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- 2023 Edition
- Title 21. Food and Drugs
- Chapter 9. Federal Food, Drug, and Cosmetic Act
- Subchapter V. Drugs and Devices
- Part A. Drugs and Devices
21 U.S.C. § 355e Pharmaceutical Security
Library | United States Statutes |
Edition | 2023 Edition |
Currency | Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023) |
(a) In general
The Secretary shall develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs.
(b) Standards development
(1) In general
The Secretary shall, in consultation with the agencies specified in paragraph (4), manufacturers, distributors, pharmacies, and other supply chain stakeholders, prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription drugs.
(2) Standardized numeral identifier
Not later than 30 months after September 27, 2007, the Secretary shall develop a standardized numerical identifier (which, to the extent practicable, shall be harmonized with international consensus standards for such an identifier) to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.
(3) Promising technologies
The standards developed under this subsection shall address promising technologies, which may include-
(A) radio frequency identification technology;
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