78 FR 128 pgs. 40175-40186 - Exempt Chemical Preparations Under the Controlled Substances Act
Type: NOTICEVolume: 78Number: 128Pages: 40175 - 40186
Pages: 40175, 40176, 40177, 40185, 40186Docket number: [Docket No. DEA-372]
FR document: [FR Doc. 2013-16010 Filed 7-2-13; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-372]
Exempt Chemical Preparations Under the Controlled Substances Act
AGENCY:
Drug Enforcement Administration (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.
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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).1DEA 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.
Footnotes:
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.
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| Supplier | Product name | Form | Application date |
|---|---|---|---|
| AccuStandard, Inc | APP-9-086, a,a-Dimethylphenethylamine | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | APP-9-086-20X, a,a-Dimethylphenethylamine | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | AS-E1179, Chloral hydrate | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | CLP-HC-X1, Composite Mix #3A | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | M-551.1B, Disinfectant by-products | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | M-551B, Disinfectant by-products | Amber ampule: 1 mL | 1/28/2013 |
| 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 by Method 8206B | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | M-8270-02, Semi-Volatile by Capillary Column GC/MS Mix 2 | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | M-8270-04-ASL, Method 8270B-Base/Neutrals Mix | Amber ampule: 1 mL | 1/28/2013 |
| AccuStandard, Inc | M-8270-23-R1, Method 8270 Semi-Volatile Additions | Amber ampule: 1 mL | 1/28/2013 |
| 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 Mix-Submix 6 | Amber ampule: 1 mL | 8/3/2012 |
| Agilent Technologies | Forensic Toxicology Comprehensive Mix-Submix 3 | Amber ampule: 1 mL | 8/3/2012 |
| Agilent Technologies | Forensic Toxicology Comprehensive Mix-Submix 5 | Amber ampule: 1 mL | 8/3/2012 |
| Agilent Technologies | Forensic Toxicology Comprehensive Mix-Submix 2 | Amber ampule: 1 mL | 8/3/2012 |
| Agilent Technologies | Forensic Toxicology Checkout Mix | Amber ampule: 1 mL | 8/3/2012 |
| Agilent Technologies | Forensic Toxicology Comprehensive Mix-Submix 1 | Amber ampule: 1 mL | 12/6/2012 |
| 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/mL | Glass ampule: 1 mL | 9/26/2012 |
| Alltech Associates, Inc | Carisoprodol Quik Check, 1.0 mg/mL | Glass ampule: 1 mL | 9/26/2012 |
| American Proficiency Institute | American Proficiency Institute SHBG/Testosterone | Amber bottle: 7 mL | 12/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF23 | Glass vials: 1 ml-200 mL | 8/14/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD17 | Glass vials: 1 ml-200 mL | 8/14/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC176 | Glass vials: 1 ml-200 mL | 9/27/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC179 | Glass vials: 1 ml-200 mL | 10/23/2012 |
| Biochemical Diagnostics, Inc | Salivabuse Custom Liquid Control Oral Fluid, OF25 | Glass vials: 1 ml-200 mL | 10/23/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC177 | Glass vials: 1 ml-200 mL | 11/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC178 | Glass vials: 1 ml-200 mL | 1/24/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF24 | Glass vials: 1 ml-200 mL | 1/24/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC181 | Glass vials: 1 ml-200 mL | 1/29/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC183 | Glass vials: 1 ml-200 mL | 3/12/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC184 | Glass vials: 1 ml-200 mL | 3/12/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC180 | Glass vials: 1 ml-200 mL | 3/14/2013 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Trilevel MiniPak | Box: 3 vials, 2.5 mL each | 11/14/2012 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Level 1,2 and 3, Trilevel | Box: 12 vials, 5 mL each | 11/21/2012 |
| Bio-Rad Laboratories | Liquid Assayed Multiqual Premium, Levels 1-3 | Box: 6 vials, 5 mL each | 11/21/2012 |
| Bio-Rad Laboratories | Liquid Assayed Multiqual Premium, Trilevel Minipak | Box: 3 vials, 5 mL each | 11/21/2012 |
| Bio-Rad Laboratories | Lyphocheck Urine Toxicology Control MiniPak, Cat. No. 470X | Glass vial: 25 mL | 1/11/2013 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Level 1 | Glass vial: 2.5 mL, Box 12 vials | 2/20/2013 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Level 2 | Glass vial: 2.5 mL, Box 12 vials | 2/20/2013 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Level 3 | Glass vial: 2.5 mL, Box 12 vials | 2/20/2013 |
| Cerilliant Corporation | Benzodiazepine Mix (1 mg/mL) | Glass Ampule: 1 mL | 7/2/2012 |
| Cerilliant Corporation | Class C Mix Urinalysis Internal Standard Fortified Morphine | Glass Ampule: 1 mL | 7/9/2012 |
| Cerilliant Corporation | Spice Cannabinoid Mix 2 (0.1 mg/mL) | Amber ampule: 1 mL | 9/26/2012 |
| Cerilliant Corporation | Spice Cannabinoid Mix 3 (0.1 mg/mL) | Amber ampule: 1 mL | 9/26/2012 |
| Cerilliant Corporation | Retigabine (1 mg/mL) | Glass Ampule: 1 mL | 11/7/2012 |
| Cerilliant Corporation | ±-Norpseudoephedrine-D3 HCl (0.1 mg/mL) | Glass Ampule: 1 mL | 1/7/2013 |
| Cerilliant Corporation | Amobarbital-D5 (0.1 mg/mL) | Glass Ampule: 1 mL | 1/7/2013 |
| Cerilliant Corporation | 2,5-Dimethoxy-4-(n)-propylthiophenethylamine HCl (2C-T-7 HCl) (1 mg/mL) | Glass Ampule: 1 mL | 1/7/2013 |
| Cerilliant Corporation | Class B Mix Urinalysis 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) | Glass ampule: 1 ml | 1/22/2013 |
| 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 (0.5-50 ng/mL) | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Controls, Methamphetamine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Controls, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Controls, Multidrug (THC, Benzoylecgonine, Amphetamine, Methamphetamine, Morphine, Codeine, 6-Acetylmorphine, & PCP) at 0.5-50 ng/mL | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, THC (0.5-50 ng/mL) | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, Methamphetamine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 10/22/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, Multidrug (THC, Benzoylecgonine, Amphetamine, Methamphetamine, Morphine, Codeine, 6-Acetylmorphine, & PCP) at 0.5-200 ng/mL | Glass vial: 5 ml-4 L | 10/22/2012 |
| Environmental Resource Associates (ERA) | USGS-BQS LS 4434 Mix 1 | Glass Ampule: 2 mL | 8/9/2012 |
| Environmental Resource Associates (ERA) | USGS-BQS LS 4434 Mix 2 | Glass Ampule: 2 mL | 8/9/2012 |
| Immunalysis Corporation | Tapentadol Calibrator Level 1 (100 ng/mL) | Glass vial: 10 mL | 12/11/2012 |
| Immunalysis Corporation | Tapentadol Calibrator Level 2 (200 ng/mL) | Glass vial: 10 mL | 12/11/2012 |
| Immunalysis Corporation | Tapentadol Calibrator Level 3 (500 ng/mL) | Glass vial: 10 mL | 12/11/2012 |
| Immunalysis Corporation | Tapentadol Calibrator Level 4 (1,000 ng/mL) | Glass vial: 10 mL | 12/11/2012 |
| Immunalysis Corporation | Tapentadol Low Control (150 ng/mL) | Glass vial: 10 mL | 12/11/2012 |
| Immunalysis Corporation | Tapentadol High Control (250 ng/mL) | Glass vial: 10 mL | 12/11/2012 |
| LGC Limited | (S)-(+)-Amphetamine (Dextroamphetamine) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Amphetamine 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Amphetamine 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Amphetamine-D11 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Amphetamine-D11 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Amphetamine-D5 (D-label on ring) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Methamphetamine ((S)-(+)-Methamphetamine) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Methamphetamine 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Methamphetamine 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Methamphetamine-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Methamphetamine-D5 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Methcathinone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Methylphenidate Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Amobarbital 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Pentobarbital 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Pentobarbital-D5 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Pentobarbital-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Secobarbital 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDA-D5 (rac-3,4-Methylenedioxyamphetamine-D5) 0.1 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDA-D5 (rac-3,4-Methylenedioxyamphetamine-D5) 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MBDB HCl (rac-N-Methyl-1-(3,4-Methylenedioxyphenyl)-2-butanamine Hydrochloride) 1.0 mg/mL Methanol (as free base) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MBDB-D5 (rac-N-Methyl-1-(3,4-Methylenedioxyphenyl)-2-butanamine-D5) 0.1 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDEA-D5 (rac-3,4-Methylenedioxy-N-ethylamphetamine-D5) 0.1 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDEA-D5 (rac-3,4-Methylenedioxy-N-ethylamphetamine-D5) 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDEA-D6 (rac-3,4-Methylenedioxy-N-ethylamphetamine-D6) 0.1 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDMA-D5 (rac-3,4-Methylenedioxymethamphetamine-D5) 0.1 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-MDMA-D5 (rac-3,4-Methylenedioxymethamphetamine-D5) 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Phencyclidine (PCP) 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Phencyclidine-D5 (PCP-D5) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Phencyclidine-D5 (PCP-D5) 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| 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 Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Codeine-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Codeine-D6 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Codeine-D6 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Isocodeine 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Norcodeine 0.01 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Norcodeine 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Codeine N-Oxide 0.01 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Oxycodone-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Oxycodone-D6 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Oxycodone-D6 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Hydromorphone 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Norhydromorphone Hydrochloride 1.0 mg/mL Methanol (as free base) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Pethidine (Meperidine) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Pethidine-D4 (Meperidine-D4) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Pethidine-D4 (Meperidine-D4) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| 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 0.1 mg/mL in Methanol/Water ( 1⁄1 ) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Morphine 3-beta-D-Glucuronide 1.0 mg/mL in Methanol with 0.05 percent Sodium Hydroxide (w/v) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Morphine 6-beta-D-Glucuronide 0.1 mg/mL in Methanol/Water ( 1⁄1 ) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Morphine 6-beta-D-Glucuronide 1.0 mg/mL Water/Methanol (80/20) | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Morphine-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Morphine-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Morphine N-Oxide 0.01 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | Normorphine 1.0 mg/mL Methanol | Glass vial: 1 mL | 9/24/2012 |
| LGC Limited | rac-Amphetamine-D10 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D5 (D-label on ring) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D5 (D-label on side chain) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D5 (D-label on side chain) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D6 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D6 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D8 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Amphetamine-D8 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D11 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D11 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D14 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D14 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D8 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D8 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D9 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methamphetamine-D9 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (+)-Norpseudoephedrine Hydrochloride (Cathine Hydrochloride) 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (R)-(+)-Cathinone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (S)-(-)-Cathinone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (S)-(-)-Methcathinone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Phentermine 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Fenfluramine Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methylphenidate-D9 Hydrochloride 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Pipradrol Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Pipradrol Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | GHB Sodium Salt (Sodium Gammahydroxybutyrate) 1.0 mg/mL in Methanol (as free acid) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | GHB-D6 Sodium Salt (Sodium Gammahydroxybutyrate-D6) 0.1 mg/mL in Methanol (as free acid) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | GHB-D6 Sodium Salt (Sodium Gammahydroxybutyrate-D6) 1.0 mg/mL in Methanol (as free acid) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Hexobarbital 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methohexital 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methohexital-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Phenobarbital 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Phenobarbital-D5 (D-label on ring) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Phenobarbital-D5 (D-label on ring) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Phenobarbital-D5 (D-label on side chain) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Phenobarbital-D5 (D-label on side chain) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methaqualone 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methaqualone-D7 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Clonazepam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Clonazepam-D4 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Chlordiazepoxide 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Chlordiazepoxide-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Bromazepam 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Bromazepam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Clobazam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Delorazepam 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Estazolam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Estazolam-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Flunitrazepam 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Flunitrazepam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Flunitrazepam-D7 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| 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 Methanol | Glass vial: 1 mL | 11/30/2012 |
| 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 Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Diazepam-D5 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Flurazepam 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Flurazepam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Lormetazepam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Zaleplon 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Pregabalin 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Pregabalin-D6 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Zolpidem Tartrate 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Zolpidem-D6 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Zopiclone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Zopiclone Oxide 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Zopiclone-D4 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Meprobamate 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nitrazepam 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nitrazepam 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nitrazepam-D5 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| 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 Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Oxazepam-D5 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nordazepam (Nordiazepam) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nordazepam (Nordiazepam) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nordazepam-D5 (Nordiazepam-D5) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nordazepam-D5 (Nordiazepam-D5) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Alprazolam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Alprazolam-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Alprazolam-D5 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methyltestosterone (17alpha-Methyltestosterone) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Midazolam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Midazolam-D4 Maleate 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Lorazepam 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Lorazepam 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Lorazepam Acetate ((3RS)-7-Chloro-5-(2-chlorophenyl)-2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl Acetate) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Lorazepam-D4 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Lorazepam-D4 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Tetrazepam 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Triazolam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Triazolam-D4 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Temazepam 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Temazepam 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Temazepam-D5 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Temazepam-D5 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Androstanolone (5alpha-Dihydrotestosterone, Stanolone) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Androstenedione (Androst-4-ene-3, 17-dione) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Boldenone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Fluoxymesterone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Mesterolone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methandienone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nandrolone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Norandrostenedione (19-Norandrost-4-ene-3,17-dione) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Norethandrolone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Stanozolol 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Stanozolol-D3 0.1 mg/mL in 1,2-Dimethoxyethane | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Testosterone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Testosterone Benzoate 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Testosterone Isocaproate 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Testosterone Propionate 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Trenbolone 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | RCS-4 (DD-001, (4-Methoxyphenyl)(1-pentylindol-3-yl)methanone) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | JWH-081 ((4-Methoxynaphthalen-1-yl)(1-pentylindol-3-yl)methanone) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | JWH-122 ((4-Methylnaphthalen-1-yl)(1-pentylindol-3-yl)methanone) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | JWH-203 (2-(2-Chlorophenyl)-1-(1-pentylindol-3-yl)ethanone) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ketamine Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ketamine-D4 Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Iso-LSD (Lysergic Acid Diethylamide) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | LAMPA (Lysergic Acid N-Methyl-N-propylamide) 0.025 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | LSD (Lysergic Acid Diethylamide) 0.025 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | LSD-D3 (Lysergic Acid Diethylamide-D3) 0.025 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | PMA HCl (p-Methoxyamphetamine) 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-MDA (rac-3,4-Methylenedioxyamphetamine) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-MDEA (rac-3,4-Methylenedioxy-N-ethylamphetamine) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 1-Methylamino-1-(3,4-methylenedioxyphenyl)propane Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-BDB HCl (rac-3,4-Methylenedioxyphenyl-2-butanamine Hydrochloride) 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-MDMA (rac-3,4-Methylenedioxymethamphetamine) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Bufotenine 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methylone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Methylone-D3 Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cocaine 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cocaine-D3 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cocaine-D3 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Norcocaine Hydrochloride 1.0 mg/mL in Acetonitrile (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Norcocaine-D3 Hydrochloride 0.1 mg/mL in Acetonitrile (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | O-Methylcodeine 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Buprenorphine 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Buprenorphine 3-beta-D-Glucuronide 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Buprenorphine-D4 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Dihydrocodeine Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Dihydrocodeine-D6 Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Noroxycodone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Noroxycodone-D3 Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Oxycodone 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Oxycodone-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Dihydromorphine 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Hydromorphone-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Anhydroecgonine Hydrochloride 1.0 mg/mL in Acetonitrile (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Anhydroecgonine Methyl Ester 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Benzoylecgonine 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Benzoylecgonine-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Benzoylecgonine-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Benzoylecgonine-D8 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Benzoylecgonine-D8 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cocaethylene (Benzoylethylecgonine) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cocaethylene-D3 (Benzoylethylecgonine-D3) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cocaethylene-D8 (Benzoylethylecgonine-D8) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| 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 in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ecgonine Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ecgonine Methyl Ester 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ecgonine Methyl Ester 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ecgonine-D3 Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ecgonine-D3 Methyl Ester 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Ethylmorphine 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Hydrocodone 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Hydrocodone-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Hydrocodone-D6 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Norhydrocodone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Heroin (Diacetylmorphine) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Heroin-D9 (Diacetylmorphine-D9) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Heroin-D9 (Diacetylmorphine-D9) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methadone 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methadone 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methadone-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methadone-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methadone-D9 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Methadone-D9 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Dextropropoxyphene 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Dextropropoxyphene 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Propoxyphene-D11 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Propoxyphene-D11 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Propoxyphene-D5 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | rac-Propoxyphene-D5 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 6-Acetylmorphine 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 6-Acetylmorphine 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 6-Acetylmorphine-D3 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 6-Acetylmorphine-D3 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 6-Acetylmorphine-D6 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | 6-Acetylmorphine-D6 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Acetylcodeine 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Acetylcodeine 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Nordihydromorphine Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Oxymorphone 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Oxymorphone-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Oxymorphone-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Noroxymorphone Hydrochloride 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Noroxymorphone Hydrochloride 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Butorphanol Tartrate 1.0 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Sufentanil Citrate 0.1 mg/mL in Methanol (as free base) | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | cis-Tilidine (Ethyl (1R,2RS)-2-(Dimethylamino)-1-phenylcyclohex-3-enecarboxylate) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Tilidine 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| Microgenics Corporation | Abbott TDM Multiconstituent Calibrator (CAL 1-6) Catalog Number: 5P04-01 | Box: 7 vials; 5 mL each | 7/2/2012 |
| Microgenics Corporation | Thermo Scientific DRI Opiate Assay Catalog Number: 100014602 | Vial: 18 mL, Box: 3 vials | 1/30/2013 |
| Microgenics Corporation | Thermo Scientific DRI Cannabinoid Assay Catalog Number: 10014665 | Vial: 18 mL, Box: 3 vials | 1/30/2013 |
| Microgenics Corporation | Thermo Scientific Phencyclidine Assay Catalog Number: 10014673 | Vial: 18 mL, Box: 3 vials | 1/30/2013 |
| Microgenics Corporation | Thermo Scientific Ecstacy Assay Catalog Number: 10014681 | Vial: 18 mL, Box: 3 vials | 1/30/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1: Catalog Number 10016362 | Vial: 5 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2: Catalog Number 10063 | Vial: 5 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3: Catalog Number 10016364 | Vial: 5 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Control 1: Catalog Number 10017686 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Control 2: Catalog Number 10017687 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Control 3: Catalog Number 1007688 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1: Catalog Number 10016882 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2: Catalog Number 10016883 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3: Catalog Number 10016884 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Control 1: Catalog Number 10017711 | Vial: 15 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Control 2: Catalog Number 10017712 | Vial: 15 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Control 3: Catalog Number 10017713 | Vial: 15 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 1: Catalog Number 10016700 | Vial: 5 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 2: Catalog Number 10016701 | Vial: 5 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 3: Catalog Number 10016702 | Vial: 5 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Control 1: Catalog Number 10017702 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Control 2: Catalog Number 10017703 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Control 3: Catalog Number 10017704 | Vial: 10 mL; Box: 1 vial | 2/11/2013 |
| Ortho Clinical Diagnostics, Inc | VITROS Immunodiagnostics Products Testosterone Reagent Pack | Plastic chamber: 8.4 mL | 9/28/2012 |
| Ortho Clinical Diagnostics, Inc | VITROS Immunodiagnostics Products Estradiol Reagent Pack | Plastic chamber: 13.3 mL | 9/28/2012 |
| Ortho Clinical Diagnostics, Inc | VITROS Immunodiagnostics Products Testosterone Calibrators (1-3) | Box: 3 vials; 2 mL each | 10/19/2012 |
| Ortho Clinical Diagnostics, Inc | VITROS Immunodiagnostics Products Testosterone Controls (1-3) | Box: 9 vials; 1 mL each | 10/19/2012 |
| Ortho Clinical Diagnostics, Inc | VITROS Immunodiagnostics Products Testosterone Range Verifiers (Low and High) | Box: 4 vials; 1-1.5 mL each | 10/19/2012 |
| Restek | Custom Revised Appendix IX Mix #1 | Glass vial: 1.3 mL | 2/14/2013 |
| Restek Corporation | Product and Reactor Samples Standard | Ampule: 2 mL | 10/12/2012 |
| Restek Corporation | 8270 Supplemental Standard #1 | Ampule: 2 mL | 12/13/2012 |
| Siemens Healthcare Diagnostics Inc | TTST Stock X (Bulk) | Stock container: 50 mL-1 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | VS TTST Cal Bulk Soln Level 1 | Bulk container: 4 mL-100 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | VS TTST Cal Bulk Soln Level 2 | Bulk container: 4 mL-100 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | VS TTST Cal Bulk Soln Level 3 | Bulk container: 4 mL-100 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | VS TTST Cal Bulk Soln Level 4 | Bulk container: 4 mL-100 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | VS TTST Cal Bulk Soln Level 5 | Bulk container: 4 mL-100 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | VS TTST Cal Bulk Soln Level 6 | Bulk container: 4 mL-100 L | 7/26/2012 |
| 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 CAL | Box: 12 vials; 1 ml each | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | MP TTST Lvl 1 Bulk | Bulk container: 4 mL-20 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | MP TTST Lvl 2 Bulk | Bulk container: 4 mL-20 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | MP TTST Lvl 3 Bulk | Bulk container: 4 mL-20 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | MP TTST Lvl 4 Bulk | Bulk container: 4 mL-20 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | MP TTST Lvl 5 Bulk | Bulk container: 4 mL-20 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | MP TTST Lvl 6 Bulk | Bulk container: 4 mL-20 L | 7/26/2012 |
| 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 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | TTST Stock T (Bulk) | Stock container: 50 mL-1 L | 7/26/2012 |
| Siemens Healthcare Diagnostics Inc | Estradiol Diluent | Plastic container: 0.5L-1.0L | 11/14/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista Drug 1 CAL Pilot, Level B | Plastic test tube: 15 mL | 12/3/2012 |
| 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.
[top]
| Supplier | Product name | Form | Application date |
|---|---|---|---|
| Agilent Technologies | Forensic Toxicology Comprehensive Mix-Submix 9A | Ampule: 1 mL | 12/6/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC177 | Glass vials: 1 ml-200 mL | 10/11/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC178 | Glass vials: 1 ml-200 mL | 10/23/2012 |
| Biochemical Diagnostics, Inc | Salivabuse Custom Liquid Control Oral Fluid, OF24 | Glass vials: 1 ml-200 mL | 10/23/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC180 | Glass vials: 1 ml-200 mL | 12/14/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC181 | Glass vials: 1 ml-200 mL | 12/14/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC182 | Glass vials: 1 ml-2 L | 1/22/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC180 | Glass vials: 1 ml-200 mL | 1/29/2013 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC182 | Glass vials: 1 ml-2 L | 2/14/2013 |
| Cerilliant Corporation | (-)-11-nor-9-Carboxy-delta9-THC (1 mg/mL) | Glass ampule: 5 mL | 7/6/2012 |
| 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 (0.5-50 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Controls, Methamphetamine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Controls, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Controls, Multidrug (selected from THC, Cocaine/Benzoylecgonine, Amphetamines, Opiates, & PCP at 0.5-50 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, THC (0.5-50 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, Methamphetamine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (2-200 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| ElSohly Laboratories, Inc | ELI Oral Fluid Calibrators, Multidrug (selected from THC, Cocaine/Benzoylecgonine, Amphetamines, Opiates, & PCP at 0.5-200 ng/mL) | Glass vial: 5 ml-4 L | 8/9/2012 |
| LGC Limited | LAMPA (Lysergic Acid N-Methyl-N-propylamide) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | LSD (Lysergic Acid Diethylamide) 1.0 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | LSD-D3 (Lysergic Acid Diethylamide-D3) 0.1 mg/mL in Acetonitrile | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (-)-Cannabidiol 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | Cannabinol 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (-)-delta9-THC (Dronabinol) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | (-)-delta9-THC-D3 (Dronabinol-D3) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | trans-11-Hydroxy-delta9-THC ((6aRS,10aRS)-11-Hydroxy-delta9-tetrahydrocannabinol) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | trans-11-Hydroxy-delta9-THC ((6aRS,10aRS)-11-Hydroxy-delta9-tetrahydrocannabinol) 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | trans-11-Hydroxy-delta9-THC-D3 (trans-11-Hydroxy-delta9-tetrahydrocannabinol-D3) 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | trans-11-Nor-9-carboxy-delta9-THC 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | trans-11-Nor-9-carboxy-delta9-THC-D3 0.1 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| LGC Limited | trans-11-Nor-9-carboxy-delta9-THC-D3 1.0 mg/mL in Methanol | Glass vial: 1 mL | 11/30/2012 |
| 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 Methanol | Glass vial: 1 mL | 11/30/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista Drug 1 CAL Bulk, Level B | Plastic container: 4-100 L | 12/3/2012 |
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.
[top] 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
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