Industry Group Urges FDA to Better Define Terms in Supply Chain Security Guidance

April 3, 2018

The FDA should clarify some key definitions in its draft guidance on drug supply chain security, according to one industry group.

The agency issued draft guidances last month to aid drugmakers in implementing the Drug Supply Chain Security Act. One laid out the definitions of counterfeit, diverted and unfit for distribution products, as well as fraudulent transactions.

The National Association of Chain Drug Stores expressed concern about the draft guidance’s definition of “unfit for distribution.” In the guidance, the FDA identifies trigger terms for the designation, including “drugs rendered nonsaleable because conditions (such as return, recall, damage, or expiry) cast doubt on the drug’s safety, identity, strength, quality, or purity” and those considered misbranded under the FD&C Act.

“NACDS is concerned that using this definition, chain pharmacies would be required to quarantine and investigate every damaged or expired drug product,” the group said.

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