Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration between July 1, 2025, and March 31, 2026, as listed below, were accepted for fi...
Drug Enforcement Administration, Department of Justice.
ACTION:
Order with opportunity for comment.
( printed page 29506)
SUMMARY:
The applications for exempt chemical preparations received by the Drug Enforcement Administration between July 1, 2025, and March 31, 2026, as listed below, were accepted for filing and have been approved or denied as indicated. This publication addresses preparations through March 31, 2026, that were not included in previous
Federal Register
notices, and it does not affect preparations that have been previously published. This order also corrects the listing of several preparations that were published in the
Federal Register
notice on March 20, 2026.
DATES:
Comments must be submitted electronically or postmarked on or before July 20, 2026.
ADDRESSES:
Interested persons may file written comments on this order in accordance with 21 CFR 1308.23(e). The electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. To ensure proper handling of comments, please reference “Docket No. DEA-372” on all correspondence, including any attachments.
Electronic comments:
The 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.
Paperwork Reduction Act Comments:
All comments concerning collections of information under the Paperwork Reduction Act must be submitted to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comment refers to Docket No. DEA-1189.
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 in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make comments available for public inspection online at
http://www.regulations.gov.
Such information includes personal or business identifiers (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 confidential PII and business information already redacted. DEA will post only the redacted comment on
http://www.regulations.gov
for public inspection.
For easy reference, an electronic copy of this document and supplemental information to this proposed scheduling action are available at
http://www.regulations.gov.
Legal Authority
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]
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 July 1, 2025, and March 31, 2026
DEA received applications between July 1, 2025, and March 31, 2026, requesting exempt chemical preparation status detailed in 21 CFR 1308.23. This publication addresses preparations through March 31, 2026, that were not included in previous
Federal Register
notices, and it does not affect preparations that have been previously published. Additionally, this order corrects the listing of several preparations that were incorrectly listed in the previous
Federal Register
notice dated, March 20, 2026. The company name, product name, and/or form have been corrected. 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
( printed page 29507)
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 manufacturer, and may not be distributed for any purpose, or transported to other facilities.
Additional exempt chemical preparation requests received between January 1, 2026, and March 31, 2026, and not otherwise referenced in this order or in prior orders, 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 name
Product name
Form
Application date
Cayman Chemical Company
Alprazolam (CRM) 1 mg/mL in methanol
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Alprazolam-d5 (CRM) 1 mg/mL in methanol
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Clonazepam (CRM) 1 mg/mL in acetonitrile
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Custom 13-Phytocannabinoid Mixture (CRM)—AIT (500 μg/mL each in Acetonitrile)
Glass ampule: 1 mL
1/19/2026
Cayman Chemical Company
Custom Phytocannabinoid Mixture 3, 1 mg/mL ea in acetonitrile
Glass ampule: 1 mL
1/29/2026
Cayman Chemical Company
Flunitrazepam (CRM) 1 mg/mL in acetonitrile
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Flunitrazepam (CRM) 1 mg/mL in methanol
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Lorazepam (CRM) 1 mg/mL in acetonitrile
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Lorazepam-13C2-d4 (CRM) 0.1 mg/mL in acetonitrile
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Lorazepam-13C2-d4 (CRM) 1 mg/mL in acetonitrile
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Lorazepam-d4 (CRM) 1 mg/mL in acetonitrile
Glass ampule: 2 mL
3/17/2026
Cayman Chemical Company
Methylmethcathinone Isomer Mixture 1 mg/mL in methanol
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Methylmethcathinone Isomer Mixture 100 μg/mL in methanol
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Phytocannabinoid Mixture 3 (CRM) 1 mg/mL ea in acetonitrile
Glass ampule: 1 mL
1/29/2026
Cayman Chemical Company
Δ8-THC-C9 (CRM) 1 mg/mL in acetonitrile
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THC (CRM) 1 mg/mL in acetonitrile
Glass ampule: 1 mL
1/29/2026
Cayman Chemical Company
Δ9-THC (CRM) 100 μg/mL in acetonitrile
Glass ampule: 1 mL
1/29/2026
Cayman Chemical Company
Δ9-THCA-B (CRM) 1 mg/mL in acetonitrile
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THCA-B (CRM) 1 mg/mL in methanol
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THCA-B (CRM) 100 μg/mL in acetonitrile
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THCA-B (CRM) 100 μg/mL in methanol
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THCB Butanoate (CRM) 1 mg/mL in acetonitrile
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THC-C9 (CRM) 1 mg/mL in acetonitrile
Glass ampule: 1 mL
10/1/2025
Cayman Chemical Company
Δ9-THC-d9 (CRM) 1 mg/mL in acetonitrile
Glass ampule: 1 mL
1/29/2026
Cayman Chemical Company
Δ9-THC-d9 (CRM) 100 μg/mL in acetonitrile
Glass ampule: 1 mL
1/29/2026
Cerilliant Corporation
Buprenorphine Related Compound A 1.0 mg/mL solvent
Glass ampule: 2 mL
1/29/2026
CPI International
Custom Cannabinoid mixture 3-0539 1000 ug/mL, 0.5 mL (ISO 17034) Z-G34-140539-01
Glass ampule: 0.5 mL
2/4/2026
CPI International
Custom Cannabinoid mixture 7-0538 1000 ug/mL, 0.5 mL (ISO 17034) Z-G34-140538-01
Glass ampule: 0.5 mL
2/4/2026
LGC—Dr. Ehrenstorfer
Custom 1-Methylamino-1-(3,4-methylenedioxyphenyl)-propane Hydrochloride 10 ug/mL in Acetonitrile
Amber ampule: 1 mL
9/24/2025
LGC—Dr. Ehrenstorfer
Custom Hormone Mixture 17762 100 ug/mL in Methanol DRE-Q60017762
Glass ampule: 5 mL
2/17/2026
LGC—Dr. Ehrenstorfer
Custom p-Hydroxycocaine Hydrochloride 100 ug/mL in Acetonitrile DRE-Q60020132
Pack: 5 x 1 mL glass ampules
3/4/2026
LGC-Lipomed
4-Methylmethcathinone HCl (Mephedrone), 1mg/ml in Methanol (as free base)
Glass ampule: 1 ml
8/5/2025
LGC-Lipomed
4-MethylmethcathinoneD3 HCl (Mephedrone) 0.1mg/ml in Methanol (as free base)
Glass Ampule: 1 ml
10/13/2025
LGC-Lipomed
Phenobarbital-D5 (side chain), 0.1 mg/ml in Methanol Prod No: LPM-PHB-1720-FA-0.1LM
Oral Fluid Methamphetamine Control Methamphetamine, Level 1 Control Ref# S0056b
Dropper bottle: 5 mL
2/26/2026
Lin-Zhi International
Oral Fluid Methamphetamine Control Methamphetamine, Level 2 Control Ref# S0057b
Dropper bottle: 5 mL
2/26/2026
Microgenics Corporation
MASTM
Omni•IMMUNETM
Control, Level 1
Glass bottle: 5 mL
1/16/2026
Microgenics Corporation
MASTM
Omni•IMMUNETM
Control, Level 2
Glass bottle: 5 mL
1/16/2026
Microgenics Corporation
MASTM
Omni•IMMUNETM
Control, Level 3
Glass bottle: 5 mL
1/16/2026
RTI International
OF26-01
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-02
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-03
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-04
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-05
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-06
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-07
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-08
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-09
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-10
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-11
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-12
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-13
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-14
HDPE vials: 3 mL
2/17/2026
RTI International
OF26-15
HDPE vials: 3 mL
2/17/2026
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.
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 she 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 she determines appropriate.
Approved Exempt Chemical Preparations Are Posted on DEA's Website
This document of the Drug Enforcement Administration was signed on May 14, 2026, by DEA Assistant Administrator Cheri Oz. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Federal Register
.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
Footnotes
1.
This authority has been delegated from the Attorney General to the DEA Administrator by 28 CFR 0.100, and subsequently redelegated to the Deputy 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.
91 FR 29505
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 20, 2026), https://thefederalregister.org/documents/2026-10090/exempt-chemical-preparations-under-the-controlled-substances-act.