U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
OTC vs. Prescription
Adequate Directions for Use

One important regulatory distinction between OTC and prescription drug products involves the requirement for "adequate directions for use."

All drugs must have labeling that bears "adequate directions for use." Prescription drugs, however, by definition, require the intervention of a licensed healthcare professional.

Since these products require the intervention of a healthcare professional, also known as a "learned intermediary," "adequate directions for use" for OTC drug products should not include those uses which require a prescription.


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