Compounding Pharmacies Further Regulated by FDA: Senate Bill Proposed July 10, 2013 --Good summary of Each Sides View of Western States SCt decision and Vary Interesting questions Raised by this Law Firm

Compounding pharmacies have been on FDA's priority list since the 61 deaths and 749 cases of fungal infections from steroid injections contaminated during manufacture by New England Compounding Center ("NECC"), last fall. When appearing before Congress last November, FDA Commissioner Margaret A. Hamburg, M.D. plead a lack of regulatory authority in the wake of the Western States U.S. Supreme Court decision. Arguably, it is unclear if Western States struck down just the regulation of advertisements (as industry has contended) leaving the regulatory structure untouched or if it invalidated the authorization of compounding pharmacies (as FDA has contended, since the 9th circuit held the provisions not-severable and that decision was affirmed), leaving compounding pharmacies technically illegal but ignored by FDA regulatory discretion. Either way, FDA appeared to retain certain regulatory authority over compounding pharmacies, but FDA's scope was unclear.

Congress did not want to leave the deaths resulting from compounded drugs alone, so S. 959 was proposed to fix the problem, despite the lack of clarity what problem needed to be fixed. Among other things, S. 959 would forbid compounding pharmacies to copy FDA-approved but nonpatented medicines. 

continue to read  Frommer Lawrence & Haug blog here