Title: Modern Authentication of Pharmaceuticals Act of 2022
Policy area: Health

Summary:
Modern Authentication of Pharmaceuticals Act of 2022
This bill requires each dose of a pharmaceutical product that is a controlled substance and that is taken orally in solid form (i.e., pills) to include a physical chemical identifier. The bill applies to products manufactured on or after January 1, 2026.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7653 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 7653

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 3, 2022

 Mr. Mullin (for himself and Mr. O'Halleran) 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Modern Authentication of 
Pharmaceuticals Act of 2022''.

SEC. 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 January 1, 
                        2026; 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).''.
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