Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I; Correction
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-re...
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: (571) 362-3249.
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]
(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
( printed page 16669)
* * * * *
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.
21 CFR 1308.11(b)
21 U.S.C. 811