FDA Warns Compounders for Adulterated Products
Two drug compounders found themselves caught up in FDA’s increased focus on drug compounding when they were slapped with warning letters for the production of adulterated drugs and for sterility concerns.
During inspections of the two compounders in March and May 2017, investigators found that the firms violated section 503A of the FD&C Act as they did not receive valid prescriptions for individually-identified patients for some of the drug products they manufactured, making their products ineligible for the section’s exemptions.
Pharmacy Resources, a Denver, Colorado-based compounder, was found to have produced adulterated drugs and the agency said its contact times for sporicidal agents as part of its aseptic processing disinfection program were inadequate. The facility also lacked an adequate procedure for cleaning and disinfecting a room and equipment for aseptic conditions.