Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 28, 2022, and September 30, 2023, as listed below, were accepted ...
Drug Enforcement Administration, Department of Justice.
ACTION:
Order with opportunity for comment.
SUMMARY:
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 28, 2022, and September 30, 2023, as listed below, were accepted for filing and have been approved or denied as indicated.
DATES:
Interested persons may file written comments on this order in accordance with 21 CFR 1308.23(e). Electronic comments must be submitted, and written comments must be postmarked, on or before July 15, 2024. Commenters should be aware that the electronic Federal Docket
( printed page 42487)
Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
ADDRESSES:
To ensure proper handling of comments, please reference “Docket No. DEA-372” on all correspondence, including any attachments.
Electronic comments:
Drug Enforcement Administration (DEA) encourages that all comments be submitted through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Please go to
http://www.regulations.gov
and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on
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.
Paper comments:
Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a comment
in lieu of
an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Ph.D., Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-8201.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the public record and made available for public inspection online at
http://www.regulations.gov
and in the DEA's public docket. Such information includes personal or business identifying information (such as name, address, State or Federal identifiers, etc.) voluntarily submitted by the commenter. Generally, all information voluntarily submitted by the commenter, unless clearly marked as Confidential Information in the method described below, will be publicly posted. Comments may be submitted anonymously. The Freedom of Information Act applies to all comments received.
Commenters submitting comments which include personal identifying information (PII), confidential or proprietary business information that the commenter does not want made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed PII and business information redacted. DEA will post only the redacted comment on
http://www.regulations.gov
for public inspection.
Section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA certain compounds, mixtures, or preparations containing a controlled substance, if he finds that such compounds, mixtures, or preparations meet the requirements detailed in 21 U.S.C. 811(g)(3)(B).[1]
The DEA regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria by which the DEA Assistant Administrator may exempt a chemical preparation or mixture from certain provisions of the CSA. The Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which exemptions are granted and modify the scope of exemptions at any time.
Exempt Chemical Preparation Applications Submitted Between April 28, 2022, and September 30, 2023
DEA received applications between April 28, 2022, and September 30, 2023, requesting exempt chemical preparation status detailed in 21 CFR 1308.23. Pursuant to the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart I below is intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or animal and either: (1) contains no narcotic controlled substance and is packaged in such a form or concentration that the packaged quantity does not present any significant potential for abuse; or (2) contains either a narcotic or non-narcotic controlled substance and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion, or concentration that the preparation or mixture does not present any potential for abuse and, if the preparation or mixture contains a narcotic controlled substance, is formulated in such a manner that it incorporates methods of denaturing or other means so that the preparation or mixture is not liable to be abused or have ill effects, if abused, and so that the narcotic substance cannot in practice be removed.
Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), 21 CFR 1308.23, and 21 CFR 1308.24, the Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by DEA is exempt, to the extent described in 21 CFR 1308.24, from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA, and 21 CFR 1301.74, as of the date that was provided in the approval letters to the individual requesters.
Scope of Approval
The exemptions are applicable only to the precise preparation or mixture described in the application submitted to DEA in the form(s) listed in this order and only for those above mentioned sections of the CSA and the CFR. In accordance with 21 CFR 1308.24(h), any change in the quantitative or qualitative composition of the preparation or mixture, or change in the trade name or other designation of the preparation or mixture after the date of application requires a new application. The requirements set forth in 21 CFR 1308.24(b)-(e) apply to the exempted materials. In accordance with 21 CFR 1308.24(g), DEA may prescribe requirements other than those set forth in 21 CFR 1308.24(b)-(e) on a case-by-case basis for materials exempted in bulk quantities. Accordingly, in order to limit opportunities for diversion from the larger bulk quantities, DEA has determined that each of the exempted bulk products listed in this order may only be used in-house by the
( printed page 42488)
manufacturer, and may not be distributed for any purpose, or transported to other facilities.
Additional exempt chemical preparation requests received between April 28, 2022, and September 30, 2023, and not otherwise referenced in this order, may remain under consideration until DEA receives additional information required, pursuant to 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. DEA's order on such requests will be communicated to the public in a future
Federal Register
publication.
DEA also notes that these exemptions are limited to exemption from only those sections of the CSA and the CFR that are specifically identified in 21 CFR 1308.24(a). All other requirements of the CSA and the CFR apply, including registration as an importer as required by 21 U.S.C. 957.
Chart I
Supplier
Product name
Form
Application
date
Absolute Standards, Inc
(6aR,9R)-Δ10-THC, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
(6aR,9S)-Δ10-THC, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
2019 × 560 Mix, 1000 µg/mL, in Methanol
Glass ampoule: 1 mL
3/9/2023
Absolute Standards, Inc
2020 × 112 Mix A, 100 µg/mL, in Methanol:Water [9:1]
Glass ampoule: 1 mL
3/9/2023
Absolute Standards, Inc
9(R)-Δ7-THC, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
9(S)-Δ7-THC, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Cannabis PT, Varied ug/mL, in Acetonitrile
Glass ampoule: 1 ml
4/18/2023
Absolute Standards, Inc
LCMS 14BDO Mix, 20 mM, in Methanol
Glass ampoule: 1 ml
5/6/2022
Absolute Standards, Inc
LCMS 14BDO PT, Varied ug/mL, in Methanol
Glass ampoule: 1 ml
5/6/2022
Absolute Standards, Inc
LS 2440 Mix #1, Varied ng/mL, in Methanol
Glass ampoule: 1 ml
4/28/2022
Absolute Standards, Inc
LS 2440 Mix #2, Varied ng/mL, in Methanol
Glass ampoule: 1 ml
4/28/2022
Absolute Standards, Inc
LS 2440 Mix #3, Varied ng/mL, in Methanol
Glass ampoule: 1 ml
4/28/2022
Absolute Standards, Inc
Psilocin, 100 µg/mL, in Acetonitrile
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Psilocin, 1000 µg/mL, in Acetonitrile
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Psilocybin, 100 µg/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Psilocybin, 1000 µg/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Tryptamine Mix, 100 µg/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Tryptamine Mix, 1000 µg/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Tryptamine PT, Varied µg/g, in Mushroom Matrix [Porcini Powder:Acetonitrile, 1:1]
Glass ampoule: 1 mL
3/16/2023
Absolute Standards, Inc
Tryptamine PT, Varied µg/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
2/10/2023
Absolute Standards, Inc
Δ10-THC PT, Varied ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Δ7-THC PT, Varied ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Δ8-Tetrahydrocannabivarin, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Δ8-Tetrahydrocannabivarin, 1000 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Δ9-Tetrahydrocannabiphorol PT, Varied ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Δ9-Tetrahydrocannabiphorol, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
Absolute Standards, Inc
Δ9-Tetrahydrocannabiphorol, 1000 ug/mL, in Acetonitrile
Glass ampoule: 1 ml
5/19/2023
ARK Diagnostics
ARK Hydrocodone Calibrator A-E (Kit Reference Number 5076-0002-00)
Kit: 5 Dropper vials, 10 mL each
7/27/2023
ARK Diagnostics
ARK Hydrocodone Calibrator D (Cutoff) (Kit Reference Number 5076-0002-02)
Kit: 2 Dropper vials, 10 mL each
7/27/2023
ARK Diagnostics
ARK Hydrocodone Control (Kit Reference Number 5076-0003-00)
Kit: 4 Dropper vials, 10 mL each
7/27/2023
ASI Chemicals
Dihydrotestosterone- [2H3] (100 µg/mL in methanol)
Glass ampule: 1 mL
1/28/2023
ASI Chemicals
Testosterone- [2H3] (100 µg/mL in acetonitrile)
Glass ampule: 1 mL
1/28/2023
ASI Chemicals
Testosterone- [2H5] (100 µg/mL in acetonitrile)
Glass ampule: 1 mL
1/28/2023
Audit MicroControls, Inc
Linearity FD TDM
Kit: 5 vials, 5 mL each
8/15/2023
Audit MicroControls, Inc
Linearity FD TDM Level A
Vial: 5 mL
8/15/2023
Audit MicroControls, Inc
Linearity FD TDM Level B
Vial: 5 mL
8/15/2023
Audit MicroControls, Inc
Linearity FD TDM Level C
Vial: 5 mL
8/15/2023
Audit MicroControls, Inc
Linearity FD TDM Level D
Vial: 5 mL
8/15/2023
Audit MicroControls, Inc
Linearity FD TDM Level E
Vial: 5 mL
8/15/2023
Biochemical Diagnostics, Inc
Detectabuse Custom Liquid Control Urine, MC284
Glass vial: 5 mL, 10 mL, 20 mL, 25 mL, 50 mL
3/1/2023
Biochemical Diagnostics, Inc
Detectabuse Custom Liquid Control Urine, MC285
Glass vial: 5 mL, 10 mL, 20 mL, 25 mL, 50 mL
3/1/2023
Biochemical Diagnostics, Inc
Detectabuse Custom Liquid Control Urine, MC286
Glass vial: 5 mL, 10 mL, 20 mL, 25 mL, 50 mL
3/1/2023
CAP
2024 DMPM-01
HDPE bottle: 40 mL
6/6/2023
CAP
2024 DMPM-02
HDPE bottle: 40 mL
6/6/2023
CAP
2024 DMPM-03
HDPE bottle: 40 mL
6/6/2023
CAP
2024 DMPM-05
HDPE bottle: 40 mL
6/6/2023
CAP
2024 DMPM-06
HDPE bottle: 40 mL
6/6/2023
CAP
2024 DMPM-07
HDPE bottle: 40 mL
6/6/2023
( printed page 42489)
CAP
2024 FTC-03
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-05
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-06
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-07
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-08
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-09
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-10
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-12
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-13
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-14
HDPE bottle: 20 mL
6/6/2023
CAP
2024 FTC-15
HDPE bottle: 20 mL
6/6/2023
CAP
2024 OFD-01
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-02
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-03
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-04
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-05
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-06
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-07
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-08
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-10
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-11
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-12
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-13
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-14
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-15
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-16
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-17
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-18
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-19
HDPE vial: 2 mL
6/6/2023
CAP
2024 OFD-20
HDPE vial: 2 mL
6/6/2023
CAP
2024 T-01
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-03
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-04
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-05
HDPE bottle: 50 mL
6/6/2023
CAP
2024 T-08
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-09
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-10
HDPE bottle: 50 mL
6/6/2023
CAP
2024 T-11
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-13
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-14
HDPE bottle: 20 mL
6/6/2023
CAP
2024 T-15
HDPE bottle: 50 mL
6/6/2023
CAP
2024 THCB-01
Glass vial: 10 mL
6/6/2023
CAP
2024 THCB-02
Glass vial: 10 mL
6/6/2023
CAP
2024 THCB-03
Glass vial: 10 mL
6/6/2023
CAP
2024 THCB-04
Glass vial: 10 mL
6/6/2023
CAP
2024 THCB-05
Glass vial: 10 mL
6/6/2023
CAP
2024 THCB-06
Glass vial: 10 mL
6/6/2023
CAP
2024 UDS-01
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-02
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-03
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-04
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-05
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-06
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-07
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-08
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-09
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-10
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-11
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-12
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-13
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-14
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UDS-15
HDPE bottle: 10 mL
6/6/2023
CAP
2024 UT-01
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-02
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-03
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-04
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-05
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-06
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-07
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-08
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-09
HDPE bottle: 50 mL
6/6/2023
( printed page 42490)
CAP
2024 UT-10
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-11
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-12
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-13
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-14
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UT-15
HDPE bottle: 50 mL
6/6/2023
CAP
2024 UTCO-01
HDPE bottle: 40 mL
6/6/2023
CAP
2024 ZE-01
Glass vial: 5 mL
6/6/2023
CAP
2024 ZE-02
Glass vial: 5 mL
6/6/2023
CAP
2024 ZE-03
Glass vial: 5 mL
6/6/2023
CAP
2024 ZE-04
Glass vial: 5 mL
6/6/2023
CAP
2024 ZE-05
Glass vial: 5 mL
6/6/2023
CAP
2024 ZE-06
Glass vial: 5 mL
6/6/2023
CAP
2024-OFD-09
HDPE vial: 2 mL
6/6/2023
Cayman Chemical Company
(−)-11-hydroxy-Δ8-THC-d3 (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(−)-11-hydroxy-Δ8-THC-d3 (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(±)-cis-Δ8-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
(±)-cis-Δ8-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
(±)-cis-Δ8-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
(±)-cis-Δ8-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
(±)-Methadone-d9 (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
(±)-Methadone-d9 (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
(6aR,9R)-11-hydroxy-Δ10-THC (exempt preparation)1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(6aR,9R)-11-hydroxy-Δ10-THC (exempt preparation)1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(6aR,9R)-11-hydroxy-Δ10-THC (exempt preparation)100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(6aR,9R)-11-hydroxy-Δ10-THC (exempt preparation)100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-anti-Δ6a,7-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-anti-Δ6a,7-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-anti-Δ6a,7-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-anti-Δ6a,7-THC (exempt preparation)1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-syn-Δ6a,7-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-syn-Δ6a,7-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-syn-Δ6a,7-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
(9,10a)-syn-Δ6a,7-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
3,4-Methylenedioxy-α-Cyclohexylaminopropiophenone (hydrochloride) (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
3,4-Methylenedioxy-α-propylaminobutiophenone (hydrochloride) (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
3′-hydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
3′-hydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
3′-hydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
3′-hydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
5-fluoro AEB (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
5-fluoro AEB (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
( printed page 42491)
Cayman Chemical Company
5-methoxy DMT-d4 (exempt preparation) 1 mg/mL in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
5-methoxy DMT-d4 (exempt preparation) 1 mg/mL in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
6α-Oxymorphol (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
6α-Oxymorphol (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
6β-Naloxol (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
6β-Naloxol (CRM) 1mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
6β-Naloxol-d5 (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
6β-Naloxol-d5 (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
8α,11-dihydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α,11-dihydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α,11-dihydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α,11-dihydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-exo-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-exo-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-exo-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-exo-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8α-hydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β,11-dihydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β,11-dihydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β,11-dihydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β,11-dihydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-exo-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-exo-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-exo-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-exo-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-Δ9-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
8β-hydroxy-Δ9-THC (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
9(R)-11-hydroxy-Δ6a,10a-THC (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
9(R)-11-hydroxy-Δ6a,10a-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
9(S)-11-hydroxy-Δ6a,10a-THC (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
9(S)-11-hydroxy-Δ6a,10a-THC (exempt preparation)1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
BDB (hydrochloride) (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
BDB (hydrochloride) (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
( printed page 42492)
Cayman Chemical Company
Benzodiazepine Mixture 1 (CRM) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Benzodiazepine Mixture 1 (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Cannabidiol Conversion GC-MS Mixture 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Cannabidiol Conversion GC-MS Mixture 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Cannabidiol Conversion GC-MS Mixture 500 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Cannabidiol Conversion GC-MS Mixture 500 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Chlordiazepoxide (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Chlordiazepoxide (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Chlordiazepoxide-D5 (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Chlordiazepoxide-D5 (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
EMB-FUBINACA (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
EMB-FUBINACA (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Etodesnitazene (citrate) (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Etodesnitazene (citrate) (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Etodesnitazene (citrate) (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Etodesnitazene (citrate) (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Flunitazene (hydrochloride) (exempt preparation) 1 mg/mL in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Flunitazene (hydrochloride) (exempt preparation) 1 mg/mL in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Ibogaine (hydrochloride) (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Ibogaine (hydrochloride) (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
iso-LSD (exempt preparation) 25 µg/mL in Acetonitrile
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
iso-LSD (exempt preparation) 50 µg/mL in Acetonitrile
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
iso-LSD (exempt preparation) 50 µg/mL in Acetonitrile
Glass ampule: 0.5 mL
4/6/2023
Cayman Chemical Company
Ketamine-d4 (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Ketamine-d4 (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
LSB (exempt preparation) 25 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
LSB (exempt preparation) 50 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Mescaline-d4 (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Methohexital (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Methohexital (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Metonitazene (citrate) (exempt preparation) 1 mg/ml in Methyl Acetate
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Metonitazene (citrate) (exempt preparation) 100 µg/ml in Methyl Acetate
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Metonitazene (exempt preparation) (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Metonitazene (exempt preparation) 100 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Norhydrocodone (hydrochloride) (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Norhydrocodone (hydrochloride) (CRM) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Noroxymorphone (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Noroxymorphone (exempt preparation) 1 mg/ml in Methanol:DMSO (80:20)
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Noroxymorphone (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Noroxymorphone (exempt preparation) 100 µg/ml in Methanol:DMSO (80:20)
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
ortho-methoxy Butyryl fentanyl (hydrochloride) (exempt preparation) 100 µg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Phytocannabinoid Acids Mixture 7 (CRM) 1 mg/mL ea in 99:1 Acetonitrile:DIPEA (w. 0.05% Ascorbic acid)
Glass ampule: 1.0 mL
4/6/2023
( printed page 42493)
Cayman Chemical Company
Phytocannabinoid Acids Mixture 7 (CRM) 500 µg/mL ea in 99:1 Acetonitrile:DIPEA (w. 0.05% Ascorbic acid)
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
Phytocannabinoid Neutrals Mixture 9 (CRM) 1 mg/ml ea in Acetonitrile
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
Phytocannabinoid Neutrals Mixture 9 (CRM) 1 mg/ml ea in Methanol
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
Phytocannabinoid Neutrals Mixture 9 (CRM) 500 µg/mL ea in Acetonitrile
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
Phytocannabinoid Neutrals Mixture 9 (CRM) 500 µg/mL ea in Methanol
Glass ampule: 1.0 mL
4/6/2023
Cayman Chemical Company
Pregabalin (CRM) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
2/21/2023
Cayman Chemical Company
Retigabine (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Retigabine (exempt preparation) 1 mg/ml in Methanol
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Retigabine (hydrochloride) (exempt preparation) 1 mg/ml in Acetonitrile
Glass ampule: 1.0 mL
8/1/2023
Cayman Chemical Company
Retigabine (hydrochloride) (exempt preparation) 1 mg/ml in Methanol
The Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart II, below, is not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23. Accordingly, the Assistant Administrator has determined that the chemical preparations or mixtures generally described in Chart II, below, and specifically described in the application materials received by DEA, are not exempt from application of any part of the CSA or from application of any part of the CFR, with regard to the requested exemption pursuant to 21 CFR 1308.23, as of the date that was provided in the determination letters to the individual requesters.
Chart II
Supplier
Product name
Form
Application date
Absolute Standards, Inc
Florida Total THC—PT HPLC in Hemp Oil, 10-1,000 ug/g, in Hemp Oil:Acetone:Acetonitrile (5:4:1)
Glass ampoule: 1 mL (~1 g)
6/23/2023
Absolute Standards, Inc
Tryptamine PT, Varied µg/g, in Mushroom Matrix
Glass ampoule: 1 g
2/10/2023
Cayman Chemical Company
Benzodiazepine Mixture 1 (CRM) 250 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Benzodiazepine Mixture 1 (CRM) 250 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Benzodiazepine Mixture 1 (CRM) 500 µg/ml in Acetonitrile
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
Benzodiazepine Mixture 1 (CRM) 500 µg/ml in Methanol
Glass ampule: 1.0 mL
6/8/2023
Cayman Chemical Company
iso-LSD (exempt preparation) 100 µg/mL in Acetonitrile
Glass ampule: 1.0 mL
4/6/2023
CPI International
Custom NM Cannabinoid Mixture 4-0442, 2,500 ug/mL, 1 mL (ISO 17025)
Glass ampule: 1 mL
1/19/2023
LGC GmbH
LGCAMP0528.00-01
Glass Vial: 1 mL
8/9/2023
LGC GmbH
LGCAMP1346.00-11
Glass vial: 1 mL
8/9/2023
LGC GmbH
LGCAMP1346.06-11
Glass vial: 1 mL
8/9/2023
o2si smart solutions
Custom NM Cannabinoid Mixture 4-0442, 2,500 ug/mL, 1 mL (ISO 17025)
Amber ampule: 1 mL
1/19/2023
o2si smart solutions
EPA Method 8270 Appendix IX Mix 1 with Phentermine, 17 components, 2,000 µg/mL in Dichloromethane 1 mL DRE-GS09000443DI
5 Amber ampules, 1 mL each
8/30/2022
( printed page 42507)
Opportunity for Comment
Pursuant to 21 CFR 1308.23(e), any interested person may submit written comments on or objections to any chemical preparation in this order that has been approved or denied as exempt. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Assistant Administrator will immediately suspend the effectiveness of any applicable part of this order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.
Approved Exempt Chemical Preparations Are Posted on the DEA's Website
1.
This authority has been delegated from the Attorney General to the DEA Administrator by 28 CFR 0.100, and subsequently redelegated to the Assistant Administrator pursuant to 28 CFR 0.104 and section 7 of the appendix to subpart R of part 0.
Use this for formal legal and research references to the published document.
89 FR 42486
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Exempt Chemical Preparations Under the Controlled Substances Act,” thefederalregister.org (May 15, 2024), https://thefederalregister.org/documents/2024-10465/exempt-chemical-preparations-under-the-controlled-substances-act.