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Chapter <797> Pharmaceutical Compounding—Sterile Preparations of the United States Pharmacopeia is a set of regulations that came into effect on January 1, 2004. These regulations, commonly known simply as USP <797>, cover a wide variety of topics concerning the compounding of sterile preparations, from the environmental controlled needed for the compounding area to procedures for proper labeling and storage of the preparations, and are enforceable by the US Food and Drug Administration and other organizations including State Boards of Pharmacy and JCAHO.


Clinical IQ, LLC, has been at the forefront of USP <797> since its inception, and offers a wide variety of services to pharmacies to assist in compliance with these regulations. Some of these services include:


  • Gap Analysis: On-site consultants will review your pharmacy operation, behaviors and practices of compounding personnel, environmental conditions and monitoring, labeling and storage procedures, and a number of other areas that are critical for the proper compounding of sterile preparations and therefore patient safety. From this on-site visit, a gap analysis and action plan can be created, comparing current practices against the requirements of USP <797> and items that need to be addressed in order to achieve compliance.
  • Plan Execution: In conjunction with a gap analysis, or based on existing action plans, we can assist in all of the steps necessary in order to make your operation fully compliant with USP <797>, including facility design and build consulting (described below).
  • Facility Design & Build Consulting: To assist in the renovation of an existing pharmacy operation, or in the development of a new pharmacy, we will work with you and your architects and engineers to create a set of design and performance criteria that will meet or exceed the requirements of state pharmacy regulations and USP <797>.
  • Training: A customized training program, whether on-site or online, can be developed in order to fully educate pharmacy personnel in any aspect of compounding sterile preparations, including aseptic technique, environmental monitoring, engineering controls, cleaning and disinfecting, and many more.

  • Policies and Procedure: We offer a wide range of policies and procedures that include both pre-written templates, which have been proven in both pharmacy and manufacturing operations, as well as custom documents for any type of operation.
If your organization is interested in any of these services, please contact us by phone or email.

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