[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
----------------------------------------------------------------------------------------------------------------
                                                                                                     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