Draft Guidance for Industry on
Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
Today FDA announced the availability of a new draft guidance describing the Agency’s annual reporting procedures for prescription drug wholesale distributors and third-party logistics providers as required under the supply chain provisions of the Drug Quality and Security Act.
The draft guidance, Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers, outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format for the submissions, and a preferred method for reporting to FDA.
CDER Small Business and Industry Assistance will produce a webinar covering this guidance and annual reporting requirements on December 16, 2014. The webinar will be available via the CDER SBIA web page.
Annual reporting by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal.
Last month, FDA also published the draft guidance on DSCSA Standards for the Interoperable Exchange of Information for Tracing of Human, Finished Prescription Drugs: How to Exchange Product Tracing Information, to assist manufacturers, repackagers, wholesale distributors and dispensers to comply with the new product tracing requirements.
For more information about DSCSA implementation and new requirements to develop and enhance drug distribution security, please visit FDA’s Drug Supply Chain Security Act web page.
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