Prescription drugs should only be purchased from wholesale drug distributors holding a valid license in the United States and who are authorized1 by law. Unlicensed and unauthorized trading partners put patients at risk of taking unsafe, possibly illegitimate product such as counterfeit, stolen, or diverted drugs. If a manufacturer, wholesale distributor, or dispenser uses a third-party logistics provider (3PL) to coordinate warehousing or other logistics services, the 3PL must also be authorized.
To check if a wholesale drug distributor or third party-logistics provider2 is an authorized trading partner:
- Check the applicable state licensure website listed below to determine if the wholesale drug distributor or third-party logistics provider has a valid license in the state where they are conducting business, and
- Check the FDA annual reporting database to determine if a wholesale drug distributor or third-party logistics provider submitted an annual report to FDA.3 Learn more about DSCSA authorized trading partner requirements at: Are you ready for the Drug Supply Chain Security Act?
U.S. State Agencies Responsible for Licensing Wholesale Prescription Drug Distributors2
1 Authorized in compliance with section 582 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by the Drug Supply Chain Security Act (DSCSA).
2 A third-party logistics provider is considered to be licensed for purposes of the DSCSA until the effective date of the third-party logistics provider licensing regulations issued by FDA, unless FDA publishes notice of a finding that a 3PL does not utilize good handling and distribution practices. In cases where a state operates a specific third-party logistics provider licensing program, state requirements for third-party logistics licensures apply until the final regulations take effect. This information will be revised when final regulations are issued.
3 FDA asks that annual reports be submitted between January 1 and March 31 of each year. See FDA’s draft Guidance for Industry, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.