Oklahoma Board of Pharmacy takes action against pharmacists for problems relating to compounding and 797

David Kent Johnson, DPh #13429 – Case No. 1377: Agreed to guilt on 1,887 counts; neither admits nor denies guilt on five counts including failing to supervise all employees as they relate to the practice of pharmacy; failing to comply with all aspects of USP compounding standards; failing to mix, prepare, and otherwise manipulate, count, crush, compound powders, or pour liquid hazardous drugs inside a ventilated cabinet designed to prevent hazardous drugs from being released into the work environment; failing to verify all critical processes; failing to ensure appropriate stability evaluation is performed; failing to have available written policies and procedures for all steps in the compounding of preparations; failing to train and evaluate staff by using media-fill challenge tests to evaluate sterile technique; compounding a drug preparation that is commercially available in the marketplace or that is essentially a copy of an available FDA-approved drug product; failing to use total aseptic techniques; failing to establish procedures for sterilization of all preparations compounded with any nonsterile ingredients; failing to test all high-risk level compounded sterile preparations (CSPs) for administration by injection; failing to establish procedures for semiannually testing the techniques of pharmacists using simulated aseptic procedures; failing to have a controlled limited access area that has a certified and inspected ISO Class 5 environment that is inspected and certified semiannually; failing to routinely inspect, calibrate as necessary, and check to ensure proper performance of automated, mechanical, electronic, limited commercial scale manufacturing or testing equipment; failure to use USP–NF drug substances and inactive components that have been made in an FDA-registered facility; failure to have written procedures for the compounding of drug preparations to ensure that the finished preparations have the identity, strength, quality, and purity they purport to have; failing to assign the correct BUDs for CSPs; and failing to maintain a ratio of no more than two pharmacy technicians per supervising pharmacist on duty. Five years’ probation until December 3, 2020, and $5,000 fine. Shall attend an eight-hour law seminar in addition to the required 15 hours of CE during the calendar years 2016 and 2017. All 15 hours of required CE that respondent must have to renew his license shall be live during his five years of probation. Respondent shall provide documentation of recently completed training in compounding under USP <797> guidelines. Respondent shall attend and provide the Board with proof of biannual training under USP <797> guidelines for five years until December 3, 2020.

source Oklahoma Board of Pharmacy April 2016 Newsletter