{"description":"Documents matching '\"nitrous oxide\" inhalant'","count":3,"total_pages":1,"results":[{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.","document_number":"2024-13190","html_url":"https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-18/pdf/2024-13190.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13190.pdf?1718628314","publication_date":"2024-06-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"statement requirements for oxygen in § 201.161(a)(1)(i) to § 201.161(a)(1), without proposing any changes to the requirements. We also proposed moving the warning statement requirements for nitrogen, carbon dioxide, helium, <span class=\"match\">nitrous oxide</span>, and medically appropriate combinations of oxygen, nitrogen, carbon dioxide, helium, and <span class=\"match\">nitrous oxide</span> in § 201.161(a)(1)(ii) to § 201.161(a)(2) and proposed expanding their scope to all designated medical gases other than oxygen as well as medically appropriate combinations of any medical gases. We also proposed adding"},{"title":"Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing new regulations that would amend the requirements concerning current good manufacturing practice (CGMP) and postmarketing safety reporting that apply to certain medical gases. FDA further proposes to establish regulations regarding certification of designated medical gases and amend the labeling regulations that apply to certain medical gases. This action, if finalized, will clarify the regulatory obligations of entities that manufacture, process, pack, label, or distribute certain medical gases, as well as reduce regulatory burden in this area. This proposed rule is intended to establish requirements that are more specifically tailored to the medical gas industry.","document_number":"2022-10458","html_url":"https://www.federalregister.gov/documents/2022/05/23/2022-10458/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-05-23/pdf/2022-10458.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-10458.pdf?1653050713","publication_date":"2022-05-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"505 or 512, subject to all applicable postapproval requirements,” for certain indications for use. FDA interprets the term “combination” in this section to mean two or more distinct designated medical gases that are mixed together. For example, a mixture of oxygen and <span class=\"match\">nitrous oxide</span> that each meet the standards set forth in an official compendium could constitute a medically appropriate combination of designated medical gases. However, the addition of oxygen to a container that already contains oxygen would not result in a medically appropriate combination"},{"title":"Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Flunisolide, etc.)","type":"Rule","abstract":"The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA- regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil as products that do not release ODSs, and therefore they will no longer be essential uses of ODSs as of the effective dates of this rule. MDIs for these active moieties containing an ODS may not be marketed after the relevant effective date.","document_number":"2010-8467","html_url":"https://www.federalregister.gov/documents/2010/04/14/2010-8467/use-of-ozone-depleting-substances-removal-of-essential-use-designation-flunisolide-etc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-04-14/pdf/2010-8467.pdf","public_inspection_pdf_url":null,"publication_date":"2010-04-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"greenhouse gases such as carbon dioxide and <span class=\"match\">nitrous oxide</span>. FDA's regulations at 21 CFR 2.125 reflect an international effort to reduce the production, importation, and use of substances that deplete the ozone layer. We are publishing this rule because the criteria in § 2.125 have been met, rather than because of any contribution CFCs may be making towards global warming. \n (Comment 26) Another comment suggests FDA retain the essential-use designation for Combivent Inhalation Aerosol and instead remove other <span class=\"match\">inhalants</span>, such as aerosol hair sprays, spray"}]}