Monday, October 10, 2016

Oklahoma Board of Pharmacy takes action against PPM Pharmacy--Pharmacy admitted guilt to 1,279 courts and fined $125,000

PPM Pharmacy, #1-6190 – Case No. 1407: Admitted to guilt on 1,279 counts including manufacturing without a license; failing to dispense only those prescription drugs legal to sell in the United States; failing to purchase prescription drugs only from entities licensed to sell such drugs; compounding sterile preparations without having a sterile compounding preparation pharmacy permit; failing to train all individuals who compound sterile preparations; failing to conduct annually for every individual involved in sterile preparation compounding testing involving media challenge tests; failing to require personnel to follow proper procedures for personnel cleansing and garbing prior to compounding and maintain proper competency of aseptic work practices; failing to do routine disinfection and air quality testing of the direct compounding environment; failing to use total aseptic techniques; failing to do sterility testing (bacterial and fungal), bacterial endotoxin (pyrogen) testing, and testing to ensure that they are of labeled potency when preparing high-risk level CSP; 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; and failing to prepare hazardous drugs within a certified Class II, Type A (exhaust may be discharged to the outdoors) or Class II, Type B (exhaust may be discharged to the outdoors) laminar flow biological safety cabinet. $125,000 fine. License placed on probation for five years until June 15, 2021.

source Oklahoma Board of Pharmacy October 2016 Newsletter

No comments: