{"description":"Documents matching 'pharmaceutical'","count":10000,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=pharmaceutical&format=json&page=2","results":[{"title":"Notice of Reduction of Tariffs on Patented Pharmaceuticals and Pharmaceutical Ingredients for Products of the United Kingdom Implemented by Presidential Proclamation 11020","type":"Notice","abstract":"This notice revises the tariff rate on patented pharmaceuticals and associated pharmaceutical ingredients that are products of the United Kingdom from 10 percent to zero percent in accordance with Proclamation 11020 \"Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States.\"","document_number":"2026-15799","html_url":"https://www.federalregister.gov/documents/2026/08/04/2026-15799/notice-of-reduction-of-tariffs-on-patented-pharmaceuticals-and-pharmaceutical-ingredients-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-04/pdf/2026-15799.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15799.pdf?1785528908","publication_date":"2026-08-04","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"Bureau of Industry and Security","name":"Industry and Security Bureau","id":241,"url":"https://www.federalregister.gov/agencies/industry-and-security-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/241","parent_id":54,"slug":"industry-and-security-bureau"}],"excerpts":"President issued Proclamation 11020 “Adjusting Imports of <span class=\"match\">Pharmaceuticals</span> and <span class=\"match\">Pharmaceutical</span> Ingredients Into the United States,” (Presidential Proclamation) on April 2, 2026, to adjust imports of patented <span class=\"match\">pharmaceuticals</span> and associated <span class=\"match\">pharmaceutical</span> ingredients, (Proclamation 11020 of April 2, 2026) (91 FR 18183). \n \n The Presidential Proclamation directed the Secretary to publish a \n Federal Register \n Notice indicating that the tariff rate on patented <span class=\"match\">pharmaceuticals</span> and associated <span class=\"match\">pharmaceutical</span> ingredients that are products of the United Kingdom"},{"title":"Procedures To Apply for Company-Specific Onshoring Agreements To Obtain Tariff Adjustments for Pharmaceuticals and Pharmaceutical Ingredients Under Proclamation 11020","type":"Notice","abstract":"This notice announces the procedures for companies that manufacture pharmaceutical products to apply for company-specific agreements with the Department of Commerce (Commerce) to onshore manufacturing of pharmaceutical products and their ingredients. Companies that enter into such agreements are eligible for a reduced Section 232 duty rate for imports of their pharmaceutical products and associated ingredients. Companies are requested to submit applications within 30 days of publication in the Federal Register.","document_number":"2026-09489","html_url":"https://www.federalregister.gov/documents/2026/05/13/2026-09489/procedures-to-apply-for-company-specific-onshoring-agreements-to-obtain-tariff-adjustments-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-13/pdf/2026-09489.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09489.pdf?1778512513","publication_date":"2026-05-13","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"Bureau of Industry and Security","name":"Industry and Security Bureau","id":241,"url":"https://www.federalregister.gov/agencies/industry-and-security-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/241","parent_id":54,"slug":"industry-and-security-bureau"}],"excerpts":"18183), “Adjusting Imports of <span class=\"match\">Pharmaceuticals</span> and <span class=\"match\">Pharmaceutical</span> Ingredients Into the United States,” (Proclamation 11020) finding that imports of <span class=\"match\">pharmaceuticals</span> and <span class=\"match\">pharmaceutical</span> ingredients threaten to impair the national security of the United States and imposing tariffs to adjust imports of such products pursuant to Section 232 of the Trade Expansion Act of 1962 (Section 232). Proclamation 11020 imposed a 100 percent ad valorem tariff on certain imports of patented <span class=\"match\">pharmaceuticals</span> and associated <span class=\"match\">pharmaceutical</span> ingredients, effective September"},{"title":"Importer of Controlled Substances Application: Royal Emerald Pharmaceuticals","type":"Notice","abstract":"Royal Emerald Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.","document_number":"2026-07561","html_url":"https://www.federalregister.gov/documents/2026/04/17/2026-07561/importer-of-controlled-substances-application-royal-emerald-pharmaceuticals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-17/pdf/2026-07561.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07561.pdf?1776343520","publication_date":"2026-04-17","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Royal Emerald <span class=\"match\">Pharmaceuticals</span> has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n SUPPLEMENTARY INFORMATION \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 18, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: Veterans Pharmaceuticals, Inc.","type":"Notice","abstract":"Veterans Pharmaceuticals, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-13148","html_url":"https://www.federalregister.gov/documents/2026/06/30/2026-13148/importer-of-controlled-substances-application-veterans-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-30/pdf/2026-13148.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13148.pdf?1782737114","publication_date":"2026-06-30","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Veterans <span class=\"match\">Pharmaceuticals</span>, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n Supplementary Information \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 30, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: Amneal Pharmaceuticals, LLC","type":"Notice","abstract":"Amneal Pharmaceuticals, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.","document_number":"2026-10089","html_url":"https://www.federalregister.gov/documents/2026/05/20/2026-10089/importer-of-controlled-substances-application-amneal-pharmaceuticals-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-20/pdf/2026-10089.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10089.pdf?1779194712","publication_date":"2026-05-20","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Amneal <span class=\"match\">Pharmaceuticals</span>, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n SUPPLEMENTARY INFORMATION \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before June 22, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: ANI Pharmaceuticals Inc.","type":"Notice","abstract":"ANI Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.","document_number":"2026-08587","html_url":"https://www.federalregister.gov/documents/2026/05/04/2026-08587/importer-of-controlled-substances-application-ani-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-04/pdf/2026-08587.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08587.pdf?1777639510","publication_date":"2026-05-04","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n ANI <span class=\"match\">Pharmaceuticals</span> Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n SUPPLEMENTARY INFORMATION \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before June 3, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: Quagen Pharmaceuticals LLC","type":"Notice","abstract":"Quagen Pharmaceuticals LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.","document_number":"2026-07559","html_url":"https://www.federalregister.gov/documents/2026/04/17/2026-07559/importer-of-controlled-substances-application-quagen-pharmaceuticals-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-17/pdf/2026-07559.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07559.pdf?1776343520","publication_date":"2026-04-17","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Quagen <span class=\"match\">Pharmaceuticals</span> LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n SUPPLEMENTARY INFORMATION \n listed below for further drug information.\n \n \n \n DATES: \n \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 18, 2026. Such persons may also file a written request for a \n \n hearing on the application"},{"title":"Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc.","type":"Notice","abstract":"Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-08585","html_url":"https://www.federalregister.gov/documents/2026/05/04/2026-08585/bulk-manufacturer-of-controlled-substances-application-patheon-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-04/pdf/2026-08585.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08585.pdf?1777639510","publication_date":"2026-05-04","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"accordance with 21 CFR 1301.33(a), this is notice that on March 18, 2026, Patheon <span class=\"match\">Pharmaceuticals</span> Inc., 2110 East Galbraith Road, Cincinnati, Ohio 45237-1625, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n \n Drug\n code \n \n Schedule \n \n \n Gamma Hydroxybutyric Acid \n 2010 \n I \n \n \n The company plans to bulk manufacture the listed controlled substance as an Active <span class=\"match\">Pharmaceutical</span> Ingredient that will be further synthesized into Food and Drug Administration approved"},{"title":"Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals","type":"Notice","abstract":"Royal Emerald Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-06256","html_url":"https://www.federalregister.gov/documents/2026/04/01/2026-06256/bulk-manufacturer-of-controlled-substances-application-royal-emerald-pharmaceuticals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-01/pdf/2026-06256.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06256.pdf?1774961109","publication_date":"2026-04-01","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":" Royal Emerald <span class=\"match\">Pharmaceuticals</span>, 14011 Palm Drive, Building B, Desert Hot Springs, California 92240-6845, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n Marihuana Extract \n 7350 \n I \n \n \n Marihuana \n 7360 \n I \n \n \n Tetrahydrocannabinols \n 7370 \n I \n \n \n The company plans to bulk manufacture the listed controlled substance(s) to provide Marihuana (Cannabis) as botanical raw material and/or active <span class=\"match\">pharmaceutical</span> ingredients (API)"},{"title":"Importer of Controlled Substances Application: Amneal Pharmaceuticals, LLC","type":"Notice","abstract":"Amneal Pharmaceuticals, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.","document_number":"2026-04289","html_url":"https://www.federalregister.gov/documents/2026/03/04/2026-04289/importer-of-controlled-substances-application-amneal-pharmaceuticals-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-04/pdf/2026-04289.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04289.pdf?1772545523","publication_date":"2026-03-04","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Amneal <span class=\"match\">Pharmaceuticals</span>, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n SUPPLEMENTARY INFORMATION \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 3, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.","type":"Notice","abstract":"Galephar Pharmaceutical Research Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-17284","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17284/importer-of-controlled-substances-application-galephar-pharmaceutical-research-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17284.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17284.pdf?1787575520","publication_date":"2026-08-25","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Galephar <span class=\"match\">Pharmaceutical</span> Research Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n Supplementary Information \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before September 24, 2026. Such persons may also file a written request for a hearing"},{"title":"Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals Inc.","type":"Notice","abstract":"ANI Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-08586","html_url":"https://www.federalregister.gov/documents/2026/05/04/2026-08586/bulk-manufacturer-of-controlled-substances-application-ani-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-04/pdf/2026-08586.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08586.pdf?1777639510","publication_date":"2026-05-04","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n ANI <span class=\"match\">Pharmaceuticals</span> Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information. \n \n \n DATES: \n \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration \n \n on or before July 6, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.","type":"Notice","abstract":"Mylan Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-01072","html_url":"https://www.federalregister.gov/documents/2026/01/21/2026-01072/importer-of-controlled-substances-application-mylan-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-21/pdf/2026-01072.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-01072.pdf?1768916717","publication_date":"2026-01-21","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n Mylan <span class=\"match\">Pharmaceuticals</span> Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information. \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before February 20, 2026. Such person may also file a hearing on the application on or before February"},{"title":"Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.","type":"Notice","abstract":"Janssen Pharmaceuticals Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2026-00128","html_url":"https://www.federalregister.gov/documents/2026/01/08/2026-00128/importer-of-controlled-substances-application-janssen-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-08/pdf/2026-00128.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00128.pdf?1767793510","publication_date":"2026-01-08","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n Janssen <span class=\"match\">Pharmaceuticals</span> Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information. \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before February 9, 2026. Such persons may also file a written request for a hearing on the application"},{"title":"Importer of Controlled Substances Application: Halo Pharmaceutical Inc.","type":"Notice","abstract":"Halo Pharmaceutical Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2025-21177","html_url":"https://www.federalregister.gov/documents/2025/11/26/2025-21177/importer-of-controlled-substances-application-halo-pharmaceutical-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-26/pdf/2025-21177.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21177.pdf?1764078326","publication_date":"2025-11-26","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Halo <span class=\"match\">Pharmaceutical</span> Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to \n Supplementary Information \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before December 26, 2025. Such persons may also file a written request for a hearing on the application"},{"title":"Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.","type":"Notice","abstract":"Janssen Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2025-23467","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23467/bulk-manufacturer-of-controlled-substances-application-janssen-pharmaceuticals-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23467.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23467.pdf?1766065528","publication_date":"2025-12-19","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Janssen <span class=\"match\">Pharmaceuticals</span>, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to \n Supplementary Information \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before February 17, 2026. Such persons may also file a written request for a hearing"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with CGMP for drugs, finished pharmaceuticals, including active pharmaceutical ingredients (APIs), and the advanced manufacturing technologies (AMT) designation program.","document_number":"2026-03326","html_url":"https://www.federalregister.gov/documents/2026/02/20/2026-03326/agency-information-collection-activities-proposed-collection-comment-request-current-good","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-20/pdf/2026-03326.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03326.pdf?1771508709","publication_date":"2026-02-20","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":"Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished <span class=\"match\">Pharmaceuticals</span> (Including Active <span class=\"match\">Pharmaceutical</span> Ingredients), and the Advanced Manufacturing Technologies Designation Program \n OMB Control Number 0910-0139—Revision \n This information collection supports statutory and regulatory requirements that govern the manufacture, processing, packing, or holding of finished <span class=\"match\">pharmaceuticals</span>, including active <span class=\"match\">pharmaceutical</span> ingredients (APIs). Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C"},{"title":"Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products.\" When finalized, this guidance will assist sponsors in implementing streamlined approaches for general toxicology, for nonclinical safety assessments of certain oncology pharmaceuticals. The guidance is intended to facilitate drug development for biological products and conjugated products for the treatment of cancer while avoiding unnecessary animal use. The recommendations in this draft guidance are informed by data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce use of non-human primates.","document_number":"2026-10873","html_url":"https://www.federalregister.gov/documents/2026/06/01/2026-10873/oncology-pharmaceuticals-streamlined-nonclinical-safety-studies-for-biologics-and-conjugated","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-01/pdf/2026-10873.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10873.pdf?1780058723","publication_date":"2026-06-01","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":"Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Oncology <span class=\"match\">Pharmaceuticals</span>: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products.” When finalized, this guidance will assist sponsors in implementing streamlined approaches for general toxicology, for nonclinical safety assessments of certain oncology <span class=\"match\">pharmaceuticals</span>. The guidance is intended to facilitate drug development for biological products and conjugated products for the treatment of cancer while"},{"title":"Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients","type":"Notice","abstract":"The Secretary of Commerce initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended. Interested parties are invited to submit written comments, data, analyses, or other information pertinent to the investigation to the Department of Commerce's (Department) Bureau of Industry and Security (BIS), Office of Strategic Industries and Economic Security. This notice identifies issues on which the Department is especially interested in obtaining the public's views.","document_number":"2025-06587","html_url":"https://www.federalregister.gov/documents/2025/04/16/2025-06587/notice-of-request-for-public-comments-on-section-232-national-security-investigation-of-imports-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-16/pdf/2025-06587.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06587.pdf?1744661708","publication_date":"2025-04-16","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"Bureau of Industry and Security","name":"Industry and Security Bureau","id":241,"url":"https://www.federalregister.gov/agencies/industry-and-security-bureau","json_url":"https://www.federalregister.gov/api/v1/agencies/241","parent_id":54,"slug":"industry-and-security-bureau"}],"excerpts":"the following: \n (i) the current and projected demand for <span class=\"match\">pharmaceuticals</span> and <span class=\"match\">pharmaceutical</span> ingredients in the United States; \n (ii) the extent to which domestic production of <span class=\"match\">pharmaceuticals</span> and <span class=\"match\">pharmaceutical</span> ingredients can meet domestic demand; \n (iii) the role of foreign supply chains, particularly of major exporters, in meeting United States demand for <span class=\"match\">pharmaceuticals</span> and <span class=\"match\">pharmaceutical</span> ingredients; \n (iv) the concentration of United States imports of <span class=\"match\">pharmaceuticals</span> and <span class=\"match\">pharmaceutical</span> ingredients from a small number of suppliers and the associated"},{"title":"Bulk Manufacturer of Controlled Substances Application: Continuus Pharmaceuticals","type":"Notice","abstract":"Continuus Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.","document_number":"2025-16007","html_url":"https://www.federalregister.gov/documents/2025/08/21/2025-16007/bulk-manufacturer-of-controlled-substances-application-continuus-pharmaceuticals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-21/pdf/2025-16007.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-16007.pdf?1755693966","publication_date":"2025-08-21","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":"ACTION: \n Notice of application. \n \n \n SUMMARY: \n \n Continuus <span class=\"match\">Pharmaceuticals</span> has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to \n Supplementary Information \n listed below for further drug information.\n \n \n \n DATES: \n Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before October 20, 2025. Such persons may also file a written request for a hearing on"}]}