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
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
- Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information
- Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments
- 2011 FDA Public Workshop on Determination of System Attributes for the Tracking and Tracing of Prescription Drugs