What is an FDA Monograph?

An FDA monograph is a publication of the U.S. Food and Drug Association (FDA) about a particular class of over-the-counter drug. The FDA publishes separate monographs for more than 80 different classes of medications, including analgesics, antacids and sunscreens.

History

• In 1962, a law was passed saying that no drugs could be marketed in the United States until their efficacy and safety had been tested and approved by the FDA. In 1972, this was extended to include non-prescription drugs. To streamline the approval process, the monograph system was implemented.

Included Information

• FDA monographs include lists of ingredients that have proven effectiveness and safety for a particular health concern, as well as information about dosing, drug formulations and labeling.

Uses

• Instead of applying for approval for every new over-the-counter drug released, manufacturers instead seek to have their product approved based on an existing monograph. If, for example, a manufacturer is seeking approval for a new antacid, they apply to have it approved based on its conformity to a particular monograph because it contains pre-approved, active ingredients rather than applying for approval of an entirely new drug.