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Tuesday, July 11, 2017

Amerita, #2-7746 – Case No. 1453: Admitted guilt on 18 counts and pled nolo contendere to six counts relating to compounding; $36,000 fine and placed on probation for five years until March 29, 2022

Amerita, #2-7746 – Case No. 1453: Admitted guilt on 18 counts and pled nolo contendere to six counts including failure to comply with all aspects of USP compounding standards; failing to have available written policies and procedures for all steps in the compounding of preparations; failure to establish procedures for yearly testing the techniques of pharmacists using simulated aseptic procedures; failing to routinely inspect, calibrate as necessary, and check to ensure proper performance of equipment used in the compounding of drug products; failing to train all individuals who compound sterile preparations; failure to comply with all applicable federal, state, and local law and regulation concerning pharmacy; failing to require personnel to follow proper procedures for personnel cleansing and garbing prior to compounding; failing to do routine disinfection and air quality testing of the direct compounding environment; failure to install a pressure gauge or velocity meter to monitor the pressure differential or airflow between the clean room and the general environment outside the compounding area; failing to establish and maintain effective controls to prevent prescription errors; failing to ensure that only authorized personnel are in the immediate vicinity of the drug compounding operation; failing to require personnel to follow proper procedures in the cleaning and disinfection of sterile compounding areas; failing to have compounding equipment that is of suitable composition; failing to ensure the proper maintenance, cleanliness, and use of all equipment used in a prescription compounding practice; failing to have equipment used in the compounding of drug preparations that is of appropriate design and capacity; and failure to have a pharmacy manager who is responsible for the development and/or implementation of a pharmacy technician training program. $36,000 fine and placed on probation for five years until March 29, 2022. All pharmacists and pharmacy technicians currently employed by or hired by respondent before March 29, 2017, shall be trained in sterile compounding by a Board-approved entity by September 29, 2017. Every three months of the first year and every six months of the remaining four years that respondent is on probation, all of respondent’s employees doing sterile compounding shall pass fingertip glove tests, media fill tests, and competency tests. At all times during the compounding process, a pharmacist must be garbed and present inside the sterile compounding room. All sterile compounding lab areas shall be ISO-certified biannually.

quoted from July 2017 Oklahoma Board of Pharmacy Newsletter