Time to Fix Glitch in Pharmacy Law?
After a long delay, the Florida Department of Health wants to fix a gap in the law that made it powerless over out-of-state compounding pharmacies.
When tainted injections from New England Compounding Pharmacy caused a fungal meningitis epidemic in 2012, the state discovered it had licensed hundreds of such facilities to send drugs into Florida. It also found that Florida law gave DOH no authority over those located in other states.
DOH could have asked the legislature to fix the gap in the law during the 2013 session in the spring, but did not, as Health News Florida reported last June (see Who Forgot to Fix Compounding Law?). It was never made clear who dropped the ball.
In any event, DOH now has a proposed bill – approved by the Board of Pharmacy in October – that would plug the gap. It would allow Florida to send or hire inspectors to an out-of-state licensee and bill that pharmacy for the cost.
It also would require the pharmacy to provide a toll-free number that patients in Florida could call and maintain clear records of who got which drugs so that if there were a problem, those at risk could be contacted.
Sixty-four people, including seven in Florida, were killed by the outbreak caused by contamination of the steroid injectable liquids shipped from New England Compounding Pharmacy, according to the Centers for Disease Control and Prevention.
The pharmacy that made the tainted drugs was shut down soon after the outbreak was discovered in September 2012, and was later declared bankrupt. Other Florida-licensed compounding pharmacies based in and out-of-state also have triggered outbreaks or been found to be operating in dangerous conditions by DOH or the U.S. Food and Drug Administration.
Compounding pharmacies are allowed to tailor-make a drug for an individual patient who can't use the official mass-produced version, and if they have a doctor's prescription. These pharmacies are not supposed to mass-produce other companies' patented drugs or sell them in bulk.
But in recent years, many compounders have become de facto manufacturers without an FDA license, as that agency discovered after the NECC outbreak.
Current Florida law leaves it up to other states to monitor the compounders based inside their borders. But outbreaks caused by bad drugs produced in Florida and a number of other states – as listed recently by the Ocala Star-Banner’s Fred Hiers -- indicate that system hasn’t worked.
Recognizing that, in November 2013 Congress passed and President Obama signed into law the Drug Quality and Security Act, which attempts to clarify federal law so that the FDA would have more authority over bulk compounders under a new classification: “outsourcing facilities.”
However, the federal law appears to leave state health officials in charge of monitoring traditional compounding pharmacies; it’s unclear whether the language proposed by the DOH will need tweaking. DOH “is in the process of analyzing the impact of the federal legislation,” agency Press Secretary Sheri Hutchinson wrote in an e-mail reply to a question.
Another discovery: Most states, including Florida, had no idea how many of their licensed pharmacies were making their own compounded drugs and – more worrisome – how many of those drugs were in the high-risk “sterile” category because they were to be infused or injected into the blood stream (see Florida Law, Health Agency Lax on Compounding Pharmacies).
A late-2012 DOH survey of licensed pharmacies found that about 4,500 engaged in compounding to some extent and about 950 of those were making high-risk products. The numbers were regarded as staggering, given that there were only a handful of state pharmacy inspectors trained to gauge the safety of such facilities.
As of last month, according to DOH, there were 687 pharmacies with Florida licenses engaged in sterile compounding, of which 418 had been inspected since July 1. DOH found 94 with safety violations, half of them serious.
In the past year the Florida Board of Pharmacy has adopted several rule changes after study and hearings by its Compounding Committee. The Board:
--Now requires sterile compounders to apply for a special permit that requires an inspection before license issue or renewal.
--Requires sterile compounders based in other states to submit copies of their last two inspections in their home state.
--Is scheduled to act in February on a proposal that would raise the safety standards that sterile compounders must meet (to USP 797, set by the U.S. Pharmacopeial Convention).