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 rooted in patient safety.
The end of the line for compliance and drug verification is at the pharmacies and dispensaries. However, recently industry associations such as HDA, APhA, NACDS and NCPA have penned letters to the FDA requesting extensions and outlining a phased approach to the implementation of the requirements. At some point—and it may not be the slated November 2023 date— intake at pharmacies will include verifying the received drugs match the digital transaction information sent from the supplier.
When things don’t match, the situation needs to be rectified and documented. Pharmacies need a prescribed and documented process to work with suppliers to resolve issues. This could be straightforward, and administrative communications via email can trigger data resolution of quantity or product accuracy.
When a possible illegitimate product is discovered, there is an additional formal process the FDA mandates—the submission of Form 3911:
- Notify FDA of Illegitimate Products
- INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911 – DRUG NOTIFICATION
The requirements of DSCSA impact how pharmacies operate today, is your pharmacy equipped with the tested process to discover and document exceptions?
Exceptions inevitably occur. Systech’s UniTrace® DSCSA for Dispensers has an optional module that helps automate the exception handling process with suppliers.