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  1. CDER Small Business & Industry Assistance (SBIA)

Brewing a Cup of TEA Using FDA's Recipe Book

There are over 300,000 over-the-counter (OTC) drug products marketed to consumers for their purchase without a needing a prescription.  FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs for safety and effectiveness as part of its OTC drug review program.

For each therapeutic class, FDA develops and publishes an OTC drug monograph in the Federal Register

Each OTC drug monograph is a kind of “recipe book” that covers acceptable ingredients, doses, formulations, labeling, and testing. OTC drug monographs are continually updated to add additional ingredients and labeling as needed.

This is where a Time and Extent Application (TEA) comes into play. A TEA could be used to amend an OTC drug monograph to add a new condition.

OTC conditions covered by this guidance include:
  • Active ingredient or botanical drug substance (or combination of both)
  • Dosage form
  • Dosage strength
  • Route of administration marketed for a particular OTC use

OTC products that may qualify for a TEA must have been either marketed under a New Drug Application (NDA) in the U.S. after 1972, or not have been marketed in the United States.

To determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application to show that a drug product can meet the statutory standard of marketing to a material extent (how much) and for a material time (how long).

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