Important track-and-trace changes are coming

NCPA April 23, 2019

Additional requirements for trading partners under the Drug Supply Chain Security Act (also known as the "track-and-trace law") are coming. After Nov. 27, 2019, wholesalers can only accept pharmaceutical products that have a DSCSA-compliant product identifier, subject to exceptions listed in FDA guidance regarding grandfathered product. Further, after this date wholesalers will be required to verify with the manufacturer of a product the DSCSA-compliant product identifier if that product is being submitted as a saleable return. It is important for community pharmacists to know this date because the changes may impact saleable returns and inventory management at the pharmacy level. But the changes don't stop there. After Nov. 27, 2020, pharmacies can also only accept pharmaceutical products that have a DSCSA-compliant product identifier, subject to the FDA guidance on grandfathered product. NCPA recommends that pharmacy owners immediately ask their trading partners how these compliance dates may impact your pharmacy and plan accordingly.

Here's a poster on track-and-trace requirements.

Here's more information from the FDA.

NCPA