OTC Drug Review and Monograph Process

The OTC Drug Monograph process, begun in 1972, is a three-phase rulemaking process that established the standards for specified OTC therapeutic categories.

Phase 1: advisory review panels evaluated OTC drug active ingredients to determine if they were safe and effective for self-treatment and subsequently classified the ingredients as “generally recognized as safe and effective, “not generally recognized as safe and effective” or “insufficient data available to permit classification”.

Phase 2: FDA evaluated the ingredients in each class of drugs and, based on the panel’s findings, public comments, and any new data available, developed tentative final monographs. Many of the therapeutic categories set forth in the drug review process are still in this phase.

Phase 3: Final monographs were published for many therapeutic categories, establishing conditions under which OTC drug products were generally recognized as safe and effective.

Once finalized, monographs can only be updated based on Citizen’s Petitions or Time and Extent Applications by interested parties, or by the Commissioner’s own initiatives.

Citizen’s Petitions

A Citizen’s Petition is used to request a change to a monograph at any phase of its development, but can only be used for ingredients that would have been eligible for inclusion in the original monograph (i.e., were marketed for the same purpose prior to 1972 when the OTC Drug Review process began).

Time and Extent Applications

The TEA is used for OTC drug products marketed under certain conditions “to a material extent” and “for a material time” and generally applies to products marketed under an NDA in the U.S. after the OTC Drug Review process began, or have only been marketed outside of the U.S.

EAS Consulting Group can help clients develop responses to agency initiatives concerning OTC drug monographs or can file the necessary petition or application on their behalf to request a specific change to a monograph. Our team of toxicologists can help your company determine the best course of action for a potentially positive outcome.