The U.S. Food and Drug Administration (FDA) has published on its website a searchable database of licensing information reported by wholesale distributors and third-party logistics providers (3PL) in accordance with the Drug Supply Chain and Security Act (DSCSA).
As expressed in the DSCSA, beginning November 27, 2014, 3PLs are required to report annually "the State by which the facility is licensed and the appropriate identification number of such license," and "the name and address of the facility and all trade names under which such facility conducts business." Additionally, beginning January 1, 2015, the DSCSA requires any person who owns or operates an establishment that engages in wholesale distribution to report annually "each State by which the person is licensed and the appropriate identification number of each such license," and "the name, address, and contact information of each facility at which, and all trade names under which, the person conducts business." Wholesale distributors must also report any significant disciplinary actions taken by a state or the federal government during the reporting period against the wholesale distributor.
The FDA required 3PLs to submit their initial report between November 27, 2014, and March 31, 2015, which must have included the name of the company, the address of the facility, all trade names that the company does business as, and the licensure information for each state. The FDA requested that 3PLs report the facility's contact person, email address, telephone number, unique facility identifier, the expiration date for licenses, and significant disciplinary actions taken by any state or federal agency against the 3PL that occurred in the 12 months preceding the initial report.
Further, wholesale distributors were required to submit their initial report between January 1 and March 31, 2015, which must have included identifying information for the facility and licensure information for each state. Wholesale distributors must also report significant disciplinary actions taken by a state or the federal government against the wholesale distributor within 30 days of a final action or ruling. The FDA also requested that wholesale distributors provide their unique facility identifier, the expiration date for their licenses, and any documents associated with the disciplinary action.
The FDA requires wholesale distributors and 3PLs to use its CDER Direct Electronic Submissions Portal to facilitate reporting as required by the DSCSA. Both 3PLs and wholesale distributors are required to submit subsequent reports between January 1 and March 31, annually.
Click here to view the FDA database.