FDA has proposed some amendments in the existing regulations on over-the-counter drugs and fixed-combination prescription. According to the current regulations, it is the responsibility of the sponsor to make sure that in a fixed combination drug, each of the ingredients should make some contribution towards the claimed effects of the product. The proposed regulation would simplify the existing regulations on over-the-counter combination and prescription drugs. The existing policy would be codified to make it a single set of regulations. It will make the kind of studies required easier to know to make sure that the FDA requirements for combination drug are met.
It would also be applicable to drug biological product combinations. This rule would also seek to clarify FDA’s requirements in reference to fixed-dose combinations to certain natural source drugs and certain synthetic drugs. It will also include the conditions in which FDA can waive the combination requirements for some specific drug and also the circumstances in which it can address the issues related to a Co-Packaged Drug.
