{"description":"Documents matching 'bulk drug substances compounding'","count":968,"total_pages":49,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=bulk+drug+substances+compounding&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Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled \"Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities.\" This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding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":"from other non-federally registered compounders vs. combined data).\n \n \n 1. FDA seeks comment on whether it should expand the recommendations in this guidance to additional drugs that are not currently on “The List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals” (available at \n https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals \n ). FDA remains concerned that compounded office stock potentially exposes large"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: semaglutide, tirzepatide, and liraglutide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.","document_number":"2026-08552","html_url":"https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08552.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08552.pdf?1777553125","publication_date":"2026-05-01","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":"decided not to place on the 503B Bulks List. This list is available at \n https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list. \n FDA will only place a bulk drug substance on the 503B Bulks List when we have determined there is a clinical need for outsourcing facilities to compound drug products using the bulk drug substance. If a clinical need to compound drug products using the bulk drug substance has not been demonstrated, based on the information submitted by the nominator and any other information considered by the Agency"},{"title":"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled \"List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act\" that appeared in the Federal Register of May 1, 2026. In the Federal Register notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","document_number":"2026-12937","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12937.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12937.pdf?1782391517","publication_date":"2026-06-26","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":"of comment period. \n \n \n SUMMARY: \n \n The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that appeared in the \n Federal Register \n of May 1, 2026. In the \n Federal Register \n notice, FDA requested comments on FDA's proposal not to include semaglutide, tirzepatide, or liraglutide on a list of bulk drug substances (active pharmaceutical ingredients) for which there"},{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.","document_number":"2026-07361","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07361.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07361.pdf?1776257113","publication_date":"2026-04-16","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":"following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/MOTs-C acetate). The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances","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 recordkeeping provisions set forth in Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk Substances.","document_number":"2025-07578","html_url":"https://www.federalregister.gov/documents/2025/05/01/2025-07578/agency-information-collection-activities-proposed-collection-comment-request-compounding-animal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-01/pdf/2025-07578.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-07578.pdf?1746017117","publication_date":"2025-05-01","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":"current thinking about animal drug compounding from bulk substances, our Center for Veterinary Medicine developed GFI #256 entitled “\n Compounding Animal Drugs from Bulk Drug Substances \n ” (\n https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances \n ). The guidance describes circumstances under which FDA generally does not intend to take enforcement action against pharmacists and veterinarians who compound animal drugs from bulk drug substances.\n \n FDA estimates the burden"},{"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.\" This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.","document_number":"2024-31546","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31546/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503a-of-the-federal-food-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31546.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31546.pdf?1736171123","publication_date":"2025-01-07","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 or Agency) is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic"},{"title":"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.\" This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.","document_number":"2024-31545","html_url":"https://www.federalregister.gov/documents/2025/01/07/2024-31545/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503b-of-the-federal-food-drug","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-07/pdf/2024-31545.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31545.pdf?1736171123","publication_date":"2025-01-07","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":"the outsourcing facility does not compound a drug using a bulk drug substance unless: (1) the bulk drug substance appears on a list established by the Secretary of the Department of Health and Human Services identifying bulk drug substances for which there is a clinical need (the 503B bulks list) (see section 503B(a)(2)(A)(i)) or (2) the drug product compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing (see"},{"title":"Bulk Manufacturer of Controlled Substances Application: SpecGx LLC","type":"Notice","abstract":"SpecGx 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":"2026-05912","html_url":"https://www.federalregister.gov/documents/2026/03/26/2026-05912/bulk-manufacturer-of-controlled-substances-application-specgx-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-26/pdf/2026-05912.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05912.pdf?1774442728","publication_date":"2026-03-26","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":"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 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 26, 2026. Such persons may also file a written request for a hearing on the application on or before May 26, 2026. \n \n \n ADDRESSES: \n \n The Drug Enforcement Administration"},{"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":"Dextropropoxyphene, bulk (non-dosage forms) \n 9273 \n II \n \n \n Morphine \n 9300 \n II \n \n \n Oripavine \n 9330 \n II \n \n \n Thebaine \n 9333 \n II \n \n \n Oxymorphone \n 9652 \n II \n \n \n \n Phenazocine \n 9715 \n II \n \n \n Carfentanil \n 9743 \n II \n \n \n Fentanyl \n 9801 \n II \n \n \n The company plans to bulk manufacture the listed controlled substances for internal use as intermediates or for sale to its customers. The company plans to manufacture small quantities of the above listed controlled substances as radiolabeled compounds for biochemical research. In reference to drug 7370"},{"title":"Bulk Manufacturer of Controlled Substances Application: Restek Corporation","type":"Notice","abstract":"Restek 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":"2026-04306","html_url":"https://www.federalregister.gov/documents/2026/03/04/2026-04306/bulk-manufacturer-of-controlled-substances-application-restek-corporation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-04/pdf/2026-04306.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04306.pdf?1772545526","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":" 9830 \n I \n \n \n Beta-hydroxy-3-methylfentanyl \n 9831 \n I \n \n \n The company plans to bulk manufacture the listed controlled substances for the Drug Enforcement Administration-exempted certified reference materials. In-house synthesis gives access to compounds that are difficult to source. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. \n \n Thomas Prevoznik, \n Deputy Assistant"},{"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":"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 June 2, 2026. Such persons may also file a written request for a hearing on the application on or before June 2, 2026. \n \n \n ADDRESSES: \n \n The Drug Enforcement Administration"},{"title":"Importer of Controlled Substances Application: Prof Compounding CTS of Ameri","type":"Notice","abstract":"Prof Compounding CTS of Ameri 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":"2026-17285","html_url":"https://www.federalregister.gov/documents/2026/08/25/2026-17285/importer-of-controlled-substances-application-prof-compounding-cts-of-ameri","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-25/pdf/2026-17285.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17285.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":"registered as an importer 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 Morphine \n 9300 \n II \n \n \n The company plans to import Morphine Sulfate USP as a narcotic raw material for domestic bulk manufacturing and supply under the ASPR Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) Program. The imported material will be used to support the strategic domestic supply of essential controlled substance Active Pharmaceutical Ingredients for national preparedness and resilience"},{"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 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 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 Drug Enforcement Administration"},{"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 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 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 Drug Enforcement Administration"},{"title":"Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company","type":"Notice","abstract":"Cayman Chemical 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":"2025-21183","html_url":"https://www.federalregister.gov/documents/2025/11/26/2025-21183/bulk-manufacturer-of-controlled-substances-application-cayman-chemical-company","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-26/pdf/2025-21183.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21183.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":"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 January 26, 2026. Such persons may also file a written request for a hearing on the application on or before January 26, 2026. \n \n \n ADDRESSES: \n \n The Drug Enforcement Administration"},{"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":"Dextropropoxyphene, bulk (non-dosage forms) \n 9273 \n II \n \n \n Morphine \n 9300 \n II \n \n \n Oripavine \n 9330 \n II \n \n \n Thebaine \n 9333 \n II \n \n \n Oxymorphone \n 9652 \n II \n \n \n Phenazocine \n 9715 \n II \n \n \n Carfentanil \n 9743 \n II \n \n \n Fentanyl \n 9801 \n II \n \n \n The company plans to bulk manufacture the listed controlled substances for internal use as intermediates or for sale to its customers. The company plans to manufacture small quantities of the above listed controlled substances as radiolabeled compounds for biochemical research. In reference to drug code"},{"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":"2025-15115","html_url":"https://www.federalregister.gov/documents/2025/08/08/2025-15115/bulk-manufacturer-of-controlled-substances-application-chemtos-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-08/pdf/2025-15115.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15115.pdf?1754570728","publication_date":"2025-08-08","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":" II \n \n \n Bezitramide \n 9800 \n II \n \n \n Fentanyl \n 9801 \n II \n \n \n Moramide-intermediate \n 9802 \n II \n \n \n \n The company plans to bulk manufacture the listed controlled substances for distribution as reference standards to its customers. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the \n \n company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.\n \n \n Justin Wood, \n Acting Deputy Assistant Administrator. \n \n \n [FR Doc. 2025-15115 Filed"},{"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":"2025-13446","html_url":"https://www.federalregister.gov/documents/2025/07/17/2025-13446/bulk-manufacturer-of-controlled-substances-application-cerilliant-corporation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-17/pdf/2025-13446.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13446.pdf?1752669920","publication_date":"2025-07-17","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":"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 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 15, 2025. Such persons may also file a written request for a hearing on the application on or before September 15, 2025. \n \n \n ADDRESSES: \n \n The Drug Enforcement Administration"},{"title":"Bulk Manufacturer of Controlled Substances Application: SpecGx LLC","type":"Notice","abstract":"SpecGx 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":"2025-07154","html_url":"https://www.federalregister.gov/documents/2025/04/25/2025-07154/bulk-manufacturer-of-controlled-substances-application-specgx-llc","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-25/pdf/2025-07154.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-07154.pdf?1745498716","publication_date":"2025-04-25","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 bulk manufacturer of basic class(es) of controlled \n \n substance(s). Refer to Supplementary Information 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 24, 2025. Such persons may also file a written request for a hearing on the application on or before June 24, 2025. \n \n \n ADDRESSES: \n \n The Drug Enforcement Administration"},{"title":"Bulk Manufacturer of Controlled Substances Application: Restek Corporation","type":"Notice","abstract":"Restek 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":"2025-06709","html_url":"https://www.federalregister.gov/documents/2025/04/18/2025-06709/bulk-manufacturer-of-controlled-substances-application-restek-corporation","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-04-18/pdf/2025-06709.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-06709.pdf?1744893920","publication_date":"2025-04-18","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":" 9830 \n I \n \n \n Beta-hydroxy-3-methylfentanyl \n 9831 \n I \n \n \n The company plans to bulk manufacture the listed controlled substances for the Drug Enforcement Administration-exempted certified reference materials. In-house synthesis gives access to compounds that are difficult to source. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. \n \n Matthew Strait, \n Deputy Assistant Administrator"}]}