USA – Pharmaceutical distributors seek two-year delay in DSCSA tracking rules

Pharmaceutical distributors are calling for the US Food and Drug Administration (FDA) to grant a two-year delay enforcing the pharmaceutical tracking provisions of the Drug Supply Chain Security Act (DSCSA), saying that industry still does not have the necessary tracing systems in place to comply with the law. The Healthcare Distribution Alliance (HDA) is instead calling for a phased approach to implementation to minimize supply chain disruptions and avoid drug shortages.

Scott Mooney, vice-president of distribution operations for McKesson explained the HDA’s request and why the group is calling for the enforcement delay during a 27 July webinar.

Beginning on 27 November 2023, DSCSA requires manufacturers, wholesalers, distributors and dispensers to exchange serialized product information, and marks the culmination of the law’s phased implementation…