Annual Reporting by Prescription Drug Wholesale Distributors: Questions and Answers

Author:

Monitoring and Reporting Working Group

On January 10, 2017, FDA issued draft guidance addressing questions and clarifying FDA’s expectations for annual reporting to FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Drug Supply Chain Security Act of 2013 (DSCSA).  Topics covered in this guidance include clarifications about who must report, what should be reported, when to report, and how to report.  This guidance also addresses questions related to the public availability of reported information.

Comments on this draft guidance must be submitted to FDA no later than March 13, 2017.

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