In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. Today I want to talk about one of the most important concepts in OTC drug compliance: FDA monographs.
An OTC drug monograph is essentially a set of FDA regulations that establish the conditions under which specific types of OTC drug products are considered generally recognized as safe and effective, and therefore don’t require an approved New Drug Application to be marketed.
Think of a monograph as a rulebook for a specific drug category. There are monographs for antacids, pain relievers, sunscreens, cough and cold products, sleep aids, and many other OTC drug categories. Each monograph specifies the active ingredients that are permitted, the allowable concentrations, the conditions of use, and the required labeling — including the specific language that must appear in the Drug Facts panel.
If your OTC drug product falls within the scope of a monograph and you follow all of the monograph’s conditions, you can legally market the product without an approved NDA. That’s the significant benefit of monograph-based marketing.
However, if your product deviates from the monograph in any way — a non-monograph active ingredient, a different concentration, a different indication — you’re outside the monograph and you need an approved application.
Understanding which monograph applies to your product and whether your formulation and labeling comply with its requirements is fundamental to OTC drug compliance. We help OTC drug brands navigate monograph requirements. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.