Modern Authentication of Pharmaceuticals Act of 2025
The Modern Authentication of Pharmaceuticals Act of 2025 would modernize how controlled substances (as defined by the Controlled Substances Act) are authenticated within the pharmaceutical supply chain. It requires that, for solid oral dosage forms manufactured five years after the bill’s enactment, each dose include a physical chemical identifier (PCI) to authenticate the product. The bill also updates the broader framework for product identification and verification, allowing either a standardized graphic data carrier (such as a barcode with human- and machine-readable data) or a PCI to serve as a product identifier. Verification provisions are expanded to permit authentication either by cross-checking the standard identifier or by using the PCI. In short, the bill seeks to reduce counterfeit or diverted controlled substances by adding a modern, machine-readable chemical authentication layer to dosage forms. The bill, introduced in the House on February 6, 2025, is titled the Modern Authentication of Pharmaceuticals Act of 2025. It would amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) and would require conforming changes to certain definitions to accommodate PCI and its verification, with a five-year phase-in period for PCI implementation on new solid oral dosage forms of controlled substances.
Key Points
- 1PCI requirement for new products: Beginning five years after enactment, every dose of a manufactured solid oral dosage form of a controlled substance must include a physical chemical identifier to authenticate the product.
- 2Expanded product identifier options: A product identifier can be either (a) a standardized graphic with human-readable and machine-readable data (conforming to standards set by a recognized standards organization) that includes the numerical identifier, lot number, and expiration date; or (b) a PCI with a unique chemical substance or combination, that is on or in the product, machine readable, and used to authenticate the product or dosage form.
- 3Updated verification framework: “Verification” or “verify” means either checking that the product’s identifier matches the manufacturer’s/ repackager’s data (standard identifier) or verifying authenticity using the PCI.
- 4Conforming FD&C Act changes: The bill updates the statutory definitions of “product identifier” and “verification” to accommodate PCI and its use in authentication, alongside existing standard identifiers.
- 5Scope and limitations: The PCI requirement applies to controlled substances in solid oral dosage form manufactured after the specified five-year date; it does not extend to all drug forms or all products immediately, creating a phased-in approach.