National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers (Proposed Rule) Preliminary Regulatory Impact Analysis
If finalized, the proposed rule would establish new national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs). The rule would also establish a federal licensing system for WDDs and 3PLs to use in the absence of a state licensure program that is consistent with the proposed national standards.
The proposed rule, if finalized, would result in public health benefits to consumers from reducing the diversion of prescription drugs. Cost savings would result from reducing the frequency and quantity of licensure applications and reducing state licensing standards in some states. Costs to WDDs and 3PLs would include costs to read and understand the rule, report to FDA, undergo routine inspections, write and revise standard operating procedures, and conduct background checks. States would incur costs to read and understand the rule, inspect WDD and 3PL facilities, and pass or revise laws and regulations governing state licensure programs. Approved organizations would incur legal, application, and training costs, as well as costs to inspect WDD and 3PL facilities. Costs to FDA would include costs to establish and operate a reporting database and licensure program for WDDs and 3PLs.
We intend to publish this rule in conjunction with the proposed rule titled “Certain Requirements Regarding Prescription Drug Marketing” (or Part 203). We include the benefits and costs of Part 203 in this economic analysis.
Regulatory Impact Analysis
Federal Register: 87 FR 6708, February 4, 2022
Docket: FDA-2020-N-1663