It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”). Let’s step back and look at where we have come and where we need to go.
On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch. They are required to:
This morning the FDA announced their intention to publish the long overdue draft guidance on Drug Supply Chain Security Act waivers, exceptions and exemptions tomorrow. The timing of the publication of this particular draft guidance is critical to the FDA holding their current enforcement deadline for serialization and verification for manufacturers and repackagers. In fact, if they had failed to meet their late May deadline for publication of this particular draft guidance Continue reading FDA To Publish Key Draft Guidance Tomorrow→
Last week I covered the likely impact of the recent draft compliance policy currently under a 60-day public comment period (see “DSCSA and RxTrace: The Song Remains The Same“). This week, I will take a look at its likely impact on downstream trading partners, including repackagers, wholesale distributors and dispensers.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.