DOCSLIB.ORG

Removal of Thresholds for the List I Chemicals

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Removal of Thresholds for the List I Chemicals 38915 Rules and Regulations Federal Register Vol. 75, No. 129 Wednesday, July 7, 2010 This section of the FEDERAL REGISTER the Controlled Substances Import and these provisions (21 U.S.C. 830(d), (e); contains regulatory documents having general Export Act (CSIEA) (21 U.S.C. 801–971), 21 CFR part 1314). applicability and legal effect, most of which as amended. DEA publishes the The CMEA also subjects material are keyed to and codified in the Code of implementing regulations for these containing ephedrine, pseudoephedrine, Federal Regulations, which is published under and phenylpropanolamine to 50 titles pursuant to 44 U.S.C. 1510. statutes in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to manufacturing and import restrictions. The Code of Federal Regulations is sold by end. These regulations are designed to Specifically, CMEA amended section the Superintendent of Documents. Prices of ensure that there is a sufficient supply 1002 of the CSA (21 U.S.C. 952(a)(1)) by new books are listed in the first FEDERAL of controlled substances for legitimate adding the List I chemicals ephedrine, REGISTER issue of each week. medical, scientific, research, and pseudoephedrine, and industrial purposes and deter the phenylpropanolamine to those narcotic diversion of controlled substances to raw materials whose importation into DEPARTMENT OF JUSTICE illegal purposes. The CSA mandates that the United States is prohibited except for such amounts as the Attorney Drug Enforcement Administration DEA establish a closed system of control for manufacturing, distributing, and General finds to be necessary to provide for medical, scientific, or other 21 CFR Part 1310 dispensing controlled substances. Any person who manufactures, distributes, legitimate purposes. CMEA also [Docket No. DEA–296F] dispenses, imports, exports, or conducts amended section 306 of the Act (21 U.S.C. 826) to establish the total annual RIN 1117–AB10 research or chemical analysis with controlled substances must register with needs of ephedrine, pseudoephedrine, Removal of Thresholds for the List I DEA (unless exempt) and comply with and phenylpropanolamine to provide Chemicals Pseudoephedrine and the applicable requirements for the for the estimated medical, scientific, Phenylpropanolamine activity. The CSA, as amended, also research, and industrial needs of the requires DEA to regulate the United States, for lawful export AGENCY: Drug Enforcement manufacture, distribution, retail sale, requirements, and for the establishment Administration, Department of Justice. import, and export of chemicals that and maintenance of reserve stocks. ACTION: Final rule. may be used to manufacture controlled Individual manufacturing and substances illegally. Listed chemicals procurement quotas for ephedrine, SUMMARY: The Drug Enforcement pseudoephedrine, and Administration (DEA) is removing the that are classified as List I chemicals are important to the manufacture of phenylpropanolamine were also thresholds for importation, exportation, required to be established for persons and domestic distributions of the List I controlled substances. Those classified as List II chemicals may be used to conducting manufacturing activities chemicals pseudoephedrine and with those chemicals. In a separate manufacture controlled substances. phenylpropanolamine. This rulemaking rulemaking, ‘‘Import and Production is being conducted as part of DEA’s Combat Methamphetamine Epidemic Quotas for Certain List I Chemicals’’ implementation of the Combat Act of 2005 [Docket No. DEA–293, RIN 1117–AB08] Methamphetamine Epidemic Act of (72 FR 37439, July 10, 2007; Final Rule 2005 and is needed to implement the On March 9, 2006, the President 73 FR 73549, December 3, 2008), DEA Act’s requirements for import and signed the Combat Methamphetamine promulgated regulations to implement production quotas and to address the Epidemic Act of 2005 (CMEA), which is these provisions (21 CFR part 1315). potential diversion of these chemicals. Title VII of the USA PATRIOT Further, the CMEA requires that DEA is also clarifying that all Improvement and Reauthorization Act importers, exporters, and persons transactions of drug products containing of 2005 (Pub. L. 109–177). Among other involved in international transactions of ephedrine, pseudoephedrine, and actions, CMEA imposed new all listed chemicals, including phenylpropanolamine, except retail requirements regarding the retail sale of ephedrine, pseudoephedrine, and transactions, are considered to be scheduled listed chemical products phenylpropanolamine, provide DEA regulated transactions. (drugs containing ephedrine, with information regarding the DATES: Effective Date: This rule is pseudoephedrine, or transferee (i.e., the downstream effective August 6, 2010. phenylpropanolamine, that may be customer), of the chemical, as well as FOR FURTHER INFORMATION CONTACT: marketed or distributed lawfully in the information regarding the quantity of Mark W. Caverly, Chief, Liaison and United States under the Federal Food, the chemical to be transferred. Policy Section, Office of Diversion Drug and Cosmetic Act as Importers, exporters, and persons Control, Drug Enforcement nonprescription products) (21 U.S.C. involved in international transactions Administration, 8701 Morrissette Drive, 802(45)(A)). In a separate rulemaking, are further required to provide DEA Springfield, VA 22152, (202) 307–7297. ‘‘Retail Sales of Scheduled Listed with a return declaration regarding each SUPPLEMENTARY INFORMATION: Chemical Products; Self-Certification of import, export, or international Regulated Sellers of Scheduled Listed transaction after the transaction is DEA’s Legal Authority Chemical Products’’ [Docket No. DEA– completed (CMEA § 716, 21 U.S.C. DEA implements the Comprehensive 291, RIN 1117–AB05] (71 FR 56008, 971(d) and (g), as amended). In a Drug Abuse Prevention and Control Act September 26, 2006; corrected at 71 FR separate rulemaking, ‘‘Implementation of 1970, often referred to as the 60609, October 13, 2006), DEA of the Combat Methamphetamine Controlled Substances Act (CSA) and promulgated regulations implementing Epidemic Act of 2005; Notice of VerDate Mar<15>2010 15:15 Jul 06, 2010 Jkt 220001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\07JYR1.SGM 07JYR1 cprice-sewell on DSK8KYBLC1PROD with RULES 38916 Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Rules and Regulations Transfers Following Importation or ephedrine in combination with other are set in the CMEA and were addressed Exportation’’ [Docket No. DEA–292, RIN active ingredients such as potassium in DEA’s Interim Rule regarding the 1117–AB06] (72 FR 17401, April 9, iodide (an expectorant) and/or retail provisions of the CMEA (71 FR 2007; Temporary Stay of Certain theophylline (a bronchospamolytic). 56008, September 26, 2006; corrected at Provisions 72 FR 28601, May 22, 2007), Pseudoephedrine is lawfully 71 FR 60609, October 13, 2006). Second, DEA promulgated regulations marketed under the Federal Food, Drug, DEA proposed to clarify that all implementing these provisions (21 CFR and Cosmetic Act for over-the-counter distribution, importation, and 1313.16, 1313.17, 1313.26, 1313.27, use as a decongestant. exportation transactions involving drug 1313.32, 1313.35). Phenylpropanolamine has historically products containing ephedrine, Finally, the CMEA requires that the been marketed in the United States for pseudoephedrine, or notice of importation (DEA Form 486) OTC use as a decongestant and diet aid phenylpropanolamine are regulated for ephedrine, pseudoephedrine, and and there have been many legend transactions. phenylpropanolamine ‘‘shall include all (prescription) drug products that The comment period for the NPRM information known to the importer on contain pseudoephedrine or closed on January 22, 2008. DEA the chain of distribution of such phenylpropanolamine. In the vast received one comment on the NPRM. chemical from the manufacturer to the majority of these preparations, Thresholds importer.’’ (CMEA § 721, 21 U.S.C. pseudoephedrine or 971(h) as amended). In a separate phenylpropanolamine were in Under the existing regulations (21 rulemaking, ‘‘Information on Foreign combination with other active CFR 1310.04), the threshold for non- Chain of Distribution for Ephedrine, ingredients, such as antihistamines, retail distribution, import, export, and Pseudoephedrine, and expectorants, and/or antitussives. international transactions of Phenylpropanolamine’’ [Docket No. In November 2000, the U.S. Food and pseudoephedrine is 1 kilogram and for DEA–295, RIN 1117–AB07] (73 FR Drug Administration (FDA) issued a phenylpropanolamine, 2.5 kilograms. A 16793, March 31, 2008), DEA proposed public health advisory concerning single transaction or multiple regulations to implement this provision. phenylpropanolamine and requested transactions in a month with a single The List I chemicals ephedrine, that all drug companies discontinue customer that equal or exceed the pseudoephedrine, and marketing products containing threshold are considered regulated phenylpropanolamine as single entity or phenylpropanolamine due to risk of transactions and trigger the reporting combination products all serve as hemorrhagic stroke. In response, many and recordkeeping requirements of 21 precursor chemicals for the illicit companies have voluntarily CFR part 1310. If DEA has not manufacture of controlled substances. reformulated their products to exclude established a monthly threshold for a Ephedrine and pseudoephedrine are the
Load more

Recommended publications
  • Dextroamphetamine PI 202006
    HIGHLIGHTS OF PRESCRIBING INFORMATION • Glaucoma (4) 5.4 Long-Term Suppression of Growth Cardiovascular • Agitated states (4) Monitor growth in children during treatment with stimulants. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. These highlights do not include all the information needed to use DEXTROAMPHETAMINE saccharate, AMPHET- • History of drug abuse (4) Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over Central Nervous System AMINE aspartate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE sulfate extended-release capsules • During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) (4, 7.1) 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, safely and effectively. See full prescribing information for DEXTROAMPHETAMINE saccharate, AMPHETAMINE aspar- suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of logorrhea, dermatillomania, paresthesia (including formication), and bruxism. tate monohydrate, DEXTROAMPHETAMINE sulfate, AMPHETAMINE sulfate extended-release capsules. ----------------------------------------------------------- WARNINGS AND PRECAUTIONS ----------------------------------------------------------- about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
    [Show full text]
  • Preparation of Amphetamines From
    Europäisches Patentamt *EP001442006B1* (19) European Patent Office Office européen des brevets (11) EP 1 442 006 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.7: C07C 209/00 of the grant of the patent: 24.08.2005 Bulletin 2005/34 (86) International application number: PCT/US2002/034400 (21) Application number: 02802245.7 (87) International publication number: (22) Date of filing: 28.10.2002 WO 2003/037843 (08.05.2003 Gazette 2003/19) (54) PREPARATION OF AMPHETAMINES FROM PHENYLPROPANOLAMINES VERFAHREN ZUR HERSTELLUNG VON AMPHETAMINEN AUS PHENYLPROPANOLAMINEN PREPARATION D’AMPHETAMINES A PARTIR DE PHENYLPROPANOLAMINES (84) Designated Contracting States: • REINER LUCKENBACH: "Beilstein Handbuch AT BE BG CH CY CZ DE DK EE ES FI FR GB GR der Organischen Chemie, vol. XII, 4th Ed., 4th IE IT LI LU MC NL PT SE SK TR Suppl., p. 2586 to 2591" 1984 , SPRINGER VERLAG , BERLIN . HEIDELBERG . NEW YORK (30) Priority: 29.10.2001 US 20488 TOKYO XP002235852 page 2586 -page 2591 • HANS-G. BOIT: "Beilsteins Handbuch der (43) Date of publication of application: Organischen Chemie, vol. XII, 4th Ed., Third 04.08.2004 Bulletin 2004/32 Suppl. page 2664 to page 2669" 1973 , SPRINGER VERLAG , BERLIN . HEIDELBERG . (73) Proprietor: Boehringer Ingelheim Chemicals, Inc. NEW YORK XP002235853 page 2664 -page 2669 Peterburg, VA 23805 (US) • DATABASE CROSSFIRE BEILSTEIN [Online] BEILSTEIN INSTITUT ZUR FOEDERUNG DER (72) Inventors: CHEMISCHEN WISSENSCHAFTEN, • BOSWELL, Robert F., FRANKFURT AM MAIN, DE; Boehringer Ingelheim Chem.
    [Show full text]
  • Federal Register/Vol. 85, No. 76/Monday, April 20, 2020/Notices
    Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices 21889 Controlled substance Drug code Schedule Desomorphine ................................................................................................................................................................. 9055 I Dihydromorphine ............................................................................................................................................................. 9145 I Heroin .............................................................................................................................................................................. 9200 I Morphine-N-oxide ............................................................................................................................................................ 9307 I Normorphine .................................................................................................................................................................... 9313 I Tilidine ............................................................................................................................................................................. 9750 I Alpha-methylfentanyl ....................................................................................................................................................... 9814 I Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................... 9821 I Methamphetamine
    [Show full text]
  • Recommended Methods for the Identification and Analysis Of
    Vienna International Centre, P.O. Box 500, 1400 Vienna, Austria Tel: (+43-1) 26060-0, Fax: (+43-1) 26060-5866, www.unodc.org RECOMMENDED METHODS FOR THE IDENTIFICATION AND ANALYSIS OF AMPHETAMINE, METHAMPHETAMINE AND THEIR RING-SUBSTITUTED ANALOGUES IN SEIZED MATERIALS (revised and updated) MANUAL FOR USE BY NATIONAL DRUG TESTING LABORATORIES Laboratory and Scientific Section United Nations Office on Drugs and Crime Vienna RECOMMENDED METHODS FOR THE IDENTIFICATION AND ANALYSIS OF AMPHETAMINE, METHAMPHETAMINE AND THEIR RING-SUBSTITUTED ANALOGUES IN SEIZED MATERIALS (revised and updated) MANUAL FOR USE BY NATIONAL DRUG TESTING LABORATORIES UNITED NATIONS New York, 2006 Note Mention of company names and commercial products does not imply the endorse- ment of the United Nations. This publication has not been formally edited. ST/NAR/34 UNITED NATIONS PUBLICATION Sales No. E.06.XI.1 ISBN 92-1-148208-9 Acknowledgements UNODC’s Laboratory and Scientific Section wishes to express its thanks to the experts who participated in the Consultative Meeting on “The Review of Methods for the Identification and Analysis of Amphetamine-type Stimulants (ATS) and Their Ring-substituted Analogues in Seized Material” for their contribution to the contents of this manual. Ms. Rosa Alis Rodríguez, Laboratorio de Drogas y Sanidad de Baleares, Palma de Mallorca, Spain Dr. Hans Bergkvist, SKL—National Laboratory of Forensic Science, Linköping, Sweden Ms. Warank Boonchuay, Division of Narcotics Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand Dr. Rainer Dahlenburg, Bundeskriminalamt/KT34, Wiesbaden, Germany Mr. Adrian V. Kemmenoe, The Forensic Science Service, Birmingham Laboratory, Birmingham, United Kingdom Dr. Tohru Kishi, National Research Institute of Police Science, Chiba, Japan Dr.
    [Show full text]
  • Product Monograph
    PRODUCT MONOGRAPH VYVANSE®* lisdexamfetamine dimesylate Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg Chewable Tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg Central Nervous System Stimulant Takeda Canada Inc. Date of Preparation: 22 Adelaide Street West, Suite 3800 19 February 2009 Toronto, Ontario M5H 4E3 Date of Revision: July 21, 2020 Submission Control No.: 240669 *VYVANSE® and the VYVANSE Logo are registered trademarks of Shire LLC, a Takeda company. Takeda and the Takeda Logo are trademarks of Takeda Pharmaceutical Company Limited, used under license. © 2020 Takeda Pharmaceutical Company Limited. All rights reserved. Pa ge 1 of 60 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ............................................................................................ 5 WARNINGS AND PRECAUTIONS ............................................................................ 6 ADVERSE REACTIONS........................................................................................... 12 DRUG INTERACTIONS ........................................................................................... 23 DOSAGE AND ADMINISTRATION ........................................................................ 25 OVERDOSAGE .......................................................................................................
    [Show full text]
  • Studies of Synthetic Particles and Nerve Endings on Mass
    STUDIES OF SYNTHETIC PARTICLES AND NERVE ENDINGS ON MASS TRANSPORT AND KINETICS AND INHIBITION OF THE DEGLYCOSYLATED DOPAMINE TRANSPORTER By VERONICA MANLING CHIU A dissertation submitted in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY WASHINGTON STATE UNIVERSITY Department of Chemistry May 2012 To the Faculty of Washington State University: The members of the Committee appointed to examine the dissertation of VERONICA MANLING CHIU find it satisfactory and recommend that it be accepted. __________________________________ James O. Schenk, Ph.D., Chair ___________________________________ Herbert H. Hill, Jr., Ph.D. ___________________________________ Chulhee Kang, Ph.D. ___________________________________ Barbara A. Sorg, Ph.D. ii ACKNKOWLEDGEMENTS I would like to start by thanking my committee, Drs. Jim Schenk, Herb Hill, Chulhee Kang, and Barb Sorg for their support, encouragement, and guidance. I am especially grateful to my mentor as well as my friend, Dr. Jim Schenk, for the infinite support, patience, and encouragement. Jim, you allowed me to learn, think and find answers on my own, but at the same time you provided help whenever I needed it. You also encouraged me to believe who I am. You taught me how to write a scientific paper and allowed me to write in my own words. You also provided me much help with giving presentations, which I am still learning about. In addition to science knowledge, I learned a lot from you on cooking, food, American culture, and arts. I really enjoyed the time when we gathered and shared food, and of course, your food is always so tasty. I know I am going to miss it! I also enjoyed our talks, and I never met a person who has as much knowledge as you do.
    [Show full text]
  • Review: Synthetic Methods for Amphetamine
    Review: Synthetic Methods for Amphetamine A. Allen1 and R. Ely2 1Array BioPharma Inc., Boulder, Colorado 80503 2Drug Enforcement Administration, San Francisco, CA Abstract: This review focuses on synthesis of amphetamine. The chemistry of these methods will be discussed, referenced and precursors highlighted. This review covers the period 1985 to 2009 with emphasis on stereoselective synthesis, classical non-chiral synthesis and bio-enzymatic reactions. The review is directed to the Forensic Community and thus highlights precursors, reagents, stereochemistry, type and name reactions. The article attempts to present, as best as possible, a list of references covering amphetamine synthesis from 1900 -2009. Although this is the same fundamental ground as the recent publication by K. Norman; “Clandestine Laboratory Investigating Chemist Association” 19, 3(2009)2-39, this current review offers another perspective. Keywords: Review, Stereoselective, Amphetamine, Syntheses, references, Introduction: It has been 20 years since our last review of the synthetic literature for the manufacture of amphetamine and methamphetamine. Much has changed in the world of organic transformation in this time period. Chiral (stereoselective) synthetic reactions have moved to the forefront of organic transformations and these stereoselective reactions, as well as regio-reactions and biotransformations will be the focus of this review. Within the synthesis of amphetamine, these stereoselective transformations have taken the form of organometallic reactions, enzymatic reactions, ring openings, - aminooxylations, alkylations and amination reactions. The earlier review (J. Forensic Sci. Int. 42(1989)183-189) addressed for the most part, the ―reductive‖ synthetic methods leading to this drug of abuse. It could be said that the earlier review dealt with ―classical organic transformations,‖ roughly covering the period from 1900-1985.
    [Show full text]
  • State Methamphetamine Precursor Control Policies
    The author(s) shown below used Federal funds provided by the U.S. Department of Justice and prepared the following final report: Document Title: From Policy to Practice: State Methamphetamine Precursor Control Policies Author: Jean O’Connor, J.D., M.P.H.; Jamie Chriqui, Ph.D., M.H.S.; Duane McBride, Ph.D.; Shelby Smith Eidson, J.D.; Carissa Baker; Yvonne Terry-McElrath, M.S.; Curt VanderWaal, Ph.D. Document No.: 228133 Date Received: August 2009 Award Number: 2005-IJ-CX-0028 This report has not been published by the U.S. Department of Justice. To provide better customer service, NCJRS has made this Federally- funded grant final report available electronically in addition to traditional paper copies. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S. Department of Justice. From Policy to Practice: State Methamphetamine Precursor Control Policies A report on state methamphetamine laws and regulations, effective October 1, 2005 Prepared by: Jean O’Connor, J.D., M.P.H.1 Jamie Chriqui, Ph.D., M.H.S.1 Duane McBride, Ph.D.2 Shelby Smith Eidson, J.D.1 Carissa Baker1 Yvonne Terry-McElrath, M.S.3 Curt VanderWaal, Ph.D. 2 1The MayaTech Corporation 2Andrews University 3University of Michigan March 2, 2007 This document is a research report submitted to the U.S. Department of Justice. This report has not been published by the Department. Opinions or points of view expressed are those of the author(s) and do not necessarily reflect the official position or policies of the U.S.
    [Show full text]
  • 1 Billing Code 4410-09-P DEPARTMENT of JUSTICE Drug Enforcement Administration 21 CFR Part 1310
    This document is scheduled to be published in the Federal Register on 07/14/2017 and available online at https://federalregister.gov/d/2017-14878, and on FDsys.gov Billing Code 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 [Docket No. DEA-379] RIN 1117-ZA04 Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. SUMMARY: The Drug Enforcement Administration (DEA) is finalizing the designation of the chemical alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act (CSA). The DEA proposed control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine. This rulemaking finalizes, without change, the control of APAAN as a list I chemical. This action does not establish a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, shall be regulated. In addition, chemical mixtures containing APAAN are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical 1 mixtures containing any quantity of APAAN shall be regulated pursuant to the CSA. However, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption. DATES: Effective date: [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Michael J.
    [Show full text]
  • Billing Code 4410-09-P DEPARTMENT
    This document is scheduled to be published in the Federal Register on 03/30/2021 and available online at federalregister.gov/d/2021-05346, and on govinfo.govBilling Code 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 [Docket No. DEA-678] Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. SUMMARY: The Drug Enforcement Administration is proposing the control of the chemical methyl alpha-phenylacetoacetate (also known as MAPA; methyl 3-oxo-2- phenylbutanoate; methyl 2-phenylacetoacetate; α-acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) and its optical isomers as a list I chemical under the Controlled Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. If finalized, this action would subject handlers of methyl alpha-phenylacetoacetate to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of methyl alpha-phenylacetoacetate. As such, all transactions of chemical mixtures containing methyl alpha-phenylacetoacetate would be regulated at any concentration and would be subject to control under the CSA. DATES: Comments must be submitted electronically or postmarked on or before [INSERT DATE 60 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. Commenters should be aware that the electronic Federal Docket Management System will not accept any comments after 11:59 p.m.
    [Show full text]
  • List of Controlled Substances Disclaimer Section 812 of The
    List of Controlled Substances Disclaimer Section 812 of the Controlled Substances Act (21 U.S.C. §801 et seq.) (CSA) lists substances which were controlled in 1970 when the law was enacted. Since then, approximately 160 substances have been added, removed, or transferred from one schedule to another. The current official list of controlled substances can be found in section 1308 of the most recent issue of Title 21 Code of Federal Regulations (CFR) Part 1300 to end (21 CFR §1308) and the final rules which were published in the Federal Register subsequent to the issuance of the CFR. This list describes the basic or parent chemical and do not describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may be controlled substances. These lists are intended as general references and are not comprehensive listings of all controlled substances. Please note that a substance need not be listed as a controlled substance to be treated as a Schedule I substance for criminal prosecution. A controlled substance analogue is a substance which is intended for human consumption and is structurally or pharmacologically substantially similar to or is represented as being similar to a Schedule I or Schedule II substance and is not an approved medication in the United States. (See 21 U.S.C. §802(32)(A) for the definition of a controlled substance analogue and 21 U.S.C. §813 for the schedule.) Defined Abbreviations 2C-B 4-Bromo-2,5-dimethoxyphenethylamine 2C-T-7 2,5-Dimethoxy-4(n)-propylthiophenethylamine BZP N-Benzylpiperazine DMT
    [Show full text]
  • The Excretion of Dexamphetamine and Its Derivatives
    Brit. J. Pharmacol. (1965), 24, 293-300. THE EXCRETION OF DEXAMPHETAMINE AND ITS DERIVATIVES BY A. M. ASATOOR, B. R. GALMAN, J. R. JOHNSON AND M. D. MILNE From the Department ofMedicine, Westminster Medical School, London, S. W.1 (Received June 2, 1964) The urinary excretion of amphetamine has been studied by Richter (1938), Jacobsen & Gad (1940), Beyer & Skinner (1940), Keller & Ellenbogen (1952) and Axelrod (1954). These investigators, however, have not examined the effect of acid-base changes on the excretion of the drug. Since amphetamine is a weak base with a high partition coefficient between lipoid solvents and water when in the un-ionized form, it was considered likely that its excretion would be influenced by changes in urinary pH (Milne, Scribner & Crawford, 1958). We have, therefore, examined the excretion and fate of dexamphetamine in man and in the rat when the urinary pH was varied. METHODS Rats. Albino rats (Wistar) weighing 250k 15 g were used. In six rats, the urine was made acid by giving ammonium chloride (100 mg as a loading dose followed by 50 mg three-times daily). In six other rats, the urine was made alkaline by giving sodium bicarbonate (100 mg as a loading dose followed by 50 mg three- times daily). The ammonium chloride and sodium bicarbonate were administered in glucose solution by intragastric tube, beginning 24 hr before the test and continuing throughout the test. The rats were placed in metabolic cages and the urine was collected. After a 24-hr control period, 3.5 mg of dexamphetamine sulphate was administered to each rat by subcutaneous injection.
    [Show full text]