Tuesday, December 31, 2013

December 31, 2013 Law regulating compounding pharmacies falls short

HealthDay News -- 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.
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