Now, A Tennessee Compounder Is Tied To Serious Infections

Less than a month after Tennessee adopted a law that eased restrictions on compounding pharmacies, the FDA is investigating seven cases in which patients suffered adverse events after being injected with what are apparently contaminated medications that were compounded by a specialty pharmacy. As a result, Main Street Family Pharmacy is recalling all of its sterile products, most of which are injectable drugs, although the medications traced to the adverse events contain methylprednisolone acetate, which is the same drug that caused the deadly outbreak last year of fungal meningitis (see this). That outbreak, which has so far caused 741 cases, including 55 deaths, has been called the worst public health crisis in the US in decades and was traced to the New England Compounding Center (look here and here). The episode led to stepped up efforts by the FDA and some state officials to increase oversight of compounders (read here). The FDA, for instance, earlier this year launched an aggressive effort to inspect dozens of compounders in various states and, in some cases, product recalls have followed. The agency wants Congress to authorize increased oversight authority, although FDA officials recently acknowledged that more could have been done to enforce measures against NECC (read this) Last month, meanwhile, Tennessee enacted a law to alleviate medicine shortages by allowing compounders to produce more drugs and also avoid having to rely on out-of-state compounders. But the meas...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs