FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Unveils New Supply Chain Pilot Program

Feb. 14, 2019

The FDA announced a new pilot program under the Drug Supply Chain Security Act (DSCSA) to help trace prescription drugs.

The DSCSA imposes verification requirements for certain drugmakers and others in the supply chain, mandating a system to identify and quarantine suspect products. The mandated pharmaceutical serialization deadline under the law was Nov. 27, 2018, extended from 2017.

The FDA is inviting manufacturers, dispensers, repackagers and wholesale distributors to sign up for the voluntary program and says they should be prepared to begin pilot projects within four months of FDA acceptance. The pilot projects will generally last no longer than six months, the agency said.

The projects should include large and small entities to reflect the diversity of the supply chain, the agency said, adding that the program is intended to help identify the best way to “operationalize” supply chain security requirements.

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