[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40175-40186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16010]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-372]
Exempt Chemical Preparations Under the Controlled Substances Act
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Order with opportunity for comment.
-----------------------------------------------------------------------
SUMMARY: The applications for exempt chemical preparations received by
DEA between July 1, 2012, and March 31, 2013, as listed below, were
accepted for filing and have been approved or denied as indicated.
DATES: Electronic comments must be submitted and written comments must
be postmarked on or before September 3, 2013. The electronic Federal
Docket Management System will not accept comments after midnight
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 electronic and written correspondence.
DEA encourages that all comments be submitted electronically through
http://www.regulations.gov using the electronic comment form provided
on that site. An electronic copy of this document is also available at
http://www.regulations.gov for easy reference. Paper comments that
duplicate the electronic submission are not necessary as all comments
submitted to www.regulations.gov will be posted for public review and
are part of the official docket record. Written comments submitted via
regular or express mail should be sent to the Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODL,
8701 Morrissette Drive, Springfield, Virginia 22152.
[[Page 40176]]
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (202) 307-7165.
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. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
DEA's public docket file. Please note that the Freedom of Information
Act applies to all comments received. If you wish to inspect the
agency's public docket file in person by appointment, please see the
FOR FURTHER INFORMATION CONTACT paragraph.
Legal Authority
DEA implements and enforces Titles II and III of the Comprehensive
Drug Abuse Prevention and Control Act of 1970, often referred to as the
Controlled Substances Act and the Controlled Substances Import and
Export Act (codified at Title 21, Chapter 13 of the U.S.C.), as amended
(CSA). DEA drafts and publishes the implementing regulations for these
statutes in Title 21 of the Code of Federal Regulations (CFR), parts
1300 to 1321. 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 providing for a
sufficient supply of controlled substances and listed chemicals for
legitimate medical, scientific, research, and industrial purposes.
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\ DEA
regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria
by which the DEA Deputy Assistant Administrator may exempt a chemical
preparation or mixture from the application of certain provisions of
the CSA. The Deputy Assistant Administrator may, pursuant to 21 CFR
1308.23(f), modify or revoke the criteria by which exemptions are
granted and modify the scope of exemptions at any time.
---------------------------------------------------------------------------
\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 the
Appendix to Subpart R of 28 CFR 0.104.
---------------------------------------------------------------------------
Exempt Chemical Preparation Applications Submitted Between July 1,
2012, and March 31, 2013
The Deputy Assistant Administrator received applications between
July 1, 2012, and March 31, 2013, requesting exempt chemical
preparation status pursuant to 21 CFR 1308.23. Pursuant to the criteria
stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Deputy
Assistant Administrator has found that each of the compounds, mixtures,
and preparations described in Chart I below is intended for laboratory,
industrial, educational, or special research purposes and not for
general administration to a human being or other 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 Deputy Assistant Administrator has determined
that each of the chemical preparations or mixtures generally described
in Chart I below and specifically described in the application
materials received by DEA, are 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 listed below that was
provided in the approval letters to the individual requesters.
Chart I
----------------------------------------------------------------------------------------------------------------
Application
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
AccuStandard, Inc..................... APP-9-086, a,a- Amber ampule: 1 mL...... 1/28/2013
Dimethylphenethylamine.
AccuStandard, Inc..................... APP-9-086-20X, a,a- Amber ampule: 1 mL...... 1/28/2013
Dimethylphenethylamine.
AccuStandard, Inc..................... AS-E1179, Chloral hydrate..... Amber ampule: 1 mL...... 1/28/2013
AccuStandard, Inc..................... CLP-HC-X1, Composite Mix Amber ampule: 1 mL...... 1/28/2013
3A.
AccuStandard, Inc..................... M-551.1B, Disinfectant by- Amber ampule: 1 mL...... 1/28/2013
products.
[[Page 40177]]
AccuStandard, Inc..................... M-551B, Disinfectant by- Amber ampule: 1 mL...... 1/28/2013
products.
AccuStandard, Inc..................... M-551B-2, Chloral hydrate..... Amber ampule: 1 mL...... 1/28/2013
AccuStandard, Inc..................... M-8015B/5031-21, Paraldehyde.. Amber ampule: 1 mL...... 1/28/2013
AccuStandard, Inc..................... M-8206B-05, Additional VOC's Amber ampule: 1 mL...... 1/28/2013
by Method 8206B.
AccuStandard, Inc..................... M-8270-02, Semi-Volatile by Amber ampule: 1 mL...... 1/28/2013
Capillary Column GC/MS Mix 2.
AccuStandard, Inc..................... M-8270-04-ASL, Method 8270B-- Amber ampule: 1 mL...... 1/28/2013
Base/Neutrals Mix.
AccuStandard, Inc..................... M-8270-23-R1, Method 8270 Semi- Amber ampule: 1 mL...... 1/28/2013
Volatile Additions.
AccuStandard, Inc..................... M-E-1179-M, Chloral hydrate... Amber ampule: 1 mL...... 1/28/2013
Agilent Technologies.................. Veterinary Drugs Checkout Mix. Amber ampule: 1 mL...... 8/3/2012
Agilent Technologies.................. Veterinary Drugs Comprehensive Amber ampule: 1 mL...... 8/3/2012
Mix--Submix 6.
Agilent Technologies.................. Forensic Toxicology Amber ampule: 1 mL...... 8/3/2012
Comprehensive Mix--Submix 3.
Agilent Technologies.................. Forensic Toxicology Amber ampule: 1 mL...... 8/3/2012
Comprehensive Mix--Submix 5.
Agilent Technologies.................. Forensic Toxicology Amber ampule: 1 mL...... 8/3/2012
Comprehensive Mix--Submix 2.
Agilent Technologies.................. Forensic Toxicology Checkout Amber ampule: 1 mL...... 8/3/2012
Mix.
Agilent Technologies.................. Forensic Toxicology Amber ampule: 1 mL...... 12/6/2012
Comprehensive Mix--Submix 1.
Alltech Associates, Inc............... 2C-T-2 Quik Check, 1.0 mg/mL.. Glass ampule: 1 mL...... 9/26/2012
Alltech Associates, Inc............... 5-MeO-DMT Quick Check, 1.0 mg/ Glass ampule: 1 mL...... 9/26/2012
mL.
Alltech Associates, Inc............... Carisoprodol Quik Check, 1.0 Glass ampule: 1 mL...... 9/26/2012
mg/mL.
American Proficiency Institute........ American Proficiency Institute Amber bottle: 7 mL...... 12/5/2012
SHBG/Testosterone.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 8/14/2012
Control Oral Fluid, OF23.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 8/14/2012
Control Urine, SD17.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 9/27/2012
Control Urine, MC176.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 10/23/2012
Control Urine, MC179.
Biochemical Diagnostics, Inc.......... Salivabuse Custom Liquid Glass vials: 1 ml-200 mL 10/23/2012
Control Oral Fluid, OF25.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 11/5/2012
Control Urine, MC177.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 1/24/2013
Control Urine, MC178.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 1/24/2013
Control Oral Fluid, OF24.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 1/29/2013
Control Urine, MC181.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 3/12/2013
Control Urine, MC183.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 3/12/2013
Control Urine, MC184.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 3/14/2013
Control Urine, MC180.
Bio-Rad Laboratories.................. Liquichek Immunoassay Plus Box: 3 vials, 2.5 mL 11/14/2012
Control Trilevel MiniPak. each.
Bio-Rad Laboratories.................. Liquichek Immunoassay Plus Box: 12 vials, 5 mL each 11/21/2012
Control Level 1,2 and 3,
Trilevel.
Bio-Rad Laboratories.................. Liquid Assayed Multiqual Box: 6 vials, 5 mL each. 11/21/2012
Premium, Levels 1-3.
Bio-Rad Laboratories.................. Liquid Assayed Multiqual Box: 3 vials, 5 mL each. 11/21/2012
Premium, Trilevel Minipak.
Bio-Rad Laboratories.................. Lyphocheck Urine Toxicology Glass vial: 25 mL....... 1/11/2013
Control MiniPak, Cat. No.
470X.
Bio-Rad Laboratories.................. Liquichek Immunoassay Plus Glass vial: 2.5 mL, Box 2/20/2013
Control Level 1. 12 vials.
Bio-Rad Laboratories.................. Liquichek Immunoassay Plus Glass vial: 2.5 mL, Box 2/20/2013
Control Level 2. 12 vials.
Bio-Rad Laboratories.................. Liquichek Immunoassay Plus Glass vial: 2.5 mL, Box 2/20/2013
Control Level 3. 12 vials.
Cerilliant Corporation................ Benzodiazepine Mix (1 mg/mL).. Glass Ampule: 1 mL...... 7/2/2012
Cerilliant Corporation................ Class C Mix Urinalysis Glass Ampule: 1 mL...... 7/9/2012
Internal Standard Fortified
Morphine.
Cerilliant Corporation................ Spice Cannabinoid Mix 2 (0.1 Amber ampule: 1 mL...... 9/26/2012
mg/mL).
Cerilliant Corporation................ Spice Cannabinoid Mix 3 (0.1 Amber ampule: 1 mL...... 9/26/2012
mg/mL).
Cerilliant Corporation................ Retigabine (1 mg/mL).......... Glass Ampule: 1 mL...... 11/7/2012
Cerilliant Corporation................ - Glass Ampule: 1 mL...... 1/7/2013
Norpseudoephedrine-D3 HCl
(0.1 mg/mL).
Cerilliant Corporation................ Amobarbital-D5 (0.1 mg/mL).... Glass Ampule: 1 mL...... 1/7/2013
Cerilliant Corporation................ 2,5-Dimethoxy-4-(n)- Glass Ampule: 1 mL...... 1/7/2013
propylthiophenethylamine HCl
(2C-T-7 HCl) (1 mg/mL).
Cerilliant Corporation................ Class B Mix Urinalysis Glass ampule: 1 ml...... 1/22/2013
Internal Standard-8 (0.002-
0.2 mg/mL), Pregabalin-D6
(1.0 mg/mL), Codeine-6-beta-
glucoronide (1.0 mg/mL),
Desomorphine (1.0 mg/mL),
Levorphanol-D3 (0.1 mg/mL).
Cerilliant Corporation................ Zaleplon-D4 (0.1 mg/mL)....... Glass Ampule: 1 mL...... 1/31/2013
Cerilliant Corporation................ Retigabine-D4 (0.1 mg/mL)..... Glass ampule: 1ml....... 3/22/2013
Cerilliant Corporation................ Tilidine-D6 HCl (0.1 mg/mL)... Glass ampule: 1ml....... 3/22/2013
Cliniqa Corporation................... TDM Control, Levels 1-3....... Dropper bottle: 5 mL.... 12/4/2012
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, THC Glass vial: 5 ml-4 L.... 10/22/2012
(0.5-50 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, Glass vial: 5 ml-4 L.... 10/22/2012
Methamphetamine (2-200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, Glass vial: 5 ml-4 L.... 10/22/2012
Amphetamine, Benzoylecgonine,
Morphine, Phencyclidine (2-
200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, Glass vial: 5 ml-4 L.... 10/22/2012
Multidrug (THC,
Benzoylecgonine, Amphetamine,
Methamphetamine, Morphine,
Codeine, 6-Acetylmorphine, &
PCP) at 0.5-50 ng/mL.
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 10/22/2012
THC (0.5-50 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 10/22/2012
Methamphetamine (2-200 ng/mL).
[[Page 40178]]
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 10/22/2012
Amphetamine, Benzoylecgonine,
Morphine, Phencyclidine (2-
200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 10/22/2012
Multidrug (THC,
Benzoylecgonine, Amphetamine,
Methamphetamine, Morphine,
Codeine, 6-Acetylmorphine, &
PCP) at 0.5-200 ng/mL.
Environmental Resource Associates USGS-BQS LS 4434 Mix 1........ Glass Ampule: 2 mL...... 8/9/2012
(ERA).
Environmental Resource Associates USGS-BQS LS 4434 Mix 2........ Glass Ampule: 2 mL...... 8/9/2012
(ERA).
Immunalysis Corporation............... Tapentadol Calibrator Level 1 Glass vial: 10 mL....... 12/11/2012
(100 ng/mL).
Immunalysis Corporation............... Tapentadol Calibrator Level 2 Glass vial: 10 mL....... 12/11/2012
(200 ng/mL).
Immunalysis Corporation............... Tapentadol Calibrator Level 3 Glass vial: 10 mL....... 12/11/2012
(500 ng/mL).
Immunalysis Corporation............... Tapentadol Calibrator Level 4 Glass vial: 10 mL....... 12/11/2012
(1,000 ng/mL).
Immunalysis Corporation............... Tapentadol Low Control (150 ng/ Glass vial: 10 mL....... 12/11/2012
mL).
Immunalysis Corporation............... Tapentadol High Control (250 Glass vial: 10 mL....... 12/11/2012
ng/mL).
LGC Limited........................... (S)-(+)-Amphetamine Glass vial: 1 mL........ 9/24/2012
(Dextroamphetamine) 1.0 mg/mL
in Methanol.
LGC Limited........................... rac-Amphetamine 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... rac-Amphetamine 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... rac-Amphetamine-D11 0.1 mg/mL Glass vial: 1 mL........ 9/24/2012
in Methanol.
LGC Limited........................... rac-Amphetamine-D11 1.0 mg/mL Glass vial: 1 mL........ 9/24/2012
in Methanol.
LGC Limited........................... rac-Amphetamine-D5 (D-label on Glass vial: 1 mL........ 9/24/2012
ring) 0.1 mg/mL in Methanol.
LGC Limited........................... Methamphetamine ((S)-(+)- Glass vial: 1 mL........ 9/24/2012
Methamphetamine) 1.0 mg/mL in
Methanol.
LGC Limited........................... rac-Methamphetamine 0.1 mg/mL Glass vial: 1 mL........ 9/24/2012
in Methanol.
LGC Limited........................... rac-Methamphetamine 1.0 mg/mL Glass vial: 1 mL........ 9/24/2012
in Methanol.
LGC Limited........................... rac-Methamphetamine-D5 0.1 mg/ Glass vial: 1 mL........ 9/24/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D5 1.0 mg/ Glass vial: 1 mL........ 9/24/2012
mL in Methanol.
LGC Limited........................... Methcathinone Hydrochloride Glass vial: 1 mL........ 9/24/2012
1.0 mg/mL in Methanol (as
free base).
LGC Limited........................... Methylphenidate Hydrochloride Glass vial: 1 mL........ 9/24/2012
1.0 mg/mL in Methanol (as
free base).
LGC Limited........................... Amobarbital 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Pentobarbital 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Pentobarbital-D5 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Pentobarbital-D5 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Secobarbital 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... rac-MDA-D5 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxyamphetamine-D5)
0.1 mg/mL Methanol.
LGC Limited........................... rac-MDA-D5 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxyamphetamine-D5)
1.0 mg/mL Methanol.
LGC Limited........................... rac-MBDB HCl (rac-N-Methyl-1- Glass vial: 1 mL........ 9/24/2012
(3,4-Methylenedioxyphenyl)-2-
butanamine Hydrochloride) 1.0
mg/mL Methanol (as free base).
LGC Limited........................... rac-MBDB-D5 (rac-N-Methyl-1- Glass vial: 1 mL........ 9/24/2012
(3,4-Methylenedioxyphenyl)-2-
butanamine-D5) 0.1 mg/mL
Methanol.
LGC Limited........................... rac-MDEA-D5 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxy-N-
ethylamphetamine-D5) 0.1 mg/
mL Methanol.
LGC Limited........................... rac-MDEA-D5 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxy-N-
ethylamphetamine-D5) 1.0 mg/
mL Methanol.
LGC Limited........................... rac-MDEA-D6 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxy-N-
ethylamphetamine-D6) 0.1 mg/
mL Methanol.
LGC Limited........................... rac-MDMA-D5 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxymethamphetamine-
D5) 0.1 mg/mL Methanol.
LGC Limited........................... rac-MDMA-D5 (rac-3,4- Glass vial: 1 mL........ 9/24/2012
Methylenedioxymethamphetamine-
D5) 1.0 mg/mL Methanol.
LGC Limited........................... Phencyclidine (PCP) 1.0 mg/mL Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Phencyclidine-D5 (PCP-D5) 0.1 Glass vial: 1 mL........ 9/24/2012
mg/mL in Methanol.
LGC Limited........................... Phencyclidine-D5 (PCP-D5) 1.0 Glass vial: 1 mL........ 9/24/2012
mg/mL Methanol.
LGC Limited........................... Codeine 0.1 mg/mL in Methanol. Glass vial: 1 mL........ 9/24/2012
LGC Limited........................... Codeine 1.0 mg/mL in Methanol. Glass vial: 1 mL........ 9/24/2012
LGC Limited........................... Codeine-D3 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Codeine-D3 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Codeine-D6 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Codeine-D6 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Isocodeine 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Norcodeine 0.01 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Norcodeine 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Codeine N-Oxide 0.01 mg/mL Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Oxycodone-D3 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
[[Page 40179]]
LGC Limited........................... Oxycodone-D6 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Oxycodone-D6 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Hydromorphone 1.0 mg/mL Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Norhydromorphone Hydrochloride Glass vial: 1 mL........ 9/24/2012
1.0 mg/mL Methanol (as free
base).
LGC Limited........................... Pethidine (Meperidine) 1.0 mg/ Glass vial: 1 mL........ 9/24/2012
mL in Methanol.
LGC Limited........................... Pethidine-D4 (Meperidine-D4) Glass vial: 1 mL........ 9/24/2012
0.1 mg/mL in Methanol.
LGC Limited........................... Pethidine-D4 (Meperidine-D4) Glass vial: 1 mL........ 9/24/2012
1.0 mg/mL in Methanol.
LGC Limited........................... Morphine 0.1 mg/mL in Methanol Glass vial: 1 mL........ 9/24/2012
LGC Limited........................... Morphine 1.0 mg/mL in Methanol Glass vial: 1 mL........ 9/24/2012
LGC Limited........................... Morphine 3-beta-D-Glucuronide Glass vial: 1 mL........ 9/24/2012
0.1 mg/mL in Methanol/Water
(\1/1\).
LGC Limited........................... Morphine 3-beta-D-Glucuronide Glass vial: 1 mL........ 9/24/2012
1.0 mg/mL in Methanol with
0.05 percent Sodium Hydroxide
(w/v).
LGC Limited........................... Morphine 6-beta-D-Glucuronide Glass vial: 1 mL........ 9/24/2012
0.1 mg/mL in Methanol/Water
(\1/1\).
LGC Limited........................... Morphine 6-beta-D-Glucuronide Glass vial: 1 mL........ 9/24/2012
1.0 mg/mL Water/Methanol (80/
20).
LGC Limited........................... Morphine-D3 0.1 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Morphine-D3 1.0 mg/mL in Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Morphine N-Oxide 0.01 mg/mL Glass vial: 1 mL........ 9/24/2012
Methanol.
LGC Limited........................... Normorphine 1.0 mg/mL Methanol Glass vial: 1 mL........ 9/24/2012
LGC Limited........................... rac-Amphetamine-D10 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... rac-Amphetamine-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
ring) 0.1 mg/mL in Methanol.
LGC Limited........................... rac-Amphetamine-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
side chain) 0.1 mg/mL in
Methanol.
LGC Limited........................... rac-Amphetamine-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
side chain) 1.0 mg/mL in
Methanol.
LGC Limited........................... rac-Amphetamine-D6 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... rac-Amphetamine-D6 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... rac-Amphetamine-D8 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... rac-Amphetamine-D8 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... rac-Methamphetamine-D11 0.1 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D11 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D14 0.1 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D14 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D8 0.1 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D8 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D9 0.1 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... rac-Methamphetamine-D9 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol.
LGC Limited........................... (+)-Norpseudoephedrine Glass vial: 1 mL........ 11/30/2012
Hydrochloride (Cathine
Hydrochloride) 0.1 mg/mL in
Methanol (as free base).
LGC Limited........................... (R)-(+)-Cathinone Glass vial: 1 mL........ 11/30/2012
Hydrochloride 1.0 mg/mL in
Methanol (as free base).
LGC Limited........................... (S)-(-)-Cathinone Glass vial: 1 mL........ 11/30/2012
Hydrochloride 1.0 mg/mL in
Methanol (as free base).
LGC Limited........................... (S)-(-)-Methcathinone Glass vial: 1 mL........ 11/30/2012
Hydrochloride 1.0 mg/mL in
Methanol (as free base).
LGC Limited........................... Phentermine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Fenfluramine Hydrochloride 1.0 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol (as free
base).
LGC Limited........................... Methylphenidate-D9 Glass vial: 1 mL........ 11/30/2012
Hydrochloride 0.1 mg/mL in
Methanol.
LGC Limited........................... Pipradrol Hydrochloride 0.1 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol (as free base).
LGC Limited........................... Pipradrol Hydrochloride 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol (as free base).
LGC Limited........................... GHB Sodium Salt (Sodium Glass vial: 1 mL........ 11/30/2012
Gammahydroxybutyrate) 1.0 mg/
mL in Methanol (as free acid).
LGC Limited........................... GHB-D6 Sodium Salt (Sodium Glass vial: 1 mL........ 11/30/2012
Gammahydroxybutyrate-D6) 0.1
mg/mL in Methanol (as free
acid).
LGC Limited........................... GHB-D6 Sodium Salt (Sodium Glass vial: 1 mL........ 11/30/2012
Gammahydroxybutyrate-D6) 1.0
mg/mL in Methanol (as free
acid).
LGC Limited........................... Hexobarbital 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Methohexital 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Methohexital-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Phenobarbital 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Phenobarbital-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
ring) 0.1 mg/mL in Methanol.
LGC Limited........................... Phenobarbital-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
ring) 1.0 mg/mL in Methanol.
LGC Limited........................... Phenobarbital-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
side chain) 0.1 mg/mL in
Methanol.
[[Page 40180]]
LGC Limited........................... Phenobarbital-D5 (D-label on Glass vial: 1 mL........ 11/30/2012
side chain) 1.0 mg/mL in
Methanol.
LGC Limited........................... Methaqualone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Methaqualone-D7 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Clonazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Clonazepam-D4 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Chlordiazepoxide 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Chlordiazepoxide-D5 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... Bromazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Bromazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Clobazam 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Delorazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Estazolam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Estazolam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Flunitrazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Flunitrazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Flunitrazepam-D7 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Prazepam 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Prazepam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Diazepam 0.1 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Diazepam 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Diazepam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Diazepam-D5 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Flurazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Flurazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Lormetazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Zaleplon 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Pregabalin 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Pregabalin-D6 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Zolpidem Tartrate 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol (as free base).
LGC Limited........................... Zolpidem-D6 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Zopiclone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Zopiclone Oxide 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Zopiclone-D4 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Meprobamate 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Nitrazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Nitrazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Nitrazepam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Oxazepam 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Oxazepam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Oxazepam-D5 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Nordazepam (Nordiazepam) 0.1 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol.
LGC Limited........................... Nordazepam (Nordiazepam) 1.0 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol.
LGC Limited........................... Nordazepam-D5 (Nordiazepam-D5) Glass vial: 1 mL........ 11/30/2012
0.1 mg/mL in Methanol.
LGC Limited........................... Nordazepam-D5 (Nordiazepam-D5) Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Methanol.
LGC Limited........................... Alprazolam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Alprazolam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Alprazolam-D5 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Methyltestosterone (17alpha- Glass vial: 1 mL........ 11/30/2012
Methyltestosterone) 1.0 mg/mL
in Acetonitrile.
LGC Limited........................... Midazolam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Midazolam-D4 Maleate 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol (as free base).
LGC Limited........................... Lorazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Lorazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Lorazepam Acetate ((3RS)-7- Glass vial: 1 mL........ 11/30/2012
Chloro-5-(2-chlorophenyl)-2-
oxo-2,3-dihydro-1H-1,4-
benzodiazepin-3-yl Acetate)
0.1 mg/mL in Acetonitrile.
LGC Limited........................... Lorazepam-D4 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Lorazepam-D4 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Tetrazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Triazolam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Triazolam-D4 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Temazepam 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Temazepam 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Temazepam-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Temazepam-D5 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Androstanolone (5alpha- Glass vial: 1 mL........ 11/30/2012
Dihydrotestosterone,
Stanolone) 1.0 mg/mL in
Acetonitrile.
LGC Limited........................... Androstenedione (Androst-4-ene- Glass vial: 1 mL........ 11/30/2012
3, 17-dione) 1.0 mg/mL in
Acetonitrile.
[[Page 40181]]
LGC Limited........................... Boldenone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Fluoxymesterone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Mesterolone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Methandienone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Nandrolone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Norandrostenedione (19- Glass vial: 1 mL........ 11/30/2012
Norandrost-4-ene-3,17-dione)
1.0 mg/mL in Acetonitrile.
LGC Limited........................... Norethandrolone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Stanozolol 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Stanozolol-D3 0.1 mg/mL in 1,2- Glass vial: 1 mL........ 11/30/2012
Dimethoxyethane.
LGC Limited........................... Testosterone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Testosterone Benzoate 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Acetonitrile.
LGC Limited........................... Testosterone Isocaproate 1.0 Glass vial: 1 mL........ 11/30/2012
mg/mL in Acetonitrile.
LGC Limited........................... Testosterone Propionate 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Acetonitrile.
LGC Limited........................... Trenbolone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... RCS-4 (DD-001, (4- Glass vial: 1 mL........ 11/30/2012
Methoxyphenyl)(1-pentylindol-
3-yl)methanone) 1.0 mg/mL in
Acetonitrile.
LGC Limited........................... JWH-081 ((4-Methoxynaphthalen- Glass vial: 1 mL........ 11/30/2012
1-yl)(1-pentylindol-3-
yl)methanone) 1.0 mg/mL in
Acetonitrile.
LGC Limited........................... JWH-122 ((4-Methylnaphthalen-1- Glass vial: 1 mL........ 11/30/2012
yl)(1-pentylindol-3-
yl)methanone) 1.0 mg/mL in
Acetonitrile.
LGC Limited........................... JWH-203 (2-(2-Chlorophenyl)-1- Glass vial: 1 mL........ 11/30/2012
(1-pentylindol-3-yl)ethanone)
1.0 mg/mL in Acetonitrile.
LGC Limited........................... Ketamine Hydrochloride 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol (as free base).
LGC Limited........................... Ketamine-D4 Hydrochloride 0.1 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol (as free
base).
LGC Limited........................... Iso-LSD (Lysergic Acid Glass vial: 1 mL........ 11/30/2012
Diethylamide) 0.1 mg/mL in
Acetonitrile.
LGC Limited........................... LAMPA (Lysergic Acid N-Methyl- Glass vial: 1 mL........ 11/30/2012
N-propylamide) 0.025 mg/mL in
Acetonitrile.
LGC Limited........................... LSD (Lysergic Acid Glass vial: 1 mL........ 11/30/2012
Diethylamide) 0.025 mg/mL in
Acetonitrile.
LGC Limited........................... LSD-D3 (Lysergic Acid Glass vial: 1 mL........ 11/30/2012
Diethylamide-D3) 0.025 mg/mL
in Acetonitrile.
LGC Limited........................... PMA HCl (p-Methoxyamphetamine) Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Methanol (as
free base).
LGC Limited........................... rac-MDA (rac-3,4- Glass vial: 1 mL........ 11/30/2012
Methylenedioxyamphetamine)
1.0 mg/mL in Methanol.
LGC Limited........................... rac-MDEA (rac-3,4- Glass vial: 1 mL........ 11/30/2012
Methylenedioxy-N-
ethylamphetamine) 1.0 mg/mL
in Methanol.
LGC Limited........................... 1-Methylamino-1-(3,4- Glass vial: 1 mL........ 11/30/2012
methylenedioxyphenyl)propane
Hydrochloride 1.0 mg/mL in
Methanol (as free base).
LGC Limited........................... rac-BDB HCl (rac-3,4- Glass vial: 1 mL........ 11/30/2012
Methylenedioxyphenyl-2-
butanamine Hydrochloride) 1.0
mg/mL in Methanol (as free
base).
LGC Limited........................... rac-MDMA (rac-3,4- Glass vial: 1 mL........ 11/30/2012
Methylenedioxymethamphetamine
) 1.0 mg/mL in Methanol.
LGC Limited........................... Bufotenine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Methylone Hydrochloride 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol (as free base).
LGC Limited........................... Methylone-D3 Hydrochloride 0.1 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol (as free
base).
LGC Limited........................... AM-694 (1-(5-Fluoropentyl)-3- Glass vial: 1 mL........ 11/30/2012
(2-iodobenzoyl)indole) 1.0 mg/
mL in Acetonitrile.
LGC Limited........................... Cocaine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Cocaine-D3 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Cocaine-D3 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Norcocaine Hydrochloride 1.0 Glass vial: 1 mL........ 11/30/2012
mg/mL in Acetonitrile (as
free base).
LGC Limited........................... Norcocaine-D3 Hydrochloride Glass vial: 1 mL........ 11/30/2012
0.1 mg/mL in Acetonitrile (as
free base).
LGC Limited........................... O-Methylcodeine 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Buprenorphine 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Buprenorphine 3-beta-D- Glass vial: 1 mL........ 11/30/2012
Glucuronide 0.1 mg/mL in
Methanol.
LGC Limited........................... Buprenorphine-D4 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Dihydrocodeine Hydrochloride Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Methanol (as
free base).
LGC Limited........................... Dihydrocodeine-D6 Glass vial: 1 mL........ 11/30/2012
Hydrochloride 0.1 mg/mL in
Methanol (as free base).
LGC Limited........................... Noroxycodone Hydrochloride 1.0 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol (as free
base).
[[Page 40182]]
LGC Limited........................... Noroxycodone-D3 Hydrochloride Glass vial: 1 mL........ 11/30/2012
0.1 mg/mL in Methanol (as
free base).
LGC Limited........................... Oxycodone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Oxycodone-D3 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Dihydromorphine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Hydromorphone-D3 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Anhydroecgonine Hydrochloride Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Acetonitrile (as
free base).
LGC Limited........................... Anhydroecgonine Methyl Ester Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Acetonitrile.
LGC Limited........................... Benzoylecgonine 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Benzoylecgonine-D3 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... Benzoylecgonine-D3 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... Benzoylecgonine-D8 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... Benzoylecgonine-D8 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol.
LGC Limited........................... Cocaethylene Glass vial: 1 mL........ 11/30/2012
(Benzoylethylecgonine) 1.0 mg/
mL in Acetonitrile.
LGC Limited........................... Cocaethylene-D3 Glass vial: 1 mL........ 11/30/2012
(Benzoylethylecgonine-D3) 0.1
mg/mL in Acetonitrile.
LGC Limited........................... Cocaethylene-D8 Glass vial: 1 mL........ 11/30/2012
(Benzoylethylecgonine-D8) 0.1
mg/mL in Acetonitrile.
LGC Limited........................... Ecgonine 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Ecgonine Ethyl Ester 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... Ecgonine Hydrochloride 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Methanol (as free base).
LGC Limited........................... Ecgonine Methyl Ester 0.1 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Acetonitrile.
LGC Limited........................... Ecgonine Methyl Ester 1.0 mg/ Glass vial: 1 mL........ 11/30/2012
mL in Acetonitrile.
LGC Limited........................... Ecgonine-D3 Hydrochloride 0.1 Glass vial: 1 mL........ 11/30/2012
mg/mL in Methanol (as free
base).
LGC Limited........................... Ecgonine-D3 Methyl Ester 0.1 Glass vial: 1 mL........ 11/30/2012
mg/mL in Acetonitrile.
LGC Limited........................... Ethylmorphine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Hydrocodone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Hydrocodone-D3 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Hydrocodone-D6 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Norhydrocodone Hydrochloride Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Methanol (as
free base).
LGC Limited........................... Heroin (Diacetylmorphine) 1.0 Glass vial: 1 mL........ 11/30/2012
mg/mL in Acetonitrile.
LGC Limited........................... Heroin-D9 (Diacetylmorphine- Glass vial: 1 mL........ 11/30/2012
D9) 0.1 mg/mL in Acetonitrile.
LGC Limited........................... Heroin-D9 (Diacetylmorphine- Glass vial: 1 mL........ 11/30/2012
D9) 1.0 mg/mL in Acetonitrile.
LGC Limited........................... rac-Methadone 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... rac-Methadone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... rac-Methadone-D3 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... rac-Methadone-D3 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... rac-Methadone-D9 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... rac-Methadone-D9 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Dextropropoxyphene 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... Dextropropoxyphene 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... rac-Propoxyphene-D11 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... rac-Propoxyphene-D11 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... rac-Propoxyphene-D5 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... rac-Propoxyphene-D5 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... 6-Acetylmorphine 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... 6-Acetylmorphine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... 6-Acetylmorphine-D3 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... 6-Acetylmorphine-D3 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... 6-Acetylmorphine-D6 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... 6-Acetylmorphine-D6 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Acetonitrile.
LGC Limited........................... Acetylcodeine 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Acetylcodeine 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
LGC Limited........................... Nordihydromorphine Glass vial: 1 mL........ 11/30/2012
Hydrochloride 1.0 mg/mL in
Methanol (as free base).
LGC Limited........................... Oxymorphone 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Oxymorphone-D3 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Oxymorphone-D3 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Noroxymorphone Hydrochloride Glass vial: 1 mL........ 11/30/2012
0.1 mg/mL in Methanol (as
free base).
LGC Limited........................... Noroxymorphone Hydrochloride Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Methanol (as
free base).
LGC Limited........................... Butorphanol Tartrate 1.0 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol (as free base).
LGC Limited........................... Sufentanil Citrate 0.1 mg/mL Glass vial: 1 mL........ 11/30/2012
in Methanol (as free base).
[[Page 40183]]
LGC Limited........................... cis-Tilidine (Ethyl (1R,2RS)-2- Glass vial: 1 mL........ 11/30/2012
(Dimethylamino)-1-
phenylcyclohex-3-
enecarboxylate) 0.1 mg/mL in
Acetonitrile.
LGC Limited........................... Tilidine 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Acetonitrile.
Microgenics Corporation............... Abbott TDM Multiconstituent Box: 7 vials; 5 mL each. 7/2/2012
Calibrator (CAL 1-6) Catalog
Number: 5P04-01.
Microgenics Corporation............... Thermo Scientific DRI Opiate Vial: 18 mL, Box: 3 1/30/2013
Assay Catalog Number: vials.
100014602.
Microgenics Corporation............... Thermo Scientific DRI Vial: 18 mL, Box: 3 1/30/2013
Cannabinoid Assay Catalog vials.
Number: 10014665.
Microgenics Corporation............... Thermo Scientific Vial: 18 mL, Box: 3 1/30/2013
Phencyclidine Assay Catalog vials.
Number: 10014673.
Microgenics Corporation............... Thermo Scientific Ecstacy Vial: 18 mL, Box: 3 1/30/2013
Assay Catalog Number: vials.
10014681.
Microgenics Corporation............... Thermo Scientific CEDIA Vial: 5 mL; Box: 1 vial. 2/11/2013
Methamphetamine OFT
Calibrator 1: Catalog Number
10016362.
Microgenics Corporation............... Thermo Scientific CEDIA Vial: 5 mL; Box: 1 vial. 2/11/2013
Methamphetamine OFT
Calibrator 2: Catalog Number
10063.
Microgenics Corporation............... Thermo Scientific CEDIA Vial: 5 mL; Box: 1 vial. 2/11/2013
Methamphetamine OFT
Calibrator 3: Catalog Number
10016364.
Microgenics Corporation............... Thermo Scientific CEDIA Vial: 10 mL; Box: 1 vial 2/11/2013
Methamphetamine OFT Control
1: Catalog Number 10017686.
Microgenics Corporation............... Thermo Scientific CEDIA Vial: 10 mL; Box: 1 vial 2/11/2013
Methamphetamine OFT Control
2: Catalog Number 10017687.
Microgenics Corporation............... Thermo Scientific CEDIA Vial: 10 mL; Box: 1 vial 2/11/2013
Methamphetamine OFT Control
3: Catalog Number 1007688.
Microgenics Corporation............... Thermo Scientific CEDIA Multi- Vial: 10 mL; Box: 1 vial 2/11/2013
Drug OFT Calibrator 1:
Catalog Number 10016882.
Microgenics Corporation............... Thermo Scientific CEDIA Multi- Vial: 10 mL; Box: 1 vial 2/11/2013
Drug OFT Calibrator 2:
Catalog Number 10016883.
Microgenics Corporation............... Thermo Scientific CEDIA Multi- Vial: 10 mL; Box: 1 vial 2/11/2013
Drug OFT Calibrator 3:
Catalog Number 10016884.
Microgenics Corporation............... Thermo Scientific CEDIA Multi- Vial: 15 mL; Box: 1 vial 2/11/2013
Drug OFT Control 1: Catalog
Number 10017711.
Microgenics Corporation............... Thermo Scientific CEDIA Multi- Vial: 15 mL; Box: 1 vial 2/11/2013
Drug OFT Control 2: Catalog
Number 10017712.
Microgenics Corporation............... Thermo Scientific CEDIA Multi- Vial: 15 mL; Box: 1 vial 2/11/2013
Drug OFT Control 3: Catalog
Number 10017713.
Microgenics Corporation............... Thermo Scientific CEDIA THC Vial: 5 mL; Box: 1 vial. 2/11/2013
OFT Calibrator 1: Catalog
Number 10016700.
Microgenics Corporation............... Thermo Scientific CEDIA THC Vial: 5 mL; Box: 1 vial. 2/11/2013
OFT Calibrator 2: Catalog
Number 10016701.
Microgenics Corporation............... Thermo Scientific CEDIA THC Vial: 5 mL; Box: 1 vial. 2/11/2013
OFT Calibrator 3: Catalog
Number 10016702.
Microgenics Corporation............... Thermo Scientific CEDIA THC Vial: 10 mL; Box: 1 vial 2/11/2013
OFT Control 1: Catalog Number
10017702.
Microgenics Corporation............... Thermo Scientific CEDIA THC Vial: 10 mL; Box: 1 vial 2/11/2013
OFT Control 2: Catalog Number
10017703.
Microgenics Corporation............... Thermo Scientific CEDIA THC Vial: 10 mL; Box: 1 vial 2/11/2013
OFT Control 3: Catalog Number
10017704.
Ortho Clinical Diagnostics, Inc....... VITROS Immunodiagnostics Plastic chamber: 8.4 mL. 9/28/2012
Products Testosterone Reagent
Pack.
Ortho Clinical Diagnostics, Inc....... VITROS Immunodiagnostics Plastic chamber: 13.3 mL 9/28/2012
Products Estradiol Reagent
Pack.
Ortho Clinical Diagnostics, Inc....... VITROS Immunodiagnostics Box: 3 vials; 2 mL each. 10/19/2012
Products Testosterone
Calibrators (1-3).
Ortho Clinical Diagnostics, Inc....... VITROS Immunodiagnostics Box: 9 vials; 1 mL each. 10/19/2012
Products Testosterone
Controls (1-3).
Ortho Clinical Diagnostics, Inc....... VITROS Immunodiagnostics Box: 4 vials; 1-1.5 mL 10/19/2012
Products Testosterone Range each.
Verifiers (Low and High).
Restek................................ Custom Revised Appendix IX Mix Glass vial: 1.3 mL...... 2/14/2013
1.
Restek Corporation.................... Product and Reactor Samples Ampule: 2 mL............ 10/12/2012
Standard.
Restek Corporation.................... 8270 Supplemental Standard Ampule: 2 mL............ 12/13/2012
1.
Siemens Healthcare Diagnostics Inc.... TTST Stock X (Bulk)........... Stock container: 50 mL-1 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... VS TTST Cal Bulk Soln Level 1. Bulk container: 4 mL-100 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... VS TTST Cal Bulk Soln Level 2. Bulk container: 4 mL-100 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... VS TTST Cal Bulk Soln Level 3. Bulk container: 4 mL-100 7/26/2012
L.
[[Page 40184]]
Siemens Healthcare Diagnostics Inc.... VS TTST Cal Bulk Soln Level 4. Bulk container: 4 mL-100 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... VS TTST Cal Bulk Soln Level 5. Bulk container: 4 mL-100 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... VS TTST Cal Bulk Soln Level 6. Bulk container: 4 mL-100 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... Dimension Vista TTST CAL A.... Vial: 1 mL.............. 7/26/2012
Siemens Healthcare Diagnostics Inc.... Dimension Vista TTST CAL B.... Vial: 1 mL.............. 7/26/2012
Siemens Healthcare Diagnostics Inc.... Dimension Vista TTST CAL C.... Vial: 1 mL.............. 7/26/2012
Siemens Healthcare Diagnostics Inc.... Dimension Vista TTST CAL D.... Vial: 1 mL.............. 7/26/2012
Siemens Healthcare Diagnostics Inc.... Dimension Vista TTST CAL E.... Vial: 1 mL.............. 7/26/2012
Siemens Healthcare Diagnostics Inc.... Dimension Vista TTST CAL F.... Vial: 1 mL.............. 7/26/2012
Siemens Healthcare Diagnostics Inc.... Dimension Vista System TTST Box: 12 vials; 1 ml each 7/26/2012
CAL.
Siemens Healthcare Diagnostics Inc.... MP TTST Lvl 1 Bulk............ Bulk container: 4 mL-20 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... MP TTST Lvl 2 Bulk............ Bulk container: 4 mL-20 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... MP TTST Lvl 3 Bulk............ Bulk container: 4 mL-20 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... MP TTST Lvl 4 Bulk............ Bulk container: 4 mL-20 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... MP TTST Lvl 5 Bulk............ Bulk container: 4 mL-20 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... MP TTST Lvl 6 Bulk............ Bulk container: 4 mL-20 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... MP TTST CAL Lvl 1 FC.......... Vial: 1-5 mL............ 7/26/2012
Siemens Healthcare Diagnostics Inc.... MP TTST CAL Lvl 2 FC.......... Vial: 1-5 mL............ 7/26/2012
Siemens Healthcare Diagnostics Inc.... MP TTST CAL Lvl 3 FC.......... Vial: 1-5 mL............ 7/26/2012
Siemens Healthcare Diagnostics Inc.... MP TTST CAL Lvl 4 FC.......... Vial: 1-5 mL............ 7/26/2012
Siemens Healthcare Diagnostics Inc.... MP TTST CAL Lvl 5 FC.......... Vial: 1-5 mL............ 7/26/2012
Siemens Healthcare Diagnostics Inc.... MP TTST CAL Lvl 6 FC.......... Vial: 1-5 mL............ 7/26/2012
Siemens Healthcare Diagnostics Inc.... TTST Stock S (Bulk)........... Stock container: 50 mL-1 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... TTST Stock T (Bulk)........... Stock container: 50 mL-1 7/26/2012
L.
Siemens Healthcare Diagnostics Inc.... Estradiol Diluent............. Plastic container: 0.5L- 11/14/2012
1.0L.
Siemens Healthcare Diagnostics Inc.... Dimension Vista Drug 1 CAL Plastic test tube: 15 mL 12/3/2012
Pilot, Level B.
Supelco, Inc.......................... Titan C18 Batch Test 1 Mix.... Glass ampule: 1 mL...... 2/28/2013
----------------------------------------------------------------------------------------------------------------
The Deputy Assistant Administrator has found that each of the
compounds, mixtures, and preparations described in Chart II below is
not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and
in 21 CFR 1308.23. Accordingly, the Deputy Assistant Administrator has
determined that the chemical preparations or mixtures generally
described in Chart II below and specifically described in the
application materials received by DEA, are not exempt from application
of any part of the CSA or from application of any part of the CFR, with
regard to the requested exemption pursuant to 21 CFR 1308.23, as of the
date listed below that was provided in the determination letters to the
individual requesters.
Chart II
----------------------------------------------------------------------------------------------------------------
Application
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
Agilent Technologies.................. Forensic Toxicology Ampule: 1 mL............ 12/6/2012
Comprehensive Mix-Submix 9A.
[[Page 40185]]
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 10/11/2012
Control Urine, MC177.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 10/23/2012
Control Urine, MC178.
Biochemical Diagnostics, Inc.......... Salivabuse Custom Liquid Glass vials: 1 ml-200 mL 10/23/2012
Control Oral Fluid, OF24.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 12/14/2012
Control Urine, MC180.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 12/14/2012
Control Urine, MC181.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-2 L... 1/22/2013
Control Urine, MC182.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL 1/29/2013
Control Urine, MC180.
Biochemical Diagnostics, Inc.......... Detectabuse Custom Liquid Glass vials: 1 ml-2 L... 2/14/2013
Control Urine, MC182.
Cerilliant Corporation................ (-)-11-nor-9-Carboxy-delta9- Glass ampule: 5 mL...... 7/6/2012
THC (1 mg/mL).
Cerilliant Corporation................ Cocaine HCl (10 mg/mL)........ Glass Ampule: 1 mL...... 7/6/2012
Cerilliant Corporation................ Lacosamide (10 mg/mL)......... Glass Ampule: 1 mL...... 9/12/2012
Cliniqa Corporation................... TDM Control, Levels 1-3 Bulk.. Plastic Container: 500 L 12/4/2012
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, THC Glass vial: 5 ml-4 L.... 8/9/2012
(0.5-50 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, Glass vial: 5 ml-4 L.... 8/9/2012
Methamphetamine (2-200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, Glass vial: 5 ml-4 L.... 8/9/2012
Amphetamine, Benzoylecgonine,
Morphine, Phencyclidine (2-
200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Controls, Glass vial: 5 ml-4 L.... 8/9/2012
Multidrug (selected from THC,
Cocaine/Benzoylecgonine,
Amphetamines, Opiates, & PCP
at 0.5-50 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 8/9/2012
THC (0.5-50 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 8/9/2012
Methamphetamine (2-200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 8/9/2012
Amphetamine, Benzoylecgonine,
Morphine, Phencyclidine (2-
200 ng/mL).
ElSohly Laboratories, Inc............. ELI Oral Fluid Calibrators, Glass vial: 5 ml-4 L.... 8/9/2012
Multidrug (selected from THC,
Cocaine/Benzoylecgonine,
Amphetamines, Opiates, & PCP
at 0.5-200 ng/mL).
LGC Limited........................... LAMPA (Lysergic Acid N-Methyl- Glass vial: 1 mL........ 11/30/2012
N-propylamide) 1.0 mg/mL in
Acetonitrile.
LGC Limited........................... LSD (Lysergic Acid Glass vial: 1 mL........ 11/30/2012
Diethylamide) 1.0 mg/mL in
Acetonitrile.
LGC Limited........................... LSD-D3 (Lysergic Acid Glass vial: 1 mL........ 11/30/2012
Diethylamide-D3) 0.1 mg/mL in
Acetonitrile.
LGC Limited........................... (-)-Cannabidiol 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... Cannabinol 1.0 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
LGC Limited........................... (-)-delta9-THC (Dronabinol) Glass vial: 1 mL........ 11/30/2012
1.0 mg/mL in Methanol.
LGC Limited........................... (-)-delta9-THC-D3 (Dronabinol- Glass vial: 1 mL........ 11/30/2012
D3) 0.1 mg/mL in Methanol.
LGC Limited........................... trans-11-Hydroxy-delta9-THC Glass vial: 1 mL........ 11/30/2012
((6aRS,10aRS)-11-Hydroxy-
delta9-tetrahydrocannabinol)
0.1 mg/mL in Methanol.
LGC Limited........................... trans-11-Hydroxy-delta9-THC Glass vial: 1 mL........ 11/30/2012
((6aRS,10aRS)-11-Hydroxy-
delta9-tetrahydrocannabinol)
1.0 mg/mL in Methanol.
LGC Limited........................... trans-11-Hydroxy-delta9-THC-D3 Glass vial: 1 mL........ 11/30/2012
(trans-11-Hydroxy-delta9-
tetrahydrocannabinol-D3) 0.1
mg/mL in Methanol.
LGC Limited........................... trans-11-Nor-9-carboxy-delta9- Glass vial: 1 mL........ 11/30/2012
THC 0.1 mg/mL in Methanol.
LGC Limited........................... trans-11-Nor-9-carboxy-delta9- Glass vial: 1 mL........ 11/30/2012
THC-D3 0.1 mg/mL in Methanol.
LGC Limited........................... trans-11-Nor-9-carboxy-delta9- Glass vial: 1 mL........ 11/30/2012
THC-D3 1.0 mg/mL in Methanol.
LGC Limited........................... Fentanyl 0.1 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Fentanyl 1.0 mg/mL in Methanol Glass vial: 1 mL........ 11/30/2012
LGC Limited........................... Fentanyl-D5 0.1 mg/mL in Glass vial: 1 mL........ 11/30/2012
Methanol.
Siemens Healthcare Diagnostics Inc.... Dimension Vista Drug 1 CAL Plastic container: 4-100 12/3/2012
Bulk, Level B. L.
----------------------------------------------------------------------------------------------------------------
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. Pursuant to 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. Pursuant to 21 CFR 1308.24(g), 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, DEA has determined that each of the exempted bulk products
listed in this order may only be used by the manufacturer and may not
be distributed by the manufacturer for any purpose or transported to
other facilities.
Additional exempt chemical preparation requests received between
July 1, 2012, and March 31, 2013, and not otherwise referenced in this
order may remain under consideration until DEA receives additional
information required, pursuant to 21 CFR 1308.23(d), as detailed in
separate correspondence to individual requesters. DEA's order on such
requests will be communicated to the public in a future Federal
Register publication.
DEA also notes that these exemptions are limited to exemption from
only those sections of the CSA and the CFR that are specifically
identified in 21 CFR
[[Page 40186]]
1308.24(a). All other requirements of the CSA and the CFR apply,
including, but not limited to, registration as an importer as required
by 21 U.S.C. 957.
Chemical Preparations Containing Newly Controlled Substances
The statutory authority for exempt chemical preparations is based
on the control status of substances contained within a preparation, the
intended administration of a preparation, and the packaged form of a
preparation. DEA conducts a case-by-case analysis of each application
for exemption to determine whether exemption of a preparation from
certain provisions of the CSA is appropriate pursuant to the specified
statutory and regulatory requirements.
Most exempt chemical preparations have remained effective until the
holder of a specific exempt chemical preparation specifically requested
that the exemption be terminated. The CSA allows for modifications to
the controlled substances schedules to add, remove, or change the
schedule of substances thus resulting in periodic modifications to the
control status of various substances. 21 U.S.C. 811(a). Since the CSA
was enacted in 1970, DEA has on several occasions added to, removed
from, or modified the schedules of controlled substances in accordance
with the CSA. Such changes may result in the non-compliance of exempt
chemical preparations with current statutes or regulations if chemical
preparations that have already obtained exempt status contain newly
controlled substances. For example, although an exempt chemical
preparation may continue to be packaged in the same manner as when it
was approved, non-controlled substances in the preparation may become
controlled, thus prompting the need for a new application for exemption
of the chemical preparation to ensure continued compliance. Other
preparations that previously contained no controlled substances may
contain newly controlled substances and thus would require an
application for exemption.
DEA reviews applications for chemical preparation exemptions based
on the statutes and regulations that are in place at the time of the
application, including the control status of substances included in the
preparation. DEA must remain vigilant to ensure that exempt chemical
preparations remain consistent with the standards set forth in the CSA
and its implementing regulations. As such, DEA reminds the public that
any chemical preparation, regardless of whether it was previously
exempt, that contains a newly controlled substance will require a new
application for exemption pursuant to 21 U.S.C. 811(g)(3)(B) and 21 CFR
1308.23-1308.24.
Review of Exemptions Pursuant to 21 U.S.C. 811(g)(3)
Based on inquiries received from industry, DEA is conducting a
comprehensive review of the exempt chemical preparation regulations.
DEA's regulations at 21 CFR 1308.24(a) state that approved chemical
preparations are exempt from certain provisions of both Subchapter I
and Subchapter II of the CSA: ``The chemical preparations and mixtures
approved pursuant to 1308.23 are exempt from application of sections
302, 303, 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21
U.S.C. 822-823, 825-829, 952-954) and 1301.74 of this chapter, to the
extent described in paragraphs (b) to (h) of this section.'' Pursuant
to its regulations, DEA has provided exemptions from the application of
section 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 of the
Act (21 U.S.C. 822-823, 825-829, 952-954) and 21 CFR 1301.74 since the
implementation of the regulations in the early 1970s. Until DEA's
analysis of the exemption regulations is complete, DEA will continue to
review and provide exemptions to chemical preparations consistent with
the implementing regulations, when warranted. DEA will publish a future
notice regarding the outcome of DEA's review of its regulations with
respect to the exemption of chemical preparations.
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 Deputy Assistant
Administrator will immediately suspend the effectiveness of any
applicable part of this order until he may reconsider the application
in light of the comments and objections filed.
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 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: June 17, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2013-16010 Filed 7-2-13; 8:45 am]
BILLING CODE 4410-09-P