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503 Compounding: Challenges, Compliance & the Road Ahead
Manage episode 482542117 series 2807097
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In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies. Together, they explore the critical role compounders play in personalized medicine, their differences from traditional pharmaceutical manufacturers, and the increasing regulatory scrutiny they face—especially 503B outsourcing facilities.
The discussion covers:
- The origins and types of compounding pharmacies (503A vs. 503B)
- Regulatory challenges post-New England Compounding Center crisis
- Key compliance hurdles including aseptic processing and FDA inspections
- Practical advice for both new and established compounders to stay compliant
Whether you're entering the compounding space or navigating the latest compliance expectations, this episode offers timely insights and actionable guidance.
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