FDA Issues Draft Guidance on Verification Duties Under Drug Supply Chain Law
The Food and Drug Administration recently issued a draft guidance document clarifying certain product verification responsibilities for entities subject to the Drug Supply Chain Security Act (DSCSA). Under DSCSA, manufacturers, repackagers, wholesale distributors and dispensers of drugs must be able…
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to identify a suspect product and make a determination about whether that product is an illegitimate product. Product may be considered suspect or illegitimate because it is counterfeit or diverted, subject to a fraudulent transaction or appears to be unfit for distribution, among other things. FDA’s draft guidance provides definitions for these terms to assist companies subject to DSCSA in complying with the verification requirement. Comments are due April 2, FDA said.