Comment Period Extended for the Proposed Rule for the Licensure of WDDs and 3PLs
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.
Related GMP News
10.06.2025Stimuli Article Proposes Revision of USP Definition of Controlled Room Temperature (CRT)
10.06.2025New MHRA Blog Post: Supplying Medicines to Ships, Aircraft and Oil Platforms
10.06.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 3
10.06.2025Meet the GDPA Board Members at the GDP Forum in Barcelona
10.06.2025Swissmedic Technical Interpretation: What Counts as a Major Change in GDP?
10.06.2025MHRA informes about Validity Date of UK issued GDP Certificates