In
the wake of the meningitis outbreak and controversy over compounding
pharmacies, the Florida Department of Health late last week suspended a
compounder in Boca Raton after determining the pharmacy had violated a
number of statutes and rules. The move came following an inpsection
earlier this month.In reaching its decision, the department cited problems with cleanliness, dispensing and compounding medications, and record keeping. A review of previous inspections also found that Rejuvi Pharmaceuticals had previously been notified of the violations, but failed to correct them, according to a statement.
The suspension, which will be followed by a hearing, is the latest fallout from the scandal surrounding the New England Compounding Center – which has been identified as the source of contaminated vials of injectable steroids traced to the meningitis outbreak – and the role of regulators in overseeing compounding pharmacies.
Since the outbreak emerged this month, there has been a mixture of confusion and outrage over the extent to which the FDA and state regulators are responsible for enforcing regulations, and whether the appropriate actions were taken. NECC, for instance, received an FDA warning letter in 2006 and Massachusetts regulators had received complaints.
Although debate remains over FDA powers and whether Congress should clarify agency authority with additional legislation, the FDA last Friday issued the results of an inspection of NECC that found the compounding pharmacy had serious problems keeping its facilities free of mold and bacteria, notably in so-called clean rooms used for production (see this).
Meanwhile, state regulators are facing mounting pressure to ensure that compounders are adhering to local laws, a development reflected in the suspension in Florida. The state has, so far, tallied 22 cases of meningitis, including three deaths, accoring to the state health department (read here).
And in Massachusetts, regulators closed yet another compounder. In addition to shuttering NECC and a related operation called Ameridose, which voluntarily closed earlier this month, Infusion was closed after inspectors last week found “significant issues” and “expressed concerns for the sterility of products,” according to Madeleine Biondolillo, director of the Bureau for Health Care Safety and Quality.
In addition, “there was an adjacent space set up for giving patients intravenous medications onsite. Infusion Resource does not have an appropriate clinic license to conduct these activities, which is a violation of state regulations.” The pharmacy has now surrendered its license (here is the statement).
On a broader scale, the state is filing regulations to require compounding pharmacies in Masschusetts to submit frequent reports of production, volume and distribution of sterile, injectable medications. And a commission is being formed to examine best practices in other states and potential changes to state law or regulations.
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