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

(November 2010)
Department of the Treasury — Internal Revenue Service
Item A: Check one (see instructions)
1 Single-person covered entity

Information report for
calendar year:

Entity name

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

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

.

.

2b Other designated entity .

.

2009

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
This section must be completed if you checked Item A, box 2a or 2b. Beginning with the information for the designated
entity, list the information for all members (as of the end of the day on December 31, 2009) of the controlled group.
(a)
Entity
No.

(b)
Name of Entity

(c)
Address of Entity

(d)
Employer
Identification No.

1
2
3
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For Paperwork Reduction Act Notice, see instructions.

Cat. No. 37765S

Form

8947 (11-2010)

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Form 8947 (11-2010)

Part II

Branded Prescription Drug Information (see instructions)

Entity name

Employer identification number (EIN).

(a)
Part I
entity no.

(c)
Medicare Part D rebate
amount, if applicable
(if none, enter -0-)

(b)
National
Drug Code

(d)
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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$

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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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$

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$

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$

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$

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$

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$

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$

.

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

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

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

Form

8947 (11-2010)

Page 3

Form 8947 (11-2010)

Part III

Controlled Group Designated Entity Consent
(sign and complete if you checked Item A, box 2b, on page 1) (see instructions)

Entity name

Employer identification number (EIN).
The designated entity receives IRS correspondence relating to the fee imposed by section 9008 of the Patient Protection and
Affordable Care Act and pays 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.
Under penalties of perjury, I declare that each entity in the controlled group identified on this report consents to the choice of the
designated entity indicated on this report for this controlled group, and that I have examined this report, including accompanying
statements, and to the best of my knowledge and belief, it is true, correct, and complete.

▲

Sign
Here

Signature of official

Date

Name of signing official

Part IV

Title

Daytime telephone number

Signature for Single-Person Covered Entity
(sign and complete if you checked Item A, box 1, on page 1)

Entity name

Employer identification number (EIN).
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.

▲

Sign
Here

Signature of official

Name of signing official

Date

Title

Daytime telephone number

Send Form 8947 to: Internal Revenue Service
1973 Rulon White Boulevard
Mail Stop 4916
Ogden, UT 84404
Form 8947 (11-2010)

Form 8947 (11-2010)

Page

4

Continuation Sheet for Part II. Branded Prescription Drug Information
Sheet

of

Use as many Continuation Sheets for Part II as necessary. Number each sheet. For example, sheet 1 of 4, sheet 2 of 4, etc.

Entity name

Employer identification number (EIN).

(a)
Part I
entity no.

(c)
Medicare Part D rebate
amount, if applicable
(if none, enter -0-)

(b)
National
Drug Code

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

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

$

.

(e)
Latest tax year section
45C credit allowed,
if applicable
(yyyy)

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

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

Form 8947 (11-2010)

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Form 8947 (11-2010)

General Instructions

Branded prescription drug sales do not include sales of
section 45C orphan drugs (defined below).

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

Specified government programs. Specified government
programs under the Act are:

Purpose of Form

• The Medicare Part D program under part D of title XVIII of
the Social Security Act;

Use Form 8947 to report the following information for all
branded prescription drugs sold by covered entities to specified
government programs (or sales due to coverage under the
programs) during calendar year 2009.

• The Medicare Part B program under part B of title XVIII of
the Social Security Act;

• National Drug Codes.
• Medicare and Medicaid 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”).
See Item A. Covered Entity Information and Definitions later.
Also, see Notice 2010-71 for more information.

Who Should File
All manufacturers and importers of branded prescription drugs
with sales to specified government programs (or sales due to
coverage under the programs) should file Form 8947. All entities
that are treated as single covered entities are requested to file
one Form 8947, disclosing all requested information for each
entity, as described in these instructions and Notice 2010-71.

When To File
File Form 8947 by January 20, 2011, for 2009 calendar year
sales information.

Where To File
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 and EIN 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).

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

• 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. Branded prescription drug sales do
not include sales of orphan drugs if the covered entity claimed
the section 45C tax credit for the orphan drugs on a return or
claim for refund, 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. A branded prescription drug is
not treated as an orphan drug after December 31 of the year in
which the drug or biological was approved by the Food and
Drug Administration (FDA) for non-orphan drug marketing. Nonorphan 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 A. 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
National Drug Code (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.
A covered entity is either unaffiliated (a single-person covered
entity) or a member of a controlled group. 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). 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). Also, a controlled group that is an affiliated group
that filed a consolidated federal tax return for tax year 2009
("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 and complete Part IV, Signature for SinglePerson Covered Entity.

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Form 8947 (11-2010)

Designated entity

Medicaid state supplemental rebate amount

Generally, the designated entity is one of the following.
• The member chosen to be the designated entity by the
members of a controlled group that is not an affiliated group.

Enter the rebates for each NDC paid in the 2009 sales year by
the covered entity for sales under Medicaid occurring in the
2009 sales year. For this purpose, a rebate is considered paid in
the 2009 sales year if it is taken into account on the covered
entity's tax return(s) for the 2009 sales year.

The designated entity files Form 8947, receives IRS
correspondence about the fee for the group, and pays the fee to
the IRS.

Latest tax year section 45C orphan drug credit
allowed

• The common parent of an affiliated group.

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 each member
as of the end of the day on December 31, 2009, listing the
designated entity's name first. You must also sign and complete
Part III, Controlled Group Designated Entity Consent.
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 each member as of the end of the day on December 31,
2009, listing the designated entity's name first. You must also
sign and complete Part III, Controlled Group Designated Entity
Consent.

For the drug listed, enter the latest tax year that the section 45C
orphan drug credit was allowed on your tax return, if applicable.
Use the format yyyy. Fiscal year filers must show the tax year
according to the tax year's beginning.

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.

Name and Address

Part III. Controlled Group Designated Entity
Consent

Entity name

Complete this section if you checked Item A, box 2b.

If you checked box 1 in Item A, enter the name of the
single-person covered entity. If you checked box 2a or 2b, enter
the name of the designated entity.

The choice of designated entity must be consented to by all
the members of the Act section 9008(d)(2) controlled group that
are members as of the end of the day on December 31, 2009.
The consent must be signed by a person with the authority to
bind 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.

Part II. Branded Prescription Drug
Information
Entity number
Enter the same entity number for each member that was shown
in Part I.

National Drug Code
Enter the 11-digit National Drug Code (omitting hyphens)
maintained by the FDA for any branded prescription drug sold
to any specified government program (or sold due to coverage
under the programs) during 2009.

Medicare Part D rebate amount
Enter the rebates for each NDC paid in the 2009 sales year by
the covered entity to Medicare Part D for sales occurring in the
2009 sales year. For this purpose, a rebate is considered paid in
the 2009 sales year if it is taken into account on the covered
entity's tax return(s) for the 2009 sales year.

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 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

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8 hrs., 51 min.

Preparing, copying, assembling,
and sending the form . . . .

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Learning about the law or the form .

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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 write to: Internal
Revenue Service, Tax Products Coordinating Committee,
SE:W:CAR:MP:T:T:SP, 1111 Constitution Ave. NW, IR-6526,
Washington, DC 20224. Do not send Form 8947 to this address.
Instead, see Where To File on page 5.