Established 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 2016

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Final order.

SUMMARY:

This final order establishes the initial 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.

DATES:

Effective October 6, 2015.

FOR FURTHER INFORMATION CONTACT:

John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826, requires the Attorney General to determine the total quantity and establish production quotas for each basic class of controlled substance in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. This responsibility has been delegated to the Administrator of the DEA through 28 CFR 0.100(b).

Background

The 2016 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 2016 to provide for the estimated medical, scientific, research, and 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 July 17, 2015, a notice titled, “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016” was published in the Federal Register. 80 FR 42540. This notice proposed the 2016 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2016 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 August 17, 2015.

Comments Received

Twenty comments were received from four DEA-registered manufacturers within the published comment period regarding 17 different schedule I and II controlled substances. The DEA did not receive any comments regarding the proposed assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Commenters stated that the proposed aggregate production quotas for [1-(5-fluoropentyl)-1 H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), amphetamine (for sale), codeine (for sale), gamma hydroxybutric acid, levorphanol, marihuana, methylphenidate, N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide (ADB-PINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide (AB-FUBINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide (AB-CHMINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide (AB-PINACA), N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), nabilone, oxymorphone (for conversion), oxymorphone (for sale), Quinolin-8-yl 1-(5-fluoropentyl)-1 H-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-yl 1-pentyl-1 H-indole-3-carboxylate (PB-22) 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.

Determination of 2016 Aggregate Production Quotas and Assessment of Annual Needs

In determining the 2016 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments along with the factors set forth at 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2015 manufacturing quotas, current 2015 sales and inventories, anticipated 2016 export requirements, industrial use, additional applications for 2016 quotas, as well as information on research and product development requirements. Based on this information, the DEA has determined that adjustments to the proposed aggregate production quotas for codeine (for sale), hydromorphone, marihuana, methylphenidate, and N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl) are warranted. This final order reflects those adjustments.

Regarding [1-(5-fluoropentyl)-1 H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), amphetamine (for sale), gamma hydroxybutric acid, levorphanol, N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide (ADB-PINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide (AB-FUBINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide (AB-CHMINACA), N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide (AB-PINACA), nabilone, oxymorphone (for conversion), oxymorphone (for sale), Quinolin-8-yl 1-(5-fluoropentyl)-1 H-indole-3-carboxylate (5-Flouro-PB-22), and Quinolin-8-yl 1-pentyl-1 H-indole-3-carboxylate (PB-22), the DEA has determined that the proposed aggregate production quotas are sufficient to provide for the 2016 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas at the same amounts as proposed.

As described in the previously published notice proposing 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. See 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 has included in all established 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 established 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.

In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes 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:

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 2016 aggregate production quotas and assessment of annual needs as needed.