Nonprescription products have traditionally been limited to drugs that can be labeled with information for consumers to safely and appropriately self-select and use the drug product without supervision of a health care provider.  There are certain prescription medications that may have comparable risk-benefit profiles to over-the-counter medications in selected populations.  However, appropriate consumer selection and use may be difficult to achieve in the nonprescription setting based solely on information included in labeling.  FDA is proposing regulations that would establish the requirement for a drug product could be marketed as a nonprescription drug product with an additional condition that an applicant  must implement to ensure appropriate self-selection or appropriate actual use or both for consumers.