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Food and Drug Administration and Compliance Issues
Florida authorities are tracing the steroids that were shipped into the state from a Tennessee-based compounding pharmacy thought to be responsible for seven infections. The pharmacy had been in trouble before, but Florida and a dozen other states were still allowing it to ship in high-risk drugs.
Tennessee health inspectors cited Main Street Family Pharmacy of Newbern, Tenn., in 2011 and again in 2012 for violations of safety standards but did not shut it down, the Nashville Tennesseean reported Saturday.
Tennessee authorities had placed the pharmacy on probation, issued three consent agreements and fined it over $39,000, the newspaper reported. But they did not shut it down, so it continued to sell its drugs -- including high-risk sterile injectables -- to clinics and hospitals in other states.
It is not clear whether Florida's Department of Health was ever notified of the disciplinary actions in Tennessee. According to the Florida DOH license lookup site online, Florida's DOH and Board of Pharmacy have taken no disciplinary action against the Tennessee compounder.
Main Street Family Pharmacy sent out the steroids thought to have been contaminated in December, a few weeks after the Tennessee inspection that found many problems, the Tennesseean reported. The probation and major fines were imposed in March, long after the drugs were shipped.
The seven infections found so far were traced to injections from January and February, according to releases from the Food and Drug Administration and Tennessee health authorities.
A spokesman for Main Street Family Pharmacy sent the following statement on Tuesday: “As the FDA reported, an investigation into the exact source of the potential adverse effects from the methylprednisolone acetate is inconclusive and ongoing.
"The company is fully supportive and compliant with the FDA’s recommendation that a voluntarily recall take place and patients not be administered this compounded medicine until the investigation is complete.”
Florida DOH issued a release Friday evening that said at least three in-state facilities -- two in Melbourne and one in Chipley -- received the suspect drugs, Florida Department of Health said Friday evening.
DOH identified them as Family Health Care of Chipley, The B.A.C.K. Center of Melbourne and Dr. Parvesh Bansal, also in Melbourne.
The steroids in question are the same type that caused an outbreak last year that hurt 720 people and killed 48 -- including five in Florida.
"DOH has notified each of these facilities and is currently working with them to notify patients who may have been exposed," the agency said in its release.
Tennessee health officials said that Main Street has been cooperative in recalling all of its sterile products. Those are liquids that are injected or infused into a sterile space, such as the blood stream, spine, joint or eye.
Last year's outbreak, caused by contaminated steroid injections from the now-defunct New England Compounding Center in Massachusetts, triggered severe cases of fungal meningitis, as well strokes and other problems.
The patients in both outbreaks received injections of methylprednisolone acetate, according to the FDA. The drug is called MPA for short.
Five of the patients in the new outbreak, who got the shots at a primary care clinic in Herrin, Ill., developed skin infections at their injection sites on the hips and buttocks, CDC reported. At least one of two patients in North Carolina was reported to have a fungal infection.
Compounding pharmacies tailor-make drugs for particular patients who can't take brand-name manufactured drugs, and must do so under a doctor's prescription. However, as the Florida Board of Pharmacy has reported, many compounding pharmacies have become de facto manufacturers, producing drugs in bulk outside the regulatory reach of the FDA.
States are responsible for regulating pharmacies, but it has been difficult for them to ride herd on compounders, particularly those that are based in other states.
As Health News Florida reported in December, about half of Florida's 9,000 licensed pharmacies engage in compounding to some extent, and 950 of those are in the high-risk category because they make drugs that must be produced in ultra-clean facilities and kept sterile.
One-third of the high-risk compounders licensed in Florida are based in other states, shipping their products to hospitals and clinics.
--Health News Florida, www.HealthNewsFlorida.org, is published by WUSF Public Media. Editor Carol Gentry can be reached at 813-974-8629 (desk) or 727-410-3266 (cell) or by e-mail, email@example.com.