Every filing that matters

Bulk Manufacturer of Controlled Substances Application: Usona Institute, Inc.

Usona Institute, 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.

Bulk Manufacturer of Controlled Substances Application: Purisys, LLC

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.

Importer of Controlled Substances Application: Lipomed/LGC Standards

Lipomed/LGC Standards 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.

Importer of Controlled Substances Application: Research Triangle Institute

Research Triangle Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Importer of Controlled Substances Application: Usona Institute

Usona Institute. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Bulk Manufacturer of Controlled Substances Application: SpecGx LLC

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.

Schedules of Controlled Substances: Placement of 3-Methoxyphencyclidine (1-(1-(3-Methoxyphenyl)cyclohexyl)piperidine) in Schedule I

With the issuance of this final rule, the Drug Enforcement Administration places substance 3-methoxyphencyclidine (1-(1-(3- methoxyphenyl)cyclohexyl)piperidine; 3-MeO-PCP), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action 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 3-MeO-PCP.

Exempt Chemical Preparations Under the Controlled Substances Act

The applications for exempt chemical preparations received by the Drug Enforcement Administration between September 1, 2024, and December 31, 2025, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through December 31, 2025, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published.

Bulk Manufacturer of Controlled Substances Application: Siegfried Grafton, Inc.

Siegfried Grafton, 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.

Bulk Manufacturer of Controlled Substances Application: Sterling Wisconsin, LLC

Sterling Wisconsin, 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.

Importer of Controlled Substances Application: Patheon API Services, Inc.

Patheon API Services, 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.

Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories Inc

Pisgah Laboratories 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.

Bulk Manufacturer of Controlled Substances Application: Patheon API Services Inc

Patheon API Services 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.

Importer of Controlled Substances Application: Lonza Tampa, LLC

Lonza Tampa, 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.

Mandatory Guidelines for Federal Workplace Drug Testing Programs-Authorized Testing Panels

HHS herein publishes the panels of Schedule I and II drugs and biomarkers authorized for testing in federal workplace drug testing programs. The Department has made no revisions to the current drug testing panels for both urine and oral fluid and current required nomenclature for laboratory and Medical Review Officer Reports, effective July 7, 2025.

Importer of Controlled Substances Application: Parexel International, LLC

Parexel International, 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.

Bulk Manufacturer of Controlled Substances Application: Restek Corporation

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.

Importer of Controlled Substances Application: Patheon API Inc.

Patheon API 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.

Importer of Controlled Substances Application: Restek Corporation

Restek Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Importer of Controlled Substances Application: Catalent Greenville, Inc.

Catalent Greenville, 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.

Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute

Scottsdale Research Institute has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC

Sterling Pharma USA 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.

Importer of Controlled Substances Application: Sharp Clinical Services, LLC

Sharp Clinical Services, 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.

Bulk Manufacturer of Controlled Substances Application: Promega Corporation

Promega 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.

Schedules of Controlled Substances: Temporary Placement of 2-Fluorodeschloroketamine in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 2-(2-fluorophenyl)-2-(methylamino)cyclohexan-1-one (commonly known as 2-fluorodeschloroketamine or 2-FDCK), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose 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 2-fluorodeschloroketamine.

Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine in Schedule I

With the issuance of this final rule, the Drug Enforcement Administration places 4-fluoroamphetamine (4-FA; 1-(4- fluorophenyl)propan-2-amine; para-fluoroamphetamine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action 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 4-fluoroamphetamine.

Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2026

This final order establishes the initial 2026 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC

IsoSciences 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.

Importer of Controlled Substances Application: Groff Health Inc.

Groff Health Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC

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.

Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2026

The Drug Enforcement Administration (DEA) proposes to establish the 2026 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Importer of Controlled Substances Application: Fisher Clinical Services, Inc.

Fisher Clinical Services, 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.

Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc.

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.

Bulk Manufacturer of Controlled Substances Application: Organix Chemistry Solutions, LLC

Organix Chemistry Solutions, 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.

Bulk Manufacturer of Controlled Substances Application: Siegfried Grafton, Inc.

Siegfried Grafton, 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.

Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company

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.

Importer of Controlled Substances Application: NSI Lab Solutions, LLC.

NSI Lab Solutions, LLC. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Importer of Controlled Substances Application: Halo Pharmaceutical Inc.

Halo Pharmaceutical Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Importer of Controlled Substances Application: Organic Standards Solutions International, LLC

Organic Standards Solutions International, 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.

Importer of Controlled Substances Application: Irvine Labs, Inc.

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.

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots

This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. In addition, this final rule with comment period announces the closure of a teaching hospital and the opportunity to apply for available slots, and updates and refines the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency, as well as summarizes comments received in response to a request for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for the OQR, REHQR, and ASCQR programs.

Schedules of Controlled Substances: Placement of 4-Chloromethcathinone in Schedule I

With the issuance of this final rule, the Drug Enforcement Administration places 4-chloromethcathinone (4-CMC, 1-(4-chlorophenyl)- 2-(methylamino)propan-1-one), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action 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 4- chloromethcathinone.

Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.

Bulk Manufacturer of Controlled Substances Application: Groff Health Inc

Groff Health Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Importer of Controlled Substance Application: Fisher Clinical Services, Inc.

Fisher Clinical Services, 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.

Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC

Catalent Pharma Solutions, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Fentanyl to the Department of Transportation's Drug-Testing Panel; Harmonization With Certain Items in the HHS Mandatory Guidelines for Urine and Oral Fluid; and Technical Amendments

The U.S. Department of Transportation (Department or DOT) proposes to amend its drug-testing program regulation, 49 CFR part 40 (part 40), to add fentanyl (a synthetic opioid) and norfentanyl (a metabolite of fentanyl) to its drug testing panels. The proposed rulemaking would harmonize part 40 with the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), which DOT must follow for the minimum list of drugs for which DOT requires testing, and the comprehensive standards for laboratory drug testing per the Omnibus Employee Testing Act of 1991. Adding fentanyl and norfentanyl is also in the interest of transportation safety, given compelling information regarding the number of overdose deaths in the United States involving fentanyl. The Department also proposes to amend certain provisions of part 40 to harmonize, as appropriate, with the current HHS Mandatory Guidelines using urine (UrMG) and oral fluid (OFMG). This NPRM also proposes to clarify certain existing part 40 drug testing program provisions and to make technical amendments.

Importer of Controlled Substances Application: Cambrex Charles City

Cambrex Charles City 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.

Medicare Program; FY 2026 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update

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 revises the payment adjustment factors for teaching status and for IPFs located in rural areas. These changes will be effective for IPF discharges occurring during the fiscal year beginning October 1, 2025, through September 30, 2026. We are finalizing changes to measures used in the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program, updating and codifying the Extraordinary Circumstances Exception policy, and summarizing comments received through requests for information regarding future changes to the IPFQR Program.

Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency

This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2026 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment systems. This proposed rule would also update and refine the requirements for the Hospital Outpatient Quality Reporting Program, Rural Emergency Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Overall Hospital Quality Star Rating, and hospitals to make public their standard charge information and enforcement of hospital price transparency. This rule also contains requests for information on measure concepts regarding Well-Being and Nutrition for consideration in future years for all three programs (OQR, REHQR, and ASCQR; expanding the method to control for unnecessary increases in the volume of covered OPD services to on- campus clinic visits; software as a service; and adjusting payment under the OPPS for services predominately performed in the ambulatory surgical center or physician office settings.

Exempt Chemical Preparations Under the Controlled Substances Act

The applications for exempt chemical preparations received by the Drug Enforcement Administration between March 1, 2023, and March 31, 2025, as listed below, were accepted for filing and have been approved or denied as indicated.

Schedules of Controlled Substances: Placement of 3-Methoxyphencyclidine (1-[1-(3-methoxyphenyl)cyclohexyl]piperidine) in Schedule I

The Drug Enforcement Administration proposes placing 3- methoxyphencyclidine, including its salts, isomers, and salts of isomers, an arylcyclohexylamine hallucinogen, in schedule I of the Controlled Substances Act. This action is proposed to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose 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 3-methoxyphencyclidine.

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals

The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. The Drug Enforcement Administration is hereby publishing a notice to update the Special Surveillance List.

Schedules of Controlled Substances: Placement of 4-Fluoroamphetamine in Schedule I

The Drug Enforcement Administration proposes placing the substance 4-fluoroamphetamine (4-FA; 1-(4-fluorophenyl)propan-2-amine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken, in part, to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose 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 4-fluoroamphetamine.

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes

This proposed rule would 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.

National Institute on Aging; Notice of Closed Meeting

David Bockoff, M.D.; Decision and Order

Sentencing Guidelines for United States Courts

The United States Sentencing Commission is considering promulgating amendments to the sentencing guidelines, policy statements, and commentary. This notice sets forth the proposed amendments and, for each proposed amendment, a synopsis of the issues addressed by that proposed amendment. This notice also sets forth several issues for comment, some of which are set forth together with the proposed amendments, and one of which (regarding retroactive application of proposed amendments) is set forth in the Supplementary Information section of this notice.

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2024. The animal drug regulations are also being amended to improve their accuracy and readability.

Special Registrations for Telemedicine and Limited State Telemedicine Registrations

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act") generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the "practice of telemedicine" within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at https://www.regulations.gov/docket/DEA-2023-0029.