[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26944-26951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12110]
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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 April 1, 2016, and
December 31, 2016, 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 August
11, 2017. 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: The Drug Enforcement Administration
(DEA) encourages that all comments be submitted through the Federal
eRulemaking Portal, which provides the ability to type short comments
directly into the comment field on the Web page or to attach a file for
lengthier comments. Please go to http://www.regulations.gov and follow
the online instructions at that site for submitting comments. Upon
completion of your submission you will receive a Comment Tracking
Number for your comment. Please be aware that submitted comments are
not instantaneously available for public view on Regulations.gov. If
you have received a comment tracking number, your comment has been
successfully submitted and there is no need to resubmit the same
comment.
Paper comments: Paper comments that duplicate the
electronic submission are not necessary and are discouraged. Should you
wish to mail a comment in lieu of an electronic comment, it should be
sent via regular or express mail to: Drug Enforcement Administration,
Attention: DEA Federal Register Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
[[Page 26945]]
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
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.
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
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. Titles II and II are referred to as
the ``Controlled Substances Act'' and the ``Controlled Substances
Import and Export Act,'' or the ``CSA'' for the purpose of this action.
21 U.S.C. 801-971. The DEA publishes the implementing regulations for
these statutes in title 21 of the Code of Federal Regulations (CFR),
chapter II.
The CSA and its implementing regulations are designed to prevent,
detect, and eliminate the diversion of controlled substances and listed
chemicals into the illicit market while ensuring an adequate supply is
available for the legitimate medical, scientific, research, and
industrial needs of the United States. Controlled substances have the
potential for abuse and dependence and are controlled to protect the
public health and safety.
Section 201 of the 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 DEA
regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria
by which the DEA Assistant Administrator may exempt a chemical
preparation or mixture from certain provisions of the CSA. The
Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or
revoke the criteria by which exemptions are granted and modify the
scope of exemptions at any time.
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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
Section 7 of 28 CFR 0.104, Appendix to Subpart R.
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Exempt Chemical Preparation Applications Submitted Between April 1,
2016, and December 31, 2016
The Assistant Administrator received applications between April 1,
2016, and December 31, 2016, 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; if the preparation or mixture contains a narcotic
controlled substance, it must be 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 the 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.
Chart I
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Application
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
Aalto Scientific, Ltd.................. Endocrine Program.............. Amber vial: 5 mL......... 8/23/2016
Aalto Scientific, Ltd.................. Endocrinology.................. Amber vial: 5 mL......... 8/23/2016
Aalto Scientific, Ltd.................. Linearity FD Testosterone, Kit: 5 vials; 3 mL each.. 12/7/2016
Siemens Centaur.
Absolute Standards, Inc................ ISO G34 Calibrator Spike High.. Glass ampoule: 1 mL...... 8/3/2016
Absolute Standards, Inc................ ISO G34 Calibrator Spike Low... Glass ampoule: 1 mL...... 8/3/2016
Absolute Standards, Inc................ ISO G34 Calibrator Spike Glass ampoule: 1 mL...... 8/3/2016
Solution.
[[Page 26946]]
Absolute Standards, Inc................ ISO G34 Internal Standard...... Glass ampoule: 1 mL...... 8/3/2016
Accriva Diagnostics, Inc............... Hemochron PT................... Box: 45 cuvettes; 5/17/2016
7.5[mu]L each.
Arbor Assays........................... Testosterone 5-pack Enzyme Kit: 400 [mu]L vial...... 10/18/2016
Immunoassay Kit (K032-H5).
Arbor Assays........................... Testosterone Enzyme Immunoassay Kit: 1 mL vial........... 10/18/2016
Kit (ISWE001).
Arbor Assays........................... Testosterone Enzyme Immunoassay Kit: 90 [mu]L vial....... 10/18/2016
Kit (K032-H1).
Arbor Assays........................... Testosterone Standard (1,000 ng/ Plastic vial: 1 mL....... 10/18/2016
mL).
Arbor Assays........................... Testosterone Standard (200,000 Plastic vial: 90 [mu]L... 10/18/2016
pg/mL).
Arbor Assays........................... Testosterone Standard (200,000 Plastic vial: 400 [mu]L.. 10/18/2016
pg/mL).
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vial: 1 mL-200 mL.. 7/29/2016
Control Urine, MC252.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 9/30/2016
Control Urine, MC253.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vial: 1 mL-200 mL.. 7/29/2016
Control Urine, MC254.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vial: 1 mL-200 mL.. 7/29/2016
Control Urine, MC255.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 12/19/2016
Control Urine, MC256.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 12/19/2016
Control Urine, MC257.
Cayman Chemical Company................ 11-Keto Testosterone CRM; 1 mg/ Glass ampule: 1 mL....... 6/28/2016
mL in Acetonitrile.
Cayman Chemical Company................ AB-CHMINACA (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016
Acetonitrile.
Cayman Chemical Company................ AB-CHMINACA (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016
Methanol.
Cayman Chemical Company................ AB-CHMINACA (CRM); 100 [micro]g/ Glass ampule: 1 mL....... 8/26/2016
mL in Acetonitrile.
Cayman Chemical Company................ AB-CHMINACA (CRM); 100 [micro]g/ Glass ampule: 1 mL....... 8/26/2016
mL in Methanol.
Cayman Chemical Company................ AB-PINACA CRM; 1 mg/mL in Glass ampule: 1 mL....... 6/28/2016
Methanol.
Cayman Chemical Company................ Acetyl Fentanyl CRM; 1 mg/mL in Glass ampule: 1 mL....... 6/28/2016
Methanol.
Cayman Chemical Company................ Acetyl Fentanyl CRM; 100 Glass ampule: 1 mL....... 6/28/2016
[micro]g/mL in Methanol.
Cayman Chemical Company................ Cocaine CRM; 1 mg/mL in Glass ampule: 1 mL....... 6/28/2016
Acetonitrile.
Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016
Mixture CRM; 1 mg/mL each in
Acetonitrile.
Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016
Mixture CRM; 100 [micro]g/mL
each in Acetonitrile.
Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016
Mixture CRM; 250 [micro]g/mL
each in Acetonitrile.
Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016
Mixture CRM; 500 [micro]g/mL
each in Acetonitrile.
Cayman Chemical Company................ GC-MS Drug Standard Mixture 1 Glass ampule: 1 mL....... 6/28/2016
in Acetonitrile.
Cayman Chemical Company................ Phytocannabinoid Mixture 1; 1 Glass ampule: 1 mL....... 6/28/2016
mg/mL in Acetonitrile.
Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016
1 mg/mL in Acetonitrile.
Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016
1 mg/mL in Methanol.
Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016
100 [micro]g/mL in
Acetonitrile.
Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016
100 [micro]g/mL in Methanol.
Cayman Chemical Company................ THJ2201 (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016
Acetonitrile.
Cayman Chemical Company................ THJ2201 (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016
Methanol.
Cayman Chemical Company................ THJ2201 (CRM); 100 [micro]g/mL Glass ampule: 1 mL....... 8/26/2016
in Acetonitrile.
Cayman Chemical Company................ THJ2201 (CRM); 100 [micro]g/mL Glass ampule: 1 mL....... 8/26/2016
in Methanol.
Cayman Chemical Company................ ToxBox THC/THC Metabolite Plate 48-well plate............ 6/28/2016
Cerilliant Corporation................. ()-11-Hydroxy- Glass ampule: 1 mL....... 11/11/2016
delta9-THC glucuronide (0.01
mg/mL).
Cerilliant Corporation................. ()-Cannabicyclol Glass ampule: 1.0 mL..... 7/18/2016
(1.0 mg/mL).
Cerilliant Corporation................. ()-cis-3- Glass ampule: 1 mL....... 6/21/2016
Methylfentanyl HCl (0.05 mg/
mL).
Cerilliant Corporation................. ()-cis-3- Glass ampule: 0.5 mL..... 7/18/2016
Methylfentanyl HCl (0.1 mg/mL).
Cerilliant Corporation................. 5alpha-Dihydrotestosterone-D3 Glass ampule: 1 mL....... 9/28/2016
[16, 16, 17-D3]; 10 [micro]g/
mL.
Cerilliant Corporation................. 6beta-Naltrexol (1 mg/mL)...... Glass ampule: 1 mL....... 5/6/2016
Cerilliant Corporation................. AH-7921 HCl (1 mg/mL).......... Glass ampule: 1 mL....... 5/20/2016
Cerilliant Corporation................. AH-7921-D3 HCl (0.1 mg/mL)..... Glass ampule: 1 mL....... 5/20/2016
Cerilliant Corporation................. Brivaracetam-D3 (0.1 mg/mL).... Glass ampule: 1 mL....... 11/30/2016
Cerilliant Corporation................. Butyryl fentanyl (0.05 mg/mL).. Glass ampule: 1 mL....... 6/21/2016
Cerilliant Corporation................. Butyryl fentanyl (0.1 mg/mL)... Glass ampule: 0.5 mL..... 7/18/2016
Cerilliant Corporation................. Cannabichromenic acid (CBCA) Glass ampule: 1 mL....... 11/30/2016
(1.0 mg/mL).
Cerilliant Corporation................. Cannabicyclolic acid (CBLA) Glass ampule: 1 mL....... 11/30/2016
(1.0 mg/mL).
Cerilliant Corporation................. Carfentanil (0.1 mg/mL)........ Glass ampule: 0.5 mL..... 9/28/2016
Cerilliant Corporation................. Carfentanil oxalate (0.1 mg/mL) Glass ampule: 0.5 mL..... 11/30/2016
Cerilliant Corporation................. Carfentanil-D5 oxalate (0.1 mg/ Glass ampule: 0.5 mL..... 11/30/2016
mL).
Cerilliant Corporation................. Clorazepate dipotassium (1 mg/ Glass ampule: 1 mL....... 5/6/2016
mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 1 (20 pg/mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 2 (50 pg/mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 3 (100 pg/mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 4 (500 pg/mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 5 (1000 pg/mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 6 (2500 pg/mL).
Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016
Level 7 (10 ng/mL).
Cerilliant Corporation................. Diphenoxylate HCl (1 mg/mL).... Glass ampule: 1 mL....... 5/20/2016
Cerilliant Corporation................. Furanyl fentanyl (0.1 mg/mL)... Glass ampule: 0.5 mL..... 11/30/2016
Cerilliant Corporation................. Norhydromorphone-D3 HCl (0.1 mg/ Glass ampule: 1.0 mL..... 7/18/2016
mL).
Cerilliant Corporation................. Noroxymorphone-D3 HCl (0.1 mg/ Glass ampule: 1.0 mL..... 7/18/2016
mL).
[[Page 26947]]
Cerilliant Corporation................. Pholcodine (1 mg/mL)........... Glass ampule: 1 mL....... 5/6/2016
Cerilliant Corporation................. Tapentadol-D3 HCl (1 mg/mL).... Glass ampule: 1 mL....... 11/11/2016
Cerilliant Corporation................. U-47700 (1.0 mg/mL)............ Glass ampule: 1 mL....... 11/30/2016
IDEXX Laboratories..................... Coag Dx PT..................... Box: 10 cartridges; 10/21/2016
7.5[mu]L each.
IDEXX Laboratories..................... Coag Dx PT Cartridge........... Cartridges: 7.5[mu]L each 10/21/2016
Immunalysis Corporation................ cTHC Urine Calibrator 1 (20 ng/ Dropper bottle: 5 mL, 15 5/27/2016
mL). mL.
Immunalysis Corporation................ cTHC Urine Calibrator 2 (50 ng/ Dropper bottle: 5 mL, 15 5/27/2016
mL). mL.
Immunalysis Corporation................ cTHC Urine Calibrator 3 (100 ng/ Dropper bottle: 5 mL, 15 5/27/2016
mL). mL.
Immunalysis Corporation................ cTHC Urine Calibrator 4 (200 ng/ Dropper bottle: 5 mL, 15 5/27/2016
mL). mL.
Immunalysis Corporation................ cTHC Urine Control HIGH (62.5 Dropper bottle: 5 mL, 15 5/27/2016
ng/mL). mL.
Immunalysis Corporation................ cTHC Urine Control LOW (37.5 ng/ Dropper bottle: 5 mL, 15 5/27/2016
mL). mL.
Immunalysis Corporation................ Fentanyl Urine Calibrator 1 (1 Dropper bottle: 5 mL..... 5/27/2016
ng/mL).
Immunalysis Corporation................ Fentanyl Urine Calibrator 2 (2 Dropper bottle: 5 mL..... 5/27/2016
ng/mL).
Immunalysis Corporation................ Fentanyl Urine Calibrator 3 (4 Dropper bottle: 5 mL..... 5/27/2016
ng/mL).
Immunalysis Corporation................ Fentanyl Urine Control HIGH Dropper bottle: 5 mL..... 5/27/2016
(1.5 ng/mL).
Immunalysis Corporation................ Fentanyl Urine Control LOW (0.5 Dropper bottle: 5 mL..... 5/27/2016
ng/mL).
Immunalysis Corporation................ MDC Calibrator 1............... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Calibrator 2............... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Calibrator 3............... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Calibrator 4............... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Control HIGH Set 1......... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Control HIGH Set 1......... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Control LOW Set 1.......... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ MDC Control LOW Set 2.......... Dropper bottle: 15 mL, 25 5/27/2016
mL.
Immunalysis Corporation................ Opiates Urine Calibrator 2000 1 Dropper bottle: 5 mL, 15 5/27/2016
(1000 ng/mL). mL.
Immunalysis Corporation................ Opiates Urine Calibrator 2000 2 Dropper bottle: 5 mL, 15 5/27/2016
(2000 ng/mL). mL.
Immunalysis Corporation................ Opiates Urine Calibrator 2000 3 Dropper bottle: 5 mL, 15 5/27/2016
(4000 ng/mL). mL.
Immunalysis Corporation................ Opiates Urine Calibrator 2000 4 Dropper bottle: 5 mL, 15 5/27/2016
(6000 ng/mL). mL.
Immunalysis Corporation................ Oxazepam Urine Control HIGH Dropper bottle: 5 mL, 15 5/27/2016
(125 ng/mL). mL.
Immunalysis Corporation................ Oxazepam Urine Control LOW (75 Dropper bottle: 5 mL, 15 5/27/2016
ng/mL). mL.
Instrumentation Laboratory............. Gem Test PT.................... Box: 45 cuvettes; 10/6/2016
7.5[mu]L each.
IsoSciences, LLC....................... Codeine-[13C4, 15N], 1000 [mu]g/ Amber ampule: 1 mL....... 10/20/2016
mL in methanol.
IsoSciences, LLC....................... Codeine-6[beta]-Glucuronide- Amber ampule: 1 mL....... 10/20/2016
[13C10, 15N], 1000 [mu]g/mL in
methanol:water (2:8).
IsoSciences, LLC....................... Morphine-[13C4, 15N], 1000 Amber ampule: 1 mL....... 10/20/2016
[mu]g/mL in methanol.
IsoSciences, LLC....................... Morphine-6[beta]-Glucuronide- Amber ampule: 1 mL....... 10/20/2016
[13C10, 15N], 1000 [mu]g/mL in
methanol:water (2:8).
IsoSciences, LLC....................... Testosterone-[2H8], 100 Amber Ampule: 1 mL....... 8/10/2016
[micro]g/mL in methanol.
IsoSciences, LLC....................... Testosterone-[2H8], 1000 Amber Ampule: 1 mL....... 8/10/2016
[micro]g/mL in methanol.
ITC.................................... Hemochron Jr................... Box: 45 cuvettes; 7/1/2016
7.5[mu]L each.
Lipomed Inc............................ 25B-NB2OMe (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ 25C-NB2OMe (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ 25I-NB2OMe (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ 25I-NB2OMe-D9 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ 25I-NB2OMe-D9 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ 3,4-Methylendioxypyrovalerone Glass ampule: 1 mL....... 10/28/2016
(1 mg/mL methanol).
Lipomed Inc............................ 3,4-Methylenedioxy-[alpha]- Glass ampule: 1 mL....... 10/28/2016
pyrrolidinopropiophenone (1 mg/
mL methanol).
[[Page 26948]]
Lipomed Inc............................ 3-Desmethylprodine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
acetonitrile).
Lipomed Inc............................ 4-Ethylmethcathinone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ 4-Methylethcathinone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ 4-Methylmethcathinone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ 4-Methylmethcathinone-D3 (0.1 Glass ampule: 1 mL....... 10/28/2016
mg/mL methanol).
Lipomed Inc............................ 4-Methylmethcathinone-D3 (1 mg/ Glass ampule: 1 mL....... 10/28/2016
mL methanol).
Lipomed Inc............................ Benzodiazepines mixture (.001 Glass ampule: 1 mL....... 10/28/2016
mg free base/ml acetonitrile).
Lipomed Inc............................ Benzodiazepines mixture 5 (1 mg Glass ampule: 1 mL....... 10/28/2016
free base/mL acetonitrile).
Lipomed Inc............................ Bufotenine.oxalate.monohydrate Glass ampule: 1 mL....... 10/28/2016
(1 mg/mL methanol).
Lipomed Inc............................ Butabarbital (1 mg/mL methanol) Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Butalbital (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Butalbital-D5 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Butylone (1 mg/mL methanol).... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Cannabidiol-D3 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Cannabidiol-D3 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Cannabinol-D3 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Cannabinol-D3 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Carisoprodol (1 mg/mL methanol) Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Clotiazepam (1 mg/mL methanol). Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Cocaethylene-D3 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
acetonitrile).
Lipomed Inc............................ Cocaine mixture 2 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Desomorphine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
acetonitrile).
Lipomed Inc............................ Ethylone (1 mg/mL methanol).... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-018 (0.1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-018 (1 mg/mL methanol)..... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-018-D11 metabolite (0.1 mg/ Glass ampule: 1 mL....... 10/28/2016
mL methanol).
Lipomed Inc............................ JWH-018-D11 metabolite (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ JWH-019 (0.1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-019 (1 mg/mL methanol)..... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-081 (0.1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-081 (1 mg/mL methanol)..... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-122 (0.1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-122 (1 mg/mL methanol)..... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-200 (0.1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ JWH-200 (1 mg/mL methanol)..... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ L-Methamphetamine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Loprazolam (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Mazindol (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
Dimethylformamide).
Lipomed Inc............................ Meprobamate (1 mg/mL methanol). Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Methandienone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Methylone (1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Methylone-D3 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Methylone-D3 (1 mg/mL methanol) Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ N,N-Dimethylamphetamine (1 mg/ Glass ampule: 1 mL....... 10/28/2016
mL methanol).
Lipomed Inc............................ Naphyrone (1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Nimetazepam (1 mg/mL methanol). Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Norbuprenorphine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Normeperidine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Pentedrone (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Pentylone (1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Phenobarbital-D5 (side chain) Glass ampule: 1 mL....... 10/28/2016
(0.1 mg/mL methanol).
Lipomed Inc............................ Phenobarbital-D5 (side chain) Glass ampule: 1 mL....... 10/28/2016
(1 mg/mL methanol).
Lipomed Inc............................ Pregabalin (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ Propoxyphen-D5 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Propoxyphen-D5 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016
methanol).
Lipomed Inc............................ Pyrovalerone (1 mg/mL methanol) Glass ampule: 1 mL....... 10/28/2016
Lipomed Inc............................ [alpha]- Glass ampule: 1 mL....... 10/28/2016
Pyrrolidinopropiophenone (1 mg/
mL methanol).
Lipomed Inc............................ [alpha]- Glass ampule: 1 mL....... 10/28/2016
Pyrrolidinovalerophenone (1 mg/
mL methanol).
Microgenics Corporation................ Cascadion SM Total Testosterone Box: 8 bottles, 29 mL 12/16/2016
Internal Standard. each.
Microgenics Corporation................ Cedia Buprenorphine OFT Control Vial: 10 mL; Box: 2 vials 11/15/2016
Set (Low and High) Catalog
Number: 10022377.
Microgenics Corporation................ Cedia Buprenorphine OFT Cutoff Vial: 5 mL; Box: 1 vial.. 11/15/2016
Calibrator Catalog Number:
10022376.
Microgenics Corporation................ Cedia Multi-Drug OFT Cutoff Vial: 10 mL; Box: 1 vial. 10/20/2016
Calibrator Set B Catalog
Number: 10022355.
Microgenics Corporation................ Cedia Multi-Drug OFT Cutoff Vial: 15 mL; Box: 2 vials 10/20/2016
Control Set B (Low and High)
Catalog Number: 10022356.
Microgenics Corporation................ Intercept i2he Multi-Drug Oral Vial: 10 mL; Box: 1 vial. 10/19/2016
Fluid Cutoff Calibrator Set B
Catalog Number: 1001-0419.
Microgenics Corporation................ Intercept i2he Multi-Drug Oral Vial: 15 mL; Box: 2 vials 10/19/2016
Fluid Cutoff Control Set B
(Low and High) Catalog Number:
1001-0420.
[[Page 26949]]
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016
Buprenorphine II Calibrator 10
ng/mL Catalog Number: 10020799.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016
Buprenorphine II Calibrator
100 ng/mL Catalog Number:
10020802.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016
Buprenorphine II Calibrator 20
ng/mL Catalog Number: 10020800.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016
Buprenorphine II Calibrator 50
ng/mL Catalog Number: 10020801.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 4 vials.. 8/30/2016
Buprenorphine II Controls (Low
and High) Catalog Number:
10020804.
Siemens Healthcare Diagnostics, Inc.... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L. 8/23/2016
Negative Control 100.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Negative Vial: 10 mL.............. 8/23/2016
Control 100.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Negative Vial: 10 mL.............. 8/23/2016
Control 300.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Positive Vial: 10 mL.............. 8/23/2016
Control 100.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Positive Vial: 10 mL.............. 8/23/2016
Control 300.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
1.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
2.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
3.
Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
4.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016
Negative Control 100.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016
Negative Control 300.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016
Positive Control 100.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016
Positive Control 300.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
1.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
2.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
3.
Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016
Drug Calibrator/Control Level
4.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Negative Vial: 10 mL.............. 8/23/2016
Control 100.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Negative Vial: 10 mL.............. 8/23/2016
Control 300.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Positive Vial: 10 mL.............. 8/23/2016
Control 100.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Positive Vial: 10 mL.............. 8/23/2016
Control 300.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016
Calibrator/Control LVL 1.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016
Calibrator/Control LVL 2.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016
Calibrator/Control LVL 3.
Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016
Calibrator/Control LVL 4.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016
Negative Control 100. mL.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016
Negative Control 300. mL.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016
Positive Control 100. mL.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016
Positive Control 300. mL.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016
Multi Drug Calibrator/Control mL.
LVL 1.
[[Page 26950]]
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016
Multi Drug Calibrator/Control mL.
LVL 2.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016
Multi Drug Calibrator/Control mL.
LVL 3.
Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016
Multi Drug Calibrator/Control mL.
LVL 4.
USP.................................... USP Levomethorphan Solution Box: 3 vials, 1.2 mL each 9/13/2016
Reference Standard.
UTAK Laboratories, Inc................. AED II HR Serum Control, Ref: Carton: 5 bottles, 5 mL 12/27/2016
72740. each.
UTAK Laboratories, Inc................. AED II MR Serum Control, Ref: Carton: 5 bottles, 5 mL 12/27/2016
72741. each.
UTAK Laboratories, Inc................. Benzodiazepines 2 Serum Control Carton: 5 bottles, 5 mL 12/27/2016
HR, Ref: 22615. each.
UTAK Laboratories, Inc................. Benzodiazepines 2 Serum Control Carton: 5 bottles, 5 mL 12/27/2016
MR, Ref: 22616. each.
UTAK Laboratories, Inc................. Benzodiazepines Plus 100 Urine Carton: 5 bottles, 5 mL 12/27/2016
Control, Ref: 12090. each.
UTAK Laboratories, Inc................. Benzodiazepines Plus 100 Whole Carton: 5 bottles, 5 mL 12/27/2016
Blood Control, Ref: 12092. each.
UTAK Laboratories, Inc................. Benzodiazepines Plus 400 ng/mL Carton: 5 bottles, 5 mL 12/27/2016
Urine Control, Ref: 12091. each.
UTAK Laboratories, Inc................. Clonazepam Serum Control HR, Carton: 5 bottles, 5 mL 12/27/2016
Ref: 22610. each.
UTAK Laboratories, Inc................. Clonazepam Serum Control MR, Carton: 5 bottles, 5 mL 12/27/2016
Ref: 22611. each.
UTAK Laboratories, Inc................. DHEA Plus High Serum Control, Carton: 5 bottles, 3 mL 12/27/2016
Ref: 51411. each.
UTAK Laboratories, Inc................. DHEA Plus Low Serum Control, Carton: 5 bottles, 3 mL 12/27/2016
Ref: 51410. each.
UTAK Laboratories, Inc................. Pentobarbital Serum Control, Carton: 5 bottles, 5 mL 12/27/2016
Ref: 66319. each.
UTAK Laboratories, Inc................. Steroids Level 1 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016
Control, Ref: 51401. each.
UTAK Laboratories, Inc................. Steroids Level 2 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016
Control, Ref: 51402. each.
UTAK Laboratories, Inc................. Steroids Level 3 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016
Control, Ref: 51403. each.
UTAK Laboratories, Inc................. Steroids Level 4 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016
Control, Ref: 51404. each.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Application
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
Aalto Scientific, Ltd................... General Chemistry Serum...... Box: 1056 vials; 5 mL each 6/20/2016
Biochemical Diagnostics, Inc............ Detectabuse Custom Liquid Glass vial: 1 mL-200 mL... 7/29/2016
Control Urine, MC253.
Cerilliant Corporation.................. ()-cis-3- Glass ampule: 1 mL........ 6/21/2016
Methylfentanyl HCl (0.1 mg/
mL).
Cerilliant Corporation.................. ()-cis-3- Glass ampule: 1 mL........ 5/6/2016
Methylfentanyl HCl (1 mg/mL).
Cerilliant Corporation.................. Butyryl fentanyl (0.1 mg/mL). Glass ampule: 1 mL........ 6/21/2016
Cerilliant Corporation.................. Butyryl fentanyl HCl (1 mg/ Glass ampule: 1 mL........ 5/20/2016
mL).
Lipomed Inc............................. Benzodiazepines mixture 8 Glass ampule: 1 mL........ 10/28/2016
(0.25 mg free base/mL
acetonitrile).
Lipomed Inc............................. Estazolam (1 mg/mL methanol). Glass ampule: 1 mL........ 10/28/2016
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L.. 8/23/2016
Negative Control 300.
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L.. 8/23/2016
Positive Control 100.
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L.. 8/23/2016
Positive Control 300.
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016
Multi Drug Calibrator/
Control LVL 1.
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016
Multi Drug Calibrator/
Control LVL 2.
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016
Multi Drug Calibrator/
Control LVL 3.
Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016
Multi Drug Calibrator/
Control LVL 4.
----------------------------------------------------------------------------------------------------------------
[[Page 26951]]
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 sections of the CSA and the CFR
that are specifically identified. 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. In accordance with 21 CFR 1308.24(g), the
DEA may prescribe requirements other than those set forth in
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, the 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
April 1, 2016, and December 31, 2016, and not otherwise referenced in
this order may remain under consideration until the DEA receives
additional information required, pursuant to 21 CFR 1308.23(d), as
detailed in separate correspondence to individual requesters. The DEA's
order on such requests will be communicated to the public in a future
Federal Register publication.
The 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.
Opportunity for Comment
Pursuant to 21 CFR 1308.23, 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.
Approved Exempt Chemical Preparations Are Posted on DEA's Web Site
A list of all current exemptions, including those listed in this
order, is available on the DEA's Web site at http://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The
dates of applications of all current exemptions are posted for easy
reference.
Dated: May 24, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-12110 Filed 6-9-17; 8:45 am]
BILLING CODE 4410-09-P