[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38765-38770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15024]
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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.
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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.
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\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.
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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
[[Page 38766]]
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
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Application
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
Aalto Scientific, Ltd.................. Cal Ver FLQ Drugs of Abuse for Glass vial: 3 mL......... 2/23/2021
Roche Systems Level 1.
Aalto Scientific, Ltd.................. Cal Ver FLQ Drugs of Abuse for Glass vial: 3 mL......... 2/23/2021
Roche Systems Level 2.
Aalto Scientific, Ltd.................. Cal Ver FLQ Drugs of Abuse for Glass vial: 3 mL......... 2/23/2021
Roche Systems Level 3.
Aalto Scientific, Ltd.................. Linearity FD Fertility Siemens Kit: 10 vials; 3 mL each. 3/29/2021
Centaur.
Aalto Scientific, Ltd.................. Linearity FLQ TDM for Ortho Kit: 5 dropper bottles; 4 3/31/2021
Vitros. mL each.
Agilent Technologies................... Custom Organic Std--11 analytes Amber ampule: 1 mL....... 2/19/2021
at 250 [micro]g/mL.
Cambridge Isotope Laboratories, Inc.... Labeled Steroid Mix 40X Set S Glass vial: 1 mL......... 3/1/2021
NSK-S-40X.
Cambridge Isotopes Laboratories, Inc... Delta-9-tetrahydrocannabinol Glass ampule: 1.2 mL..... 2/19/2021
(THC) Unlabeled (95% CP), 1000
[micro]g/mL in methanol (0.1%).
Cambridge Isotopes Laboratories, Inc... Delta-9-Trans- Glass ampule: 1.2 mL..... 2/19/2021
tetrahydrocannabinol (THC)
(Methyl-D3, 98%), 100 [micro]g/
mL in methanol (0.01%).
Cambridge Isotopes Laboratories, Inc... Testosterone (2,3,4-13C3, 99%) Glass ampule: 1 mL....... 2/19/2021
100 [micro]g/mL in
acetonitrile.
Cayman Chemical Company................ (+/-)-11-hydroxy-d8-THC (CRM) 1 Glass ampule: 1 mL....... 2/3/2021
mg/ml, 1 mL in acetonitrile.
Cayman Chemical Company................ (+/-)-11-hydroxy-d8-THC (CRM) 1 Glass ampule: 1 mL....... 2/3/2021
mg/ml, 1 mL in methanol.
Cayman Chemical Company................ (+/-)-11-hydroxy-d8-THC (CRM) Glass ampule: 1 mL....... 2/3/2021
100 [micro]g/mL, 1 mL in
acetonitrile.
Cayman Chemical Company................ (+/-)-11-hydroxy-d8-THC (CRM) Glass ampule: 1 mL....... 2/3/2021
100 [micro]g/mL, 1 mL in
methanol.
Cayman Chemical Company................ Benzoylecgonine (CRM) 1 mg/mL, Glass ampule: 1 mL....... 2/23/2021
1 mL in methanol.
Cayman Chemical Company................ Benzoylecgonine (CRM) 100 Glass ampule: 1 mL....... 2/23/2021
[micro]g/mL, 1 mL in methanol.
Cayman Chemical Company................ Benzoylecgonine-d3 (CRM) 1 mg/ Glass ampule: 1 mL....... 2/23/2021
mL, 1 mL in methanol.
Cayman Chemical Company................ Benzoylecgonine-d3 (CRM) 100 Glass ampule: 1 mL....... 2/23/2021
[micro]g/mL, 1 mL in methanol.
Cayman Chemical Company................ Cocaine-d3 (CRM) 1 mg/mL, 1 mL Glass ampule: 1 mL....... 2/23/2021
in acetonitrile.
Cayman Chemical Company................ Cocaine-d3 (CRM) 100 [micro]g/ Glass ampule: 1 mL....... 2/23/2021
mL, 1 mL in acetonitrile.
Cayman Chemical Company................ D8-THCB (CRM) 100 [micro]g/mL, Glass ampule: 1 mL....... 2/3/2021
1 mL acetonitrile.
Cayman Chemical Company................ D8-THCB (CRM) 1 mg/ml, 1 mL in Glass ampule: 1 mL....... 2/3/2021
acetonitrile.
Cayman Chemical Company................ D8-THCB (CRM) 1 mg/ml, 1 mL Glass ampule: 1 mL....... 2/3/2021
methanol.
Cayman Chemical Company................ D8-THCB (CRM) 100 [micro]g/mL, Glass ampule: 1 mL....... 2/3/2021
1 mL methanol.
Cayman Chemical Company................ D8-THCP (CRM) 1 mg/ml, 1 mL in Glass ampule: 1 mL....... 2/3/2021
acetonitrile.
Cayman Chemical Company................ D8-THCP (CRM) 1 mg/ml, 1 mL Glass ampule: 1 mL....... 2/3/2021
methanol.
Cayman Chemical Company................ D8-THCP (CRM) 100 [micro]g/mL, Glass ampule: 1 mL....... 2/3/2021
1 mL acetonitrile.
Cayman Chemical Company................ D8-THCP (CRM) 100 [micro]g/mL, Glass ampule: 1 mL....... 2/3/2021
1 mL methanol.
Cayman Chemical Company................ D9-THC Acetate (CRM) 1 mg/mL, 1 Glass ampule: 1 mL....... 2/23/2021
mL in acetonitrile.
Cayman Chemical Company................ D9-THC Acetate (CRM) 1 mg/mL, 1 Glass ampule: 1 mL....... 2/23/2021
mL in methanol.
Cayman Chemical Company................ D9-THC Acetate (CRM) 100 Glass ampule: 1 mL....... 2/23/2021
[micro]g/mL, 1 mL in
acetonitrile.
Cayman Chemical Company................ D9-THC Acetate (CRM) 100 Glass ampule: 1 mL....... 2/23/2021
[micro]g/mL, 1 mL in methanol.
Cayman Chemical Company................ Norfentanyl-d5 (CRM) 1 mg/mL, 1 Glass ampule: 1 mL....... 2/23/2021
mL in methanol.
Cayman Chemical Company................ Norfentanyl-d5 (CRM) 100 Glass ampule: 1 mL....... 2/23/2021
[micro]g/mL, 1 mL in methanol.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
5 (CRM) 100 [micro]g/mL 0.5 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
5 (CRM) 100 [micro]g/mL 0.5 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
6 (CRM) 1 mg/mL 0.5 mL in 1:99
DIPEA: acetonitrile with 0.05%
ascorbic acid.
[[Page 38767]]
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
6 (CRM) 1 mg/mL 0.5 mL in
acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
6 (CRM) 1 mg/mL 1 mL in 1:99
DIPEA: acetonitrile with 0.05%
ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
6 (CRM) 1 mg/mL 1 mL in
acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
6 (CRM) 100 [micro]g/mL 1 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
6 (CRM) 100 [micro]g/mL 1 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
6 (CRM) 250 [micro]g/mL 0.5 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
6 (CRM) 250 [micro]g/mL 0.5 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
6 (CRM) 250 [micro]g/mL 1 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
6 (CRM) 250 [micro]g/mL 1 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
6 (CRM) 500 [micro]g/mL 0.5 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
6 (CRM) 500 [micro]g/mL 0.5 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
6 (CRM) 500 [micro]g/mL 1 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
6 (CRM) 500 [micro]g/mL 1 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
7 (CRM) 1 mg/mL 0.5 mL in 1:99
DIPEA: acetonitrile with 0.05%
ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
7 (CRM) 1 mg/mL 0.5 mL in
acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
7 (CRM) 1 mg/mL, 1 mL in 1:99
DIPEA: acetonitrile with 0.05%
ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
7 (CRM) 1 mg/mL, 1 mL in
acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
7 (CRM) 100 [micro]g/mL 0.5 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
7 (CRM) 100 [micro]g/mL 0.5 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
7 (CRM) 100 [micro]g/mL, 1 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
7 (CRM) 100 [micro]g/mL, 1 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
7 (CRM) 250 [micro]g/mL 0.5 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
7 (CRM) 250 [micro]g/mL 0.5 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
7 (CRM) 250 [micro]g/mL, 1 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
7 (CRM) 250 [micro]g/mL, 1 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/23/2021
7 (CRM) 500 [micro]g/mL, 1 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 1 mL....... 2/3/2021
7 (CRM) 500 [micro]g/mL, 1 mL
in acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/23/2021
7 (CRM) 500 [micro]g/mL 0.5 mL
in 1:99 DIPEA: acetonitrile
with 0.05% ascorbic acid.
Cayman Chemical Company................ Phytocannabinoid Acids Mixture Glass ampule: 0.5 mL..... 2/3/2021
7 (CRM) 500 [micro]g/mL 0.5 mL
in acetonitrile.
Cayman Chemical Company................ Psilocin (CRM) 1 mg/mL in Glass ampule: 1.0 mL..... 2/24/2021
Acetonitrile.
Cayman Chemical Company................ Psilocin (CRM) 100 [micro]g/mL Glass ampule: 0.5 mL..... 2/24/2021
in Acetonitrile.
Cayman Chemical Company................ Psilocin-d10 (CRM) 1 mg/mL in Glass ampule: 1.0 mL..... 2/24/2021
Acetonitrile.
Cayman Chemical Company................ Psilocin-d10 (CRM) 100 [micro]g/ Glass ampule: 1.0 mL..... 2/24/2021
mL in Acetonitrile.
Cayman Chemical Company................ Psilocin-d4 (CRM) 1 mg/mL in Glass ampule: 1.0 mL..... 2/24/2021
Acetonitrile.
Cayman Chemical Company................ Psilocin-d4 (CRM) 100 [micro]g/ Glass ampule: 1.0 mL..... 2/24/2021
mL in Acetonitrile.
Cayman Chemical Company................ Psilocybin (CRM) 1 mg/mL in 1:1 Glass ampule: 1.0 mL..... 2/24/2021
Acetonitrile:H2O.
Cayman Chemical Company................ Psilocybin (CRM) 100 [micro]g/ Glass ampule: 0.5 mL..... 2/24/2021
mL in 1:1 Acetonitrile:H2O.
Cayman Chemical Company................ Psilocybin-d10 (CRM) 1 mg/mL in Glass ampule: 1.0 mL..... 2/24/2021
1:1 Acetonitrile:H2O.
Cayman Chemical Company................ Psilocybin-d10 (CRM) 100 Glass ampule: 1.0 mL..... 2/24/2021
[micro]g/mL in 1:1
Acetonitrile:H2O.
Cayman Chemical Company................ Psilocybin-d4 (CRM) 1 mg/mL in Glass ampule: 0.5 mL..... 2/24/2021
1:1 Acetonitrile:H2O.
Cayman Chemical Company................ Psilocybin-d4 (CRM) 100 Glass ampule: 0.5 mL..... 2/24/2021
[micro]g/mL in 1:1
Acetonitrile:H2O.
Cayman Chemical Company................ U-47700 (CRM) 1 mg/mL, 1 mL in Glass ampule: 1 mL....... 2/23/2021
methanol.
Cayman Chemical Company................ U-47700 (CRM) 100 [micro]g/mL, Glass ampule: 1 mL....... 2/23/2021
1 mL in methanol.
Cayman Chemical Company................ U-47700-d6 (CRM) 1 mg/mL, 1 mL Glass ampule: 1 mL....... 2/23/2021
in methanol.
Cayman Chemical Company................ U-47700-d6 (CRM) 100 [micro]g/ Glass ampule: 1 mL....... 2/23/2021
mL, 1 mL in methanol.
Cerilliant Corporation................. (-)-delta8-THC-D3.............. Glass ampule: 1 mL....... 1/26/2021
Cerilliant Corporation................. 4-Methyl-alpha- Glass ampule: 1 mL....... 3/4/2021
pyrrolidinobutiophenone HCl
(MPBP HCl) (1.0 mg/mL).
Cerilliant Corporation................. Tetrahydrocannabivarin-D5 (THCV- Glass ampule: 1 mL....... 1/26/2021
D5).
Cerilliant Corporation................. Tetrahydrocannabivarinic acid- Glass ampule: 1 mL....... 1/26/2021
D5 (THCVA-D5).
Immunalysis Corporation................ AMP/6-AM Oral Fluid Calibrator Amber vial: 10 mL........ 2/10/2021
1.
Immunalysis Corporation................ AMP/6-AM Oral Fluid Calibrator Amber vial: 10 mL........ 2/10/2021
2.
Immunalysis Corporation................ AMP/6-AM Oral Fluid Calibrator Amber vial: 10 mL........ 2/10/2021
3.
Immunalysis Corporation................ AMP/6-AM Oral Fluid Calibrator Amber vial: 10 mL........ 2/10/2021
4.
Immunalysis Corporation................ AMP/6-AM Oral Fluid Set........ Kit: 2 vials, 10 mL each. 2/10/2021
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 202 Kit 250 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 203 Kit 500 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 204 Kit 1000 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 205 Kit 250 [mu]g/mL
in Acetonitrile.
[[Page 38768]]
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 206 Kit 500 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 207 Kit 1000 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 214 Kit 250 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 Kit: 2 vials x 0.4 mL.. 10/9/2020
Mixture 214 Kit 250 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 215 Kit 500 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 Kit: 2 vials x 0.4 mL.. 10/9/2020
Mixture 215 Kit 500 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 216 Kit 1000 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 Kit: 2 vials x 0.4 mL.. 10/9/2020
Mixture 216 Kit 1000 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 kit: 2 vials x 0.4 mL.. 3/19/2021
Mixture 250 Kit 1000 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acid/Neutrals 1 Kit: 2 vials x 0.4 mL.. 10/9/2020
Mixture 250 Kit 1000 [mu]g/mL
in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 184 Amber ampule: 0.4 mL..... 3/19/2021
1000 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 185 Amber ampule: 0.4 mL..... 3/19/2021
500 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 186 Amber ampule: 0.4 mL..... 3/19/2021
250 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 194 Amber ampule: 0.4 mL..... 3/19/2021
250 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 195 Amber ampule: 0.4 mL..... 3/19/2021
500 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 200 Amber ampule: 0.4 mL..... 3/19/2021
1000 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 210 Amber ampule: 0.4 mL..... 3/19/2021
250 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 210 Amber ampule: 0.4 mL..... 10/9/2020
250 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 211 Amber ampule: 0.4 mL..... 3/19/2021
500 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 211 Amber ampule: 0.4 mL..... 10/9/2020
500 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 212 Amber ampule: 0.4 mL..... 3/19/2021
1000 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Acids Mixture 212 Amber ampule: 0.4 mL..... 10/9/2020
1000 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 187 100 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 188 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 189 1000 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 190 50 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 191 100 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 192 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 193 1000 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 197 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 198 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 213 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 254 250 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 254 250 Amber ampule: 0.4 mL..... 10/9/2020
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 255 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 255 500 Amber ampule: 0.4 mL..... 10/9/2020
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 256 250 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 256 250 Amber ampule: 0.4 mL..... 3/10/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 257 500 Amber ampule: 0.4 mL..... 3/19/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 257 500 Amber ampule: 0.4 mL..... 3/10/2021
[mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 258 Kit 1 kit: 2 vials x 0.4 mL.. 3/31/2021
250 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 258 Kit 1 Kit: 2 vials x 0.4 mL.. 3/10/2021
250 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 259 Kit 1 kit: 2 vials x 0.4 mL.. 3/19/2021
500 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Cannabinoids Mixture 259 Kit 1 Kit: 2 vials x 0.4 mL.. 3/10/2021
500 [mu]g/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. Custom [Delta]9- Amber ampule: 1 mL....... 1/19/2021
Tetrahydrocannabivarin (THCV)
1000 ug/mL in Acetonitrile.
LGC--Dr. Ehrenstorfer.................. [Delta]9- Amber ampule: 1 mL....... 3/10/2021
Tetrahydrocannabivarinic acid
(THCVA) 100 ug/mL in
Acetonitrile.
o2si smart solutions................... Chloral Hydrate 1000 [micro]g/ Amber ampule: 1 mL....... 3/24/2021
mL in methanol.
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
CCV 16-0260, 10.0 [micro]g/mL, [micro]L.
300 [micro]L with a 2 mL
silanized vial (ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
ICV (second source), 16-0260, [micro]L.
10.0 [micro]g/mL, 300 [micro]L
with a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #1, 16-0260, 0.3 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #2, 16-0260, 1.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #3, 16-0260, 5.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #4, 16-0260, 10.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #5, 16-0260, 25.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #6, 16-0260, 50.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #7, 16-0260, 100.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 300 3/1/2021
Level #8, 16-0260, 250.0 [micro]L.
[micro]g/mL, 300 [micro]L with
a 2 mL silanized vial
(ISO17034).
o2si smart solutions................... Custom Pharmaceutical Mixture 1 kit; 26 amber ampules x 3/1/2021
Calibration Kit 16-0260, (2 x 300 [micro]L.
G34-140260-98).
o2si smart solutions................... Custom Pharmaceutical Mixture 1 pack; 13 amber ampules 3/1/2021
Calibration Pack 16-0260, 13 x x 300 [micro]L.
1 ml.
o2si smart solutions................... Custom Pharmaceutical Mixture Amber ampule: 1 mL....... 3/1/2021
LCS, 16-0260, 10.0 ug/mL, 1 mL
with a 2 ml Silanized Vial
(ISO17034).
Research Triangle Institute............ 0584, 7232, 6089, 8785, 7227, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 3370, 1411, 5883, 5713, 8800, HDPE tubes: 5 mL......... 3/11/2021
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.
[[Page 38769]]
Research Triangle Institute............ 4118, 3472, 9120, 3742, 9323, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 4761, 2869, 4267, 9207, 1568, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 4946, 2135, 7589, 456, 2617, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 6673, 1920, 9080, 9040, 1769, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 7155, 9763, 5721, 5161, 0009, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 7938, 8287, 2990, 7693, 6858, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 8497, 8384, 3406, 0324, 6930, HDPE tubes: 5 mL......... 3/11/2021
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.
Research Triangle Institute............ 9493, 8564, 6768, 1670, 2733, HDPE tubes: 5 mL......... 3/11/2021
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.
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 Kit: 5 bottles, 5 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. Amphetamines Panel Level 2 Kit: 5 bottles, 5 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. Benzodiazepines Hydrolysis QC Kit: 5 bottles, 3 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. Benzodiazepines Plus 100 ng/mL Kit: 5 bottles, 5 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. Benzodiazepines Plus 100 ng/mL Kit: 5 bottles, 5 mL each 11/20/2020
Whole Blood Control.
UTAK Laboratories, Inc................. Benzodiazepines Plus 400 ng/mL Kit: 5 bottles, 5 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. DAU IA 1 Urine Control......... Kit: 4 bottles, 10 mL 11/20/2020
each.
UTAK Laboratories, Inc................. DAU IA 2 Urine Control......... Kit: 4 bottles, 10 mL 11/20/2020
each.
UTAK Laboratories, Inc................. DAU IA 3 Urine Control......... Kit: 4 bottles, 10 mL 11/20/2020
each.
UTAK Laboratories, Inc................. DAU IA 4 Urine Control......... Kit: 4 bottles, 10 mL 11/20/2020
each.
UTAK Laboratories, Inc................. DAU IA 5 Urine Control......... Kit: 4 bottles, 10 mL 11/20/2020
each.
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 Kit: 5 bottles, 3 mL each 11/20/2020
Oral Fluid Control.
UTAK Laboratories, Inc................. Drugs of Abuse 50% Cutoff SMX Kit: 5 bottles, 3 mL each 11/20/2020
Oral Fluid Control.
UTAK Laboratories, Inc................. Drugs of Abuse Cutoff SMX Oral Kit: 5 bottles, 3 mL each 11/20/2020
Fluid Control.
UTAK Laboratories, Inc................. Drugs of Abuse Level 2 Whole Kit: 5 bottles, 5 mL each 11/20/2020
Blood Control.
UTAK Laboratories, Inc................. Miscellaneous Panel Level 1 Kit: 5 bottles, 5 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. Miscellaneous Panel Level 2 Kit: 5 bottles, 5 mL each 11/20/2020
Urine Control.
UTAK Laboratories, Inc................. Opiates Hydrolysis QC Urine Kit: 5 bottles, 3 mL each 11/20/2020
Control.
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 Kit: 5 bottles, 3 mL each 11/20/2020
Control.
UTAK Laboratories, Inc................. Steroids Level 2 SMX Serum Kit: 5 bottles, 3 mL each 11/20/2020
Control.
UTAK Laboratories, Inc................. Steroids Level 3 SMX Serum Kit: 5 bottles, 3 mL each 11/20/2020
Control.
UTAK Laboratories, Inc................. Steroids Level 4 SMX Serum Kit: 5 bottles, 3 mL each 11/20/2020
Control.
UTAK Laboratories, Inc................. Tapentadol Hydrolysis QC Urine Kit: 5 bottles, 3 mL each 11/20/2020
Control.
UTAK Laboratories, Inc................. Urine Drug Screen Urine Control Kit: 5 bottles, 10 mL 11/20/2020
each.
UTAK Laboratories, Inc................. Z Drugs Plus Level 1 Urine Kit: 5 bottles, 3 mL each 11/20/2020
Control.
UTAK Laboratories, Inc................. Z Drugs Plus Level 2 Urine Kit: 5 bottles, 3 mL each 11/20/2020
Control.
Xvivo Perfusion........................ Supplemented XVIVO Heart Glass vial: 10 mL........ 9/11/2020
Solution (SXHS).
Xvivo Perfusion........................ XVIVO Heart Perfusion System Kit: Heart Box, 9/11/2020
(XHPS). Disposable, Supplemented
Soln.
----------------------------------------------------------------------------------------------------------------
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.
[[Page 38770]]
Chart II
----------------------------------------------------------------------------------------------------------------
Application
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
Cambridge Isotopes Laboratories, Inc... Delta-9-tetrahydrocannabinol Glass ampule: 5 mg....... 2/19/2021
(THC) unlabeled (Chemical
Purity 95%), 5 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-tetrahydrocannabinol Glass ampule: 0.5 mg..... 2/19/2021
(THC) unlabeled (Chemical
Purity 95%), 0.5 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-tetrahydrocannabinol Glass ampule: 1 mg....... 2/19/2021
(THC) unlabeled (Chemical
Purity 95%), 1 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-tetrahydrocannabinol Glass ampule: 10 mg...... 2/19/2021
(THC) unlabeled (Chemical
Purity 95%), 10 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-Trans- Glass ampule: 5 mg....... 2/19/2021
tetrahydrocannabinol (THC)
(Methyl-D3, 98%), 5 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-Trans- Glass ampule: 0.5 mg..... 2/19/2021
tetrahydrocannabinol (THC)
(Methyl-D3, 98%), 0.5 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-Trans- Glass ampule: 1 mg....... 2/19/2021
tetrahydrocannabinol (THC)
(Methyl-D3, 98%), 1 mg.
Cambridge Isotopes Laboratories, Inc... Delta-9-Trans- Glass ampule: 10 mg...... 2/19/2021
tetrahydrocannabinol (THC)
(Methyl-D3, 98%), 10 mg.
Cayman Chemical Company................ Clonazepam (CRM) 1 mg/mL, 1 mL Glass ampule: 1 mL....... 2/23/2021
in acetonitrile.
LGC--Dr. Ehrenstorher.................. [Delta]9-Tetrahydrocannabivarin Boston Round, Amber 1/19/2021
10,000 mg/L Parent stock in glass: 14 mL.
Methanol--NOT FOR SALE.
LGC--Dr. Ehrenstorfer.................. Delta-9-THC 10000 [mu]g/mL in Amber ampule: 2 mL....... 2/16/2021
Methanol.
----------------------------------------------------------------------------------------------------------------
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