Can OTC medicines be marketed without pre-approval from FDA?
Yes. Any product that conforms to an OTC monograph may be manufactured and sold without an individual product license. A monograph is a regulatory standard for the labeling and ingredients for products within a specific category such as antacids, analgesics, etc. It is a kind of “recipe book” covering acceptable ingredients, doses, formulations, indications, and labeling. Final monographs are published in the government’s Code of Federal Regulations (CFR) and are FDA’s “stamp of approval” for the products. But some OTC medicines do not fall within the monograph system. These products require a new drug application (NDA).
