In this review the US policy in the area of self-medication and OTC products regulation is considered. Main principles of evaluation drug products for the over-the-counter sale in the US are discussed. Data are presented on potential advantages and risks for consumers and public health system of enlarging the list of OTC preparations. It is emphasized that in the future an increase in number of efficacious drugs suitable for OTC dispensing may be expected, as well as the enlargement of indications for their use.