The FDA is the major regulator of legal drugs at the federal level with some FTC responsibility for advertising. Regulation of the dispensation of prescription drugs is done at the state level. In some states professionals other than physicians can write prescriptions. Twin Bases for Regulating Drugs A. Safety Established by the Food, Drug and Cosmetic Act of 1938.
Safety is relative and a risk vs. benefit basis is used.
B. Effectiveness Established by the Kefauver-Harris Drug Amendments of 1962. Basically assumes that ineffective drugs are unsafe. Both must be proven pre-market. Kentucky requires substitution if requested by the patient unless the physician indicates otherwise on the prescription. When a prescription is written for a generic version, consumers can request the brand name version.