The DSCSA requires pharmaceutical trading partners to only transact with authorised trading partners (ATPs) — licensed manufacturers, wholesale distributors, and dispensers. This guide covers ATP verification requirements and procedures.
Authorised Trading Partner Definition
An authorised trading partner is a manufacturer, wholesale distributor, or dispenser that: holds a valid state licence (for wholesale distributors and dispensers); or holds a valid registration with the FDA (for manufacturers and wholesale distributors). Third-party logistics providers (3PLs) must also be licensed as wholesale distributors if they take title to products.
Licence Verification
Trading partners must verify the licence status of their counterparties before conducting transactions. Licence verification can be performed through: the FDA's Drug Establishment Registration database; state pharmacy board licence databases; and third-party licence verification services. Verification must be performed at onboarding and periodically thereafter.
Suspect Product Procedures
When a trading partner receives a product that they suspect is counterfeit, diverted, stolen, or otherwise illegitimate, they must: quarantine the product immediately; investigate the product's legitimacy; notify the FDA and immediate trading partners within 24 hours if the product is determined to be illegitimate; and not distribute the product until its legitimacy is confirmed.