All OTC drug products must meet established standards for safety and effectiveness, must be manufactured according to current good manufacturing practices (cGMPs), and must comply with labeling content and format requirements.
OTC drug monographs specify the active ingredients that can be contained within OTC drug products. An OTC drug product containing ingredients that comply with standards established in an applicable monograph is considered to be “generally recognized as safe and effective” (GRASE) and does not require specific FDA approval before marketing.
Some Examples of OTC Drug Products Include:
- Hand Sanitizer
- Antibactierial Soaps