Meningitis Deaths Prompt FDA Crackdown on Drug Mixing

[xchrom]

http://www.bloomberg.com/news/2013-04-05/drug-compounders-fail-to-learn-lesson-as-fda-boosts-raids.html


Six months after a U.S. meningitis outbreak that killed 51 people put the spotlight on their industry, specialty pharmacies that mix their own drugs are falling short of federal safety and sanitation requirements.

Since the deaths, the Food and Drug Administration has uncovered a wide range of shortcomings at so-called compounding pharmacies, including failure to set or follow procedures to prevent contamination, inappropriate protection worn by people working in sanitary areas and inadequate testing to determine expiration dates, a review of 30 inspection reports shows.

The reports covering inspections from January through March come as Congress investigates failures in regulating compounding pharmacies, a role typically held by states, following the meningitis deaths. The unprecedented number of publicly released inspection reports, known as form 483s, may be used as a tool by the FDA in its quest to gain authority over the industry.

“It’s very aggressive on the part of the FDA,” said Sarah Sellers, a former agency compliance officer who now works for the drugmaker Ther-Rx Corp. (0414967D), which sells a maternity medication threatened by compounding competition. “Without this information the FDA would not be able to move forward with new legislation. We’ve identified that there’s an absolute and critical need for greater oversight.”