Food & Drug Administration's Proposed Rule:
- Title: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
- Docket ID No. FDA-2020-N-1663-0001
- RIN: 0910-AH11
Background on Proposed Rule and Statutory Authority
On February 4, 2022, the FDA published a proposed rule that outlined national standards for the licensing of drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) in the prescription drug chain. The FDA concurrently provided a regulatory impact analysis (RIA) on its website. The FDA asked for public comments to be submitted by June 6, 2022.
The FDA cites the statutory authority provided by the Drug Supply Chain Security Act (DSCSA) to issue this regulation, which was enacted as Title II of the Drug Quality and Security Act in 2013. DSCSA directed the FDA explicitly to take most of the actions contained in the proposed rule. Among other changes to previous legislation, the FDA notes that DSCSA added Section 583, requiring the FDA to establish national standards for licensing of WDDs and Section 584 which requires national standards and licensing for 3PLs in the prescription drug supply chain. DSCSA alone provides the FDA statutory authority since it explicitly requires FDA to create these national standards and take the other associated actions.
The FDA’s proposed rule states that the regulation is intended to create a uniform national standard for licenses for WDDs and 3PLs operating in the prescription drug supply chain, rather than relying on the existing system of licensure provided by distinct state governments. Much of the text of the proposed regulation outlines specifics of these standards that would be applied to these entities. The regulation also sets forth other measures related to this market, including requiring WDDs to furnish a surety bond, establishing qualifications for key personnel involved in the management of WDD or 3PL operations, and providing procedures for licensure denial, suspension reinstatement, termination, of license and more. The proposed rule also sets forth standards and requirements for approval of secondary organizations that monitor the licensure and inspection process (known as Approved Organizations).