Some healthcare providers turned to compounding pharmacies to solve drug shortages when closures at big manufacturers made some drugs hard to come by. Now that compounders have run into new regulatory issues, providers are again looking for new ways to come up with what they need.
State officials in Massachusetts, home of the large-scale compounder at the heart of a national meningitis outbreak, are trying a program there to ease the problems that are particularly acute for rural hospitals. According to The Boston Globe, the state is setting aside a rule that prevented hospitals from sharing drugs. Under the new regulation, the state health commissioner can permit long-term agreements for certain hospitals, such as rural or smaller facilities that don't have as many resources for finding the drugs they require, the newspaper reports.
When injectable steroids produced at New England Compounding Center (NECC) in Framingham, MA, were tied to a meningitis outbreak that has sickened more than 700 and led to 46 deaths, it turned into a national scandal. It has raised questions about whether the FDA needs to be actively regulating large-scale compounders. NECC closed down and filed for bankruptcy protection and a sister company, Ameridose, voluntarily ceased operations while the FDA and others examined its operations. That has exacerbated shortages of certain drugs that the compounders had started making on a larger scale when other producers ran into their own supply issues.
The FDA realized when the compounders closed, shortages would be exacerbated. At the time, the FDA said it was "working with alternative manufacturers to maintain supplies of these life-saving drugs." The whole situation has embroiled the FDA in congressional investigations that have questioned whether the agency could have and should have been taking an active role in overseeing manufacturing at compounders. The agency has asked Congress to pass legislation that would make its authority more precise, given that compounders are traditionally the responsibility of states and compounders have even gone to court to resist FDA involvement.
- here's the Boston Globe story
Drug shortages aided rise of compounding pharmacies
Hamburg, FDA inspection practices go under microscope in meningitis outbreak
Congress investigating compounding pharmacy trade group