DSCSA Provisions Delayed While Counterfeits Continue
There is still much to be done to get to the DSCSA’s vision of an electronic, interoperable system to trace pharmaceutical products | Catalyst Corner | By Marsha Millonig
Having just wrapped up the 2024 ASAP Annual Conference, readers who attended got the latest update on the Drug Supply Chain Security Act (DSCSA) from speaker Randy Hoggle. You may recall the DSCSA called for the creation of a uniform, national standard for tracing pharmaceuticals through the supply chain. Specifically, it outlined a timeline for implementing a new electronic interoperable system for product tracking and tracing over a 10-year period ending Nov. 27, 2023. According to the FDA, the new system would allow them to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
A National Prescription Drug “Track and Trace” System
The DSCSA was part of the Drug Quality and Security Act (DQSA) that was signed into law on Nov. 17, 2013. The DQSA’s purpose was to address issues related to drug compounding oversight, and incorporates a national prescription drug “track and trace” system inclusive of standards for prescription drug wholesale distributors and third-party logistics (3PL) providers. The DQSA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act ). Title 1 of the DQSA addresses the compounding provisions through the Compounding Quality Act (CQA). The impetus behind the CQA was contaminated compounded drugs that led to the death of more than 60 people and infected more than 750 patients in the fall of 2012. Title 2 of the DQSA is the DSCSA.
The key provisions that were to be implemented by 2023 are requirements for:
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