USP 797
- Certification Submission Form - March 2025
- Inspection Form - February 2024
- Sterile Compounding Complex (SCC) Inspection Document List - Please use this document to prepare for your Sterile Compounding inspection.
Designated Pharmacist - Pharmacist responsible for overseeing the compounding of sterile pharmaceuticals and the application of the USP chapters, as said chapters pertain to sterile compounding.
- The Designated Pharmacist in a licensed pharmacy or an institutional pharmacy must notify the department when they commence or cease being the designated pharmacist via email to DCP.PharmacistLicense@ct.gov.
- The Designated Pharmacist must satisfactorily complete training, in the following areas (training may be obtained from different programs):
- Fundamentals of sterile compounding
- Facility design and engineering controls
- Maintaining quality of the sterile compounding environment
- Non-hazardous and hazardous sterile compounding
- Personnel sampling
- Viable sampling
- Aseptic Technique
- Documentation (master formulation records and compounding records)
- Equipment
- Below are courses that have been approved. If you have a course that you would like to submit for approval please, send the course to DCP.DrugUSPcompounding@ct.gov with all pertinent information. It is the responsibility of the individual designated pharmacist to acquire the appropriate number of hours from the areas outlined above and maintain a records of the courses that have been completed.
- Essential Elements of Compounded Sterile Preparations (LP3 Network) - ACPE number 0864-9999-18-047-H07-P/T
- Sterile Compounding eLearning Course Curriculum 29 lessons with 34.5 hours of CE
- (New) Compounded Sterile Preparations Certificate for Pharmacists - American Society of Health-System Pharmacists
For questions and reporting USP related issues please email DCP.DrugUSPcompounding@ct.gov.
Non-Sterile Compounding
USP 795
Inspection Form Version 1 September 2015 - Please use this form as a reference for our inspection of your facility.
For questions and reporting USP related issues please email DCP.DrugUSPcompounding@ct.gov.
For information about USP 795, USP 797, and USP 800 or official copies of the chapters please go to the USP website.