FDA Issues Draft Guidance on Info Requirements under Drug Supply Chain Security Act

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-09-2014 13:34


The US Food and Drug Administration has issued draft guidance describing FDA’s expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) for the annual reporting to FDA as required under the Drug Supply Chain Security Act of 2013 (DSCSA).

Under section 584(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-3(b)), beginning November 27, 2014, 3PLs must report certain information to FDA, including state licensure information for each facility and the name and address for each facility. Under section 503(e)(2)(A) (21 U.S.C. 353(e)(2)(A) (as amended by the DSCSA), beginning January 1, 2015, wholesale distributors also must report certain information to the FDA, including State licensure information for each facility, contact information for each facility, and any significant disciplinary actions taken by a state or the federal government. This guidance outlines the information that should be submitted to the FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting to the FDA.

Source: FDA

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