78 FR 14 pgs. 4446-4458 - Exempt Chemical Preparations Under the Controlled Substances Act
Type: NOTICEVolume: 78Number: 14Pages: 4446 - 4458
Docket number: [Docket No. DEA-361]
FR document: [FR Doc. 2013-01133 Filed 1-18-13; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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.
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).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 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 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.
| Supplier | Product name | Form | Exemption date |
|---|---|---|---|
| Abbott Laboratories | ARCHITECT 2nd Generation Testosterone Calibrators (B,C,D,E,F) | Bottle: 4 mL; Box: 6 bottles | 12/22/2011 |
| Abbott Laboratories | ARCHITECT 2nd Generation Testosterone Controls (L,M,H) | Bottle: 8 mL; Box: 3 bottles | 12/22/2011 |
| Abbott Laboratories | ARCHITECT Estradiol Assay Diluent, No. 2K25J | Bag-in-box: 18-200 L; Flask/Carboy: 1-50 L; Bottle/Vial: 0.5 mL-1 L; Box: 1-50 bottles | 12/22/2011 |
| Abbott Laboratories | ARCHITECT Estradiol Assay Diluent, No. 7K72J | Bottle: 5.9 mL | 12/22/2011 |
| Abbott Laboratories | ARCHITECT Estradiol Reagent Kit, No. 07K72-20 | Bottle: 5.9 mL; Kit: 16 bottles | 12/22/2011 |
| Abbott Laboratories | ARCHITECT Estradiol Reagent Kit, No. 07K72-25 | Bottle: 5.9 mL; Kit: 4 bottles | 12/22/2011 |
| Abbott Laboratories | ARCHITECT Estradiol Reagent Kit, No. 2K25-20 | Bottle: 5.9 mL; Kit: 16 bottles | 12/22/2011 |
| Abbott Laboratories | ARCHITECT Estradiol Reagent Kit, No. 2K25-25 | Bottle: 5.9 mL; Kit: 4 bottles | 12/22/2011 |
| Abbott Laboratories | AxSYM Estradiol Buffer | Flask/Carboy: 1-50 L; Bottle/Vial: 0.5 mL-1 L; Box: 1-50 bottles | 12/22/2011 |
| Abbott Laboratories | AxSYM Estradiol Reagent Pack | Bottle: 5.5 mL, Pack: 4 bottles | 12/22/2011 |
| Agilent Technologies | Special Order Standard TOXI-LAB DISCS; 1, 2, or 3 drugs | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Procedure Standard TOXI-LAB DISCS: Benzodiazepines: Hydrolysis Procedure | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Procedure Standard TOXI-LAB DISCS: Benzoylecgonine | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Procedure Standard TOXI-LAB DISCS: MDMA, MDA, MDEA | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Procedure Standard TOXI-LAB DISCS: Morphine and Hydromorphone: Differentiation | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Procedure Standard TOXI-LAB DISCS: Opiate | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Procedure Standard TOXI-LAB DISCS: Sympathomimetic amines: Differentiation | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | Special Standard TOXI-LAB DISCS LTD-Opiate: 1, 2, or 3 drugs | Plastic Vial: 50 discs | 12/22/2011 |
| Agilent Technologies | TOXI-LAB Chromatograms A | Glass jar: 100 Chromatograms | 12/22/2011 |
| Agilent Technologies | TOXI-LAB Chromatograms B | Glass jar: 100 Chromatograms | 12/22/2011 |
| 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 diethylamide [125I] | Vial: 1 mL | 12/22/2011 |
| 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-methyl-3H] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | (±)-Ketamine hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | 1,1-Dimethyltryptamine (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | 1,1-Dimethyltryptamine [a,ß-3H] as TFA salt | Vial: 1 mL | 12/22/2011 |
| 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] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Amphetamine, DL-[ring-2,3,5-3H] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Amphetamine, L-[ring-2,3,5-3H] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Buprenorphine [ring-3H] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Buprenorphine hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Cocaine (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Cocaine [methyl-14C] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Cocaine, levo-[benzoyl-3,4-3H(N)] | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Codeine (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | D-Amphetamine hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| 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 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | D-Methamphetamine hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| 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] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Ibogaine (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | L-Amphetamine hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | L-Methamphetamine hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Lysergic Acid (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Lysergic acid diethylamide [N-methyl-3H] | Vial: 1 mL | 3/22/2012 |
| American Radiolabeled Chemicals, Inc | Mazindol (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Meperidine Hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| 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] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Methamphetamine, L-[methyl-14C] hydrochloride | Vial: 1 mL | 12/22/2011 |
| 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] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Oxycodone hydrochloride (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| 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 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Phenylacetone (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Tetrahydrocannabidinol (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Thebaine (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Thebaine [N-methyl-14C] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Thebaine [N-methyl-3H] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Thebaine [O-methyl-14C] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | Thebaine [O-methyl-3H] hydrochloride | Vial: 1 mL | 12/22/2011 |
| American Radiolabeled Chemicals, Inc | ?-Hydroxybutyric acid sodium salt (1 mg/mL) | Vial: 1 mL | 12/22/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF10 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF11 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF12 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF13 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF14 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF15 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF16 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF17 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF18 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF19 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF20 | Glass vials: 1 ml-200 mL | 7/31/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF21 | Glass vials: 1 ml-200 mL | 7/31/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF4 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF5 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF6 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF8 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Oral Fluid, OF9 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC134 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC135 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC136 | Glass vials: 1 ml-100 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC137 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC138 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC139 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC140 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC141 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC143 | Glass vials: 1 ml-200 mL | 2/1/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC144 | Glass vials: 1 ml-200 mL | 3/8/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC145 | Glass vials: 1 ml-200 mL | 3/8/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC146 | Glass vials: 1 ml-200 mL | 3/8/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC147 | Glass vials: 1 ml-200 mL | 3/8/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC148 | Glass vials: 1 ml-200 mL | 3/8/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC149 | Glass vials: 1 ml-200 mL | 3/22/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC150 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC151 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC152 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC153 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC154 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC155 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC156 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC157 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC158 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC159 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC160 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC161 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC162 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC163 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC164 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC165 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC166 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC167 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC168 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC169 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC170 | Glass vials: 1 ml-200 mL | 8/20/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC171 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC172 | Glass vials: 1 ml-200 mL | 7/31/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, MC173 | Glass vials: 1 ml-200 mL | 7/31/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD10 | Glass vials: 1 ml-200 mL | 2/1/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD11 | Glass vials: 1 ml-200 mL | 2/1/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD12 | Glass vials: 1 ml-200 mL | 2/1/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD13 | Glass vials: 1 ml-200 mL | 2/1/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD14 | Glass vials: 1 ml-200 mL | 2/1/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD15 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Biochemical Diagnostics, Inc | Detectabuse Custom Liquid Control Urine, SD16 | Glass vials: 1 ml-200 mL | 7/5/2012 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Levels 1, 2, and 3 | Amber Vial: 10 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Trilevel | Amber Vial: 10 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Immunoassay Plus Control Trilevel Minipak | Amber Vial: 5 mL; Box: 3 vials | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S10 | Box: 10 vials, 10 mL each | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S10 Low Opiate | Box: 10 vials, 10 mL each | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S10 Low Opiate Minipak | Amber vial: 10 mL | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S10 Minipak | Amber vial: 10 mL | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S20 | Box: 10 vials, 10 mL each | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S20 Low Opiate | Box: 10 vials, 10 mL each | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S20 Low Opiate Minipak | Amber vial: 10 mL | 5/31/2012 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S20 Minipak | Amber vial: 10 mL | 5/31/2012 |
| Bio-Rad Laboratories | Liquid Assayed Multiqual Levels 1-3 | Amber Vial: 2.5 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Liquid Assayed Multiqual Trilevel MiniPak | Amber Vial: 2.5 mL; Box: 3 vials | 12/22/2011 |
| Bio-Rad Laboratories | Liquid Unassayed Multiqual Levels 1-3 | Amber Vial: 2.5 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Liquid Unassayed Multiqual Trilevel MiniPak | Amber Vial: 2.5 mL; Box: 3 vials | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Assayed Chemistry Control Bilevel MiniPak | Box 2 vials; 5 mL each | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Assayed Chemistry Control Levels 1-2 | Amber Vial: 5 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Immunoassay Plus Control Levels 1, 2, and 3 | Amber Vial: 10 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Immunoassay Plus Control Trilevel | Amber Vial: 10 mL; Box: 12 vials | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Immunoassay Plus Control Trilevel Minipak | Amber Vial: 5 mL; Box: 3 vials | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Unassayed Chemistry Control (Human) Bilevel MiniPak | Box 2 vials; 5 mL each | 12/22/2011 |
| Bio-Rad Laboratories | Lyphochek Unassayed Chemistry Control (Human) Levels 1-2 | Amber Vial: 5 mL; Box: 25 vials | 12/22/2011 |
| Cerilliant Corporation | (±) Pentazocine-13C3 (0.1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | (±)-cis-11-Nor-9-carboxy-delta9-THC-D3 glucuronide (0.1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | 3,4-Methylenedioxypyrovalerone HCl (1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | 3,4-Methylenedioxypyrovalerone-D8 HCl (0.1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | 3-Desmethylprodine (1 mg/mL) | Glass Ampule: 1 mL | 7/31/2012 |
| Cerilliant Corporation | 3-Desmethylprodine HCl (1 mg/mL) | Glass Ampule: 1 mL | 7/31/2012 |
| Cerilliant Corporation | 6-alpha/beta-Hydroxyoxymorphone (1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | 6-alpha/beta-Hydroxyoxymorphone-D3 (0.1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| 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/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | Cocaine N-oxide-D3 HCl (0.1 mg/mL) | Glass Ampule: 2 mL | 3/8/2012 |
| 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 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | Lisdexamfetamine-D4 dimesylate (0.1 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| 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 µg/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 Mix (0.5 mg/mL) | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | Opiate Internal Standard Mix-15 | Glass Ampule: 2 mL | 12/22/2011 |
| Cerilliant Corporation | Pseudobuprenorphine dihydrochloride (1.0mg/mL) | Glass Ampule: 1 mL | 2/1/2012 |
| 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 ?9-Tetrahydrocannabinol-glucoronide (10 µg/mL in MeOH) | Glass vial: 1 ml | 5/31/2012 |
| ElSohly Laboratories, Inc | ELI Drug Standards ?9-Tetrahydrocannabinol-glucoronide (100 µg/mL in MeOH) | Glass vial: 1 ml | 5/31/2012 |
| Environmental Resource Associates (ERA) | Chloral Hydrate, Proficiency Testing Material, Catalog No. 853 | Glass Ampule: 2 mL | 3/8/2012 |
| Environmental Resource Associates (ERA) | Chloral Hydrate, Reference Material, Catalog No. 676 | Glass Ampule: 2 mL | 3/8/2012 |
| Environmental Resource Associates (ERA) | Waters Steroid Test Mix, Part No. 07364 | Glass Ampule: 2 mL | 3/8/2012 |
| 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 Pain Management Prediluted in Extraction Buffer | Glass vial: 10 mL | 6/19/2012 |
| Immunalysis Corporation | Oral Fluid High Positive Control Pain Management Prediluted in Extration Buffer | Glass vial: 10 mL | 6/19/2012 |
| Immunalysis Corporation | Oral Fluid Low Positive Control Pain Management Prediluted in Extraction Buffer | Glass vial: 10 mL | 6/19/2012 |
| 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 (1.0 mg/mL) | Glass Ampule: 1 mL | 5/9/2012 |
| Microgenics Corporation | CEDIA Amphetamine OFT Assay, Catalog Number: 10014947 | Box: 4 bottles; 65 mL each | 12/22/2011 |
| Microgenics Corporation | CEDIA Cannabinoids OFT Assay, Catalog Number: 10014910 | Box: 4 bottles; 65 mL each | 12/22/2011 |
| Microgenics Corporation | CEDIA Cocaine OFT Assay, Catalog Number: 10014764 | Box: 4 bottles; 65 mL each | 12/22/2011 |
| Microgenics Corporation | CEDIA Methamphetamine OFT Assay, Catalog Number: 10014949 | Box: 4 bottles; 65 mL each | 12/22/2011 |
| Microgenics Corporation | CEDIA Methamphetamine OFT Control Set (Low and High) , Catalog #10014953 | Vial: 10 mL Box: 2 vials | 12/22/2011 |
| Microgenics Corporation | CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog #10014951 | Vial: 5 mL Box: 1 vial | 12/22/2011 |
| Microgenics Corporation | CEDIA Methamphetamine OFT High Calibrator, Catalog #10014952 | Vial: 5 mL Box: 1 vial | 12/22/2011 |
| Microgenics Corporation | CEDIA Multi-Drug OFT Control Set (Low and High), Catalog #10014957 | Vial: 15 mL Box: 2 vials | 12/22/2011 |
| Microgenics Corporation | CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog #10014955 | Vial: 10 mL Box: 1 vial | 12/22/2011 |
| Microgenics Corporation | CEDIA Multi-Drug OFT High Calibrator, Catalog #10014956 | Vial: 10 mL Box: 1 vial | 12/22/2011 |
| Microgenics Corporation | CEDIA Opiate OFT Assay, Catalog Number: 10014873 | Box: 4 bottles; 65 mL each | 12/22/2011 |
| Microgenics Corporation | CEDIA PCP OFT Assay, Catalog Number: 10014888 | Box: 4 bottles; 65 mL each | 12/22/2011 |
| Microgenics Corporation | CEDIA THC OFT Control Set (Low and High), Catalog #10014925 | Vial: 10 mL Box: 2 vials | 12/22/2011 |
| Microgenics Corporation | CEDIA THC OFT Cutoff Calibrator, Catalog #10014923 | Vial: 5 mL Box: 1 vial | 12/22/2011 |
| Microgenics Corporation | CEDIA THC OFT High Calibrator, Catalog #10014924 | Vial: 5 mL Box: 1 vial | 12/22/2011 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016345 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016362 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016346 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016363 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016347 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016364 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Calibrator 4, Catalog Number: 10016348 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016349 | Vial: 10 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016365 | Vial: 10 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016808 | Vial: 10 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog Number: 10016807 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016865 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016882 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016866 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016883 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016867 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016884 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Calibrator 4, Catalog Number: 10016868 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016869 | Vial: 15 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016885 | Vial: 15 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016895 | Vial: 15 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog Number: 10016894 | Vial: 10 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016644 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016700 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016646 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016701 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016647 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016702 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Calibrator 4 Catalog Number: 10016648 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016649 | Vial: 10 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016703 | Vial: 10 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016731 | Vial: 10 mL Box: 2 vials | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific CEDIA THC OFT Cutoff Calibrator Catalog Number: 10016730 | Vial: 5 mL Box: 1 vial | 7/5/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016005 | Vials: 500 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016006 | 3 vials, 18 mL each | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl Assay Catalog Number: 10016437 | 3 vials, 18 mL each | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl Calibrator 2 ng/mL Catalog Number: 10016023 | Vials: 10 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl High Control 1 ng/mL Catalog Number: 10016484 | Box: 1 vial; 25 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl High Control 2 ng/mL Catalog Number: 10016485 | Box: 1 vial; 10 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl High Control 3 ng/mL Catalog Number: 10016024 | Vials: 25 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl High Control 3 ng/mL Catalog Number: 10016486 | Box: 1 vial; 25 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific DRI Fentanyl Low Control 1 ng/mL Catalog Number: 10016022 | Vials: 25 mL | 5/31/2012 |
| Microgenics Corporation | Thermo Scientific MAS Omni•CORE Liquid Assayed Integrated Chemistry Control Levels 1-3 | Vial 5 mL; Box: 6 vials | 12/22/2011 |
| Microgenics Corporation | Thermo Scientific MAS Omni•CORE Liquid Assayed Integrated Chemistry Control Sample Pack | Box: 6 vials; 5 mL each | 12/22/2011 |
| Microgenics Corporation | Thermo Scientific MAS Omni•IMMUNE Liquid Assayed Integrated Chemistry Control Levels 1-3 | Vial 5 mL; Box: 6 vials | 12/22/2011 |
| Microgenics Corporation | Thermo Scientific MAS Omni•IMMUNE Liquid Assayed Integrated Chemistry Control Sample Pack | Box: 6 vials; 5 mL each | 12/22/2011 |
| Microgenics Corporation | Thermo Scientific MAS Omni•IMMUNE PRO Liquid Assayed Integrated Chemistry Control Levels 1-3 | Vial 5 mL; Box: 6 vials | 12/22/2011 |
| Microgenics Corporation | Thermo Scientific MAS Omni•IMMUNE PRO Liquid Assayed Integrated Chemistry Control Sample Pack | Box: 6 vials; 5 mL each | 12/22/2011 |
| Restek Corporation | Appendix IX Mix #1, Revised | Ampule: 2 mL | 12/22/2011 |
| Restek Corporation | Custom a,a-Dimethylphenethylamine Standard | Ampule: 2 mL | 12/22/2011 |
| 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 | Ampule: 2 mL | 2/1/2012 |
| Restek Corporation | UCMR3 Method 539 Calibration Standard | Ampule: 2 mL | 12/22/2011 |
| Restek Corporation | UCMR3 Method Calibration Standard | Ampule: 2 mL | 5/31/2012 |
| 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 Material No. 05473390190 | Box of 6 vials, 10 mL each | 7/31/2012 |
| Roche Diagnostics Operations, Inc | Oral Fluid DAT Control Set B Material No. 05473411190 | Box of 6 vials, 10 mL each | 7/31/2012 |
| Roche Diagnostics Operations, Inc | Oral Fluid DAT Qual Cal Material No. 05475929190 | Box of 4 vials, 5 mL each | 7/31/2012 |
| Roche Diagnostics Operations, Inc | Oral Fluid DAT SQ Cal A Material No. 05475872190 | Box of 6 vials, 5 mL each | 7/31/2012 |
| Roche Diagnostics Operations, Inc | Oral Fluid DAT SQ Cal B Material No. 05475899190 | Box of 6 vials, 5 mL each | 7/31/2012 |
| SAFC Biosciences | HH-4 Cell Culture Medium | Bag: 1L, 200L, 500L; Bottle: 1L, 2L | 2/3/2012 |
| 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 each | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | ADVIA Chemistry Drug CAL 1, Level 2 | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | ADVIA Chemistry Drug CAL 1, Level 3 | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | ADVIA Chemistry Drug CAL 1, Level 4 | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | ADVIA Chemistry Drug CAL 1, Level 5 | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC CAL 2 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC CAL 3 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC CAL 4 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC CAL 5 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC Control 1 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC Control 2 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC Control 3 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC Control 4 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC Control 5 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Bulk EII Plus THC Control 6 ML | Bulk Container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Dimension Drug Calibrator, Level 2 | Vial: 2.5 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Drug Calibrator, Level 3 | Vial: 2.5 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Drug Calibrator, Level 4 | Vial: 2.5 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Drug Calibrator, Level 5 | Vial: 2.5 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Clinical Chemistry System DRUG Calibrator | Carton: 10 vials; 2.5 ml each | 11/5/2012 |
| 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, Level B | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista Drug 4 CAL, Level C | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista Drug 4 CAL, Level D | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista Drug 4 CAL, Level E | Vial: 3 mL | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista LOCI 8 CAL | Box of 10 vials; Vial: 2.5 mL | 3/22/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista LOCI 9 CAL Levels A-E | Vial: 1.5 mL | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista System DRUG 1 CAL | Carton: 6 vials; 2.5 mL each | 7/31/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista System Drug 4 CAL | Carton: 10 vials; 3 ml each | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista System LOCI 9 Calibrator | Box of 10 vials; Vial: 1.5 mL | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista UDAT CAL | Glass vial: 3 mL; Carton: 6 vials | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista UDAT CAL Bulk, Level B | Bulk Container: 20 L-25 L | 5/31/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista UDAT CAL Pilot, Level B | Pilot Container: 2 mL-125 mL | 5/31/2012 |
| Siemens Healthcare Diagnostics Inc | Dimension Vista UDAT CAL, Level B | Glass vial: 3 mL | 12/22/2011 |
| 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 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | VS Drug 1 Cal Bulk Soln, Level B | Bulk container: 2 mL-1 L | 7/31/2012 |
| Siemens Healthcare Diagnostics Inc | VS LOCI 9 CAL BULK SOLN Levels 1-5 | Bulk container: 4 mL-100 L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc | VS LOCI CAL 8 BULK SOLN Level 2 | Bulk container: 4 mL-100 L | 3/22/2012 |
| Siemens Healthcare Diagnostics Inc | VS LOCI CAL 8 BULK SOLN Level 3 | Bulk container: 4 mL-100 L | 3/22/2012 |
| Siemens Healthcare Diagnostics Inc | VS LOCI CAL 8 BULK SOLN Level 4 | Bulk container: 4 mL-100 L | 3/22/2012 |
| Siemens Healthcare Diagnostics Inc | VS LOCI CAL 8 BULK SOLN Level 5 | Bulk container: 4 mL-100 L | 3/22/2012 |
| 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 µg/mL in methanol | Glass ampule: 1 mL | 7/31/2012 |
| Ultra Scientific, Inc | DSA Detection Cocaine HCl Standard | Amber ampule: 1 mL | 12/22/2011 |
| Ultra Scientific, Inc | DSA Detection Cocaine HCl StandardPhenobarbital (625 µg/mL) | Amber ampule: 1 mL | 12/22/2011 |
| Ultra Scientific, Inc | DSA Detection Cocaine HCl StandardPhenobarbital (6400 µg/mL) | Amber ampule: 1 mL | 12/22/2011 |
| Ultra Scientific, Inc | GE-Ion Track 100 ng/µL TNT/Cocaine HCl Standard Rev. 1 | Amber ampule: 10 mL | 12/22/2011 |
| Ultra Scientific, Inc | GE-Ion Track 100 ng/µL TNT/Cocaine HCl Standard Rev. 1 | Glass bottle: 100 mL | 12/22/2011 |
| Ultra Scientific, Inc | Phenobarbital (625 µg/mL) | Amber ampule: 1 mL | 5/31/2012 |
| Ultra Scientific, Inc | Phenobarbital (6400 µg/mL) | Amber ampule: 1 mL | 5/31/2012 |
| Ultra Scientific, Inc | Ultracheck WS Chloral Hydrate Sample | Glass ampule: 2 mL | 12/22/2011 |
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.
| Supplier | Product name | Form | Denial date |
|---|---|---|---|
| Abbott Laboratories | ARCHITECT Estradiol Assay Diluent, No. 2K25J | Tank: 50-500 L | 12/22/2011 |
| Abbott Laboratories | AxSYM Estradiol Buffer | Bulk Tank: 50-500 L; Bag-in-box: 18-200 L | 12/22/2011 |
| American Radiolabeled Chemicals, Inc. | Lysergic acid diethylamide | Vial: 1 mL | 12/22/2011 |
| Biochemical Diagnostics, Inc. | Benzoylecgonine Bulk Solution (5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| 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 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC134 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC135 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC136 | Glass vials: 200 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC137 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC138 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC139 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC140 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC141 | Glass vials: 500 ml-2 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Detectabuse Custom Liquid Control Urine, MC142 | Glass vials: 1 ml-200 mL | 11/15/2011 |
| Biochemical Diagnostics, Inc. | d-Methamphetamine Bulk Solution(5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | d-Propoxyphene Bulk Solution (5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Hydrocodone Bulk Solution(5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Hydromorphone Bulk Solution(5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| 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/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Methaqualone Bulk Solution(5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Morphine Bulk Solution (5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Oxazepam Bulk Solution (5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Biochemical Diagnostics, Inc. | Secobarbital Bulk Solution (5 mg/mL) | Bottle: 1 ml-1 L | 11/15/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control C1 Minipak | Amber Vial: 20mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control C2 Minipak | Amber Vial: 20mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control C3 Minipak | Amber Vial: 20mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control C4 Minipak | Amber Vial: 20mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control Low Opiate Level C2 Minipak | Amber Vial: 20mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control Low Opiate Level C3 Minipak | Amber Vial: 20mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S1 Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S1E Low Opiate Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S1E Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S1S Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S2 Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S2E Low Opiate Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S2E Minipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S2SMinipak | Amber Vial: 10mL | 12/22/2011 |
| Bio-Rad Laboratories | Liquichek Urine Toxicology Control S3 Minipak | Amber Vial: 10mL | 12/22/2011 |
| Cayman Chemical Company | 4-Methylmethcathinone (hydrochloride), 10 mg in 1 mL Methanol | Glass vial: 1 mL | 7/31/2012 |
| Cayman Chemical Company | 4-Methylmethcathinone (hydrochloride), 25 mg in 2.5 mL Methanol | Glass vial: 2.5 mL | 7/31/2012 |
| Cayman Chemical Company | 4-Methylmethcathinone (hydrochloride), 5 mg in 500 µL Methanol | Glass vial: 500 µL | 7/31/2012 |
| Cayman Chemical Company | 5-methoxy DMT, 10 mg in 1 mL Methanol | Glass vial: 1 mL | 7/31/2012 |
| Cayman Chemical Company | 5-methoxy DMT, 25 mg in 2.5 mL Methanol | Glass vial: 2.5 mL | 7/31/2012 |
| Cayman Chemical Company | 5-methoxy DMT, 5 mg in 500 µL Methanol | Glass vial: 500 µL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone (hydrochloride), 10 mg in 1 mL Methanol | Glass vial: 1 mL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone (hydrochloride), 25 mg in 2.5 mL Methanol | Glass vial: 2.5 mL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone (hydrochloride), 5 mg in 500 µL Methanol | Glass vial: 500 µL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone, 10 mg in 1 mL Methanol | Glass vial: 1 mL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone, 25 mg in 2.5 mL Methanol | Glass vial: 2.5 mL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone, 5 mg in 500 µL Methanol | Glass vial: 500 µL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone-d8 (hydrochloride), 10 mg in 1 mL Methanol | Glass vial: 1 mL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone-d8 (hydrochloride), 25 mg in 2.5 mL Methanol | Glass vial: 2.5 mL | 7/31/2012 |
| Cayman Chemical Company | Methylenedioxy Pyrovalerone-d8 (hydrochloride), 5 mg in 500 µL Methanol | Glass vial: 500 µL | 7/31/2012 |
| Cayman Chemical Company | Methylone (hydrochloride), 10 mg in 1 mL Methanol | Glass vial: 1 mL | 7/31/2012 |
| Cayman Chemical Company | Methylone (hydrochloride), 25 mg in 2.5 mL Methanol | Glass vial: 2.5 mL | 7/31/2012 |
| Cayman Chemical Company | Methylone (hydrochloride), 5 mg in 500 µL Methanol | Glass vial: 500 µL | 7/31/2012 |
| 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 |
| 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 1-4 | Glass vial: 10 mL | 6/19/2012 |
| 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 mg/mL) | Ampule: 2 mL | 7/5/2012 |
| Siemens Healthcare Diagnostics Inc. | Dimension Vista UDAT CAL Bulk, Level B | Bulk Container: 4mL-100L | 12/22/2011 |
| Siemens Healthcare Diagnostics Inc. | Dimension Vista UDAT CAL Bulk, Level B | Bulk Container: 26 L-50L | 5/31/2012 |
| 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 L | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc. | Drug CAL BULK SOLN, Level 4 | Bulk container: 2 mL-100 L | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc. | Drug CAL BULK SOLN, Level 5 | Bulk container: 2m L-100 L | 11/5/2012 |
| Siemens Healthcare Diagnostics Inc. | VS Drug 1 Cal Bulk Soln, Level B | Bulk container: 2 mL-100 L | 7/31/2012 |
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. 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 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