Safety issues at compounding pharmacy underscore oversight problems

In March FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by the Texas compounder IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but IV Specialty refused an agency recommendation to halt production or issue a recall until the problems were fixed.

In March FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by the Texas compounder IV Specialty. The agency found numerous safety issues during an inspection earlier this year, but IV Specialty refused an agency recommendation to halt production or issue a recall until the problems were fixed. FDA, which is not aware of any adverse events attributed to the drugs, lacks authority to force the compounder to take these steps. Meanwhile, though, the medicines, which are injected or infused, remain available. In early April, the consumer advocacy group Public Citizen urged the Texas State Board of Pharmacy to suspend the compounder's license. However, the Texas State Board of Pharmacy is declining to do so. In response to the FDA actions, the state agency sent its own inspector to review IV Specialty facilities. But "our inspector was comfortable that there wasn't an immediate danger to the public," said Gay Dodson, the board's executive director. "According to our rules, they're doing what they need to do. We didn't see anything that we felt would prompt us to immediately close them down." The incident underscores the unsettled approach to government oversight of compounders.