An Open Letter from TraceLink’s CEO on the DSCSA Saleable Returns Enforcement Discretion
Yesterday, the FDA announced that it does not intend to take enforcement action before November 27, 2020, against wholesale distributors who do not verify returned drug products before they are resold, as required under the DSCSA verification requirement for saleable returns. It is important to note that the announcement does not delay the law itself and that the saleable returns requirement will still go into effect on November 27, 2019.
With this announcement, the FDA acknowledges that some wholesale distributors may need additional time before they can begin verifying returned products prior to further distribution. However, the FDA does not want wholesalers to stop their ongoing projects and still expects them to make good faith efforts to march towards compliance. This includes the need for wholesale distributors to strongly collaborate with their manufacturing suppliers and communicate their immediate requirements for VRS, EPCIS and product master data, in order to keep projects progressing.
For manufacturers, the 12-month period of enforcement discretion provides no blanket reprieve on the verification issue. The Request for Verification clause for manufacturers in DSCSA still holds and under it, manufacturers are still responsible for responding to requests from authorized supply chain entities for verification of a product identifier within 24 hours. A manufacturer may receive a verification request for the following reasons:
- A wholesaler may want to implement their saleable returns verification processes prior to the end of the enforcement discretion because they do not want to wait to secure their supply chain or they want to ensure that they prepare early to be fully operationally ready for the November 27, 2020 deadline;
- A wholesaler may need to verify a product identifier with the manufacturer as part of a DSCSA suspect product investigation into potentially counterfeit, adulterated or stolen medicines.
With 109 VRS customers, TraceLink will be ready for November 27, 2019. We have completed interoperability testing to meet the major wholesale distributor requirements, including the required request and sub-second response time, as well as the synchronization of lookup directories. In fact, the stress testing we have performed against our system has simulated receiving ~700 simultaneous requests per second with an average response time of 370ms.
VRS is not the only component for companies to be ready and compliant. Wholesalers are also asking their suppliers to provide GTIN and related product master data, as well as sending EPCIS shipment transactions defining the serialized products that are being shipped.
One major lesson we learned from lot-level is that many of the large wholesalers have anywhere from 300 to 600 suppliers, which warrants a long lead time to get connected to each one. In fact, being ready for the saleable returns requirement is even more complex for the manufacturer because a verification request could come from hundreds of trading partners in the supply chain, even those with whom a manufacturer may not have a direct trade relationship. Manufacturers will want to ensure that they are interoperable and can perform end-to-end testing with their largest companies. The longer companies wait to test and validate their integrations, the riskier it is to be compliant by November 2020.
By partnering with TraceLink, manufacturers can meet the requirements of wholesalers that include providing a VRS, providing GTIN and pack level product master data and providing EPCIS shipment transaction data. Our network of 275,000 pre-validated partners eliminates the need to create point-to-point integrations with each trade partner and ensures that the trade partners inquiries are vetted. To ensure network security and authorized access, we have dedicated substantial time and resources to network governance, with over 20 full-time in-house professionals responsible for authenticating companies. With one platform and a common repository for master data and trade partner integration, TraceLink provides a single destination that can monitor, manage, and administer all your DSCSA requirements.
Saleable returns can be a threat to patient safety and have been used in the past as a means to introduce counterfeit drugs into the supply chain. As President and CEO of TraceLink, my fundamental duty is to ensure our customers’ success and work toward the greater good of patient safety.
I look forward to supporting your long-term journey and helping you achieve DSCSA compliance in our shared mission to continue keeping patients safe.
President and CEO