Time is Running Out
A look at the calendar tells us that summer is drawing to a close, and while that means trying to sneak in those last few bits of summer fun and recreation, wholesalers in the pharmaceutical industry are focused on something a bit more serious. This coming November, just a few short months away, we’ll meet the next deadline of the Drug Supply Chain Security Act. The coming November deadline is focused on wholesalers and their responsibility to protect consumers through the traceability and serialization standards outlined within the DSCSA.
“the clock is ticking on wholesalers, making it important to look at where wholesalers are in regard to meeting the deadline, what pain points they’re currently experiencing, and the FDA’s roles in aiding in the smoothest transition possible for affected drug supply chain trading partners. ”
Understanding What the November Deadline Means for Wholesalers
The November deadline for wholesaler serialization and traceability requirements has been looming for some time, meaning there shouldn’t be too many surprises about what’s expected of wholesalers this fall. The industry has been amping up for this ever since last fall’s deadline – which was originally set for 2017 but was granted a one-year extension.
The November 27, 2019 deadline for wholesalers represents one of the final steppingstones of the DSCSA. Once this deadline has passed, the only major milestones that remain will be the authentication and verification standards deadline for dispensers next year and complete unit level traceability and aggregations throughout the entire pharmaceutical supply chain in 2023.
That said, the clock is ticking on wholesalers, making it important to look at where wholesalers are in regard to meeting the deadline, what pain points they’re currently experiencing, and the FDA’s roles in aiding in the smoothest transition possible for affected drug supply chain trading partners.
As of November 27, 2019, wholesale distributors in the pharmaceutical supply chain will need to meet additional requirements that center on both their inbound and outbound shipping processes. For instance, wholesalers must be prepared to identify and verify all incoming product at the package level using standardized identifiers. This requires wholesalers to adopt the use of specialized equipment, if they have not done so already.
Concerning outbound shipments, wholesalers must be able to provide complete tracing information to any dispenser whom they transfer or sell products to. Additionally, there are grandfathered exemptions that need to be taken into consideration that compound the complexity of their authentication and verification standards. At this point, wholesalers may be required to have multiple processes in place for processing serialized and grandfathered product, at least initially.
Where Are Wholesalers in Preparing for the Upcoming DSCSA Deadline?
Wholesalers have had the advantage of not being one of the first sectors of the drug supply chain required to meet a full scope of regulatory standards. The ability to view the trial and error of trading partners that have went before them can be considered an asset. Not only have some of the major glitches of the past been anticipated and worked out, we’ve all learned something by watching manufacturers and repackagers work towards their deadline goals.
That’s not to say that meeting the November deadline will be seamlessly easy for every wholesaler. Wholesalers are still in the position of adopting new technology and streamlining their operational processes for maximized efficiency. There’s an incredibly amount of training looming ahead for many wholesalers.
At this point, wholesalers should be reasonably close to meeting the requirements of the DSCSA, if not already on board for complete compliancy. November might seem like it’s still a ways in the future, but we’re all too well aware of how quickly time passes, especially in the midst of adapting to requirements that demand massive restructuring for some wholesalers.
As we usher into fall, there are a few key areas that wholesalers should really be focusing their attention on, including new technology. The FDA has been implementing pilot programs looking for interoperable solutions that streamline the serialization and traceability, along with easing communication among trading partners. Wholesalers have the responsibility of looking at which technological solutions are currently available and assessing which ones meet their needs. This is a costly venture, and one that should be well under way for all wholesalers.
The next area of focus for wholesalers is equipment. With standardized identifiers on pharmaceutical products, wholesalers require equipment that can scan, identify and verify each identifier. Wholesalers should be in the process of assessing which equipment will need to be replaced or upgraded to ensure full compliancy come November.
Next, we come to operation procedures and processes. The changes brought about by the DSCSA is sure to bring with it unavoidable changes in processes and procedures for wholesalers. This includes processes for accepting incoming shipments, providing the proper documentation for outcoming shipments, and preparation for additional scenarios – such as how suspicious products will be handled at the wholesaler level.
Finally, one of the most important adaptations that wholesalers should be looking at as the November deadline draws closer is how all these changes will impact their workforce. There are multiple layers of complexity to the wholesaler requirements under the DSCSA. It’s key that wholesalers are looking at their workforce to determine where the need for training exists and whether their current workforce has the capabilities to navigate the initial changes as they are put into place. Now is the time for wholesalers to determine whether there is a need to bring additional workers, possibly with specialized skills in technology and equipment, to handle the transitions.
Serialization Solutions for Every Trading Partner Within the Drug Supply Chain
The Drug Supply Chain Security Act has demanded major change and refocus throughout the pharmaceutical supply chain in the United States. The end goal is to protect the consumer, however the process for reaching that goal is complex and filled with challenges.
