The FDA has been inspecting the largest compounding pharmacies and in December said it had concerns about the sterility of calcium gluconate 10% injections made by Rx Formulations of Mesa, AZ. The FDA now says testing has confirmed those concerns.
Rx Formulations voluntarily recalled the products in December, but the agency wants to make sure doctors and patients get the message. The agency issued a MedWatch announcement saying that the testing identified gram-positive rod bacteria in the injections. It pointed out that the contamination puts patients at risk for serious infections or reactions.
The FDA understands the potential dangers contaminated drugs pose. In November, Congress passed the Drug Quality and Security Act in response to the 2012 fungal meningitis outbreak, tied to a compounder, that sickened more than 750 people, 64 fatally. The FDA was criticized for not having a better handle on compounders, some of which have grown significantly in recent years as hospitals and doctors sought new sources for drugs that were in short supply. Some of the companies have extensive sales forces and distribute drugs on a national basis. It asked Congress for more oversight powers to keep a closer watch on the bigger operators.
The new law defined and broadened the FDA's oversight of compounders, but instead of giving the agency absolute powers, it allows compounders to volunteer for FDA oversight, to set themselves apart from the pack. The law also makes clear the FDA can inspect and take action against companies that don't volunteer if it believes there is a safety issue. Congress created the voluntary program with the idea that hospitals would want to buy from regulated companies with an FDA seal of approval.
Rx Formulations is not on the FDA's posted list of companies that have agreed to more oversight, but 24 sites, including multiple sites from some companies, have signed up. To be part of the program, the so-called outsourcing facilities must register with the FDA, agree to routine inspections and report adverse events associated with their products. They also pay a fee.
- here's the FDA MedWatch announcement
- see the FDA registration list