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What types of standards must my pharmacy meet?

As we evaluate your pharmacy’s compliance to our comprehensive set of practice standards, we confirm adherence to operational regulatory requirements, licensure, quality assurance practices, and compounding-specific requirements. 

Compounding pharmacies must be in alignment with all applicable USP sections and FDA 503A requirements:

  1. A pharmacy performing non-sterile compounding must comply with the current USP <795> chapter;
  2. A pharmacy performing sterile compounding must comply with the current USP <797> chapter;
  3. A pharmacy performing hazardous drug compounding must comply with applicable sections of USP <800>.