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U.S. Department of Health and Human Services

Drugs

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Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers

What is the difference between prescription drugs and OTC drugs?

A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Here are the main differences between OTC drugs and prescription drugs.

Prescription drugs are:

  • Prescribed by a doctor
  • Bought at a pharmacy
  • Prescribed for and intended to be used by one person
  • Regulated by FDA through the New Drug Application (NDA) process. This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. For more information on the NDA process, please see "The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective."

OTC drugs are:

  • Drugs that do NOT require a doctor's prescription
  • Bought off-the-shelf in stores
  • Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."