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USP Chapter <797>

Effective on January 1, 2004 a standard on compounding sterile products (USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations) was established.  These stringent guidelines detail the following 12 domains of quality necessary for compounding sterile preparations:

  • Compounding conditions
  • Quality Assurance programs and practices
  • Contamination risk levels
  • Outcome monitoring
  • Reports and documentation
  • Personnel garb
  • Education and training
  • Evaluation
  • Storage and handling in the pharmacy
  • Process validation
  • End product sterility
  • Identity testing

AnazaoHealth Corporation is unique.  Unlike other compounding pharmacies, upon the institution of USP Chapter <797> Regulations in January 2004, we were already working at this level of compliance.  No restructuring was necessary in order to continue filling high risk preparations.  Our validated compounding methods meet or exceed the standards of USP Chapter <797> and are used to ensure the sterility and quality of all finished preparations. Specifically, our quality program includes the following:

  • Our state-of-the-art facility houses one of the largest clean rooms available for high-risk compounding that meets or exceeds the USP Chapter <797> guidelines.
  • Our ISO Class 7 clean room has multiple High Efficiency Particulate Air (HEPA) filters.
  • Certified Laminar Flow Hoods.
  • All powders received are received from FDA registered manufacturers or suppliers.
  • All powders are accompanied by a certificate of analysis and material data safety sheet.
  • Our preparations undergo pyrogen and sterility testing. Sterile preparations are tested by an independent lab to ensure its identity using High Performance Liquid Chromatography (HPLC).
  • Drug Utilization Review (DUR) is performed.
  • All preparations are prepared by qualified media-fill personnel.
  • We conduct routine environmental microbiological testing and strictly adhere to aseptic technique guidelines. Our pharmacy environment meets or exceeds ASHP Risk Level III guidelines and USP High Risk Sterile Compounding guidelines

AnazaoHealth Corporation is proud to have met the challenge of USP Chapter <797>.  This standard helps to protect the patient and ensures pharmacy quality standards.  We encourage you to speak with your current provider of high-risk sterile preparations and put them to the same challenge.  If your current provider is unable to comply with the strict standards of USP Chapter <797>, we stand ready to meet your high-risk compounding needs.  Please do not hesitate to give us a call at 1-800-995-4363, Ext. 1 to obtain a copy of our latest Sterile Products Pharmacy Quarterly Summary Report which outlines our performance against the USP Chapter <797> standards

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