Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act." The Drug Supply Chain Security Act (DSCSA) outlines critical enhanced drug distribution security requirements for building an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs at the package level as they are distributed within the United States. This draft guidance clarifies these requirements and provides recommendations on the system attributes necessary to enable the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary.