OTC Drug Monograph
OTC drugs can be brought to the market following the NDA process as described above or under an OTC monograph. Each OTC drug monograph is a kind of "recipe book" covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling as needed.
Products conforming to a monograph may be marketed without FDA pre-approval. The NDA and monograph processes can be used to introduce new ingredients into the OTC marketplace. For example, OTC drug products previously available only by prescription are first approved through the NDA process and their "switch" to OTC status is approved via the NDA process.
OTC ingredients marketed overseas can be introduced into the U.S. market via a monograph under a Time and Extent Application (TEA) as described in 21 CFR 330.14.
Featured Products
FDA's requirements - regulatory pathways for commercialization - OTC Monograph process -FDA's permitted Rx-to-OTC Switch Process - Labeling - Marketing
FDA's labeling requirements - Compliance parameters within FDA's 21 CFR 201 - open market & internet OTC labeling & advertising
Whether a drug product can be marketed and sold as an OTC - Pathways - OTC Monograph process - mitigating potential FDA regulatory risks
