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U.S. Department of Health and Human Services


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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.