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
source Oklahoma Board of Pharmacy October 2016 Newsletter
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