Friday, April 1, 2016

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


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

Oklahoma Board of Pharmacy April 2016 Newsletter (a lot of compounding related news and information)

Oklahoma Board of Pharmacy Disciplines Prescriptions Compounding Pharmacy for compounding commercially available drugs that were essentially a copy of an FDA-approved drug

Prescriptions Compounding Pharmacy, #2-5915 – Case No. 1370: Agreed to guilt on nine counts including compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available Food and Drug Administration (FDA)-approved drug product; failing to ensure that preparations are of acceptable strength, quality, and purity; failing to verify all critical processes; and failing to be familiar with all details of USP compounding standards. Two years’ probation until December 3, 2017, and $4,000 fine.
Trisha Ann Henson, DPh #15523 – Case No. 1371: Agreed to guilt on nine counts including compounding a drug product that is commercially available in the marketplace or that is essentially a copy of an available FDA-approved drug product; failing to ensure that preparations are of acceptable strength, quality, and purity; failing to verify all  critical processes; and failing to be familiar with all details of USP compounding standards. Two years’ probation until December 3, 2017, and $2,000 fine. Shall attend a one-day (eight-hour) law seminar in addition to the required 15 hours of CE during the calendar years of 2016 and 2017. All 15 hours of required CE that respondent must have to renew her license shall be live during her two years of probation. Respondent shall attend a Board-approved compounding course by March 1, 2016.


source:  Oklahoma Board of Pharmacy April 2016 Newsletter

Alabama Board of Pharmacy January 2016 Minutes ( a lot of discussion relating to compounding)

  Meeting Agenda