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Volume 03 Issue 08
February 18, 2022
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The Editorial
Proposed FDA Rules Could Be Game Changers for the Pharmaceutical Supply Chain

By Shannon Britton Hartsfield

New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug Administration (FDA) published proposed rules on Feb. 4, 2022, that would preempt state and local licensure requirements for many companies in the drug supply chain. Members of the public may submit written comments regarding the proposal. The deadline to provide comments is June 6, 2022.
The FDA recognizes that "[a] breach at any point in the supply chain carries potential for dangerous, and even deadly, outcomes for American consumers." In the preamble to the proposed rules, the FDA stated that "[t]heft and diversion of prescription drugs continue to be major issues contributing to drug shortages and creating significant financial losses, the effects of which cascade through the supply chain to consumers." The rules are designed to "secure and strengthen the supply chain." All 3PLs and wholesale distributors will be held to national standards relating to handling, storage and transportation of prescription drugs, instead of the current "patchwork" of differing standards among the states. States with their own licensure programs will continue to issue permits. If a state lacks a licensing program that complies with the federal rules, the "FDA will be the licensing authority."
The proposed rules, if

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