Lawmakers question oversight of compounding pharmacies

At least two U.S. lawmakers sent letters to FDA questioning whether FDA should have more authority over compounding pharmacies in light of a fungal meningitis outbreak caused by contaminated injectable steroids from pharmacy New England Compound Center (NECC). Sen. Richard Blumenthal (D-Conn.) wrote that FDA's authority over compounding pharmacies should be extended "if necessary," citing a need for "for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies." Under the FDA Modernization Act, FDA does not have authority over compounding pharmacies if the product is not "compounded regularly or in inordinate amounts." Blumenthal said NECC shipped the compounded steroid to 23 states, which he said calls into question whether the pharmacy "crossed the line into drug manufacturing." He asked for more information on FDA's role in regulating compounding pharmacies, including whether the agency would issue additional guidance. ...