2021-06596. Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I; Correction

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Final rule; correcting amendment.

SUMMARY:

The Drug Enforcement Administration is correcting a final rule that appeared in the Federal Register on November 25, 2020. The document issued an action placing five fentanyl-related substances (cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, permanently in schedule I of the Controlled Substances Act, specifically to the opiates list under DEA regulations. The published document assigned incorrect paragraph numbers to all five substances, and inadvertently removed four other substances from the listed opiates.

DATES:

Effective date: March 31, 2021.

FOR FURTHER INFORMATION CONTACT:

Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

On November 25, 2020, the Drug Enforcement Administration (DEA) permanently placed five fentanyl-related substances (cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide) in schedule I of the Controlled Substances Act (CSA), specifically to the opiates list under 21 CFR 1308.11(b). 85 FR 75231. The final rule incorrectly assigned paragraph numbers 22, 40, 56, and 59 under paragraph (b) to cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, and para-methoxybutyryl fentanyl, respectively, overriding previously assigned paragraph numbers for four listed opiates crotonyl fentanyl, ketobemidone, para-fluorofentanyl, and phenampromide (i.e., (b)(22), (40), (56), and (59)). In addition, the final rule incorrectly added valeryl fentanyl as a new paragraph (b)(75) instead of (b)(76). This document updates the numbering of all listed opiates in paragraph (b), and specifically corrects the paragraph numbers for cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl, and reassigns paragraph numbers for crotonyl fentanyl, ketobemidone, para-fluorofentanyl, and phenampromide. It bears emphasis that DEA still considers the four substances (crotonyl fentanyl, ketobemidone, para-fluorofentanyl, and phenampromide) to have been schedule I substances during the time period from the issuance of the November 25, 2020, final rule to this correction, despite these inadvertent numbering errors.^[1]

List of Subjects in 21 CFR Part 1308

• Administrative practice and procedure
• Drug traffic control
• Reporting and recordkeeping requirements

For the reasons set out above, 21 CFR part 1308 is amended as follows:

PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for 21 CFR part 1308 continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.

2. In § 1308.11(b), revise the table to read as follows:

§ 1308.11

Schedule I.

* * * * *

(b) * * *

(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N-phenylacetamide)	9815
(2) Acetylmethadol	9601
(3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)	9821
(4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide; also known as acryloylfentanyl)	9811
(5) AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)	9551
(6) Allylprodine	9602
(7) Alphacetylmethadol (except levo-alphacetylmethadol also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM)	9603
(8) Alphameprodine	9604
(9) Alphamethadol	9605
(10) alpha-Methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-piperidyl]propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido)piperidine)	9814
(11) alpha-Methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide)	9832
(12) Benzethidine	9606
(13) Betacetylmethadol	9607
(14) beta-Hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-piperidinyl]-N-phenylpropanamide)	9830
(15) beta-Hydroxy-3-methylfentanyl (N-[1-(2-hydroxy-2-phenylethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide)	9831
(16) beta-Hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide)	9836
(17) Betameprodine	9608
(18) Betamethadol	9609
(19) Betaprodine	9611
(20) Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide)	9822
(21) Clonitazene	9612
(22) Crotonyl fentanyl ((E)-N-(1-phenethylpiperidin-4-yl)-N-phenylbut-2-enamide)	9844
(23) Cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide)	9847
(24) Cyclopropyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide)	9845
(25) Dextromoramide	9613
(26) Diampromide	9615
(27) Diethylthiambutene	9616
(28) Difenoxin	9168
(29) Dimenoxadol	9617
(30) Dimepheptanol	9618
(31) Dimethylthiambutene	9619
(32) Dioxaphetyl butyrate	9621
(33) Dipipanone	9622
(34) Ethylmethylthiambutene	9623
(35) Etonitazene	9624
(36) Etoxeridine	9625
(37) 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide; also known as para-fluoroisobutyryl fentanyl)	9824
(38) Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide)	9834
(39) Furethidine	9626
(40) Hydroxypethidine	9627
(41) Isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide)	9827
(42) Ketobemidone	9628
(43) Levomoramide	9629
(44) Levophenacylmorphan	9631
(45) Methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)	9825
(46) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide)	9813
(47) 3-Methylthiofentanyl (N-[3-methyl-1-(2-thienylethyl)-4-piperidinyl]-N-phenylpropanamide)	9833
(48) Morpheridine	9632
(49) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine)	9661
(50) MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine)	9560
(51) Noracymethadol	9633
(52) Norlevorphanol	9634
(53) Normethadone	9635
(54) Norpipanone	9636
(55) Ocfentanil (N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide)	9838
(56) ortho-Fluorofentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide); also known as 2-fluorofentanyl)	9816
(57) para-Chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide)	9826
(58) para-Fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide)	9823
(59) para-Fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide)	9812
(60) para-Methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide)	9837
(61) PEPAP (1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine)	9663
(62) Phenadoxone	9637
(63) Phenampromide	9638
(64) Phenomorphan	9647
(65) Phenoperidine	9641
(66) Piritramide	9642
(67) Proheptazine	9643
(68) Properidine	9644
(69) Propiram	9649
(70) Racemoramide	9645
(71) Tetrahydrofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide)	9843
(72) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]propanamide)	9835
(73) Tilidine	9750
(74) Trimeperidine	9646
(75) U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide)	9547
(76) Valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide)	9840

* * * * *

D. Christopher Evans,

Acting Administrator.

Footnotes

1.  Under the CSA, a controlled substance may only be removed from the schedules, or transferred to another schedule, where DEA expressly does so by a scheduling action issued in accordance with 21 U.S.C. 811 and published in the Federal Register. DEA took no such action with respect to crotonyl fentanyl, ketobemidone, para-fluorofentanyl, and phenampromide. Accordingly, the scheduling status of these four substances was never altered by the final rule that appeared in the Federal Register on November 25, 2020.