USP 795, 797 & 800 Compliance

EOC1 offers testing, certification and validation to meet USP standards.  We provide these services for over 600 customers through-out the United States and Internationally. We provide certification of your Primary and Secondary Engineering Controls as well as your USP Employee Validations.  In addition, we also provide Viable Air and Surface Sampling as well Hazardous Drug Sampling to meet USP standards and requirements of other organizations such as State Boards of Pharmacy and JCAHO.

USP


USP <797> - Compounding Sterile Preparations

The U.S. Pharmacopeia has implemented USP 797 to control the compounding and administration of pharmaceutical products in the United States. The regulations comprising USP <797> are intended to protect patients by preventing the contamination of compounded sterile preparations.   

USP <800> - Hazardous Drugs – Handling in Healthcare Setting

Chapter USP 800 has also been promulgated to protect patients and pharmacy personnel from exposure to hazardous drugs as part of compounding.  Hazardous drugs include categories such chemotherapy, hormones and antiviral drugs as well as others.  EOC1 can provide the required USP <800> sampling for hazardous drugs.

USP <795> - Non-Sterile Pharmaceutical Compounding

Although USP <795> relates to non-sterile compounding with little specifications around environmental controls, many non-sterile compounded drugs may fall under USP <800> specifications for hazardous drug compounding.  Understanding the differences in drug compounding in reference to sterile, non-sterile and hazardous compounding is important in concept and application.

CETA Logo

EOC1 is involved with the Controlled Environment Testing Association (CETA).  Our association includes CETA Membership, Registration, National Board Testing, Application Guide Development and Working Groups.

Contact us online or call 404.806.0927 to discuss your specific needs and to schedule service.

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