Updated: FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics Providers
The Food and Drug Administration (FDA) on Tuesday released draft question-and-answer guidance, supplementing another draft from 2014, to help drug wholesale distributors and third-party logistics understand their annual reporting requirements.
The new draft, entitled "Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers," addresses questions about and clarifies FDA's expectations for annual reporting to FDA by wholesale distributors and third-party logistics providers as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA).
FDA said Monday the draft should be viewed in tandem with a 2014 draft guidance as it addresses questions and comments FDA received about such annual reporting. Topics in the Q&A include clarifications about what companies must report, what should be reported, when to report and how to report, as well as questions related to the public availability of reported information.
The agency also says that it intends to finalize this draft Q&A and the 2014 draft in one unified final guidance on annual reporting requirements under the DSCSA.
Wholesale Distributor and Third-Party Logistics Providers Reporting
Editor's note: This article was updated on 1/10/17 with a link to the draft guidance.