Additional steps are needed for regulating compounding pharmacies beyond those outlined in the Drug Quality and Security Act of 2013, some are warning.
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
The FDA has clearer authority, but needs support from other stakeholders, including adequate funding from Congress, Outterson noted. Furthermore, providers and health plans can play a role by insisting compounded drugs are exclusively sourced from FDA-regulated facilities.
"The Drug Quality and Security Act may have been a good first step, but patients will not be protected unless states, the FDA, and healthcare providers and plans act quickly to fill in the gaps left by Congress," Outterson concluded.