delete PART 300—GENERAL
This FDA regulation governs fixed-combination prescription drugs (requiring each component to contribute to claimed effects and be safe/effective), prohibits CFC propellants in drug containers, and mandates annual reporting on investigational drugs provided under the Right to Try Act.
The regulation imposes significant compliance costs on pharmaceutical companies, stifles innovation in drug formulation, and creates bureaucratic overhead that increases drug prices. The combination drug rules prevent potentially beneficial formulations, the CFC ban may limit delivery options without considering market-driven alternatives, and the Right to Try reporting requirement burdens manufacturers assisting dying patients. These unseen costs outweigh any marginal safety benefits, as market forces, liability, and state regulation could more efficiently ensure drug safety.