For more than two years, the FDA has been very clear about the standards its expects U.S. drug compounders to maintain and the very harsh penalties that can await those who don't comply, including indictments and murder charges for some. But some still haven't heeded the message, and last week North Carolina authorities closed one and the FDA warned providers not to use any of its products.
The Prescription Center in Fayetteville, NC, was closed by the North Carolina Board of Pharmacy last week over concerns about a "lack of sterility assurance and other conditions at the facility." While there have been no reports of adverse reactions, the board issued a nationwide recall of all of the compounder's products, sterile and nonsterile, human and veterinary, manufactured between Sept. 10, 2014, and March 10, 2015.
"There's always a risk those products could be contaminated or not as potent as they are labeled or more potent than they are labeled being, and a patient could experience an illness or other adverse effect as a result of using that medication," Jay Campbell, executive director of the North Carolina Pharmacy Board, told WRAL.com. He said state inspectors determined that Prescription Center wasn't testing its products to ensure sterility, stability and potency.
"Given the shortfalls that we observed in their compounding practices and in an abundance of caution, we're advising folks who received those products to go ahead and destroy them," Campbell said.
The FDA stepped up its game with compounders after a fatal fungal meningitis outbreak in 2012 was tied to compounded drugs. The backlash led Congress to pass a law that gave the FDA authority over the largest compounders in the country and to step in when needed with smaller facilities.
The meningitis outbreak, which killed 64 of 751 people who were infected, was traced to injections of a steroid drug produced by the now-defunct New England Compounding Center (NECC) in Framingham, MA. Late last year, 14 NECC owners and former employees were named in a 73-count indictment that included 25 counts of second-degree murder against its two lead pharmacists.
Last month a federal judge issued a permanent injunction against Specialty Compounding, a Texas compounder whose contaminated drugs gave bacterial bloodstream infections to 17 patients in 2013. The injunction prevents co-owners Raymond Solano III and William Swail from reopening the compounding pharmacy in Cedar Park, TX, near Austin, until upgrades are made and the FDA deems it safe for making sterile products.
- see the FDA press release
- here's the recall notice (PDF)