1. Short title
This Act may be cited as the “Supply Chain Security and Pharmaceutical Authentication Act of 2020”.
Supply Chain Security and Pharmaceutical Authentication Act of 2020
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.
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.”