Supply Chain Security and Pharmaceutical Authentication Act of 2021

Bill: 117-hr-1186
Sponsor: full_name: Rep. Van Drew, Jefferson [R-NJ-2]
Introduced: 2021-02-18
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Manufacturing
Latest action: action_date: 2021-02-19
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2021-02-18
action_desc: Introduced in House
text: <p><b>Supply Chain Security and Pharmaceutical Authentication Act of 2021 </b></p> <p>This bill modifies the application of requirements for drug packaging to include certain information, such as the product's lot number and expiration date. </p> <p>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.</p>

tv_txt: I 117th CONGRESS 1st Session H. R. 1186 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 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.

1. Short title This Act may be cited as the Supply Chain Security and Pharmaceutical Authentication Act of 2021 . 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. .