Form 8947 - Report Of Branded Prescription Drug Information Page 8
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Form 8947 (Rev. 10-2011)
Page
Branded prescription drug sales. Branded prescription drug sales are
Designated entity
sales of branded prescription drugs made to specified government
Generally, the designated entity is one of the 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
submitted under section 505(b) of the Federal Food, Drug, and
• The member chosen to be the designated entity by the members of a
Cosmetic Act (21 U.S.C. 355(b)), or any biological product the license
controlled group that is not an affiliated group. If a controlled group
for which was submitted under section 351(a) of the Public Health
does not select a designated entity, the IRS will select a member of
Service Act (42 U.S.C. 262(a)). A prescription drug is any drug that is
the controlled group as the designated entity for the controlled group.
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
Security Act;
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,
• 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, 2010, are manufacturers or
• The Medicaid program under title XIX of the Social Security Act;
importers with gross receipts from the sale of branded prescription
• Any program under which branded prescription drugs are procured
drugs to specified government programs (or sales due to coverage
by the Department of Veterans Affairs;
under the program), listing the designated entity's name first. You must
also sign Part II on page 6.
• Any program under which branded prescription drugs are procured
by the Department of Defense; and
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
• 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, 2010, 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
for the drug.
Name and Address
Non-orphan drug marketing. However, a branded prescription drug is
Entity name
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
If you checked box 1, enter the name of the single-person covered
Administration (FDA) for non-orphan drug marketing, regardless of
entity. If you checked box 2a or 2b, enter the name of the designated
whether a section 45C credit was allowed for an orphan drug either
entity.
before or after the non-orphan drug designation. Non-orphan drug
Address
marketing is marketing for any indication other than the treatment of the
rare disease or condition for which the section 45C tax credit was
P.O. box. Enter your box number only if your post office does not
allowed.
deliver mail to your street address.
Foreign address. Enter the information in the following order: city,
Specific Instructions
province or state, and country. Follow the country's practice for entering
the postal code. In some countries the postal code may come before
Item B. Covered Entity Information
the city or town name. Enter the full name of the country using
uppercase letters in English.
Covered entity
Third party. If you receive your mail in care of a third party (such as an
A covered entity is any manufacturer or importer with gross receipts
accountant or an attorney), enter on the street address line “C/O”
from branded prescription drug sales. A manufacturer or importer is the
followed by the third party's name and street address or P.O. box.
person identified in the Labeler Code of the NDC for the branded
Schedule A. Branded Prescription Drug Information –
prescription drug. The NDC is an identifier assigned by the FDA to a
First Time Filers Only
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
If you filed Form 8947 for sales year 2009, do not use Schedule A for the
characters when the available five-character code combinations are
2010 sales year. If you checked Item A, box 1, use Schedule A to report
exhausted.
the following.
For purposes of the Act, all persons treated as a single employer
Controlled group member EIN
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
Enter the same EIN for each member that was shown in Part I, column
entity is either a single-person covered entity or a member of a
(c).
controlled group. In applying the single employer rules, a foreign entity
NDC
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
Enter the 11-digit NDC (omitting hyphens) for any branded prescription
member of a controlled group if it is a member of the group at the end of
drug sold to any specified government program (or sold due to
the day on December 31, 2010. Also, a controlled group that is an
coverage under the programs) during 2010.
affiliated group that filed a consolidated federal tax return for tax year
Medicaid state supplemental rebate amount
2010 (“affiliated group”) will be treated as one covered entity.
Enter the Medicaid state supplemental rebates for each NDC paid by
Box 1. Check box 1 if you are a single-person covered entity. You must
the covered entity for sales under Medicaid in sales year 2010. For this
sign Part II on page 6.
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.
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