Compounding Pharmacies – An Unregulated Minefield

Compounding Pharmacies

The controversy over the fungal meningitis outbreak that is traced to contaminated steroid injections has brought compounding pharmacies under the spotlight. This is not the first time.

A compounding pharmacy mixes drugs for use by hospitals and clinics. Often they make up for a shortfall in drugs, as was the case with the steroid injection given to patients for back pain. Now at least 119 are sickened and 11 have died from the fungal meningitis. The New England Compounding Company (NECC) has recalled more than 17,000 vials of its tainted steroid injections which it sold to 23 states.

What do we know about compounding pharmacies? They mix solutions from powder and other ingredients to make medicines used for back pain, to treat cancer, for menopause symptoms. The drugs are usually sold for much lower prices than major pharmaceutical companies and they are not subject to oversight by the U.S. Food and Drug Administration (FDA).

Compounding pharmacies become essentially mini-pharmaceutical companies that fill the gap in drug back orders. With more than 7,500 in the U.S., they account for 3 percent of all prescriptions, reports the Associated Press.

An FDA Warning

This isn’t the first time the NECC has come under the national spotlight.

The FDA issued a warning letter to it and four other firms in December 2006 over an anesthetic cream, reports the Associated Press. Too much anesthetic in the cream could cause a seizure and an irregular heartbeat. The FDA had identified two deaths as a result.

Last May there were 33 cases reported of a fungal eye infection from a compounding pharmacy in Florida. Patients in seven states were affected. That was the same pharmacy identified in 2009 for compounding supplements that led to the death of 21 polo horses, also in Florida.

In 2002, the same steroid named in the current outbreak, was tied to five cases of fungal infection in North Carolina. One patient died.

The online news site about the pharmaceutical industry, Pharmalot, reports that U.S. Sen. Richard Blumenthal of Connecticut wrote FDA Commissioner Margaret Hamburg this week that, “clear guidelines have been drawn by both FDA and Congress, first in 1992 and later under section 503A as added by the FDA Modernization Act of 1997, and still again in FDA’s own compliance guidance in 2002 that require certain conditions be met in order to compound prescription drugs” (here is the letter).

The New York Times reports the FDA has more regulatory authority over a Chinese drug factory than a domestic one.