Bacteria, Fungus Found in Vials
Microbial contamination has been verified in two batches of drugs from a Tennessee compounding pharmacy that were shipped into Florida and other states, federal health officials say.
The Food and Drug Administration reported Thursday that vials of injectable steroids from separate batches contained both bacterial and fungal contaminants. The drugs were a type of steroids, prepared for injections, and were subject to contamination because they were free of preservatives.
FDA is working with the Centers of Disease Control and Prevention to identify the exact species of the organisms and is continuing to evaluate drugs from Main Street Family Pharmacy in Newbern, Tenn., FDA said in a release posted on its website.
Meanwhile, CDC updated its website on the Tennessee-pharmacy outbreak to show the number of patients who've developed infections holding steady at 24 in four states. Florida, with 13 cases, has the most.
The infections are mostly confined to skin abscesses at the site of injection, usually the hip. None is considered life-threatening.
Thousands of Florida-licensed pharmacies do compounding -- altering drugs or making their own version from scratch -- but most do not engage in bulk-production, which appears to fall between the regulatory cracks between FDA and state pharmacy boards.
A survey by the state in late last year found that nearly 1,000 pharmacies with Florida licenses engage in high-risk compounding -- making drugs that must be kept sterile because they do not have preservatives and are being injected or infused into sensitive places in the body, such as the spine or blood stream.
About one-third of those high-risk compounders are located beyond the reach of Florida inspectors, in other states, the survey found.
The Department of Health said Wednesday that the Tennessee pharmacy has voluntarily agreed not to ship any more sterile products into Florida. If the firm violates the agreement, DOH said, the agency will suspend its license.
DOH also removed one clinic from the list of facilities it had said earlier received sterile drugs compounded by the Newbern pharmacy: Southern Healthcare Rural Health Clinic of Bonifay.
That leaves three sites that received the drugs in question, DOH said: Family Health Care of Chipley, The Back Center of Melbourne and Dr. Parvesh Bansal, also of Melbourne. DOH said it is working with the clinics to notify patients of possible exposure.
The drug thought to be responsible for the outbreak is methylprednisolone acetate, or MPA. The same drug was linked to a larger and more serious outbreak last year involving the now-defunct New England Compounding Center.