119-hr1060

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1060 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 1060

 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

 February 6, 2025

 Mr. Davis of North Carolina (for himself, Mr. Rutherford, and Mr. 
 Bacon) 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 2025''.

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 2025; 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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