U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Standards Development for Prescription Drug Supply Chain Security
  1. Drug Safety and Availability

Standards Development for Prescription Drug Supply Chain Security

FDA has been developing standards for further securing the drug supply chain pursuant to Section 913 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This act states that, “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.” FDA will also be developing standards pursuant to the Drug Supply Chain Security Act.

Standards Development Activities under Section 913 of FDAAA

Back to Top