Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Friday, April 1, 2016
Oklahoma Board of Pharmacy takes action against pharmacists for problems relating to compounding and 797
David Kent Johnson, DPh #13429 – Case No. 1377: Agreed
to guilt on 1,887 counts; neither admits nor denies guilt on
five counts including failing to supervise all employees as
they relate to the practice of pharmacy; failing to comply
with all aspects of USP compounding standards; failing
to mix, prepare, and otherwise manipulate, count, crush,
compound powders, or pour liquid hazardous drugs inside a
ventilated cabinet designed to prevent hazardous drugs from
being released into the work environment; failing to verify
all critical processes; failing to ensure appropriate stability
evaluation is performed; failing to have available written
policies and procedures for all steps in the compounding
of preparations; failing to train and evaluate staff by
using media-fill challenge tests to evaluate sterile technique;
compounding a drug preparation that is commercially available
in the marketplace or that is essentially a copy of an
available FDA-approved drug product; failing to use total
aseptic techniques; failing to establish procedures for sterilization
of all preparations compounded with any nonsterile
ingredients; failing to test all high-risk level compounded
sterile preparations (CSPs) for administration by injection; failing to establish procedures for semiannually testing the
techniques of pharmacists using simulated aseptic procedures;
failing to have a controlled limited access area that
has a certified and inspected ISO Class 5 environment that
is inspected and certified semiannually; failing to routinely
inspect, calibrate as necessary, and check to ensure proper
performance of automated, mechanical, electronic, limited
commercial scale manufacturing or testing equipment;
failure to use USP–NF drug substances and inactive components
that have been made in an FDA-registered facility;
failure to have written procedures for the compounding of
drug preparations to ensure that the finished preparations
have the identity, strength, quality, and purity they purport
to have; failing to assign the correct BUDs for CSPs; and
failing to maintain a ratio of no more than two pharmacy
technicians per supervising pharmacist on duty. Five
years’ probation until December 3, 2020, and $5,000
fine. Shall attend an eight-hour law seminar in addition
to the required 15 hours of CE during the calendar
years 2016 and 2017. All 15 hours of required CE that
respondent must have to renew his license shall be live
during his five years of probation. Respondent shall
provide documentation of recently completed training
in compounding under USP <797> guidelines. Respondent
shall attend and provide the Board with proof of
biannual training under USP <797> guidelines for five
years until December 3, 2020.
source Oklahoma Board of Pharmacy April 2016 Newsletter
source Oklahoma Board of Pharmacy April 2016 Newsletter
Oklahoma Board of Pharmacy takes action against pharmacist for a number of issues, including compounding a drug product that is commercially available in the marketplace; compounding preparations to be given or sold for resale by prescribers or other persons; failing to prepare and review all compounding records to ensure that no errors have occurred in the compounding process; failing to have written procedures for the compounding of drug preparations; failing to document a listing of the components, the order of component mixing, and a description of the compounding process; failing to label any excess compounded preparation; failing to follow written procedures in the execution of the compounding procedure; failing to accurately weigh, measure, and subdivide, as appropriate, components; failing to retain any procedures or other records required to comply with USP compounding standards
Michael Brent Moore, DPh #10778 – Case No. 1373:
Neither admits nor denies guilt on 300 counts including failing
to establish and maintain effective controls against the
diversion of prescription drugs; failing to oppose any secret
arrangement between pharmacist and physician whereby
fees are divided; filling a CDS prescription that did not contain
the name, address, and DEA number of the practitioner,
the date of delivery of the prescription, the name, dosage,
and strength per dosage unit, the name and address of the
patient, the directions for use and, if allowable, the number
of refills; filling a written prescription for a Schedule III,
IV, or V drug transmitted by facsimile that was not signed
by the prescribing practitioner; filling a written prescription
that was not signed by the practitioner; failing, as pharmacy
manager, to be responsible for all aspects of the operation
related to the practice of pharmacy; filling or refilling a
prescription without authorization; compounding a drug
product that is commercially available in the marketplace; compounding preparations to be given or sold for resale by
prescribers or other persons; failing to prepare and review
all compounding records to ensure that no errors have occurred
in the compounding process; failing to have written
procedures for the compounding of drug preparations; failing
to document a listing of the components, the order of
component mixing, and a description of the compounding
process; failing to label any excess compounded preparation;
failing to follow written procedures in the execution
of the compounding procedure; failing to accurately weigh,
measure, and subdivide, as appropriate, components; failing
to retain any procedures or other records required to comply
with USP compounding standards; and failing to ensure that
all tasks performed by pharmacy technicians are performed
under the immediate and direct supervision of a pharmacist.
Suspended for 100 days until April 29, 2016. Probation
for 10 years from April 30, 2016, to April 29, 2026.
$105,000 fine. May not work as PIC during probation.
Shall attend a one-day (eight-hour) law seminar in addition
to the required 15 hours of CE during the calendar
years of 2016, 2017, and 2018. All 15 hours of required
CE that respondent must have to renew his license shall
be live during the years 2016, 2017, and 2018.
source Oklahoma Board of Pharmacy April 2016 Newsletter
source Oklahoma Board of Pharmacy April 2016 Newsletter
Oklahoma Board of Pharmacy fines The Apothecary Shoppe $45,000
The Apothecary Shoppe, LLC, #2-6500 – Case No. 1376:
Agreed to guilt on 1,892 counts including failing to supervise
all employees as they relate to the practice of pharmacy;
failing to comply with all aspects of USP compounding
standards; failing to mix, prepare, and otherwise manipulate,
count, crush, compound powders, or pour liquid hazardous
drugs inside a ventilated cabinet designed to prevent hazardous
drugs from being released into the work environment;
failing to verify all critical processes; failing to ensure appropriate
stability evaluation is performed; failing to have
available written policies and procedures for all steps in the
compounding of preparations; failing to train and evaluate
staff by using media-fill challenge tests to evaluate sterile
technique; compounding a drug preparation that is commercially
available in the marketplace; failing to use total aseptic
techniques; failing to establish procedures for sterilization of
all preparations compounded with any nonsterile ingredients;
failing to test all high-risk level CSPs for administration by
injection; failing to establish procedures for semiannually
testing the techniques of pharmacists using simulated aseptic
procedures; failing to have a controlled limited access area
that has a certified and inspected ISO Class 5 environment;
failing to routinely inspect, calibrate as necessary, and check
to ensure proper performance of equipment used in the compounding
of drug products; failure to have written procedures
for the compounding of drug preparations; failure to assign
the correct BUDs for CSPs; and failing to maintain a ratio
of no more than two pharmacy technicians per supervising
pharmacist on duty. Five years’ probation until January
20, 2021, and $45,000 fine
source Oklahoma Board of Pharmacy April 2016 Newsletter
source Oklahoma Board of Pharmacy April 2016 Newsletter
Subscribe to:
Posts (Atom)