By now, you’ve probably heard of the DSCSA. Since its passing in 2013, the act has been the talk of the industry as it continues to reshape the distribution landscape. However, because of the staggered roll out, varied enforcement dates, and multiple moving pieces, the DSCSA can be tricky. To help you keep track of the most important changes, we have mapped out the key things to know about the DSCSA in 2018 and beyond.
Background: Why was it created?
For the past 5 years, companies have been heads-down working on new processes and infrastructure to meet the requirements of the regulations. While hustling to adapt to a new system, it’s important to take a step back and remember the positive impact the act will have on the pharma industry. The DSCSA was created with a distinct goal in mind:
Through the pursuit of these objectives, the DSCSA is transforming the pharma industry, making it safer, more transparent, and more efficient. As the FDA enforces the regulations, the new system will:
- Facilitate the exchange of information by trading partners at the individual package level
- Improve efficiency of recalls
- Enable prompt response to suspect and illegitimate products when found
- Create transparency and accountability in the drug supply chain
What’s the timeline?
Though the DSCSA was enacted in November 2013, full implementation won’t be reached until 2023. To give companies ample time to comply, individual regulations are rolling out in stages over the course of the decade. To date, the timeline is:
What’s happening in 2018?
While manufacturers were required to serialize product in 2017, enforcement has been delayed until November 2018. By this date, manufacturers must add serial numbers to their products that can be read, identified, and tracked by the FDA.
However, serialization is far from simple and as the industry interprets the new regulation, companies are realizing unanticipated extra resources are necessary. For example, manufacturers must select a system that will create, share, and store their product’s unique serial numbers to allow verification/validation. The system must also support EPCIS exchanges between their CMOs and their down-stream trading partners.
What does this mean? Budgets and timelines must be accurately planned out far in advance to avoid last minute surprises and costly delays. Project management becomes key.
In 2019, wholesalers must trade only in serialized products and must validate saleable returns. This can be accomplished in two different ways.
The first option is for the manufacturer to send aggregated purchased unit data to the respective wholesaler’s system to build their own database. For this option, the FDA selected EPCIS (Electronic Product Code Information Services) to establish a standard data communication protocol which will be used by all data trading partners.
If they don’t use the first option, manufacturers must subscribe to the Verification Router Service (VRS). The HDA has established requirements to support a database query which will route serial number validation requests to the appropriate manufacturer serialization database. The catch? The VRS is currently in a testing phase and is not yet available.
Why should I bring in a DSCSA consultant?
In the pharma industry, so much relies on timing. Failure to comply with DSCSA regulations can result in expensive product delays. Unfortunately, not all of the regulations are easily interpreted, and there are still some major points of the DSCSA that need FDA clarification or final guidance. Researching the changes and interpreting how to comply takes valuable time – time that your team should be spending on product launch prep.
By working with a full service DSCSA consultant, you’ll have someone on your team who dedicates their time to understanding the regulations and creating tailored processes that ensure your company compliance.
Two Labs has launched a DSCSA Consulting Service to help companies navigate the uncharted DSCSA waters. To make the process as smooth as possible, our team works with clients to:
- Understand the regulations
- Develop implementation strategies
- Facilitate implementation testing
- Plan and manage projects and timelines
- Work with, and manage, data serialization vendors
By taking over the DSCSA management process, we free up your time to focus on things like product approval and launch. Click the button below to talk to one of our DSCSA experts about how we can help you.