This PDF is the current document as it appeared on Public Inspection on 10/24/2016 at 08:45 am.
Drug Enforcement Administration (DEA), Department of Justice (DOJ).
This final order establishes the final adjusted 2016 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
This order is effective October 25, 2016.Start Further Info
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 End Preamble Start Supplemental Information
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826), Start Printed Page 73422requires 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 DEA pursuant to 28 CFR 0.100.
The DEA published the 2016 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 6, 2015. 80 FR 60400. This notice stated that the Administrator would adjust, as needed, the established aggregate production quotas in 2016 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2016 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 July 22, 2016, (81 FR 47829) 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 August 22, 2016.
Four DEA-registered entities submitted timely comments regarding a total of six schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for amphetamine (for sale), etorphine hydrochloride, methadone, methadone intermediate, nabilone, and phencyclidine 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 one comment from a non-DEA registered entity requesting the reduction of oxycodone (for sale) to pre-2013 levels. The DEA received one comment from a DEA registrant regarding the proposed removal of the additional 25% of the estimated medical, scientific, and research needs of the United States for the calendar year 2017 published in the Federal Register on July 22, 2016 (81 FR 47821).
The DEA received one comment from a DEA-registered entity and two comments from non-DEA registered entities for the proposed adjustments to the 2016 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. Comments received proposed that the annual assessment of needs for ephedrine (for sale) and pseudoephedrine (for sale) 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.
Analysis for Final Adjusted 2016 Aggregate Production Quotas and Assessment of Annual Needs
In determining the final adjusted 2016 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 1303.13 and 21 CFR 1315.13 in accordance with 21 U.S.C. 826(a), and other relevant factors including the 2015 year-end inventories, initial 2016 manufacturing and import quotas, 2016 export requirements, actual and projected 2016 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator has determined that the proposed adjusted 2016 aggregate production quotas and assessment of annual needs for amphetamine (for sale), etorphine hydrochloride, dextropropoxyphene, levorphanol, nabilone, noroxymorphone (for sale), phencyclidine, and secobarbital required additional consideration, and hereby further adjusts the 2016 aggregate production quotas and assessment of annual needs for these substances. This final order reflects those adjustments.
Regarding ephedrine (for sale), methadone, methadone intermediate, oxycodone (for sale), and pseudoephedrine (for sale) the Administrator hereby determines that the proposed adjusted 2016 aggregate production quotas and assessment of annual needs for these substances and list I chemicals as published on July 22, 2016, (81 FR 47829) are sufficient to meet the current 2016 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.
As described in the previously published notice establishing the 2016 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. 21 CFR 1303.24. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA included in all final schedule II aggregate production quotas, and certain schedule I aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting final aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event results in the substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances.
Pursuant to the above, the Administrator hereby finalizes the 2016 aggregate production quotas for the following schedule I and II controlled substances and the 2016 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:Start Printed Page 73423
|Basic class||Revised 2016 quotas|
|Temporarily Scheduled Substances|
|1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)||45|
|1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)||45|
|1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)||45|
|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)||15|
|5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)||53|
|Start Printed Page 73424|
|Lysergic acid diethylamide (LSD)||40|
|N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl)||100|
|Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)||25|
|Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)||25|
|Start Printed Page 73425|
|Amphetamine (for conversion)||15,000,000|
|Amphetamine (for sale)||50,000,000|
|Codeine (for conversion)||50,000,000|
|Codeine (for sale)||63,900,000|
|Diphenoxylate (for conversion)||18,750|
|Diphenoxylate (for sale)||1,337,500|
|Hydrocodone (for conversion)||177,500|
|Hydrocodone (for sale)||86,000,000|
|Methadone (for sale)||31,875,000|
|[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]|
|Morphine (for conversion)||91,250,000|
|Morphine (for sale)||62,500,000|
|Noroxymorphone (for conversion)||17,500,000|
|Noroxymorphone (for sale)||875,000|
|Oxycodone (for conversion)||5,000,000|
|Oxycodone (for sale)||139,150,000|
|Oxymorphone (for conversion)||25,000,000|
|Oxymorphone (for sale)||6,250,000|
|Start Printed Page 73426|
|List I Chemicals|
|Ephedrine (for conversion)||50,000|
|Ephedrine (for sale)||4,000,000|
|Phenylpropanolamine (for conversion)||15,000,000|
|Phenylpropanolamine (for sale)||8,500,000|
|Pseudoephedrine (for conversion)||40|
|Pseudoephedrine (for sale)||200,000,000|
Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.Start Signature
Dated: October 19, 2016.
[FR Doc. 2016-25696 Filed 10-24-16; 8:45 am]
BILLING CODE 4410-09-P