12.05.2022

FDA posts Webinar on Proposed Rule for the Licensure of WDDs and 3PLs

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

In February 2022, 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.

Background

The FDA points out the following: "When final and effective, every U.S. wholesale distributor and third-party logistics facility will be held to these standards. Only those licensed according to the proposed national standards would be able to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain."

Information on the background and content of the planned changes can be found in our news article "Proposed Rule for the Licensure of WDDs and 3PLs published".

Content of the Webinar

Already when the draft document was published, a webinar was announced. The recording of this webinar was now posted.

The webinar aims to help stakeholders submit comments and understand the proposed changes. During the approx. 1.5 hour presentation, the following topics are covered:

How to submit a comment on the proposed regulations
Licensure application requirements
Procedures surrounding pre-licensure inspection as well as denial, revocation, and suspension of licenses
Standards for the storage and handling of prescription drugs, including facility requirements and security, inventory management, and equipment maintenance
Personnel requirements and qualifications
Recordkeeping and document maintenance requirements
Requirements for written policies and procedures

The recording of the webinar can be viewed either on the FDA homepage or on the FDA YouTube channel. The slides of the presentation as a PDF file were also published.