Comment Period Extended for the 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

The U.S. Food and Drug Administration (FDA) has extended the comment period for the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)" to September 6, 2022.

According to the agency, "the proposed rule, when finalized, would establish national standards for the licensing of prescription drug wholesale distributors and third-party logistics providers. The rule would help ensure supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain."

The availability of the proposed rule was announced in February 2022. It was initially planned that the comment period would end on June 6, 2022 (120 days after publication). The FDA believes that a 90-day extension until September 6, 2022, allows adequate time for interested stakeholders to submit comments.

Shortly after the publication of the proposal, we had already prepared a summary, which you can read in our news archive. The FDA has also posted a webinar to help stakeholders submit comments and understand the proposed changes.

To read the proposed rule and submit comments, please go to the federal register website.