FDA: Fungus found in Tenn. drug compounder

WASHINGTONFungal contamination has been found in steroid injections from a Tennessee drug compounding pharmacy linked to reports of side effects like abscesses in two. U.S. states last month.

The Food and Drug Administration (FDA) said in an online posting Friday that it identified the growths in two unopened vials of a steroid injection distributed by the Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn. The agency said it is working with the Centers for Disease Control and Prevention (CDC) to identify the exact species of fungus and bacteria.

State and federal officials began investigating the pharmacy last month after seven patients in North Carolina and Illinois reported skin abscesses after being injected with methylprednisolone acetate, a steroid used to treat inflammation, joint pain and respiratory issues.

The same steroid was involved in a deadly fungal meningitis outbreak last year that has killed 58 people and sickened more than 740 others, many of whom had received treatment for back pain.

That outbreak was linked todrugs made by the New England Compounding Center, and investigations of the Framingham, Mass. facility found fungal contamination, molds and bacteria.

The FDA said it is not aware of any cases of meningitis associated with Main Street Family Pharmacy's products.

Last month the pharmacy recalled its entire stock of sterile products manufactured after Dec. 6, 2012.

The company's steroid was shipped to medical facilities in 13 states: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

The Main Street Family Pharmacy's license was placed on three-year probation in March and its owners were fined $25,600 after a pair of inspections found various problems at the facility.

According to a consent order, the 2011 inspection found out-of-date medications on the pharmacy's shelves that were being used in drug manufacturing. It also found a technician who had been working without proper registration for more than four years. When inspectors returned in November 2012 they found 109 out-of-date or deteriorated medications on the shelves, as well as other problems.

Compounding pharmacies have long operated in a legal gray area between state and federal regulations. Since last year's outbreak, the FDA has stepped up inspections of compounding pharmacies across the country, triggering several national recalls of potentially contaminated medications.

Legislation moving through Congress would give the FDA direct oversight over these so-called compounding manufacturers.