Supply Chain Security and Pharmaceutical Authentication Act of 2021
This bill modifies the application of requirements for drug packaging to include certain information, such as the product's lot number and expiration date.
Under the bill, the requirements shall apply to the packaging of the smallest or individual solid oral dosage form of the product. Currently, such requirements apply to the smallest container (which might contain multiple dosages) of the product that is intended for individual sale to a dispenser, such as a pharmacy.
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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Supply Chain Security and Pharmaceutical Authentication Act of 2021
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.
Supply Chain Security and Pharmaceutical Authentication Act of 2021
Rep. Van Drew, Jefferson