Bulk Manufacturer of Controlled Substances Application: Irvine Labs, Inc., 33911 [2023-11178]

Download as PDF 33911 Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices Controlled substance Drug code 3, 4-Methylenedioxyamphetamine ......................................................................................................................................... 3, 4-Methylenedioxymethamphetamine ................................................................................................................................. 5-Methoxy-N-N-dimethyltryptamine ....................................................................................................................................... Dimethyltryptamine ................................................................................................................................................................ Psilocybin ............................................................................................................................................................................... Psilocyn ................................................................................................................................................................................. 5-Methoxy-N, N-diisopropyltryptamine .................................................................................................................................. The company plans to bulk manufacture the listed controlled substances for the internal use intermediates or for sale to its customers. In reference to dug codes 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–11158 Filed 5–24–23; 8:45 am] BILLING CODE P Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration Lysergic acid diethylamide. Mescaline ........................ Peyote ............................. Diethyltryptamine ............. Dimethyltryptamine .......... Psilocybin ........................ Psilocyn ........................... [Docket No. DEA–1206] Bulk Manufacturer of Controlled Substances Application: Irvine Labs, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Irvine Labs, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 24, 2023. Such persons may also file a written request for a hearing on the application on or before July 24, 2023. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:04 May 24, 2023 aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on April 5, 2023, Irvine Labs, Inc., 7305 Murdy Drive, Hunting Beach, California 92647–3533, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Jkt 259001 Drug code Schedule 7315 I 7381 7415 7434 7435 7437 7438 I I I I I I The company plans to bulk manufacture the listed controlled substances to support their internal research, clinical trials, and analytical purposes as well as to distribute to their customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–11178 Filed 5–24–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE 7400 7405 7431 7435 7437 7438 7439 Schedule I I I I I I I SUPPLEMENTARY INFORMATION listed below for further drug information. Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 24, 2023. Such persons may also file a written request for a hearing on the application on or before July 24, 2023. DATES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on March 31, 2023, Patheon API Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605–5420, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug Enforcement Administration Controlled substance [Docket No. DEA–1191] Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. Dimethyltryptamine .......... Psilocybin ........................ Psilocyn ........................... Drug code Schedule 7435 7437 7438 I I I AGENCY: Patheon API Manufacturing, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUMMARY: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. No other activities for these E:\FR\FM\25MYN1.SGM 25MYN1

Agencies

[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Page 33911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11178]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1206]


Bulk Manufacturer of Controlled Substances Application: Irvine 
Labs, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Irvine Labs, Inc. has applied to be registered as a bulk 
manufacturer of basic class(es) of controlled substance(s). Refer to 
Supplementary Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
July 24, 2023. Such persons may also file a written request for a 
hearing on the application on or before July 24, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for submitting comments. Upon 
submission of your comment, you will receive a Comment Tracking Number. 
Please be aware that submitted comments are not instantaneously 
available for public view on https://www.regulations.gov. If you have 
received a Comment Tracking Number, your comment has been successfully 
submitted and there is no need to resubmit the same comment.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on April 5, 2023, Irvine Labs, Inc., 7305 Murdy Drive, 
Hunting Beach, California 92647-3533, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide..............    7315  I
Mescaline...............................    7381  I
Peyote..................................    7415  I
Diethyltryptamine.......................    7434  I
Dimethyltryptamine......................    7435  I
Psilocybin..............................    7437  I
Psilocyn................................    7438  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances to support their internal research, clinical trials, and 
analytical purposes as well as to distribute to their customers. No 
other activities for these drug codes are authorized for this 
registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-11178 Filed 5-24-23; 8:45 am]
BILLING CODE P
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