California Developing Track-and-Trace Regs for Sealed Cases

Certifying and verifying each individual drug unit within a case would be time consuming and cumbersome under California’s ePedigree rules. So the California Board of Pharmacy is preparing regulations that will set limits for when and what shippers and receivers can infer from a packed case, and when contents must be verified. A proposed rule now under consideration will allow inference under certain circumstances such as:

• Where the source has transmitted a certified electronic pedigree with the sealed container that establishes a hierarchical data relationship between the unique identifier on the sealed case and the individual unit identifiers;

• When the electronic pedigree data was received via a secured transmission and includes a digital signature from the responsible party;

• Where the case hasn’t been opened, tampered or its seal is unbroken; or

• When the sealed case contains only one product and contains no more than 48 units of that product.

For more on preparing for the track-and-trace requirements, visit the FDAnews Pharmaceutical Track and Trace Virtual Conference.