New Draft Guidance: Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy- Drug Information Update

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The FDA recently published a draft guidance, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.
This draft guidance describes FDA’s compliance policy on enforcing requirements related to product identifiers under the DSCSA. Specifically, this compliance policy addresses manufacturers’ product identifier and verification requirements, which begin November 27, 2017. This compliance policy 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 product.