This legislation, titled the Modern Authentication of Pharmaceuticals Act of 2025, aims to modernize the authentication of controlled substances within the pharmaceutical distribution supply chain. It amends the Federal Food, Drug, and Cosmetic Act to introduce new requirements for product identification and verification. The bill mandates that a physical chemical identifier be included in or on each dose of specific products. This requirement applies to controlled substances in solid oral dosage form that are manufactured five years after the Act's enactment. A physical chemical identifier is defined as a unique, machine-readable substance intended to authenticate the product or its dosage form. The legislation also updates the definitions of "product identifier" and "verification" to incorporate these new authentication methods, ensuring their integration into existing regulatory frameworks.
Modern Authentication of Pharmaceuticals Act of 2023
Introduced in House
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR H519)
Health
Drug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesPrescription drugs
Modern Authentication of Pharmaceuticals Act of 2025
USA119th CongressHR-1060| House
| Updated: 2/6/2025
This legislation, titled the Modern Authentication of Pharmaceuticals Act of 2025, aims to modernize the authentication of controlled substances within the pharmaceutical distribution supply chain. It amends the Federal Food, Drug, and Cosmetic Act to introduce new requirements for product identification and verification. The bill mandates that a physical chemical identifier be included in or on each dose of specific products. This requirement applies to controlled substances in solid oral dosage form that are manufactured five years after the Act's enactment. A physical chemical identifier is defined as a unique, machine-readable substance intended to authenticate the product or its dosage form. The legislation also updates the definitions of "product identifier" and "verification" to incorporate these new authentication methods, ensuring their integration into existing regulatory frameworks.