Drug Enforcement Administration, Department of Justice.
This final order establishes the initial 2018 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.
Applicable November 8, 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.
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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 substance 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 DEA pursuant to 28 CFR 0.100.
The 2018 aggregate production quotas and assessment of annual needs represent those quantities of schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine that may be manufactured in the United States in 2018 to provide for the estimated medical, scientific, research, industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes.
On August 7, 2017, a notice titled “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018” was published in the Federal Register. 82 FR 36830. This notice proposed the 2018 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2018 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. All interested persons were invited to comment on or object to the proposed aggregate production quotas and the proposed assessment of annual needs on or before September 6, 2017.
Within the public comment period, the DEA received seventeen comments from three DEA-registered manufacturers regarding sixteen different schedule I and II controlled substances and one comment from a DEA-registered manufacturer regarding the proposed assessment of annual needs for the list I chemical phenylpropanolamine (for conversion). Commenters stated the proposed aggregate production quotas for 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, methylphenidate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, as well as the proposed assessment of annual needs for phenylpropanolamine (for conversion), were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. These comments were considered in setting the final 2018 Aggregate Production Quotas as discussed below.
In addition to these seventeen comments, the DEA received one comment from a DEA-registered manufacturer seeking clarification on whether DEA considers manufacturing at outsourcing facilities when determining the Aggregate Production Quotas. The DEA notes that it is the responsibility of all DEA-registered dosage form manufacturers to submit quota applications by April 1, in order for their individual business practices to be considered when the DEA proposes the Aggregate Production Quota for the following year. 21 CFR 1303.12(b). These quota applications and comments with discrete data regarding the quantities of the basic classes of schedule I or II controlled substances received during the comment period for the proposed Aggregate Production Quotas are taken into consideration before establishing the values presented in this Final Order. This DEA-registered manufacturer provided no quantitative data supporting the position that the proposed quota for 2018 will adversely impact outsourcing facilities for DEA to consider. The DEA also received one hundred five comments that expressed concern that DEA's proposed reduction of opioids by twenty percent would adversely impact the availability of pain relieving prescription drugs for people with chronic pain. These comments were general in nature, and raised issues of specific medical illnesses and medical treatment, and therefore are outside of the scope of this Final Order for 2018. As a result, these one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas.
Determination of 2018 Aggregate Production Quotas and Assessment of Annual Needs
In determining the 2018 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2017 manufacturing quotas, current 2017 sales and inventories, anticipated 2018 export requirements, industrial use, additional applications for 2018 quotas, as well as information on research and product development requirements. Based on all of the above, the Administrator is adjusting the 2018 aggregate production quotas for 2-(4-bromo-2,5-dimethoxyphenyl)-n-(2-methoxybenzyl) ethanamine, 3,4,5-trimethoxy amphetamine, 4-bromo-2,5-dimethoxy-amphetamine, acryl fentanyl, alfentanil, amobarbital, methylphenidate, and nabilone, are warranted. Adjustment to the proposed assessment of annual needs for Start Printed Page 51874pseudoephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments.
Regarding 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, and phenylpropanolamine (for conversion), the DEA has determined the proposed aggregate production quotas and assessment of annual needs are sufficient to provide for the 2018 estimated medical, scientific, research, industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas and assessment of annual needs at the same amounts as proposed.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2018 aggregate production quotas for the following schedule I and II controlled substances and the 2018 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:
|Basic class||2018 Established
|Temporarily Scheduled Substances|
|2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)||30|
|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|
|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|
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|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|
|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|
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|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)||11,280,000|
|Amphetamine (for sale)||39,856,000|
|Codeine (for conversion)||15,040,000|
|Codeine (for sale)||40,015,800|
|Diphenoxylate (for conversion)||14,100|
|Diphenoxylate (for sale)||770,800|
|Hydrocodone (for conversion)||114,680|
|Hydrocodone (for sale)||50,348,280|
|Methadone (for sale)||22,278,000|
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|[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]|
|Morphine (for conversion)||4,089,000|
|Morphine (for sale)||33,958,440|
|Noroxymorphone (for conversion)||14,044,540|
|Noroxymorphone (for sale)||376,000|
|Oxycodone (for conversion)||2,453,400|
|Oxycodone (for sale)||95,692,000|
|Oxymorphone (for conversion)||20,962,000|
|Oxymorphone (for sale)||3,395,280|
|List I Chemicals|
|Ephedrine (for conversion)||47,000|
|Ephedrine (for sale)||4,136,000|
|Phenylpropanolamine (for conversion)||14,100,000|
|Phenylpropanolamine (for sale)||7,990,000|
|Pseudoephedrine (for conversion)||40|
|Pseudoephedrine (for sale)||180,000,000|
The Administrator also establishes aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2018 aggregate production quotas and assessment of annual needs as needed.
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Dated: November 1, 2017.
Robert W. Patterson,
[FR Doc. 2017-24306 Filed 11-7-17; 8:45 am]
BILLING CODE 4410-09-P