FDA meeting resistance on compounding

Pharmacists who synthesize drugs fear rise of regulation

Posted: May 19, 2013 at 3:28 a.m.

Warren Lee, owner of Lee Pharmacy at 4300 Grand Ave in Fort Smith, works in his pharmacy Thursday afternoon in Fort Smith. Inspectors for the U.S. Food and Drug Administration and the Arkansas State Board of Pharmacy saw things entirely different from each other as they inspected the Lee Pharmacy in Fort Smith on Feb 19, 2013. The federal inspectors found seven areas of concern in the pharmacy. State inspectors gave the pharmacy a Class A rating. The divergence of opinion highlights a debate ongoing in Congress over whether the federal government needs more authority, or just needs to use the authority it already has. It also raises the questions about whose standards are appropriate for so-called "compounding pharmacies."

State and federal authorities agreed that things got out of hand when the New England Compounding Center produced mass quantities of contaminated injectable steroids linked to more than 50 deaths among hundreds of cases of meningitis last fall.

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Business, Pages 63 on 05/19/2013