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 in Pink Shirt](/sites/default/files/styles/narrow/public/media/images/2020-10/88751829-FullRightsfind-source.jpg?h=40dc845e&itok=3eETc8m2)
Child-Resistant Packaging
![Pharmacist with long dark hair assisting customer in dark green shirt Pharmacist with long dark hair assisting customer in dark green shirt](/sites/default/files/styles/narrow/public/media/images/2020-11/Pharmacist-With-Customer.jpg?h=49deeebc&itok=w8KXGB7g)
Switch List
![white tablets being shaken from a bottle into a hand white tablets being shaken from a bottle into a hand](/sites/default/files/styles/narrow/public/media/images/2020-11/tablets-1-1562053.jpg?h=3aa399d6&itok=MZd5ox4B)
Distribution & National Uniformity
![red capsules being sorted in a circular hopper red capsules being sorted in a circular hopper](/sites/default/files/styles/narrow/public/media/images/2020-10/iStock-1031880380.jpg?h=119335f7&itok=HlAfOX5F)
Current Good Manufacturing Practices (cGMPs)
![woman using travel sized hand sanitizer woman using travel sized hand sanitizer](/sites/default/files/styles/narrow/public/media/images/2020-11/sanitizing-5095967_1920.png?h=a8213087&itok=cUFyDqVb)
Structured Product Labeling
![Pharmacist with long dark hair assisting customer in dark green shirt Pharmacist with long dark hair assisting customer in dark green shirt](/sites/default/files/styles/narrow/public/media/images/2020-11/Pharmacist-With-Customer.jpg?h=49deeebc&itok=w8KXGB7g)
Advertising
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FAQs About the OTC Review
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In-use Product Stability Testing for OTC Products