Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
The Drug Supply Chain Security Act (DSCSA) requires wholesale distributors and third-party logistics providers to report licensure and other information to FDA annually under sections 503(e)(2) and 584 Federal Food, Drug, and Cosmetic Act. FDA recently published a draft guidance, Identifying Trading Partners Under the Drug Supply Chain Security Act (DSCSA), to clarify whether entities are engaged in activities that require licensure and annual reporting.
FDA issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers,” that addresses what information and how wholesale distributors and third-party logistics providers should report to the FDA. A webinar that provides an overview of the guidance is also available. FDA asks stakeholders to also review the Annual Reporting Q&A to better understand applicable DSCSA requirements.
Annual reporting by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal. FDA has posted a webinar with technical tips on how to report using CDER Direct.
If a company determines that it has reported in error, email [email protected].
Database Search and Download
The database contains information self-submitted by wholesale distributors and third-party logistics providers. Changes to the information can only be made by the entity reporting the information, who must resubmit the information to the FDA. Reporting by a wholesale distributor or third-party logistics providers does not denote that the facility is licensed or approved by FDA or that the firm and facility is in compliance with applicable state and federal laws and regulations.
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.
This database does not contain establishments registered under FD&C Act section 510 as a drug facility, which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the United States or offered for import to the United States. The list of section 510 registrants can be found in the Drug Establishments Current Registration Site database (DECRS).
This database also does not contain establishments registered as Human Drug Compounding Outsourcing Facilities under section 503B.