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Zdrowie i gospodarka · 2.11.2015

The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy; Updated Guidance for Industry, Availability

The Food and Drug Administration (FDA or we) is issuing a revised guidance document that extends the compliance policy described in the guidance for industry entitled "DSCSA Implementation: Product Tracing Requirements for Dispensers--Compliance Policy." This revised guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act.

Source: Federal Register — Food and Drug AdministrationOpen original release →