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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Drug Application Process for Nonprescription Drugs
  1. Types of Applications

Drug Application Process for Nonprescription Drugs

New Drug Application (NDA) and Abbreviated New Drug Application (ANDA)

There are two regulatory pathways to bring a nonprescription drug to market in the U.S. -- the drug application process and the Over-the-Counter (OTC) Drug Review (OTC monograph) process.

Drug Application Process

Under the drug application process, a sponsor of a nonprescription drug submits a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) to FDA for approval. The sponsor cannot market the nonprescription drug until FDA approves the NDA or ANDA. Under the drug application process, a nonprescription drug may be marketed direct-to-nonprescription. A sponsor can submit an application to market a new drug as nonprescription without first receiving approval as a prescription drug. However, a sponsor may also submit an application to market a drug product as nonprescription for a drug product that was first approved as prescription. For more information, see the Prescription-to-Nonprescription (Rx-to-OTC) Switches webpage and the Nonprescription Drug Product with an Additional Condition for Nonprescription Use webpage.

Consumer Studies

One important difference between a drug application for a prescription drug and a nonprescription drug is that consumer behavior studies are often needed to demonstrate that consumers can use the nonprescription drug product safely and effectively without the supervision of a healthcare provider.  

Consumer behavior studies are used to evaluate how consumers will use the drug in a nonprescription setting (without the supervision of a health care provider). The types of consumer behavior studies conducted by a sponsor of nonprescription drug may include: label comprehension, self-selection, actual use, and/or human factors studies.

  • Label comprehension studies assess the extent to which consumers understand the information on nonprescription drug labeling and then apply this information when making drug product use decisions in a hypothetical situation. For more information, see the Label Comprehension Studies for Nonprescription Drug Products guidance document.
  • Self-selection studies assess the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for the consumer to use a drug product. After the label comprehension studies are performed and the most effective Drug Facts label is developed, self-selection studies are conducted. For more information, see the Self-Selection Studies for Nonprescription Drug Products guidance document.
  • Actual use studies evaluate the use of the product under “real world” conditions to identify any issues with use that have not previously been recognized and to confirm that consumers can self-diagnose and treat themselves appropriately without the intervention of a healthcare provider.
  • Human factors studies assess the adequacy of the product user interface design to eliminate or mitigate potential use-related hazards.

Meet with FDA

FDA encourages all potential drug sponsors or investigators of nonprescription drugs to examine the information available from FDA's Web site related to the NDA or ANDA processes. FDA also encourages all potential drug sponsors or investigators of nonprescription drugs to initiate contact with the Office of Nonprescription Drugs (NDA products) or the Office of Generic Drugs (ANDA products) as early as possible, so that drug sponsors or investigators have the opportunity to consider FDA’s recommendations in planning preclinical and clinical development programs.

Additional Information



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