116 HR 8905 IH: Supply Chain Security and Pharmaceutical Authentication Act of 2020 U.S. House of Representatives 2020-12-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS2d SessionH. R. 8905IN THE HOUSE OF REPRESENTATIVESDecember 8, 2020Mr. Van Drew introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.

1.

Short title

This Act may be cited as the Supply Chain Security and Pharmaceutical Authentication Act of 2020.

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..