Date="04/28/93" Citation="58 FR 25788" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Proposed Placement of Methcathinon e Into Schedule I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Proposed Placement of Methcathinone Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Proposed Placement of Methcathinone Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Notice of proposed rulemaking. + ------------------------------------------------------------ SUMMARY: This notice of proposed rulemaking is issued by the Administrator of the Drug Enforcement Administration (DEA) to place methcathinone into Schedule I of the Controlled Substances Act (CSA). This proposed action by the DEA Administrator is based on data gathered and reviewed by the DEA. If finalized, this proposed action would impose the regulatory control mechanisms and criminal sanctions of Schedule I on the manufacture, distribution and possession of methcathinone. DATES: Comments must be submitted on or before May 28, 1993. ADDRESSES: Comments and objections should be submitted to the Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative. FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537. Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: On May 1, 1992, the Administrator of the DEA published a final rule in the Federal Register (57 FR 18824) temporarily placing methcathinone into Schedule I of the CSA using the temporary scheduling provisions of the CSA (21 U.S.C. 811(h)). This final rule, which became effective on the date of publication, was based on a finding by the Administrator that the temporary scheduling of methcathinone was necessary to avoid an imminent hazard to the public safety. Section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)) requires that the temporary scheduling of a substance expires at the end of one year from the effective date of the order. However, if proceedings to schedule a substance pursuant to 21 U.S.C. 811(a)(1) have been initiated and are pending, the temporary scheduling of a substance may be extended for up to six months. Under this provision, the temporary scheduling of methcathinone which would expire on May 1, 1993, may be extended to November 1, 1993. This extension is being ordered by the DEA Administrator in a separate action. The DEA has gathered and reviewed the available information regarding the actual base and relative potential for abuse for methcathinone. The DEA, in conjunction with the National Institute on Drug Abuse (NIDA), has provided for the synthesis and biological testing of methcathinone. By letter, the Administrator has submitted data which the DEA has gathered regarding methcathinone to the Assistant Secretary for Health, Department of Health and Human Services. In accordance with 21 U.S.C. 811(b), the DEA Administrator also requested a scientific and medical evaluation and a scheduling recommendation for methcathinone from the Assistant Secretary for Health. Methcathinone has a chemical structure and pharmacological profile similar to that of methamphetamine and cathinone. All forms of methamphetamine have been controlled in Schedule II of the CSA since 1971. As a result of prior control of cathinone in Schedule I of the 1971 Convention on Psychotropic Substances and in response to a recommendation received by the Administrator from the Assistant Secretary for Health and Human Services, cathinone was placed into Schedule I of the CSA on February 14, 1993. In preclinical studies, methcathinone hydrochloride produces pharmacological effects and appears to have an abuse potential similar to that of psychomotor stimulants such as the amphetamines. In a manner similar to that of other amphetamines, methcathinone hydrochloride increases spontaneous rodent locomotor activity, potentiates the release of radiolabelled dopamine from dopaminergic nerve terminals in the brain and causes appetite suppression. In drug discrimination studies, methcathinone hydrochloride evokes either (+)-amphetamine or cocaine induced appropriate responding. When examined in particular pharmacological assays for psychomotor stimulant-like activity, both the d and the l enantiomeric forms of methcathinone hydrochloride have been found to be pharmacologically active. In these assays, the l- form of methcathinone is more active than either d-methcathinone or (+)-amphetamine. Racemic methcathinone hydrochloride is intravenously self-addressed by baboons, thus indicating that methcathinone produces reinforcing effects in this laboratory animal and suggesting that this drug has a potential for abuse in the human population. To date, the distribution and abuse of methcathinone has been documented in Michigan and Wisconsin. Abuse of methcathinone has been known since at least January 1991. Since that time, the abuse of methcathinone has increased substantially in the upper peninsula of Michigan and, more recently, in Wisconsin. The principal form of methcathinone distributed and abused is the hydrochloride salt of the 1-enantiomer, which exists as a white to off-white, chunky powdered material. It is usually sold as itself under such street names as "Cat" and "Goob". Less often it is passed off as methamphetamine under such names as "Crank" or "Speed". The most common route of administration is via nasal insufflation. Other routes of administration include oral ingestion, intravenous injection and smoking. Methcathinone is abused in binges lasting two to six days. During this time, methcathinone is repeatedly administered, resulting in the daily administration of amounts surpassing one or two grams. The methcathinone binge resembles amphetamine binges in that the abuser does not sleep or eat and takes in little in the way of liquids. The methcathinone binge is followed by a "crash" characterized by long periods of sleep, excess eating and possibly depression. Methcathinone is abused for its psychomotor stimulant effects. It is reported by abusers to produce such effects as a "burst of energy", "headrush", "bodyrush", a "speeding of the mind", an "increased feeling of self-confidence" and "euphoria". Abusers have also reported that methcathinone produces unpleasant effects such as paranoia, hallucinations, anxiety, tremor, insomnia, malnutrition, weight loss, dehydration, sweating, stomach pains, noise bleeding and body aches. Following the crash, some individuals have experienced depression with or without thoughts of suicide. Methcathinone hydrochloride is produced for street distribution in clandestine laboratories. Between June, 1991 and February, 1993, 19 active or clandestine methcathinone laboratories were seized by Federal, state and local law enforcement officials in Michigan. In August 1991 a clandestine methcathinone laboratory was seized in Seattle, Washington. Since January , 1993, at least two clandestine methcathinone laboratories have been encountered in Wisconsin. Methcathinone has been encountered by law enforcement officials in Michigan and Wisconsin. Michigan State Police obtained the first street sample of methcathinone in February 1991. Since that time there have been over 50 encounters of methcathinone by Federal, state and law enforcement officials in Michigan. Methcathinone was first encountered in Wisconsin in March 1992. Since October 1992, there have been more than twenty Federal, state or local law enforcement encounters of methcathinone in Wisconsin. With the exception of the seizure of a single clandestine methcathinone laboratory in Washington, the DEA is not aware of any other law enforcement encounters of methcathinone within the United States, other than those in Michigan and Wisconsin. Health officials in Michigan and Wisconsin have encountered abusers of methcathinone. There have been a number of documented emergency room cases involving the purported abuse of methcathinone. Drug abuse treatment centers in Marquette and Iron Mountain, Michigan, as well as several psychiatric treatment centers in Wisconsin have reported encounters with methcathinone abusers. Sigma Chemical Company is the only known commercial manufacturer and supplier of methcathinone in the United States. The Food and Drug Administration (FDA) has notified the DEA that there are no exemptions or approvals in effect under section 505 of the Federal Food, Drug and Cosmetic Act for methcathinone. A search of the scientific and medical literature revealed no indications of current medical use of methcathinone in the United States. The DEA Administrator, based on the information gathered and reviewed by his staff and after consideration of the factors in 21 U.S.C. 811(c), believes that sufficient data exists to propose and to support that methcathinone be placed into Schedule I of the CSA pursuant to 21 U.S.C. 811(a). The specific findings required pursuant to 21 U.S.C. 811 and 812 for a substance to be placed into Schedule I are as follows: (1) The drug or other substance has a high potential for abuse. (2) The drug or other substance has no currently accepted medical use in treatment in the United States. (3) There is a lack of accepted safety for use of the drug or other substance under medical supervision. Before issuing a final rule in this matter, the DEA Administrator will take into consideration the scientific and medical evaluation and scheduling recommendation of the Secretary of the Department of Health and Human Services in accordance with 21 U.S.C. 811(b). The recommendations of the Secretary regarding scientific and medical matters are binding on the Administrator and if the Secretary recommends that a substance should not be controlled, the DEA Administrator will not control it. The Administrator will also consider relevant comments from other concerned parties. Interested persons are invited to submit their comments, objections or requests for a hearing in writing with regard to this proposal. Requests for a hearing should state with particularity the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative. In the event that comments, objections or requests for a hearing raise one or more issues which the Administrator finds warrant a hearing, the Administrator shall order a public hearing by notice of the Federal Register, summarizing the issues to be heard and setting the time for hearing. The Administrator of the DEA hereby certifies that the proposed placement of methcathinone into Schedule I of the CSA will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action involves the control of a substance with no currently approved medical use or manufacture in the United States. This proposed rulemaking is not a major rule for the purposes of Executive Order 12291 (46 FR 13193) of February 17, 1981. It has been determined that drug scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of Executive Order 12291. Accordingly, this drug scheduling action is not subject to the provisions of Executive Order 12778 which are contingent upon review by OMB. This action has been analyzed in accordance with the principles and criteria in Executive Order 12612, and it has been determined that this proposed rulemaking does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Under the authority vested in the Attorney General by section 201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of the DEA by Department of Justice regulations (28 CFR 0.100), the Administrator hereby proposes that 21 CFR part 1308 be amended as follows: PART 1308-[AMENDED] 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871b, unless otherwise noted. 2. Section 1308.11 is amended by adding paragraph (f)(6) to read as follows: sec1308.11 Schedule I. * * * * * (f) * * * (6) Methcathinone (Some other names: 2-(methylamino)-propiophenone, alpha (methylamino)-propiophenone, 2-(methylamino)-1-phenylpropan- 1-one, alpha-N-methylaminopropiophenone, monomethylpropion, ephedrone, N-methylcathinone, methycathinone, AL-464, AL-422, AL-463 and UR1431) its salts, optical isomers and salts of optical isomers . . . 1237. 3. sec1308.11 is further amended by removing and reserving paragraph (g)(3). Dated: April 22, 1993. Robert C. Bonner, Administrator of Drug Enforcement. [FR Doc. 93-9945 Filed 4-27-93; 8:45 am] BILLING CODE 4410-09-M