H.R. 4988House118th Congress (2023-2025)In Committee

Modern Authentication of Pharmaceuticals Act of 2023

Introduced July 27, 2023

AI-Generated Summary

Updated January 20, 2026 at 10:46 AM UTC

The Modern Authentication of Pharmaceuticals Act of 2023 amends the Federal Food, Drug, and Cosmetic Act to require a physical‑chemical identifier on each dose of solid oral controlled‑substance products manufactured five years after the law takes effect. It also expands the definitions of “product identifier” and “verification” to include these new identifiers, aiming to improve authentication throughout the pharmaceutical supply chain. The changes affect manufacturers, repackagers, and distributors of controlled‑substance drugs.

Key Provisions

  • Requires a machine‑readable physical‑chemical identifier to be included on or in each dose of a solid oral controlled‑substance product manufactured on or after five years after enactment.
  • Redefines “product identifier” to cover either a standardized graphic with numeric data or a physical‑chemical identifier that is unique, machine‑readable, and intended for authentication.
  • Expands the definition of “verification” to include confirming authenticity using the new physical‑chemical identifier as well as traditional product identifiers.
  • Updates related sections of the FD&C Act (e.g., redesignating subparagraphs, removing an extraneous “and”) to incorporate the new requirements.

Legislative Activity

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2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

July 28, 2023

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HouseIntro Referral

Introduced in House

July 27, 2023

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

July 27, 2023

HouseCommittee

Referred to the Subcommittee on Health.

July 28, 2023

Floor Debate

8 members

What members said about H.R. 4988 on the floor

4 Republicans4 Democrats
Jill N. Tokuda
Rep. Jill N. TokudaD-HI-2 · Nov 29, 2023

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material for the Record. Mr. Speaker, it is my…

Derek Kilmer
Rep. Derek KilmerD-WA-6 · Nov 29, 2023

Mr. Speaker, I thank my colleague for yielding. Mr. Speaker, 49 years ago in Port Angeles, Washington, I was born in what was then called Olympic Memorial Hospital. Over the years, members of my…

Glenn Thompson
Rep. Glenn ThompsonR-PA-15 · Nov 29, 2023

Madam Speaker, I thank the gentlewoman for her leadership with this bipartisan Rural Healthcare Caucus. It is incredibly important and really defines my life. Prior to coming to Congress 15 years…

Diana Harshbarger
Rep. Diana HarshbargerR-TN-1 · Nov 29, 2023

Mr. Speaker, I rise today to recognize National Rural Health Month and to highlight the work of the congressional Bipartisan Rural Health Caucus, which I am proud to cosponsor with my colleague,…

Donald G. Davis
Rep. Donald G. DavisD-NC-1 · Nov 29, 2023

Mr. Speaker, I thank the gentlewoman and our co-chairs for leading this Special Order. Mr. Speaker, I rise on behalf of eastern North Carolina to address my highest legislative priority: improving…

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Jack Bergman
Rep. Jack BergmanR-MI-1 · Nov 29, 2023

Mr. Speaker, it is so interesting to walk in and wonder if you have walked into the middle of something. Mr. Speaker, I appreciate the gentlewoman for yielding, and I am honored to join my colleagues…

Susan Wild
Rep. Susan WildD-PA-7 · Nov 29, 2023

Mr. Speaker, I thank the co-chairs of this caucus for forming the Rural Health Caucus, something that is long overdue and very much needed. Mr. Speaker, this Rural Health Month, I am thrilled to join…

Doug LaMalfa
Rep. Doug LaMalfaR-CA-1 · Nov 29, 2023

Mr. Speaker, I thank my colleague and friend from Hawaii for yielding. I would chime in as well on the importance of improving and expanding rural health and the challenges faced in the most rural…

Bill Text

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Introduced in HouseIssued July 27, 2023

I

118th CONGRESS

1st Session

H. R. 4988

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.

1.

Short title

This Act may be cited as the Modern Authentication of Pharmaceuticals Act of 2023.

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).

.