Annual Licensure Reporting by Wholesale Drug Distributors and Third-Party Logistics Providers
Annual Licensure Reporting Requirements
Wholesale drug distributors and third-party logistics providers must be appropriately licensed and report licensure and other information to FDA annually to be authorized trading partners under the Drug Supply Chain Security Act.
Review the Identifying Trading Partners Under the Drug Supply Chain Security Act (DSCSA) guidance to help determine whether your entity is considered a wholesale drug distributor or a third-party logistics provider.
FDA’s Reporting Database
The reporting database contains information submitted by wholesale drug distributors and third-party logistics providers. Each line of the database represents a license for a particular facility. One facility may have multiple licenses and therefore multiple lines may be listed in the database. This database is updated every business day.
Reporting by a wholesale drug distributor or third-party logistics provider does not mean the facility is licensed or approved by FDA or the facility is in compliance with applicable state and federal regulations. Check licensure of wholesale drug distributors and third-party logistics providers for more information.
The reporting database does not contain establishments registered under section 510 of the Federal Food, Drug and Cosmetic Act as a drug establishment, which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S. The registrants under section 510 of the FD&C Act are in the drug establishments current registration site database (DECRS). This database also does not contain establishments registered as outsourcing facilities under section 503B of the FD&C Act.
Information that Must be Reported to FDA
Wholesale drug distributors and third-party logistics providers must report certain information to FDA, including:
- state licensure and contact information for facilities
- significant state or federal disciplinary actions
Review the following FDA guidance documents for specific information on reporting, including submission timing:
- DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
- Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers, which includes step-by-step instructions on using CDER Direct
Annual Reporting Using CDER Direct
Annual reporting submissions by wholesale drug distributors and third-party logistics providers can be made using CDER Direct. Review our webinar for technical tips on how to report using CDER Direct.
Updates to an annual report can be done through CDER Direct by updating a previous submission. An entity also can withdraw its report through CDER Direct if the entity determines that it has reported in error.