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Congressional Research Service
Version 00 · Introduced in House · Feb 6, 2025
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.
People & committees
Rep. Davis, Donald G. [D-NC-1] · D–NC
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Sponsor introductory remarks on measure. (CR H519)
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Apr 8, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-06 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
This bill proposes requiring each dose of a controlled-substance medicine in solid form taken by mouth to contain or carry a machine-readable physical or chemical marker intended to check authenticity. The requirement would cover products manufactured starting five years after enactment. It would also update federal drug supply-chain definitions to recognize these markers and their use in checking authenticity.
(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;
(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.
(B) determining whether a product or a dosage form thereof is authentic using a physical chemical identifier described in paragraph (14)(B).
Section 1 names the proposed legislation the Modern Authentication of Pharmaceuticals Act of 2025.
1. Short title This Act may be cited as the Modern Authentication of Pharmaceuticals Act of 2025.
Section 2 would add a mandatory identifier requirement for every dose of a covered product. All three conditions must apply: the product is a controlled substance under the referenced law, it is in solid oral dosage form, and it was manufactured on or after the five-year anniversary of enactment. The trigger is the manufacturing date; the bill supplies no fixed calendar date.
(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—
(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;
The proposed definition of “product identifier” would recognize two alternatives: a standardized graphic containing the product's numerical identifier, lot number, and expiration date in human-readable and machine-readable forms; or a physical or chemical marker in or on the product. The marker must contain a unique substance or combination of substances, be machine readable, and be intended to authenticate the product or its dosage form.
(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.
The proposed definition of “verification” would recognize both checking a package or case identifier against information assigned by the manufacturer or repackager, and checking whether a product or dosage form is authentic using the physical or chemical marker.
(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).
The supplied action snapshot, updated April 8, 2026, records introduction in the House, referral to the House Committee on Energy and Commerce, and sponsor introductory remarks on February 6, 2025. This snapshot does not establish subsequent passage or enactment.
Source snapshot updated 2026-04-08T17:28:33Z. 2025-02-06: Referred to the House Committee on Energy and Commerce. 2025-02-06: Introduced in House 2025-02-06: Sponsor introductory remarks on measure. (CR H519) 2025-02-06: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-02-06. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion does not cover other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion does not establish the absence of earmarks in other versions or accompanying materials.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow preferential treatment, special exemption, or benefit carve-out was identified in the complete supplied introduced text. This conclusion is limited to that version.
Full text preserved for this analysis. Legislative record snapshot: Apr 8, 2026. How PlainBill uses AI