Over-the-counter (nonprescription) drug products are medicines considered safe and effective for use by the general public without the necessity of first seeking treatment from a health care provider.They are either marketed as OTC drug monographs, categorized by therapeutic classes and providing a “recipe” for allowable active ingredients, dosages and labeling. Products that meet the requirements of an OTC drug monograph do not need FDA preapproval prior to marketing. OTCs may also be considered through an Rx to OTC switch.
In addition, homeopathic medicines may be marketed over-the-counter provided they are indicated only for self-limiting, self-diagnosable conditions and meet the requirements outlined in FDA’s Compliance Policy Guide Sec. 400.400.