Product News and Recalls

FDA, state officials take look at compounding pharmacies

During a conference that included public health officials from all 50 states, the U.S. Food and Drug Administration examined the role of the federal government in regulating “compounding pharmacies.”

A compounding pharmacy called the New England Compounding Center – where specialty drugs are prepared using ingredients from other sources – produced the steroid medication responsible for the 19-state fungal meningitis outbreak that has so far sickened 620 people and killed 39.

Subsequent investigations found unsanitary conditions at the NECC, giving rise to concerns about the regulatory loopholes under which many compounding pharmacies operate.

According to an account in the New York Times, pharmacies operate primarily under state regulation. But large-scale operations such as the NECC have expanded drastically since the early 1990s, spurred by changes in the health care system such as the rise of hospital outsourcing.

The New York Times says that some state health officials recommended having the FDA oversee regulation of large-scale compounders such as the NECC.

But critics of the FDA argue that the agency already has the legal jurisdiction over manufacturers, which should give it the authority to regulate large-scale compounders.

Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.

See the story here:

http://www.nytimes.com/2012/12/20/health/fda-and-states-meet-about-regulation-of-drug-compounders.html