Who Regulates Compounding Pharmacies?

That is the question both the state of Massachusetts and the Food and Drug Administration will be required to answer as the death toll rises to 14 with 170 sickened in 23 states from a contaminated steroid injection.

As it turns out both state and federal agencies can regulate the 3,000 compounding pharmacies making a so-called sterile product such as the New England Compounding Center (NECC), but neither does a very good job.

The NECC, located in a warehouse section in a suburb of Boston next to a recycling center, distributed since May thousands of vials of preservative-free methylprednisolone acetate steroid around the country. It is still unknown how a toxic fungal meningitis contaminated the injections.

In this case, the NECC had turned from a small custom drug mixing facility to a full blown mini-pharmaceutical manufacturing company, said Michael Carome of Public Citizen speaking on the Diane Rehm Show this week. He called this a “predictable event” as compounding facilities fill the shortfalls for much needed drugs and often at a cheaper price.

In 2004, United States Pharmacopeia, an industry-backed nonprofit, established safe-practice guidelines for compounding pharmacies, but in this case the NECC may have been working outside of the scope of its license.

As it turns out the NECC had received warning letters from the FDA that products were not sterile. The agency said it had the authority to shut down NECC in 2006 and to remove products from shelves, but that never happened.

Over the years, the FDA has pushed for more authority over compounding pharmacies, reports the Wall Street Journal. A 2002 U.S. Supreme Court decision struck down a portion of a 1997 law as unconstitutional that would have established how the FDA regulated compounding pharmacies.

Back in 2007, the agency warned that compounded drugs are not FDA-approved but it never went back to Congress to establish regulatory standards. While the FDA often defers to states to monitor manufacturing facilities, in this case NECC was sending products across state lines making it interstate commerce and a federal problem.

Late Thursday, October 11, bipartisan members of the House Subcommittee on Health and Energy called for a full briefing by the owner of the compounding pharmacy, and U.S. Senator Richard Blumenthal says the next step should be a federal criminal probe to determine if officers of NECC may have misled federal and state agencies about their products.

Why was a health clinic in Tennessee ordering steroid injections from Massachusetts? Tennessee remains the hardest hit state with 49 cases, while Michigan follows with 39 and Virginia with 30. Was the company offering a cheaper price or making representations that were dishonest?

Consumers – how often do you ask your doctor if a drug came from a compounding pharmacy? That might not be a bad question to pose to your healthcare provider the next time you are about to be injected with any drug.