House Subcommittee on Health explores pharmacy compounding
WASHINGTON — Aftershocks from last year's nationwide outbreak of fungal meningitis linked to a Massachusetts-based compounding pharmacy continued to be felt in a House subcommittee meeting Thursday.
The House Energy and Commerce Committee Subcommittee on Health convened a hearing to examine the state of pharmacy compounding in the United States and the current regulatory environment under which it operates.
Since last year, more than 50 people have died and nearly 700 have become sick with fungal meningitis and other fungal infections linked to contaminated injectable steroids shipped from the New England Compounding Center. Compounding consists of mixing or altering medical ingredients by a licensed pharmacist in response to a prescription for an individual patient and comprises two basic types, sterile and nonsterile. Nonsterile compounding is done for such medications as suppositories, mouthwashes and ointments and can involve pre-packaged ingredients in kits or changing an existing drug, such as the common practice of breaking open capsules of Genentech's flu drug Tamiflu (oseltamivir) for administration as a drinkable liquid. Sterile compounding involves injectable pharmaceutical and biotech drugs, and must be done in clean rooms under strict adherence to sterile practices; this was the type of compounding that the NECC was doing.
In light of the NECC scandal, many people such as Food and Drug Administration commissioner Margaret Hamburg have called for increased federal scrutiny of compounding pharmacies, and Thursday's meeting was one of a series of actions taken by the committee to determine how to prevent similar incidents in the future.
"Compounding is a backbone of pharmacy practice and, for many decades, independent community pharmacists have provided millions of adults, children and animals with access to safe effective and affordable medications through traditional compounding services," Arlington, Texas-based DFW Prescriptions owner Joseph Harmison said in testimony before the subcommittee on behalf of the National Community Pharmacists Association, a trade group representing independent pharmacies. "When manufactured drugs aren't an option, independent community pharmacists provide traditional pharmacy compounding to prepare customized medications for patients in accordance with a doctor's prescription based on the patient's individual needs. Traditional compounding services also can help bridge the gaps during times of prescription-drug shortages."