As of 2007, the FDA has the  authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs and biological products, to ensure that the benefits of such products outweighed the risks.  Although the FDA mandated risk-management plan applies only to prescription drugs and biologicals, the effect of a REMS extends down the supply chain to affect which physicians may prescribe and how pharmacies dispense medication, even though the FDA has no regulatory authority beyond manufacturers.  Ned Milenkovich (Modern Medicine, 8 Oct 2009) poses the question, therefore, whether Congress and the FDA are exceeding their authority by indirectly regulating professions that traditionally have been governed by the various states?  This article gives a good overview of the status and use of REMS by the FDA and Industry and considers the indirect effects.