FDA investigation finds widespread problems at compounding pharmacies
SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.
The agency inspected 31 pharmacies that were known to have engaged in sterile compounding of sterile drugs. At all but one of the pharmacies, inspectors found problems such as mold and rust in clean rooms, black particles floating in supposedly sterile drugs, technicians using their bare hands to handle products that require latex gloves and wearing nonsterile lab coats. In at least two instances, FDA officials had to get administrative warrants to obtain access to pharmacies' records, and U.S. Marshals had to accompany the agency's investigators to one pharmacy.
In traditional pharmacy compounding, a pharmacist mixes drugs according to a physician's prescription, usually oral solids, liquids, ointments and suppositories, which can be done from a pre-made kit or with an existing drug, such as the common practice of using capsules of Genentech's Tamiflu (oseltamivir) to create a drinkable liquid formulation for children. But sterile compounding usually involves mixing drugs for injection, such as chemotherapy and biotech drugs, and it requires strict adherence to sterilization practices.
Hamburg has called for giving the FDA increased authority over compounding pharmacies in the wake of a nationwide outbreak of fungal meningitis linked to the New England Compounding Center of Framingham, Mass. An inspection by health officials of that pharmacy found widespread disregard for sterile practices as the pharmacy, according to officials, had effectively become a drug manufacturer.
According to the Centers for Disease Control and Prevention, the meningitis outbreak has sickened 733 and resulted in 53 deaths.