FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers

24 Nov 2017

• By Joanne S. Eglovitch

US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.

Industry has warned FDA that the continued lack of guidance on its criteria for downstream trading partners accepting “grandfathered” un-serialized drug products by a Nov. 27 statutory deadline under the Drug Supply Chain Security Act could lead to chaos.

Ilisa Bernstein, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, told a Nov....