News Feature | March 5, 2014

FDA Overhauls Non-Prescription Drug Approval Process

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By Cyndi Root

The Food and Drug Administration (FDA) published notice of its intention to overhaul the over-the-counter (OTC) drug approval process. The notice precedes a public hearing seeking input on the Monograph Process, also known as the OTC Monograph or the OTC Drug Review. The agency seeks feedback on the strengths and weaknesses of the current system and ideas on how to improve it. Non-prescription drugs number over 100,000 and are a 30 billion dollar industry. The last review of the process was 1972. Dr. Janet Woodcock, FDA Director for Drug Evaluation, said, "The current system isn't working well for the public or for us. We would like monograph drugs to have the same safety framework as prescription drugs."

The Monograph Process

The Monograph Process  evaluates the safety and effectiveness of drug products. It is a set of standards with three phases. Advisory panels review the drug in the first phase, looking for the active ingredients and advising whether these ingredients are generally recognized as safe. The panel also recommends labeling including indication, dosage, and warnings. Drugs are placed in categories.

  • Category I: generally recognized as safe and effective for the claimed therapeutic indication
  • Category II: not generally recognized as safe and effective or unacceptable indications
  • Category III: insufficient data available to permit final classification

In the second phase, the agency reviews the advisory panels’ work including drug ingredients, classification, and public comments. The FDA published its finding in the Federal Register as a Tentative Final Monograph (TFM). The agency allows a period of time for public comment on the TFM. 

The third and final phase is the publication of final regulations. The monograph issues the conditions under which the drug is approved. Any deviations from the monograph must be approved in a new application. The FDA may amend the monograph after publication. Many monographs are amended to reflect changes in ingredients, labeling, or other important information.


The FDA has identified biggest challenges in revamping the system. The agency is limited in its ability to move quickly to change labels when emerging situations or new information dictates. The outdated system cannot accommodate innovative changes. There is a large backlog of products with incomplete monographs.