§379j–71 Definitions

Summary

Lists the key words used for the rules about over‑the‑counter (OTC) monograph drugs and what each word means. Affiliate: a business that controls, is controlled by, or shares a controller with another business. Contract manufacturing organization facility: an OTC monograph drug factory where neither the owner nor any affiliate sells the drug directly to wholesalers, retailers, or consumers in the United States. Costs of resources allocated for OTC monograph drug activities: the money spent on FDA staff and contractors, IT and computer work, buildings and equipment, and collecting fees under section 379j–72 and related accounting. FDA establishment identifier: the unique number the FDA’s FACTS system (or its successor) gives to a facility. OTC monograph drug: a nonprescription drug without an approved new drug application that is covered by section 355h. OTC monograph drug activities: work by the Secretary related to OTC monographs and inspections, including reviewing monographs and order requests (for example, proposing or finalizing conditions of use, status changes, label review, standards and policy work, meetings, and regulatory science), inspections, monitoring research, safety work (like collecting adverse events and improving IT and analysis), and other actions needed to carry out section 355h. OTC monograph order request: a request filed under section 355h(b)(5). Tier 1: any order request that is not Tier 2. Tier 2: seven specific kinds of order requests, such as reordering Drug Facts information; adding limited items to the “other information” part of the label; certain changes to directions that match section 355h(c)(3)(A); standardizing a finalized ingredient’s dose or concentration; aligning ingredient names with a standards body; adding an interchangeable term under 21 CFR 330.1; or adding or changing a testing method that follows a voluntary consensus pharmaceutical quality standard recognized through the FDA guidance first published in July 2023. The Secretary may reclassify requests between Tier 1 and Tier 2 and publish that decision in a proposed order. OTC monograph drug facility: a domestic or foreign business under one management at one location that makes the finished dosage form, including contract manufacturers, but not places that only make clinical study supplies, run tests, or only put outer overpacks on already finished products; nearby buildings count as one location if they are the same enterprise, under the same local management, have one FDA establishment identifier, and can be inspected in a single visit, and a site under multiple managements is treated as multiple facilities. OTC monograph drug meeting: any meeting about what a proposed order request should say. Person: includes an affiliate. Requestor and sponsor: have the meanings given in section 355h.