21 U.S.C. § 379j–41 — Definitions

submitted 88 years ago by Pub. L. 112-144 to r/title-21-FOOD-AND-DRUGS · 1,219 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law defines terms used for generic drug user fees, like "facility" and "submission." It explains what counts as an FDA generic-drug review activity and which costs it covers.

This section defines terms used throughout this part of the law. (1) "Abbreviated new drug application" (A) means an application filed under the standard generic-drug approval process, an abbreviated application filed under an older provision as it read before November 21, 1997, or one filed under regulations that predate the 1984 Drug Price Competition and Patent Term Restoration Act. (B) It does NOT include an application for a positron emission tomography drug, or one filed by a State or Federal government entity for a drug that won't be sold commercially. (2) "Active pharmaceutical ingredient" means (A) a substance — or, if it's unstable or can't be shipped alone, a mixture — meant to be a component of a drug and to have a real pharmacological effect: to diagnose, treat, cure, or prevent disease, or to affect the body's structure or function; or (B) a substance meant to be purified, crystallized, or turned into a salt so it becomes that kind of substance. (3) "Adjustment factor" means the Consumer Price Index for October of the prior fiscal year, divided by the Index for October 2011. (4) "Affiliate" means a business connected to another business where, directly or indirectly, either one controls the other, or a third party controls both. (5) "Contract manufacturing organization facility" means a facility that makes the finished form of a generic drug but isn't itself named in that drug's approved application, whether it's owned by the application holder, an affiliate of the holder, or someone else. (6) "Facility" (A) means a business at one location, under one management, that manufactures or processes an active ingredient or a finished drug form — but does not include a business whose only activities are repackaging, relabeling, or testing. (B) Separate nearby buildings count as one location if they're part of the same business, run by the same local managers, and can be inspected together in a single FDA visit. (C) If what would otherwise be one facility is actually run by separate management teams, each team's part counts as its own separate facility. (7) "Finished dosage form" means (A) the form given directly to a patient, like a tablet, capsule, solution, or topical product; (B) a form that needs to be mixed or dissolved before use, like an oral suspension or a freeze-dried powder; or (C) any combination of an active ingredient with another drug component to make (A) or (B). (8) "Generic drug submission" means an abbreviated new drug application, an amendment to one, or a "prior approval supplement" to one. (9) "Human generic drug activities" covers: (A) reviewing generic drug submissions, including referenced drug master files; (B) issuing approval letters, or "complete response" letters listing an application's deficiencies and, where appropriate, how to fix them; (C) issuing letters about Type II drug master files, either listing deficiencies and how to resolve them or confirming there are none; (D) inspections related to generic drugs; (E) monitoring related research; (F) postmarket safety work — collecting and reviewing adverse-event reports, building better safety data-collection systems and analysis tools, and enforcing post-approval study, labeling-change, and risk-management rules for generic drugs; and (G) broader scientific research related to generic drugs. (10) "Positron emission tomography drug" has the same meaning as a related, more specific term defined elsewhere in this title, except that one exclusion within that definition does not apply here. (11) "Prior approval supplement" means a request to change something in an approved generic drug's substance, product, manufacturing process, quality controls, equipment, or facilities, when that change has a real potential to hurt the drug's identity, strength, quality, purity, or potency in a way that could affect its safety or effectiveness. (12) "Resources allocated for human generic drug activities" means the FDA's expenses for: (A) staff, contractors, and advisory committees, and related costs; (B) managing information and computer systems; (C) leasing, maintaining, and repairing facilities, equipment, and supplies; and (D) collecting fees and accounting for the resources used in reviewing applications and inspecting facilities. (13) "Type II active pharmaceutical ingredient drug master file" means information someone submits so the FDA can use it to support approving a generic drug application, without the submitter having to disclose that information directly to the generic-drug applicant.

the actual law source: uscode.house.gov ↗public domain

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;

(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).

(8)

The term “generic drug submission” means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.

(9)

The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:

(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—

(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.

(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

(ii)

document that no deficiencies need to be addressed.

(D)

Inspections related to generic drugs.

(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:

(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.

(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.

(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.

(10)

The term “positron emission tomography drug” has the meaning given to the term “compounded positron emission tomography drug” in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply.

(11)

The term “prior approval supplement” means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.

(12)

The term “resources allocated for human generic drug activities” means the expenses 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 and employees and 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 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.

(13)

The term “Type II active pharmaceutical ingredient drug master file” means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.

Source credit: (June 25, 1938, ch. 675, § 744A, as added Pub. L. 112–144, title III, § 302, July 9, 2012, 126 Stat. 1008; amended Pub. L. 115–52, title III, § 302, Aug. 18, 2017, 131 Stat. 1020.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 112-144 · 126 Stat. 1008
2017Amended · Pub. L. 115-52 · 131 Stat. 1020

A history note hasn’t been published yet. The record shows enactment by Pub. L. 112-144 on 1938-06-25.

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