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Compounding Law: How Many “Outsourcing Facilities” Will Emerge?

 
• By Derrick Gingery

As bill heads to President, voluntary registration system for compounders likely means not all large-scale operations will subject themselves to FDA oversight.

Large-scale compounders likely soon will have to decide whether to register with FDA and become subject to agency oversight, a critical aspect of new compounding regulation that remains largely unknown.

FDA and other supporters of the soon-to-be law are taking a substantial leap of faith that market forces will influence compounders to view agency oversight as a good business practice...

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