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This bill amends the Federal Food, Drug, and Cosmetic Act to require a physical chemical identifier in or on each dose of certain controlled substances in solid oral dosage form, manufactured five years after enactment, to modernize authentication in the pharmaceutical distribution supply chain. It also updates definitions for 'product identifier' and 'verification' to include physical chemical identifiers.
Sec. 2, Modernizing the authentication of controlled substances in the pharmaceutical distribution supply chain: This section amends section 582(a)(9) of the Federal Food, Drug, and Cosmetic Act to require that a physical chemical identifier be included in or on each dose of a product that is a controlled substance under the Controlled Substances Act, in solid oral dosage form, and manufactured on or after five years after enactment. It also makes conforming changes to definitions: 'product identifier' now includes either a standardized graphic with human-readable and machine-readable data or a physical chemical identifier that is machine readable and intended to authenticate the product or dosage form; 'verification' now includes determining authenticity using a physical chemical identifier.
Summary of the bill text as introduced in House (Jul 27, 2023), generated by SecBot from the official bill text; the Library of Congress summary is not yet published.
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Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.