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Published Document: 2025-12198 (90 FR 28785)
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AGENCY:
Drug Enforcement Administration, Department of Justice.
( printed page 28786)
ACTION:
Order with opportunity for comment.
SUMMARY:
The applications for exempt chemical preparations received by the Drug Enforcement Administration between March 1, 2023, and March 31, 2025, as listed below, were accepted for filing and have been approved or denied as indicated.
DATES:
Comments must be submitted electronically or postmarked on or before September 2, 2025.
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. 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 March 1, 2023, and March 31, 2025
DEA received applications between March 1, 2023, and March 31, 2025, requesting exempt chemical preparation status detailed in 21 CFR 1308.23. This publication addresses preparations through September 30, 2023, that were not included in previous
Federal Register
notices, and it does not affect preparations that have been previously published. 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
( printed page 28787)
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 March 1, 2023, and March 31, 2025, 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 name
Product name
Form
Application
date
(AAB-MLE) American Association of Bioanalysts-Medical Laboratory Evaluation
(AAB-MLE) Chemistry
Amber vial: 5 mL
8/7/2024
(API) American Proficiency Institute
(API) Chemistry
Amber vial: 5 mL
8/7/2024
(API) American Proficiency Institute
(API) Remedial Chemistry
Amber vial: 5 mL
8/7/2024
(WSLH) Wisconsin Laboratory of Hygeine
(WSLH) Chemistry/Endocrinology/TDM
Amber vial: 5 mL
8/7/2024
(WSLH) Wisconsin Laboratory of Hygeine
(WSLH) Chemistry-Waived
Amber vial: 5 mL
8/7/2024
Aalto Scientific, Ltd. | Eatonton
Linearity FD Immunoassay for Abbott Systems
Kit: 5 vials, 5 mL each
8/22/2024
Aalto Scientific, Ltd. | Eatonton
Linearity FD Immunoassay for Abbott Systems Level A
Glass vial: 5 mL
8/22/2024
Aalto Scientific, Ltd. | Eatonton
Linearity FD Immunoassay for Abbott Systems Level B
Glass vial: 5 mL
8/22/2024
Aalto Scientific, Ltd. | Eatonton
Linearity FD Immunoassay for Abbott Systems Level C
Glass vial: 5 mL
8/22/2024
Aalto Scientific, Ltd. | Eatonton
Linearity FD Immunoassay for Abbott Systems Level D
Glass vial: 5 mL
8/22/2024
Aalto Scientific, Ltd. | Eatonton
Linearity FD Immunoassay for Abbott Systems Level E
Glass vial: 5 mL
8/22/2024
Absolute Standards, Inc
(+/−)-Amphetamine PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(+/−)-Amphetamine-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(+/−)-MDA PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(+/−)-MDA-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(+/−)-MDMA-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(+/−)-Methamphetamine PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(+/−)-Methamphetamine-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
(6aR,9S)-Δ10-THC, 10 ug/g, in Hemp oil:Acetone:Acetonitrile [5:4:1]
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
6-Acetylmorphine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
6-Acetylmorphine-D3 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Alprazolam PT, 1-100 µg/mL, in Methanol
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Alprazolam-D5 PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Amobarbital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Benzoylecgonine PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Benzoylecgonine-D3 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Buprenorphine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Buprenorphine, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Buprenorphine, 100 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Buprenorphine, 1000 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Butabarbital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Butalbital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
CA CRM Standard Mix 1—Acids/Acetates, 10 ug/g, in Hemp oil:Acetone:Acetonitrile [5:4:1]
Glass vial: 1 g
11/21/2024
Absolute Standards, Inc
CA CRM Standard Mix 1—Acids/Acetates, 10 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
CA CRM Standard Mix 1—Acids/Acetates, 18 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
CA CRM Standard Mix 2—Neutrals, 10 ug/g, in Hemp oil:Acetone:Acetonitrile [5:4:1]
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
CA CRM Standard Mix 2—Neutrals, 10 ug/mL, in Methanol
Glass vial: 1 g
11/21/2024
Absolute Standards, Inc
CA CRM Standard Mix 2—Neutrals, 18 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Calibrator Mix, Varied ug/L, in Methanol
Glass vial: 1 g
11/21/2024
Absolute Standards, Inc
Cannabis PT in Hemp Oil, Varied ug/g, in Hemp Oil:Acetone:Acetonitrile [5:4:1]
Glass ampoule: 1 g
6/21/2024
Absolute Standards, Inc
Carfentanil PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Carfentanil, 100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Chlordiazepoxide PT, 1-1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
cis-Δ9-THC, 10 ug/g, in Hemp oil:Acetone:Acetonitrile [5:4:1]
Glass vial: 1 g
11/21/2024
Absolute Standards, Inc
cis-Δ9-THC, 100 ug/mL, in Acetonitrile
Glass vial: 1 g
11/21/2024
Absolute Standards, Inc
Clonazepam PT, 1-100 µg/mL, in Methanol
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Clonazepam-D4 PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Cocaethylene PT, 1-1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Cocaine PT, 1-100 µg/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
( printed page 28788)
Absolute Standards, Inc
Cocaine-D3 PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Codeine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Codeine-6-β-D-glucuronide PT, 1-1000 ug/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Codeine-D3 PT, 1-1000 ug/mL, in Ethanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
d,l-MDMA PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
d,l-Methadone PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
d,l-Methadone-D3 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Diazepam PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Diazepam-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Dihydrocodeine, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Dihydrocodeine, 1000 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Diphenoxylate hydrochloride, 100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
d-Propoxyphene PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Estazolam PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Ethylmorphine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Etonitazene PT, 1-100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Etonitazene, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
exo-THC PT, Varied µg/mL in Methanol
Glass ampoule: 1 mL
12/8/2023
Absolute Standards, Inc
exo-THC, 100 µg/mL in Methanol
Glass ampoule: 1 mL
12/8/2023
Absolute Standards, Inc
Fentanyl PT, 1-100 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Fentanyl, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Fentanyl, Cocaine, & Xylazine PT, Varied µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Fentanyl-D5 PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Flunitrazepam PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Flunitrazepam-D7 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Gamma Hydroxybutyrate (GHB) PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Heroin PT, 1-1000 µg/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Hexobarbital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Hydrocodone (+)-bitartrate salt PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Hydrocodone PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Hydrocodone-D3 PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Hydromorphone PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Hydromorphone-D3 PT, 1-1000 µg/mL, in Methanol Glass ampoule
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Isotonitazene PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Isotonitazene, 100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Ketamine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Lorazepam PT, 1-100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Meperidine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Methaqualone PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Methaqualone-D7 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Methohexital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Methylphenidate PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Metonitazene PT, 1-100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Metonitazene, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Midazolam PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Morphine PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Morphine, 100 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Morphine, 1000 ug/mL, in Methanol
Glass ampoule: 1 mL
6/21/2024
Absolute Standards, Inc
Morphine-6-β-D-glucuronide PT, 1-1000 ug/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Morphine-6-β-D-glucuronide, 100 ug/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Morphine-6-β-D-glucuronide, 1000 ug/mL, in Acetonitrile:Water [1:1]
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Morphine-D3 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Morphine-D3, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Morphine-D3, 1000 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norbuprenorphine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Norbuprenorphine, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norbuprenorphine, 100 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norbuprenorphine, 1000 ug/mL, in Methanol
Glass ampoule: 1 mL
6/21/2024
Absolute Standards, Inc
Norbuprenorphine-D3 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Norcocaine, 1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
6/21/2024
Absolute Standards, Inc
Nordiazepam PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Norfentanyl PT, 1-100 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Norfentanyl, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norfentanyl, 100 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norfentanyl, 1000 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norhydrocodone, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norhydrocodone, 100 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Norhydrocodone, 1000 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Noroxycodone, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Noroxycodone, 100 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Noroxycodone, 1000 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Oxazepam PT, 1-1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Oxazepam-D5 PT, 1-1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Oxycodone PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Oxycodone-D6 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Oxymorphone PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Oxymorphone-D3 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Pentobarbital PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
( printed page 28789)
Absolute Standards, Inc
Pentobarbital-D5 PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Phencyclidine (PCP) PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Phencyclidine-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Phenobarbital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Phentermine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Prazepam PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Protonitazene PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Protonitazene, 100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
R(−)-Amphetamine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
R(−)-Methamphetamine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
S(+)-Amphetamine PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
S(+)-Methamphetamine PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
SC Labs Drug Mix, Varied ug/L, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Secobarbital PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Secobarbital-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Tapentadol, 10 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tapentadol, 100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tapentadol, 1000 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tapentadol-D3, 10 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tapentadol-D3, 100 ug/mL, in Methanol
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tapentadol-D5, 10 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tapentadol-D5, 100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Temazepam PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Temazepam-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Total THC Calibration in Hemp Oil-Acids, 100 ug/g, in Hemp oil:Acetone:Acetonitrile [5:4:1]
Glass vial: 1 g
11/21/2024
Absolute Standards, Inc
Total THC Calibration in Hemp Oil-Neutrals, 100 ug/g, in Hemp oil:Acetone:Methanol [5:4:1]
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Tramadol PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Triazolam PT, 1-100 ug/mL, in Methanol
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Zolpidem PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Zolpidem, 10 ug/mL, in Methanol
Glass ampoule: 1 ml
6/21/2024
Absolute Standards, Inc
Δ8-iso-THC, 10 ug/g, in Hemp oil:Acetone:Acetonitrile [5:4:1]
Glass ampoule: 1 mL
11/21/2024
Absolute Standards, Inc
Δ8-iso-THC, 100 ug/mL, in Acetonitrile
Glass vial: 1 g
11/21/2024
ARK Diagnostics, Inc
ARK HS Benzodiazepine II 100 Cutoff Calibrator (Kit Reference Number 5073-0002-02)
Kit: 2 Dropper vials, 10 mL each
12/18/2023
ARK Diagnostics, Inc
ARK HS Benzodiazepine II 200 Cutoff Calibrator (Kit Reference Number 5073-0002-03)
Kit: 2 Dropper vials, 10 mL each
12/18/2023
ARK Diagnostics, Inc
ARK HS Benzodiazepine II Calibrator (Kit Reference Number 5073-0002-00)
Kit: 5 Dropper vials, 10 mL each
12/18/2023
ARK Diagnostics, Inc
ARK HS Benzodiazepine II Control (150/250) (Kit Reference Number 5073-0003-01)
Kit: 4 Droppers vials, 10 mL each
12/18/2023
ARK Diagnostics, Inc
ARK HS Benzodiazepine II Control (75/125) (Kit Reference Number 5073-0003-00)
Kit: 4 Dropper vials, 10 mL each
12/18/2023
Ark Diagnostics, Inc
ARKTM
Zopiclone Calibrator (Kit Reference Number 5043-0002-00)
5 Dropper Vials, 10 ml each
7/8/2024
ARK Diagnostics, Inc
ARKTM
Zopiclone Calibrator (Kit Reference Number 5043-0002-00R)
5 Dropper Vials, 10 ml each
7/8/2024
ARK Diagnostics, Inc
ARKTM
Zopiclone Calibrator A-E
Kit: 5 Dropper Vials, 10 ml each
2/10/2025
ARK Diagnostics, Inc
ARKTM
Zopiclone Calibrator C (Cutoff)
Kit: 2 Dropper Vials, 10 ml each
2/10/2025
ARK Diagnostics, Inc
ARKTM
Zopiclone Calibrator C (Cutoff) (Kit Reference Number 5043-0002-02)
2 Dropper Vials, 10 ml each
7/8/2024
ARK Diagnostics, Inc
ARKTM
Zopiclone Calibrator C (Cutoff) (Kit Reference Number 5043-0002-02R)
2 Dropper Vials, 10 ml each
7/8/2024
ARK Diagnostics, Inc
ARKTM
Zopiclone Control
Kit: 4 Dropper Vials, 10 ml each
2/10/2025
ARK Diagnostics, Inc
ARKTM
Zopiclone Control (Kit Reference Number 5043-0003-00)
4 Dropper Vials, 10 ml each Kit: 2 Dropper Vials, 10 ml each
7/8/2024
ARK Diagnostics, Inc
ARKTM
Zopiclone Control (Kit Reference Number 5043-0003-00R)
4 Dropper Vials, 10 ml each
7/8/2024
Audit MicroControls
Linearity FLQ Fertility Siemens Atellica
Kit: 10 vials, 2 mL each
10/9/2023
Audit MicroControls
Linearity FLQ Fertility Siemens Atellica Set 2 Level A
Vial: 2 mL
10/9/2023
Audit MicroControls
Linearity FLQ Fertility Siemens Atellica Set 2 Level B
Vial: 2 mL
10/9/2023
Audit MicroControls
Linearity FLQ Fertility Siemens Atellica Set 2 Level C
Vial: 2 mL
10/9/2023
Audit MicroControls
Linearity FLQ Fertility Siemens Atellica Set 2 Level D
Vial: 2 mL
10/9/2023
Audit MicroControls
Linearity FLQ Fertility Siemens Atellica Set 2 Level E
Vial: 2 mL
10/9/2023
Audit MicroControls, Inc
Control FD Immunoassay
Kit: 6 glass vials, 3 mL each
2/25/2025
Audit MicroControls, Inc
Control FD Immunoassay Level 1
2 glass vials, 3 mL each
2/25/2025
Audit MicroControls, Inc
Control FD Immunoassay Level 2
2 glass vials, 3 mL each
2/25/2025
Audit MicroControls, Inc
Control FD Immunoassay Level 3
2 glass vials, 3 mL each
2/25/2025
Audit MicroControls, Inc
Linearity FD Fertility Siemens Atellica
Kit: 10 vials; 3 mL each
10/11/2024
Audit MicroControls, Inc
Linearity FD Fertility Siemens Atellica, Set 2 Level A
Glass vial: 3 mL
10/11/2024
Audit MicroControls, Inc
Linearity FD Fertility Siemens Atellica, Set 2 Level B
Glass vial: 3 mL
10/11/2024
Audit MicroControls, Inc
Linearity FD Fertility Siemens Atellica, Set 2 Level C
Glass vial: 3 mL
10/11/2024
Audit MicroControls, Inc
Linearity FD Fertility Siemens Atellica, Set 2 Level D
Glass vial: 3 mL
10/11/2024
Audit MicroControls, Inc
Linearity FD Fertility Siemens Atellica, Set 2 Level E
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 name
Product name
Form
Application
date
Absolute Standards, Inc
Alprazolam PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Alprazolam, 1000 ug/mL, in Methanol
Glass ampoule: 1 mL
6/21/2024
Absolute Standards, Inc
Alprazolam-D5 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Clonazepam PT, 1-1000 µg/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Clonazepam-D4 PT, 1-1000 ug/mL, in Methanol
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Fentanyl, 1000 ug/mL, in Methanol
Glass ampoule: 1 mL
6/21/2024
Absolute Standards, Inc
Fentanyl-D5, 1000 ug/mL, in Methanol
Glass ampoule: 1 mL
6/21/2024
Absolute Standards, Inc
Lorazepam PT, 1-1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Lysergic acid diethylamide (LSD) PT, 1-100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Lysergic acid diethylamide (LSD) PT, 1-1000 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
7/30/2024
Absolute Standards, Inc
Lysergic acid diethylamide-D3 (LSD-D3) PT, 1-100 ug/mL, in Acetonitrile
Glass ampoule: 1 mL
12/6/2024
Absolute Standards, Inc
Lysergic acid diethylamide-D3 (LSD-D3) PT, 1-1000 ug/mL, in Acetonitrile
Kit: Glass bottles, 10 L, 20 L, 45 L, Plastic or Glass bottles, 20 L, 25 L, 50L, 100 L
1/31/2025
Microgenics Corporation
MGC MD Calibrator 4, Bulk
Kit: Glass bottles, 10 L, 20 L, 45 L, Plastic or Glass bottles, 20 L, 25 L, 50L, 100 L
1/31/2025
Restek Corporation
Cannabinoids 11 (1000) Standard
Glass ampoule: 1.3 mL
1/30/2025
Roche Diagnostics
Control Set iCSTDMA cobas I
HDPE Bottle: 16 bottles, 2.5 mL each
5/1/2024
Technopath Clinical Diagnostics
Multichem MS TDMS Level 2 09922580529
Plastic Bottle: 12 bottles, 4.5 mL each
5/1/2024
Thermo Fisher Scientific
Kontact Pool, Catalog Number: JB350308
HDPE Tank: 30 L
11/6/2024
Thermo Fisher Scientific
Kontact Reagent Bulk
HDPE Tank, 10 L
2/19/2025
Thermo Fisher Scientific
PCT Reference Calibrator A JY6P22AREF
Kit: 529 LDPE Bottles, 4.42 mL each
11/7/2024
Thermo Fisher Scientific
PCT Reference Calibrator A JY6P22AREF
Kit: 529 LDPE Bottle, 4.42 mL each
10/23/2024
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 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
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.