Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers
The Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27, 2013, outlines new requirements to develop and enhance drug supply chain security over the next 10 years. This includes requirements for prescription drug wholesale distributors and third-party logistics providers. In addition to establishing standards for licensure of wholesale distributors and third-party logistics providers, the DSCSA requires wholesale distributors and third-party logistics providers to report licensure and other information to FDA annually.
Reporting by wholesale distributors and third-party logistics providers
The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015.
FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers” that addresses what information and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.
FDA is soliciting comments from interested stakeholders about this guidance for 60 days following the publication date. For instructions on how to submit comments, see the Federal Register notice.
Annual reporting by third-party logistics providers and wholesale distributors can be made using FDA’s CDER Direct Electronic Submissions Portal.
The Wholesale Distributor and Third-Party Logistics Provider Reporting Database contains information submitted by wholesale distributors and third-party logistics providers (3PLs).
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.
The wholesale distributor and 3PL reporting database will be updated every business day.
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This information is submitted to FDA to comply with the reporting provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and additional information is submitted voluntarily.
Wholesale distributors and 3PLs are required to report licensure and certain other information for each facility annually to FDA under FD&C Act section 503(e)(2) and section 584 respectively.
The information included in the database is self-reported by wholesale distributors and 3PLs. 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 3PL 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.
Annual reporting by wholesale distributors and 3PLs can be made using FDA’s CDER Direct Electronic Submissions Portal at https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP. If a company determines that it has reported in error, please e-mail firstname.lastname@example.orgNotes: