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Fri April 12, 2013
FDA Finds Trouble at 4 FL Compounding Pharmacies
The Food and Drug Administration has released a list of 30 compounding pharmacies in 18 states – including four in Florida – where federal inspectors found dangerous conditions in recent spot checks.
At one of the Florida facilities, inspectors found “black particles of an unknown origin” floating in seven vials of an injectable drug. At another, FDA officials said, the agency had to go to court for a warrant after inspectors were blocked from entering.
The four Florida pharmacies on the FDA list are Axium Healthcare Pharmacy in Lake Mary, The Compounding Shop in St. Petersburg, Lowlite Investments doing business as Olympia Pharmacy in Orlando, and Anazaohealth Corp. in Tampa.
The Washington Post identified the pharmacy with the “black particles” as Axium Healthcare Pharmacy in Lake Mary. The Post said officials at the company did not return phone calls seeking comment.
Axium, which has had a Florida pharmacy license for 13 years, has a clear record on the Department of Health website. DOH is supposed to inspect compounding pharmacies. DOH spokeswoman Ashley Carr said she is not permitted by state law to say whether there is an investigation under way.
The New York Times reported that Olympia Compounding Pharmacy in Orlando required FDA to get a warrant in order to enter. Scott A. Livingston, Olympia’s lawyer, told the Times the pharmacy required the warrant because it was concerned about patient privacy.
Olympia also has a clear license on the state web site. The other two pharmacies on the FDA list, Anazaohealth Corp. and The Compounding Shop, have had discipline from the state in the past, according to the DOH website.
FDA officials apparently released the list and granted interviews to major newspapers to make the point that the agency has not been granted sufficient authority to keep an eye on the booming business of sterile compounding. Congress has grilled Commissioner Margaret Hamburg in the past and has another hearing scheduled for Tuesday.
FDA officials say the courts have ruled that states are responsible for inspecting pharmacies. But the Florida Department of Health lacks the legal authority to require special permits for sterile compounders that are located out of state, and also lacks authority to arrange inspections, the Board of Pharmacy concluded after recent state hearings.
Last week at a meeting in St. Petersburg, the pharmacy board requested that DOH ask the Legislature to change the law to give it more legal authority over out-of-state sterile compounders. With only three weeks remaining in this year’s legislative session, it is not clear whether that will happen.
The board began studying the issue after last year’s multistate outbreak of fungal meningitis, transmitted by contaminated vials of injectable painkillers shipped from New England Compounding Pharmacy. The drugs made 680 people sick and killed at least 50; in Florida, 25 got sick and five died. Some have lingering effects.