21 U.S.C. § 379j–71 — Definitions

This section defines the terms used in the OTC (over-the-counter) monograph drug fee law. (1) "Affiliate" means a business connected to a second business if either one controls (or can control) the other, or a third party controls (or can control) both. (2) "Contract manufacturing organization facility" means an OTC monograph drug facility where neither the facility's owner nor any affiliate of the owner or facility sells the OTC monograph drug made there directly to wholesalers, retailers, or consumers in the United States. (3) "Costs of resources allocated for OTC monograph drug activities" means the FDA's expenses for: (A) officers, employees, contractors, and advisory committees involved in these activities, and related costs; (B) managing information and acquiring, maintaining, and repairing computer resources; (C) leasing, maintaining, renovating, and repairing facilities, and acquiring, maintaining, and repairing fixtures, furniture, scientific equipment, and other necessary supplies; and (D) collecting the fees under section 379j–72 and tracking how the resources are used. (4) "FDA establishment identifier" means the unique number automatically generated by the FDA's Field Accomplishments and Compliance Tracking System (FACTS), or any system that replaces it. (5) "OTC monograph drug" means a nonprescription drug without an approved new drug application that is governed by section 355h of this title. (6) "OTC monograph drug activities" means the FDA's activities tied to these drugs and to inspecting related facilities. This includes: (A) reviewing and evaluating OTC monographs and monograph order requests — covering orders that set or finalize allowed uses, orders on whether an ingredient or combination is generally recognized as safe and effective, all monograph drug development and review work (including work shared across FDA divisions), related regulation and policy development, developing product standards, meetings under section 355h(i), reviewing labeling before issuing orders, and related regulatory-science work; (B) inspections tied to these drugs; (C) monitoring clinical and other research connected to them; (D) safety work, including collecting, developing, and reviewing safety information such as adverse-event reports, building better adverse-event data-collection systems including information technology, and building better analytical tools to spot safety risks, including access to outside databases; and (E) other activities needed to carry out section 355h. (7) "OTC monograph order request" means a request for an order submitted under section 355h(b)(5) of this title. (8) "Tier 1 OTC monograph order request" means any monograph order request that is not classified as a Tier 2 request. (9) "Tier 2 OTC monograph order request" generally means a request for: reordering existing information on a drug facts label; adding information to the "other information" section of a drug facts label, within the limits set in the regulations; modifying the directions-for-use section of a drug facts label consistent with changes made under section 355h(c)(3)(A); standardizing the concentration or dose of a specific finalized ingredient within a particular finalized monograph; changing an ingredient's name to match a standards-setting organization's naming; adding an interchangeable term allowed under the regulations; or adding or modifying a testing procedure that reflects a voluntary consensus quality standard set by a national or international standards body and recognized by the FDA under its July 2023 guidance (or any successor guidance). The FDA may also, based on program experience or other factors it finds appropriate, decide that any order request counts as Tier 2 — including moving a request from Tier 1 to Tier 2 — by publishing that decision in a proposed order under section 355h. (10) "OTC monograph drug facility" means a foreign or domestic business or other entity that is under one direct or indirect management, at one geographic location, making or processing the finished form of an OTC monograph drug — including a finished-dosage manufacturer under contract with the drug's sponsor to make or process it. It does not include a business whose only related activities are making clinical research supplies, testing, or just adding outer packaging (such as for multipacks) around monograph drug products that are already in their final packaged form. Separate buildings or locations close to each other still count as "one location" if the activities there are closely tied to the same business, run by the same local management, and share a single FDA establishment identifier that lets the FDA inspect them together in one inspection. If a business would otherwise qualify as one facility but is under separate management, each management entity is instead treated as running its own separate facility. (11) "OTC monograph drug meeting" means any meeting about the content of a proposed OTC monograph order request. (12) "Person" includes a person's affiliate. (13) "Requestor" and "sponsor" have the meanings given those terms in section 355h of this title — this section does not itself spell out those meanings.