I 
112TH CONGRESS 
1ST SESSION H. R. 3026 
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
of drugs. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 22, 2011 
Mr. MATHESON (for himself and Mr. BILBRAY) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
improve the safety of drugs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safeguarding Amer-
ica’s Pharmaceuticals Act of 2011’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Destruction of counterfeit drugs offered for import. 
Sec. 4. Interim provisions to assure the safety of the wholesale distribution of 
prescription drugs. 
Sec. 5. Unique standardized numerical identifiers for each prescription drug. 
Sec. 6. Prescription drug identification and tracking system. 
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Sec. 7. Uniform national standards. 
Sec. 8. Requirements for licensure of wholesale distributors. 
Sec. 9. Injunctions; civil penalties. 
Sec. 10. State enforcement of Federal requirements. 
Sec. 11. Study on threats to domestic prescription drug supply chain. 
SEC. 3. DESTRUCTION OF COUNTERFEIT DRUGS OFFERED 
FOR IMPORT. 
Section 801(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(a)) is amended— 
(1) in the third sentence— 
(A) by striking ‘‘or (2) such’’ and inserting 
‘‘(2) such’’; and 
(B) by striking ‘‘or (3) such’’ and inserting 
‘‘(3) such’’; and 
(C) by striking ‘‘or (4) such’’ and inserting 
‘‘(4) such’’; and 
(D) by inserting ‘‘or (5) such article is a 
counterfeit drug,’’ before ‘‘then such article 
shall be refused admission’’; and 
(2) in the last sentence, by striking ‘‘Clause (2) 
of the third sentence of this paragraph’’ and insert-
ing ‘‘Notwithstanding the preceding sentence, the 
Secretary of the Treasury shall cause the destruction 
of any such article refused admission if (1) the arti-
cle is a drug, the article appears to be adulterated, 
misbranded, or in violation of section 505, and the 
article has a value less than $2,000 or such amount 
as the Secretary of Health and Human Services may 
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determine by regulation; or (2) the article appears to 
be a counterfeit drug. Before causing the destruction 
of an article with a value greater than $2,000 under 
the preceding sentence, the Secretary shall provide 
notice and an opportunity for an informal hearing to 
the owner or consignee. The Secretary of Health and 
Human Services shall retain a sample of any prod-
uct destroyed under the seventh sentence of this 
subsection and shall investigate any counterfeit 
products so destroyed. Clause (2) of the third sen-
tence of this subsection’’. 
SEC. 4. INTERIM PROVISIONS TO ASSURE THE SAFETY OF 
THE WHOLESALE DISTRIBUTION OF PRE-
SCRIPTION DRUGS. 
(a) IN GENERAL.—Subsection (e) of section 503 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
353) is amended— 
(1) by striking ‘‘(e)(1)(A)’’ and all that follows 
through the end of paragraph (1) and inserting the 
following: 
‘‘(e) REGULATION OF WHOLESALE DISTRIBUTORS 
OF PRESCRIPTION DRUGS.—’’; 
(2) by striking paragraph (3); 
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(3) by redesignating paragraph (2) as para-
graph (4) and moving the margin of such paragraph 
2 ems to the right; and 
(4) by inserting before paragraph (4), as so re-
designated by paragraph (3) of this subsection, the 
following: 
‘‘(1) INTERIM PROVISIONS.— 
‘‘(A) DEFINITIONS.—Except as otherwise 
provided, for purposes of this subsection— 
‘‘(i) for purposes of this paragraph 
and subsection (d) only, the term ‘author-
ized distributor of record’ with respect to 
a prescription drug means a wholesale dis-
tributor that has a written agreement for 
such drug currently in effect with the 
drug’s manufacturer (as defined in clause 
(iv)(I) or (II)) to distribute such drug; 
‘‘(ii) the term ‘co-licensed partner’ 
means one of two or more persons who has 
the right to engage in the manufacturing 
or marketing of a prescription drug; 
‘‘(iii) the term ‘dispenser’ means a re-
tail pharmacy, hospital pharmacy, or any 
other person authorized by law to dispense 
or administer prescription drugs; 
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‘‘(iv) for purposes of this paragraph 
and subsection (d) only, the term ‘manu-
facturer’ means, with respect to a prescrip-
tion drug— 
‘‘(I) the person that holds the ap-
plication approved under section 505 
or the license issued under section 
351 of the Public Health Service Act 
for the drug, or if the drug is not the 
subject of an approved application or 
license, the person identified on the 
original label of the drug as the man-
ufacturer, distributor, or both; 
‘‘(II) a co-licensed partner of the 
person identified in subclause (I) that 
obtains the drug directly from the 
person identified in subclause (I) or 
(III); 
‘‘(III) a person that manufac-
tures the prescription drug for the 
person identified in subclause (I) or 
(II); 
‘‘(IV) a third-party logistics pro-
vider operating on behalf of the per-
son identified in subclause (I) or (II) 
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that obtains the drug directly from 
the person identified in subclause (I), 
(II), or (III); or 
‘‘(V) the exclusive distributor of 
the person identified in subclause (I) 
or (II) that obtains the drug directly 
from the person identified in sub-
clause (I), (II), or (III); 
‘‘(v) the term ‘exclusive distributor’ 
means any person who contracts with an-
other person to provide or coordinate 
warehousing, distribution, or other services 
on behalf of such person and who takes 
title to that person’s prescription drug, but 
who does not have general responsibility to 
direct the sale or disposition of that per-
son’s prescription drug; 
‘‘(vi) the term ‘prescription drug’ 
means a drug subject to subsection (b); 
‘‘(vii) the term ‘third party logistics 
provider’ means a person that, by agree-
ment with another person, is responsible 
for providing or coordinating distribution, 
warehousing, and related services with re-
spect to a prescription drug on behalf of 
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