Oklahoma Board of Pharmacy fines The Apothecary Shoppe $45,000

The Apothecary Shoppe, LLC, #2-6500 – Case No. 1376: Agreed to guilt on 1,892 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; 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 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; failing to routinely inspect, calibrate as necessary, and check to ensure proper performance of equipment used in the compounding of drug products; failure to have written procedures for the compounding of drug preparations; failure 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 January 20, 2021, and $45,000 fine

source Oklahoma Board of Pharmacy April 2016 Newsletter