A deadly national meningitis outbreak, which stemmed from a batch of tainted steroids sold by a Framingham company, has rightly launched fierce reactions from state and federal officials. The Patrick administration is taking necessary steps to scrutinize the actions of the New England Compounding Company and its sister company, Ameridose — and to ensure that all Massachusetts pharmacies are complying with state regulations. But this crisis has also shed attention on the murky world of compounding pharmacies, and the reasons why they need to be subject to more of the national rules that govern prescription drugs.
Compounding pharmacies have existed since the 1700s and are intended to serve a particular health care purpose: They prepare medications for people who can’t take them in traditional forms, such as by producing a liquid dosage or injection for someone who can’t swallow a pill. But while these companies once tended to be small, local operations, many are now big businesses. Massachusetts has 26 compounding pharmacies that account for 37 million prescriptions per year. Many operate across state lines amid surprisingly limited oversight. Large drug manufacturers are subject to an arduous approval process from the Food and Drug Administration, but compounding pharmacies operate outside of the agency’s regulatory framework, and the industry has aggressively fought against increased regulation.