Drug Enforcement Administration (DEA), Department of Justice (DOJ).
This final order establishes the final adjusted 2017 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
This order is applicable November 3, 2017.
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FOR FURTHER INFORMATION CONTACT:
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.
End Further Info
Start Supplemental Information
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substances listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100.
The DEA published the 2017 established aggregate production quotas for controlled substances in schedules I and II and for the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the Federal Register on October 5, 2016. 81 FR 69079. This notice stated that the Start Printed Page 51294Administrator would adjust, as needed, the established aggregate production quotas in 2017 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2017 proposed adjusted aggregate production quotas for controlled substances in schedules I and II and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the Federal Register on August 4, 2017, (82 FR 36449) in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas and assessment of annual needs on or before September 5, 2017.
Three DEA-registered entities submitted timely comments regarding a total of eleven schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for amphetamine (for conversion), dihydrocodeine, diphenoxylate (for sale), heroin, levorphanol, lisdexamfetmine, methadone intermediate, noroxymorphone (for conversion), oripavine, oxycodone (for sale), and oxymorphone (for conversion) were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements, and for the establishment and maintenance of reserve stocks. The DEA received 43 comments from non-DEA registered entities in response to the DEA's August 4, 2017, press release for the proposed 2018 aggregate production quotas. The majority of these commenters expressed concerns about the 20 percent decrease to the production quotas of controlled substances. The DEA also received two comments from non-DEA registered entities suggesting that the rescheduling of marihuana would drastically reduce opioid use, misuse, and addiction. These 45 comments addressed issues that were outside the scope of this final order, and therefore are not relevant to the analysis involved in finalizing the 2017 aggregate production quotas.
The DEA received no comments from DEA-registered or non-DEA registered entities for previously established values of the 2017 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine.
Analysis for Final Adjusted 2017 Aggregate Production Quotas and Assessment of Annual Needs
In determining the final adjusted 2017 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments that are specifically relevant to this Final Order for calendar year 2017 along with the factors set forth in 21 CFR 1303.13 and 21 CFR 1315.13 in accordance with 21 U.S.C. 826(a), and other relevant factors including the 2016 year-end inventories, initial 2017 manufacturing and import quotas, 2017 export requirements, actual and projected 2017 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator is adjusting the 2017 aggregate production quotas and assessment of annual needs for 4-Anilino-N-Phenethyl-4-Piperidine (ANPP), dihydrocodeine, ephedrine (for sale), fentanyl, hydrocodone (for sale), meperidine, methadone intermediate, morphine (for sale), opium (tincture), Oripavine, oxycodone (for sale), Oxymorphone (for conversion), Oxymorphone (for sale), phenylpropanolamine (for conversion), phenylpropanolamine (for sale), pseudoephedrine (for sale), tapentadol, and thiafentanil. This final order reflects those adjustments.
Regarding diphenoxylate (for sale), heroin, levorphanol, and noroxymorphone (for conversion) the Administrator hereby determines that the proposed adjusted 2017 aggregate production quotas and assessment of annual needs for these substances and list I chemicals as published on August 4, 2017, (82 FR 36449) are sufficient to meet the current 2017 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate reserve stock. This final order establishes these aggregate production quotas at the same amounts as proposed.
Pursuant to the above, the Administrator hereby finalizes the 2017 aggregate production quotas for the following schedule I and II controlled substances and the 2017 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:
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|Basic class||Final revised 2017 quotas
|2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)||25|
|2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)||25|
|2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)||30|
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|5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)||40|
|5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)||30|
|5F-AMB (methyl 2-(1-(5-fluoropentyl)-1 H-indazole-3-carboxamido)-3-methylbutanoate)||30|
|5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1 H-indazole-3-carboxamide)||30|
|5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 H indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone||25|
|ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide)||30|
|ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide)||50|
|APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1 H-indazole-3-carboxamide)||25|
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|JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)||35|
|Lysergic acid diethylamide (LSD)||40|
|MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide)||30|
|MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1 H-indole-3-carboxamido)-3,3-dimethylbutanoate)||30|
|MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1 H-indazole-3-carboxamido)-3,3-dimethylbutanoate)||30|
|SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)||45|
|SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)||30|
|THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)||30|
|Amphetamine (for conversion)||12,000,000|
|Amphetamine (for sale)||42,400,000|
|Codeine (for conversion)||40,000,000|
|Codeine (for sale)||45,000,000|
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|Diphenoxylate (for conversion)||15,000|
|Diphenoxylate (for sale)||1,110,000|
|Hydrocodone (for conversion)||122,000|
|Hydrocodone (for sale)||51,900,000|
|Methadone (for sale)||23,700,000|
|[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]|
|Morphine (for conversion)||27,300,000|
|Morphine (for sale)||35,000,000|
|Noroxymorphone (for conversion)||17,700,000|
|Noroxymorphone (for sale)||400,000|
|Oxycodone (for conversion)||2,610,000|
|Oxycodone (for sale)||101,500,000|
|Oxymorphone (for conversion)||23,000,000|
|Oxymorphone (for sale)||3,600,000|
|List I Chemicals|
|Ephedrine (for conversion)||50,000|
|Ephedrine (for sale)||4,810,000|
|Phenylpropanolamine (for conversion)||13,600,000|
|Phenylpropanolamine (for sale)||7,000,000|
|Pseudoephedrine (for conversion)||40|
|Pseudoephedrine (for sale)||186,000,000|
Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.
End Supplemental Information
Dated: October 27, 2017.
Robert W. Patterson,
[FR Doc. 2017-24009 Filed 11-2-17; 8:45 am]
BILLING CODE 4410-09-P