[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4446-4458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01133]
[[Page 4446]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-361]
Exempt Chemical Preparations Under the Controlled Substances Act
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Order with opportunity for comment.
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SUMMARY: The applications for exempt chemical preparations received by
DEA between June 12, 2011, and June 30, 2012, 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 March 25, 2013. Commenters should be aware
that 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-361'' 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
the http://www.regulations.gov Web site 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.
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.
SUPPLEMENTARY INFORMATION:
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
(hereinafter, ``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.
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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 the
Appendix to Subpart R of 28 CFR 0.104.
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Exempt Chemical Preparation Applications Submitted Between June 12,
2011, and June 30, 2012
The Deputy Assistant Administrator received applications between
June 12, 2011, and June 30, 2012, 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
[[Page 4447]]
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 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 from application of 21 CFR
1301.74, to the extent described in 21 CFR 1308.24, as of the date
listed below that was provided in the approval letters to the
individual requesters.
Chart I
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Exemption
Supplier Product name Form date
----------------------------------------------------------------------------------------------------------------
Abbott Laboratories.................... ARCHITECT 2nd Generation Bottle: 4 mL; Box: 6 12/22/2011
Testosterone Calibrators bottles.
(B,C,D,E,F).
Abbott Laboratories.................... ARCHITECT 2nd Generation Bottle: 8 mL; Box: 3 12/22/2011
Testosterone Controls (L,M,H). bottles.
Abbott Laboratories.................... ARCHITECT Estradiol Assay Bag-in-box: 18-200 L; 12/22/2011
Diluent, No. 2K25J. Flask/Carboy: 1-50 L;
Bottle/Vial: 0.5 mL-1 L;
Box: 1-50 bottles.
Abbott Laboratories.................... ARCHITECT Estradiol Assay Bottle: 5.9 mL........... 12/22/2011
Diluent, No. 7K72J.
Abbott Laboratories.................... ARCHITECT Estradiol Reagent Bottle: 5.9 mL; Kit: 16 12/22/2011
Kit, No. 07K72-20. bottles.
Abbott Laboratories.................... ARCHITECT Estradiol Reagent Bottle: 5.9 mL; Kit: 4 12/22/2011
Kit, No. 07K72-25. bottles.
Abbott Laboratories.................... ARCHITECT Estradiol Reagent Bottle: 5.9 mL; Kit: 16 12/22/2011
Kit, No. 2K25-20. bottles.
Abbott Laboratories.................... ARCHITECT Estradiol Reagent Bottle: 5.9 mL; Kit: 4 12/22/2011
Kit, No. 2K25-25. bottles.
Abbott Laboratories.................... AxSYM Estradiol Buffer......... Flask/Carboy: 1-50 L; 12/22/2011
Bottle/Vial: 0.5 mL-1 L;
Box: 1-50 bottles.
Abbott Laboratories.................... AxSYM Estradiol Reagent Pack... Bottle: 5.5 mL, Pack: 4 12/22/2011
bottles.
Agilent Technologies................... Special Order Standard TOXI-LAB Plastic Vial: 50 discs... 12/22/2011
DISCS; 1, 2, or 3 drugs.
Agilent Technologies................... Special Procedure Standard TOXI- Plastic Vial: 50 discs... 12/22/2011
LAB DISCS: Benzodiazepines:
Hydrolysis Procedure.
Agilent Technologies................... Special Procedure Standard TOXI- Plastic Vial: 50 discs... 12/22/2011
LAB DISCS: Benzoylecgonine.
Agilent Technologies................... Special Procedure Standard TOXI- Plastic Vial: 50 discs... 12/22/2011
LAB DISCS: MDMA, MDA, MDEA.
Agilent Technologies................... Special Procedure Standard TOXI- Plastic Vial: 50 discs... 12/22/2011
LAB DISCS: Morphine and
Hydromorphone: Differentiation.
Agilent Technologies................... Special Procedure Standard TOXI- Plastic Vial: 50 discs... 12/22/2011
LAB DISCS: Opiate.
Agilent Technologies................... Special Procedure Standard TOXI- Plastic Vial: 50 discs... 12/22/2011
LAB DISCS: Sympathomimetic
amines: Differentiation.
Agilent Technologies................... Special Standard TOXI-LAB DISCS Plastic Vial: 50 discs... 12/22/2011
LTD-Opiate: 1, 2, or 3 drugs.
Agilent Technologies................... TOXI-LAB Chromatograms A....... Glass jar: 100 12/22/2011
Chromatograms.
Agilent Technologies................... TOXI-LAB Chromatograms B....... Glass jar: 100 12/22/2011
Chromatograms.
Agilent Technologies................... TOXI-LAB CONTROL LTD FM........ Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB CONTROL No. 19........ Plastic bottle: 2 oz..... 12/22/2011
Agilent Technologies................... TOXI-LAB CONTROL No. 2......... Plastic bottle: 2 oz..... 12/22/2011
Agilent Technologies................... TOXI-LAB CONTROL No. 3......... Plastic bottle: 2 oz..... 12/22/2011
Agilent Technologies................... TOXI-LAB CONTROL No. 5......... Plastic bottle: 2 oz..... 12/22/2011
Agilent Technologies................... TOXI-LAB CONTROL THC........... Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS A-1............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS A-2............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS A-3............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS A-4............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS B-1............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS B-2............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS B-3............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS B-4............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS LTD HD.......... Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS LTD OP.......... Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS LTD OPI......... Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB DISCS THC............. Plastic vial: 50 discs... 12/22/2011
Agilent Technologies................... TOXI-LAB Proficiency Sample.... Plastic bottle: 2 oz..... 12/22/2011
American Radiolabeled Chemicals, Inc... (+)-iodo-Lysergic Acid Vial: 1 mL............... 12/22/2011
diethylamide [125I].
American Radiolabeled Chemicals, Inc... (+)-Pentazocine (1 mg/mL)...... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... (+)-Pentazocine [ring-1,3-3H].. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... ()-Ketamine [N- Vial: 1 mL............... 12/22/2011
methyl-3H] hydrochloride.
[[Page 4448]]
American Radiolabeled Chemicals, Inc... ()-Ketamine Vial: 1 mL............... 12/22/2011
hydrochloride (1 mg/mL).
American Radiolabeled Chemicals, Inc... 1,1-Dimethyltryptamine (1 mg/ Vial: 1 mL............... 12/22/2011
mL).
American Radiolabeled Chemicals, Inc... 1,1-Dimethyltryptamine Vial: 1 mL............... 12/22/2011
[a,[beta]-3H] as TFA salt.
American Radiolabeled Chemicals, Inc... Amobarbital (1 mg/mL).......... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Amphetamine, D-[ring-2,3,5-3H] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Amphetamine, DL-[ring-2,3,5-3H] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Amphetamine, L-[ring-2,3,5-3H] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Buprenorphine [ring-3H] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Buprenorphine hydrochloride (1 Vial: 1 mL............... 12/22/2011
mg/mL).
American Radiolabeled Chemicals, Inc... Cocaine (1 mg/mL).............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Cocaine [methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Cocaine, levo-[benzoyl-3,4- Vial: 1 mL............... 12/22/2011
3H(N)].
American Radiolabeled Chemicals, Inc... Codeine (1 mg/mL).............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... D-Amphetamine hydrochloride (1 Vial: 1 mL............... 12/22/2011
mg/mL).
American Radiolabeled Chemicals, Inc... Dextropropoxyphene (1 mg/mL)... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Diazepam (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Dihydrocodeine (1 mg/mL)....... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Dihydromorphine (1 mg/mL)...... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Diprenorphine (1 mg/mL)........ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... DL-Amphetamine hydrochloride (1 Vial: 1 mL............... 12/22/2011
mg/mL).
American Radiolabeled Chemicals, Inc... D-Methamphetamine hydrochloride Vial: 1 mL............... 12/22/2011
(1 mg/mL).
American Radiolabeled Chemicals, Inc... Ecgonine (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Fentanyl (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Fentanyl [3H(G)] as TFA salt... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Fludiazepam (1 mg/mL).......... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Flunitrazepam (1 mg/mL)........ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Flunitrazepam [methyl-3H]...... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Flurazepam (1 mg/mL)........... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Flurazepam [N-methyl-3H]....... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Heroin (1 mg/mL)............... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Heroin [methyl-14C]............ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Heroin [methyl-3H]............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Hydrocodone (1 mg/mL).......... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Hydromorphone (1 mg/mL)........ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Hydromorphone [N-methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
[[Page 4449]]
American Radiolabeled Chemicals, Inc... Ibogaine (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... L-Amphetamine hydrochloride (1 Vial: 1 mL............... 12/22/2011
mg/mL).
American Radiolabeled Chemicals, Inc... L-Methamphetamine hydrochloride Vial: 1 mL............... 12/22/2011
(1 mg/mL).
American Radiolabeled Chemicals, Inc... Lysergic Acid (1 mg/mL)........ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Lysergic acid diethylamide [N- Vial: 1 mL............... 3/22/2012
methyl-3H].
American Radiolabeled Chemicals, Inc... Mazindol (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Meperidine Hydrochloride (1 mg/ Vial: 1 mL............... 12/22/2011
mL).
American Radiolabeled Chemicals, Inc... Metazocine (1 mg/mL)........... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Metazocine [ring-1,3-3H]....... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Methamphetamine, D-[methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Methamphetamine, L-[methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Midazolam (1 mg/mL)............ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Midazolam [3H(G)].............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Morphine (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Morphine [N-methyl-14C]........ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Normorphine (1 mg/mL).......... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Oripavine (1 mg/mL)............ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Oxycodone [N-methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Oxycodone hydrochloride (1 mg/ Vial: 1 mL............... 12/22/2011
mL).
American Radiolabeled Chemicals, Inc... Oxymorphone (1 mg/mL).......... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Phenazocine (1 mg/mL).......... Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Phencyclidine hydrochloride (1 Vial: 1 mL............... 12/22/2011
mg/mL).
American Radiolabeled Chemicals, Inc... Phenylacetone (1 mg/mL)........ Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Tetrahydrocannabidinol (1 mg/ Vial: 1 mL............... 12/22/2011
mL).
American Radiolabeled Chemicals, Inc... Thebaine (1 mg/mL)............. Vial: 1 mL............... 12/22/2011
American Radiolabeled Chemicals, Inc... Thebaine [N-methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Thebaine [N-methyl-3H] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Thebaine [O-methyl-14C] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... Thebaine [O-methyl-3H] Vial: 1 mL............... 12/22/2011
hydrochloride.
American Radiolabeled Chemicals, Inc... [gamma]-Hydroxybutyric acid Vial: 1 mL............... 12/22/2011
sodium salt (1 mg/mL).
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF10.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF11.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF12.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF13.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF14.
[[Page 4450]]
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF15.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF16.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF17.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF18.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF19.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/31/2012
Control Oral Fluid, OF20.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/31/2012
Control Oral Fluid, OF21.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF4.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF5.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF6.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF8.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Oral Fluid, OF9.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC134.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC135.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-100 mL. 11/15/2011
Control Urine, MC136.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC137.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC138.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC139.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC140.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC141.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 2/1/2012
Control Urine, MC143.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 3/8/2012
Control Urine, MC144.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 3/8/2012
Control Urine, MC145.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 3/8/2012
Control Urine, MC146.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 3/8/2012
Control Urine, MC147.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 3/8/2012
Control Urine, MC148.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 3/22/2012
Control Urine, MC149.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Urine, MC150.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC151.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC152.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC153.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC154.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC155.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC156.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC157.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC158.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC159.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC160.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC161.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC162.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC163.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC164.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC165.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC166.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC167.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC168.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC169.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 8/20/2012
Control Urine, MC170.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Urine, MC171.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/31/2012
Control Urine, MC172.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/31/2012
Control Urine, MC173.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 2/1/2012
Control Urine, SD10.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 2/1/2012
Control Urine, SD11.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 2/1/2012
Control Urine, SD12.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 2/1/2012
Control Urine, SD13.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 2/1/2012
Control Urine, SD14.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Urine, SD15.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 7/5/2012
Control Urine, SD16.
[[Page 4451]]
Bio-Rad Laboratories................... Liquichek Immunoassay Plus Amber Vial: 10 mL; Box: 12/22/2011
Control Levels 1, 2, and 3. 12 vials.
Bio-Rad Laboratories................... Liquichek Immunoassay Plus Amber Vial: 10 mL; Box: 12/22/2011
Control Trilevel. 12 vials.
Bio-Rad Laboratories................... Liquichek Immunoassay Plus Amber Vial: 5 mL; Box: 3 12/22/2011
Control Trilevel Minipak. vials.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Box: 10 vials, 10 mL each 5/31/2012
Control S10.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Box: 10 vials, 10 mL each 5/31/2012
Control S10 Low Opiate.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber vial: 10 mL........ 5/31/2012
Control S10 Low Opiate Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber vial: 10 mL........ 5/31/2012
Control S10 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Box: 10 vials, 10 mL each 5/31/2012
Control S20.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Box: 10 vials, 10 mL each 5/31/2012
Control S20 Low Opiate.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber vial: 10 mL........ 5/31/2012
Control S20 Low Opiate Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber vial: 10 mL........ 5/31/2012
Control S20 Minipak.
Bio-Rad Laboratories................... Liquid Assayed Multiqual Levels Amber Vial: 2.5 mL; Box: 12/22/2011
1-3. 12 vials.
Bio-Rad Laboratories................... Liquid Assayed Multiqual Amber Vial: 2.5 mL; Box: 12/22/2011
Trilevel MiniPak. 3 vials.
Bio-Rad Laboratories................... Liquid Unassayed Multiqual Amber Vial: 2.5 mL; Box: 12/22/2011
Levels 1-3. 12 vials.
Bio-Rad Laboratories................... Liquid Unassayed Multiqual Amber Vial: 2.5 mL; Box: 12/22/2011
Trilevel MiniPak. 3 vials.
Bio-Rad Laboratories................... Lyphochek Assayed Chemistry Box 2 vials; 5 mL each... 12/22/2011
Control Bilevel MiniPak.
Bio-Rad Laboratories................... Lyphochek Assayed Chemistry Amber Vial: 5 mL; Box: 12 12/22/2011
Control Levels 1-2. vials.
Bio-Rad Laboratories................... Lyphochek Immunoassay Plus Amber Vial: 10 mL; Box: 12/22/2011
Control Levels 1, 2, and 3. 12 vials.
Bio-Rad Laboratories................... Lyphochek Immunoassay Plus Amber Vial: 10 mL; Box: 12/22/2011
Control Trilevel. 12 vials.
Bio-Rad Laboratories................... Lyphochek Immunoassay Plus Amber Vial: 5 mL; Box: 3 12/22/2011
Control Trilevel Minipak. vials.
Bio-Rad Laboratories................... Lyphochek Unassayed Chemistry Box 2 vials; 5 mL each... 12/22/2011
Control (Human) Bilevel
MiniPak.
Bio-Rad Laboratories................... Lyphochek Unassayed Chemistry Amber Vial: 5 mL; Box: 25 12/22/2011
Control (Human) Levels 1-2. vials.
Cerilliant Corporation................. () Pentazocine-13C3 Glass Ampule: 2 mL....... 12/22/2011
(0.1 mg/mL).
Cerilliant Corporation................. ()-cis-11-Nor-9- Glass Ampule: 2 mL....... 12/22/2011
carboxy-delta9-THC-D3
glucuronide (0.1 mg/mL).
Cerilliant Corporation................. 3,4-Methylenedioxypyrovalerone Glass Ampule: 2 mL....... 12/22/2011
HCl (1 mg/mL).
Cerilliant Corporation................. 3,4-Methylenedioxypyrovalerone- Glass Ampule: 2 mL....... 12/22/2011
D8 HCl (0.1 mg/mL).
Cerilliant Corporation................. 3-Desmethylprodine (1 mg/mL)... Glass Ampule: 1 mL....... 7/31/2012
Cerilliant Corporation................. 3-Desmethylprodine HCl (1 mg/ Glass Ampule: 1 mL....... 7/31/2012
mL).
Cerilliant Corporation................. 6-alpha/beta-Hydroxyoxymorphone Glass Ampule: 2 mL....... 12/22/2011
(1 mg/mL).
Cerilliant Corporation................. 6-alpha/beta-Hydroxyoxymorphone- Glass Ampule: 2 mL....... 12/22/2011
D3 (0.1 mg/mL).
Cerilliant Corporation................. Buprenorphine N-oxide (1 mg/mL) Glass Ampule: 1 mL....... 12/22/2011
Cerilliant Corporation................. Cannabinol-D3 (0.1 mg/mL)...... Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Carisoprodol (1 mg/mL)......... Glass Ampule: 2 mL....... 12/22/2012
Cerilliant Corporation................. Carisoprodol-D7 (0.1 mg/mL).... Glass Ampule: 2 mL....... 12/22/2012
Cerilliant Corporation................. Carisoprodol-D7 (1 mg/mL)...... Glass Ampule: 2 mL....... 7/31/2012
Cerilliant Corporation................. Cocaine N-oxide HCl (1 mg/mL).. Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Cocaine N-oxide HCl (1 mg/mL).. Glass Ampule: 2 mL....... 3/8/2012
Cerilliant Corporation................. Cocaine N-oxide-D3 HCl (0.1 mg/ Glass Ampule: 2 mL....... 12/22/2011
mL).
Cerilliant Corporation................. Cocaine N-oxide-D3 HCl (0.1 mg/ Glass Ampule: 2 mL....... 3/8/2012
mL).
Cerilliant Corporation................. Drug Solution 15..... Screw-cap Vial: 50 mL.... 6/5/2012
Cerilliant Corporation................. Lacosamide (1 mg/mL)........... Glass Ampule: 2 mL....... 5/31/2012
Cerilliant Corporation................. Lacosamide-13C, D3 (0.1 mg/mL). Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Lacosamide-13C, D3 (1 mg/mL)... Glass Ampule: 1 mL....... 7/31/2012
Cerilliant Corporation................. Lisdexamfetamine dimesylate (1 Glass Ampule: 2 mL....... 12/22/2011
mg/mL).
Cerilliant Corporation................. Lisdexamfetamine-D4 dimesylate Glass Ampule: 2 mL....... 12/22/2011
(0.1 mg/mL).
Cerilliant Corporation................. Mephedrone HCl (1 mg/mL)....... Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Mephedrone-D3 HCl (0.1 mg/mL).. Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Methylone HCl (1 mg/mL)........ Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Methylone-D3 HCl (0.1 mg/mL)... Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Morphine (8 [mu]g/mL).......... Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Naloxone N-oxide (0.1 mg/mL)... Glass Ampule: 2 mL....... 6/5/2012
Cerilliant Corporation................. Norcodeine-D3 (1 mg/mL)........ Glass Ampule: 1 mL....... 7/31/2012
Cerilliant Corporation................. Normeperidine-D4 (1 mg/mL)..... Glass Ampule: 1 mL....... 7/31/2012
Cerilliant Corporation................. Noroxycodone and Norhydrocodone Glass Ampule: 2 mL....... 12/22/2011
Mix (0.5 mg/mL).
Cerilliant Corporation................. Opiate Internal Standard Mix-15 Glass Ampule: 2 mL....... 12/22/2011
[[Page 4452]]
Cerilliant Corporation................. Pseudobuprenorphine Glass Ampule: 1 mL....... 2/1/2012
dihydrochloride (1.0mg/mL).
Cerilliant Corporation................. Pyrovalerone HCl (1 mg/mL)..... Glass Ampule: 2 mL....... 12/22/2011
Cerilliant Corporation................. Secobarbital-D5 (1 mg/mL)...... Glass Ampule: 1 mL....... 7/31/2012
Cerilliant Corporation................. Zolpidem-D7 (0.1 mg/mL)........ Glass Ampule: 2 mL....... 12/22/2011
ElSohly Laboratories, Inc.............. ELI Drug Standards [Delta]9- Glass vial: 1 ml......... 5/31/2012
Tetrahydrocannabinol-
glucoronide (10 [mu]g/mL in
MeOH).
ElSohly Laboratories, Inc.............. ELI Drug Standards [Delta]9- Glass vial: 1 ml......... 5/31/2012
Tetrahydrocannabinol-
glucoronide (100 [mu]g/mL in
MeOH).
Environmental Resource Associates (ERA) Chloral Hydrate, Proficiency Glass Ampule: 2 mL....... 3/8/2012
Testing Material, Catalog No.
853.
Environmental Resource Associates (ERA) Chloral Hydrate, Reference Glass Ampule: 2 mL....... 3/8/2012
Material, Catalog No. 676.
Environmental Resource Associates (ERA) Waters Steroid Test Mix, Part Glass Ampule: 2 mL....... 3/8/2012
No. 07364.
Immunalysis Corporation................ Methadone Calibrator Levels 1-4 Glass vial: 10 mL........ 6/19/2012
Immunalysis Corporation................ Methadone High Control......... Glass vial: 10 mL........ 6/19/2012
Immunalysis Corporation................ Methadone Low Control.......... Glass vial: 10 mL........ 6/19/2012
Immunalysis Corporation................ Oral Fluid Cutoff Calibrator Glass vial: 10 mL........ 6/19/2012
Pain Management Prediluted in
Extraction Buffer.
Immunalysis Corporation................ Oral Fluid High Positive Glass vial: 10 mL........ 6/19/2012
Control Pain Management
Prediluted in Extration Buffer.
Immunalysis Corporation................ Oral Fluid Low Positive Control Glass vial: 10 mL........ 6/19/2012
Pain Management Prediluted in
Extraction Buffer.
Immunalysis Corporation................ Zolpidem Calibrator............ Glass vial: 10 mL........ 6/19/2012
Immunalysis Corporation................ Zolpidem High Control.......... Glass vial: 10 mL........ 6/19/2012
Immunalysis Corporation................ Zolpidem Low Control........... Glass vial: 10 mL........ 6/19/2012
Insys Therapeutics, Inc................ (-)-delta9-Tetrahydrocannabinol Glass Ampule: 1 mL....... 5/9/2012
(1.0 mg/mL).
Microgenics Corporation................ CEDIA Amphetamine OFT Assay, Box: 4 bottles; 65 mL 12/22/2011
Catalog Number: 10014947. each.
Microgenics Corporation................ CEDIA Cannabinoids OFT Assay, Box: 4 bottles; 65 mL 12/22/2011
Catalog Number: 10014910. each.
Microgenics Corporation................ CEDIA Cocaine OFT Assay, Box: 4 bottles; 65 mL 12/22/2011
Catalog Number: 10014764. each.
Microgenics Corporation................ CEDIA Methamphetamine OFT Box: 4 bottles; 65 mL 12/22/2011
Assay, Catalog Number: each.
10014949.
Microgenics Corporation................ CEDIA Methamphetamine OFT Vial: 10 mL Box: 2 vials. 12/22/2011
Control Set (Low and High) ,
Catalog 10014953.
Microgenics Corporation................ CEDIA Methamphetamine OFT Vial: 5 mL Box: 1 vial... 12/22/2011
Cutoff Calibrator, Catalog
10014951.
Microgenics Corporation................ CEDIA Methamphetamine OFT High Vial: 5 mL Box: 1 vial... 12/22/2011
Calibrator, Catalog 10014952.
Microgenics Corporation................ CEDIA Multi-Drug OFT Control Vial: 15 mL Box: 2 vials. 12/22/2011
Set (Low and High), Catalog
10014957.
Microgenics Corporation................ CEDIA Multi-Drug OFT Cutoff Vial: 10 mL Box: 1 vial.. 12/22/2011
Calibrator, Catalog 10014955.
Microgenics Corporation................ CEDIA Multi-Drug OFT High Vial: 10 mL Box: 1 vial.. 12/22/2011
Calibrator, Catalog 10014956.
Microgenics Corporation................ CEDIA Opiate OFT Assay, Catalog Box: 4 bottles; 65 mL 12/22/2011
Number: 10014873. each.
Microgenics Corporation................ CEDIA PCP OFT Assay, Catalog Box: 4 bottles; 65 mL 12/22/2011
Number: 10014888. each.
Microgenics Corporation................ CEDIA THC OFT Control Set (Low Vial: 10 mL Box: 2 vials. 12/22/2011
and High), Catalog 10014925.
Microgenics Corporation................ CEDIA THC OFT Cutoff Vial: 5 mL Box: 1 vial... 12/22/2011
Calibrator, Catalog 10014923.
Microgenics Corporation................ CEDIA THC OFT High Calibrator, Vial: 5 mL Box: 1 vial... 12/22/2011
Catalog 10014924.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
1, Catalog Number: 10016345.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
1, Catalog Number: 10016362.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
2, Catalog Number: 10016346.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
2, Catalog Number: 10016363.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
3, Catalog Number: 10016347.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
3, Catalog Number: 10016364.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Calibrator
4, Catalog Number: 10016348.
[[Page 4453]]
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 10 mL Box: 2 vials. 7/5/2012
Methamphetamine OFT Control
Set (Low and High), Catalog
Number: 10016349.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 10 mL Box: 2 vials. 7/5/2012
Methamphetamine OFT Control
Set (Low and High), Catalog
Number: 10016365.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 10 mL Box: 2 vials. 7/5/2012
Methamphetamine OFT Control
Set (Low and High), Catalog
Number: 10016808.
Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 7/5/2012
Methamphetamine OFT Cutoff
Calibrator, Catalog Number:
10016807.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 1, Catalog
Number: 10016865.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 1, Catalog
Number: 10016882.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 2, Catalog
Number: 10016866.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 2, Catalog
Number: 10016883.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 3, Catalog
Number: 10016867.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 3, Catalog
Number: 10016884.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Calibrator 4, Catalog
Number: 10016868.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 15 mL Box: 2 vials. 7/5/2012
Drug OFT Control Set (Low and
High), Catalog Number:
10016869.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 15 mL Box: 2 vials. 7/5/2012
Drug OFT Control Set (Low and
High), Catalog Number:
10016885.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 15 mL Box: 2 vials. 7/5/2012
Drug OFT Control Set (Low and
High), Catalog Number:
10016895.
Microgenics Corporation................ Thermo Scientific CEDIA Multi- Vial: 10 mL Box: 1 vial.. 7/5/2012
Drug OFT Cutoff Calibrator,
Catalog Number: 10016894.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 1 Catalog Number:
10016644.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 1 Catalog Number:
10016700.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 2 Catalog Number:
10016646.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 2 Catalog Number:
10016701.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 3 Catalog Number:
10016647.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 3 Catalog Number:
10016702.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Calibrator 4 Catalog Number:
10016648.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 10 mL Box: 2 vials. 7/5/2012
Control Set (Low and High),
Catalog Number: 10016649.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 10 mL Box: 2 vials. 7/5/2012
Control Set (Low and High),
Catalog Number: 10016703.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 10 mL Box: 2 vials. 7/5/2012
Control Set (Low and High),
Catalog Number: 10016731.
Microgenics Corporation................ Thermo Scientific CEDIA THC OFT Vial: 5 mL Box: 1 vial... 7/5/2012
Cutoff Calibrator Catalog
Number: 10016730.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Vials: 500 mL............ 5/31/2012
Assay Catalog Number: 10016005.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl 3 vials, 18 mL each...... 5/31/2012
Assay Catalog Number: 10016006.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl 3 vials, 18 mL each...... 5/31/2012
Assay Catalog Number: 10016437.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Vials: 10 mL............. 5/31/2012
Calibrator 2 ng/mL Catalog
Number: 10016023.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Box: 1 vial; 25 mL....... 5/31/2012
High Control 1 ng/mL Catalog
Number: 10016484.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Box: 1 vial; 10 mL....... 5/31/2012
High Control 2 ng/mL Catalog
Number: 10016485.
[[Page 4454]]
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Vials: 25 mL............. 5/31/2012
High Control 3 ng/mL Catalog
Number: 10016024.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Box: 1 vial; 25 mL....... 5/31/2012
High Control 3 ng/mL Catalog
Number: 10016486.
Microgenics Corporation................ Thermo Scientific DRI Fentanyl Vials: 25 mL............. 5/31/2012
Low Control 1 ng/mL Catalog
Number: 10016022.
Microgenics Corporation................ Thermo Scientific MAS Vial 5 mL; Box: 6 vials.. 12/22/2011
OmniCORE Liquid
Assayed Integrated Chemistry
Control Levels 1-3.
Microgenics Corporation................ Thermo Scientific MAS Box: 6 vials; 5 mL each.. 12/22/2011
OmniCORE Liquid
Assayed Integrated Chemistry
Control Sample Pack.
Microgenics Corporation................ Thermo Scientific MAS Vial 5 mL; Box: 6 vials.. 12/22/2011
OmniIMMUNE Liquid
Assayed Integrated Chemistry
Control Levels 1-3.
Microgenics Corporation................ Thermo Scientific MAS Box: 6 vials; 5 mL each.. 12/22/2011
OmniIMMUNE Liquid
Assayed Integrated Chemistry
Control Sample Pack.
Microgenics Corporation................ Thermo Scientific MAS Vial 5 mL; Box: 6 vials.. 12/22/2011
OmniIMMUNE PRO Liquid
Assayed Integrated Chemistry
Control Levels 1-3.
Microgenics Corporation................ Thermo Scientific MAS Box: 6 vials; 5 mL each.. 12/22/2011
OmniIMMUNE PRO Liquid
Assayed Integrated Chemistry
Control Sample Pack.
Restek Corporation..................... Appendix IX Mix 1, Ampule: 2 mL............. 12/22/2011
Revised.
Restek Corporation..................... Custom a,a- Ampule: 2 mL............. 12/22/2011
Dimethylphenethylamine
Standard.
Restek Corporation..................... Custom Chloral Hydrate Standard Ampule: 2 mL............. 12/22/2011
Restek Corporation..................... Custom LS4434 Standard 1....... Ampule: 2 mL............. 7/5/2012
Restek Corporation..................... Metabolomic Standard Mix 1.
Restek Corporation..................... UCMR3 Method 539 Calibration Ampule: 2 mL............. 12/22/2011
Standard.
Restek Corporation..................... UCMR3 Method Calibration Ampule: 2 mL............. 5/31/2012
Standard.
Roche Diagnostics Operations, Inc...... Oral Fluid DAT Cal A Levels 1-5 Glass vial: 5 mL......... 7/31/2012
Roche Diagnostics Operations, Inc...... Oral Fluid DAT Cal B Levels 1-5 Glass vial: 5 mL......... 7/31/2012
Roche Diagnostics Operations, Inc...... Oral Fluid DAT Control Set A Box of 6 vials, 10 mL 7/31/2012
Material No. 05473390190. each.
Roche Diagnostics Operations, Inc...... Oral Fluid DAT Control Set B Box of 6 vials, 10 mL 7/31/2012
Material No. 05473411190. each.
Roche Diagnostics Operations, Inc...... Oral Fluid DAT Qual Cal Box of 4 vials, 5 mL each 7/31/2012
Material No. 05475929190.
Roche Diagnostics Operations, Inc...... Oral Fluid DAT SQ Cal A Box of 6 vials, 5 mL each 7/31/2012
Material No. 05475872190.
Roche Diagnostics Operations, Inc...... Oral Fluid DAT SQ Cal B Box of 6 vials, 5 mL each 7/31/2012
Material No. 05475899190.
SAFC Biosciences....................... HH-4 Cell Culture Medium....... Bag: 1L, 200L, 500L; 2/3/2012
Bottle: 1L, 2L.
SAFC Biosciences....................... HH-4 Cell Culture Medium....... Bag: 20 L, 100L, 1,000 L. 3/22/2012
Siemens Healthcare Diagnostics Inc..... ADVIA Chemistry Drug CAL 1..... Carton: 10 vials; 3 ml 11/5/2012
each.
Siemens Healthcare Diagnostics Inc..... ADVIA Chemistry Drug CAL 1, Vial: 3 mL............... 11/5/2012
Level 2.
Siemens Healthcare Diagnostics Inc..... ADVIA Chemistry Drug CAL 1, Vial: 3 mL............... 11/5/2012
Level 3.
Siemens Healthcare Diagnostics Inc..... ADVIA Chemistry Drug CAL 1, Vial: 3 mL............... 11/5/2012
Level 4.
Siemens Healthcare Diagnostics Inc..... ADVIA Chemistry Drug CAL 1, Vial: 3 mL............... 11/5/2012
Level 5.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC CAL 2 ML..... Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC CAL 3 ML..... Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC CAL 4 ML..... Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC CAL 5 ML..... Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC Control 1 ML. Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC Control 2 ML. Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC Control 3 ML. Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC Control 4 ML. Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC Control 5 ML. Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Bulk EII Plus THC Control 6 ML. Bulk Container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... Dimension Drug Calibrator, Vial: 2.5 mL............. 11/5/2012
Level 2.
Siemens Healthcare Diagnostics Inc..... Dimension Drug Calibrator, Vial: 2.5 mL............. 11/5/2012
Level 3.
Siemens Healthcare Diagnostics Inc..... Dimension Drug Calibrator, Vial: 2.5 mL............. 11/5/2012
Level 4.
Siemens Healthcare Diagnostics Inc..... Dimension Drug Calibrator, Vial: 2.5 mL............. 11/5/2012
Level 5.
Siemens Healthcare Diagnostics Inc..... Dimension Clinical Chemistry Carton: 10 vials; 2.5 ml 11/5/2012
System DRUG Calibrator. each.
Siemens Healthcare Diagnostics Inc..... Dimension Vista DRUG 1 CAL, B.. Vial: 2.5 mL............. 7/31/2012
Siemens Healthcare Diagnostics Inc..... Dimension Vista Drug 4 CAL, Vial: 3 mL............... 11/5/2012
Level B.
Siemens Healthcare Diagnostics Inc..... Dimension Vista Drug 4 CAL, Vial: 3 mL............... 11/5/2012
Level C.
Siemens Healthcare Diagnostics Inc..... Dimension Vista Drug 4 CAL, Vial: 3 mL............... 11/5/2012
Level D.
Siemens Healthcare Diagnostics Inc..... Dimension Vista Drug 4 CAL, Vial: 3 mL............... 11/5/2012
Level E.
Siemens Healthcare Diagnostics Inc..... Dimension Vista LOCI 8 CAL..... Box of 10 vials; Vial: 3/22/2012
2.5 mL.
Siemens Healthcare Diagnostics Inc..... Dimension Vista LOCI 9 CAL Vial: 1.5 mL............. 12/22/2011
Levels A-E.
[[Page 4455]]
Siemens Healthcare Diagnostics Inc..... Dimension Vista System DRUG 1 Carton: 6 vials; 2.5 mL 7/31/2012
CAL. each.
Siemens Healthcare Diagnostics Inc..... Dimension Vista System Drug 4 Carton: 10 vials; 3 ml 11/5/2012
CAL. each.
Siemens Healthcare Diagnostics Inc..... Dimension Vista System LOCI 9 Box of 10 vials; Vial: 12/22/2011
Calibrator. 1.5 mL.
Siemens Healthcare Diagnostics Inc..... Dimension Vista UDAT CAL....... Glass vial: 3 mL; Carton: 12/22/2011
6 vials.
Siemens Healthcare Diagnostics Inc..... Dimension Vista UDAT CAL Bulk, Bulk Container: 20 L-25 L 5/31/2012
Level B.
Siemens Healthcare Diagnostics Inc..... Dimension Vista UDAT CAL Pilot, Pilot Container: 2 mL-125 5/31/2012
Level B. mL.
Siemens Healthcare Diagnostics Inc..... Dimension Vista UDAT CAL, Level Glass vial: 3 mL......... 12/22/2011
B.
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC CAL 2 ML....... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC CAL 3 ML....... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC CAL 4 ML....... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC CAL 5 ML....... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC Control 1 ML... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC Control 2 ML... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC Control 3 ML... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC Control 4 ML... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC Control 5 ML... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... FC EII Plus THC Control 6 ML... Plastic vial: 15 mL...... 12/22/2011
Siemens Healthcare Diagnostics Inc..... MP LOCI 9 TTST Cal Lvl 1-7 FC.. Vial: 1-5 mL............. 12/22/2011
Siemens Healthcare Diagnostics Inc..... MP LOCI 9 TTST Lvl 1-7 Bulk.... Bulk container: 4 mL-100 12/22/2011
L.
Siemens Healthcare Diagnostics Inc..... VS Drug 1 Cal Bulk Soln, Level Bulk container: 2 mL-1 L. 7/31/2012
B.
Siemens Healthcare Diagnostics Inc..... VS LOCI 9 CAL BULK SOLN Levels Bulk container: 4 mL-100 12/22/2011
1-5. L.
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 BULK SOLN Level 2 Bulk container: 4 mL-100 3/22/2012
L.
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 BULK SOLN Level 3 Bulk container: 4 mL-100 3/22/2012
L.
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 BULK SOLN Level 4 Bulk container: 4 mL-100 3/22/2012
L.
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 BULK SOLN Level 5 Bulk container: 4 mL-100 3/22/2012
L.
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 Vial Level E..... Vial: 2.5 mL............. 3/22/2012
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 Vial Level B..... Vial: 2.5 mL............. 3/22/2012
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 Vial Level C..... Vial: 2.5 mL............. 3/22/2012
Siemens Healthcare Diagnostics Inc..... VS LOCI CAL 8 Vial Level D..... Vial: 2.5 mL............. 3/22/2012
Supelco, Inc........................... Custom Mix, 0.2-163.2 [mu]g/mL Glass ampule: 1 mL....... 7/31/2012
in methanol.
Ultra Scientific, Inc.................. DSA Detection Cocaine HCl Amber ampule: 1 mL....... 12/22/2011
Standard.
Ultra Scientific, Inc.................. DSA Detection Cocaine HCl Amber ampule: 1 mL....... 12/22/2011
StandardPhenobarbital (625
[mu]g/mL).
Ultra Scientific, Inc.................. DSA Detection Cocaine HCl Amber ampule: 1 mL....... 12/22/2011
StandardPhenobarbital (6400
[mu]g/mL).
Ultra Scientific, Inc.................. GE-Ion Track 100 ng/[mu]L TNT/ Amber ampule: 10 mL...... 12/22/2011
Cocaine HCl Standard Rev. 1.
Ultra Scientific, Inc.................. GE-Ion Track 100 ng/[mu]L TNT/ Glass bottle: 100 mL..... 12/22/2011
Cocaine HCl Standard Rev. 1.
Ultra Scientific, Inc.................. Phenobarbital (625 [mu]g/mL)... Amber ampule: 1 mL....... 5/31/2012
Ultra Scientific, Inc.................. Phenobarbital (6400 [mu]g/mL).. Amber ampule: 1 mL....... 5/31/2012
Ultra Scientific, Inc.................. Ultracheck WS Chloral Hydrate Glass ampule: 2 mL....... 12/22/2011
Sample.
----------------------------------------------------------------------------------------------------------------
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 the CSA or from application 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
----------------------------------------------------------------------------------------------------------------
Supplier Product name Form Denial date
----------------------------------------------------------------------------------------------------------------
Abbott Laboratories.................... ARCHITECT Estradiol Assay Tank: 50-500 L........... 12/22/2011
Diluent, No. 2K25J.
Abbott Laboratories.................... AxSYM Estradiol Buffer......... Bulk Tank: 50-500 L; Bag- 12/22/2011
in-box: 18-200 L.
American Radiolabeled Chemicals, Inc... Lysergic acid diethylamide..... Vial: 1 mL............... 12/22/2011
Biochemical Diagnostics, Inc........... Benzoylecgonine Bulk Solution Bottle: 1 ml-1 L......... 11/15/2011
(5 mg/mL).
Biochemical Diagnostics, Inc........... Cocaine Bulk Solution(5 mg/mL). Bottle: 1 ml-1 L......... 11/15/2011
Biochemical Diagnostics, Inc........... Codeine Bulk Solution(5 mg/mL). Bottle: 1 ml-1 L......... 11/15/2011
Biochemical Diagnostics, Inc........... d-Amphetamine Bulk Solution (5 Bottle: 1 ml-1 L......... 11/15/2011
mg/mL).
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC134.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC135.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 200 ml-2 L.. 11/15/2011
Control Urine, MC136.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC137.
[[Page 4456]]
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC138.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC139.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC140.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 500 ml-2 L.. 11/15/2011
Control Urine, MC141.
Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 11/15/2011
Control Urine, MC142.
Biochemical Diagnostics, Inc........... d-Methamphetamine Bulk Bottle: 1 ml-1 L......... 11/15/2011
Solution(5 mg/mL).
Biochemical Diagnostics, Inc........... d-Propoxyphene Bulk Solution (5 Bottle: 1 ml-1 L......... 11/15/2011
mg/mL).
Biochemical Diagnostics, Inc........... Hydrocodone Bulk Solution(5 mg/ Bottle: 1 ml-1 L......... 11/15/2011
mL).
Biochemical Diagnostics, Inc........... Hydromorphone Bulk Solution(5 Bottle: 1 ml-1 L......... 11/15/2011
mg/mL).
Biochemical Diagnostics, Inc........... MDA Bulk Solution(5 mg/mL)..... Bottle: 1 ml-1 L......... 11/15/2011
Biochemical Diagnostics, Inc........... MDEA Bulk Solution(5 mg/mL).... Bottle: 1 ml-1 L......... 11/15/2011
Biochemical Diagnostics, Inc........... MDMA Bulk Solution(5 mg/mL).... Bottle: 1 ml-1 L......... 11/15/2011
Biochemical Diagnostics, Inc........... Methadone Bulk Solution(5 mg/ Bottle: 1 ml-1 L......... 11/15/2011
mL).
Biochemical Diagnostics, Inc........... Methaqualone Bulk Solution(5 mg/ Bottle: 1 ml-1 L......... 11/15/2011
mL).
Biochemical Diagnostics, Inc........... Morphine Bulk Solution (5 mg/ Bottle: 1 ml-1 L......... 11/15/2011
mL).
Biochemical Diagnostics, Inc........... Oxazepam Bulk Solution (5 mg/ Bottle: 1 ml-1 L......... 11/15/2011
mL).
Biochemical Diagnostics, Inc........... Secobarbital Bulk Solution (5 Bottle: 1 ml-1 L......... 11/15/2011
mg/mL).
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 20mL......... 12/22/2011
Control C1 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 20mL......... 12/22/2011
Control C2 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 20mL......... 12/22/2011
Control C3 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 20mL......... 12/22/2011
Control C4 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 20mL......... 12/22/2011
Control Low Opiate Level C2
Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 20mL......... 12/22/2011
Control Low Opiate Level C3
Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S1 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S1E Low Opiate Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S1E Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S1S Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S2 Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S2E Low Opiate Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S2E Minipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S2SMinipak.
Bio-Rad Laboratories................... Liquichek Urine Toxicology Amber Vial: 10mL......... 12/22/2011
Control S3 Minipak.
Cayman Chemical Company................ 4-Methylmethcathinone Glass vial: 1 mL......... 7/31/2012
(hydrochloride), 10 mg in 1 mL
Methanol.
Cayman Chemical Company................ 4-Methylmethcathinone Glass vial: 2.5 mL....... 7/31/2012
(hydrochloride), 25 mg in 2.5
mL Methanol.
Cayman Chemical Company................ 4-Methylmethcathinone Glass vial: 500 [micro]L. 7/31/2012
(hydrochloride), 5 mg in 500
[micro]L Methanol.
Cayman Chemical Company................ 5-methoxy DMT, 10 mg in 1 mL Glass vial: 1 mL......... 7/31/2012
Methanol.
Cayman Chemical Company................ 5-methoxy DMT, 25 mg in 2.5 mL Glass vial: 2.5 mL....... 7/31/2012
Methanol.
Cayman Chemical Company................ 5-methoxy DMT, 5 mg in 500 Glass vial: 500 [micro]L. 7/31/2012
[micro]L Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone Glass vial: 1 mL......... 7/31/2012
(hydrochloride), 10 mg in 1 mL
Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone Glass vial: 2.5 mL....... 7/31/2012
(hydrochloride), 25 mg in 2.5
mL Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone Glass vial: 500 [micro]L. 7/31/2012
(hydrochloride), 5 mg in 500
[micro]L Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone, 10 Glass vial: 1 mL......... 7/31/2012
mg in 1 mL Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone, 25 Glass vial: 2.5 mL....... 7/31/2012
mg in 2.5 mL Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone, 5 Glass vial: 500 [micro]L. 7/31/2012
mg in 500 [micro]L Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone-d8 Glass vial: 1 mL......... 7/31/2012
(hydrochloride), 10 mg in 1 mL
Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone-d8 Glass vial: 2.5 mL....... 7/31/2012
(hydrochloride), 25 mg in 2.5
mL Methanol.
Cayman Chemical Company................ Methylenedioxy Pyrovalerone-d8 Glass vial: 500 [micro]L. 7/31/2012
(hydrochloride), 5 mg in 500
[micro]L Methanol.
Cayman Chemical Company................ Methylone (hydrochloride), 10 Glass vial: 1 mL......... 7/31/2012
mg in 1 mL Methanol.
Cayman Chemical Company................ Methylone (hydrochloride), 25 Glass vial: 2.5 mL....... 7/31/2012
mg in 2.5 mL Methanol.
Cayman Chemical Company................ Methylone (hydrochloride), 5 mg Glass vial: 500 [micro]L. 7/31/2012
in 500 [micro]L Methanol.
Cerilliant Corporation................. Codeine (1 mg/mL).............. Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Codeine-D3 (1 mg/mL)........... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Drug Solution 16..... Screw-cap Vial: 50 mL.... 6/5/2012
[[Page 4457]]
Cerilliant Corporation................. Drug Solution 17..... Screw-cap Vial: 50 mL.... 6/5/2012
Cerilliant Corporation................. Drug Solution 18..... Screw-cap Vial: 50 mL.... 6/5/2012
Cerilliant Corporation................. Drug Solution 19..... Screw-cap Vial: 50 mL.... 6/5/2012
Cerilliant Corporation................. Drug Solution 20..... Screw-cap Vial: 50 mL.... 6/5/2012
Cerilliant Corporation................. Hydrocodone (1 mg/mL).......... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Hydrocodone-D6 (1 mg/mL)....... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Hydromorphone (1 mg/mL)........ Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Hydromorphone-D3 (1 mg/mL)..... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Morphine (1 mg/mL)............. Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Morphine-D3 (1 mg/mL).......... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Noroxycodone HCl (1 mg/mL)..... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Noroxycodone-D3 HCl (1 mg/mL).. Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Oxycodone (1 mg/mL)............ Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Oxycodone-D3 (1 mg/mL)......... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Oxymorphone (1 mg/mL).......... Glass ampule: 5 mL....... 7/31/2012
Cerilliant Corporation................. Oxymorphone-D3 (1 mg/mL)....... Glass ampule: 5 mL....... 7/31/2012
Environmental Resource Associates (ERA) USGS BQS LS4434 Mix 1.......... Glass Ampule: 1-2 mL..... 7/31/2012
Environmental Resource Associates (ERA) USGS BQS LS4434 Mix 2.......... Glass Ampule: 1-2 mL..... 7/31/2012
Immunalysis Corporation................ Tapentadol Calibrator Levels 1- Glass vial: 10 mL........ 6/19/2012
4.
Immunalysis Corporation................ Tapentadol High Control........ Glass vial: 10 mL........ 6/19/2012
Immunalysis Corporation................ Tapentadol Low Control......... Glass vial: 10 mL........ 6/19/2012
Restek Corporation..................... Custom Cannabinoids Standard... Ampule: 2 mL............. 5/31/2012
Restek Corporation..................... Custom Paraldehyde Standard (10 Ampule: 2 mL............. 7/5/2012
mg/mL).
Siemens Healthcare Diagnostics Inc..... Dimension Vista UDAT CAL Bulk, Bulk Container: 4mL-100L. 12/22/2011
Level B.
Siemens Healthcare Diagnostics Inc..... Dimension Vista UDAT CAL Bulk, Bulk Container: 26 L-50L. 5/31/2012
Level B.
Siemens Healthcare Diagnostics Inc..... Drug CAL BULK SOLN, Level 2.... Bulk container: 2 L-100 L 11/5/2012
Siemens Healthcare Diagnostics Inc..... Drug CAL BULK SOLN, Level 3.... Bulk container: 2 mL-100 11/5/2012
L.
Siemens Healthcare Diagnostics Inc..... Drug CAL BULK SOLN, Level 4.... Bulk container: 2 mL-100 11/5/2012
L.
Siemens Healthcare Diagnostics Inc..... Drug CAL BULK SOLN, Level 5.... Bulk container: 2m L-100 11/5/2012
L.
Siemens Healthcare Diagnostics Inc..... VS Drug 1 Cal Bulk Soln, Level Bulk container: 2 mL-100 7/31/2012
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. 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 in-house and may not be transported to other
facilities.
Additional exempt chemical preparation requests received between
June 12, 2011, and June 30, 2012, and not otherwise referenced in this
order may remain pending 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 published in a future Federal Register.
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
indefinitely unless 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
[[Page 4458]]
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.
Request 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: January 14, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2013-01133 Filed 1-18-13; 8:45 am]
BILLING CODE 4410-09-P