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Licensed Drug Distributors Would Get More Scrutiny in FDA Plan

Feb. 3, 2022, 5:08 PM

Wholesale distributors would have to establish written policies to ensure their facilities are fully capable of storing and transporting prescription drugs to qualify for licensure under a proposed rule from the FDA.

The proposed rule (RIN 0910-AH11) released Thursday would set national standards for licensing to make sure supply chain participants are properly vetted and qualified to distribute drug products. “These measures are intended to help protect American consumers from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful,” the Food and Drug Administration said.

The proposal codifies a requirement that distributors be licensed by the states ...