Exempt Chemical Preparations Under the Controlled Substances Act

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-372]

Exempt Chemical Preparations Under the Controlled Substances Act

AGENCY:

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 (DEA) between September 1, 2020, and March 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 September 20, 2021. 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.

An electronic copy of this document is available at

http://www.regulations.gov

for easy reference.

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 DEA's 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.

1

This authority has been delegated from the Attorney General to the Administrator of the DEA 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.

Exempt Chemical Preparation Applications Submitted Between September 1, 2020, and March 31, 2021

The Assistant Administrator received applications between September 1, 2020, and March 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 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 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 September 1, 2020, and March 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

Aalto Scientific, Ltd

Cal Ver FLQ Drugs of Abuse for Roche Systems Level 1

Glass vial: 3 mL

2/23/2021

Aalto Scientific, Ltd

Cal Ver FLQ Drugs of Abuse for Roche Systems Level 2

Glass vial: 3 mL

2/23/2021

Aalto Scientific, Ltd

Cal Ver FLQ Drugs of Abuse for Roche Systems Level 3

Glass vial: 3 mL

2/23/2021

Aalto Scientific, Ltd

Linearity FD Fertility Siemens Centaur

Kit: 10 vials; 3 mL each

3/29/2021

Aalto Scientific, Ltd

Linearity FLQ TDM for Ortho Vitros

Kit: 5 dropper bottles; 4 mL each

3/31/2021

Agilent Technologies

Custom Organic Std—11 analytes at 250 µg/mL

Amber ampule: 1 mL

2/19/2021

Cambridge Isotope Laboratories, Inc

Labeled Steroid Mix 40X Set S NSK-S-40X

Glass vial: 1 mL

3/1/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-tetrahydrocannabinol (THC) Unlabeled (95% CP), 1000 µg/mL in methanol (0.1%)

Glass ampule: 1.2 mL

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-Trans-tetrahydrocannabinol (THC) (Methyl-D3, 98%), 100 µg/mL in methanol (0.01%)

Glass ampule: 1.2 mL

2/19/2021

Cambridge Isotopes Laboratories, Inc

Testosterone (2,3,4-13C3, 99%) 100 µg/mL in acetonitrile

Glass ampule: 1 mL

2/19/2021

Cayman Chemical Company

(+/−)-11-hydroxy-d8-THC (CRM) 1 mg/ml, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

(+/−)-11-hydroxy-d8-THC (CRM) 1 mg/ml, 1 mL in methanol

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

(+/−)-11-hydroxy-d8-THC (CRM) 100 µg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

(+/−)-11-hydroxy-d8-THC (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Benzoylecgonine (CRM) 1 mg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Benzoylecgonine (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Benzoylecgonine-d3 (CRM) 1 mg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Benzoylecgonine-d3 (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Cocaine-d3 (CRM) 1 mg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Cocaine-d3 (CRM) 100 µg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

D8-THCB (CRM) 100 µg/mL, 1 mL acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCB (CRM) 1 mg/ml, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCB (CRM) 1 mg/ml, 1 mL methanol

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCB (CRM) 100 µg/mL, 1 mL methanol

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCP (CRM) 1 mg/ml, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCP (CRM) 1 mg/ml, 1 mL methanol

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCP (CRM) 100 µg/mL, 1 mL acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D8-THCP (CRM) 100 µg/mL, 1 mL methanol

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

D9-THC Acetate (CRM) 1 mg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

D9-THC Acetate (CRM) 1 mg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

D9-THC Acetate (CRM) 100 µg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

D9-THC Acetate (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Norfentanyl-d5 (CRM) 1 mg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Norfentanyl-d5 (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 5 (CRM) 100 µg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 5 (CRM) 100 µg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 1 mg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 1 mg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 1 mg/mL 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 1 mg/mL 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 100 µg/mL 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 100 µg/mL 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 250 µg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 250 µg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 250 µg/mL 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 250 µg/mL 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 500 µg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 500 µg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 500 µg/mL 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 6 (CRM) 500 µg/mL 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 1 mg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 1 mg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 1 mg/mL, 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 1 mg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 100 µg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 100 µg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 100 µg/mL, 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 100 µg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 250 µg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 250 µg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 250 µg/mL, 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 250 µg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 500 µg/mL, 1 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 500 µg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/3/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 500 µg/mL 0.5 mL in 1:99 DIPEA: acetonitrile with 0.05% ascorbic acid

Glass ampule: 0.5 mL

2/23/2021

Cayman Chemical Company

Phytocannabinoid Acids Mixture 7 (CRM) 500 µg/mL 0.5 mL in acetonitrile

Glass ampule: 0.5 mL

2/3/2021

Cayman Chemical Company

Psilocin (CRM) 1 mg/mL in Acetonitrile

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocin (CRM) 100 µg/mL in Acetonitrile

Glass ampule: 0.5 mL

2/24/2021

Cayman Chemical Company

Psilocin-d10 (CRM) 1 mg/mL in Acetonitrile

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocin-d10 (CRM) 100 µg/mL in Acetonitrile

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocin-d4 (CRM) 1 mg/mL in Acetonitrile

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocin-d4 (CRM) 100 µg/mL in Acetonitrile

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocybin (CRM) 1 mg/mL in 1:1 Acetonitrile:H2O

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocybin (CRM) 100 µg/mL in 1:1 Acetonitrile:H2O

Glass ampule: 0.5 mL

2/24/2021

Cayman Chemical Company

Psilocybin-d10 (CRM) 1 mg/mL in 1:1 Acetonitrile:H2O

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocybin-d10 (CRM) 100 µg/mL in 1:1 Acetonitrile:H2O

Glass ampule: 1.0 mL

2/24/2021

Cayman Chemical Company

Psilocybin-d4 (CRM) 1 mg/mL in 1:1 Acetonitrile:H2O

Glass ampule: 0.5 mL

2/24/2021

Cayman Chemical Company

Psilocybin-d4 (CRM) 100 µg/mL in 1:1 Acetonitrile:H2O

Glass ampule: 0.5 mL

2/24/2021

Cayman Chemical Company

U-47700 (CRM) 1 mg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

U-47700 (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

U-47700-d6 (CRM) 1 mg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cayman Chemical Company

U-47700-d6 (CRM) 100 µg/mL, 1 mL in methanol

Glass ampule: 1 mL

2/23/2021

Cerilliant Corporation

(−)-delta8-THC-D3

Glass ampule: 1 mL

1/26/2021

Cerilliant Corporation

4-Methyl-alpha-pyrrolidinobutiophenone HCl (MPBP HCl) (1.0 mg/mL)

Glass ampule: 1 mL

3/4/2021

Cerilliant Corporation

Tetrahydrocannabivarin-D5 (THCV-D5)

Glass ampule: 1 mL

1/26/2021

Cerilliant Corporation

Tetrahydrocannabivarinic acid-D5 (THCVA-D5)

Glass ampule: 1 mL

1/26/2021

Immunalysis Corporation

AMP/6-AM Oral Fluid Calibrator 1

Amber vial: 10 mL

2/10/2021

Immunalysis Corporation

AMP/6-AM Oral Fluid Calibrator 2

Amber vial: 10 mL

2/10/2021

Immunalysis Corporation

AMP/6-AM Oral Fluid Calibrator 3

Amber vial: 10 mL

2/10/2021

Immunalysis Corporation

AMP/6-AM Oral Fluid Calibrator 4

Amber vial: 10 mL

2/10/2021

Immunalysis Corporation

AMP/6-AM Oral Fluid Set

Kit: 2 vials, 10 mL each

2/10/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 202 Kit 250 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 203 Kit 500 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 204 Kit 1000 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 205 Kit 250 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 206 Kit 500 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 207 Kit 1000 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 214 Kit 250 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 214 Kit 250 μg/mL in Acetonitrile

1 Kit: 2 vials × 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 215 Kit 500 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 215 Kit 500 μg/mL in Acetonitrile

1 Kit: 2 vials × 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 216 Kit 1000 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 216 Kit 1000 μg/mL in Acetonitrile

1 Kit: 2 vials × 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 250 Kit 1000 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acid/Neutrals Mixture 250 Kit 1000 μg/mL in Acetonitrile

1 Kit: 2 vials × 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 184 1000 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 185 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 186 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 194 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 195 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 200 1000 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 210 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 210 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 211 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 211 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 212 1000 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Acids Mixture 212 1000 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 187 100 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 188 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 189 1000 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 190 50 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 191 100 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 192 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 193 1000 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 197 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 198 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 213 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 254 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 254 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 255 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 255 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

10/9/2020

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 256 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 256 250 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/10/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 257 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 257 500 μg/mL in Acetonitrile

Amber ampule: 0.4 mL

3/10/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 258 Kit 250 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/31/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 258 Kit 250 μg/mL in Acetonitrile

1 Kit: 2 vials × 0.4 mL

3/10/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 259 Kit 500 μg/mL in Acetonitrile

1 kit: 2 vials × 0.4 mL

3/19/2021

LGC—Dr. Ehrenstorfer

Cannabinoids Mixture 259 Kit 500 μg/mL in Acetonitrile

1 Kit: 2 vials × 0.4 mL

3/10/2021

LGC—Dr. Ehrenstorfer

Custom Δ9-Tetrahydrocannabivarin (THCV) 1000 ug/mL in Acetonitrile

Amber ampule: 1 mL

1/19/2021

LGC—Dr. Ehrenstorfer

Δ9-Tetrahydrocannabivarinic acid (THCVA) 100 ug/mL in Acetonitrile

Amber ampule: 1 mL

3/10/2021

o2si smart solutions

Chloral Hydrate 1000 µg/mL in methanol

Amber ampule: 1 mL

3/24/2021

o2si smart solutions

Custom Pharmaceutical Mixture CCV 16-0260, 10.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture ICV (second source), 16-0260, 10.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #1, 16-0260, 0.3 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #2, 16-0260, 1.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #3, 16-0260, 5.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #4, 16-0260, 10.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #5, 16-0260, 25.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #6, 16-0260, 50.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #7, 16-0260, 100.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Level #8, 16-0260, 250.0 µg/mL, 300 µL with a 2 mL silanized vial (ISO17034)

Amber ampule: 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Calibration Kit 16-0260, (2 × G34-140260-98)

1 kit; 26 amber ampules × 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture Calibration Pack 16-0260, 13 × 1 ml

1 pack; 13 amber ampules × 300 µL

3/1/2021

o2si smart solutions

Custom Pharmaceutical Mixture LCS, 16-0260, 10.0 ug/mL, 1 mL with a 2 ml Silanized Vial (ISO17034)

Amber ampule: 1 mL

3/1/2021

Research Triangle Institute

0584, 7232, 6089, 8785, 7227, 8588, 7541, 4336, 1817, 0737, 5340, 2985, 8470, 3501, 7362, 6850, 5497, 4097, 2479, 1536, 7431, 9541, 1585, 8534, 2113, 9789, 2482, 1013, 1483, 8092, 6365, 2209, 5434, 4035, 9222, 9674, 5622, 3806, 1798, 9820

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

3370, 1411, 5883, 5713, 8800, 3630, 8683, 4541, 8161, 0359, 9704, 2184, 0341, 2901, 0790, 6548, 3466, 0352, 5288, 8594, 0279, 8762, 3687, 2819, 8743, 7197, 5064, 0199, 1609, 8643, 6467, 2245, 0706, 0147, 6876, 3732, 9314, 1059, 8245, 8685

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

4118, 3472, 9120, 3742, 9323, 4475, 5116, 7455, 3780, 9052, 4910, 2630, 6141, 9351, 5220, 2730, 6408, 3560, 4063, 0427, 0669, 8350, 9163, 6359, 0113, 1893, 4552, 2951, 1357, 8372, 9203, 3150, 9587, 9290, 4399, 2454, 2468, 7560, 6645, 8756

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

4761, 2869, 4267, 9207, 1568, 8723, 7042, 6810, 0605, 7181, 8624, 0015, 5050, 7046, 3626, 7515, 9023, 8821, 6767, 0861, 0689, 5934, 2105, 2006, 1040, 5645, 2749, 7908, 9154, 8450, 5251, 6608, 3152, 9027, 2731, 7530, 1329, 0320, 5833, 7580

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

4946, 2135, 7589, 456, 2617, 2224, 5066, 4134, 9514, 0206, 2691, 2807, 1571, 2201, 0943, 6995, 1299, 3729, 9561, 2552, 1248, 7138, 1634, 0813, 6352, 3567, 2017, 6701, 6915, 4448, 1967, 3179, 2480, 5144, 8826, 5515, 0949, 6109, 4040, 8632

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

6673, 1920, 9080, 9040, 1769, 9824, 8015, 4813, 1535, 4285, 5824, 7430, 3338, 2989, 2743, 1537, 6009, 4808, 0243, 7097, 5533, 6638, 3414, 8238, 2573, 6806, 3959, 7896, 3448, 5652, 5273, 1341, 1063, 6664, 9471, 7136, 3571, 8916, 8617, 8946

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

7155, 9763, 5721, 5161, 0009, 8118, 7420, 0527, 4415, 6892, 6896, 8988, 6477, 9903, 6688, 0292, 9380, 4579, 9601, 7337, 1518, 2189, 8886, 8880, 6963, 9446, 7721, 9988, 7688, 2525, 4017, 6826, 3426, 4128, 6270, 4207, 0646, 5741, 6086, 0528

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

7938, 8287, 2990, 7693, 6858, 5995, 1929, 3740, 4461, 0196, 4271, 9853, 5024, 6378, 3409, 2702, 7629, 6194, 4553, 2871, 0203, 4812, 7073, 0834, 2732, 1841, 9545, 5063, 5062, 6234, 0210, 9740, 9472, 9938, 5122, 8677, 3537, 5198, 5977, 8203

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

8497, 8384, 3406, 0324, 6930, 3165, 1564, 8858, 4968, 8840, 7836, 9412, 9009, 0109, 0695, 0923, 0912, 3228, 6855, 5103, 8580, 4499, 8347, 7831, 8420, 2875, 6778, 6680, 9098, 1987, 6813, 6572, 9943, 6165, 0958, 5884, 1843, 2991, 3191, 1151

HDPE tubes: 5 mL

3/11/2021

Research Triangle Institute

9493, 8564, 6768, 1670, 2733, 0560, 7822, 7495, 1290, 4534, 6583, 3937, 6596, 2599, 9164, 5702, 8328, 9643, 5747, 1923, 0976, 3416, 1445, 3834, 3069, 7609, 6580, 3945, 1726, 2891, 4325, 8970, 7248, 1981, 3906, 0989, 3648, 7769, 4122, 9050

HDPE tubes: 5 mL

3/11/2021

Restek Corporation

Cannabinoids Acids 7 Standard

Glass ampule: 1.3 mL

3/31/2021

UTAK Laboratories, Inc

AED II MR Serum Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Amphetamines Panel Level 1 Urine Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Amphetamines Panel Level 2 Urine Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Benzodiazepines Hydrolysis QC Urine Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Benzodiazepines Plus 100 ng/mL Urine Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Benzodiazepines Plus 100 ng/mL Whole Blood Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Benzodiazepines Plus 400 ng/mL Urine Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

DAU IA 1 Urine Control

Kit: 4 bottles, 10 mL each

11/20/2020

UTAK Laboratories, Inc

DAU IA 2 Urine Control

Kit: 4 bottles, 10 mL each

11/20/2020

UTAK Laboratories, Inc

DAU IA 3 Urine Control

Kit: 4 bottles, 10 mL each

11/20/2020

UTAK Laboratories, Inc

DAU IA 4 Urine Control

Kit: 4 bottles, 10 mL each

11/20/2020

UTAK Laboratories, Inc

DAU IA 5 Urine Control

Kit: 4 bottles, 10 mL each

11/20/2020

UTAK Laboratories, Inc

DHEA Plus High Serum Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

DHEA Plus Low Serum Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Drugs of Abuse 200% Cutoff SMX Oral Fluid Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Drugs of Abuse 50% Cutoff SMX Oral Fluid Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Drugs of Abuse Cutoff SMX Oral Fluid Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Drugs of Abuse Level 2 Whole Blood Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Miscellaneous Panel Level 1 Urine Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Miscellaneous Panel Level 2 Urine Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Opiates Hydrolysis QC Urine Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Pentobarbital Serum Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

STABBS Negative Serum Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

STABBS Positive Serum Control

Kit: 5 bottles, 5 mL each

11/20/2020

UTAK Laboratories, Inc

Steroids Level 1 SMX Serum Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Steroids Level 2 SMX Serum Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Steroids Level 3 SMX Serum Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Steroids Level 4 SMX Serum Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Tapentadol Hydrolysis QC Urine Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Urine Drug Screen Urine Control

Kit: 5 bottles, 10 mL each

11/20/2020

UTAK Laboratories, Inc

Z Drugs Plus Level 1 Urine Control

Kit: 5 bottles, 3 mL each

11/20/2020

UTAK Laboratories, Inc

Z Drugs Plus Level 2 Urine Control

Kit: 5 bottles, 3 mL each

11/20/2020

Xvivo Perfusion

Supplemented XVIVO Heart Solution (SXHS)

Glass vial: 10 mL

9/11/2020

Xvivo Perfusion

XVIVO Heart Perfusion System (XHPS)

Kit: Heart Box, Disposable, Supplemented Soln

9/11/2020

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

Cambridge Isotopes Laboratories, Inc

Delta-9-tetrahydrocannabinol (THC) unlabeled (Chemical Purity 95%), 5 mg

Glass ampule: 5 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-tetrahydrocannabinol (THC) unlabeled (Chemical Purity 95%), 0.5 mg

Glass ampule: 0.5 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-tetrahydrocannabinol (THC) unlabeled (Chemical Purity 95%), 1 mg

Glass ampule: 1 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-tetrahydrocannabinol (THC) unlabeled (Chemical Purity 95%), 10 mg

Glass ampule: 10 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-Trans-tetrahydrocannabinol (THC) (Methyl-D3, 98%), 5 mg

Glass ampule: 5 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-Trans-tetrahydrocannabinol (THC) (Methyl-D3, 98%), 0.5 mg

Glass ampule: 0.5 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-Trans-tetrahydrocannabinol (THC) (Methyl-D3, 98%), 1 mg

Glass ampule: 1 mg

2/19/2021

Cambridge Isotopes Laboratories, Inc

Delta-9-Trans-tetrahydrocannabinol (THC) (Methyl-D3, 98%), 10 mg

Glass ampule: 10 mg

2/19/2021

Cayman Chemical Company

Clonazepam (CRM) 1 mg/mL, 1 mL in acetonitrile

Glass ampule: 1 mL

2/23/2021

LGC—Dr. Ehrenstorher

Δ9-Tetrahydrocannabivarin 10,000 mg/L Parent stock in Methanol—NOT FOR SALE

Boston Round, Amber glass: 14 mL

1/19/2021

LGC—Dr. Ehrenstorfer

Delta-9-THC 10000 μg/mL in Methanol

Amber ampule: 2 mL

2/16/2021

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 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

A list of all current exemptions, including those listed in this order, is available on the DEA's website at

http://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf.

The dates of applications of all current exemptions are posted for easy reference.

William T. McDermott,

Assistant Administrator.

[FR Doc. 2021-15024 Filed 7-21-21; 8:45 am]

BILLING CODE 4410-09-P