Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between July 1, 2021, and December 31, 2021, as listed below, were accept...
Drug Enforcement Administration, Department of Justice.
( printed page 23229)
ACTION:
Order with opportunity for comment.
SUMMARY:
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between July 1, 2021, and December 31, 2021, 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 June 21, 2022. Commenters should be aware that 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.
ADDRESSES:
To ensure proper handling of comments, please reference “Docket No. DEA-372” on all correspondence, including any attachments.
Electronic comments:
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 identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received.
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
http://www.regulations.gov
may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.
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 Drug Enforcement Administration (DEA) regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria by which the DEA Deputy Assistant Administrator may exempt a chemical preparation or mixture from certain provisions of the CSA. The Deputy 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, 2021, and December 31, 2021
The Deputy Assistant Administrator received applications between July 1, 2021, and December 31, 2021, 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 Deputy 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 Deputy 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
( printed page 23230)
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 opportunity 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 July 1, 2021, and December 31, 2021, 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
(+/−)-MDA-D5, 100 ug/ml, in Methanol
Glass ampoule: 1 ml
10/21/2021
Absolute Standards, Inc
(+/−)-Methamphetamine-D9, 100 ug/ml, in Methanol
Glass ampoule: 1 ml
10/21/2021
Absolute Standards, Inc
4-Androstene-3,17-dione, 1000 ug/ml, in Methanol
Glass ampoule: 1 ml
10/21/2021
Absolute Standards, Inc
6-Acetylmorphine, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
6-Acetylmorphine-D3, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Amfepramone, 100 ug/ml, in Acetonitrile:Water [1:1]
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Amfepramone-D10, 100 ug/ml, in 1% lM HCI Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Anhydroecgonine methyl ester, 100 ug/ml, in Acetonitrile
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Barbital, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Benzoylecgonine-D3, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Chlordiazepoxide, 100 ug/ml, in Acetonitrile
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Cocaethylene, 100 ug/ml, in Acetonitrile
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Cocaethylene-D3, 100 ug/ml, in Acetonitrile
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Codeine-D3, 100 ug/ml, in Ethanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Dihydrotestosterone, 1000 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Ecgonine methyl ester, 1000 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Fenproporex, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Fenproporex-D5, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Fentanyl, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17025 Calibrator—Level 0, ≥500 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17025 Calibrator—Level 3, ≥5000 ng/ml, In Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17025 Calibrator—Level 4, ≥10 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17025 Calibrator—Level 5, ≥20 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17025 Calibrator • Level 1, ≥1000 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17025 Calibrator • Level 2, ≥2500 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO 17043 Internal Standard, ≥3000 ng/ml, in Methanol
Glass ampoule: 5 ml
10/21/2021
Absolute Standards, Inc
ISO G34 calibrator Spike Solution Rev 1, ≥50 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO G34 Control Spike High Rev-1, ≥7000 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
ISO G34 Control Spike Low Rev-1, ≥4000 ng/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
JWH-018, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
JWH-018-d9, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Ketamine-d4, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Mazindol, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Mazindol-D4, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Morphine, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Morphine-D3, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Norcocaine, 100 ug/ml, in Acetonitrile
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Norcocaine-D3, 100 ug/ml, in Acetonitrile
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Paraldehyde, 1000 ug/ml, in Water
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Phencyclidine, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Pregabalin-d6, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Psilocybin, 100 ug/ml, in Acetonitrile.:Water [1:1]
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
Psilocybin, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
THC-O-Acetate, 100 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
THC-O-Acetate, 1000 ug/ml, in Methanol
Glass ampoule: 1 mL
10/21/2021
Absolute Standards, Inc
WS Chloral hydrate, 4-30 ug/ml, in Acetone
Glass ampoule: 2 ml
10/21/2021
Absolute Standards, Inc
WS Chloral hydrate, 4-30 ug/ml, in MTBE
Glass ampoule: 2 ml
10/21/2021
Audit MicroControls, Inc
Linearity FD Immunoassay
Kit: 10 vials; 5 mL each
8/23/2021
( printed page 23231)
Audit MicroControls, Inc
Linearity FD Immunoassay for Abbott Systems
Kit: 10 vials; 5 mL each
7/19/2021
Audit MicroControls, Inc
Linearity FD Immunoassay for Abbott Systems Level A
Glass vial: 5 mL
7/19/2021
Audit MicroControls, Inc
Linearity FD Immunoassay for Abbott Systems Level B
Glass vial: 5 mL
7/19/2021
Audit MicroControls, Inc
Linearity FD Immunoassay for Abbott Systems Level C
Glass vial: 5 mL
7/19/2021
Audit MicroControls, Inc
Linearity FD Immunoassay for Abbott Systems Level D
Glass vial: 5 mL
7/19/2021
Audit MicroControls, Inc
Linearity FD Immunoassay for Abbott Systems Level E
Glass vial: 5 mL
7/19/2021
Audit MicroControls, Inc
Linearity FLQ Fertility Siemens Atellica/Centaur
Kit: 10 vials; 2 mL each
8/18/2021
Audit MicroControls, Inc
Linearity FLQ Fertility Siemens Atellica/Centaur, Set 2 Level A
Glass vial: 2 mL
8/18/2021
Audit MicroControls, Inc
Linearity FLQ Fertility Siemens Atellica/Centaur, Set 2 Level B
Glass vial: 2 mL
8/18/2021
Audit MicroControls, Inc
Linearity FLQ Fertility Siemens Atellica/Centaur, Set 2 Level C
Glass vial: 2 mL
8/18/2021
Audit MicroControls, Inc
Linearity FLQ Fertility Siemens Atellica/Centaur, Set 2 Level D
Glass vial: 2 mL
8/18/2021
Audit MicroControls, Inc
Linearity FLQ Fertility Siemens Atellica/Centaur, Set 2 Level E
The Deputy 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 Deputy 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.
((-)-delta9-THC (Dronabinol)) for 1.0 mg/mL in Methanol
Glass Vial: 1 mL
12/7/2021
LGC GmbH
Fentanyl 1.0 mg/ml in methanol
Glass vial: 1 mL
12/10/2021
LGC GmbH
LSD (Lysergic Acid Diethylamide) 1.0 mg/ml in acetonitrile
Glass vial: 1 mL
12/10/2021
Lipomed Inc
Iso LSD 0.1 mg/1 mL acetonitrile
Amber ampule: 1 mL
7/23/2021
Lipomed Inc
Iso LSD 1 mg/1 mL acetonitrile
Amber ampule: 1 mL
7/23/2021
Lipomed, Inc
Iso LSD 0.1 mg/1 mL acetonitrile
Amber ampule: 1 mL
7/23/2021
Lipomed, Inc
Iso LSD 1 mg/1 mL acetonitrile
Amber ampule: 1 mL
7/23/2021
Purisys, LLC
Tetrahydrocannabinolic acid in dimethylsulfoxide (10 mg/mL)
Sealed ampule: 1 mL
8/30/2021
Purisys, LLC
Tetrahydrocannabinolic acid in dimethylsulfoxide (5 mg/mL)
Sealed ampule: 1 mL
8/30/2021
Purisys, LLC
Δ9-Tetrahydrocannabinol in dimethylsulfoxide (10 mg/mL)
Sealed ampule: 1 mL
8/30/2021
Purisys, LLC
Δ9-Tetrahydrocannabinol in dimethylsulfoxide (5 mg/mL)
Sealed ampule: 1 mL
8/30/2021
Siemens Healthcare Diagnostics Inc
IMMULITE Estradiol Diluent
Plastic container: 0.5L-3L
10/11/2021
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 Deputy 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 Deputy 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 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.
87 FR 23228
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 (April 19, 2022), https://thefederalregister.org/documents/2022-08300/exempt-chemical-preparations-under-the-controlled-substances-act.