---
kind: "section"
citation: "21 U.S.C. § 379j–71"
title: "21"
title_heading: "Food and Drugs"
number: "379j–71"
heading: "Definitions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/379j-71"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VII — General Authority"
  - "Part C — Fees"
  - "Subpart 10 — fees relating to over-the-counter drugs"
---

# §379j–71. Definitions


In this subpart:

- (1) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
  - (A) one business entity controls, or has the power to control, the other business entity; or
  - (B) a third party controls, or has power to control, both of the business entities.
- (2) The term “contract manufacturing organization facility” means an [OTC monograph drug facility](#10-A) where neither the owner of such manufacturing [facility](/usc/21/364.md?p=3-A) nor any [affiliate](#1) of such owner or [facility](/usc/21/364.md?p=3-A) sells the [OTC monograph drug](#5) produced at such [facility](/usc/21/364.md?p=3-A) directly to wholesalers, retailers, or consumers in the United States.
- (3) The term “costs of resources allocated for OTC monograph drug activities” means the expenses in connection with [OTC monograph drug activities](#6) for—
  - (A) officers and employees of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, contractors of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, [advisory committees](/usc/21/360fff.md?p=1), and costs related to such officers, employees, and committees and costs related to contracts with such contractors;
  - (B) management of information, and the acquisition, maintenance, and repair of computer resources;
  - (C) leasing, maintenance, renovation, and repair of [facilities](/usc/21/364.md?p=3-A) and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
  - (D) collecting fees under [section 379j–72 of this title](/usc/21/379j–72.md) and accounting for resources allocated for [OTC monograph drug activities](#6).
- (4) The term “FDA establishment identifier” is the unique number automatically generated by [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration’s Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).
- (5) The term “OTC monograph drug” means a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1) without an approved [new drug](/usc/21/321.md?p=p) application which is governed by the provisions of [section 355h of this title](/usc/21/355h.md).
- (6) The term “OTC monograph drug activities” means activities of the [Secretary](/usc/21/321.md?p=d) associated with [OTC monograph drugs](#5) and inspection of [facilities](/usc/21/364.md?p=3-A) associated with such [products](/usc/21/360eee.md?p=13), including the following activities:
  - (A) The activities necessary for review and evaluation of OTC monographs and [OTC monograph order requests](#7), including—
    - (i) orders proposing or finalizing applicable conditions of use for [OTC monograph drugs](#5);
    - (ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;
    - (iii) all [OTC monograph drug](#5) development and review activities, including intra-agency collaboration;
    - (iv) regulation and policy development activities related to [OTC monograph drugs](#5);
    - (v) development of [product](/usc/21/360eee.md?p=13) standards for [products](/usc/21/360eee.md?p=13) subject to review and evaluation;
    - (vi) meetings referred to in [section 355h(i) of this title](/usc/21/355h.md?p=i);
    - (vii) review of [labeling](/usc/21/321.md?p=m) prior to issuance of orders related to [OTC monograph drugs](#5) or conditions of use; and
    - (viii) regulatory science activities related to [OTC monograph drugs](#5).
  - (B) Inspections related to [OTC monograph drugs](#5).
  - (C) Monitoring of clinical and other research conducted in connection with [OTC monograph drugs](#5).
  - (D) Safety activities with respect to [OTC monograph drugs](#5), including—
    - (i) collecting, developing, and reviewing safety information on [OTC monograph drugs](#5), including [adverse event](/usc/21/364.md?p=1) reports;
    - (ii) developing and using improved [adverse event](/usc/21/364.md?p=1) data-collection systems, including information technology systems; and
    - (iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.
  - (E) Other activities necessary for implementation of [section 355h of this title](/usc/21/355h.md).
- (7) The term “OTC monograph order request” means a request for an order submitted under [section 355h(b)(5) of this title](/usc/21/355h.md?p=b-5).
- (8) The term “Tier 1 OTC monograph order request” means any [OTC monograph order request](#7) not determined to be a [Tier 2 OTC monograph order request](#9-A).
- (9)
  - (A) The term “Tier 2 OTC monograph order request” means, subject to [subparagraph (B)](#9-B), an [OTC monograph order request](#7) for—
    - (i) the reordering of existing information in the [drug](/usc/21/321.md?p=g-1) facts [label](/usc/21/321.md?p=k) of an [OTC monograph drug](#5);
    - (ii) the addition of information to the other information section of the [drug](/usc/21/321.md?p=g-1) facts [label](/usc/21/321.md?p=k) of an [OTC monograph drug](#5), as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);
    - (iii) modification to the directions for use section of the [drug](/usc/21/321.md?p=g-1) facts [label](/usc/21/321.md?p=k) of an [OTC monograph drug](#5), if such changes conform to changes made pursuant to [section 355h(c)(3)(A) of this title](/usc/21/355h.md?p=c-3-A);
    - (iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
    - (v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization;
    - (vi) the addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations); or
    - (vii) the addition or modification of a testing procedure applicable to one or more [OTC monograph drugs](#5), provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is—
      - (I) established by a national or international standards development organization; and
      - (II) recognized by the [Secretary](/usc/21/321.md?p=d) through a process described in guidance for industry, initially published in July 2023, or any successor guidance, publicly available on the website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, which addresses voluntary consensus standards for pharmaceutical quality.
  - (B) The [Secretary](/usc/21/321.md?p=d) may, based on program implementation experience or other factors found appropriate by the [Secretary](/usc/21/321.md?p=d), characterize any [OTC monograph order request](#7) as a [Tier 2 OTC monograph order request](#9-A) (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to [section 355h of this title](/usc/21/355h.md).
- (10)
  - (A) The term “OTC monograph drug facility” means a foreign or domestic business or other entity that—
    - (i) is—
      - (I) under one management, either direct or indirect; and
      - (II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an [OTC monograph drug](#5);
    - (ii) includes a finished dosage form [manufacturer](/usc/21/360hh.md?p=3) [facility](/usc/21/364.md?p=3-A) in a contractual relationship with the [sponsor](#13) of one or more [OTC monograph drugs](#5) to manufacture or process such [drugs](/usc/21/321.md?p=g-1); and
    - (iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer [packaging](/usc/21/364.md?p=3-C) on [packages](/usc/21/360eee.md?p=11-A) containing multiple [products](/usc/21/360eee.md?p=13), for such purposes as creating multipacks, when each monograph [drug product](/usc/21/321.md?p=dd) contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.
  - (B) For purposes of [subparagraph (A)(i)(II)](#10-A-i-II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—
    - (i) closely related to the same business enterprise;
    - (ii) under the supervision of the same local management; and
    - (iii) under a single [FDA establishment identifier](#4) and capable of being inspected by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration during a single inspection.
  - (C) If a business or other entity would meet criteria specified in [subparagraph (A)](#10-A), but for being under multiple management, the business or other entity is deemed to constitute multiple [facilities](/usc/21/364.md?p=3-A), one per management entity, for purposes of this paragraph.
- (11) The term “OTC monograph drug meeting” means any meeting regarding the content of a proposed [OTC monograph order request](#7).
- (12) The term “person” includes an [affiliate](#1) of a person.
- (13) The terms “requestor” and “sponsor” have the meanings given such terms in [section 355h of this title](/usc/21/355h.md).

## Source credit

(June 25, 1938, ch. 675, § 744L, as added Pub. L. 116–136, div. A, title III, § 3862, Mar. 27, 2020, 134 Stat. 459; amended Pub. L. 119–37, div. F, title V, § 6503, Nov. 12, 2025, 139 Stat. 637.)

## Notes

### Termination of Section

For termination of section by section 6509(a) of Pub. L. 119–37, see Termination Date note below.

### Editorial Notes

### Amendments

2025—Par. (9)(A)(vi). Pub. L. 119–37, § 6503(2)(A), substituted “the addition” for “addition”.

Par. (9)(A)(vii). Pub. L. 119–37, § 6503(1), (2)(B), (3), added cl. (vii)

### Statutory Notes and Related Subsidiaries

### Effective Date of 2025 Amendment

Amendment by Pub. L. 119–37 effective Nov. 12, 2025, with fees under this subpart to be assessed beginning Oct. 1, 2025, see section 6510 of Pub. L. 119–37, set out as a note under section 355 of this title.

### Termination Date

Pub. L. 119–37, div. F, title V, § 6509(a), Nov. 12, 2025, 139 Stat. 648, provided that: “Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71; 379j–72) shall cease to be effective October 1, 2030.”

### Savings Clause

Pub. L. 119–37, div. F, title V, § 6511, Nov. 12, 2025, 139 Stat. 648, provided that: “Notwithstanding the amendments made by this title [amending this section and sections 355, 355h, 379j–72, and 379j–73 of this title], part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), as in effect on the day before the date of enactment of this Act [Nov. 12, 2025], shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2026.”

### Finding

Pub. L. 119–37, div. F, title V, § 6502, Nov. 12, 2025, 139 Stat. 637, provided that: “Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 355, 355h, 379j–72, and 379j–73 of this title] will be dedicated to over-the-counter (OTC) monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record.”

Pub. L. 116–136, div. A, title III, § 3861, Mar. 27, 2020, 134 Stat. 458, provided that: “The Congress finds that the fees authorized by the amendments made in this part [part II of subtitle F of title III of div. A of Pub. L. 116–136, enacting this subpart] will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”