28 Aug Verify Brand’s Takeaways from the FDA’s Public Meeting Regarding DSCSA
On Wednesday, August 23, the FDA held a meeting titled “Enhancing Drug Distribution Security under the Drug Supply Chain Security Act (DSCSA).” This was the first of three public meetings, the next two taking place on December 5-6 and February 28. These meetings allow members of the drug distribution supply chain to discuss strategies and speed bumps related to the enhanced drug distribution security provisions of the DSCSA.
Wednesday’s meeting specifically addressed the overall vision for 2023 and the enhanced drug distribution security needs related to tracing prescription drugs at the package level.
The meeting was a great start to a long discussion about topics including:
- How will the 2023 system and processes protect and enhance public health?
- In what ways can the system and processes be used to prevent, detect, and respond to suspect and illegitimate products?
- What are the roles of manufacturers, wholesalers, repackagers, dispensers, FDA, and others in the 2023 systems and processes?
- What do we need to do to improve the efficiency of the supply chain?
- What do we need to do to increase the security of the drug distribution supply chain? (e.g., improve efforts regarding verification products and authorized trading partners, prevention of the distribution of illegitimate product, investigation of suspect and illegitimate product, initiation, and termination of notifications)
- What do we need to do to ensure the security of the 2023 system? (e.g., data security, authorized access)
As logistics are getting smoothed out, and questions are being asked, the existing parts of DSCSA are still in effect. We’d like to remind pharma companies that haven’t selected a serialization software provider to keep moving forward with their selection process. Due to our proven platform and global experience, Verify Brand’s serialization and traceability software can help pharma companies comply with government regulations—quickly, easily and affordably—while gathering data insights that create a smarter supply chain.
If you have already selected a provider, take this time to carefully assess whether your serialization software solution vendor is meeting your needs. If you’re unhappy with your provider because of connection challenges, poor customer support or hidden fees, we encourage you to evaluate other providers and replace underperforming vendors to mitigate the risk of missing FDA deadlines.
As the fastest growing serialization software in pharma, Verify Brand is looking forward to helping pharma companies achieve compliance and ensure they have an electronic, interoperable system by 2023 that can trace pharmaceuticals as they are distributed within the U.S. and, more importantly, protect consumers from exposure to harmful drugs that may be counterfeit, diverted, stolen, or tampered with.
Learn about our risk-free, standards-based platform and request a demo today.