“This final rule eliminates references to 7 substances that were previously subject to temporary control, but which have since been permanently controlled under schedule I, and redesignates 23 other substances that are currently temporarily controlled under schedule I. This action makes no substantive changes to the affected regulation.”
The DEA proposes to add the following to Schedule 1 using the emergency scheduling provisions of the CSA:
An Act To amend the Controlled Substances Act to more effectively regulate anabolic steroids.
Naloxegol (INN; NKTR-118), or PEGylated naloxol, is a peripherally-selective opioid antagonist under development by AstraZeneca, licensed from Nektar, for the treatment of opioid-induced constipation. (via Wikipedia).
This rule revokes the Schedule III exemption for hydrocodone combination products, effectively moving them to Schedule II of the Controlled Substances Act alongside hydrocodone proper.
The DEA makes good on their earlier proposal, placing Suvorexant on Schedule IV.
2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, optical and geometric isomers and salts of these isomers (including Tramadol), become Schedule IV controlled substances.
This final rule differs from the original proposal where Tramadol was the “primary” name. Here, prominence is given to the systematic chemical name.
Alfaxalone is added to Schedule IV. Contrary to 78 FR 17895, the earlier proposed rule which included a systematic and trivial name, this final rule has the trivial name only.
The final rule temporarily placing 10 cathinones into schedule I as proposed earlier by 79 FR 4429.
The DEA proposes to place Suvorexant into schedule IV.
Four cannabinoids are added to Schedule I, as proposed a month earlier in 79 FR 1776.
The DEA proposes to place 10 cathinones into schedule I temporarily: 4-MEC, 4-MePPP, α-PVP, Butylone, Pentedrone, Pentylone, 4-FMC, 3-FMC, Naphyrone and α-PBP.
The DEA proposes to place these four synthetic cannabinoids into Schedule I via the temporary scheduling provisions of the CSA:
The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 26 drug substances:
Perampanel [2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate], including its salts, isomers, and salts of isomers, joins Schedule III.
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe), 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe) and 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe) are added to Schedule I for at least two years.
The DEA proposes to place 2-((Dimethylamino)methyl)-1-(3-methoxyphenyl)cyclohexanol, its salts, isomers, salts of isomers, and all isomeric configurations of possible forms including Tramadol, into Schedule IV.
The DEA proposes to place Perampanel [2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate], including its salts, isomers, and salts of isomers, into Schedule III.
The DEA proposes to add 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe), 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe) and 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe) to Schedule I for at least two years.
This final rule adds lorcaserin, including its salts, isomers, and salts of isomers to Schedule IV.
Three synthetic cannabinoids (UR-144, 5F-UR-144 aka XLR11, and APINACA aka AKB48) are added to Schedule I on an emergency basis for two years.
A proposal to add three synthetic cannabinoids (UR-144, 5F-UR-144 aka XLR11, and APINACA aka AKB48) to Schedule I on an emergency basis for two years.
This final ruling adds methylone to Schedule I. The prior emergency scheduling which placed methylone on Schedule I was set to expire later this month.
A proposal to add alfaxalone, including its salts, isomers, and salts of isomers to Schedule IV.
“On July 9, 2012, the President signed into law the Synthetic Drug Abuse Prevention Act of 2012 (SDAPA). SDAPA amends the Controlled Substances Act by placing 26 substances in Schedule I. DEA is publishing this rule to establish drug codes for these 26 substances, and to make technical and conforming amendments in accordance with SDAPA.”
A proposal to add lorcaserin, including its salts, isomers, and salts of isomers to Schedule IV.
This would formally add methylone, one of three cathinones currently scheduled via the emergency scheduling procedure, to Schedule I. The other two, mephedrone and methylenedioxypyrovalerone (MDPV), were added to Schedule I by Bill S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA).
This quasi-consolidated version includes the changes enacted by Bill S. 3187 (a section of which is subtitled “Synthetic Drug Abuse Prevention Act of 2012”) and presumably any other changes by legislation.
Unfortunately, the vast majority of amendments to the schedules of the CSA are done administratively rather than legislatively, and these have not been included.
The result is a document that consolidates legislation but omits the hundreds of amendments by the DEA, published as “rules” in the Federal Register. It does not reflect the current law in any practical sense.
Subtitle D—Synthetic Drugs (aka the “Synthetic Drug Abuse Prevention Act of 2012”) adds a new generic category “cannabimimetic agents” and 26 named substances to Schedule I. The act further doubles the duration of emergency scheduling to 24/12 months from 12/6 months.
This would formally add to Schedule I the same five cannabinoids currently included through the emergency scheduling procedure. Some stereochemical designations have been removed as have the explicit inclusion of the optical, positional, and geometric isomers, salts and salts of isomers.
“This final rule updates the Code of Federal Regulations pertaining to DEA by alphabetizing definitions and eliminating the numeric listings in those definitions in order to simplify future rulemakings where additional definitions are added or deleted. This rule also corrects typographic errors, reflects organizational changes, and updates cross-reference listings in the CFR. This action makes no substantive changes to the affected rules.”
The chief consequence of this amendment here is to renumber and correct some largely inconsequential typographical errors in the chemical names of anabolic steroids. These are not actually enumerated in CSA Schedule III as set out here, but in the definition of the term “Anabolic steroids.” In fact, the names here were for the most part already, if unwittingly, correct. I have added the earlier, uncorrected names for historical completeness.
“A bill to ban the sale of certain synthetic drugs.”
“A bill to amend the Controlled Substances Act to place synthetic drugs in Schedule I.”
Corrects the prior notice of proposed scheduling, 75 FR 71635, by striking out parts addressing the Regulatory Flexibility Act and the Congressional Review Act on the grounds that neither Act applies to the proposal and are therefore immaterial.
Implementation of the Comprehensive Methamphetamine Control Act of 1996 (Pub. L. 104-237)
“To amend the Public Health Service Act with respect to children’s health.”
Division B, title XXXV, section 3501 is subtitled the Drug Addiction Treatment Act of 2000.
Division B, title XXXVI, section 3601 is subtitled the Methamphetamine Anti-Proliferation Act of 2000.
“An act to amend the Controlled Substances Act to direct the emergency scheduling of Gamma hydroxybutyric acid, to provide for a national awareness campaign, and for other purposes.”
“Making omnibus consolidated and emergency appropriations for the fiscal year ending September 30, 1999, and for other purposes.”
Division C, title VIII, section 801 is subtitled the Western Hemisphere Drug Elimination Act.
Division C, title VIII, subtitle G is further subtitled the Controlled Substances Trafficking Prohibition Act.
Division E, section 1 is subtitled the Methamphetamine Trafficking Penalty Enhancement Act of 1998.
Proposed implementation of the Comprehensive Methamphetamine Control Act of 1996 (Pub. L. 104-237)
“To combat drug-facilitated crimes of violence, including sexual assaults”
“A bill to prevent the illegal manufacturing and use of methamphetamine.”
“To amend the Omnibus Crime Control and Safe Streets Act of 1968 to allow grants to increase police presence, to expand and improve cooperative efforts between law enforcement agencies and members of the community to address crime and disorder problems, and otherwise to enhance public safety.”
Title XVIII, section 180201 is subtitled the Drug Free Truck Stop Act.
“To amend the Comprehensive Drug Abuse Prevention and Control Act of 1970 to control the diversion of certain chemicals used in the illicit production of controlled substances such as methcathinone and methamphetamine, and for other purposes.”
This act comes into force on 16 April 1994.
“A bill to control crime.”
Title XIX is subtitled the Anabolic Steroids Control Act of 1990.
“A bill to prevent the manufacturing, distribution, and use of illegal drugs, and for other purposes.”
Title VI, section 6051 is subtitled the Chemical Diversion and Trafficking Act of 1988.
Title VI, section 6071 is subtitled the Asset Forfeiture Amendments Act of 1988.
“A bill to strengthen Federal efforts to encourage foreign cooperation in eradicating illicit drug crops and in halting international drug traffic, to improve enforcement of Federal drug laws and enhance interdiction of illicit drug shipments, to provide strong Federal leadership in establishing effective drug abuse prevention and education programs, to expand Federal support for drug abuse treatment and rehabilitation efforts, and for other purposes.”
Title I, section 1001 is subtitled the Narcotics Penalties and Enforcement Act of 1986.
Title I, section 1051 is subtitled the Drug Possession Penalty Act of 1986.
Title I, section 1101 is subtitled the Juvenile Drug Trafficking Act of 1986.
Title I, section 1201 is subtitled the Controlled Substance Analogue Enforcement Act of 1986.
Title I, section 1251 is subtitled the Continuing Drug Enterprises Act of 1986.
Title I, section 1301 is subtitled the Controlled Substances Import and Export Penalties Enhancement Act of 1986.
Title I, section 1821 (since repealed) is subtitled the Continuing Drug Enterprises Act of 1986.
Title I, section 1991 is subtitled the Federal Drug Law Enforcement Agent Protection Act of 1986.
“A joint resolution making continuing appropriations for the fiscal year 1985, and for other purposes.”
Title II, chapter V, section 501 is subtitled the Controlled Substances Penalties Amendments Act of 1984.
Title II, chapter V, section 506(a) is subtitled the Dangerous Drug Diversion Control Act of 1984, also known as the Emergency Scheduling Act.
“A bill to amend the Comprehensive Drug Abuse Prevention and Control Act of 1970 and other laws to meet obligations under the Convention on Psychotropic Substances relating to regulatory controls on the manufacture, distribution, importation, and exportation of psychotropic substances, and for other purposes.”
“A bill to amend the Controlled Substances Act to provide for the registration of practitioners conducting narcotic treatment programs.”