Drug-mix industry stymies regulators
Mass. congressman seeks tougher rules for compounders
Lawmakers’ calls for tougher regulation of compounding pharmacies are nothing new. Over decades, there have been a series of attempts at the federal level to rein in a business that has largely evaded the kind of stringent oversight established drug makers face. Federal regulators long have been flummoxed by the growth of the compounding pharmacy industry, which is made up of thousands of small outfits that specially mix medicines for patients, along with an expanding class of industrial-scale manufacturers that ship products to health care providers nationally. The spotty oversight — veering from lax to tighter scrutiny and slowed by lobbying, aborted legislation, and court decisions — has come into sharper focus after steroid injections traced to the New England Compounding Center in Framingham exposed up to 14,000 patients to fungal meningitis.