The new regulations allow the state to penalize compounding pharmacies whose products fail to comply with safety standards, giving the pharmacy board power to quarantine compounded drugs they suspect to be unsafe — such as the tainted steroid shots, which ended up exposing thousands of Americans to meningitis and killing nearly 30 people — without waiting to hold a hearing first. The Boston Globe reports that Massachusetts’ efforts to tighten regulations in the pharmaceutical industry are also being replicated on a national level, now that the meningitis outbreak has brought more attention to the lack of regulatory power over compounded pharmacies and their potentially dangerous products:
At the same time, Massachusetts Congressman Ed Markey unveiled federal legislation Thursday to address what he called a “regulatory black hole” currently governing these pharmacies by giving the FDA new oversight authority. […]
“No one should live in fear that their medicine is unsafe, and these actions at the state and federal level will help ensure we’re at the forefront of efforts to protect public health,” interim state public health commissioner Dr. Lauren Smith said in a statement.
The Department of Public Health also announced Thursday that Christian A. Hartman, a specialist in pharmacy practice and patient safety, would chair a new Special Commission that will study potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight.
Over 20,000 U.S. pharmacies across the country practice compounding, which involves repackaging or recombining medications in an attempt to keep down the costs of filling prescriptions. However, despite the widespread practice, the Food and Drug Administration hasn’t been able to oversee this sector of the pharmaceutical industry because it doesn’t have the power to regulate pharmacies — which means that compounded drugs do not have to meet the agency’s safety guidelines. Public health advocates have been calling on Congress to strengthen the FDA’s regulatory power to prevent future outbreaks, and Massachusetts’ new regulations are a step in the right direction to correcting the situation that allowed meningitis to spread in the first place.