In this subpart:
(1) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(2)
The term “contract manufacturing organization facility” means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility 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 for—
(A)
officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and costs related to contracts with such contractors;
(C)
leasing, maintenance, renovation, and repair of facilities 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 and accounting for resources allocated for OTC monograph drug activities.
(4)
The term “FDA establishment identifier” is the unique number automatically generated by Food and Drug Administration’s Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).
(5)
The term “OTC monograph drug” means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title.
(6) The term “OTC monograph drug activities” means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:
(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—
(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 development and review activities, including intra-agency collaboration;
(vii)
review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and
(D) Safety activities with respect to OTC monograph drugs, including—
(i)
collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;
(7)
The term “OTC monograph order request” means a request for an order submitted under section 355h(b)(5) of this title.
(8)
The term “Tier 1 OTC monograph order request” means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.
(9)
(A) The term “Tier 2 OTC monograph order request” means, subject to subparagraph (B), an OTC monograph order request for—
(ii)
the addition of information to the other information section of the drug facts label of an OTC monograph drug, 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 facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 355h(c)(3)(A) of this title;
(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, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is—
(II)
recognized by the Secretary 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 and Drug Administration, which addresses voluntary consensus standards for pharmaceutical quality.
(B)
The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (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.
(10)
(A) The term “OTC monograph drug facility” means a foreign or domestic business or other entity that—
(i) is—
(II)
at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;
(ii)
includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; 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 on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product 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), 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—
(iii)
under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.
(11)
The term “OTC monograph drug meeting” means any meeting regarding the content of a proposed OTC monograph order request.
(13)
The terms “requestor” and “sponsor” have the meanings given such terms in section 355h of this title.
(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.)