More Compounding Pharmacies Busted for Rust and Mold, FDA Reports
After the contamination cases and recent recalls of drugs from compounding companies, the Food and Drug Administration (FDA) has looked into the conditions of several other compounding pharmacies. The FDA announced that they found rust and mold in 30 other compounding pharmacies that were all supposed to have sterile labs. This discovery is alarming and leaves many worried about the safety of drugs.
According to health standards and guidelines, drugs must all be produced under sterile and sanitary conditions to minimize the risk for contamination and infections. The meningitis outbreak in Massachusetts resulted in deaths and several hospitalizations, which is why it is extremely important to double-check the safety of these facilities. The New England Compounding Center, which was the first company to deal with contamination last year, was responsible for 53 deaths and 733 illnesses. Therefore, the FDA underwent this investigation, looking into 31 specialty pharmacies, and only one of them passed health sanitary regulations. The other 30 companies were issued reports that stated that they needed to change their conditions, which included cleaning up rust and mold found in rooms meant to be sterile, improving ventilation, and requiring employees to wear sterile lab coats.
These pharmacies are usually monitored and overseen by state pharmacy boards, but due to several recent outbreaks, the FDA has intervened. Since these companies are not used to FDA inspectors, some agencies apparently refused initial entrance for the evaluations. According to the FDA's website, inspectors had to obtain two search warrants and enlist the help of U.S. marshals to enter and investigate the sanitary conditions of two locations.
The FDA states that new laws should make it easier for the FDA to inspect these companies that clearly have a problem keeping their labs sterile and clean. It is important that these companies are regulated to a certain extend to prevent horrible outbreaks and preventable deaths.