FDA’s Office of Compliance provides an overview of the proposed rule. Comments are due by June 6, 2022. 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. Where a state does not have a licensing program in accordance with the regulation, FDA would be the licensing authority.
0:01 - SBIA Introduction
3:00 - Webinar overview and background into the proposed regulations
19:15 - How to comment on the proposed regulation
21:51 - Discussion of the Contents of the Proposed Rule
23:54 - Overview of Proposed Standards for 3PL Licensure
53:58 - Overview of Proposed Standards for WDD Licensure
Learn more: www.fda.gov/dr...
To read the proposed rule and submit a comment: www.fda.gov/dr...
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