What must wholesale drug and device distributors include in their annual report to the FDA?

• A. Employee training records.
• B. A listing of licenses and registrations they hold in each state into which they ship products.
• C. A list of customers.
• D. A summary of sales.

Answer: (B)

Distributors must show they are legally authorized to operate in every state they ship to, and the annual report to the FDA requires a listing of all licenses and registrations held in those states. This confirms the distributor is properly licensed across the jurisdictions it serves and helps FDA verify ongoing legal authority to distribute drugs or devices, supporting regulatory oversight and chain-of-custody integrity.

Other items aren’t required in that annual report: employee training records are important but are not what the FDA asks for in the annual submission; a list of customers is not mandated and would raise confidentiality concerns; and a summary of sales isn’t the type of regulatory authorization data the FDA needs in this context.