Section 1 Short title
This Act may be cited as the “Modern Authentication of Pharmaceuticals Act of 2022”.
Modern Authentication of Pharmaceuticals Act of 2022
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.
Sec. 2 Modernizing the authentication of controlled substances in the pharmaceutical distribution supply chain
In general— Section 582(a)(9) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee–1(a)(9)) is amended—
in subparagraph (A)(ii), by striking “and” at the end;
by redesignating subparagraph (B) as subparagraph (C); and
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 January 1, 2026; and”
Conforming changes—
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.”
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).”