Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Product Identifier Requirements Under the Drug Supply Chain Security Act-- Compliance Policy." This draft guidance describes FDA's intention with regard to enforcement of requirements related to product identifiers under the Drug Supply Chain Security Act (DSCSA). Specifically, this guidance addresses manufacturers' product identifier and verification requirements, which begin November 27, 2017. This guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products.