Form 8947 - Report Of Branded Prescription Drug Information Page 8
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Form 8947 (Rev. 10-2012)
Page
Branded prescription drug sales. Branded prescription drug sales are
Designated entity. Generally, the designated entity is one of the
sales of branded prescription drugs made to specified government
following.
programs (or sales due to coverage under the programs). A branded
• The common parent of an affiliated group.
prescription drug is any prescription drug for which an application was
• The member chosen to be the designated entity by the members of a
submitted under section 505(b) of the Federal Food, Drug, and
controlled group that is not an affiliated group. If a controlled group
Cosmetic Act (21 U.S.C. 355(b)), or any biological product the license
does not select a designated entity, the IRS will select a member of
for which was submitted under section 351(a) of the Public Health
the controlled group as the designated entity for the controlled group.
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
The designated entity is responsible for the following for the group.
(21 U.S.C. 353(b)).
• Filing Form 8947,
Branded prescription drug sales do not include sales of section 45C
• Receiving IRS communications about the fee,
orphan drugs (defined below).
• Filing any necessary error report (as described in Temporary
Specified government programs. Specified government programs
Regulations section 51.7T), and
under the Act are:
• Paying the fee to the IRS.
• The Medicare Part D program under part D of title XVIII of the Social
Box 2a. Check box 2a if you are a common parent of an affiliated group.
Security Act;
Also complete Part I, Controlled Group Members, giving the name,
• The Medicare Part B program under part B of title XVIII of the Social
address, and EIN of only those members of the controlled group who,
Security Act;
as of the end of the day on December 31, 2011, are manufacturers or
• The Medicaid program under title XIX of the Social Security Act;
importers with gross receipts from the sale of branded prescription
drugs to specified government programs (or sales due to coverage
• Any program under which branded prescription drugs are procured
under the program), listing the designated entity's name first. You must
by the Department of Veterans Affairs;
also sign Part II on page 6.
• Any program under which branded prescription drugs are procured
Box 2b. Check box 2b if you are the designated entity for a covered
by the Department of Defense; and
entity that is not an affiliated group. Also complete Part I, Controlled
• The TRICARE retail pharmacy program under section 1074g of title
Group Members, giving the name, address, and EIN of only those
10, United States Code.
members of the controlled group who, as of the end of the day on
Section 45C orphan drugs. Generally, branded prescription drug sales
December 31, 2011, are manufacturers or importers with gross receipts
do not include sales of an orphan drug if any person claimed (and was
from the sale of branded prescription drugs to specified government
allowed) a section 45C tax credit for the orphan drug on a return or
programs (or sales due to coverage under the program), listing the
claim for refund for any taxable year, and there has not been a final
designated entity's name first. You must also sign Part II on page 6.
assessment or a court disallowance of the full section 45C credit taken
Name and Address
for the drug.
Non-orphan drug marketing. However, a branded prescription drug is
Entity name. If you checked box 1, enter the name of the single-person
not treated as an orphan drug after December 31 of the year in which
covered entity. If you checked box 2a or 2b, enter the name of the
the drug or biological product was approved by the Food and Drug
designated entity.
Administration (FDA) for non-orphan drug marketing, regardless of
P.O. box. Enter your box number only if your post office does not
whether a section 45C credit was allowed for an orphan drug either
deliver mail to your street address.
before or after the non-orphan drug designation. Non-orphan drug
Foreign Address. Enter the information in the following order: city,
marketing is marketing for any indication other than the treatment of the
province or state, and country. Follow the country's practice for entering
rare disease or condition for which the section 45C tax credit was
the postal code. In some countries the postal code may come before
allowed.
the city or town name. Enter the full name of the country using
uppercase letters in English.
Specific Instructions
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”
Item B. Covered Entity Information
followed by the third party's name and street address or P.O. box.
Covered entity. A covered entity is any manufacturer or importer with
Schedule A. Branded Prescription Drug Information –
gross receipts from branded prescription drug sales. A manufacturer or
First Time Filers Only
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
If you filed Form 8947 for sales year 2010, do not use Schedule A for the
to a branded prescription drug, as well as other drugs. The Labeler
2011 sales year. If you checked Item A, box 1, use Schedule A to report
Code is the first five numeric characters of the NDC, or the first six
the following.
numeric characters when the available five-character code
Controlled group member EIN. Enter the same EIN for each member
combinations are exhausted.
that was shown in Part I, column (c).
For purposes of the Act, all persons treated as a single employer
NDC. Enter the 11-digit NDC (omitting hyphens) for any branded
under sections 52(a), 52(b), 414(m), or 414(o) will be treated as one
prescription drug sold to any specified government program (or sold
covered entity (an Act section 9008(d)(2) controlled group). A covered
due to coverage under the programs) during 2011.
entity is either a single-person covered entity or a member of a
controlled group. In applying the single employer rules, a foreign entity
Medicaid state supplemental rebate amount. Enter the Medicaid
subject to tax under section 881 is included within a controlled group
state supplemental rebates for each NDC paid by the covered entity for
under section 52(a) or 52(b). A covered entity is treated as being a
sales under Medicaid in sales year 2011. For this purpose, enter
member of a controlled group if it is a member of the group at the end of
Medicaid state supplemental rebates invoiced by states and paid by the
the day on December 31, 2011. Also, a controlled group that is an
covered entity for drugs in sales year 2011 and paid before you file Form
affiliated group that filed a consolidated federal tax return for tax year
8947.
2011 (“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.
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