{"description":"Documents matching 'bulk drug substances compounding' and published on or after 07/23/2026","count":10,"total_pages":1,"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Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled \"Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities.\" This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding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 <span class=\"match\">compounders</span> vs. combined data).\n \n \n 1. FDA seeks comment on whether it should expand the recommendations in this guidance to additional <span class=\"match\">drugs</span> that are not currently on “The List of <span class=\"match\">Bulk</span> <span class=\"match\">Drug</span> <span class=\"match\">Substances</span> for <span class=\"match\">Compounding</span> Office Stock <span class=\"match\">Drugs</span> for Use in Nonfood-Producing Animals” (available at \n https://www.fda.gov/animal-veterinary/animal-<span class=\"match\">drug</span>-<span class=\"match\">compounding</span>/list-<span class=\"match\">bulk</span>-<span class=\"match\">drug</span>-<span class=\"match\">substances</span>-<span class=\"match\">compounding</span>-office-stock-<span class=\"match\">drugs</span>-use-nonfood-producing-animals \n ). FDA remains concerned that <span class=\"match\">compounded</span> office stock potentially exposes large"},{"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, <span class=\"match\">bulk</span> (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 <span class=\"match\">bulk</span> manufacture the listed controlled <span class=\"match\">substances</span> for internal use as intermediates or for sale to its customers. The company plans to manufacture small quantities of the above listed controlled <span class=\"match\">substances</span> as radiolabeled <span class=\"match\">compounds</span> for biochemical research. In reference to <span class=\"match\">drug</span> 7370"},{"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 <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 Morphine \n 9300 \n II \n \n \n The company plans to import Morphine Sulfate USP as a narcotic raw material for domestic <span class=\"match\">bulk</span> 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 <span class=\"match\">substance</span> Active Pharmaceutical Ingredients for national preparedness and resilience"},{"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":"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":"must also indicate: (1) whether it intends to <span class=\"match\">compound</span>, 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 <span class=\"match\">compounds</span> from <span class=\"match\">bulk</span> <span class=\"match\">drug</span> <span class=\"match\">substances</span> and, if so, whether it <span class=\"match\">compounds</span> 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"},{"title":"Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I","type":"Rule","abstract":"The Drug Enforcement Administration (DEA) is issuing this temporary order to schedule three 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. DEA bases this action on a finding that placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I is necessary to avoid an imminent hazard to public safety. This order imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these three 7-hydroxymitragynine-related substances.","document_number":"2026-17429","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17429/schedules-of-controlled-substances-temporary-placement-of-mitragynine-pseudoindoxyl-mgm-15-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17429.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17429.pdf?1787602521","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":"whether the <span class=\"match\">substance</span> has a currently accepted medical use in treatment in the United States. Nonetheless, there is no evidence suggesting that mitragynine pseudoindoxyl, MGM-15, and MGM-16 have a currently accepted medical use in treatment in the United States. First, DEA looks to whether the <span class=\"match\">drug</span> or <span class=\"match\">substance</span> has FDA approval for marketing in interstate commerce. When no FDA approval exists, DEA has traditionally applied a five-part test to determine whether a <span class=\"match\">drug</span> or <span class=\"match\">substances</span> has a currently accepted medical use: (1) the <span class=\"match\">drug's</span> chemistry must"},{"title":"Exempt Chemical Preparations Under the Controlled Substances Act","type":"Notice","abstract":"The applications for exempt chemical preparations received by the Drug Enforcement Administration between March 1, 2026, and June 30, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through June 30, 2026, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published.","document_number":"2026-16665","html_url":"https://www.federalregister.gov/documents/2026/08/14/2026-16665/exempt-chemical-preparations-under-the-controlled-substances-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-14/pdf/2026-16665.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16665.pdf?1786625121","publication_date":"2026-08-14","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":"supplemental information to this proposed scheduling action are available at \n http://www.regulations.gov. \n \n Legal Authority \n \n Section 201 of the Controlled <span class=\"match\">Substances</span> Act (CSA) (21 U.S.C. 811) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA certain <span class=\"match\">compounds</span>, mixtures, or preparations containing a controlled <span class=\"match\">substance</span>, if he finds that such <span class=\"match\">compounds</span>, mixtures, or preparations meet the requirements detailed in 21 U.S.C. 811(g)(3)(B).\n 1 \n \n DEA regulations at 21 CFR 1308.23 and 1308.24 further detail the"},{"title":"Substances Generally Recognized as Safe","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).","document_number":"2026-16296","html_url":"https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16296.pdf?1786374907","publication_date":"2026-08-11","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":"notices for the use of a human or animal food <span class=\"match\">substance</span> that is purported to be GRAS under the conditions of its intended use under section 201(s) of the FD&amp;C Act (21 U.S.C. 321(s))\n . \n Food <span class=\"match\">substances</span> include both ingredients and <span class=\"match\">substances</span> added indirectly, such as from food packaging. The proposed rule would require any person introducing a <span class=\"match\">substance</span> into interstate commerce under the GRAS provision of section 201(s) of the FD&amp;C Act to notify FDA of the basis for their conclusion that the <span class=\"match\">substance</span> is GRAS under the conditions of its intended"},{"title":"Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update","type":"Rule","abstract":"This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final rule also refines the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) outlier policy. These changes will be effective for IPF discharges occurring during the fiscal year beginning October 1, 2026, through September 30, 2027. We are also finalizing the implementation of a standardized IPF patient assessment instrument, and removing two measures used in the Inpatient Psychiatric Facilities Quality Reporting Program.","document_number":"2026-15588","html_url":"https://www.federalregister.gov/documents/2026/07/31/2026-15588/medicare-program-fy-2027-inpatient-psychiatric-facilities-prospective-payment-system-rate-update","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-31/pdf/2026-15588.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15588.pdf?1785356109","publication_date":"2026-07-31","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Classification System (NAICS) code 622210, Psychiatric and <span class=\"match\">Substance</span> Abuse hospitals. The SBA defines small Psychiatric and <span class=\"match\">Substance</span> Abuse hospitals as businesses having less than $47 million in total annual revenue. SUSB data shows there are 190 firms below this threshold.\n \n \n \n ER31JY26.042 \n \n According to Table 18, 190 psychiatric and <span class=\"match\">substance</span> abuse hospitals, at the firm level, can be considered small according to the SBA. As we stated earlier, the SBA defines small Psychiatric and <span class=\"match\">Substance</span> Abuse hospitals (firms) as businesses having less than"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards","type":"Rule","abstract":"This final rule will revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy- related changes. ONC also adopts certain health information technology (health IT) standards and specifications on behalf of HHS.","document_number":"2026-15833","html_url":"https://www.federalregister.gov/documents/2026/08/04/2026-15833/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-04/pdf/2026-15833.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15833.pdf?1785528912","publication_date":"2026-08-04","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"schizophrenia: A post hoc analysis of pooled data from 3 trials.\n \n \n 52 \n  Schizophr Res. 2024 Dec;274:57-65. doi: 10.1016/j.schres.2024.08.001. Epub 2024 Sep 10. PMID: 39260339.\n \n \n 53 \n  U.S. Food and <span class=\"match\">Drug</span> Administration. <span class=\"match\">Drug</span> Trials Snapshot: Cobenfy. U.S. Food and <span class=\"match\">Drug</span> Administration. \n https://www.fda.gov/<span class=\"match\">drugs</span>/<span class=\"match\">drug</span>-trials-snapshots/<span class=\"match\">drug</span>-trials-snapshot-cobenfy. \n \n \n \n In reference to CMS's concern about Horan et al. (2024)'s lack of discussion on side effects, the applicant stated its belief that CMS's concern is inaccurate. The applicant"}]}