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21 U.S.C. § 360ddd — Definitions
Federal law — U.S. Code and appendices · legal_authorities
In this part:
(1) The term “designated medical gas” means any of the following:
(A) Oxygen that meets the standards set forth in an official compendium.
(B) Nitrogen that meets the standards set forth in an official compendium.
(C) Nitrous oxide that meets the standards set forth in an official compendium.
(D) Carbon dioxide that meets the standards set forth in an official compendium.
(E) Helium that meets the standards set forth in an official compendium.
(F) Carbon monoxide that meets the standards set forth in an official compendium.
(G) Medical air that meets the standards set forth in an official compendium.
(H) Any other medical gas deemed appropriate by the Secretary, after taking into account any investigational new drug application or investigational new animal drug application for the same medical gas submitted in accordance with regulations applicable to such applications in title 21 of the Code of Federal Regulations, unless any period of exclusivity for a new drug under [section 355(c)(3)(E)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3/E/ii&num=0&edition=prelim) or [section 355(j)(5)(F)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/F/ii&num=0&edition=prelim), or the extension of any such period under [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim), or any period of exclusivity for a new animal drug under [section 360b(c)(2)(F) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/c/2/F&num=0&edition=prelim), applicable to such medical gas has not expired.
(2) The term “medical gas” means a drug
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Stable record: federal_law:legal_authorities:record_usc_0153e60dbadecd79a6e4d449
Source file: Laws/federal/codes/united-states-code/title-21/section-360ddd-definitions--134db85794.md
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Source location: Title 21, Chapter 9, § 360ddd; chapter-009-federal-food-drug-and-cosmetic-act.md
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In this part:
(1) The term “designated medical gas” means any of the following:
(A) Oxygen that meets the standards set forth in an official compendium.
(B) Nitrogen that meets the standards set forth in an official compendium.
(C) Nitrous oxide that meets the standards set forth in an official compendium.
(D) Carbon dioxide that meets the standards set forth in an official compendium.
(E) Helium that meets the standards set forth in an official compendium.
(F) Carbon monoxide that meets the standards set forth in an official compendium.
(G) Medical air that meets the standards set forth in an official compendium.
(H) Any other medical gas deemed appropriate by the Secretary, after taking into account any investigational new drug application or investigational new animal drug application for the same medical gas submitted in accordance with regulations applicable to such applications in title 21 of the Code of Federal Regulations, unless any period of exclusivity for a new drug under [section 355(c)(3)(E)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3/E/ii&num=0&edition=prelim) or [section 355(j)(5)(F)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/F/ii&num=0&edition=prelim), or the extension of any such period under [section 355a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355a&num=0&edition=prelim), or any period of exclusivity for a new animal drug under [section 360b(c)(2)(F) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/c/2/F&num=0&edition=prelim), applicable to such medical gas has not expired.
(2) The term “medical gas” means a drug that—
(A) is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; and
(B) is administered as a gas.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** As used in this section, the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.
**(b) Market exclusivity for new drugs**
(1) **In general** — Except as provided in paragraph (2), if, prior to approval of an application that is submitted under [section 355(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b/1&num=0&edition=prelim), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with subsection (d)(4)—
(A)
(i)
(I) the period referred to in subsection (c)(3)(E)(ii) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), and in subsection (j)(5)(F)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Regulations for goods to be processed, labeled, or repacked elsewhere** The Secretary is directed to promulgate regulations exempting from any labeling or packaging requirement of this chapter drugs and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment.
**(b) Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws**
(1) A drug intended for use by man which—
(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) to use under the professional supervision of a practitioner licensed by law to administer such drug;
shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 353
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Federal law — U.S. Code and appendices · legal_authorities
In this part:
(1) **Affiliate** — 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 the power to control, both of the business entities.
(2) **Authorized** — The term “authorized” means—
(A) in the case of a manufacturer or repackager, having a valid registration in accordance with [section 360 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360&num=0&edition=prelim);
(B) in the case of a wholesale distributor, having a valid license under State law or [section 360eee–2 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360eee-2&num=0&edition=prelim), in accordance with [section 360eee–1(a)(6) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360eee–1/a/6&num=0&edition=prelim), and complying with the licensure reporting requirements under [section 353(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/e&num=0&edition=prelim);
(C) in the case of a third-party logistics provider, having a valid license under State law or [section 360eee–3(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360eee–3/a/1&num=0&edition=prelim), in accordance with [section 360eee–1(a)(7) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360eee–1/a/7&num=0&edition=prelim), and complying with the licensure reporting requirements under [section 360eee–3(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-p
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360eee
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Federal law — U.S. Code and appendices · legal_authorities
Page 449
TITLE 21—FOOD AND DRUGS
§ 360ddd
species may request that the Secretary declare
that drug a ‘‘designated new animal drug’’. A re-
quest for designation of a new animal drug shall
be made before the submission of an application
under section 360b(b) of this title or section
360ccc of this title for the new animal drug.
(2) The Secretary may declare a new animal
drug a ‘‘designated new animal drug’’ if—
(A) it is intended for a minor use or use in
a minor species; and
(B) the same drug in the same dosage form
for the same intended use is not approved
under section 360b or 360ccc of this title or des-
ignated under this section at the time the re-
quest is made.
(3) Regarding the termination of a designa-
tion—
(A) the sponsor of a new animal drug shall
notify the Secretary of any decision to dis-
continue active pursuit of approval under sec-
tion 360b or 360ccc of this title of an applica-
tion for a designated new animal drug. The
Secretary shall terminate the designation
upon such notification;
(B) the Secretary may also terminate des-
ignation if the Secretary independently deter-
mines that the sponsor is not actively pur-
suing approval under section 360b or 360ccc of
this title with due diligence;
(C) the sponsor of an approved designated
new animal drug shall notify the Secretary of
any discontinuance of the manufacture of such
new animal drug at least one year before dis-
continuance. The Secretary shall terminate
the designation upon such notification; and
(D) the designation shall terminate upon the
expiration of any applicable exclusivity period
under subsection (c).
(4) Notice respecting the designation or termi-
nation of designation of a new animal drug shall
be made available to the public.
(b) Grants and contracts for de
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360ddd
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