FDA Clarifies Annual Reporting Expectations for Wholesale Distributors, Third-Party Logistics Providers

The FDA is clearing up its annual reporting requirements for wholesale distributors and third-party logistics providers (3PL), explaining who must report and when to submit filings, among other clarifications, in a draft Q&A guidance.

The document addresses questions and comments to the agency on draft guidance covering the implementation of mandatory reporting for the supply chain.

Manufacturers that only distribute their own drugs are not classified as wholesale distributors and are exempt from submitting the annual filing. The requirement applies to wholesale distributors of bulk prescription substances, and 3PL providers of prescription drug samples, even facilitates located in states without licensing requirements for a 3PL.