U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Regulation Overview
Tentative Final Monograph (TFM)

At this point you may ask, "I can only find a TFM for my drug’s category – how does that impact my plans to market this product?"

Remember, the OTC Drug Review was developed to create GRASE conditions for various OTC therapeutic categories based on products that were being marketed at or prior to the inception of the review (i.e., May 12, 1972 - later extended to December 4, 1975).

Therefore, in order for an OTC drug product to be eligible for inclusion in the OTC Drug Review, the product had to be marketed as an OTC drug prior to the inception of the OTC Drug Review. Or, FDA has otherwise determined through rulemaking that a product so formulated and labeled is eligible for the review.

In other words, OTC drug products that came to market after the inception of the OTC Drug Review and contained new conditions are not eligible for inclusion in the OTC Drug Review, with a few exceptions that will be discussed later.

There may be, however, TFM in place for your drug's category. We will address the topic of TFMs in more detail in a later module.

Graphic with words: TFM = Tentative Final Monograph.
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