21 U.S.C. § 379g — Definitions
submitted 88 years ago by Pub. L. 102-571 to r/title-21-FOOD-AND-DRUGS · 1,471 words · no verdicts yet
This section defines terms used for FDA drug-review fees, like "human drug application," "supplement," and "prescription drug product." It also explains "final dosage form," "prescription drug establishment," and the FDA's review process. It also defines "affiliate," "adjustment factor," and other fee-related terms.
This section defines words used in this part of the law.
(1) "Human drug* application" means an application to approve a new drug* under section 355(b), or to license a biological product under section 262(a) of title 42. It does NOT include: a supplement (a request to change an already-approved application); an application for whole blood or a blood part used for transfusions; an application for a bovine blood product for use on skin, licensed before September 1, 1992; an application for an allergenic extract product licensed before October 1, 2022; an application for a standardized allergenic extract product, if the Secretary* told the applicant there's a potency test for an allergenic extract product the applicant already had licensed before October 1, 2022; an application for an in vitro diagnostic biologic product licensed under section 262; an application for a large-volume drug given by injection, approved before September 1, 1992; an application to license a biological product only for further manufacturing (not sale to patients); or an application or supplement from a state or federal government agency for a drug that isn't sold commercially. It DOES include an application to license a large-volume biological product meant for a single intravenous injection or infusion.
(2) "Supplement" means a request to the Secretary to approve a change to a human drug application that's already been approved.
(3) "Prescription drug product*" means a specific strength of a drug, in its finished form, that: has an approved human drug application; can only be sold with a prescription, under section 353(b); and appears on one of two lists — either the FDA's list under section 355(j)(7)(A) (not counting products in the "discontinued" part of that list), or a similar list the Secretary keeps for products approved under section 262 of title 42 (also not counting the discontinued part). It excludes the same things listed under "human drug application" above — whole blood, blood parts, older bovine blood and allergenic extract products, in vitro diagnostic biologics, biologics licensed only for further manufacturing, and noncommercial government drugs — and it includes large-volume biological products for single-dose IV use, just like above. There's a special timing rule: if someone asks in writing to move a product to the "discontinued" part of one of those lists, and says when the product is (or will be) pulled from sale, then for the purpose of calculating the prescription drug program fee under section 379h(a)(2), the Secretary treats the product as discontinued starting on whichever is later — the day the request arrived, or the future date the product actually leaves the market. A product counts as "withdrawn from sale" once the company that owns the application stops distributing it themselves — even if older stock hasn't been recalled — but a short, routine break in supply doesn't count as a withdrawal.
(4) "Final dosage form" means the finished, ready-to-use version of a prescription drug — the form approved for giving to a patient without major extra manufacturing steps. Capsules, tablets, and freeze-dried products before mixing are examples.
(5) "Prescription drug establishment" means a business location — one or more buildings all within five miles of each other — where at least one prescription drug product is manufactured into its final dosage form. Just packaging a drug doesn't count as "manufacturing" here.
(6) "Process for the review of human drug applications" means everything the Secretary does to review these applications and supplements. That includes: the actual review work; sending out letters that approve an application or explain exactly what's missing and what's needed to fix it; inspecting prescription drug establishments and other facilities as part of reviewing pending applications; reviewing applications to license facilities under section 262 and releasing batches of biologics under that section; and watching over research connected to these reviews. It also includes safety work after a drug is approved: collecting and reviewing safety data, including reports of bad reactions; building better systems and technology to collect that data; building better tools — including access to outside databases — to catch safety problems; carrying out the rules on required follow-up studies, trials, and label* changes (section 355(o)) and on risk management plans (section 355(p)); and handling adverse-event reports and other postmarket safety work under section 355(k)(5).
(7) "Costs of resources allocated for the process for the review of human drug applications" means the money spent on: FDA staff, contractors, and advisory committees connected to this review work; managing information and buying, maintaining, and fixing computer systems; leasing, fixing up, and repairing facilities, and buying and maintaining equipment, furniture, and supplies; and collecting the fees under section 379h and keeping track of how review resources are used.
(8) "Adjustment factor" for a fiscal year means the Consumer Price Index (all items, all urban consumers, national average) for October of the year before, divided by that same index for October 1996.
(9) "Person" includes an affiliate of that person.
(10) "Active," for a commercial investigational new drug application, means information was sent in about that application during the relevant time period.
(11) "Affiliate" means a business connected to another business because — directly or indirectly — one of them controls or has the power to control the other, or because a third party controls or has power to control both of them.
(12) "Skin-test diagnostic product" means a product that: is given by pricking, scratching, or injecting just under or into the skin; is expected to cause only a small, local reaction at the test site (if the result is positive), not a whole-body effect; isn't meant to prevent or treat anything; and is meant to detect an immediate or delayed skin reaction, to help diagnose an allergy to an antimicrobial drug, or another kind of allergy (if the test was already approved for marketing before October 1, 2022), or an infection from a fungus or mycobacteria. The term also includes the positive and negative control substances needed to make sense of the product's results.
For purposes of this subpart:
The term “human drug* application” means an application for—
approval of a new drug* submitted under section 355(b) of this title, or
licensure of a biological product under subsection (a) of section 262 of title 42.
Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary* regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product* approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.
The term “supplement” means a request to the Secretary to approve a change in a human drug application which has been approved.
The term “prescription drug product” means a specific strength or potency of a drug in final dosage form—
for which a human drug application has been approved,
which may be dispensed only under prescription pursuant to section 353(b) of this title, and
which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).
Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.
If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 379h(a)(2) of this title, the Secretary shall consider such product to have been included in the discontinued section on the later of—
the date such request was received; or
if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.
For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.
The term “final dosage form” means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).
The term “prescription drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term “manufactured” does not include packaging.
The term “process for the review of human drug applications” means the following activities of the Secretary with respect to the review of human drug applications and supplements:
The activities necessary for the review of human drug applications and supplements.
The issuance of action letters which approve human drug applications or 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.
The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements.
Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section.
Monitoring of research conducted in connection with the review of human drug applications.
Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:
Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.
Developing and using improved adverse-event data-collection systems, including information technology systems.
Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
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).
Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).
The term “costs of resources allocated for the process for the review of human drug applications” means the expenses in connection with the process for the review of human drug applications for—
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 to contracts with such contractors,
management of information, and the acquisition, maintenance, and repair of computer resources,
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and
collecting fees under section 379h of this title and accounting for resources allocated for the review of human drug applications and supplements.
The term “adjustment factor” applicable to a fiscal year 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 1996.
The term “person” includes an affiliate thereof.
The term “active”, with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.
The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
one business entity controls, or has the power to control, the other business entity; or
a third party controls, or has power to control, both of the business entities.
The term “skin-test diagnostic product”—
means a product—
for prick, scratch, intradermal, or subcutaneous administration;
expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;
not intended to be a preventive or therapeutic intervention; and
intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—
an allergy to an antimicrobial agent;
an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or
infection with fungal or mycobacterial pathogens; and
includes positive and negative controls required to interpret the results of a product described in subparagraph (A).
Source credit: (June 25, 1938, ch. 675, § 735, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105–115, title I, §§ 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326; Pub. L. 107–188, title V, § 503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85, title I, § 102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, § 7002(f)(3)(A), Mar. 23, 2010, 124 Stat. 818; Pub. L. 112–144, title I, § 102, title IV, § 407, July 9, 2012, 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, § 1002, Sept. 30, 2022, 136 Stat. 2140.)
- 1938Enacted · Pub. L. 102-571 · 106 Stat. 4491
- 1997Amended · Pub. L. 105-115 · 111 Stat. 2298, 2326
- 2002Amended · Pub. L. 107-188 · 116 Stat. 688
- 2007Amended · Pub. L. 110-85 · 121 Stat. 825
- 2010Amended · Pub. L. 111-148 · 124 Stat. 818
- 2012Amended · Pub. L. 112-144 · 126 Stat. 996, 1039
- 2022Amended · Pub. L. 117-180 · 136 Stat. 2140
A history note hasn’t been published yet. The record shows enactment by Pub. L. 102-571 on 1938-06-25.
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