The guidance, issued June 3, is intended to help identify a suspect product in the pharmaceutical supply chain, as well as to identify specific scenarios that increase the risk of a suspect product entering the supply chain. It also clarifies how the FDA defines suspect and illegitimate products and describes how to notify the FDA of an illegitimate product.
“Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act, we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found,” Donald Ashley, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research said in a news release.
Read the FDA’s full news release here.
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