Don’t misconstrue that the DSCSA implementation is being delayed—it isn’t.

As part of the FDA’s Drug Quality and Security Act, one key rationale for the Drug Supply Security Act (DSCSA) was to protect US patients from receiving counterfeit or illegitimate medications. Everything the industry is doing to connect manufacturers, wholesalers and dispensers to create an interoperable supply chain is all about patient safety.

In the rapidly evolving landscape of pharmaceuticals, maintaining regulatory compliance is paramount for pharmacies. The Drug Supply Chain Security Act (DSCSA) aims to enhance patient safety by establishing a secure supply chain for prescription drugs.

The receiving process for totes at pharmacies from wholesalers hasn’t changed much over the past 25 or more years.… Physical packages reconciled to a printed manifest/order. Quantities checked. Verification that nothing is damaged. Inspection to see if anything is already expired. Data entry into a pharmacy inventory system. Even if there are some issues, the medicines get put into stock. 

Even if we do get a Drug Supply Chain Security Act (DSCSA) enforcement delay from the FDA, pharmacies are still on the hook for compliance. And compliance means connections.

We discuss the requirements, challenges and guidance for pharmacies as they prep for compliance.  

Prepare your pharmacy to meet DSCSA requirements by November 27, 2023.