Regulatory tracker

Excessive Gestational Weight Gain, Pregnancy, INTUITIVE EATING, Perceived Stress, Prenatal Depression, Anxiety, Diet Quality, Physical Activity, Body Awareness — Intuitive Eating Intervention

Major Depressive Disorder (MDD) — Rejoyn, Cognitive Behavioral Therapy (CBT) exercises

Major Depressive Disorder (MDD), Thiamine, Vitamin B1, Thiamine Diphosphate (TDP), Pediatrics — thiamine hydrochloride 100 mg

PrEP Use — PrEPared Minds/ Mentes PrEParadas - Cognitive Behavioral Therapy, No Intervention

Simulation Training, Midwifery Education, Subcutaneous Injection — Mannequin-Based Subcutaneous Injection Training, Peer-Based Subcutaneous Injection Training, Self-Based Subcutaneous Injection Training

Post-Traumatic Stress Disorder, PTSD — Propranolol, Psychotherapy

Posttraumatic Stress Disorder (PTSD) — Psilocybin-assisted Psychotherapy

Opioid Abuse (Disorder), Clinical Decision Support — Refined EMBED CDS, Provider alert that nurse completed COWS

On May 29, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Cypsedo (cipepofol) for induction of general anesthesia in adults undergoing surgery. The Department of Health and Human Services provided the Drug Enforcement Administration

The Drug Enforcement Administration (DEA) issues this temporary order to schedule 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4- yl)-5,6-dichloro-1,3-dihydro-2H-benzo[d]imidazol-2-one (commonly known as 5,6-dichloro brorphine or SR-14968); 5,6-dichloro-1-(1-(4- chlorobenzyl)piperidin-

Infant Admitted to Neonatal Intensive Care Unit (NICU) — Reading Intervention

Premenstrual Syndrome — Progressive Muscle Relaxation Exercise, Kinesio Taping

Breast Cancer — AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy

Depressive Symptoms, Mental Health (Depression) — school-based depression literacy program

Depression / Major Depressive Disorder, Anxiety

Risk of Depression and Anxiety — Partners in Parenting, Shamiri

Hypertension, Poor Sleep Quality, Insomnia, Arterial Stiffness — Behavioral: Cognitive-Behavioural Therapy for Insomnia (CBT-I), Passive sleep education

COPD Patients, Depression in Chronic Obstructive Pulmonary Disease — virtual reality with pulmonary rehabilitation, controlled group received pulmonary rehabilitation without utilizing virtual reality

Psychological Stress, Depression - Major Depressive Disorder, Anxiety, Inflammation, Disaster — Mindfulness Body Scan Training

Cesarean Section, Postoperative Recovery, Postoperative Pain — Assessment of Enhanced Recovery Protocol Compliance

Dental Anxiety, Preoperative Anxiety — Passiflora incarnata extract, Placebo

Cancer Fear and Screening-Related Anxiety in Women Undergoing Cancer Screening — mandala, Music

Cesarean Section, Postoperative Pain After Cesarean Section, Acute Pain — Observational Assessment of Postoperative Pain

Nicotine Dependance, Serious Mental Illness, Smoking (Tobacco) Addiction, Tobacco Cessation, Community Health Workers, Cardiovascular (CV) Risk, Tobacco Use Disorder — Integrated CHW Support intervention, Enhanced usual care (EUC)

Smoking Cessation, Cigarette Smoking, Tobacco Use, Nicotine Dependence — Mindful Smoking and Sensor-Band Intervention, Smoking Cessation Information

Neuropsychiatric Symptom

Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation, Knee Osteoarthritis, Pain — Unipolar radiofrequency ablation, Bipolar radiofrequency ablation

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

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

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

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.

Experic 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.

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.

The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug subst

Psychological Resilience Among Midwives Working in Delivery Rooms — Mandala Coloring

Bereavement — Family-authored Digital ICU Diary Intervention, Standard Care

Doula Support, Postpartum, Postpartum Anaemia, Postpartum Depression (PPD) — Doula-coordinated, Midwife-delivered postpartum care

Ostomy - Ileostomy or Colostomy, Canser, Ileus, Intestinal Cancer — TEACH BACK METHOD

Perinatal Anxiety — Arm 2: BreLax Intervention Group 1, Arm 3: Combined Intervention Group 3

Generalized Anxiety Disorder — SEP-363856

Postpartum — Live Ukulele Music

Simulation-based Midwifery Education, Oxytocin Induction — Theoretical Training on Oxytocin Induction, Simulation-Based Oxytocin Induction Training

Addictions — data collection

Opioid Use Disorder — STORC

Alcohol Use Disorder (AUD) — Alcohol Cue Reactivity Paradigm

Schizophrenia, Schizoaffective Disorder, Cognitive Impairment, Visual Impairment — Perceptual Discrimination Training, Cognitive Control Training

Clinical High Risk for Psychosis (CHR), Psychotic Disorders, Prodromal Symptoms — Active Intermittent Theta Burst Stimulation (BEAM-F3 Targeting), Sham Comparator: Sham iTBS

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.

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

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

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.

Galephar Pharmaceutical Research 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.

Scottsdale Research Institute SRI Montana Satellite Laboratory has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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

Vici Health Sciences, 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.

Biopharmaceutical Research Company 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.

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

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

Perinatal Depression — Oura Ring (Photoplethysmography-based wearable ring), EmbracePlus Watch (Electrodermal activity wristband sensor)

Treatment-Resistant Major Depressive Disorder, Major Depressive Disorder — Closed-loop Deep Brain Stimulation (DBS), Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Outpatients or Inpatients With Depression — Shugan Jieyu Capsules

Depression / Major Depressive Disorder, Bipolar Disorder (BD) — Online Cognitive Behavioural Therapy

PTSD, Post Traumatic Stress Disorder (PTSD) — Active Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation (TMS)

Depression / Major Depressive Disorder — OMNi-BiOTiC® STRESS Repair, Matched Placebo Powder for Oral Solution

Major Depression — TMS, NRX-101

The Effect of Online Laughter Yoga Combined With Psychoeducation on Perceived Stress and Career Anxiety Among Nursing Students — Laughter Yoga Programme, Psychoeducational Programme

Labor Pain, Anxiety — Yintang Acupressure, Sham Light Touch

Premenstrual Syndrome — Mandala coloring group

Cannabis Abuse — Varenicline (Chantix), Placebo

Bipolar Affective Disorders — CD8+ T-Cell Gene Expression Analysis

Depression — Enhanced Usual Care (EUC), Supported Online Self-help for Depression (SOS-Depression)

Major Depressive Disorder (MDD), Major Depressive Disorder With Psychotic Features — Lurasidone, Placebo, Background Antidepressant Therapy

Cervical Disc Herniation, Chronic Pain, Kinesiophobia, Cervical Pain — Conventional Physiotherapy, Action Observation and Motor Imagery Training, Sham Observation

Anxiety — 40-Hz Binaural Beat Music Combined With 40-Hz Rhythmic Photic Stimulation, Sham group

Dental Anxiety in Children, Dental Pain, Virtual Reality, Distraction, Dental Caries — Immersive Virtual Reality

Breath Exercise, State Anxiety, Adult Patients, Vital Signs Monitoring, Fear — Diaphragmatic Breathing Exercises

Cancer — M-RDSI, RDSI, Usual Care

Posttraumatic Stress Disorder (PTSD), Substance Use Disorder (SUD) — Written Exposure Therapy, Treatment as Usual

Post-traumatic Stress Disorder (PTSD), Trauma and Stress Related Disorders, Occupational Stress, Emotional Regulation Difficulties, Anger Problems, Relational Problems, Irritability — Brazilian Jiu-Jitsu Program

Schizophrenia — Dyadic Multicomponent Intervention (DMI), Dyadic Benefit-Finding Intervention (DBFI)

Schizophrenia — xanomeline-trospium chloride, Oral antipsychotics

Schizophrenia — Scaffolding-Based Board Game Intervention

Behavioral Intervention, Nicotine Addiction — Standard phone call, phone call with MINDSPACE elements

Opioid Use Disorder, mHealth, Peer Support — Vira Platform, Treatment-As-Usual

Tension-Type Headache, Sleep Disturbance, Smartphone Addiction, Quality of Life

Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe — TRTME

Stress, Early Life Stress, Sex Differences, Opioid — Morphine, Placebo

Depression Disorder — Individualized resting-state functional connectivity-guided iTBS, Symptom-titrated algorithm-based longitudinal ECT (STABLE) algorithm

Schizophrenia Disorder, Schizoaffecitve Disorder — Decoded Neurofeedback

PTSD Symptoms, Violence Prevention, Depression and Anxiety Symptoms — EA$E-US, ongoing standard of care

Traumatic Grief, Post Traumatic Stress Disorder PTSD, Emotional Processing — EMDR Grief Protocol

PTSD - Post Traumatic Stress Disorder — D-Cycloserine (DCS), Placebo, Intermittent Theta Burst Stimulation (iTBS)

Smoking Cessation, Tobacco Use Disorder, Breast Feeding — Virtual Reality and Mobile Application-Based Smoking Cessation Education

Pregnancy, Substance Use Disorder (SUD) — Contingency Management, Social Drivers of Health Screening

Methamphetamine Use Disorder, Substance Use Disorder, Cue-reactivity, Craving — Closed-loop Theta-Burst Stimulation (TBS) Targeting rPO

Psychosis — group DBT

PTSD - Post Traumatic Stress Disorder — D-Cycloserine (DCS), Placebo, Intermittent Theta Burst Stimulation (iTBS)

Psychiatric Disorder — CHANGE - modularized group psychotherapy

Addiction — Short-Term Psychodynamic Group Therapy

Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30) — Placebo, Semaglutide 1.0 mg, Semaglutide 2.0 mg

Methamphetamine Use Disorder — Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct)., Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).

Schizophrenia — Active rTMS, Strong Cognitive Training, Sham rTMS

Treatment-resistant Schizophrenia — Temporal Interference Stimulation

PTSD, Posttraumatic Stress Disorder — methylphenidate (Ritalin®), Reboxetine, Placebo

HIV, Risk Behavior, Alcohol Abuse — CLT- Concrete text messages, CLT- Abstract text messages, Control messages

Opioid Use Disorder, Tobacco Use Disorder — Deep TMS System With H4 Coil

Schizophrenia Disorder, Metabolic Syndrome, Antipsychotic-induced Weight Gain, Cardiovascular Risk, Insulin Resistance — Semaglutide + TAU, Placebo + TAU

SCHIZOPHRENIA 1 (Disorder) — physiotherapy, 2 x a week for 6 weeks, basal therapy, 2 x a week for 6 weeks, Standard therapy group

Major Depressive Disorder (MDD)

Posttraumatic Stress Disorder (PTSD) — Written Exposure Therapy, Neutral Writing Condition

Post-traumatic Stress Disorder (PTSD), Intrusive Memories of Traumatic Event(s) — Unconscious Trauma Reactivation plus Eye Movements, Active Trauma Memory Reactivation plus Eye Movements, Neutral Memory Reactivation plus Eye Movements

Substance Use Disorder (SUD) — real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback

Schizophrenia, Antipsychotic Drug — Xingqi Daozhi Decoction, Placebo Group

Bipolar Disorder (BD) — BA, SHE, HE

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 Jun

Complex Post-Traumatic Stress Disorder — Trauma-Informed Parenting Group Intervention

Posttraumatic Stress Disorder (PTSD) — MDMA assisted psychotherapy

The Drug Enforcement Administration issues this temporary order to schedule O-desmethyltramadol (other names: O-DSMT; desmetramadol; 3-[(1R,2R)-2-[(dimethylamino)methyl]-1- hydroxycyclohexyl]phenol), including its isomers, esters, ethers, salts, and salts of isomers, esters and e

Written Exposure Therapy — Written Exposure Therapy (WET)

Treatment Resistant Depression (TRD) — Transcranial Magnetic Stimulation, quetiapine

SCHIZOPHRENIA 1 (Disorder) — HS-10380

Schizoaffecitve Disorder, Schizophrenia and Schizoaffective Disorder, Schizophrenia and Predominant Negative Symptoms — Deferiprone (DFP), N-Acetyl Cysteine (NAC)

The Drug Enforcement Administration proposes to transfer suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4- diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone), lemborexant ((1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)- N-(5-fluoropyri

Posttraumatic Stress Disorder (PTSD), Substance Use Disorder (SUD) — Trauma Informed Heart Rate Variability Biofeedback, Present Centered Therapy

Child Development, Early Child Development, Mental Health, PTSD - Post Traumatic Stress Disorder, Intergenerational Trauma, Refugee Health

Hand Grip Strength, Quality of Life

Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV) — Psilocybin 5 mg, Psilocybin 25 mg, Motivational Support

Depressive Disorder, Treatment-Resistant, Treatment Resistant Depression (TRD), Treatment Resistant Major Depression Disorder — Precuneus-targeted continuous theta-burst stimulation, Left dorsolateral prefrontal cortex intermittent theta-burst stimulation, Sham transcranial magne

SCHIZOPHRENIA 1 (Disorder), Simulation Based Learning, Nursing Students — Simulation

Severe Mental Disorder — Supervised multicomponent exercise programme

Cigarette Smoking, Nicotine Dependence — SPECTRUM cigarettes, SPECTRUM cigarettes

Alcohol Use Disorder (AUD), Alcoholism — Repetitive transcranial magnetic stimulation

Schizophrenia, Schizoaffecitve Disorder — Digital therapeutic (AffectUs), Psychoeducational materials

Clinical High Risk for Psychosis (CHR), Suicidal Ideation, Psychosis, Suicidal Behavior — Suicide Prevention Intervention, Standard Care (in control arm)

Internet Addiction — Acceptance and Commitment Therapy (ACT)

Opioid Abuse (Disorder), Opioid Analgesia, Opioid Analgesic Adverse Reaction, Opioid Consumption — Naproxen, Acetaminophen, oxycodone

Sacroiliac Joint Pain — Traditional bipolar radiofrequency, Cooled radiofrequency

Prostatic Hyperplasia, Lower Urinary Tract Symptoms — Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection, Conventional Bipolar Prostatic Enucleation-Enucleoresection

Healthy, Bipolar — Lithium carbonate (Priadel), Controlled light exposure

Bipolar Affective Disorder; Remission in — CBT-Based Psychological Resilience Enhancement Program for Individuals with BD

Post-traumatic Stress Disorder (PTSD)

Substance Use Disorders (SUDs) — Youth Substance Use Unit

Major Depression Moderate, Major Depression Severe, Major Depression With Comorbid Anxiety Symptoms, Major Depression With Panic Attacks, Major Depression With Psychotic Features, Major Depressive Episode, Major Depressive Disorder (MDD, Major Depression — Electroconvulsive Thera

Cognitive Functioning, Psychosis — Active tDCS, Sham tDCS, Yoga

SCHIZOPHRENIA 1 (Disorder), Alcohol Use Disorder, Alcohol Dependence (Primary Condition) — Snoezelen® therapy for 6 weeks, Snoezelen® therapy for 12 weeks

PTSD, PTSD - Post Traumatic Stress Disorder, Major Depression, Suicidality — Transcranial Magnetic Stimulation, Psilocybin (drug), Neurofeedback

Substance Use Disorders (SUDs) — Individually Tailored Behavioral Activation, Formerly Incarcerated Transitions Program

Prevention, Risk Factors for Mental Illness, Family History of Schizophrenia Spectrum Disorder — Psychosocial intervention group

Bipolar 1 Disorder, Schizophrenia Disorder — OLZ/SAM

Schizophrenia, Cognitive Functions — Aerobic exercise, Active tDCS, Sham tDCS

Bipolar I Disorder, Bipolar Depression — Medtronic Percept PC DBS system

The Drug Enforcement Administration is proposing to modify the listing of the list I chemical 3,4-MDP-2-P methyl glycidic acid (also known as PMK glycidic acid) to include esters of 3,4-MDP-2-P methyl glycidic acid, not listed elsewhere in the Controlled Substances Act (CSA), as

Schizophrenia, Treatment Resistant Depression (TRD), Bipolar Disorder (BD), Catatonia, Obsessive Compulsive Disorder (OCD) — Blood sampling, lumbar puncture, stool sampling, skin microbiopsy and psychometrics scales

Intoxication; Opioid — Structured early addiction care, Not structured early addiction care

Obesity & Overweight, Cardiometabolic Health Indicators, Addiction, Eating Disorders, Mental Health — GLP-1 Receptor Agonist Therapy, Structured Lifestyle Intervention

Substance Use Disorder (SUD), mHealth — KulaMind-Recovery

Major Depression Moderate, Major Depression Severe, Major Depression With Comorbid Anxiety Symptoms, Major Depression With Panic Attacks, Major Depression With Psychotic Features, Major Depressive Episode, Bipolar Affective Disorder, Bipolar Depression Depressed Phase, Bipolar De

Wrinkles and Rhytides

Depression, Anxiety, Substance Use Disorder (SUD), Post Traumatic Stress Disorder — Microcurrent Neurofeedback (MCN), Standard Care for Substance Use Disorder

Post-Traumatic Stress Disorder, PTSD — Psilocybin (drug), Trauma-Focused Psychotherapy

PTSD and Trauma-related Symptoms, Cognitive Decline in Older Adults, Post Menopausal Women — estradiol

Addictive Behaviors, Emotion Regulation — Transdiagnostic cognitive-behavioral therapy, Treatment as usual

Etomidate Use Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS) — high-frequency Repetitive Transcranial Magnetic Stimulation, Repetitive transcranial magnetic stimulation

Addiction, Theraphy — psychoeducation

Treatment-resistant Depression (TRD) — Group integration therapy

Intimate Partner Violence (IPV), Depression and/or Anxiety Symptoms, PTSD - Post Traumatic Stress Disorder — The Self-Compassion, Health, and Empowerment (SHE) Intervention, Health and Nutrition Program

Addiction — Observational assessments (EMA and annual DSM-5 evaluations)

Bipolar Disorder (BD), Bipolar Disorder (BPD) — Peripheral blood sampling for PBMC isolation

Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate — TURP, Epinephrine

Bipolar Disorder (BD), Internalized Stigma, Psychoeducation — Cognitive-behavioral based psychoeducation program, Standard Care (in control arm)