The state agency, which regulates Florida pharmacies, also placed Eastern Pharmacy, Inc., 2046 W. Silver Springs Blvd., on probation for the next two years and warned the pharmacy that investigators would conduct semiannual inspections to ensure it stopped violating pharmacy rules.
The Florida Pharmacy Board’s order was finalized this week. The board operates under the Department of Health, or DOH.
The order traces back to a Jan. 13, 2014, DOH inspection when investigators found that Eastern failed to:
· Document whether its sterilized compounds passed sterility tests or were stored in a fashion acceptable to Florida pharmacy rules.
· Document whether the pharmacy’s anteroom — the room leading into the clean room where sterile compounds are made — was certified, as required by state pharmacy rules.
· Document whether the laminar air flow hood, in which sterile drug are made, was maintained to state standards.
· Have a written policy addressing the use of containers used to make drugs, or a policy and procedure to verify compounding accuracy and sterility as required by Florida pharmacy laws.
· Have policy or procedures dealing with the training of personnel in doing aseptic work.
· Have a policy addressing environmental quality and control or documented quality assurance, which should have included regularly scheduled audits of its practices.
Compounding pharmacies make medications and other medical products from scratch. They cannot make copies of commercially available medications and can only make medications prescribed by a doctor.
Most make uniquely formulated medicines for patients who cannot take a commercially produced brand.
Making sterile compounded drugs is far more complex. To do that, pharmacies need an array of specialized equipment and facilities to reduce the risk of contamination. These products typically are injected or applied to areas of the body that are vulnerable to bacterial or fungal infections.
Both the state and federal government have oversight of pharmacies. States — in Florida, that means the Pharmacy Board — oversee day-to-day operations. The U.S. Food and Drug Administration plays a larger role when sterile drugs are made in greater quantity or in batches that are sent to hospitals and doctors offices.
New federal laws in 2013 gave the FDA clearer oversight and prompted state regulators to better oversee pharmacies. The reforms followed a 2012 case in which a Massachusetts drug-compounding pharmacy was linked to at least 64 deaths, including three in Marion County, due to contaminated sterile drugs.
The DOH inspection, and subsequent fine, should not have been a surprise to Eastern Pharmacy.
Inspectors visited the pharmacy just one month earlier — and noted the same problems that were then cited in the January inspection.
The pharmacy has been in business since 2012, listing Daoud Zayed as its officer/director, according to Florida Division of Corporations records. The Marion County Property Appraiser’s Office lists Zayed and the pharmacy as the owner of the West Silver Springs property. The DOH website lists a Daoud Zayed as a registered pharmacy technician.
The DOH website lists Donna Marie Monica Dunn as the business’ pharmacist.
This is not Dunn’s first run-in with the Pharmacy Board’s regulatory process. According to DOH records, Dunn was the prescription department manager at Future Pharmacy Inc. in Tampa in 2013. She was known as Donna M. Fulton at the time.
During a DOH inspection that year, investigators found that expired medications had not been removed from the Future Pharmacy’s shelves, and that the business’ policies and procedures were not available, as required by Florida pharmacy regulations.
The pharmacy board ordered Dunn to pay a $2,000 fine, complete a continuing education course regarding pharmacy laws and rules, and complete a second course on pharmacy ethics, according to DOH records.
She also agreed not to violate pharmacy regulations again. The order was made final in February 2014.
Eastern Pharmacy officials did not respond to a Star-Banner request for comment on this story.
Reach Fred Hiers at email@example.com and 867-4157.
Source Article from http://www.ocala.com/article/20150228/articles/150229690
Local pharmacy faces $5K in fines for violations
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