Regulation of OTC Medicine

The distribution of medicine in the U.S. is based on a two-class system: prescription and nonprescription medicines. A nonprescription, or over-the-counter (OTC) medicine, is one that the U.S. Food and Drug Administration (FDA) has found to be safe and effective for direct consumer use based on the label instructions and warnings. FDA requires a wider margin of safety for OTC medicines than for prescription drugs. FDA has subjected all OTC medicines to safety and effectiveness reviews since the 1970s.

Child in Pink Shirt
Child-Resistant Packaging
white tablets being shaken from a bottle into a hand
Distribution & National Uniformity
red capsules being sorted in a circular hopper
Current Good Manufacturing Practices (cGMPs)
woman using travel sized hand sanitizer
Structured Product Labeling
Pharmacist with long dark hair assisting customer in dark green shirt
Hispanic woman measuring out medicine in front of a medicine cabinet
FAQs About the OTC Review