Daily Rules, Proposed Rules, and Notices of the Federal Government
Interested persons, defined at 21 CFR 1300.01 as those "adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811)," may file a request for hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and 1316.47. Requests for hearing, notices of appearance, and waivers of participation must be received on or before November 16, 2012.
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.
Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in the DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the
In accordance with the CSA, this action is a formal rulemaking “on the record after opportunity for a hearing.” 21 U.S.C. 811(a). Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557) and 21 CFR 1308.41. Pursuant to 21 CFR 1308.44(a)-(c), requests for hearing, notices of appearance, and waivers of participation may be submitted only by interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).” Such requests or notices must conform to the requirements of 21 CFR 1308.44(a) or (b) and 1316.47 or 1316.48, as applicable. A request or notice should state, with particularity, the interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) and 1316.49, including a written statement regarding the interested person's position on the matters of fact and law involved in any hearing.
Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of the hearing is restricted to “(A) find[ing] that such drug or other substance has a potential for abuse, and (B) mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *” Requests for hearing, notices of appearance at the hearing, and waivers of participation in the hearing should be submitted to DEA using the address information provided above.
The DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act and the Controlled Substances Import and
The CSA permits these schedules to be modified by providing that scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (2) at the request of the Secretary of HHS, or (3) on the petition of any interested party. 21 U.S.C. 811(a). The Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed * * *” 21 U.S.C. 811(a). The findings required for the placement of a controlled substance in Schedule I are: “(A) The drug or other substance has a high potential for abuse. (B) The drug or substance has no currently accepted medical use in treatment in the United States. (C) There is a lack of accepted safety for use of the drug or other substance under medical supervision.” 21 U.S.C. 812(b).
On September 8, 2011, the Administrator of the DEA published a Notice of Intent to temporarily place 3,4-methylenedioxy-N-methylcathinone (methylone) along with two other synthetic cathinones (4-methyl-N-methylcathinone (mephedrone) and 3,4-methylenedioxypyrovalerone (MDPV)) into Schedule I pursuant to the temporary scheduling provisions of the CSA (76 FR 55616). Following this, on October 21, 2011, the Administrator published a Final Order in the
As described in the October 21, 2011, Final Order, methylone is a designer drug of the phenethylamine class and is structurally and pharmacologically similar to amphetamine, 3,4-methylenedioxymethamphetamine (MDMA), cathinone and other related substances. The addition of a beta-keto (β-ketone) substituent to the phenethylamine core structure produces a group of substances that have β-keto-phenethylamine as the core structure. Methylone has a β-keto-phenethylamine core structure. Methylone has been used as research chemical. Based on the review of the scientific literature, there are no known medical uses for methylone. The Assistant Secretary of Health for the U.S. Department of Health and Human Services (HHS) has advised that there are no exemptions or approvals in effect for methylone under section 505 (21 U.S.C. 355) of the Federal Food, Drug and Cosmetic Act.
This NPRM proposes the permanent scheduling of methylone pursuant to 21 U.S.C. 811(a)(1). On March 30, 2012, DEA requested a scientific and medical evaluation and scheduling recommendation from the Assistant Secretary of Health for HHS for methylone, mephedrone and MDPV pursuant to 21 U.S.C. 811(b). Upon receipt and evaluation of the scientific and medical evaluation and scheduling recommendation from the Assistant Secretary,
Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in the scheduling decision. Please note that both the DEA and HHS analyses are available under “Supporting and Related Material” of the public docket for this proposed rule at
The legislative history of the CSA suggests the following four prongs to consider in determining whether a particular drug or substance has potential for abuse:
i. There is evidence that individuals are taking the drug or other substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or
ii. There is significant diversion of the drug or substance from legitimate drug channels; or
iii. Individuals are taking the substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs; or
iv. The drug is a new drug so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that the drug or other substance will have the same potential for abuse as such drugs, thus making it reasonable to assume that there may be significant diversion from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.
With respect to the first prong, a number of case reports and case series have shown that individuals are taking methylone and products containing methylone in amounts sufficient to induce adverse health effects similar to those induced by amphetamine, methamphetamine, and MDMA, Schedule I and II substances. These effects included elevated body temperature, increases in heart rate and respiratory exchange, changes in blood pressure, seizures, erratic behavior, and coma. Even death has been reported following the abuse of methylone or products containing methylone. Further, law enforcement encounters indicate the occurrence of a fatal automotive accident that was caused by a driver under the influence of a product containing methylone.
In considering evidence of significant diversion of the drug or substance from legitimate drug channels under the second prong, it must be noted that as of October 21, 2011, methylone has been temporarily controlled as a Schedule I substance and thus has not been legally available unless for research purposes. However, the National Forensic Laboratory Information System (NFLIS), which details over 2,500 reports from state and local forensic laboratories, identified methylone in drug related exhibits for a period from January 2009 to June 2012 from 42 states. The System to Retrieve Information from Drug Evidence (STRIDE), which details reports from federal forensic laboratories, identified methylone in 220 drug related exhibits from a period from January 2009 to June 2012.
For the third prong, HHS states that there is no currently accepted medical use for methylone and no medical practitioner is currently licensed by law to administer methylone. Indeed, the FDA has not approved a new drug application (NDA) for methylone for any therapeutic indication, and no investigational new drug (IND) application for methylone is currently active. Thus, with no accepted medical use or administering practitioners, individuals currently using products containing methylone are doing so on their own initiative without medical advice from a practitioner licensed to administer methylone.
With regard to the fourth prong, HHS states that methylone produces pharmacological effects similar to those produced by the Schedule I and II central nervous system (CNS) substances such as amphetamine, methamphetamine, cocaine, and MDMA which have a high potential for abuse. Methylone, like these Schedule I and II substances, affects the concentrations of the neurotransmitters dopamine, serotonin and norepinephrine in the CNS. In drug discrimination assays, methylone substitutes for MDMA, amphetamine, methamphetamine, and cocaine, which suggests that methylone will likely produce subjective effects in humans similar to these substances and have a similar pattern of abuse. Methylone, like methamphetamine, amphetamine, and cocaine, is a CNS stimulant and produces locomotor stimulant activity in animals.
Methylone has no known medical use in the United States but evidence demonstrates that methylone is being abused by individuals for its psychoactive effects. Methylone has been encountered by law enforcement throughout the United States as reported in NFLIS and in STRIDE databases suggesting that individuals are abusing methylone. Methylone has also been identified during the toxicological screening of individual human urine samples which also demonstrates that individuals are abusing this substance. In addition, information from poison centers indicates the abuse of synthetic cathinones which likely include methylone. The American Association of Poison Control Centers (AAPCC)
State public health and poison centers have warned of the dangers associated with the use of synthetic cathinones and their associated products being found on the designer drug market. In response to the abuse of methylone and other synthetic cathinones, as of September 2012, at least 42 states have emergency scheduled or enacted legislation placing regulatory controls on some or many of the synthetic cathinones including mephedrone, methylone, MDPV and/or a defined general class of cathinones. At least 27 states specifically control methylone. Numerous local jurisdictions have also placed controls on methylone and other synthetic cathinones. All five branches of the U.S. military prohibit military personnel from possessing or using synthetic cathinones including methylone.
Methylone has been reported to cause a number of adverse effects that are characteristic of stimulants like methamphetamine, amphetamine, and cocaine. Adverse effects associated with the consumption of methylone include those typical of a sympathomimetic agent such as palpitations, hyperthermia, seizures, hyponatremia, bruxism, sweating, hypertension, tachycardia, headache, palpitations, thirst, mydriasis, tremor, fever, sweating, and hypertension. Other effects that have been reported from the use of methylone include psychological effects such as confusion, psychosis, paranoia, hallucinations, combativeness, and agitation. Finally, reports of death for individuals abusing methylone indicate that methylone is a serious public health threat.
At selected United States ports of entry, the U.S. Customs and Border Protection (CBP) has encountered shipments of products containing methylone. The most commonly identified synthetic cathinone was methylone. As of July 2012, methylone was identified in 127 of 330 shipments encountered by CBP from June 2008 to July 2012. These shipments of methylone were in powdered form ranging from gram to multi-kilogram quantities. Most of the shipments of these synthetic cathinones that contained methylone originated in China and were destined for delivery throughout the United States to places like Alaska, Arizona, Arkansas, California, Colorado, Florida, Hawaii, Illinois, Kansas, Louisiana, Oklahoma, Oregon, Missouri, Nevada, New Mexico, Tennessee, Texas, Washington, and West Virginia.
Concerns over the abuse of methylone and other synthetic cathinones have prompted many states to control these substances. As of September 2012, at least 42 states have emergency scheduled or enacted legislation placing regulatory controls on some or many of the synthetic cathinones including methylone. In addition, the U.S. Armed Forces prohibited the use of synthetic cathinones including mephedrone, methylone and MDPV.
The CSA establishes five schedules of controlled substances known as Schedules I, II, III, IV, and V. The statute outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendations of the Assistant Secretary for Health of HHS and review of all available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b)(1), finds that:
(1) 3,4-methylenedioxy-N-methylcathinone (methylone) has a high potential for abuse;
(2) 3,4-methylenedioxy-N-methylcathinone (methylone) has no currently accepted medical use in treatment in the United States; and
(3) There is a lack of accepted safety for use of 3,4-methylenedioxy-N-methylcathinone (methylone) under medical supervision.
Based on these findings, the Administrator of DEA concludes that 3,4-methylenedioxy-N-methylcathinone (methylone) including its salts, isomers and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrants control in Schedule I of the CSA (21 U.S.C. 812(b)(1)).
Methylone is currently scheduled on a temporary basis in Schedule I and is subject to the CSA regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, possession, dispensing, importing, and exporting of a Schedule I controlled substance, including those listed below. These controls on methylone will continue on a permanent basis if this rule is finalized as proposed:
In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget pursuant to Section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.
This proposed regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
This proposed rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.
This proposed rule will not have tribal implications and will not impose substantial direct compliance costs on Indian tribal governments.
This action does not impose a new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR Part 1308 is proposed to be amended to read as follows:
1. The authority citation for 21 CFR Part 1308 continues to read as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
2. Section 1308.11 is amended by adding a new paragraph (d)(36) to read as follows:
(d) * * *
(36) 3,4-Methylenedioxy-N-methylcathinone (Methylone)—7540