§379j–71 Definitions

Summary

Defines the words used for how the FDA handles nonprescription (OTC) drugs under the monograph process. It lists short meanings for terms used later so people know what is meant by words like affiliate, facility, costs, and tiers of requests. An affiliate is a business tied to another by control, directly or through a third party. A contract manufacturing organization facility is an OTC drug plant whose owner (or its affiliates) does not sell that drug directly to U.S. wholesalers, retailers, or consumers. "Costs of resources allocated for OTC monograph drug activities" means the FDA’s spending on staff and contractors, IT and data systems, buildings and equipment, and collecting and accounting for these fees. An FDA establishment identifier is the unique number the FDA’s FACTS system (or any successor) gives a facility. An OTC monograph drug is a nonprescription drug covered by the monograph rules in section 355h. OTC monograph drug activities cover the FDA’s review and rulemaking, labeling and policy work, inspections, research monitoring, safety tracking (including adverse events and related IT and analysis), and other actions needed to run the monograph system. An OTC monograph order request is a formal request under section 355h; Tier 2 requests are specific, generally minor changes (like certain label edits, dose standardization, nomenclature alignment, adding interchangeable terms, or adding/modifying testing that follows a voluntary consensus standard recognized by the FDA through guidance first published in July 2023), and any request not put in Tier 2 is Tier 1. The FDA can reclassify requests as Tier 2 and publish that in a proposed order under section 355h. An OTC monograph drug facility is a single-location manufacturer of finished dosage forms (including contract manufacturers), with nearby related buildings treated as one site if under the same local management and FDA identifier; if separate management runs parts of the site, each counts as its own facility. An OTC monograph drug meeting is any meeting about a proposed order. The word person includes an affiliate. The words requestor and sponsor have the meanings given in section 355h.