116th CONGRESS 2d Session |
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.
December 8, 2020
Mr. Van Drew introduced the following bill; which was referred to the Committee on Energy and Commerce
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,
This Act may be cited as the “Supply Chain Security and Pharmaceutical Authentication Act of 2020”.
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.”.