118 HR 4988 IH: Modern Authentication of Pharmaceuticals Act of 2023 U.S. House of Representatives 2023-07-27 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.

I 118th CONGRESS1st Session H. R. 4988 IN THE HOUSE OF REPRESENTATIVES July 27, 2023 Mr. Davis of North Carolina (for himself, Mr. Rutherford, and Ms. Pettersen) 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 modernize the methods of authenticating controlled substances in the pharmaceutical distribution supply chain, and for other purposes.

1.

Short title

This Act may be cited as the Modern Authentication of Pharmaceuticals Act of 2023.

2.

Modernizing the authentication of controlled substances in the pharmaceutical distribution supply chain

(a)

In general

Section 582(a)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee–1(a)(9)) is amended— (1)in subparagraph (A)(ii), by striking and at the end; (2)by redesignating subparagraph (B) as subparagraph (C); and (3)by inserting after subparagraph (A) the following: (B)a physical chemical identifier shall be included in or on each dose of a product that is— (i)a controlled substance (as defined in section 102 of the Controlled Substances Act); (ii)in solid oral dosage form; and (iii)manufactured on or after the date that is five years after the date of enactment of the Modern Authentication of Pharmaceuticals Act of 2023; and. (b)

Conforming changes

(1)Section 581(14) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee(14)) is amended to read as follows: (14)

Product identifier

The term product identifier means— (A)a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product; or (B)a physical chemical identifier, possessing a unique physical or chemical substance or combination of substances, that— (i)is in or on a product; (ii)is machine readable; and (iii)is intended to authenticate the product or a dosage form thereof.. (2)Section 581(28) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee(28)) is amended to read as follows: (28)

Verification or verify

The term verification or verify means— (A)determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 582; or (B)determining whether a product or a dosage form thereof is authentic using a physical chemical identifier described in paragraph (14)(B)..