Food Labeling Compliance Seminar – May 29-30, 2018 in Alexandria, VA

Specializing in FDA Regulatory Matters

The OTC Monograph System – Past, Present, and Future

July 31, 2018 at 1:00pm


FDA’s OTC Drug Monograph system has long been established as simple regulatory pathway for products with active ingredients found to be safe and effective for consumers to use in making self-medication decisions. Those products which fall into the purview of the monographs must meet specific requirements, not just in terms of the active ingredients but also dosage form and strength, therapeutic indications, warnings and instructions for use. However, over time the system has become outdated and inefficient, not only because the monographs were written prior to the Drug Facts formatting regulations, but also because the notice and comment rulemaking process is burdensome, particularly for updating safety information or approving new ingredients, dosage forms and indications.

Join EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane, as she explores in more detail how the monographs came about, how to read and interpret the different sections of the monograph and translate the required elements into Drug Facts panel. In addition, Congress is currently considering changes to the monograph system so she will discuss what the future might hold for OTC drugs.