{"description":"Documents matching '\"ipamorelin\"'","count":4,"total_pages":1,"results":[{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2024-21241","html_url":"https://www.federalregister.gov/documents/2024/09/18/2024-21241/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-18/pdf/2024-21241.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21241.pdf?1726577134","publication_date":"2024-09-18","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":"captioned, and recorded through an online teleconferencing and/or video conferencing platform. The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: ibutamoren mesylate, L-theanine, <span class=\"match\">ipamorelin</span>-related bulk drug substances (<span class=\"match\">ipamorelin</span> acetate and <span class=\"match\">ipamorelin</span> (free base)), and kisspeptin-10. The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the nominators of these substances"},{"title":"HISA Anti-Doping and Medication Control Rule","type":"Notice","abstract":"The Horseracing Integrity and Safety Act of 2020 recognizes a self-regulatory nonprofit organization, the Horseracing Integrity and Safety Authority, which is charged with developing proposed rules on a variety of subjects. Those proposed rules and later proposed rule modifications take effect only if approved by the Federal Trade Commission. The proposed rules and rule modifications must be published in the Federal Register for public comment. Thereafter, the Commission has 60 days from the date of publication to approve or disapprove the proposed rule or rule modification. The Authority submitted to the Commission a proposed rule on Anti-Doping and Medication Control on December 30, 2022. The Office of the Secretary of the Commission determined that the proposal complied with the Commission's rule governing such submissions. This document publicizes the Authority's proposed rule's text and explanation, and it seeks public comment on whether the Commission should approve or disapprove the proposed rule. This document is substantially similar to the document published on October 28, 2022, as corrected on November 4, 2022, and the Commission will consider all comments filed in response to that document as well as all comments filed in response to this document.","document_number":"2023-00957","html_url":"https://www.federalregister.gov/documents/2023/01/26/2023-00957/hisa-anti-doping-and-medication-control-rule","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-01-26/pdf/2023-00957.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-00957.pdf?1674654316","publication_date":"2023-01-26","agencies":[{"raw_name":"FEDERAL TRADE COMMISSION","name":"Federal Trade Commission","id":192,"url":"https://www.federalregister.gov/agencies/federal-trade-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/192","parent_id":null,"slug":"federal-trade-commission"}],"excerpts":"Infliximab \n Immunosuppressor \n Remicade \n \n \n BANNED \n S2 \n \n Insulin- like Growth Factor-1 (IGF-1) and its analogues \n Peptide hormone \n \n \n BANNED \n S2 \n \n Insulins \n Anti-hyperglycemics \n \n \n BANNED \n S2 \n \n IOX-2 \n Erythropoiesis \n Lacks FDA approval \n \n \n BANNED \n S2 \n \n <span class=\"match\">Ipamorelin</span> \n Growth Hormone \n Lacks FDA approval \n \n \n CONTROLLED \n S7 \n B \n Ipratropium \n Bronchodilator \n Atrovent \n Detection Time: 120 hrs. 5.5 mcg/kg once daily via nebulization for 3 total doses (6 horses) \n 0.25 ng/mL in urine. \n \n \n CONTROLLED \n S7 \n B \n Ipratropium bromide"},{"title":"HISA Anti-Doping and Medication Control Rule","type":"Notice","abstract":"The Horseracing Integrity and Safety Act of 2020 recognizes a self-regulatory nonprofit organization, the Horseracing Integrity and Safety Authority, which is charged with developing proposed rules on a variety of subjects. Those proposed rules and later proposed rule modifications take effect only if approved by the Federal Trade Commission. The proposed rules and rule modifications must be published in the Federal Register for public comment. Thereafter, the Commission has 60 days from the date of publication to approve or disapprove the proposed rule or rule modification. The Authority submitted to the Commission a proposed rule on Anti-Doping and Medication Control on August 17, 2022 and supplemented on October 13, 2022. The Office of the Secretary of the Commission determined that the proposal complied with the Commission's rule governing such submissions. This document publicizes the Authority's proposed rule text and explanation, and it seeks public comment on whether the Commission should approve or disapprove the proposed rule.","document_number":"2022-22970","html_url":"https://www.federalregister.gov/documents/2022/10/28/2022-22970/hisa-anti-doping-and-medication-control-rule","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-10-28/pdf/2022-22970.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-22970.pdf?1666874715","publication_date":"2022-10-28","agencies":[{"raw_name":"FEDERAL TRADE COMMISSION","name":"Federal Trade Commission","id":192,"url":"https://www.federalregister.gov/agencies/federal-trade-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/192","parent_id":null,"slug":"federal-trade-commission"}],"excerpts":"Infliximab \n Immunosuppressor \n Remicade \n \n \n BANNED \n S2 \n \n Insulin- like Growth Factor-1 (IGF-1) and its analogues \n Peptide hormone \n \n \n BANNED \n S2 \n \n Insulins \n Anti-hyperglycemics \n \n \n BANNED \n S2 \n \n IOX-2 \n Erythropoiesis \n Lacks FDA approval \n \n \n BANNED \n S2 \n \n <span class=\"match\">Ipamorelin</span> \n Growth Hormone \n Lacks FDA approval \n \n \n CONTROLLED \n S7 \n B \n Ipratropium \n Bronchodilator \n Atrovent \n Detection Time: 120 hrs. 5.5 mcg/kg once daily via nebulization for 3 total doses (6 horses) \n 0.25 ng/mL in urine. \n \n \n CONTROLLED \n S7 \n B \n Ipratropium bromide"},{"title":"Advice Concerning the Addition of Certain Pharmaceutical Products and Chemical Intermediates to the Pharmaceutical Appendix to the HTS","type":"Notice","abstract":"Following receipt on December 23, 1998, of a request from the United States Trade Representative (USTR), the Commission instituted investigation No. 332-402, Advice Concerning the Addition of Certain Pharmaceutical Products and Chemical Intermediates to the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States, under section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)). At the request of USTR, the Commission will provide: (1) A summary description of the products contained in the existing Pharmaceutical Appendix and the modifications to be made to that Appendix; (2) an explanation of the relationship of the various elements in the Appendix to the HTS; and (3) estimates of current U.S. imports, and where possible, U.S. exports of the products included in the Pharmaceutical Appendix and the proposed additions to the Appendix, based on product groupings as necessary. The Commission will submit its report to the USTR no later than April 1, 1999.","document_number":"99-1342","html_url":"https://www.federalregister.gov/documents/1999/01/21/99-1342/advice-concerning-the-addition-of-certain-pharmaceutical-products-and-chemical-intermediates-to-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-01-21/pdf/99-1342.pdf","public_inspection_pdf_url":null,"publication_date":"1999-01-21","agencies":[{"raw_name":"INTERNATIONAL TRADE COMMISSION","name":"International Trade Commission","id":262,"url":"https://www.federalregister.gov/agencies/international-trade-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/262","parent_id":null,"slug":"international-trade-commission"}],"excerpts":"150378-17-9\nIndisetron     141549-75-9\nInfliximab     170277-31-3\nInsulin aspart     116094-23-6\nInsulin glargine     160337-95-1\nInterferon alfacon-1     118390-30-0\nIocanlidic acid (123 I)      74855-17-7\nIoflupane (123 I)     155798-07-5\nIometopane (123 I)     136794-86-0\n<span class=\"match\">Ipamorelin</span>     170851-70-4\nIroplact     154248-96-1\nIsrapafant     117279-73-9\nIvabradine     155974-00-8\nKeliximab     174722-30-6\nLagatide     157476-77-2\nLandiolol     133242-30-5\nLanepitant     170566-84-4\nLasinavir     175385-62-3\nLedoxantrone     113457-05-9\nLefradafiban   "}]}