Form 8947 Report of Branded Prescription Drug Information

Form 8947: Report of Branded Prescription Drug Information
Read the instructions before you complete Form 8947.

OMB No. 1545-2192

(Rev. October 2011)
Department of the Treasury — Internal Revenue Service
Item A: Check one
1 First time Filer (Complete this page and page 6; attach Schedule A)

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2 Subsequent Year Filer with Changes (Complete this page and page 6; attach Schedules B, C, and D as needed) .

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3 Subsequent Year Filer with No Changes and Reporting Rebates (Complete this page and page 6; attach Schedule D)
4 Subsequent Year Filer with No Changes and Not Reporting Rebates (Complete this page and page 6)
Item B: Check one (see instructions)
1 Single-person covered entity

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Information report for
sales year:

2010

Entity name

Address (number and street). If you have a P.O. box, see instructions.

Designated entities:
2a Common parent of an
affiliated group .

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2b Other designated entity .

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City, town or post office, state, and ZIP code. If you have a foreign address, see instructions.

Employer identification number (EIN).

Part I Controlled Group Members
If you checked Item B, box 2a or 2b: Beginning with the name of the designated entity, list the information for all
members of the controlled group who, as of the end of the day on December 31, 2010, are manufacturers or importers
with gross receipts from the sale of branded prescription drugs to specified government programs (or sales due to
coverage under the programs).
Check if the entity
was not listed on
your report for
sales year 2009

(a)
Name of entity

For Paperwork Reduction Act Notice, see instructions.

(c)
Employer
identification no.

(b)
Address of entity

Cat. No. 37765S

Form

8947 (Rev. 10-2011)

Page 2

Form 8947 (Rev. 10-2011)

Schedule A

Branded Prescription Drug Information – First Time Filers Only (see instructions)

Entity name

If you have more National Drug Codes (NDCs) to report than can be shown on this
page, complete and attach as many Schedules A as you need to list them all,
numbering each page (for example, Page A1 of A5).
Page
of

Employer identification number (EIN).

(a)
Controlled group member
EIN

(b)
NDC

(c)
Medicaid state supplemental
rebate amount, if applicable
(if none, enter -0-)

$

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$

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$

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$

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(d)
Latest tax year section
45C orphan drug credit
allowed, if applicable
(yyyy)

(e)
Name of section 45C orphan drug, if applicable

(f)
Date of FDA approval
for non-orphan drug marketing,
if applicable
(mmddyyyy)

Form

8947 (Rev. 10-2011)

Page 3

Form 8947 (Rev. 10-2011)

Schedule B

Branded Prescription Drug Information NDC Additions and Deletions (see instructions)

Caution: Use Schedule B only for additions and deletions of National Drug Codes (NDCs) at the covered entity level. Do not report the movement of NDCs between members of
the controlled group.
Entity name

If you have more NDC additions and deletions to report than can be shown on this
page, complete and attach as many Schedules B as you need to list them all,
numbering each page (for example, Page B1 of B5).
Page
of

Employer identification number (EIN).

Section I

Additions

(a)
Controlled group member
EIN

Section II

(b)
NDC additions

(c)
Medicaid state supplemental
rebate amount, if applicable
(if none, enter -0-)

$

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$

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$

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$

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$

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$

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$

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$

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Deletions

Enter the NDC of any
branded prescription drug
you listed on your report for
sales year 2009 but is no
longer applicable (see
instructions).

(d)
Latest tax year section
45C orphan drug credit
allowed, if applicable
(yyyy)

(f)
Date of FDA approval
for non-orphan drug marketing,
if applicable
(mmddyyyy)

(e)
Name of section 45C orphan drug, if applicable

NDC

NDC

NDC

NDC

NDC

NDC

NDC

NDC

NDC

NDC

Form

8947 (Rev. 10-2011)

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Form 8947 (Rev. 10-2011)

Schedule C

Branded Prescription Drug Information Orphan Drug Changes—Previously Reported NDCs (do not include National Drug Codes (NDCs) or
orphan drug information reported on Schedule B - see instructions)

Entity name

If you have more orphan drug changes to report than can be shown on this page,
complete and attach as many Schedules C as you need to list them all, numbering
each page (for example, Page C1 of C5).
Page
of

Employer identification number (EIN).

(a)
Controlled group member
EIN

(b)
NDC

(c)
Latest tax year section
45C orphan drug credit
allowed, if applicable
(yyyy)

(d)
Name of section 45C orphan drug, if applicable

(e)
Date of FDA approval
for non-orphan drug marketing,
if applicable
(mmddyyyy)

Form

8947 (Rev. 10-2011)

Page 5
Branded Prescription Drug Medicaid State Supplemental Rebates—Previously Reported NDCs (do not include National Drug Codes (NDCs)
or rebate information reported on Schedule B)

Form 8947 (Rev. 10-2011)

Schedule D
Entity name

If you have more rebate information to report than can be shown on this page,
complete and attach as many Schedules D as you need to list them all, numbering
each page (for example, Page D1 of D5).
Page
of

Employer identification number (EIN).
(a)
NDC

(b)
Medicaid state supplemental
rebate amount, if applicable

(a)
NDC

(b)
Medicaid state supplemental
rebate amount, if applicable

(if none, enter -0-)

(a)
NDC

(b)
Medicaid state supplemental
rebate amount, if applicable

(if none, enter -0-)

(if none, enter -0-)

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Form

8947 (Rev. 10-2011)

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Form 8947 (Rev. 10-2011)

Schedule E

Summary of Form 8947

Entity name

Employer identification number (EIN).
1

Total number of controlled group members, including the designated entity, from page 1, Part I

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2

Total National Drug Codes (NDCs) from Schedule(s) A, column (b) .

3

Total Medicaid state supplemental rebate amounts from Schedule(s) A, column (c)

4

Total NDC additions from Schedule(s) B, Section I, column (b)

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Total Medicaid state supplemental rebate amounts from Schedule(s) B, Section I, column (c) .

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Total NDC deletions from Schedule(s) B, Section II .

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Total NDCs from Schedule(s) C, column (b)

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Total NDCs from Schedule(s) D, column (a) .

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Total Medicaid State supplemental rebate amounts from Schedule(s) D, column (b)

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Signature of Official Signing On Behalf of the Covered Entity (Single-Member, Common Parent of an
Affiliated Group, or Other Designated Entity) and Consent by the Common Parent or Designated Entity
(if applicable)

Part II

Under penalties of perjury, I declare that I have examined this report, including accompanying statements, and, to the best of my
knowledge and belief, it is true, correct, and complete.
[If you checked Item B, box 2a or 2b, on page 1] I also declare that I identified myself as the common parent of an affiliated group or
other designated entity (as per the instructions). I understand that the designated entity will receive IRS communications relating to
the fee imposed by section 9008 of the Act and is to pay this fee to the IRS on behalf of the controlled group. Each entity that is a
member of the controlled group is jointly and severally liable for this fee. I further declare that each entity in the controlled group
identified on this report consents to the choice of the designated entity indicated on this report.

▲

Sign
Here

Signature of official

Print name of signing official

Date

Title

Daytime telephone number

Email address

Send Form 8947 to: Internal Revenue Service
1973 Rulon White Boulevard
Mail Stop 4916
Ogden, UT 84404

Send the forms in a flat mailing (not folded). Do not staple, tear, or tape any of these forms. If
you are sending a large number of forms in conveniently sized packages, write your name on
each package and number the packages consecutively. United States postal regulations
require forms and packages to be sent by First-Class Mail. However, you may use private
delivery services such as DHL, Federal Express (FedEx), and United Parcel Service (UPS).
Form 8947 (Rev. 10-2011)

Page 7

Form 8947 (Rev. 10-2011)

General Instructions

Who Files

Section references are to the Internal Revenue Code unless otherwise
noted.

Generally, each manufacturer or importer of branded prescription drugs
with sales to specified government programs (or sales due to coverage
under the programs) may submit Form 8947. Each entity that is treated
as a single covered entity is requested to file one Form 8947, providing
all requested information for each such manufacturing and reporting
entity, as described in these instructions.
Schedules A, B, C, D, and E. All filers must complete page 1 and page
6, which includes Schedule E, Summary of Form 8947, and Part II,
Signature of Official Signing On Behalf of the Covered Entity (SingleMember, Common Parent of an Affiliated Group, or Other Designated
Entity) and Consent by the Common Parent or Designated Entity (if
applicable).
First time filers must also attach Schedule A, Branded Prescription
Drug Information—First Time Filers Only.
Subsequent year filers with changes to report must attach Schedule
B, Branded Prescription Drug Information NDC Additions and Deletions,
or Schedule C, Branded Prescription Drug Information Orphan Drug
Changes—Previously Reported NDCs, or both.
Subsequent year filers reporting Medicaid state supplemental rebates
for sales year 2010 drug sales must attach Schedule D, Branded
Prescription Drug Medicaid State Supplemental Rebates—Previously
Reported NDCs, to report NDCs and their Medicaid state supplemental
rebates. See Completing Pages 1 and 6, and the Correct Schedule(s)
below.

What's New
If you are filing this report for the second year (a subsequent year filer),
you are not required to resubmit all of the branded prescription drug
information submitted on your report filed for sales year 2009. For
reporting sales year 2010 information, Form 8947 is expanded with new
Schedules A, B, C, D, and E, allowing subsequent year filers to report
entity information and branded prescription drug information changes
only. See Schedules A, B, C, D, and E under Who Files below.
Medicare Part D rebate information is now directly reported to the IRS
by the Centers for Medicare and Medicaid Services and is no longer
reported on this form. However, it is still necessary for covered entities
to report Medicaid state supplemental rebate information on Schedules
A, B, D, and E, as applicable.

Purpose of Form
Use Form 8947 to report the following information for branded
prescription drugs sold by covered entities to specified government
programs (or sales due to coverage under the programs) during sales
year 2010.
• National Drug Codes (NDCs).
• Medicaid state supplemental rebate information.
• Section 45C orphan drug information.
• Designated entity and controlled group members information, if
applicable.
The IRS will use the information you submit on Form 8947 to calculate
the annual fee for branded prescription drug sales ("the fee"). The fee is
imposed by section 9008 of Public Law 111-148 (Patient Protection and
Affordable Care Act), as amended by Public Law 111-152 (Health Care
and Education Reconciliation Act of 2010) (the “Act”).
For more information, see Definitions and Item B. Covered Entity
Information below. Also, see Temporary Regulations sections 51.1T
through 51.12T, and section 51.6302-1T.

When To File
File Form 8947 by December 15, 2011, to report sales year 2010
information.

Definitions
For the definitions of covered entity, single-person covered entity, and
designated entity, see Item B. Covered Entity Information under Specific
Instructions.

Completing Pages 1 and 6, and the Correct Schedule(s)
First time filer
(check Item A, box 1)

Subsequent year filer with
changes
(check Item A, box 2)

Page 1
Schedule A

Yes
Yes

Yes
No

Yes
No

Yes
No

Schedule B
Schedule C
Schedule D
Schedule E

No
No
No

Yes, if NDC additions or
deletions (1), (2), (3)
Yes, if orphan drug changes (1), (3)
Yes, if reporting rebates (1), (3)

No
No
Yes

No
No
No

Yes, if Item B, box 2a or 2b,
checked
Yes
Yes
No
No
No
No
No
No
Yes

Yes, if Item B, box 2a or 2b,
checked
No
No
Yes, if Schedule B attached
Yes, if Schedule B attached
Yes, if Schedule B attached
Yes, if Schedule C attached
Yes, if Schedule D attached
Yes, if Schedule D attached
Yes

Yes, if Item B, box 2a or 2b,
checked
No
No
No
No
No
No
Yes
Yes
Yes

Yes, if Item B, box 2a or 2b,
checked
No
No
No
No
No
No
No
No
Yes

Schedule E, Line 1
Schedule E, Line 2
Schedule E, Line 3
Schedule E, Line 4
Schedule E, Line 5
Schedule E, Line 6
Schedule E, Line 7
Schedule E, Line 8
Schedule E, Line 9
Part II

Subsequent year filer with no Subsequent year filer with no
changes, reporting rebates changes, not reporting rebates
(check Item A, box 3)
(check Item A, box 4)

(1) NDCs reported on Schedule B cannot be shown on Schedules C or D.
(2) In Section I, report as additions only NDCs that were not associated with the covered entity for the previous sales year.
(3) On Schedule B, (Section II), Schedule C, or Schedule D, report only NDCs that were associated with the covered entity for the previous sales year.

Page 8

Form 8947 (Rev. 10-2011)

Branded prescription drug sales. Branded prescription drug sales are
sales of branded prescription drugs made to specified government
programs (or sales due to coverage under the programs). A branded
prescription drug is any prescription drug for which an application was
submitted under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)), or any biological product the license
for which was submitted under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)). A prescription drug is any drug that is
subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)).
Branded prescription drug sales do not include sales of section 45C
orphan drugs (defined below).
Specified government programs. Specified government programs
under the Act are:
• The Medicare Part D program under part D of title XVIII of the Social
Security Act;
• The Medicare Part B program under part B of title XVIII of the Social
Security Act;
• The Medicaid program under title XIX of the Social Security Act;
• Any program under which branded prescription drugs are procured
by the Department of Veterans Affairs;
• Any program under which branded prescription drugs are procured
by the Department of Defense; and
• The TRICARE retail pharmacy program under section 1074g of title
10, United States Code.
Section 45C orphan drugs. Generally, branded prescription drug sales
do not include sales of an orphan drug if any person claimed (and was
allowed) a section 45C tax credit for the orphan drug on a return or
claim for refund for any taxable year, and there has not been a final
assessment or a court disallowance of the full section 45C credit taken
for the drug.
Non-orphan drug marketing. However, a branded prescription drug is
not treated as an orphan drug after December 31 of the year in which
the drug or biological product was approved by the Food and Drug
Administration (FDA) for non-orphan drug marketing, regardless of
whether a section 45C credit was allowed for an orphan drug either
before or after the non-orphan drug designation. Non-orphan drug
marketing is marketing for any indication other than the treatment of the
rare disease or condition for which the section 45C tax credit was
allowed.

Specific Instructions
Item B. Covered Entity Information
Covered entity
A covered entity is any manufacturer or importer with gross receipts
from branded prescription drug sales. A manufacturer or importer is the
person identified in the Labeler Code of the NDC for the branded
prescription drug. The NDC is an identifier assigned by the FDA to a
branded prescription drug, as well as other drugs. The Labeler Code is
the first five numeric characters of the NDC, or the first six numeric
characters when the available five-character code combinations are
exhausted.
For purposes of the Act, all persons treated as a single employer
under sections 52(a), 52(b), 414(m), or 414(o) will be treated as one
covered entity (an Act section 9008(d)(2) controlled group). A covered
entity is either a single-person covered entity or a member of a
controlled group. In applying the single employer rules, a foreign entity
subject to tax under section 881 is included within a controlled group
under section 52(a) or 52(b). A covered entity is treated as being a
member of a controlled group if it is a member of the group at the end of
the day on December 31, 2010. Also, a controlled group that is an
affiliated group that filed a consolidated federal tax return for tax year
2010 (“affiliated group”) will be treated as one covered entity.
Box 1. Check box 1 if you are a single-person covered entity. You must
sign Part II on page 6.

Designated entity
Generally, the designated entity is one of the following.
• The common parent of an affiliated group.
• The member chosen to be the designated entity by the members of a
controlled group that is not an affiliated group. If a controlled group
does not select a designated entity, the IRS will select a member of
the controlled group as the designated entity for the controlled group.
The designated entity is responsible for the following for the group.
• Filing Form 8947,
• Receiving IRS communications about the fee,
• Filing any necessary error report (as described in Temporary
Regulations section 51.7T), and
• Paying the fee to the IRS.
Box 2a. Check box 2a if you are a common parent of an affiliated group.
Also complete Part I, Controlled Group Members, giving the name,
address, and EIN of only those members of the controlled group who,
as of the end of the day on December 31, 2010, are manufacturers or
importers with gross receipts from the sale of branded prescription
drugs to specified government programs (or sales due to coverage
under the program), listing the designated entity's name first. You must
also sign Part II on page 6.
Box 2b. Check box 2b if you are the designated entity for a covered
entity that is not an affiliated group. Also complete Part I, Controlled
Group Members, giving the name, address, and EIN of only those
members of the controlled group who, as of the end of the day on
December 31, 2010, are manufacturers or importers with gross receipts
from the sale of branded prescription drugs to specified government
programs (or sales due to coverage under the program), listing the
designated entity's name first. You must also sign Part II on page 6.

Name and Address
Entity name
If you checked box 1, enter the name of the single-person covered
entity. If you checked box 2a or 2b, enter the name of the designated
entity.

Address
P.O. box. Enter your box number only if your post office does not
deliver mail to your street address.
Foreign address. Enter the information in the following order: city,
province or state, and country. Follow the country's practice for entering
the postal code. In some countries the postal code may come before
the city or town name. Enter the full name of the country using
uppercase letters in English.
Third party. If you receive your mail in care of a third party (such as an
accountant or an attorney), enter on the street address line “C/O”
followed by the third party's name and street address or P.O. box.

Schedule A. Branded Prescription Drug Information –
First Time Filers Only
If you filed Form 8947 for sales year 2009, do not use Schedule A for the
2010 sales year. If you checked Item A, box 1, use Schedule A to report
the following.

Controlled group member EIN
Enter the same EIN for each member that was shown in Part I, column
(c).

NDC
Enter the 11-digit NDC (omitting hyphens) for any branded prescription
drug sold to any specified government program (or sold due to
coverage under the programs) during 2010.

Medicaid state supplemental rebate amount
Enter the Medicaid state supplemental rebates for each NDC paid by
the covered entity for sales under Medicaid in sales year 2010. For this
purpose, enter Medicaid state supplemental rebates invoiced by states
and paid by the covered entity for drugs in sales year 2010 and paid
before you file Form 8947.

Page 9

Form 8947 (Rev. 10-2011)

Latest tax year section 45C orphan drug credit allowed

Schedule E. Summary of Form 8947

For the drug listed, enter the latest tax year that the section 45C orphan
drug credit was allowed. The section 45C credit is considered to be
allowed if any entity claimed the credit even if that entity was not part of
the covered entity at the time the credit was claimed. Use the format
yyyy. Fiscal year filers must show the tax year according to the tax
year's beginning.

Use Schedule E to report the total number of controlled group
members, including the designated entity, shown on page 1, Part I, and
the totals from each of the other schedules attached to this report.

Name of section 45C orphan drug
Enter the generic or trade name shown on FDA Form 3671, if applicable.

Date of FDA approval for non-orphan drug marketing
Enter the date of FDA approval for non-orphan drug marketing, if
applicable. Use the format mmddyyyy.

Schedule B. Branded Prescription Drug Information
NDC Additions and Deletions
If you filed Form 8947 for sales year 2009, use Schedule B (check Item
A, box 2) to report the following for sales year 2010.
• NDCs that you did not report on your Form 8947 for sales year 2009
(additions), and
• NDCs that are no longer in the covered entity (deletions). An NDC is no
longer in the covered entity if you reported it on your Form 8947 for
sales year 2009 and it ceases to be described in the definition of
branded prescription drugs for the covered entity's 2010 sales year
(see Branded Prescription Drugs under Definitions above).
Do not report the movement of NDCs between members of the
controlled group.

Schedule C. Branded Prescription Drug Information
Orphan Drug Changes—Previously Reported NDCs
If you filed Form 8947 for sales year 2009, use Schedule C (check Item
A, box 2) to report changes in orphan drug information for previously
reported NDCs. Do not include NDCs or orphan drug information
reported on the Schedule B attached to this report.

Schedule D. Branded Prescription Drug Medicaid
State Supplemental Rebates— Previously Reported
NDCs
If you filed Form 8947 for sales year 2009, use Schedule D (check Item
A, box 2 or box 3, as applicable) to report Medicaid state supplemental
rebates paid by the covered entity for sales under Medicaid occurring in
sales year 2010. Enter rebates only for NDCs which you reported when
you filed Form 8947 for sales year 2009. For this purpose, enter
Medicaid state supplemental rebates invoiced by states and paid by the
covered entity for drugs in sales year 2010 and paid before you file Form
8947. Do not include NDCs or rebate information reported on the
Schedule B attached to this report.

Paperwork Reduction Act Notice. We ask for the information on Form
8947 to carry out the Internal Revenue laws of the United States. We
need it to ensure that you are complying with these laws and to allow us
to figure and collect the right amount of fees. You are not required to file
Form 8947. If you do not file Form 8947, we will calculate your branded
prescription drug fee based on information reported on previously filed
Forms 8947 (if any), NDC information maintained by the FDA, sales and
rebate information reported by the Agencies, and orphan drug
information maintained by the IRS.
You are not required to provide the information requested on a form
that is subject to the Paperwork Reduction Act unless the form displays
a valid OMB control number. Books or records relating to a form or its
instructions must be retained as long as their contents may become
material in the administration of any Internal Revenue law. Generally,
the information you report on this form is confidential, as required by
section 6103.
The time needed to complete and file Form 8947 will vary depending
on individual circumstances. The estimated average time is:
Recordkeeping . . . . . . . . . . . . 7 hrs., 24 min.
Preparing, copying, assembling,
and sending the form . . . . . . . . . . . . 51 min.
Learning about the law or the form . . . . . . . . 42 min.
If you have comments concerning the accuracy of these time
estimates or suggestions for making Form 8947 simpler, we would be
happy to hear from you. You can email us at [email protected] or write
to us at: Internal Revenue Service, Tax Products Coordinating
Committee, SE:W:CAR:MP:T:M:S, 1111 Constitution Ave. NW, IR-6526,
Washington, DC 20224. Do not send Form 8947 to this address.
Instead, see Where To File earlier.