Form 1 Manufacturer Data Fields for 340B Ceiling Price - FINAL

Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau

OMB No. 0915-0327; Expiration Date: XX/XX/20XX

Field	Size	Position	Remarks
Labeler Code	5	1-5	NDC #1
Product Code	4	6-9	NDC #2
Package Size Code	2	10-11	NDC3
Period Covered	5	12-16	QYYYY (Qtr/Yr)
Average Manufacturer Price (AMP)	12	17-28	99999.999999
Unit Rebate Amount (URA)	12	29-40	99999.999999
Package Size	11	41-51	9999999.999
Unit Type	3	52-54	(e.g., CAP, TAB, ML)
Case Pack	11	55-65	9999999.999
340B Price	12	66-77	999999999.99
FDA Product Name	65	78-142	FDA Product Name
Labeler Name	39	143-181	Name of Manufacturer/Labeler
Wholesale Acquisition Cost WAC	12	182-193	999999999.99

Health Resources and Services Administration (HRSA)

340B Quarterly Pricing Data

Text File for Transfer to HRSA

Source: Drug Manufacturers

Target: HRSA

Data Field Definitions:

Labeler Code: First segment of National Drug Code that identifies the labeler. Numeric values only, 5-digit field, right-justified and zero-filled for 4-digit labeler codes.

Product Code: Second segment of National Drug Code. Alpha-numeric values, 4-digit field, right-justified, zero-filled for 3-digit product codes.

Package Size Code: Third segment of National Drug Code. Alpha-numeric values, 2-digit field, right-justified, zero-filled for 1-digit package size codes.

Period Covered: Calendar quarter and year covered by data submission. Numeric 5-digit field, QYYYY.

Average Manufacturer Price: Average manufacturer price (AMP) per unit per product code only for the period covered, based on sales. If a drug is distributed in multiple package sizes, there will be one “weighted” AMP for the product, which will be the same for all package sizes. Numeric values, 12-digit field; 5 whole numbers, the decimal and 6 decimal places; right-justified; zero-filled. Compute to 7 decimal places and round to 6 decimal places.

Unit Rebate Amount (URA): -The average total rebate required under section 1927(c) of the Social Security Act with respect to the drug (for a unit of the dosage form and strength involved) during the quarterly reporting period. Refer to Centers for Medicare & Medicaid Services (CMS) Medicaid Drug Rebate Program website for URA calculation data. Numeric values, 12-digit field; 5 whole numbers, the decimal and 6 decimal places; right-justified; zero-filled Compute to 6 decimal places and round to 4 decimal places, pad positions 5 and 6 with zeros.

Package Size: The number of billing units in the labeled quantity from which the pharmacist dispenses.

Unit Type: One of the eight unit types by which the drug can be dispensed.

Valid Values:

AHF = refers only to injectable Anti-Hemophilic Factor units

CAP = Capsule

SUP = Suppository

GM = Gram

ML = Milliliter

TAB = Tablet

TDP = Transdermal patch

EA = EACH (Refers to drugs not identifiable by any other unit type)

Case Pack: the number of salable units in the shipping container.

340B Price: 340B Price = (AMP-URA)*PS*CSP for the quarterly reporting period. Numeric values, 12-digit field; 9 whole numbers, the decimal, and 2 decimal places; right-justified; zero filled. Round to 2 decimal places.

FDA Product Name: Drug name as approved by the FDA.

Labeler Name: Corporate name of entity identified by the labeler code.

Wholesale Acquisition Cost (WAC): Published catalog or list price for a drug product to wholesalers. Numeric values, 12-digit field; 9 whole numbers, the decimal, and 2 decimal places; right-justified; zero filled. Round to 2 decimal places.

Public Burden Statement:  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control number for this project is 0915-0327.  Public reporting burden for this collection of information is estimated to average 0.5 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10C-03I, Rockville, Maryland, 20857.

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