{"description":"Documents matching 'bulk drug substances' and published on or after 07/01/2026","count":47,"total_pages":3,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bpublication_date%5D%5Bgte%5D=2026-07-01&conditions%5Bterm%5D=bulk+drug+substances&format=json&page=2","results":[{"title":"Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled \"Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities.\" This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.","document_number":"2026-17580","html_url":"https://www.federalregister.gov/documents/2026/08/28/2026-17580/compounding-animal-drugs-from-bulk-drug-substances-compounding-under-cgmp-in-federally-registered","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-28/pdf/2026-17580.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17580.pdf?1787834714","publication_date":"2026-08-28","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":"policy would include compounding office stock on “The List of <span class=\"match\">Bulk</span> <span class=\"match\">Drug</span> <span class=\"match\">Substances</span> for \n \n Compounding Office Stock <span class=\"match\">Drugs</span> for Use in Nonfood-Producing Animals” \n and \n any other animal <span class=\"match\">drug</span> from a <span class=\"match\">bulk</span> <span class=\"match\">drug</span> <span class=\"match\">substance</span>, provided there is no marketed approved/indexed human or animals <span class=\"match\">drugs</span> with the same active moiety and route of administration). We invite comment on this or other options.\n \n 2. FDA seeks information on the relative percentages of <span class=\"match\">drugs</span> being compounded from <span class=\"match\">bulk</span> <span class=\"match\">drug</span> <span class=\"match\">substances</span> that meet the definition of a copy under this guidance (same"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees","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 pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.","document_number":"2026-17676","html_url":"https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17676.pdf?1787921110","publication_date":"2026-08-31","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":"(1) whether it intends to compound, within the next calendar year, a <span class=\"match\">drug</span> that appears on our <span class=\"match\">drug</span> shortage list in effect under section 506E of the FD&amp;C Act (21 U.S.C. 356e); and (2) whether it compounds from <span class=\"match\">bulk</span> <span class=\"match\">drug</span> <span class=\"match\">substances</span> and, if so, whether it compounds sterile or nonsterile <span class=\"match\">drugs</span> from <span class=\"match\">bulk</span> <span class=\"match\">drug</span> <span class=\"match\">substances</span>. Registered outsourcing facilities must submit a <span class=\"match\">drug</span> product report upon initial registration under section 503B and twice each year in June and December for <span class=\"match\">drug</span> products produced during the previous 6-month period. We require this"},{"title":"Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals","type":"Notice","abstract":"Chattem Chemicals 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":"2026-17287","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17287/bulk-manufacturer-of-controlled-substances-application-chattem-chemicals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17287.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17287.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":"Remifentanil \n 9739 \n II \n \n \n Sufentanil \n 9740 \n II \n \n \n Tapentadol \n 9780 \n II \n \n \n Fentanyl \n 9801 \n II \n \n \n \n The company plans to <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substances</span> in <span class=\"match\">bulk</span> distribution and sale to its customers. In reference to dug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to <span class=\"match\">bulk</span> manufacture these <span class=\"match\">drugs</span> as synthetic. No other activities for these \n \n <span class=\"match\">drug</span> codes are authorized for this registration.\n \n \n Justin Wood, \n Acting Deputy Assistant Administrator. \n \n \n [FR Doc. 2026-17287 Filed 8-24-26;"},{"title":"Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC","type":"Notice","abstract":"Kinetochem 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":"2026-17288","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17288/bulk-manufacturer-of-controlled-substances-application-kinetochem-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17288.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17288.pdf?1787575521","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":"Street, Suite 102, Georgetown, Texas 78626-3618, applied to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n \n <span class=\"match\">Drug</span>\n code \n \n Schedule \n \n \n 3,4-Methylenedioxy-N-methylcathinone \n 7540 \n I \n \n \n The company plans to <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substance</span> as Active Pharmaceutical Ingredients to its customers as well as for research and clinical trials. No other activity for this <span class=\"match\">drug</span> code is authorized for this registration. \n \n Justin Wood, \n Acting Deputy Assistant"},{"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":"be registered as a <span class=\"match\">bulk</span> manufacturer of basic class(es) of controlled <span class=\"match\">substance</span>(s). Refer to Supplementary Information listed below for further <span class=\"match\">drug</span> information. \n \n \n DATES: \n Registered <span class=\"match\">bulk</span> 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 21, 2026. Such persons may also file a written request for a hearing on the application on or before September 21, 2026. \n \n \n ADDRESSES: \n \n The <span class=\"match\">Drug</span> Enforcement Administration"},{"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":"2026-18204","html_url":"https://www.federalregister.gov/documents/2026/09/08/2026-18204/bulk-manufacturer-of-controlled-substances-application-irvine-labs-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18204.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18204.pdf?1788525908","publication_date":"2026-09-08","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":"California 92647-3533, applied to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> 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 <span class=\"match\">bulk</span> manufacture <span class=\"match\">bulk</span> Active Pharmaceutical Ingredients for product development and distribution to the <span class=\"match\">Drug</span> Enforcement Administration-registered researchers. No other activities for these <span class=\"match\">drug</span> codes are authorized for this registration. \n \n"},{"title":"Bulk Manufacturer of Controlled Substances Application: Curia Missouri Inc.","type":"Notice","abstract":"Curia Missouri 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":"2026-17280","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17280/bulk-manufacturer-of-controlled-substances-application-curia-missouri-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17280.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17280.pdf?1787575519","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":"to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> code \n Schedule \n \n \n Gamma Hydroxybutyric Acid \n 2010 \n I \n \n \n Amphetamine \n 1100 \n II \n \n \n Lisdexamfetamine \n 1205 \n II \n \n \n Methylphenidate \n 1724 \n II \n \n \n Phenylacetone \n 8501 \n II \n \n \n Tapentadol \n 9780 \n II \n \n \n The company plans to <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substances</span> for internal use intermediates or for sale to its customers. No other activities for these <span class=\"match\">drug</span> codes are authorized"},{"title":"Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City","type":"Notice","abstract":"Cambrex Charles City 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":"2026-17387","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17387/bulk-manufacturer-of-controlled-substances-application-cambrex-charles-city","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17387.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17387.pdf?1787661912","publication_date":"2026-08-26","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":"Noroxymorphone \n 9668 \n II \n \n \n Fentanyl \n 9801 \n II \n \n \n The company plans to manufacture the listed controlled <span class=\"match\">substances</span> in <span class=\"match\">bulk</span> for conversion to other controlled <span class=\"match\">substances</span> and sales to its customers for dosage form development, clinical trials and use in stability qualification studies. In reference to <span class=\"match\">drug</span> code 7370 (Tetrahydrocannabinols), the company plans to <span class=\"match\">bulk</span> manufacture this <span class=\"match\">drug</span> as synthetic. No other activities for these <span class=\"match\">drug</span> codes are authorized for this registration. \n \n Justin Wood, \n Acting Deputy Assistant Administrator. \n \n \n [FR"},{"title":"Bulk Manufacturer of Controlled Substances Application: Biopharmaceutical Research Company","type":"Notice","abstract":"Biopharmaceutical Research Company 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":"2026-17273","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17273/bulk-manufacturer-of-controlled-substances-application-biopharmaceutical-research-company","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17273.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17273.pdf?1787575518","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":"applied to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n \n <span class=\"match\">Drug</span>\n code \n \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 <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substances</span> to provide Pharmaceutical-grade marihuana in order to facilitate research in a manner that complies with local, state, and federal regulations. No other activities for these <span class=\"match\">drug</span> codes are authorized for this"},{"title":"Bulk Manufacturer of Controlled Substances Application: Curia New York Inc","type":"Notice","abstract":"Curia New York 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":"2026-17274","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17274/bulk-manufacturer-of-controlled-substances-application-curia-new-york-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17274.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17274.pdf?1787575518","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":" II \n \n \n Morphine \n 9300 \n II \n \n \n Fentanyl \n 9801 \n II \n \n \n The company plans to manufacture the above listed controlled <span class=\"match\">substances</span> as <span class=\"match\">bulk</span> active pharmaceutical ingredients for use in product development and for distribution to its customers. In reference to <span class=\"match\">drug</span> codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to <span class=\"match\">bulk</span> manufacture these <span class=\"match\">drugs</span> as synthetic. No other activities for these <span class=\"match\">drug</span> codes are authorized for this registration. \n \n Justin Wood, \n Acting Deputy Assistant Administrator. \n \n \n [FR Doc. 2026-17274"},{"title":"Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC","type":"Notice","abstract":"AMPAC Fine Chemicals 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":"2026-14284","html_url":"https://www.federalregister.gov/documents/2026/07/16/2026-14284/bulk-manufacturer-of-controlled-substances-application-ampac-fine-chemicals-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-16/pdf/2026-14284.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14284.pdf?1784119513","publication_date":"2026-07-16","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":"applied to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> code \n Schedule \n \n \n Norlevorphanol \n 9634 \n I \n \n \n Amphetamine \n 1100 \n II \n \n \n Lisdexamfetamine \n 1205 \n II \n \n \n Methylphenidate \n 1724 \n II \n \n \n Levomethorphan \n 9210 \n II \n \n \n Levorphanol \n 9220 \n II \n \n \n Thebaine \n 9333 \n II \n \n \n Remifentanil \n 9739 \n II \n \n \n Tapentadol \n 9780 \n II \n \n \n The company plans to <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substances</span> for use as intermediates, impurity"},{"title":"Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation","type":"Notice","abstract":"Cerilliant Corporation 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":"2026-14704","html_url":"https://www.federalregister.gov/documents/2026/07/22/2026-14704/bulk-manufacturer-of-controlled-substances-application-cerilliant-corporation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-22/pdf/2026-14704.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14704.pdf?1784637909","publication_date":"2026-07-22","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":"registered as a <span class=\"match\">bulk</span> manufacturer of basic class(es) of controlled <span class=\"match\">substance</span>(s). Refer to \n supplementary information \n listed below for further <span class=\"match\">drug</span> information.\n \n \n \n DATES: \n Registered <span class=\"match\">bulk</span> 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 21, 2026. Such persons may also file a written request for a hearing on the application on or before September 21, 2026. \n \n \n \n ADDRESSES: \n \n The <span class=\"match\">Drug</span> Enforcement Administration"},{"title":"Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc.","type":"Notice","abstract":"Cambrex High Point, 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":"2026-18753","html_url":"https://www.federalregister.gov/documents/2026/09/14/2026-18753/bulk-manufacturer-of-controlled-substances-application-cambrex-high-point-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-14/pdf/2026-18753.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18753.pdf?1789130724","publication_date":"2026-09-14","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":"Oaks Parkway, High Point, North Carolina 27265-8017, applied to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> Code \n Schedule \n \n \n Oxymorphone \n 9652 \n II \n \n \n Noroxymorphone \n 9668 \n II \n \n \n The company plans to manufacture the above listed controlled <span class=\"match\">substances</span> in <span class=\"match\">bulk</span> for use as an internal intermediates and distribution to its customers. No other activities for these <span class=\"match\">drug</span> codes are authorized for this registration. \n \n Justin Wood, \n Deputy Assistant Administrator"},{"title":"Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC","type":"Notice","abstract":"Chemtos, 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":"2026-17386","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17386/bulk-manufacturer-of-controlled-substances-application-chemtos-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17386.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17386.pdf?1787661912","publication_date":"2026-08-26","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":"be registered as a <span class=\"match\">bulk</span> manufacturer of basic class(es) of controlled <span class=\"match\">substance</span>(s). Refer to \n SUPPLEMENTARY INFORMATION \n listed below for further <span class=\"match\">drug</span> information.\n \n \n \n DATES: \n Registered <span class=\"match\">bulk</span> 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 26, 2026. Such persons may also file a written request for a hearing on the application on or before October 26, 2026. \n \n \n ADDRESSES: \n \n The <span class=\"match\">Drug</span> Enforcement Administration"},{"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":"to be registered as a <span class=\"match\">bulk</span> manufacturer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> code \n Schedule \n \n \n Ibogaine \n 7260 \n I \n \n \n 3,4-Methylenedioxymethamphetamine \n 7405 \n I \n \n \n The company plans to <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substances</span> as Active Pharmaceutical Ingredients (API) to support internal research and clinical trials, while also supplying other schedule I researchers who are collaborating on clinical trials. No other activities for these <span class=\"match\">drug</span> codes are authorized for"},{"title":"Importer of Controlled Substances Application: Chattem Chemicals","type":"Notice","abstract":"Chattem Chemicals 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":"2026-17286","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17286/importer-of-controlled-substances-application-chattem-chemicals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17286.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17286.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":"class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n \n <span class=\"match\">Drug</span>\n code \n \n Schedule \n \n \n Methamphetamine \n 1105 \n II \n \n \n 4-Anilino-N-phenethyl-4-piperidine (ANPP) \n 8333 \n II \n \n \n Phenylacetone \n 8501 \n II \n \n \n Cocaine \n 9041 \n II \n \n \n Poppy Straw Concentrate \n 9670 \n II \n \n \n Tapentadol \n 9780 \n II \n \n \n The company plans to import the listed controlled <span class=\"match\">substances</span> to manufacture <span class=\"match\">bulk</span> controlled <span class=\"match\">substances</span> for sale to its customers. The company plans to import an intermediate of Tapentadol (9780), to <span class=\"match\">bulk</span> manufacture Tapentadol"},{"title":"Importer of Controlled Substances Application: Unither Manufacturing LLC","type":"Notice","abstract":"Unither Manufacturing 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":"2026-14285","html_url":"https://www.federalregister.gov/documents/2026/07/16/2026-14285/importer-of-controlled-substances-application-unither-manufacturing-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-16/pdf/2026-14285.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14285.pdf?1784119513","publication_date":"2026-07-16","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":"14623-3226, applied to be registered as an importer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> code \n Schedule \n \n \n Methylphenidate \n 1724 \n II \n \n \n The company plans to import the listed controlled <span class=\"match\">substance</span> as <span class=\"match\">bulk</span> solely for purposes of updating their analytical testing procedures to meet European Union requirements for their exported finished dosage form product. No other activity for this <span class=\"match\">drug</span> code is authorized for this registration. \n Approval of permit applications will occur only when"},{"title":"Importer of Controlled Substances Application: Catalent CTS, LLC","type":"Notice","abstract":"Catalent CTS, 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":"2026-14280","html_url":"https://www.federalregister.gov/documents/2026/07/16/2026-14280/importer-of-controlled-substances-application-catalent-cts-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-16/pdf/2026-14280.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14280.pdf?1784119513","publication_date":"2026-07-16","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":"controlled <span class=\"match\">substance</span>(s): \n \n   \n \n \n Controlled\n <span class=\"match\">substance</span> \n \n \n <span class=\"match\">Drug</span>\n code \n \n Schedule \n \n \n Gamma Hydroxybutyric Acid \n 2010 \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 The company plans to import the listed controlled <span class=\"match\">substances</span> as <span class=\"match\">bulk</span> and dosage unit products for distribution to support customers' clinical trials. In reference to <span class=\"match\">drug</span> code 7370 (Tetrahydrocannabinols), the company plans to import a synthetic tetrahydrocannabinol. No other activities for these <span class=\"match\">drug</span> codes are"},{"title":"Importer of Controlled Substances Application: Irvine Labs, Inc.","type":"Notice","abstract":"Irvine Labs, 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":"2026-18757","html_url":"https://www.federalregister.gov/documents/2026/09/14/2026-18757/importer-of-controlled-substances-application-irvine-labs-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-14/pdf/2026-18757.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18757.pdf?1789130724","publication_date":"2026-09-14","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":"importer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n <span class=\"match\">Drug</span> code \n Schedule \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 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 import <span class=\"match\">bulk</span> <span class=\"match\">substances</span> to support internal research, clinical trials, analytical"},{"title":"Importer of Controlled Substances Application: Curia New York Inc.","type":"Notice","abstract":"Curia New York 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":"2026-17388","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17388/importer-of-controlled-substances-application-curia-new-york-inc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17388.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17388.pdf?1787661912","publication_date":"2026-08-26","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":"registered as an importer of the following basic class(es) of controlled <span class=\"match\">substance</span>(s): \n \n   \n \n Controlled <span class=\"match\">substance</span> \n \n <span class=\"match\">Drug</span>\n code \n \n Schedule \n \n \n Gamma Hydroxybutyric Acid \n 2010 \n I \n \n \n 4-Anilino-N-phenethyl-4-piperidine (ANPP) \n 8333 \n II \n \n \n Poppy Straw Concentrate \n 9670 \n II \n \n \n The company plans to import the listed controlled <span class=\"match\">substances</span> for <span class=\"match\">bulk</span> manufacturing into other controlled <span class=\"match\">substances</span> to be distributed to their customers. No other activities for these <span class=\"match\">drug</span> codes are authorized for this registration. \n Approval of permit applications"}]}