21 U.S.C. § 379j-41 Definitions

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 379j-41

For purposes of this subpart:

(1) The term "abbreviated new drug application"-

(A) means an application submitted under section 355(j) of this title, an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and

(B) does not include an application-

(i) for a positron emission tomography drug; or

(ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.

(2) The term "active pharmaceutical ingredient" means-

(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended-

(i) to be used as a component of a drug; and

(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or

(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).

(3) The term "adjustment factor" means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.

(4) 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.

(5) The term "contract manufacturing organization facility" means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.

(6)

(A) The term "facility"-

(i) means a business or other entity-

(I) under one management, either direct or indirect; and

(II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and

(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.

(B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are-

(i) closely related to the same business enterprise;

(ii) under the supervision of the same local management; and

(iii) capable of being inspected by the Food and Drug Administration during a single inspection.

(C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(7) The term "finished dosage form" means-

(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;