The U.S. Food and Drug Administration (FDA) has announced the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). The proposed rule sets national licensing standards for both federal and state licensure for WDDs and 3PLs.
In a short summary of the FDA, it says that "the proposed rule, when finalized, would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain."
The proposal goes back to the Drug Quality and Security Act (DQSA), which was enacted on November 27, 2013. The DQSA includes, besides others, provisions designed to strengthen the integrity of the pharmaceutical distribution supply chain, including the requirement of the FDA to establish by regulation national standards for the licensure of prescription drug wholesale distributors.
At present, the requirements for wholesale drug distributors vary significantly between individual U.S. states. The state requirements and standards for licensure can vary on different topics, such as
The length of time for which records must be maintained
Qualifications of facility managers and designated representatives
Exemptions from the definition of wholesale distribution
Inspection and approval requirements by certain, specific organizations in order to receive licensure in certain States
All this leads to a patchwork of different regulations.
Replacement of the Current 21 Code of Federal Regulations, Part 205
The core of the new proposal is the replacement of the current 21 Code of Federal Regulations (CFR), Part 205. It provides guidelines for state licensing of wholesale prescription drug distributors. Furthermore, the proposal also intends to include certain conforming changes to other regulations.
The current version of 21 CFR, Part 205, which is not very extensive, is divided into the following sections:
205.1 – Scope
205.2 – Purpose
205.3 – Definitions
205.4 – Wholesale drug distributor licensing requirement
205.5 – Minimum required information for licensure.
205.6 – Minimum qualifications
205.7 – Personnel
205.8 – Violations and penalties
205.50 – Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
The proposal is much more comprehensive and contains a whole series of very detailed requirements, as can already be seen from the table of contents:
205.20 – Requirement that prescription drug wholesale distributors be licensed 205.21 – Surety bond requirement 205.22 – General application requirements for licensure 205.23 – Federal licensure process 205.24 – Changes to information, operation, location, or ownership of a wholesale distributor 205.25 – Prohibited persons and qualifications for key personnel 205.26 – National standards for the storage and handling of prescription drugs for wholesale distribution 205.27 – Standards for the establishment and maintenance of records of the distribution of prescription drugs 205.28 – Inspections 205.29 – Requirements for initial and annual reporting to the Food and Drug Administration 205.30 – Licensure denial, suspension, reinstatement, revocation, and voluntary termination—notice and opportunity to request a hearing
Subpart D—Approved Organizations for Wholesale Distributors
205.31 – Use of approved third-party organizations 205.32 – General qualifications of approved organizations 205.33 – Process and procedures for approval by the Food and Drug Administration
Thus, the new Part 205 would implement the licensure requirements of the DSCSA and provide oversight of licensure of 3PLs and WDDs. All 3PL facilities would be required to obtain a 3PL license for each facility of such 3PL. Each WDD would be licensed by the State or the FDA.
The full text of the proposal and a detailed justification of each paragraph was published in the Federal Register (Vol. 87, No. 24 / Friday, February 4, 2022).
Comments and Next Steps
Comments on the proposed rule can be submitted until June 6, 2022 (120 days after publication). Further information on the commenting process can be found here.
The FDA plans to hold a webinar providing an overview of the proposed rule’s key provisions. This is intended to assist stakeholders in understanding the proposed rule and preparing comments.