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Tuesday, July 11, 2017

"Noble Pharmacy,  #7-2595 – Case No. 1443: Admitted guilt on 217 counts relating to compounding; $32,550 fine and placed on probation for five years until March 29, 2022."

"Noble Pharmacy,  #7-2595 – Case No. 1443: Admitted guilt on 217 counts including failing to comply with all applicable federal, state, and local law and regulation concerning pharmacy; failing to have available, follow, and retain written policies and procedures for all steps in the compounding of preparations; failing to routinely inspect, calibrate as necessary, or check to ensure proper performance of equipment used in the compounding of drug products; failing to assign every compounded preparation an appropriate beyond-use date (BUD); failing to label any excess compounded preparation; failing to train every individual who prepares compounded preparations; failing to administer a written test on material referenced in OAC 535:15-10-3 and to require that this test be passed by staff preparing compounded preparations upon initial hire or prior to assignment to compound preparations; failing to test annually every individual involved in compounding preparations; failing to train and evaluate staff by using media-fill challenge tests to evaluate sterile technique; failing initially and at least annually to train and evaluate staff using glove fingertip sampling processes; failing to require personnel to follow proper procedures for personnel cleansing and garbing prior to compounding; failing to handle and store drug product containers and closures in a manner to prevent contamination; failing to establish procedures for sterilization of all products prepared with any nonsterile ingredients; failing to comply with all aspects of USP compounding standards; failing 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failing to include on the prescription label for a compounded prescription BUD and storage; and failure to remove all outdated prescription drugs from the active inventory area upon expiration. $32,550 fine and placed on probation for five years until March 29, 2022."

quoted from July 2017  Oklahoma Board of Pharmacy Newsletter
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