There are two regulatory pathways to bring a nonprescription drug to market in the U.S. -- the drug application process and Over-the-Counter (OTC) Drug Review (OTC monograph) 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 either: 1) direct-to-nonprescription (commonly referred to as direct-to-OTC) or 2) prescription-to-nonprescription switch (commonly referred to as Rx-to-OTC switch).
An NDA may be submitted to market a new drug as nonprescription (direct-to-OTC) without first receiving approval as a prescription drug.
However, many nonprescription drugs that have an approved NDA or ANDA were first approved as prescription drugs, before eventually receiving FDA approval to be marketed as nonprescription (an Rx-to-OTC switch).
For more information on the Rx-to-OTC Switches, see the Prescription-to-Nonprescription (Rx-to-OTC) Switches webpage.
FDA is proposing a rule intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. Under the proposed rule, when labeling alone is not sufficient to ensure that the consumer can appropriately self-select or appropriately actually use, or both, a drug product correctly in a nonprescription setting, an applicant may submit a drug application proposing an ACNU that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU
We encourage sponsors to meet with FDA staff to discuss any questions that arise during the development of a nonprescription drug product for which an ACNU will be proposed.
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 consumer behavior studies conducted by a sponsor of nonprescription drug typically include: label comprehension, self-selection, actual use, and human factors studies.
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.