Every filing that matters

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.

Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.

Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing on the potential future therapeutic use of psychedelic drugs. In collaboration with federal partners, FDA is holding this public hearing to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.

Request for Information, Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings

On April 18, 2026, President Trump issued Executive Order (E.O.) 14401, "Accelerating Medical Treatments for Serious Mental Illness", acknowledging that individuals suffering from serious mental illness may not always respond to existing therapies. This request for information (RFI) solicits stakeholder feedback on training and care delivery models that could be used to ensure safe and effective delivery of potential future Food and Drug Administration (FDA)- approved psychedelic drugs, including drugs administered in ambulatory clinic settings, such as health centers and rural health clinics.

Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots

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 2027 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 proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There are no changes to the Rural Emergency Hospital Quality Reporting Program. We propose to expand the prior authorization requirement to include additional Botulinum Toxin Injection services. We also propose to implement certain provisions of the Consolidated Appropriations Act, 2026, for off-campus outpatient departments of a provider. In addition, this proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. This rule also requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the HPT information reported in machine- readable files and consumer-friendly displays. We propose hospital AOs with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. Finally, we are soliciting comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.

Importer of Controlled Substances Application: Benuvia Operations, LLC.

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

Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a 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. 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 these three 7-hydroxymitragynine-related substances.

Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine above a specified threshold, including its 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. 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 7-hydroxymitragynine above a specified threshold.

Importer of Controlled Substances Application: Almac Clinical Services Incorp. (ACSI)

Almac Clinical Services Incorp. (ACSI) 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: Veterans Pharmaceuticals, Inc.

Veterans Pharmaceuticals, 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.

Modernizing Security Requirements

The U.S. Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modernize security and fitness-for-duty requirements to enhance efficiency, consistent with Executive Order 14300, "Ordering the Reform of the Nuclear Regulatory Commission." The proposed revisions are intended to reduce regulatory burden, where appropriate, while continuing to provide reasonable assurance that safety and security will be adequately maintained at NRC-licensed facilities.

Bulk Manufacturer of Controlled Substances Application: Veranova, L.P.

Veranova, L.P., 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: VHG Labs DBA LGC Standards

VHG Labs DBA 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: Cerilliant Corporation

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

Schedules of Controlled Substances: Placement of Diphenidine in Schedule I

The Drug Enforcement Administration proposes placing diphenidine (1-(1,2-diphenylethyl)piperidine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, 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 diphenidine.

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

The Drug Enforcement Administration (DEA) issues this 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. DEA bases this action on a finding that placing 2-fluorodeschloroketamine 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, or possess), or propose to handle this substance.

Exempt Chemical Preparations Under the Controlled Substances Act

The applications for exempt chemical preparations received by the Drug Enforcement Administration between July 1, 2025, and March 31, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through March 31, 2026, that were not included in previous Federal Register notices, and it does not affect preparations that have been previously published. This order also corrects the listing of several preparations that were published in the Federal Register notice on March 20, 2026.

Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC

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

Bulk Manufacturer of Controlled Substances Application: Patheon API Inc.

Patheon API 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.

Schedules of Controlled Substances: Rescheduling of Food and Drug Administration Approved Products Containing Marijuana From Schedule I to Schedule III; Corresponding Change to Permit Requirements

With the issuance of this final rule, which constitutes a final order, the Acting Attorney General of the U.S. Department of Justice places drug products containing marijuana that have been approved by the Food and Drug Administration (FDA) in schedule III of the Controlled Substances Act ("CSA"). This action is required to satisfy the responsibility of the Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. In general, this final rule applies to marijuana as defined in the CSA, marijuana extracts, and delta-9-tetrahydrocannabinol and other compounds derived from the marijuana plant (other than the mature stalks and seeds) that falls outside the definition of hemp, to the extent that any of these are included in an FDA-approved drug product or are subject to a state-issued license to manufacture, distribute, and/or dispense marijuana or products containing marijuana for medical purposes ("state medical marijuana license"). Also consistent therewith, this final rule adds such drugs to the list of substances that may only be imported or exported pursuant to a permit. This final rule also establishes an expedited registration process under 21 CFR part 1301 for entities holding state medical marijuana licenses, enabling such entities to engage in the manufacture, distribution, and/or dispensing of marijuana for medical purposes under federal law consistent with the requirements of the Single Convention.

Accelerating Medical Treatments for Serious Mental Illness

Bulk Manufacturer of Controlled Substances Application: AJNA Biosciences

AJNA Biosciences 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: 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: 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.

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.

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.

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: 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.

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: 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.

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: 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.

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.

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.