21 U.S.C. § 379j-41
Section 379j-41 · Definitions
Current version, with additions and removals from the July 9, 2012 version.
For purposes of this subpart:
For purposes of this subpart:
(1) The term “abbreviated new drug application”—
(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
(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
(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—
(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—
(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
(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
(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).
(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.
(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—
(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
(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.
(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.
(i) means a business or other entity—
(i) means a business or other entity—
(I) under one management, either direct or indirect; and
(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) 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.
(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—
(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;
(i) closely related to the same business enterprise;
(ii) under the supervision of the same local management; and
(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.
(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.
(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.
(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;
(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;
(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or
(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or
(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).
(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).
(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.
(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.
(B) The issuance of—
(B) The issuance of—
(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or
(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or
(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.
(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.
(C) The issuance of letters related to Type II active pharmaceutical drug master files which—
(C) The issuance of letters related to Type II active pharmaceutical drug master files which—
(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or
(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or
(ii) document that no deficiencies need to be addressed.
(ii) document that no deficiencies need to be addressed.
(D) Inspections related to generic drugs.
(D) Inspections related to generic drugs.
(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.
(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.
(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:
(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications.
(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications.
(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).
(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).
(G) Regulatory science activities related to generic drugs.
(G) Regulatory science activities related to generic drugs.
(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 and employees and to contracts with such contractors;
(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 and employees and to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(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
(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 subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.
(D) collecting fees under subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.