Bill Details
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This bill would update how certain prescription drugs are checked as they move through the supply chain. Its main goal is to improve the way controlled substances are authenticated, especially by allowing a newer type of product ID that uses a physical or chemical marker. For some controlled substances in solid oral form, the bill would require this marker to be included in or on each dose beginning five years after the bill becomes law. It also updates federal law so that “product identifier” and “verification” can include these newer authentication methods, which could help make it harder for fake or tampered drugs to enter the market.
- Requires a physical or chemical identifier on each dose of certain controlled substances in solid oral form.
- This requirement would start for products manufactured five years after the bill is enacted.
- Updates the legal definition of a “product identifier” to include either the current standard label information or a machine-readable physical/chemical marker.
- Updates the meaning of “verification” so a drug can be checked by using the new physical/chemical identifier, not just the current label-based system.
Official Summaries
Modern Authentication of Pharmaceuticals Act of 2025
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. (Physical chemical identifiers are substances that possess a unique physical or chemical property, such as inks, pigments, flavors, and molecular taggants, that unequivocally identify and authenticate a drug or dosage.) Under the bill, physical chemical identifiers must be included in or on the product and must be machine readable.
The bill applies to products manufactured beginning five years after the bill's enactment.
Current Full Text
[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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