[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1186 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 1186

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 
  authenticity, 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.


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                    IN THE HOUSE OF REPRESENTATIVES

                           February 18, 2021

Mr. Van Drew (for himself and Mr. Baird) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

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                                 A BILL


 
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 
  authenticity, 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Supply Chain Security and 
Pharmaceutical Authentication Act of 2021''.

SEC. 2. PACKAGES SUBJECT TO PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN 
              REQUIREMENTS.

    Subparagraph (B) of section 581(11) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360eee(11)) is amended to read as follows:
                    ``(B) Individual saleable unit.--For purposes of 
                this paragraph, an `individual saleable unit' is the 
                smallest solid oral dosage form of product, or other 
                individual solid oral dosage form of product, 
                introduced into commerce by the manufacturer or 
                repackager.''.
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