U.S. Food and Drug Administration
Protecting and Promoting Your Health
OTC vs. Prescription
Congratulations! You have completed the OTC vs. Prescription module.
Let's take a minute to review the key points about what you have learned.
- A drug is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or
an article (other than food) intended to affect the structure or function of the human body.
- FDA recommends that you seek the guidance of a reputable consultant with expertise in food and drug law in determining the intended use of your product.
- An OTC drug is considered safe and effective for use by the general public without a prescriber's authorization.
- A prescription drug product requires authorization by a licensed practitioner before that drug product may be dispensed or given to a patient.
- Labeling requirements for OTC drugs are different than those of prescription drugs.
Click the MENU tab once to return to the Topic List for this lesson. Click it a second time to return to the Course Menu and select another module.