Browse Arkansas Code titles and sections
21 U.S.C. § 360ddd–1 — Regulation of medical gases
Federal law — U.S. Code and appendices · legal_authorities
**(a) Certification of designated medical gases**
(1) **Submission** — Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information:
(A) A description of the medical gas.
(B) The name and address of the sponsor.
(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.
(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.
(2) **Grant of certification** — The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that—
(A) the medical gas subject to the certification is not a designated medical gas;
(B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; or
(C) denying the request is necessary to protect the public health.
(3) **Effect of certification**
(A) *In general*
(i) *Approved uses* — A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b of this title, subject to all applicable postapproval requirements, for the following indications for use:
(I) In the case
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ddd–1
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: 6245eb7139dce53cd044a1a149de31f555a64499e7d381ee9a16d92898a95211. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Record provenance
Stable record: federal_law:legal_authorities:record_usc_c05a06793fdc480ed675d414
Source file: Laws/federal/codes/united-states-code/title-21/section-360ddd1-regulation-of-medical-gases--89b84dfe4b.md
Pages: Not recorded – Not recorded
Passage SHA-256: 13dbd0ecd2f0fe93d7055c1598d54a4324cb8550cbbc97ac995181e421a918af
Source location: Title 21, Chapter 9, § 360ddd–1; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
**(a) Certification of designated medical gases**
(1) **Submission** — Beginning 180 days after July 9, 2012, any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce may file with the Secretary a request for certification of a medical gas as a designated medical gas. Any such request shall contain the following information:
(A) A description of the medical gas.
(B) The name and address of the sponsor.
(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.
(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.
(2) **Grant of certification** — The certification requested under paragraph (1) is deemed to be granted unless, within 60 days of the filing of such request, the Secretary finds that—
(A) the medical gas subject to the certification is not a designated medical gas;
(B) the request does not contain the information required under paragraph (1) or otherwise lacks sufficient information to permit the Secretary to determine that the medical gas is a designated medical gas; or
(C) denying the request is necessary to protect the public health.
(3) **Effect of certification**
(A) *In general*
(i) *Approved uses* — A designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section 355 or 360b of this title, subject to all applicable postapproval requirements, for the following indications for use:
(I) In the case of oxygen, the treatment or prevention of hypoxemia or hypoxia.
(II) In the case of nitrogen, use in hypoxic challenge testing.
(III) In the case of nitrous oxide, analgesia.
(IV) In the case of carbon dioxide, use in extracorporeal membrane oxygenation therapy or respiratory stimulation.
(V) In the case of helium, the treatment of upper airway obstruction or increased airway resistance.
(VI) In the case of medical air, to reduce the risk of hyperoxia.
(VII) In the case of carbon monoxide, use in lung diffusion testing.
(VIII) Any other indication for use for a designated medical gas or combination of designated medical gases deemed appropriate by the Secretary, unless any period of exclusivity for a new drug under clause (iii) or (iv) of [section 355(c)(3)(E) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/c/3/E&num=0&edition=prelim), clause (iii) or (iv) of [section 355(j)(5)(F) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/j/5/F&num=0&edition=prelim), or [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&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), applicable to such indication for use for such gas or combination of gases has not expired.
(ii) *Labeling* — The requirements of sections 353(b)(4) and 352(f) of this title are deemed to have been met for a designated medical gas if the labeling on the final use container for such medical gas bears—
(I) the information required by [section 353(b)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/4&num=0&edition=prelim);
(II) a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and
(III) appropriate directions and warnings concerning storage and handling.
(B) *Inapplicability of exclusivity provisions*
(i) *No exclusivity for a certified medical gas* — No designated medical gas deemed under subparagraph (A)(i) to have in effect an approved application is eligible for any period of exclusivity for a new drug under section 355(c), 355(j), or 360cc of this title, 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), on the basis of such deemed approval.
(ii) *Effect on certification* — No period of exclusivity under section 355(c), 355(j), or [section 360cc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360cc&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), with respect to an application for a drug product, shall prohibit, limit, or otherwise affect the submission, grant, or effect of a certification under this section, except as provided in subsection (a)(3)(A)(i)(VIII) and [section 360ddd(1)(H) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ddd/1/H&num=0&edition=prelim).
(4) **Withdrawal, suspension, or revocation of approval**
(A) *Withdrawal, suspension of approval* — Nothing in this part limits the Secretary’s authority to withdraw or suspend approval of a drug product, including a designated medical gas deemed under this section to have in effect 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) or [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim).
(B) *Revocation of certification* — The Secretary may revoke the grant of a certification under paragraph (2) if the Secretary determines that the request for certification contains any material omission or falsification.
**(b) Prescription requirement**
(1) **In general** — A designated medical gas shall be subject to the requirements of [section 353(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/1&num=0&edition=prelim) unless the Secretary exercises the authority provided in [section 353(b)(3) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/3&num=0&edition=prelim) to remove such medical gas from the requirements of [section 353(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/1&num=0&edition=prelim), the gas is approved for use without a prescription pursuant to an application under section 355 or 360b of this title, or the use in question is authorized pursuant to another provision of this chapter relating to use of medical products in emergencies.
(2) **Oxygen**
(A) *No prescription required for certain uses* — Notwithstanding paragraph (1), oxygen may be provided without a prescription for the following uses:
(i) For use in the event of depressurization or other environmental oxygen deficiency.
(ii) For oxygen deficiency or for use in emergency resuscitation, when administered by properly trained personnel.
(B) *Labeling* — For oxygen provided pursuant to subparagraph (A), the requirements of [section 353(b)(4) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/4&num=0&edition=prelim) shall be deemed to have been met if its labeling bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
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
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances**
(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of [section 351(a)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/5&num=0&edition=prelim) and [section 342(a)(2)(C)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/C/ii&num=0&edition=prelim) unless—
(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application;
(B) there is in effect a conditional approval of an application filed pursuant to [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application;
(C) there is in effect an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or
(D) there is in effect an authorization pursuant to [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and su
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360b
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
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
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Exclusive approval, certification, or license** Except as provided in subsection (b), if the Secretary—
(1) approves an application filed pursuant to [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(2) issues a license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)
for a drug designated under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) for a rare disease or condition, the Secretary may not approve another application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or issue another license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for the same drug for the same disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 355(c)(2) 11 See References in Text note below. of this title does not apply to the refusal to approve an application under the preceding sentence.
**(b) Exceptions** During the 7-year period described in subsection (a) for 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) or license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), the Secretary
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360cc
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.