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I
116TH CONGRESS
2D SESSION
H. R. 8905
To amend the Federal Food, Drug, and Cosmetic Act to reduce the threat
of counterfeit drugs to the pharmaceutical supply chain, and to make
the pharmaceutical supply chain more robust, while ensuring the authen-
ticity, content, purity, and manufacturing location and batch number
of drugs (including COVID–19 therapeutics and vaccines) and allowing
patient verification of authenticity, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
DECEMBER 8, 2020
Mr. VAN DREW 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
reduce the threat of counterfeit drugs to the pharma-
ceutical supply chain, and to make the pharmaceutical
supply chain more robust, while ensuring the authen-
ticity, content, purity, and manufacturing location and
batch number of drugs (including COVID–19 thera-
peutics and vaccines) and allowing patient verification
of authenticity, and for other purposes.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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•HR 8905 IH
SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Supply Chain Security
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and Pharmaceutical Authentication Act of 2020’’.
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SEC. 2. PACKAGES SUBJECT TO PHARMACEUTICAL DIS-
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TRIBUTION SUPPLY CHAIN REQUIREMENTS.
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Subparagraph (B) of section 581(11) of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C. 360eee(11)) is
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amended to read as follows:
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‘‘(B) INDIVIDUAL
SALEABLE
UNIT.—For
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purposes of this paragraph, an ‘individual sale-
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able unit’ is the smallest solid oral dosage form
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of product, or other individual solid oral dosage
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form of product, introduced into commerce by
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the manufacturer or repackager.’’.
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Æ
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