[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4988 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4988

  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

                             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.

    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 2023''.

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 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).''.
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