NRC Comments on Compounding Pharmacies: Loopholes that Kill

October 31, 2012

This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable, and follows a familiar pattern that has resulted in other tragedies in recent years.

Twenty-eight men and women have already died and thousands more are waiting to find out if they will get potentially deadly meningitis, all because of giant loopholes in the FDA laws and regulations regarding compounding pharmacies.  The loopholes have allowed companies that manufacture prescription drugs to call themselves compounding pharmacies and because of the misnomer don’t need to prove that their “medications” are safe or effective.

These loopholes are similar to those for medical devices, including everything from heart valves to hips, which also can be sold without being proven safe or effective or inspected to make sure they are not contaminated with deadly bacteria.

We call on Congress to work in a bipartisan manner to pass legislation necessary to protect our families from these predictable, preventable tragedies.