Responding to Compounding Pharmacy Inspections - Webinar CD/Transcript
Responding to Compounding Pharmacy Inspections
The FDA is looking to shed light on the sometimes murky rules governing compounding operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations.
In April 2016 the agency released three draft guidances addressing multiple facets of the compounding industry including: what constitutes a large-scale compounding facility… associated GMP requirements… standards for hospital compounding… and requirements for compounding without a prescription.
All three guidances emphasize that all products manufactured by outsourcing facilities must comply with GMP rules or be deemed in violation.
If you want to know how these guidances might affect your company, plan on listening to Responding to Compounding Pharmacy Inspections. This 90-minute session will:
- Identify the latest areas of FDA enforcement in compounding pharmacies
- Compare requirements of 503A (traditional compounder) and 503B (outsourcing facility)
- Review USP 797 vs. GMP requirements
- Identify the constitution of your core FDA Inspection Team
- Allow you to create the outline of an appropriate FDA response
Order today and be informed about compounding facility inspections.