FDA Proposed Rule “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers”
In February 2022, the 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.
Information on the background and content of the planned changes can be found in the news “Proposed Rule for the Licensure of WDDs and 3PLs published”.
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.
This article and more like it can be found on the ECA GDP Association Website.