21 U.S.C. § 355e — Pharmaceutical security

(a) In general The Secretary must develop standards and identify and test technologies that actually work to secure the drug supply chain. The goal is to stop counterfeit, diverted, weak (subpotent), substandard, contaminated (adulterated), mislabeled (misbranded), or expired drugs from getting through. (b) Standards development (1) In general: The Secretary must work with the agencies listed in paragraph (4), plus manufacturers, distributors, pharmacies, and other supply-chain stakeholders, to prioritize and create standards for identifying, validating, authenticating, and tracking and tracing prescription drugs. (2) Standardized numerical identifier: By 30 months after September 27, 2007, the Secretary must create a standardized numerical identifier — matched to international standards where practical — to be applied to a prescription drug at the point of manufacturing or repackaging (linked, for repackaging, to the identifier from manufacturing), at the package or pallet level. It must be enough to identify, validate, authenticate, and track and trace the drug. (3) Promising technologies: The standards must address promising technologies, which may include radio frequency identification technology, nanotechnology, encryption technologies, and other track-and-trace or authentication technologies. (4) Interagency collaboration: In doing this work, the Secretary must consult federal health and security agencies, including the Department of Justice, the Department of Homeland Security, the Department of Commerce, and other appropriate federal and state agencies. (c) Inspection and enforcement (1) In general: The Secretary must expand and improve the resources and facilities of FDA components that handle regulatory and criminal enforcement, to secure the drug supply chain against counterfeit, diverted, weak, substandard, adulterated, misbranded, or expired drugs — including biological products and active pharmaceutical ingredients from both domestic and foreign sources. (2) Activities: The Secretary must carry out stepped-up, joint enforcement activities with other federal and state agencies, and set up regional capabilities to validate prescription drugs and inspect the prescription drug supply chain. (d) Definition In this section, "prescription drug" means a drug that requires a prescription under section 353(b)(1).