Top Distributor issues VRS Letter, What Steps Should Other Wholesale Distributors Be Taking?
It’s hard to believe that more than a year has passed since manufacturers were in a mad rush to meet compliancy standards, but time marches on and now there’s a new deadline looming in the near future.
This time, it’s wholesale distributors who are under pressure to meet the newest deadline of the DSCSA. While this next milestone is important for the DSCSA, there’s one significant difference between the deadline for wholesale distributors and the one that manufacturers faced last year. Manufacturers, for the most part, are larger corporations with sufficient resources to bring their operations up to current compliancy standards. Wholesale distributors on the other hand, range from small to large operations, with sometimes limited resources and capabilities.
Amerisource Bergen issues letters to their trading partners regarding VRS.
Amerisource Bergen prepares to leverage their VRS network with their trading partners. They have strictly stated that they will not support manual verification requests. When a company as large as Amerisource Bergen starts to fall in line with DSCSA requirements, the industry starts to move the needle as well.
As the November deadline inches closer, it’s important that wholesale distributors are paying close attention to where they are on their path to compliancy and what steps need to be taken to ensure they’ve meet the requirements of the DSCSA come November. The FDA has been making movement that shows they’re firm in their intentions to acknowledge and penalize drug supply chain trading partners who have not taken their commitment to the DSCSA seriously. Here is what wholesale distributors need to be doing now to prepare for the deadline that’s just down the road.
A Complete Understanding of the Distributor Requirements Beginning November 2020
The most important steps for pharmaceutical wholesale distributors, if they haven’t done so already, is to confirm that they have a firm understanding of everything that’s expected of them come November. For larger wholesale distributors, this is less of an issue. However, for smaller and mid-size operations, the requirements of the DSCSA can be complex and difficult to understand in their entirety.
The requirements placed upon pharmaceutical wholesale distributors beginning November 2020, include the following:
- All saleable returns will need to be verified through an approved verification system before they’ll be allowed to be placed back into the wholesale distributor’s inventory or resold
- In the event that a pharmaceutical product is determined to be suspect, the wholesale distributor will be required to file Form FDA 3911 with the FDA
- In addition to this, manufactures and repackagers will be required to respond to all requests for verification of saleable returns with a 24-hour period
This last point, that manufactures and repackagers will be required to respond to verification requests within a 24 hour period, could prove to be challenging for wholesale distributors – simply because it’s going to require some legwork upfront to ensure that every manufacturer or repackager they work with is equipped to hold up their end of compliancy and that all systems are interoperable for easy and fast exchange of verifying information.
“ It’s estimated there are over 60 million pharmaceutical products returned to wholesale distributors for possible resale every single year.”
Preparing for Verification of Saleable Returns
The main component of the November 2019 deadline for wholesale distributors is the verification of saleable returns. It’s estimated there are over 60 million pharmaceutical products returned to wholesale distributors for possible resale every single year. When you stop and consider that each of those 60 million products will need to be verified, the scope of the November deadline for wholesale distributors suddenly becomes clearer.
The main challenge that wholesale distributors should be preparing for now is the need for fast and accurate verifications. If turnaround times begin to lag, this can create an insurmountable backlog of returns for wholesale distributors to deal with. Some key issues that distributors should be considering solutions for include:
- How to handle the inevitable discrepancies in data
- How to prepare their operations to integrate methods of verifying saleable returns that are acceptable under the guidelines of the DSCSA
- Choosing between the compliance options available, which include VRS, EPICS and phone or email verification, in which the distributor communicates directly with the manufacturer
- How to best time out their process for meeting the requirements of the verification deadline between now and November
- How to identify and handle grandfathered product that is exempt for the verification requirements
Looking Ahead to Industry Preparedness
While the FDA has worked to establish itself as a resource for wholesalers to depend upon as they work their way toward the November deadline, there is some concern that a lack of oversight and guidance on their part has created additional challenges and hurdles for wholesale distributors. As the next deadline approaches, we can see that there’s still a great deal of work on the horizon.
Traceability and serialization will have a significant impact on the processes and daily operations of pharmaceutical wholesale distributors. While there are challenges that need to be overcome, it’s important that distributors do what they can to move forward, past those challenges and onward toward complete compliance with the DSCSA come November. Small and mid-sized wholesale distributors may find it in their best interests to work with a traceability and verification systems solution provider who can help them navigate the more complex areas of the Drug Supply Chain Security Act.
Free VRS Evaluation
With the deadline fast approaching, contact TrackTraceRx today to receive a free evaluation of your VRS strategy to comply with the DSCSA Saleable Returns. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.