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The final rule amends FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs. 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 final rule harmonizes the combination drug requirements into a single set of regulations for both prescription and OTC combination drugs and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The final rule also applies these regulations to combinations of biological drug products and to drug-biological product combinations; clarifies application of FDA's requirements regarding fixed combinations to certain natural source drugs and certain synthetic drugs; establishes circumstances under which the Agency might waive the combination requirements for a particular drug or biological product; and addresses the issue of co-packaging.