View Rule

The proposed rule would amend FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs. The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects. The proposed rule would create a single set of regulations for prescription and OTC combination drugs, and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The proposed rule also would: Apply these regulations to combinations of biological drug products and to drug-biological product combinations; clarify application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product; and address the issue of co-packaging.