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Con Father Martin Rpt 20130919.Pdf
IN THE MATTER OF * BEFORE THE * ASHLEY, INC., d/b/a * MARYLAND * FATHER MARTIN’S ASHLEY * HEALTH CARE * Docket No. 13-12-2340 * COMMISSION * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Staff Report and Recommendation September 19, 2013 Table of Contents I. INTRODUCTION......................................................................................................... 1 A. The Applicant ............................................................................................................ 1 B. The Project ................................................................................................................ 1 C. Background ............................................................................................................... 2 C. Summary of Staff Recommendation ......................................................................... 3 II. PROCEDURAL HISTORY ......................................................................................... 4 A. Review of the Record ................................................................................................ 4 B. Local Government Review and Comment ................................................................ 6 C. Interested Parties in the Review ................................................................................ 6 III. STAFF REVIEW AND ANALYSIS ........................................................................... 6 A. COMAR 10.24.01.08G (3) (a)-THE STATE HEALTH PLAN ................................ -
House Bill No.11 (2019)
LEGISLATURE OF THE STATE OF IDAHO Sixty-fifth Legislature First Regular Session - 2019 IN THE HOUSE OF REPRESENTATIVES HOUSE BILL NO. 11 BY HEALTH AND WELFARE COMMITTEE 1 AN ACT 2 RELATING TO CONTROLLED SUBSTANCES; AMENDING SECTION 37-2705, IDAHO CODE, TO 3 REVISE THE LIST OF SCHEDULE I CONTROLLED SUBSTANCES; AMENDING SECTION 4 37-2709, IDAHO CODE, TO PROVIDE AN EXCLUSION AND TO MAKE A TECHNICAL 5 CORRECTION; AMENDING SECTION 37-2713, IDAHO CODE, TO REVISE THE LIST OF 6 SCHEDULE V DRUGS AND SUBSTANCES; AND DECLARING AN EMERGENCY. 7 Be It Enacted by the Legislature of the State of Idaho: 8 SECTION 1. That Section 37-2705, Idaho Code, be, and the same is hereby 9 amended to read as follows: 10 37-2705. SCHEDULE I. (a) The controlled substances listed in this sec- 11 tion are included in schedule I. 12 (b) Any of the following opiates, including their isomers, esters, 13 ethers, salts, and salts of isomers, esters, and ethers, unless specifically 14 excepted, whenever the existence of these isomers, esters, ethers and salts 15 is possible within the specific chemical designation: 16 (1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-pip- 17 eridinyl]-N-phenylacetamide); 18 (2) Acetylmethadol; 19 (3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylac- 20 etamide); 21 (4) Allylprodine; 22 (5) Alphacetylmethadol (except levo-alphacetylmethadol also known as 23 levo-alpha-acetylmethadol, levomethadyl acetate or LAAM); 24 (6) Alphameprodine; 25 (7) Alphamethadol; 26 (8) Alpha-methylfentanyl; 27 (9) Alpha-methylthiofentanyl -
Pharmaceuticals As Environmental Contaminants
PharmaceuticalsPharmaceuticals asas EnvironmentalEnvironmental Contaminants:Contaminants: anan OverviewOverview ofof thethe ScienceScience Christian G. Daughton, Ph.D. Chief, Environmental Chemistry Branch Environmental Sciences Division National Exposure Research Laboratory Office of Research and Development Environmental Protection Agency Las Vegas, Nevada 89119 [email protected] Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Why and how do drugs contaminate the environment? What might it all mean? How do we prevent it? Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada This talk presents only a cursory overview of some of the many science issues surrounding the topic of pharmaceuticals as environmental contaminants Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada A Clarification We sometimes loosely (but incorrectly) refer to drugs, medicines, medications, or pharmaceuticals as being the substances that contaminant the environment. The actual environmental contaminants, however, are the active pharmaceutical ingredients – APIs. These terms are all often used interchangeably Office of Research and Development National Exposure Research Laboratory, Environmental Sciences Division, Las Vegas, Nevada Office of Research and Development Available: http://www.epa.gov/nerlesd1/chemistry/pharma/image/drawing.pdfNational -
Chloral Hydrate: Summary Report
Chloral Hydrate: Summary Report Item Type Report Authors Yuen, Melissa V.; Gianturco, Stephanie L.; Pavlech, Laura L.; Storm, Kathena D.; Yoon, SeJeong; Mattingly, Ashlee N. Publication Date 2020-02 Keywords Compounding; Food, Drug, and Cosmetic Act, Section 503B; Food and Drug Administration; Outsourcing facility; Drug compounding; Legislation, Drug; United States Food and Drug Administration; Chloral Hydrate Rights Attribution-NoDerivatives 4.0 International Download date 26/09/2021 09:06:16 Item License http://creativecommons.org/licenses/by-nd/4.0/ Link to Item http://hdl.handle.net/10713/12087 Summary Report Chloral Hydrate Prepared for: Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946 Prepared by: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) University of Maryland School of Pharmacy February 2020 This report was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946) totaling $2,342,364, with 100 percent funded by the FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the FDA/HHS or the U.S. Government. 1 Table of Contents REVIEW OF NOMINATION ..................................................................................................... 4 METHODOLOGY ................................................................................................................... -
Glutethimide Market in the United States of America Because of (S 116) and Methyprylon (S 117) Have Been Marketed Serious Side-Effects
44 H. ISBELL & T. L. CHRUSCIEL 184. Swanson, L. A. & Okada, T. (1963) J. Amer. med. 186. Wilson, J. C. (1963) Amer. J. Psychiat., 120, 600-601 Ass., 184, 780 (Death after withdrawal of mepro- (Status epilepticus associated with withdrawal bamate) from deprol (meprobamate and benactyzine)) 185. Taddei, J. & Parmi, E. (1959) Boll. Soc. ital. Biol. 187. Veress, F., Major, V., Fink, M. & Freedman, A. M. sper., 35, 211-214 (Pharmacological observation (1969) J. clin. Pharmacol., 9, 232-238 (High dose on the meprobamate habit) tybamate therapy of heroin dependence) PIPERIDINEDIONE DERIVATIVES Of the seven drugs listed (Table VII), glutethimide market in the United States of America because of (S 116) and methyprylon (S 117) have been marketed serious side-effects. for the longest time. Originally, both glutethimide and methyprylon were advertised as being " non- REFERENCES barbiturate" hypnotics. Actually both drugs are pharmacologically quite similar to barbiturates and 188. Berger, H. (1961) J. Amer. med. Ass.. 177, 63 glutethimide is more toxic than barbiturates when (Addiction to methyprylon) taken in large doses. Shortly after both glutethimide 189. Horn, M. H. (1968) Fortschr. Neurol. Psychiat.. 36, and methyprylon became available, case reports 310-316 (Einige Aspekte der Methyprylonsucht) began to appear in the literature indicating that the 190. Jensen, R. (1960) N. Z. med. J., 59, 431 (Addiction two drugs caused dependence of the barbiturate- to Nodular. A report of 2 cases) 191. Johnson, F. A. & VanBuren, H. C. (1962) J. Amer. alcohol type in man.1881l95 Glutethimide has been med. Ass., 180, 1024 (Abstinence syndrome shown to induce dependence in dogs and monkeys following glutethimide intoxication) and to suppress abstinence from barbital in physically 192. -
483 Administrative Records, Texas Department of Criminal Justice
Consistent with the terms of the Court’s May 22, 2017 scheduling order, the record has been redacted for all information that plaintiff, Texas Department of Criminal Justice (Texas), has identified as confidential. In addition, Defendants have also redacted information that the drug’s supplier and broker have separately advised the agency they consider confidential and private, as well as information the agency itself generally treats as confidential. This information has been redacted pending final FDA’s review of confidentiality claims, and our filing of the record with these redactions does not necessarily reflect our agreement with all of the claims of confidentiality Defendants have received. Defendants explicitly reserve the right to make an independent determination regarding the proper scope of redactions at a later time. Should we identify any of Texas’s redactions that are over-broad or otherwise improper, we will work with Texas’s counsel to revise the redactions in the record. Exhibit 14 FDA 095 Case 1:11-cv-00289-RJL Document 13-3 Filed 04/20/11 Page 1 of 74 CERTJFICATE Pursuant to the provisions ofRule 44 ofthe Federal Rules ofCivil Procedure, I hereby certifY that John Verbeten, Director ofthe Operations and Policy Branch, Division of Import Operations and Policy, Office ofRegional Operations, Office ofRegulatory Affairs, United States Food and Drug Administration, whose declaration is attached, has custody ofofficial records ofthe United States Food and Drug Administration. In witness whereof, I have, pursuant to the provision ofTitle 42, United States Code, Section 3505, and FDA StaffManual Guide 1410.23, hereto set my hand and caused the seal ofthe Department ofHealth and Human Services to be affixed th.is ~oi{. -
Drug/Substance Trade Name(S)
A B C D E F G H I J K 1 Drug/Substance Trade Name(s) Drug Class Existing Penalty Class Special Notation T1:Doping/Endangerment Level T2: Mismanagement Level Comments Methylenedioxypyrovalerone is a stimulant of the cathinone class which acts as a 3,4-methylenedioxypyprovaleroneMDPV, “bath salts” norepinephrine-dopamine reuptake inhibitor. It was first developed in the 1960s by a team at 1 A Yes A A 2 Boehringer Ingelheim. No 3 Alfentanil Alfenta Narcotic used to control pain and keep patients asleep during surgery. 1 A Yes A No A Aminoxafen, Aminorex is a weight loss stimulant drug. It was withdrawn from the market after it was found Aminorex Aminoxaphen, Apiquel, to cause pulmonary hypertension. 1 A Yes A A 4 McN-742, Menocil No Amphetamine is a potent central nervous system stimulant that is used in the treatment of Amphetamine Speed, Upper 1 A Yes A A 5 attention deficit hyperactivity disorder, narcolepsy, and obesity. No Anileridine is a synthetic analgesic drug and is a member of the piperidine class of analgesic Anileridine Leritine 1 A Yes A A 6 agents developed by Merck & Co. in the 1950s. No Dopamine promoter used to treat loss of muscle movement control caused by Parkinson's Apomorphine Apokyn, Ixense 1 A Yes A A 7 disease. No Recreational drug with euphoriant and stimulant properties. The effects produced by BZP are comparable to those produced by amphetamine. It is often claimed that BZP was originally Benzylpiperazine BZP 1 A Yes A A synthesized as a potential antihelminthic (anti-parasitic) agent for use in farm animals. -
Sedative-Hypnotics: Pharmacology and Use
CLINICAL REVIEW Sedative-Hypnotics: Pharmacology and Use Norman S. Miller, MD, and Mark S. Gold, MD White Plains, New York, Summit, New Jersey, and Delray Beach, Florida The quest for an ideal sedative-hypnotic drug has been fraught with failure. The goals of the perfect sedative-hypnotic drug are to: (1) produce a transient reduc tion in the level of consciousness for the purpose of sedation, calmness, and tran quility without lingering aftereffects: (2) produce sleep without the potential to ar rest respirations and without aftereffects on sensorium and mood; and (3) produce no abuse, addiction, tolerance, or dependence. Nonetheless, clinical conditions have required the use of sedative-hypnotic drugs in spite of the inher ent difficulties with them. The history of sedative-hypnotic drugs is replete with attempts to produce a safe and effective drug. The introduction of one sedative-hypnotic drug for an other has been heralded by unguarded optimism and misguided claims. History has repeated itself with each new drug. Toxicities, abuse, addiction, and develop ment of tolerance and dependence have remained in force for each drug that has appeared on the market. Only minor variations on a theme have differentiated one drug from another as the essential features have remained in force. he members of the class of sedative-hypnotic drugs are were initially considered to have less potential for abuse, Tremarkably similar in their pharmacological proper they may be equal to the sedative-hypnotic drugs in these ties but vary considerably in their chemical structure. The respects.3-4 method of classification arose primarily as an attempt to Other members of the sedative-hypnotic class are chlo categorize the drugs according to the subjective and be ral hydrate, ethchlorvynol, glutethimide, meprobamate, havioral effects produced by them, that is, sedation and methyprylon, paraldehyde, and triclofos. -
Hypnotic Drugs RUSSELL R
Postgrad Med J: first published as 10.1136/pgmj.46.535.314 on 1 May 1970. Downloaded from Pcstgraduate Medical Journal (May 1970) 46, 314-317. CURRENT SURVEY Hypnotic drugs RUSSELL R. MILLER* DIRK V. DEYOUNG Pharm. D. M.D. Director, Drug Communications Study, Assistant Medical Director, University of Chicago Continental Assurance Company, Chicago JAMES PAXINOS B.S (Pharm.) Assistant Director for Clinical Services, Department ofPharmacy, University of Chicago Hospitals and Clinics THIS review will treat the more commonly prescribed Human pharmacology hypnotic agents and their sleep-inducing properties. In the past, hypnotics have been divided into Hypnotic agents that are seldom used (paraldehyde), barbiturates and non-barbiturates. This classification, drugs that are not singularly soporific but may be based on chemical structure, has little contemporary used either alone or as adjuncts in inducing sleep [e.g. clinical significance since compounds in each group meprobamate (Equanil, Miltown), chlordiazepoxide have essentially the same qualitative pharmacologic (Librium) and diazepam (Valium)] and drugs that properties. Naturally, there are quantitative differ- copyright. have little soporific effect [antihistamines, bromides ences in onset and duration of action. and methylparafynol (Oblivon, Dormison) (Lasagna, 1954)] will not be discussed. Onset of action Indications Onset is generally rapid with liquid preparations Insomnia is an extremely common complaint with such as syrup of chloral hydrate (Noctec, Somnos), which are confronted. -
A Summary of California's Alcohol and Drug Abuse Laws
If you have issues viewing or accessing this file contact us at NCJRS.gov. A SUMMARY OF CALIFORNIA'S ALCOHOL AND DRUG ABUSE LAWS Prepared pursuant to SB 2599 (Seymour), (Chapter 983, Statutes of 1988) Prepared by: SENATE OFFICE OF RESEARCH Elisabeth Kersten, Director June 3D, 1989 462-8 127464 U.S. Department of Justice National Institute of Justice This document has been reproduced exactly as received from the person or organization originating It. Points of view or opinions stated In this document are those of the authors and do not necessarily represent the official position or policies of the National Institute of Justice. Permission to reproduce this copyrighted material has been granted bl:: California Legislature to the National Criminal Justice Reference Service (NCJRS). Further reproduction outside of the NCJRS system requires permis sion of the copyright owner. A SUMMARY OF CALIFORNIA'S ALCOHOL AND DRUG ABUSE LAWS Prepared pursuant to SB 2599 (Seymour), (Chapter 983, Statutes of 1988) June 30, 1989 Prepared by: SENATE OFFICE OF RESEARCH, Ken Hurdle, Project Director, Kim Connor, Dan Englund, Dolores Sanchez, Lenore Tate Edited by: Judith A. Ryder, Thomas F. Wilspn ~;:- ~~~: ~M8ERS: ~ILLIAM A. CRAVEN to DAVIS CALIFORNIA LEGISLATURE VADIE DEDDEH TERRI DELGADILLO ~'ECIL GREEN , COMMITTEE CONSULTANT ;'ARY HART !ILL" LOCKYER STATE CAPITOL. ROOM 3074 !'E8ECCA MORGAN SACRAMENTO. CA 95814 ilCHOLAS PETRIS (916) 445-4264 to ROYCE ~ANEWATSON ~ SENATE SELECT COMMITTEE ~ ON ~ ~:, SUBSTANCE ABUSE r~, ~ t; JOHN SEYMOUR ~: !i CHAIRMAN 1 ~~ tl December 19, 1989 r1 \i ~ ~, As Chairman of the Senate Select Committee on Substance l\ Abuse, I am pleased to participate with the Senate Office of I' Research in the release of A Summary of California's Alcohol ~ and Drug Abuse Laws. -
Depressants Sedative Hypnotics
Psyc 470 – Introduction to Chemical Addictions Alcohol • Oldest Sedative Hypnotic Depressants • Used thousands of years Sedative Hypnotics • Used mostly for self medication Psychology 470 Introduction to Chemical Additions Steven E. Meier, Ph.D. Listen to the audio lecture while viewing these slides 1 2 Psyc 470 – Introduction to Chemical Addictions Psyc 470 – Introduction to Chemical Addictions Used for Many Things General Names • To relieve stress •Downers • Induce sleep • Sedatives • Reduce anxiety •Hypnotics • Minor Tranquilizers • Anxiolytics • Anti Anxiety Medications 3 4 Psyc 470 – Introduction to Chemical Addictions Psyc 470 – Introduction to Chemical Addictions Classes of Compounds Based Historically Non-Barbiturates • Non-Barbiturates • Use began before 1900 • Barbiturates • Many compounds • Antianxiety Medications/Minor •Bromides * Tranquilizers • Chloral Hydrate * • Paraldehyde* •Urethane • Sulfonal • Most are not used today 5 6 1 Psyc 470 – Introduction to Chemical Addictions Psyc 470 – Introduction to Chemical Addictions Bromides Problems • Sodium Bromide • Lots of side effects • One of the earliest Sedative Hypnotics • Takes a long time to administer and • Behaves like a chloride ion eliminate from the system • Shuts down the action potential •Can be toxic • Is eliminated slowly • Can still be used for epileptic seizures • Need to gradually increase the dosage and sedation but other drug groups are over days (titrate the patient) until the better desired effect occurs • Not used much today 7 8 Psyc 470 – Introduction to Chemical Addictions Psyc 470 – Introduction to Chemical Addictions Chloral Hydrate (Noctec) Paraldehyde • Oldest sleep inducing (hypnotic) depressant • Is a polymer of acetaldehyde • First synthesized in 1832 • Occasionally used to treat DT’s • Induces sleep in approximately ½ hour • Therapeutic Doses • Sleep occurs in about 15 minutes • Little effect on respiration or BP • Drug is metabolized to acetaldehyde by •Toxic Doses the liver and eliminated through the • Severe respiration depression and low BP lungs – gives an odor. -
Clinical Evaluation of Methyprylon (Noludar®) + As A
CLINICAL EVALUATION OF METHYPRYLON (NOLUDAR| AS A PREANAESTHETIC SEDATIVE HYPNOq~]C ALLEN B. DoBKn% M.D.,* and GORDON M. WYANT, F.F.A.I~C S.* with clinical assistance of FRAN~r DYCK** MANY psychological factors affect the patient who requires an anaesthetic and an operation. To varying degrees these may influence the response to a curative or palhatlve operation, either to' advantage or to disadvantage (I 1). These factors are of such an intangible nature that the wisest clinician has difficulty when he attempts to measure them either subjectively or objectively (2). The determina- tion of the effect of drugs upon psychological changes induced by a stress situa- tion in a hospital environment multaphes the complexity of the mehsurements (3). It is exceedingly difficult for the elimcal inveshgator to eliminate prejudice and bias, and it is even more difficult to formulate reliable and vahd objective and subjechve means fo" determining the value of procedures designed to influence favourably the psychological and physiological ~esponse of a patient to operation (4, 5). A few investigators have recently tackled "this problem in a way which is unique in clinical medicine (6, 7, 8, 9, 10). They used combinations of sedative-hypnotic drugs and placebos in double blind studies. The results, of such studies have provided us with lughly revealing information. Herring (11) has studied this problem on a a even wider base. Iu evaluating the effects of premedlcant drugs he has referred to the psychological factors as "predictor'" variables and to the factors representing the surgical response as "criterion'" variables He divided the predictor variables into two categories: first, those measuring personality varlable,~ which may be elicited from patients prior to an operation, and second, the judgments made by psychologists using these measurements m an effort to predict responses during the operation.