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

Recommendation

Thursday, 8 September 2022 9 .00 - 17.15 h

Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals - Live Online Training

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.

Submitting Comments

To read the proposed rule and submit comments, please visit the federal register. Comments can be submitted until June 06, 2022.