§360ddd. Definitions — Inbound Citations
21 U.S.C. § 360ddd
Cited by 27 provisions in release 119-102.
Citations to 21 U.S.C. § 360ddd as a whole
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(Q) the distribution of medical gas, as defined in section 360ddd of this title;
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(13) The term “product” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 353a or 353b of this title.
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(xvii) the distribution of a medical gas (as defined in section 360ddd of this title); or
Citations to §360ddd(1)
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(1) 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.
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(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.
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(A) the medical gas subject to the certification is not a designated medical gas;
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(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
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(i) 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, clause (iii) or (iv) of section 355(j)(5)(F) of this title, or section 360cc of this title, or the extension of any such period under section 355a of this title, applicable to such indication for use for such gas or combination of gases has not expired.
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(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, clause (iii) or (iv) of section 355(j)(5)(F) of this title, or section 360cc of this title, or the extension of any such period under section 355a of this title, applicable to such indication for use for such gas or combination of gases has not expired.
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(ii) 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;(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.
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(i) 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, on the basis of such deemed approval.
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(A) 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 or section 360b of this title.
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(1) A designated medical gas shall be subject to the requirements of section 353(b)(1) of this title unless the Secretary exercises the authority provided in section 353(b)(3) of this title to remove such medical gas from the requirements of section 353(b)(1) of this title, 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.
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A designated medical gas, alone or in combination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an approved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval.
Citations to §360ddd(1)(H)
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(ii) No period of exclusivity under section 355(c), 355(j), or section 360cc of this title, or the extension of any such period under section 355a of this title, 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.
Citations to §360ddd(2)
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(Q) the distribution of medical gas, as defined in section 360ddd of this title;
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(1) 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.
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(A) A description of the medical gas.
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(C) The name and address of the facility or facilities where the medical gas is or will be manufactured.
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(D) Any other information deemed appropriate by the Secretary to determine whether the medical gas is a designated medical gas.
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(A) the medical gas subject to the certification is not a designated medical gas;
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(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
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(ii) 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;(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.
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(II) a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and
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(1) A designated medical gas shall be subject to the requirements of section 353(b)(1) of this title unless the Secretary exercises the authority provided in section 353(b)(3) of this title to remove such medical gas from the requirements of section 353(b)(1) of this title, 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.
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(13) The term “product” means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 353a or 353b of this title.
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(xvii) the distribution of a medical gas (as defined in section 360ddd of this title); or