Update: 6 Things We Need from FDA on DSCSA
In early 2021, we authored an industry opinion article to share thoughts on things that the FDA should consider as the final requirements of DSCSA 2023 fast approach. Please check out the original article through this link:
With the final months of that timeline winding down, we felt it was important to share a few updated thoughts. We realize there is a significant amount of DSCSA groups and events going and we welcome any comments or additional points that peers feel are important to highlight. We appreciate the work that the FDA and other regulatory groups do on a daily basis to help keep the supply chain and patients safe and hope to help provide some insights since we work with clients across the supply chain on DSCSA implementation.
While the FDA has been busy with updating guidance documents, speaking at industry conferences and all their normal activities, we have not seen the level of activity that we feel is needed to help avoid some fast approaching risks for DSCSA implementation and continued movement of safe prescription drugs.
- Develop a Clear Timeline to 2023 with the Industry- While the FDA did hold public meetings and hear thoughts from groups on possible approaches to timelines, we did not see any clarity provided to guide the industry. We did see some good activities on this topic from solution providers working together through groups like GS1, PDG, NABP and HDA that provided some informal outlines that many in the industry have been working towards around implementation of integrated testing and updated standards.
- Solidify Requirements for Minimal Compliance- This area also remains unclear as most in the industry are awaiting updated or finalized guidance for Enhanced Drug Distribution at the Package Level. Several industry trade groups and alignment related organizations did develop a website at DSCSA.pharmacy to help dispensers and other stakeholders understand basic DSCSA requirements which continues to have new material added.
- Encourage Innovation- This area has seen activity in groups working on alignment of various aspects of DSCSA. NABP has conducted significant work to help bring together state regulators, trading partners from across the supply chain, solution providers and FDA observers. The results of these pilots and proof of concept have led to the recent announcement of the Pulse by NABP platform to allow better connectivity across the supply chain especially in the transactions beyond trading partner to trading partner with product shipment related interactions. Other groups and solution providers have continued to innovate on various areas of DSCSA. While much of the activity has been positive, it has created some challenges on ensuring the industry is focused on the most pressing needs of basic DSCSA understanding and data exchange to allow product to move as NABP highlighted in a recent blog post.
- Grandfather Transaction History Data (now known as Transitory Inventory/Processes)- This is potentially the most pressing issue for the FDA to address, as not having the initial commissioning event record from the manufacturer of record could prevent trading partners from sending serialized EPCIS data or responding to future product trace requests. This issue was highlighted by almost every group that provided feedback and comments in the last FDA DSCSA Public Meeting. If unaddressed, it could cause a massive issue in product availability if trading partners are not clear on the ability to continue to move otherwise safe product. Some recent presentations at the HDA DMC event have highlighted a suggestion from the industry to consider allowing trading partners to perform "Pseudo Commissioning" which needs further industry consideration but is one of the only provided thoughts on solutions.
- Be Flexible Regarding Exception Handling- The FDA has not yet commented beyond previous guidance highlighting the need for trading partners to work to resolve any data exception or clerical errors before product is allowed to move further. This topic has gotten considerable attention in recent months and GS1, HDA and PDG conducted a workshop and mentioned further work to help the industry continue the conversation.
- Engage the Dispenser Community- Much has been done on this topic but still much work remains to help bring the large and diverse dispenser community up to speed. The FDA continues to participate in webinars and CE events with dispenser industry groups such as a recent one held by APhA and NABP. As mentioned on point 1, DSCSA.pharmacy has become a central place for dispensers to find education and latest information.
The most critical factor in all our implementation efforts as an industry is the spirit of collaboration as we focus on the activities needed to help make the US Supply Chain even safer for generations to come. We remain hopeful that the FDA will continue to expand activity and work to help the industry ensure the continue movement of life-saving prescription drugs and welcome further thoughts on any points or activities we may have missed.