DSCSA (Drug Supply Chain Security Act) compliance for pharmaceutical manufacturers

The United States Food and Drug Administration enacted Drug Supply Chain Security Act (DSCSA) to ensure the product traceability and accountability in order to prevent the counterfeit drugs into commercial distribution for the patient safety.

Each Saleable unit product must have a unique identifier, which includes Global Trade Identification Number (GTIN), Serial Number, Lot Number and Expiration Date for the traceability of the product throughout the supply chain from manufacturing of this product till dispensing of the product to patient. To trace the product, manufacturers must maintain the transaction information, transaction history and transaction statements.

Manufacturers can only supply the product to authorized trading partners (ATPs) who have the valid state license for prescription drug distribution with the capability to receive and transmit the product tracing information to their downstream customers or dispensers. All serialization data (tracing information) needs to be sent through the interoperable systems in Electronic Product Code Information Services (EPCIS) format, a global standard developed by GS1.

I started actively working on this compliance requirement from July 2023. Directed our sales team to reach out to all our existing wholesalers/distributors and collect their direct point of contact for DSCSA activities. Instructed our IT serialization team to define the process of the onboarding of all our customers and based on their readiness the testing in test environment and eventually production environment. We are one of the very handfuls of manufacturers who are connected with all their downstream customers and have an average of more than 98% posting of EPCIS data successfully in first attempt. With daily monitoring of the EPCIS data, for any technical or manual error, if EPCIS files not transmitted successfully, it will be retriggered.

Manufacturers must verify their product upon request from the downstream customers if they receive the request. If product can not be verified against the serialization data, it termed as a suspect or illegitimate product and manufacturers must notify regulatory authority using FDA Form 3911. Till date all the requests received from the downstream customers, I verified and provided positive verification, so the product can be further distributed.