FDA cites labs that tested tainted drugs

One of the selling points that many large drug compounders lean on is that their drugs are tested by independent laboratories. But FDA inspections have found issues with many of those laboratories, leading the agency to seek recalls for products that compounders were selling nationally.

According to The Washington Post, many drug compounders started using outside labs for testing after a compounder in Kansas City was convicted in 2001 of diluting cancer drugs to up his profits. But the FDA has now cited 5 outside testing labs for more than 70 observations, including one in which bacteria was repeatedly found in a clean room. Those 5 laboratories handle the testing for about 90% of the nation's large-scale compounding pharmacies.

An FDA inspection found issues with the procedures used by DynaLabs in St. Louis, MO. The lab tested the calcium gluconate solution made by Texas-based Specialty Compounding that authorities now believe was contaminated with bacteria. The compounder recalled the drug in August after the Centers for Disease Control and Prevention (CDC) linked it to two deaths and 13 illnesses at two Texas hospitals.

The agency also cited Oklahoma-based Analytical Research Laboratories (ARL), which did testing for the now-closed New England Compounding Center (NECC). It was NECC drugs that were tied to the bacterial meningitis outbreak that sickened more than 680 people, 64 of whom died. 

The NECC debacle also led to proposed new legislation this year that specifically lays out the FDA's authority over compounders, which traditionally have been overseen by state authorities. It also provides for FDA approval of compounders that choose to submit to agency oversight. The bill was passed more than a week ago by the House of Representatives. It was expected to get quick approval by the Senate, but before that body was able to act, a disagreement over the budget bill led to the current government shutdown.

- read the Washington Post story
- see a Form 483 for DynaLabs (PDF)
- here's a link to all of the compounding pharmacy and testing lab inspections