§379j–71 Definitions

Summary

Defines key words used when the FDA handles nonprescription drugs under the OTC monograph system. It says who counts as an affiliate, what a contract manufacturing organization facility is, what costs count for OTC monograph work, what the FDA establishment identifier is, what an OTC monograph drug is, what kinds of FDA activities fall under OTC monograph work, what an OTC monograph order request is, how Tier 1 and Tier 2 requests differ, what an OTC monograph drug facility is, and a few other basic terms. Affiliate means a business that controls, is controlled by, or shares a controller with another business. A contract manufacturing organization facility is an OTC drug plant whose owner or affiliates do not sell that drug directly in the United States. Costs of resources allocated for OTC monograph drug activities cover FDA staff and contractor costs, IT and computer systems, buildings and equipment, and fee collection/accounting. FDA establishment identifier is the unique number the FDA’s FACTS system (or its successor) assigns. OTC monograph drug means a nonprescription drug governed by the monograph rules rather than an approved new drug application. OTC monograph drug activities include review and orders, inspections, research monitoring, safety work (like adverse event collection and data systems), and other steps needed to run the monograph program. An OTC monograph order request is a request for an order under the monograph process. Tier 2 requests are specific, mostly low-risk label, naming, dosing, or testing changes (including testing tied to voluntary consensus standards recognized by FDA guidance first published in July 2023); Tier 1 is anything not Tier 2. An OTC monograph drug facility is a single-location manufacturer (including certain contract manufacturers) with rules about nearby buildings and separate management. A person includes their affiliates, and the terms requestor and sponsor mean what the monograph rules say.