Tuesday, December 3, 2013

Eighth Question of the Day December 3, 2013 Organizations representing compounders have taken different position at different times about the scope of the FDA's authority over compounders who are "manufacturing." (see U.S. v. Francks v. NECC outbreak) Do these organizations now support the position that the FDA has jurisdiction and authority when compounders cross the line and become manufactuers? If it looks like a manufacuter, acts like a manufactuer and smells like a manufactuer should the FDA step in and take enforcement action?

 

No comments: