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
quoted from July 2017 Oklahoma Board of Pharmacy Newsletter
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