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                Frequently Asked Questions on Popular Topics

Frequently Asked Questions on Popular Topics Home
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          Frequently Asked Questions on Popular Topics
          Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and AnswersFrequently Asked Questions on Popular Topics Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers
  
  	
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    Print**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:Hand holding prescription drug bottle**

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:Photograph of several medicine bottles**

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."Resources For You

Buying & Using Medicine Safely
	Safe Use of Over-the-Counter Drug Products
	Understanding Over-the-Counter Medicines
	Prescription Drug Advertising

                                                                                  Content current as of:
      11/13/2017Frequently Asked Questions on Popular Topics
 
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