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Understanding Wholesaler Serialization Requirements

Wholesaler serialization requirements have been looming for quite some time, even more so given the Drug Supply Chain Security Act (DSCSA) enforcement delay last year. The DSCSA consists of two major elements – product serialization and traceability. Since January 1st, 2015, wholesale distributors have been complying to the product traceability aspect of serialization.

By November 27th, 2019 wholesale distributors will face additional requirements which could impact how wholesalers purchase goods and their inbound / outbound shipping processes. How are you preparing for the imminent impacts?

Impacted Processes of Wholesaler Serialization Requirements

Sales Process
Beginning November 27th, 2019 wholesalers are only able to buy products which are encoded with a unique identifier. As a wholesaler, if product is received at the dock after November 27th, 2019 that does not meet the manufacturing requirements of DSCSA, the product will have to be returned to the manufacturer to be reworked. Otherwise, the wholesaler could face legal ramifications for transmitting non-serialized product, not to mention potential loss of customers.

Inbound Delivery
In a serialized world, wholesalers must be prepared to verify the inbound product at the package level, including the standardized identifiers – GTIN and Serial Number.  To do so, wholesalers must be equipped with handheld scanners which are integrated into their serial number management repository.

To add a level of complexity, there will be some cases such as grandfathering and exemptions that will require wholesalers to accept both serialized and non-serialized product. Wholesalers will likely have to have multiple inbound processes that employees will need to follow when accepting an inbound delivery.

Outbound Shipment
When an order is placed from a dispenser and the wholesaler is ready to ship, the wholesaler will be required to provide tracing information to their downstream supply chain partners via EDI or L4 connectivity.

Meeting Wholesaler Serialization Regulations

There is no better time to prepare for serialization than today. As discussed in our previous blog, How a Wholesale Distributor Can Launch a Serialization Pilot that Drives Return, a great first step is initiating a serialization pilot / program. A few key things on wholesaler serialization requirements to consider:

  1. Technology – The implementation of a serialization solution can be a rather large undertaking and take months to complete. If you haven’t already, start with selecting your L4 vendor and putting your implementation timeline in place.
  2. Equipment – You will likely need to purchase or upgrade some of the equipment on your shop floor. Start by doing an assessment on what is out of date and what will need to be upgraded or replaced.
  3. Process – The introduction of serialization will also introduce a handful of new scenarios to accept and release products. Understand what these new processes are and document what the to-be state looks like.
  4. People – With new regulations, equipment, technology, and processes, your people will require training and change management to get them comfortable with life in a serialized world.

With November 27th, 2019 just around the corner, wholesalers should be underway with serialization initiatives as soon as possible, if they haven’t already begun. As we get closer to the DSCSA deadline, wholesale distributors will start to see more and more serialized product landing on their docks, affording the opportunity to define processes and impacts to operations with no risk of noncompliance, yet.

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Co-author Megan Weldon.

Tags: Serialization & Traceability
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