FDA Publishes DSCSA Guidance on Distributor, 3PL Annual Reporting

The FDA published new draft guidance yesterday that addresses reporting by wholesale distributors and third-party logistics (3PL). Fundamentally, the guidance addresses questions and provides some clarifying answers on FDA expectations regarding the information submitted for the annual reporting requirements for licensure, which wholesale distributors and 3PLs have under DSCSA.

The guidance does not impact DSCSA serialization, traceability and verification regulations, or their implementation. It only impacts who may be considered an “authorized party” for DSCSA transactions, given that the information populates the FDA licensure database.

This question-and-answer document is currently available and describes:

• Who must report under different scenarios, such as manufacturers distributing their own drugs, bulk substances, and 3PLs.
• What should be reported (for example, this includes all state licenses, but not DEA registration numbers).
• When to report: annually is required, incremental updates are optional. 
• How to report: use CDER Direct portal, submit XML file via FDA ESG gateway. 

The complete FDA guidance document is available here.