"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failure to remove all outdated prescription drugs from the active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
quoted from July 2017 Oklahoma Board of Pharmacy Newsletter
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