Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement

A green lizard in front of a laptop PC keyboard“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.

FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” that addresses what information and how wholesale distributors and third-party logistics providers should report to the FDA.”

Read the full explanation: via Drug Supply Chain Security Act > Wholesale Distributor and Third-Party Logistics Providers Reporting (on FDA.gov).

Go to DREprof.com: The Designated Representative and Exemptee Training Website

Tags: , , , , , , , , ,