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What to Expect DURING the Inspection for 503A and 503B Compounding Pharmacies

Learning Objectives:
– Describe FDA’s process and procedures for inspecting compounding facilities
– Name what FDA inspectors are permitted to inspect and, by law, what they are not permitted to inspect
– Outline how staff should interact with FDA during the course of an inspection and the problems that pharmacy staff can experience when dealing with FDA inspectors in a high-stress situation

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Above and Beyond USP Chapters <795> and <797>

“There are many reasons why you should design an environmental monitoring program for your 503A that exceeds USP <797>,” said Tenille Davis, PharmD, BCSCP, the pharmacist-in-charge at Civic Center Pharmacy, in Scottsdale, Ariz., during a session on “quality built in” at the 2021 Compounding Pharmacies Grand Salon, held virtually. “First, it improves patient safety; but also, it comes closer to what the FDA is looking for during inspections. Some observations on 483s issued by the FDA are beyond <797> requirements. Knowing what the FDA would like to see can help you build a more robust program and give you more control of your space, which improves patient safety.”

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LiveStream Salon:

Compounding Pharmacies: Achieving Quality through Processes and Procedures

August 18, 19, 20

2020

Event Info
  • 3 full days of learning with playback options for revisiting key points
  • 7 round table discussions every day for enhanced peer learning
  • 5 concrete take-aways for immediate implementation
  • 25 Faculty members to learn from and exchange ideas with
  • 12 ACPE Credits
LiveStream Salon:

Coming Soon

TBA

2020

Event Info

TBA

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