A recent inspection of The Compounding Shop, a Florida specialty pharmacy located in St. Petersburg, uncovered numerous safety problems. On Wednesday, the United States Food and Drug Administration (FDA) publicly warned health care providers, hospital supply managers, and pharmacists to avoid drugs made by the specialty pharmacy. The Compounding Shop is cooperating with the FDA to recall all of its sterile drugs and is in the process of launching an informational campaign to notify its customers.
The Compounding Shop is a specialty pharmacy that mixes custom formulations of drugs to meet doctor's specifications. The nationwide fungal meningitis outbreak that occurred last year that was tied to contaminated drugs produced in a Massachusetts pharmacy; the outbreak killed more than 50 Americans and made over 700 ill. The outbreak created an increase in the inspection of pharmacies similar to and including The Compounding Shop, which previously were only inspected if a hazard report was filed. Compounding pharmacies have recently been the FDA's focus, targeting pharmacies across the country and resulting in several national recalls.
The FDA inspection of The Compounding Shop uncovered concerns about sterility problems with company drugs produced and distributed from the site that created the potential for causing bacterial contamination. The FDA advised health care professionals to remove all drugs from the company and not administer them to patients. The director of the FDA's drug center, Janet Woodcock, stated, "If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients."