CFR 1.226(f)

Facility is a non-bottled drinking water collection and distribution establishment (21
CFR 1.227(b)(2))

Unable to determine the registration number of the manufacturer

FDA Supplemental Guidance 2.4.1

351

FDA Supplemental Guidance

Appendix C: Sample use of PG04 – Product Constituent Element
Using the non-prescription Drug, Popular Product with multiple APIs§, the example below shows how PG04 can
be used at the product-level for multiple constituent elements.
OI
PG01
PG02
PG06
PG07
PG10
PG04

Analgesic/Human OTC Drug
001
(Line#)
60LBF01
(Product Code)
39
Philippines
(Source Country Name)
Popular Product
(Brand Name)
Non/Rx Combination Ingredient - Modified Release Hard Gelatin Capsules
API1
(Constituent Element #1)

PG04

API2

(Constituent Element #2)

PG04
PG19

API3

(Constituent Element #3)

API = Active Pharmaceutical Ingredient

The above example shows how the records PG05-PG06-PG07-PG08-PG10 are used at the Product level.
The FDA will accept PG05-PG06-PG07-PG08-PG10 records only at the Product-level (when they are under
a PG02) at this time.
Avoid including PG05-PG06-PG07-PG08-PG10 under a PG04. PG05-PG06-PG07-PG08-PG10 records
follow immediately the PG02 ; before any PG04 records.

FDA Supplemental Guidance 2.4.1

352

FDA Supplemental Guidance
Appendix D: Unit of Measurement Codes; See Base Units below
AE

Aerosol

Ampoule, Non-Protected

Ampoule, Protected

Atomizer

Barrel (Container)

Bobbin

Bottle crate, Bottle rack

Board

Bundle

Balloon, Non-Protected

Bag

Bunch

Bin

Bucket

Basket

Bale, Compressed

Bale, Non-Compressed

Bottle, Non-Protected, Cyl

Balloon, Protected

Bottle, Protected, Cylindrical

Bar

Bottle, Non-Protected Bulbous

Bolt

Butt

Bottle, Protected Bulbous

Box

Board in Bndl/Bnch/Truss

Bars in Bundle/Bunch/Trus

Can, Rectangular

CAG
CAP

Cage
Capsules (Dosage)

CAR

Carats Weight

Churn

Creel

Coffer

Centigrams Weight

Chest

Canister

Coffin

Cask

FDA Supplemental Guidance 2.4.1

353

FDA Supplemental Guidance
CL

Coil

Carboy, Non-Protected

CON

Container

Carboy, Protected

Crate

Case

Carton

CTR

Cartridge

Cup

Cover

Can, Cylindrical

Cylinder

Canvas

Demijohn, Non-Protected

Demijohn, Protected

Drum

Envelope

Crate, Fruit

Crate, Framed

Firkin

Flask

Footlocker

FOZ

Fluid Ounces (Volume)

Film pack

Frame

Grams Weight

GAL

Gallons (US) Volume

Bottle, Gas

Girders

Girders in Bndl/Bnch/Trus

Hogshead

Hamper

Ingot

Ingots in Bundle/Bnch/Trs

Jerri can, Rectangular

Jug

Jar

Jute bag

Jerri can, Cylindrical

KEG

Keg

Kilograms Weight

Liters Volume

FDA Supplemental Guidance 2.4.1

354

FDA Supplemental Guidance
LB

Pounds (avdp) Weight

Log

Logs In Bundle/Bunch/Trus

Cubic Meters Volume

Bag, Multi-ply

Crate, Milk

Milligrams Weight

MCG

Micrograms Weight

Milliliters Volume

Sack, Multiwall

Mat

Matchbox

Unpacked Or Unpackaged

Nest

Net

Ounces, weight (avdp) Weight

Packet

PAL

Pallet

Parcel

PCS

Pieces (Count)

Plate

Pitcher

Pipe

Package

Pail

Plank

Pouch

Pot

PTL

Pints, liquid (US) Volume

Tray or Tray Pack

Plates in Bndl/Bnch/Truss

Planks or Pipes, Bnd/Bnch

QTL

Quarts, liquid (US) Volume

Ring

Reel

Roll

Rednet

Rods in Bundle/Buch/Truus

Sack

Crate, Shallow

Spindle

Sea-chest

FDA Supplemental Guidance 2.4.1

355

FDA Supplemental Guidance
SH

Sachet

Case, Skeleton

Slipsheet

Sheet metal

Sheet

STN

Short ton (2000 LB) Weight

Suitcase

SUP

Suppositories (Dosage)

Shrinkwrapped

Syringe

Sheets in Bndl/Bnch/Truss

Metric Ton Weight

TAB

Tablets (Dosage)

Tub

Tea-Chest

Tube, Collapsible

Tank, Rectangular

Tin

Ton

TON

Long Ton (2240 LB) Weight

TOZ

Ounces, Troy or Apoth Weight

Trunk

Truss

Tube

Tank, Cylindrical

Tubes in Bndl/Bnch/Truss

Vat

Bulk Gas at 1031 MBAR

Vial

Bulk Liquid

Bulk,Solid,Lg Particles

Vacuum-packed

Bulk Liquified Gas

Bulk,Solid,Granular Parti

Bulk,Solid,Fine Particle

Wickerbottle

FDA Supplemental Guidance 2.4.1

356

File Type	application/pdf
File Title	Participating Government Agencies - FDA Supplemental Guide Release 2 4 1 Final.pdf
Author	Tyler.Scandalios
File Modified	2016-07-12
File Created	2016-07-12