Quantum Medical, Inc, #3-4367 – Case No. 1285: Admittedto guilt on 28 counts including failing to meet United StatesPharmacopeia (USP) Compounding Standards and Board rulesfor sterile compounding; failing to establish and maintain effectivecontrols against diversion; failing to supervise employeesas they relate to the practice of pharmacy; allowing someoneother than a pharmacist to unlock the pharmacy area; allowingprescription medications to be left outside the prescriptionarea when the pharmacist is not in attendance; failing to havean area designated for the preparation of sterile therapeuticpreparations; failing to have a sink with hot and cold runningwater that is convenient to the compounding area; allowing aperson to have access to the parenteral pharmacy in the absenceof an Oklahoma-registered pharmacist; failing to have a documented,ongoing quality assurance program; failing to ensurethat all compounders who compound pharmaceuticals meetall requirements for training, testing, and education; failingto have available for inspection completed documentation ofpharmacist-supervised training and testing in product preparationof pharmacy technicians participating in the preparationof compounded products; preparing an inordinate amount ofproducts in anticipation of a prescription prior to receiving avalid prescription; failing to properly label and store hazardousdrugs; failing to require that all staff wear personnel protectiveequipment (PPE) while working with hazardous drugs;failing to make the required facility improvements within thetime required; failing to require a technician to have received apharmacy technician permit before performing any of the dutiesof pharmacy technicians; failing to document training of a currentlypermitted technician within 10 days of hire; and placingdrugs with a home care agency, pursuant to agreement, that arenot allowed by Board rules. Parenteral (sterile compounding)permit is suspended. Must provide sterile and nonsterilecompounding policies and procedures manual to Board forapproval prior to being allowed to compound. $7,500 fine.
James Casebeer, DPh, #10740 – Case No. 1286: Admitted toguilt on 32 counts including failing to meet USP CompoundingStandards and Board rules for sterile compounding; failingto establish and maintain effective controls against diversion;failing to supervise employees as they relate to the practice ofpharmacy; allowing someone other than a pharmacist to unlockthe pharmacy area; allowing prescription medications to beleft outside the prescription area when the pharmacist is not inattendance; allowing a person to have access to the parenteralpharmacy in the absence of an Oklahoma-registered pharmacist;failing to have a documented, ongoing quality assuranceprogram; failing to have available for inspection completeddocumentation of pharmacist-supervised training and testingin product preparation of pharmacy technicians participatingin the preparation of compounded products; preparing an inordinateamount of products in anticipation of a prescriptionprior to receiving a valid prescription; failing to properly labeland store hazardous drugs; failing to require that all staff wearPPE while working with hazardous drugs; failing to make therequired facility improvements within the time required; failingto document training of a currently permitted technicianwithin 10 days of hire; and placing drugs with a home careagency, pursuant to agreement, that are not allowed by Boardrules. Placed on probation for five years until June 12, 2019.$5,000 fine. Must successfully complete both sterile andnonsterile compounding education approved by the Board,and show that his resumed compounding would not putthe public at risk before doing either sterile or nonsterilecompounding. Shall attend a one-day (eight-hour) lawseminar in addition to the required 15 hours of continuingeducation (CE) during the calendar years of 2014 and 2015.All CE required for license renewal shall be live during thefive years of probation.