More Kudos for Oklahoma State Board of Pharmacy Regarding Recent Disciplinary Action Against Compounding Pharmacies and Pharmacists

Quantum Medical, Inc, #3-4367 – Case No. 1285: Admitted

to guilt on 28 counts including failing to meet United States

Pharmacopeia (USP) Compounding Standards and Board rules

for sterile compounding; failing to establish and maintain effective

controls against diversion; failing to supervise employees

as they relate to the practice of pharmacy; allowing someone

other than a pharmacist to unlock the pharmacy area; allowing

prescription medications to be left outside the prescription

area when the pharmacist is not in attendance; failing to have

an area designated for the preparation of sterile therapeutic

preparations; failing to have a sink with hot and cold running

water that is convenient to the compounding area; allowing a

person to have access to the parenteral pharmacy in the absence

of an Oklahoma-registered pharmacist; failing to have a documented,

ongoing quality assurance program; failing to ensure

that all compounders who compound pharmaceuticals meet

all requirements for training, testing, and education; failing

to have available for inspection completed documentation of

pharmacist-supervised training and testing in product preparation

of pharmacy technicians participating in the preparation

of compounded products; preparing an inordinate amount of

products in anticipation of a prescription prior to receiving a

valid prescription; failing to properly label and store hazardous

drugs; failing to require that all staff wear personnel protective

equipment (PPE) while working with hazardous drugs;

failing to make the required facility improvements within the

time required; failing to require a technician to have received a

pharmacy technician permit before performing any of the duties

of pharmacy technicians; failing to document training of a currently

permitted technician within 10 days of hire; and placing

drugs with a home care agency, pursuant to agreement, that are 

not allowed by Board rules. Parenteral (sterile compounding)

permit is suspended. Must provide sterile and nonsterile

compounding policies and procedures manual to Board for

approval prior to being allowed to compound. $7,500 fine.

James Casebeer, DPh, #10740 – Case No. 1286: Admitted to

guilt on 32 counts including failing to meet USP Compounding

Standards and Board rules for sterile compounding; failing

to establish and maintain effective controls against diversion;

failing to supervise employees as they relate to the practice of

pharmacy; allowing someone other than a pharmacist to unlock

the pharmacy area; allowing prescription medications to be

left outside the prescription area when the pharmacist is not in

attendance; allowing a person to have access to the parenteral

pharmacy in the absence of an Oklahoma-registered pharmacist;

failing to have a documented, ongoing quality assurance

program; failing to have available for inspection completed

documentation of pharmacist-supervised training and testing

in product preparation of pharmacy technicians participating

in the preparation of compounded products; preparing an inordinate

amount of products in anticipation of a prescription

prior to receiving a valid prescription; failing to properly label

and store hazardous drugs; failing to require that all staff wear

PPE while working with hazardous drugs; failing to make the

required facility improvements within the time required; failing

to document training of a currently permitted technician

within 10 days of hire; and placing drugs with a home care

agency, pursuant to agreement, that are not allowed by Board

rules. Placed on probation for five years until June 12, 2019.

$5,000 fine. Must successfully complete both sterile and

nonsterile compounding education approved by the Board,

and show that his resumed compounding would not put

the public at risk before doing either sterile or nonsterile

compounding. Shall attend a one-day (eight-hour) law

seminar in addition to the required 15 hours of continuing

education (CE) during the calendar years of 2014 and 2015.

All CE required for license renewal shall be live during the

five years of probation.