FAQs About the OTC Review

What is the OTC (Over-the-Counter) Review?

The OTC Review is the name of the process established in 1972 by the U.S. Food and Drug Administration (FDA) to review the safety and efficacy of OTC ingredients, doses, formulations, and labeling used in medicines available to consumers without a prescription.

What is the purpose of the OTC Review?

When the OTC Review was initiated in 1972, then FDA Commissioner Charles C. Edwards, M.D., stated that he intended:

“. . . to build a permanent system offering all American consumers the best possible assurance that every over-the-counter drug. . .not only is safe and adequately labeled, but that it will do what the manufacturer claims it will do. . . “

While more than 40 years have passed since this statement was made, it still accurately reflects FDA’s responsibilities under the Federal Food, Drug, and Cosmetic Act.

How did the OTC Review process originally work? (historical background)

When the OTC Review process first began, FDA assembled panels made up of physicians, pharmacists, and other specialists. Each panel also included two nonvoting members, one for industry and one representing consumers. Each panel was charged with examining one or more categories of OTC medicines such as cough and cold, antacids, laxatives, etc. The panels heard testimony from scientists, consumers, and industry representatives and reviewed scientific studies, reports, and other data, most of which was submitted by manufacturers.

The panels were then asked to decide which ingredients to recommend to FDA as:

1. Generally recognized as safe and effective (or GRAS/GRAE)
2. Not generally recognized as safe or effective, or
3. Needing more studies before a GRAS/GRAE determination could be given

After each panel reported its findings to FDA, the information was published for public comment. The results, including FDA’s own reactions, were then published as tentative final monographs with another comment period. FDA then analyzed comments and issued a final monograph.

What is a monograph?

A monograph is a regulatory standard for ingredients. It is a kind of “recipe book” covering acceptable ingredients, doses, formulations, indications, and labeling. Any OTC medicine that conforms to the monograph may be manufactured and sold without an individual product license. Final monographs are published in the government’s Code of Federal Regulations (CFR). FDA’s portion of the CFR interprets the Federal Food, Drug, and Cosmetic Act.

Is the OTC Review process complete?

No, the OTC Review process is not yet complete. The current status of an OTC medicine can be viewed by visiting the rulemaking history for OTC drug products section of FDA’s Center for Drug Evaluation and Research’s web site. Those ingredients and indications which are not covered by final monographs are in “tentative final monographs.” Although progress is being made, due to the typically complex issues involved in finalizing a monograph, it will be some time before the process is complete.

How does the OTC Review process work today?

The OTC Review process is currently handled within the Agency’s Center for Drug Evaluation and Research (CDER). CDER’s Office of Drug Evaluation IV, Division of Nonprescription Regulation Development, has responsibility for finalizing remaining monographs, as well as considering new issues for monographed products or requests to amend monographs. Changes to monographs can develop from FDA as new information arises, from petitions for changes from interested stakeholders or from time and extent applications.

As FDA proposes changes on monograph issues, the agency typically publishes a proposed rule or an advance notice of proposed rulemaking in the Federal Register to invite comment on the topic. After reviewing comments received on FDA’s docket (the official repository for the administrative proceedings and rulemaking documents for proposals), the agency publishes a final rule with its conclusions and the regulatory language needed to amend the monograph in the Code of Federal Regulations.

In some instances, FDA will seek advice from its Nonprescription Drugs Advisory Committee (NDAC) and other qualified advisory committees on particular monograph issues. NDAC is made up of outside experts — including a non-voting industry liaison representative and a consumer liaison — who provide non-binding recommendations to the agency on scientific questions.

What are time and extent applications?

Time and extent applications (TEAs) provide a route to permit foreign marketing data or to allow OTCs which have been under a new drug application for more than five years into the OTC Review. First, FDA determines eligibility by assessing the TEA for OTC Review. Second, once eligibility is determined, FDA requests safety and effectiveness data for evaluation to be included in OTC Review. TEAs are kept confidential while under evaluation by FDA, but the agency’s responses to TEAs are public.

Further Reading

• FDA Listing of OTC Active Ingredients (alphabetical)
• FDA Listing of OTC Active Ingredients (by category)
• Development and Regulation of OTC (Nonprescription) Drug Products

• Over-the-Counter Drug Monograph System - Past, Present, and Future; Public Hearing