FDA Issues Draft Guidance on Drug Supply Chain Law's Verification Requirements
The Food and Drug Administration on Oct. 24 posted a new draft guidance document outlining verification requirements for pharmaceutical manufacturers, wholesale distributors, dispensers and repackagers under the Drug Supply Chain Security Act. The draft guidance includes recommendations for verification systems…
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required under the law for the determination, quarantine, and investigation of suspect and illegitimate products. It also addresses how “trading partners” under DSCSA should submit cleared product notifications after a product is found after investigation not to be legitimate, and addresses the statutory requirements for verification, FDA said. Under DSCSA, manufacturers and repackagers are also required to respond to requests for verification from other trading partners, and verify certain information prior to further distributing returned product.