DOCSLIB.ORG

Food and Drug Administration 5630 Fishers Lane, Rm

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Food and Drug Administration 5630 Fishers Lane, Rm Sent via Electronic and U.S. Mail October 13, 2015 James R. Hunter Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2015-N-0045 for International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine; Phenazepam; Etizolam; 1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine (MT-45); N-(1-Phenethylpiperidin- 4-yl)-N-phenylacetamide (Acetylfentanyl); α-Pyrrolidinovalerophenone (α-PVP); 4- Fluoroamphetamine (4-FA); para-Methyl-4-methylaminorex (4,4’-DMAR); para- Methoxymethylamphetamine (PMMA); 2-(ethylamino)-2-(3-methoxyphenyl)- cyclohexanone (Methoxetamine or MXE); Request for Comments Dear Mr. Hunter: This letter responds to the Food and Drug Administration’s (FDA) request for comments that appeared in the Federal Register on October 5, 2015, concerning International Drug Scheduling. The Association of Public and Land-grant Universities (APLU) represents 237 public research universities, land-grant institutions, state university systems, and affiliated organizations. Many of our member institutions have veterinary and medical schools and nearly all our institutions have researchers and students who conduct biomedical research. On behalf of our institutional membership, APLU appreciates this opportunity to provide the FDA with comments. APLU strongly objects to any attempt to alter the international regulation of ketamine that would result in increased difficulty for biomedical researchers to use this drug for legitimate and appropriate treatments. The United States currently classifies ketamine as a Schedule III drug under the Controlled Substance Act (CSA). As such, strict regulations and safeguards are already in place to prevent its illegal use. As known to FDA, Schedule I drugs are defined as those with no currently acceptable medical use, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Ketamine does not meet this definition, as it has important approved anesthetic uses in humans and animals, and it is already regulated appropriately and effectively by the CSA. Biomedical researchers regularly administer ketamine to sedate and provide analgesia for animals in their care. Restricting or eliminating access to this drug may unnecessarily halt countless pre-clinical research studies, many of which are federally-funded. 1307 New York Avenue, NW, Suite 400, Washington, DC 20005-4722 202.478.6040 fax 202.478.6046 www.aplu.org In contrast to the risk of restricting access to ketamine for its essential functions in legitimate and well-regulated biomedical research, stands the potential risk of abuse of the drug by unauthorized individuals. The World Health Organization reports that ketamine abuse in the United States and worldwide is uncommon, with less than 2% of the general population reporting that they had used ketamine at least once in their lifetime (WHO Critical Review Ketamine 2012). Elevating ketamine to a Schedule I drug with the accompanying restrictions of this classification is a disproportionate response to this risk, as it would unduly hamper U.S. biomedical research. APLU appreciates this opportunity to provide FDA with these comments before the November 16-20 meeting of the World Health Organization’s 36th Expert Committee on Drug Dependence (ECDD). Sincerely, Peter McPherson .
Load more

Recommended publications
  • 2015-02 Toxicology Rapid Testing Panel
    SOUTH CAROLINA LAW ENFORCEMENT DIVISION NIKKI R. HALEY MARK A. KEEL Governor Chief FORENSIC SERVICES LABORATORY CUSTOMER NOTICE 2015-02 REGARDING TOXICOLOGY RAPID TESTING PANEL August 12, 2015 This notice is to inform the Coroners of South Carolina of a new testing panel available through the SLED Toxicology Department. On Monday, August 17th, the Toxicology Department will begin offering both a Rapid Testing Panel in addition to the already available Expanded Testing Panel. This Rapid Testing Panel is to be utilized in cases where the Expanded Testing Panel is not warranted, specifically where a cause of death has already been established. The Rapid Testing Panel will consist of volatiles analysis, to include, ethanol, acetone, isopropanol and methanol, drug screens, and drug confirmation/quantitation of positive screens. The cases assigned to the Rapid Testing Panel will have an expedited turnaround time. Targeted turn around times will be two weeks for negative cases and six weeks or less for positive cases. While every effort will be made to adhere to these time frames, additional time may be required on occasion due to the nature of postmortem samples. Submitters will be notified if there is a problem with a particular sample. Please see attachment regarding specifically which substances are covered by the Rapid Testing Panel and the Expanded Testing Panel. As always, a detailed case history and list of drugs suspected is appreciated. Rapid Panel and Expanded Panel will be choices available in iLAB. Please contact Lt. Dustin Smith (803-896-7385) with additional questions. ALI-359-T An Accredited Law Enforcement Agency P.O.
    [Show full text]
  • Recommended Methods for the Identification and Analysis of Fentanyl and Its Analogues in Biological Specimens
    Recommended methods for the Identification and Analysis of Fentanyl and its Analogues in Biological Specimens MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES Laboratory and Scientific Section UNITED NATIONS OFFICE ON DRUGS AND CRIME Vienna Recommended Methods for the Identification and Analysis of Fentanyl and its Analogues in Biological Specimens MANUAL FOR USE BY NATIONAL DRUG ANALYSIS LABORATORIES UNITED NATIONS Vienna, 2017 Note Operating and experimental conditions are reproduced from the original reference materials, including unpublished methods, validated and used in selected national laboratories as per the list of references. A number of alternative conditions and substitution of named commercial products may provide comparable results in many cases. However, any modification has to be validated before it is integrated into laboratory routines. ST/NAR/53 Original language: English © United Nations, November 2017. All rights reserved. The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the United Nations concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delimitation of its frontiers or boundaries. Mention of names of firms and commercial products does not imply the endorse- ment of the United Nations. This publication has not been formally edited. Publishing production: English, Publishing and Library Section, United Nations Office at Vienna. Acknowledgements The Laboratory and Scientific Section of the UNODC (LSS, headed by Dr. Justice Tettey) wishes to express its appreciation and thanks to Dr. Barry Logan, Center for Forensic Science Research and Education, at the Fredric Rieders Family Founda- tion and NMS Labs, United States; Amanda L.A.
    [Show full text]
  • Safety Notice 009/20 Acetylfentanyl and Fentanyl In
    Safety Notice 009/20 Acetylfentanyl and fentanyl in non-opioid illicit drugs 16 October 2020 Background Distributed to: A cluster of hospitalisations due to unexpected opioid toxicity recently occured on • Chief Executives the Central Coast of NSW. Acetylfentanyl and fentanyl are circulating in NSW and • Directors of Clinical Governance may be misrepresented as or be adulterants in illicit cocaine or ketamine. • Director Regulation and Acetylfentanyl has a similar potency to fentanyl, both may cause serious harm and Compliance Unit death. People who do not use opioids regularly (‘opioid naïve’) may be unintentionally exposed and are at high risk of overdose. Even people who Action required by: regularly use opioids are at risk due to the relatively high potency of fentanyl and • Chief Executives acetylfentanyl. • Directors of Clinical Changes in illicit drug use in 2020, as well as variations in purity and alternative Governance ingredients, may be associated with unusual presentations and overdose. • Director Regulation and Compliance Unit Case management • We recommend you also Have a high index of suspicion for illicit fentanyl and fentanyl analogues in inform: suspected opioid overdose. This includes people who deny opioid use or • Drug and Alcohol Directors report use of other non-opioid illicit drugs including ketamine or stimulants and staff such as cocaine, but who present clinically with signs of an opioid • All Service Directors overdose. • Emergency Department • Intensive Care Unit • Airway management, oxygenation, and ventilation support take precedence • Toxicology Units over naloxone, where appropriate. • Ambulance • Cases may require titrated doses of naloxone with a higher total dose of • All Toxicology Staff 800 micrograms or more.
    [Show full text]
  • ESTIMATED WORLD REQUIREMENTS of NARCOTIC DRUGS in GRAMS for 2021 (July Update)
    ESTIMATED WORLD REQUIREMENTS OF NARCOTIC DRUGS IN GRAMS FOR 2021 (July update) Afghanistan Bezitramide 1 Codeine 20 000 Cannabis 7 050 Dextropropoxyphene 20 000 Cannabis resin 1 Diphenoxylate 800 Coca leaf 1 Fentanyl 6 Cocaine 15 Methadone 120 000 Codeine 700 000 Morphine 10 000 Codeine-N-oxide 1 Pethidine 2 000 Dextromoramide 1 Pholcodine 5 000 Dextropropoxyphene 170 000 Albania Difenoxin 1 Cocaine 1 Dihydrocodeine 1 Codeine 1 190 000 Diphenoxylate 1 Fentanyl 300 Dipipanone 1 Heroin 1 Ecgonine 2 Methadone 16 500 Ethylmorphine 1 Morphine 7 500 Etorphine 1 Oxycodone 1 500 Fentanyl 17 200 Pethidine 2 500 Heroin 1 Pholcodine 1 600 Hydrocodone 11 000 Remifentanil 10 Hydromorphone 4 000 Sufentanil 2 Ketobemidone 1 Algeria Levorphanol 1 Alfentanil 400 Methadone 110 000 Cannabis 3 Morphine 1 590 000 Cocaine 5 Morphine-N-oxide 1 Codeine 2 500 000 Nicomorphine 1 Etorphine 1 Norcodeine 1 Fentanyl 900 Normethadone 1 Heroin 2 Normorphine 1 Methadone 4 000 Opium 10 Morphine 15 000 Oripavine 1 Oxycodone 4 000 Oxycodone 60 000 Pethidine 3 000 Oxymorphone 1 Pholcodine 1 500 000 Pethidine 50 000 Remifentanil 1 Phenoperidine 1 Sufentanil 50 Pholcodine 1 Andorra Piritramide 1 Cannabis 2 000 Remifentanil 17 000 Fentanyl 100 Sufentanil 10 Methadone 1 000 Thebacon 1 Morphine 500 Thebaine 77 000 Oxycodone 2 000 Tilidine 1 Pethidine 500 Armenia Remifentanil 4 Codeine 3 000 Angola Fentanyl 50 Alfentanil 24 Methadone 22 000 Codeine 21 600 Morphine 8 000 Dextromoramide 188 Thebaine 4 100 Dextropropoxyphene 200 Trimeperidine 1 500 Dihydrocodeine 500 Aruba* Diphenoxylate
    [Show full text]
  • NIDA Drug Supply Program Catalog, 25Th Edition
    RESEARCH RESOURCES DRUG SUPPLY PROGRAM CATALOG 25TH EDITION MAY 2016 CHEMISTRY AND PHARMACEUTICS BRANCH DIVISION OF THERAPEUTICS AND MEDICAL CONSEQUENCES NATIONAL INSTITUTE ON DRUG ABUSE NATIONAL INSTITUTES OF HEALTH DEPARTMENT OF HEALTH AND HUMAN SERVICES 6001 EXECUTIVE BOULEVARD ROCKVILLE, MARYLAND 20852 160524 On the cover: CPK rendering of nalfurafine. TABLE OF CONTENTS A. Introduction ................................................................................................1 B. NIDA Drug Supply Program (DSP) Ordering Guidelines ..........................3 C. Drug Request Checklist .............................................................................8 D. Sample DEA Order Form 222 ....................................................................9 E. Supply & Analysis of Standard Solutions of Δ9-THC ..............................10 F. Alternate Sources for Peptides ...............................................................11 G. Instructions for Analytical Services .........................................................12 H. X-Ray Diffraction Analysis of Compounds .............................................13 I. Nicotine Research Cigarettes Drug Supply Program .............................16 J. Ordering Guidelines for Nicotine Research Cigarettes (NRCs)..............18 K. Ordering Guidelines for Marijuana and Marijuana Cigarettes ................21 L. Important Addresses, Telephone & Fax Numbers ..................................24 M. Available Drugs, Compounds, and Dosage Forms ..............................25
    [Show full text]
  • SOP414 Acetyl Fentanyl by LC MS MS
    SOP 414 – Acetylfentanyl Extraction using Protein Precipitation for Quantification by Liquid Chromatography/Electrospray Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) Table of Contents 1. Principle of Assay ........................................................................................................ 3 2. Specimens .................................................................................................................... 4 3. Reagents and Materials ................................................................................................ 4 4. Standards, Controls, and Solutions .............................................................................. 4 5. Equipment and Special Supplies ................................................................................. 5 6. Instrumentation and Parameters .................................................................................. 5 7. Target Ions ................................................................................................................... 6 8. Procedure ..................................................................................................................... 6 9. Calculations ................................................................................................................. 7 10. Quality Control ........................................................................................................ 9 11. Validation of Method ............................................................................................
    [Show full text]
  • Schedules of Controlled Substances (.Pdf)
    PURSUANT TO THE TEXAS CONTROLLED SUBSTANCES ACT, HEALTH AND SAFETY CODE, CHAPTER 481, THESE SCHEDULES SUPERCEDE PREVIOUS SCHEDULES AND CONTAIN THE MOST CURRENT VERSION OF THE SCHEDULES OF ALL CONTROLLED SUBSTANCES FROM THE PREVIOUS SCHEDULES AND MODIFICATIONS. This annual publication of the Texas Schedules of Controlled Substances was signed by John Hellerstedt, M.D., Commissioner of Health, and will take effect 21 days following publication of this notice in the Texas Register. Changes to the schedules are designated by an asterisk (*). Additional information can be obtained by contacting the Department of State Health Services, Drugs and Medical Devices Unit, P.O. Box 149347, Austin, Texas 78714-9347. The telephone number is (512) 834-6755 and the website address is http://www.dshs.texas.gov/dmd. SCHEDULES Nomenclature: Controlled substances listed in these schedules are included by whatever official, common, usual, chemical, or trade name they may be designated. SCHEDULE I Schedule I consists of: -Schedule I opiates The following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, if the existence of these isomers, esters, ethers, and salts are possible within the specific chemical designation: (1) Acetyl-α-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N- phenylacetamide); (2) Acetylmethadol; (3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide); (4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) (Other name:
    [Show full text]
  • Acetyl Fentanyl (N-(1-Phenethylpiperidin-4-Yl)-N-Phenylacetamide)
    Drug Enforcement Administration Diversion Control Division Drug & Chemical Evaluation Section Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) March 2020 Introduction: in another study using tail flick and phenylquinone writhing tests, Acetyl fentanyl, similar to the Schedule II opioid fentanyl, acetyl fentanyl produced analgesic response in mice. Acetyl is a potent opioid analgesic. Recently, it has been linked to fentanyl has been shown to completely suppress the signs of a number of overdose deaths in the United States. Acetyl withdrawal in morphine-dependent monkeys. Furthermore, fentanyl may not be a part of most illicit drug screens and acetyl fentanyl produce morphine-like subjective effects in drug may remain undetected in many of these cases. discrimination study. Besides analgesia, fentanyl-like Immunoassays (e.g. ELISA) for fentanyl do not differentiate substances, similar to other opioid analgesics, produce a variety fentanyl and acetyl fentanyl; confirmatory analysis such as of pharmacological effects including alteration in mood, gas chromatography/mass spectrometry (GC/MS) is euphoria, drowsiness, respiratory depression, suppression of required to confirm the presence of acetyl fentanyl. cough reflex, constriction of pupils (miosis), and impaired gastrointestinal motility. Licit Uses: Clinical studies evaluating pharmacological effects of acetyl Acetyl fentanyl has not been approved for medical use fentanyl in humans have not been reported in the scientific in the United States and there are no published studies on literature. safety for human use. In acute toxicity studies in mice, the LD50 (the dose causing death of 50% of test animals) of acetyl fentanyl and fentanyl are Chemistry: 9.3 mg/kg and 62 mg/kg, respectively.
    [Show full text]
  • Pdf | 6.4 Mb | Depressants
    3 DEPRESSANTS 3 DEPRESSANTS 2019 2019 © United Nations, June 2019. All rights reserved worldwide. ISBN: 978-92-1-148314-7 eISBN: 978-92-1-004174-4 United Nations publication, Sales No. E.19.XI.9 This publication may be reproduced in whole or in part and in any form for educational or non-profit purposes without special permission from the copyright holder, provided acknowledgement of the source is made. The United Nations Office on Drugs and Crime (UNODC) would appreciate receiving a copy of any publication that uses this publication as a source. Suggested citation:, World Drug Report 2019 (United Nations publication, Sales No. E.19.XI.8). No use of this publication may be made for resale or any other commercial purpose whatsoever without prior permission in writing from UNODC. Applications for such permission, with a statement of purpose and intent of the reproduction, should be addressed to the Research and Trend Analysis Branch of UNODC. DISCLAIMER The content of this publication does not necessarily reflect the views or policies of UNODC or contributory organizations, nor does it imply any endorsement. Comments on the report are welcome and can be sent to: Division for Policy Analysis and Public Affairs United Nations Office on Drugs and Crime PO Box 500 1400 Vienna Austria Tel: (+43) 1 26060 0 Fax: (+43) 1 26060 5827 E-mail: [email protected] Website: www.unodc.org/wdr2019 PREFACE The findings of this year’s World Drug Report fill in same time clamping down on organized crime and and further complicate the global picture of drug trafficking.
    [Show full text]
  • Fentanyl Analogs and Pre-Hospital Agitation
    Trending in the Emergency Department: Fentanyl Analogs and Pre-hospital agitation PATRICK AARONSON PHARM.D., DABAT CLINICAL PHARMACIST - EMERGENCY MEDICINE UNIVERSITY OF FLORIDA AND SHANDS – JACKSONVILLE [email protected] Goals and Objectives Pharmacist: – Recognize the most recent drug abuse crisis - Fentanyl Analogs – Recognize the challenges of naloxone dosing for Fentanyl analogs – Evaluate the risks and benefits of pre-hospital Ketamine for undifferentiated agitation Goals and Objectives Technician: – Discuss the Fentanyl analog crisis trajectories – Recognize the pharmacological effects of Ketamine for undifferentiated agitation Disclosure I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation. DEA: 2013: 700 Fentanyl deaths nationally CDC.gov/drugoverdose/pdf/pbss/PBSS-Report-072017.pdf Mortality Weekly Report (MMWR), 64(50–51), 378–1382 statnews.com/2016/09/29/fentanyl-heroin-photo-fatal-doses/ dea.gov/divisions/hq/2016/hq092216_attach.pdf Poison Center / Emergency Department Data • Lag time between experimentation and academic outlet • Poison center data less useful (disguised substances, familiar toxidrome) • Nonfatal fentanyl cases attributed to heroin • ELISA reports Fentanyl unless GC/MS was utilized to detect analogs Year Cases Deaths Year Cases National Florida 2015 1402 47 2017 69 2014 1418 5 2016 83 Clinical Toxicology
    [Show full text]
  • Advisories on Fentanyl and Other Synthetic Opioids
    FIN-2019-A006 August 21, 2019 Advisory to Financial Institutions on Illicit Financial Schemes and Methods Related to the Trafficking of Fentanyl and Other Synthetic Opioids Transnational criminal organizations (TCOs), foreign fentanyl suppliers, and Internet purchasers located in the United States engage in the trafficking of fentanyl, fentanyl analogues, and other synthetic opioids and the subsequent laundering of the proceeds from such illegal sales. Introduction The Financial Crimes Enforcement Network (FinCEN) is This Advisory should be issuing this advisory1 to alert financial institutions to illicit shared with: financial schemes and mechanisms related to the trafficking • Chief Executive Officers of fentanyl, fentanyl analogues, and other synthetic • Chief Operations Officers opioids,2 and to assist them in detecting and reporting • Chief Risk Officers related activity. • Legal Departments The United States is in the midst of an unparalleled • Chief Compliance/BSA Officers epidemic of addiction and death, fueled by the illicit • AML Officials trafficking, sale, distribution, and misuse of fentanyl and other synthetic opioids. The statistics are sobering; • Sanctions Compliance Officials between 2013 and 2017, deaths in the United States from • Cybersecurity Units synthetic opioids, other than methadone, increased over 800 percent.3 Every day in the United States, more than 130 people die from an opioid-related overdose.4 These numbers alone cannot fully capture the 1. This advisory is also part of a larger, United States government Fentanyl advisory covering the movement, manufacturing, marketing, and monetary aspects of the trafficking of fentanyl and other synthetic opioids. A summary of the 21st Century Drug Trafficking: Advisories on Fentanyl and Other Synthetic Opioids, which includes links to each advisory, can be found here: https://www.whitehouse.gov/wp-content/uploads/2019/08/White-House- Fentanyl-Advisories-Summary.pdf.
    [Show full text]
  • 2019 Annual Drug Report
    Department of Forensic Pathology Office of the Medical Examiner 2019 Drug Report Introduction Drug-Related Deaths - Defined We define drug deaths as those which result entirely or partially from the physiologic effects of acute toxicity. Therefore, included here are deaths which resulted from a combination of natural disease and acute intoxication (e.g. lung disease complicated by opioid intoxication). Our definition does not include deaths by violence, in which the violent behavior may have been caused or contributed to by intoxication (e.g. death due to injury from motor vehicle crash in which the at-fault driver was intoxicated). We also do not include deaths related to the effects of chronic substance use (e.g. deaths due to alcoholic liver disease or heart disease which may have been contributed to by chronic cocaine use) if not combined with acute toxicity. Methods The majority of the drug deaths reported are due to more than one substance, as you will see in the detailed tables that follow. Often, decedents have even more substances present in their body at the time of death or overdose incident than just the substances listed as having caused or contributed to death. After autopsy and review of records, including toxicology report, the medical examiner assigned to the case determines which of the substances present played a causal role in the death. Thus, there may be substances present in a given case which are not included in the cause of death statement. Occasionally, intoxicated decedents survive in the hospital for a time prior to death, following acute drug intoxication.
    [Show full text]