{"description":"Documents matching 'ibogaine'","count":361,"total_pages":19,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=ibogaine&format=json&page=2","results":[{"title":"Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD). FDA is building on the guidance for industry entitled \"Psychedelic Drugs: Considerations for Clinical Investigations\" by seeking comments, data, and information from the public on protocol elements relevant to ibogaine development--including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight, in part, because the Federal Government is funding work in this area. FDA will consider all information provided in response to this Request for Information (RFI) to inform whether and how these specific elements should be considered in its review of Investigational New Drug Applications (INDs) involving ibogaine.","document_number":"2026-20427","html_url":"https://www.federalregister.gov/documents/2026/10/06/2026-20427/design-and-safety-considerations-for-clinical-trials-involving-ibogaine-drug-products-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-06/pdf/2026-20427.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-20427.pdf?1791204314","publication_date":"2026-10-06","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":"FD&amp;C Act and FDA's regulations, and nothing in this RFI predetermines FDA's action on any submission.\n \n Research on <span class=\"match\">Ibogaine</span> Drug Products \n While published reports suggest potential benefits of <span class=\"match\">ibogaine</span> for treatment of substance use disorders and certain psychiatric and neurologic conditions—including mood disorders, PTSD, and traumatic brain injury—<span class=\"match\">ibogaine</span> also has serious known risks. Clinical data have shown that <span class=\"match\">ibogaine</span> has serious cardiovascular risks and commonly causes substantial QTc interval prolongation, which has been associated"},{"title":"Accelerating Medical Treatments for Serious Mental Illness","type":"Presidential Document","abstract":null,"document_number":"2026-07907","html_url":"https://www.federalregister.gov/documents/2026/04/22/2026-07907/accelerating-medical-treatments-for-serious-mental-illness","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-22/pdf/2026-07907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07907.pdf?1776784506","publication_date":"2026-04-22","agencies":[{"raw_name":"EXECUTIVE OFFICE OF THE PRESIDENT","name":"Executive Office of the President","id":538,"url":"https://www.federalregister.gov/agencies/executive-office-of-the-president","json_url":"https://www.federalregister.gov/api/v1/agencies/538","parent_id":null,"slug":"executive-office-of-the-president"}],"excerpts":"produce approved therapies that promote enduring improvements in the mental health condition of these most complex patients. Innovative methods are needed to find long-term solutions for these Americans beyond existing prescription medications. \n Psychedelic drugs, including <span class=\"match\">ibogaine</span> compounds, show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy. Indeed, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific psychedelic"},{"title":"Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute","type":"Notice","abstract":"Scottsdale Research Institute 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":"2026-21360","html_url":"https://www.federalregister.gov/documents/2026/10/19/2026-21360/bulk-manufacturer-of-controlled-substances-application-scottsdale-research-institute","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-19/pdf/2026-21360.pdf","public_inspection_pdf_url":null,"publication_date":"2026-10-19","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":"September 8, 2026, Scottsdale Research Institute, 12815 North Cave Creek Road, Phoenix, Arizona 85022, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n The company plans to bulk manufacture the listed controlled substance for internal research purposes and to support clinical trials. No other activity for this drug code is authorized for this registration. \n \n Justin Wood, \n Deputy Assistant Administrator"},{"title":"Bulk Manufacturer of Controlled Substances Application: Groff Health Inc","type":"Notice","abstract":"Groff Health 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":"2026-21368","html_url":"https://www.federalregister.gov/documents/2026/10/19/2026-21368/bulk-manufacturer-of-controlled-substances-application-groff-health-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-19/pdf/2026-21368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-21368.pdf?1792154726","publication_date":"2026-10-19","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":"that on September 3, 2026, Groff Health Inc, 2218 South Queen Street, York, Pennsylvania 17402-4631, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n 3,4-Methylenedioxy-methamphetamine \n 7405 \n I \n \n \n Psilocybin \n 7437 \n I \n \n \n Psilocyn \n 7438 \n I \n \n \n The company plans to bulk manufacture the listed controlled substances for internal use and for sale to its customers. No other activities for these"},{"title":"Bulk Manufacturer of Controlled Substances Application: Irvine Labs, Inc.","type":"Notice","abstract":"Irvine Labs, 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":"2026-19803","html_url":"https://www.federalregister.gov/documents/2026/09/28/2026-19803/bulk-manufacturer-of-controlled-substances-application-irvine-labs-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-28/pdf/2026-19803.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19803.pdf?1790340320","publication_date":"2026-09-28","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":"on August 13, 2026, Irvine Labs, Inc., 7305 Murdy Circle, Huntington Beach, California 92647-3533, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \n \n \n Mescaline \n 7381 \n I \n \n \n Peyote \n 7415 \n I \n \n \n Diethyltryptamine \n 7434 \n I \n \n \n Dimethyltryptamine \n 7435 \n I \n \n \n Psilocybin \n 7437 \n I \n \n \n Psilocyn \n 7438 \n I \n \n \n The company plans to bulk manufacture"},{"title":"Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute SRI Montana Satellite Laboratory","type":"Notice","abstract":"Scottsdale Research Institute SRI Montana Satellite Laboratory 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":"2026-17282","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17282/bulk-manufacturer-of-controlled-substances-application-scottsdale-research-institute-sri-montana","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17282.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17282.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":"Scottsdale Research Institute SRI Montana Satellite Laboratory, 426 Deer Creek Road, Lakeside, Montana 59922, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n The company plans to bulk manufacture the listed controlled substances as Active Pharmaceutical Ingredients (API) to support internal research and clinical trials, while also supplying other schedule I researchers"},{"title":"Importer of Controlled Substances Application: Benuvia Operations, LLC","type":"Notice","abstract":"Benuvia Operations, 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":"2026-19792","html_url":"https://www.federalregister.gov/documents/2026/09/28/2026-19792/importer-of-controlled-substances-application-benuvia-operations-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-28/pdf/2026-19792.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19792.pdf?1790340319","publication_date":"2026-09-28","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":"notice that on August 11, 2026, Benuvia Operations, LLC., 3950 North Mays Street, Round Rock, Texas 78665-2729, applied to be registered as an importer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n The company plans to import the listed controlled substance to support internal research and development toward the bulk manufacture of API for future clinical trials. No other activity for this drug code is authorized for this registration. \n Approval of"},{"title":"Importer of Controlled Substances Application: Groff Health Inc.","type":"Notice","abstract":"Groff Health 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":"2026-21355","html_url":"https://www.federalregister.gov/documents/2026/10/19/2026-21355/importer-of-controlled-substances-application-groff-health-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-19/pdf/2026-21355.pdf","public_inspection_pdf_url":null,"publication_date":"2026-10-19","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":" this is notice that on August 7, 2026, Groff Health Inc., 2218 South Queen Street, York, Pennsylvania 17402, applied to be registered as an importer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n Psilocybin \n 7437 \n I \n \n \n Psilocyn \n 7438 \n I \n \n \n The company plans to import bulk substances to support internal research, clinical trials, analytical purposes, and distribution to their customers."},{"title":"Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC","type":"Notice","abstract":"Benuvia Operations, LLC. 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":"2026-09930","html_url":"https://www.federalregister.gov/documents/2026/05/18/2026-09930/bulk-manufacturer-of-controlled-substances-application-benuvia-operations-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-18/pdf/2026-09930.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09930.pdf?1778849128","publication_date":"2026-05-18","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":"notice that on April 22, 2026, Benuvia Operations, LLC., 3950 North Mays Street, Round Rock, Texas 78665, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \n \n \n Marihuana Extract \n 7350 \n I \n \n \n Tetrahydrocannabinols \n 7370 \n I \n \n \n Mescaline \n 7381 \n I \n \n \n 3,4-Methylenedioxyamphetamine \n 7400 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n 5-Methoxy-"},{"title":"Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem","type":"Notice","abstract":"American Radiolabeled Chem 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":"2026-14915","html_url":"https://www.federalregister.gov/documents/2026/07/23/2026-14915/bulk-manufacturer-of-controlled-substances-application-american-radiolabeled-chem","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-23/pdf/2026-14915.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14915.pdf?1784724317","publication_date":"2026-07-23","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":"Radiolabeled Chem, 101 Arc Drive, Saint Louis, Missouri 63146-3502, 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 Gamma Hydroxybutyric Acid \n 2010 \n I \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \n \n \n Tetrahydrocannabinols \n 7370 \n I \n \n \n Dimethyltryptamine \n 7435 \n I \n \n \n 1-[1-(2-Thienyl)cyclohexyl]piperidine \n 7470 \n I \n \n \n Dihydromorphone \n 9145 \n I \n \n \n Heroin \n 9200 \n I \n \n \n Normorphine \n 9313 \n I"},{"title":"Importer of Controlled Substances Application: Scottsdale Research Institute","type":"Notice","abstract":"Scottsdale Research Institute 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":"2026-12140","html_url":"https://www.federalregister.gov/documents/2026/06/17/2026-12140/importer-of-controlled-substances-application-scottsdale-research-institute","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-17/pdf/2026-12140.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12140.pdf?1781613909","publication_date":"2026-06-17","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":"notice that on May 19, 2026, Scottsdale Research Institute, 12815 North Cave Creek Road, Phoenix, Arizona 85022, applied to be registered as an importer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Marihuana \n 7360 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n The company plans to import the above as bulk Active Pharmaceutical Ingredients to support clinical research by Schedule I registrants. In reference to drug codes Marihuana (7360)"},{"title":"Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc.","type":"Notice","abstract":"Irvine Labs 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":"2025-21187","html_url":"https://www.federalregister.gov/documents/2025/11/26/2025-21187/bulk-manufacturer-of-controlled-substances-application-irvine-labs-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-26/pdf/2025-21187.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21187.pdf?1764078327","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":"on October 29, 2025, Irvine Labs Inc., 7305 Murdy Circle, Huntington Beach, California 92647-3533, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \n \n \n Mescaline \n 7381 \n I \n \n \n Peyote \n 7415 \n I \n \n \n Diethyltryptamine \n 7434 \n I \n \n \n Dimethyltryptamine \n 7435 \n I \n \n \n Psilocybin \n 7437 \n I \n \n \n Psilocyn \n 7438 \n I \n \n \n The company plans to bulk manufacture"},{"title":"Importer of Controlled Substances Application: Benuvia Operations, LLC","type":"Notice","abstract":"Benuvia Operations, 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":"2025-21173","html_url":"https://www.federalregister.gov/documents/2025/11/26/2025-21173/importer-of-controlled-substances-application-benuvia-operations-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-26/pdf/2025-21173.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21173.pdf?1764078325","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":"notice that on October 2, 2025, Benuvia Operations, LLC., 3950 North Mays Street, Round Rock, Texas 78665-2729, applied to be registered as an importer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Tetrahydrocannabinols \n 7370 \n I \n \n \n Mescaline \n 7381 \n I \n \n \n 3,4-Methylenedioxyamphetamine \n 7400 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n 5-Methoxy-N-N-dimethyltryptamine \n 7431 \n I \n \n \n Dimethyltryptamine \n 7435 \n I \n \n \n 5-Methoxy-N"},{"title":"Bulk Manufacturer of Controlled Substances Application: Purisys, LLC","type":"Notice","abstract":"Purisys, LLC 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":"2026-06524","html_url":"https://www.federalregister.gov/documents/2026/04/03/2026-06524/bulk-manufacturer-of-controlled-substances-application-purisys-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-03/pdf/2026-06524.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06524.pdf?1775133914","publication_date":"2026-04-03","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":"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 Cathinone \n 1235 \n I \n \n \n Ethylphenidate (ethyl 2-phenyl-2-(piperidin-2-yl)acetate) \n 1727 \n I \n \n \n Gamma Hydroxybutyric Acid \n 2010 \n I \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \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 Mescaline \n 7381 \n I \n \n \n 2,5-Dimethoxyamphetamine \n 7396 \n I \n \n \n 3,4-Methylenedioxyamphetamine \n 7400 \n I"},{"title":"Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC","type":"Notice","abstract":"Benuvia Operations, LLC 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":"2025-15279","html_url":"https://www.federalregister.gov/documents/2025/08/12/2025-15279/bulk-manufacturer-of-controlled-substances-application-benuvia-operations-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-12/pdf/2025-15279.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15279.pdf?1754916319","publication_date":"2025-08-12","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":"notice that on June 13, 2025, Benuvia Operations, LLC, 3950 North Mays Street, Round Rock, Texas 78665, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Marihuana Extract \n 7350 \n I \n \n \n Tetrahydrocannabinols \n 7370 \n I \n \n \n Mescaline \n 7381 \n I \n \n \n 3,4-Methylenedioxyamphetamine \n 7400 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n 5-Methoxy-N,N-dimethyltryptamine \n 7431 \n I \n \n \n Dimethyltryptamine"},{"title":"Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC","type":"Notice","abstract":"Catalent Pharma Solutions, 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":"2025-17581","html_url":"https://www.federalregister.gov/documents/2025/09/12/2025-17581/importer-of-controlled-substances-application-catalent-pharma-solutions-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-12/pdf/2025-17581.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-17581.pdf?1757594707","publication_date":"2025-09-12","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":"that on June 11, 2025, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114-1123, applied to be registered as an importer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \n \n \n 5-Methoxy-N-N-dimethyltryptamine \n 7431 \n I \n \n \n Psilocybin \n 7437 \n I \n \n \n The company plans to import the listed controlled substances as finished dosage unit products for clinical trials, research, and analytical"},{"title":"Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem","type":"Notice","abstract":"American Radiolabeled Chem 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":"2025-11247","html_url":"https://www.federalregister.gov/documents/2025/06/18/2025-11247/bulk-manufacturer-of-controlled-substances-application-american-radiolabeled-chem","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11247.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-11247.pdf?1750164320","publication_date":"2025-06-18","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":"Radiolabeled Chem, 101 Arc Drive, Saint Louis, Missouri 63146-3502, 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 Gamma Hydroxybutyric Acid \n 2010 \n I \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n Lysergic acid diethylamide \n 7315 \n I \n \n \n Tetrahydrocannabinols \n 7370 \n I \n \n \n Dimethyltryptamine \n 7435 \n I \n \n \n 1-[1-(2-Thienyl)cyclohexyl]piperidine \n 7470 \n I \n \n \n Dihydromorphone \n 9145 \n I \n \n \n Heroin \n 9200 \n I \n \n \n Normorphine \n 9313 \n I"},{"title":"Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute","type":"Notice","abstract":"Scottsdale Research Institute 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":"2025-02739","html_url":"https://www.federalregister.gov/documents/2025/02/18/2025-02739/bulk-manufacturer-of-controlled-substances-application-scottsdale-research-institute","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-02-18/pdf/2025-02739.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-02739.pdf?1739540713","publication_date":"2025-02-18","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":"January 8, 2025, Scottsdale Research Institute, 12815 North Cave Creek Road, Phoenix, Arizona 85022, 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 <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n The company plans to bulk manufacture the listed controlled substances for internal research and analytical development purposes. No other activities for these drug codes are authorized for this registration"},{"title":"Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC","type":"Notice","abstract":"Catalent Pharma Solutions, 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":"2025-03061","html_url":"https://www.federalregister.gov/documents/2025/02/26/2025-03061/importer-of-controlled-substances-application-catalent-pharma-solutions-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-02-26/pdf/2025-03061.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-03061.pdf?1740491107","publication_date":"2025-02-26","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":"November 19, 2024, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114-1123, applied to be registered as an importer of the following basic class(es) of controlled substance(s): \n \n   \n \n Controlled substance \n Drug code \n Schedule \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I \n \n \n The company plans to import the listed controlled substance as finished dosage unit products for clinical trials, research, and analytical activities. No other activity for this drug code is authorized for this registration. \n \n Approval of permit applications"},{"title":"Importer of Controlled Substances Application: Cerilliant Corporation","type":"Notice","abstract":"Cerilliant Corporation 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":"2026-11909","html_url":"https://www.federalregister.gov/documents/2026/06/15/2026-11909/importer-of-controlled-substances-application-cerilliant-corporation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-15/pdf/2026-11909.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11909.pdf?1781268307","publication_date":"2026-06-15","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":" \n JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) \n 7203 \n I. \n \n \n PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate) \n 7222 \n I. \n \n \n 5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate) \n 7225 \n I. \n \n \n Alpha-ethyltryptamine \n 7249 \n I. \n \n \n <span class=\"match\">Ibogaine</span> \n 7260 \n I. \n \n \n CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) \n 7297 \n I. \n \n \n CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) \n 7298 \n I. \n \n \n Lysergic acid diethylamide \n 7315 \n I. \n \n \n 2C-T-7 (2,5-Di"}]}