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  1. Drug Supply Chain Security Act (DSCSA)

Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

All trading partners must be authorized. To be authorized, wholesale distributors and third-party logistics providers must be appropriately licensed and report licensure and other information to FDA annually.

Wholesale Distributor and Third-Party Logistics Provider in FDA’s Reporting Database1

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Submit annual report to FDA

If your firm conducts certain activities that meet the definition of a wholesale distributor or third-party logistics provider, you are required to submit annual reports to FDA.2 To help determine whether you are a wholesale distributor engaged in wholesale distribution or a third-party logistics provider, review the FDA guidance, Identifying Trading Partners Under the Drug Supply Chain Security Act (DSCSA).

What information must wholesale distributors and third-party logistics providers provide to FDA?

For more information on specific information to report, review the following FDA guidances: DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers and Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.

Additionally, FDA slides and audio provide an overview of the annual reporting guidance.

How do wholesale drug distributors and third-party logistics providers provide annual reporting information to FDA?

Annual reporting submissions by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal. An FDA webinar provides technical tips on how to report using CDER Direct. Additional information can also be found in the FDA Guidance: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.

How do companies report an error in their reporting?

If a company determines that it has reported in error, it can withdraw its report through CDER Direct. Step-by-step instructions are included in the FDA Guidance: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.

Who can make changes to information in this database?

Changes to the information can only be made by the entity reporting the information. Submission updates can be done by submitting a new submission in CDER Direct. Additional information can be found in the guidance: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.

How do I check if a wholesale drug distributor or third-party logistics provider has a valid state license?

Visit FDA’s webpage on wholesale drug distributor and third-party logistics provider licensing information.


1 The database contains information self-submitted by wholesale 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 distributor or third-party logistics provider 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. This database does not contain establishments registered under FD&C Act section 510 as a drug establishment, 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.
2 See sections 503(e)(2) and 582 of the FD&C Act.

 
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