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Notice

Exempt Chemical Preparations Under the Controlled Substances Act

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 4446

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.

Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

SUPPLEMENTARY INFORMATION:

Legal Authority

DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act and the Controlled Substances Import and Export Act (codified at Title 21, Chapter 13 of the U.S.C.), as amended (hereinafter, “CSA”). DEA drafts and publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Section 201 of the CSA (21 U.S.C. 811) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA certain compounds, mixtures, or preparations containing a controlled substance, if he finds that such compounds, mixtures, or preparations meet the requirements detailed in 21 U.S.C. 811(g)(3)(B).[1] DEA regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria by which the DEA Deputy Assistant Administrator may exempt a chemical preparation or mixture from the application of certain provisions of the CSA. The Deputy Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which exemptions are granted and modify the scope of exemptions at any time.

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 Start Printed Page 4447narcotic substance cannot in practice be removed.

Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), 21 CFR 1308.23, and 21 CFR 1308.24, the Deputy Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by DEA, are exempt from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA and from application of 21 CFR 1301.74, to the extent described in 21 CFR 1308.24, as of the date listed below that was provided in the approval letters to the individual requesters.

Chart I

SupplierProduct nameFormExemption date
Abbott LaboratoriesARCHITECT 2nd Generation Testosterone Calibrators (B,C,D,E,F)Bottle: 4 mL; Box: 6 bottles12/22/2011
Abbott LaboratoriesARCHITECT 2nd Generation Testosterone Controls (L,M,H)Bottle: 8 mL; Box: 3 bottles12/22/2011
Abbott LaboratoriesARCHITECT Estradiol Assay Diluent, No. 2K25JBag-in-box: 18-200 L; Flask/Carboy: 1-50 L; Bottle/Vial: 0.5 mL-1 L; Box: 1-50 bottles12/22/2011
Abbott LaboratoriesARCHITECT Estradiol Assay Diluent, No. 7K72JBottle: 5.9 mL12/22/2011
Abbott LaboratoriesARCHITECT Estradiol Reagent Kit, No. 07K72-20Bottle: 5.9 mL; Kit: 16 bottles12/22/2011
Abbott LaboratoriesARCHITECT Estradiol Reagent Kit, No. 07K72-25Bottle: 5.9 mL; Kit: 4 bottles12/22/2011
Abbott LaboratoriesARCHITECT Estradiol Reagent Kit, No. 2K25-20Bottle: 5.9 mL; Kit: 16 bottles12/22/2011
Abbott LaboratoriesARCHITECT Estradiol Reagent Kit, No. 2K25-25Bottle: 5.9 mL; Kit: 4 bottles12/22/2011
Abbott LaboratoriesAxSYM Estradiol BufferFlask/Carboy: 1-50 L; Bottle/Vial: 0.5 mL-1 L; Box: 1-50 bottles12/22/2011
Abbott LaboratoriesAxSYM Estradiol Reagent PackBottle: 5.5 mL, Pack: 4 bottles12/22/2011
Agilent TechnologiesSpecial Order Standard TOXI-LAB DISCS; 1, 2, or 3 drugsPlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Procedure Standard TOXI-LAB DISCS: Benzodiazepines: Hydrolysis ProcedurePlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Procedure Standard TOXI-LAB DISCS: BenzoylecgoninePlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Procedure Standard TOXI-LAB DISCS: MDMA, MDA, MDEAPlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Procedure Standard TOXI-LAB DISCS: Morphine and Hydromorphone: DifferentiationPlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Procedure Standard TOXI-LAB DISCS: OpiatePlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Procedure Standard TOXI-LAB DISCS: Sympathomimetic amines: DifferentiationPlastic Vial: 50 discs12/22/2011
Agilent TechnologiesSpecial Standard TOXI-LAB DISCS LTD-Opiate: 1, 2, or 3 drugsPlastic Vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB Chromatograms AGlass jar: 100 Chromatograms12/22/2011
Agilent TechnologiesTOXI-LAB Chromatograms BGlass jar: 100 Chromatograms12/22/2011
Agilent TechnologiesTOXI-LAB CONTROL LTD FMPlastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB CONTROL No. 19Plastic bottle: 2 oz12/22/2011
Agilent TechnologiesTOXI-LAB CONTROL No. 2Plastic bottle: 2 oz.12/22/2011
Agilent TechnologiesTOXI-LAB CONTROL No. 3Plastic bottle: 2 oz12/22/2011
Agilent TechnologiesTOXI-LAB CONTROL No. 5Plastic bottle: 2 oz12/22/2011
Agilent TechnologiesTOXI-LAB CONTROL THCPlastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS A-1Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS A-2Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS A-3Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS A-4Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS B-1Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS B-2Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS B-3Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS B-4Plastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS LTD HDPlastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS LTD OPPlastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS LTD OPIPlastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB DISCS THCPlastic vial: 50 discs12/22/2011
Agilent TechnologiesTOXI-LAB Proficiency SamplePlastic bottle: 2 oz12/22/2011
American Radiolabeled Chemicals, Inc(+)-iodo-Lysergic Acid diethylamide [125I]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, Inc(+)-Pentazocine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, Inc(+)-Pentazocine [ring-1,3-3H]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, Inc(±)-Ketamine [N-methyl-3H] hydrochlorideVial: 1 mL12/22/2011
Start Printed Page 4448
American Radiolabeled Chemicals, Inc(±)-Ketamine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, Inc1,1-Dimethyltryptamine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, Inc1,1-Dimethyltryptamine [a,β-3H] as TFA saltVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncAmobarbital (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncAmphetamine, D-[ring-2,3,5-3H] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncAmphetamine, DL-[ring-2,3,5-3H] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncAmphetamine, L-[ring-2,3,5-3H] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncBuprenorphine [ring-3H] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncBuprenorphine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncCocaine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncCocaine [methyl-14C] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncCocaine, levo-[benzoyl-3,4-3H(N)]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncCodeine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncD-Amphetamine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncDextropropoxyphene (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncDiazepam (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncDihydrocodeine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncDihydromorphine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncDiprenorphine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncDL-Amphetamine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncD-Methamphetamine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncEcgonine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFentanyl (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFentanyl [3H(G)] as TFA saltVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFludiazepam (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFlunitrazepam (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFlunitrazepam [methyl-3H]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFlurazepam (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncFlurazepam [N-methyl-3H]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncHeroin (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncHeroin [methyl-14C]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncHeroin [methyl-3H]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncHydrocodone (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncHydromorphone (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncHydromorphone [N-methyl-14C] hydrochlorideVial: 1 mL12/22/2011
Start Printed Page 4449
American Radiolabeled Chemicals, IncIbogaine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncL-Amphetamine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncL-Methamphetamine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncLysergic Acid (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncLysergic acid diethylamide [N-methyl-3H]Vial: 1 mL3/22/2012
American Radiolabeled Chemicals, IncMazindol (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMeperidine Hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMetazocine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMetazocine [ring-1,3-3H]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMethamphetamine, D-[methyl-14C] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMethamphetamine, L-[methyl-14C] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMidazolam (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMidazolam [3H(G)]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMorphine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncMorphine [N-methyl-14C]Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncNormorphine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncOripavine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncOxycodone [N-methyl-14C] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncOxycodone hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncOxymorphone (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncPhenazocine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncPhencyclidine hydrochloride (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncPhenylacetone (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncTetrahydrocannabidinol (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncThebaine (1 mg/mL)Vial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncThebaine [N-methyl-14C] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncThebaine [N-methyl-3H] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncThebaine [O-methyl-14C] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, IncThebaine [O-methyl-3H] hydrochlorideVial: 1 mL12/22/2011
American Radiolabeled Chemicals, Incγ-Hydroxybutyric acid sodium salt (1 mg/mL)Vial: 1 mL12/22/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF10Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF11Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF12Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF13Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF14Glass vials: 1 ml-200 mL7/5/2012
Start Printed Page 4450
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF15Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF16Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF17Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF18Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF19Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF20Glass vials: 1 ml-200 mL7/31/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF21Glass vials: 1 ml-200 mL7/31/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF4Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF5Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF6Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF8Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Oral Fluid, OF9Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC134Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC135Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC136Glass vials: 1 ml-100 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC137Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC138Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC139Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC140Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC141Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC143Glass vials: 1 ml-200 mL2/1/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC144Glass vials: 1 ml-200 mL3/8/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC145Glass vials: 1 ml-200 mL3/8/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC146Glass vials: 1 ml-200 mL3/8/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC147Glass vials: 1 ml-200 mL3/8/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC148Glass vials: 1 ml-200 mL3/8/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC149Glass vials: 1 ml-200 mL3/22/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC150Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC151Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC152Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC153Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC154Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC155Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC156Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC157Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC158Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC159Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC160Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC161Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC162Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC163Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC164Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC165Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC166Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC167Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC168Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC169Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC170Glass vials: 1 ml-200 mL8/20/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC171Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC172Glass vials: 1 ml-200 mL7/31/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC173Glass vials: 1 ml-200 mL7/31/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD10Glass vials: 1 ml-200 mL2/1/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD11Glass vials: 1 ml-200 mL2/1/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD12Glass vials: 1 ml-200 mL2/1/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD13Glass vials: 1 ml-200 mL2/1/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD14Glass vials: 1 ml-200 mL2/1/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD15Glass vials: 1 ml-200 mL7/5/2012
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, SD16Glass vials: 1 ml-200 mL7/5/2012
Start Printed Page 4451
Bio-Rad LaboratoriesLiquichek Immunoassay Plus Control Levels 1, 2, and 3Amber Vial: 10 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLiquichek Immunoassay Plus Control TrilevelAmber Vial: 10 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLiquichek Immunoassay Plus Control Trilevel MinipakAmber Vial: 5 mL; Box: 3 vials12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S10Box: 10 vials, 10 mL each5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S10 Low OpiateBox: 10 vials, 10 mL each5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S10 Low Opiate MinipakAmber vial: 10 mL5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S10 MinipakAmber vial: 10 mL5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S20Box: 10 vials, 10 mL each5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S20 Low OpiateBox: 10 vials, 10 mL each5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S20 Low Opiate MinipakAmber vial: 10 mL5/31/2012
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S20 MinipakAmber vial: 10 mL5/31/2012
Bio-Rad LaboratoriesLiquid Assayed Multiqual Levels 1-3Amber Vial: 2.5 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLiquid Assayed Multiqual Trilevel MiniPakAmber Vial: 2.5 mL; Box: 3 vials12/22/2011
Bio-Rad LaboratoriesLiquid Unassayed Multiqual Levels 1-3Amber Vial: 2.5 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLiquid Unassayed Multiqual Trilevel MiniPakAmber Vial: 2.5 mL; Box: 3 vials12/22/2011
Bio-Rad LaboratoriesLyphochek Assayed Chemistry Control Bilevel MiniPakBox 2 vials; 5 mL each12/22/2011
Bio-Rad LaboratoriesLyphochek Assayed Chemistry Control Levels 1-2Amber Vial: 5 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLyphochek Immunoassay Plus Control Levels 1, 2, and 3Amber Vial: 10 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLyphochek Immunoassay Plus Control TrilevelAmber Vial: 10 mL; Box: 12 vials12/22/2011
Bio-Rad LaboratoriesLyphochek Immunoassay Plus Control Trilevel MinipakAmber Vial: 5 mL; Box: 3 vials12/22/2011
Bio-Rad LaboratoriesLyphochek Unassayed Chemistry Control (Human) Bilevel MiniPakBox 2 vials; 5 mL each12/22/2011
Bio-Rad LaboratoriesLyphochek Unassayed Chemistry Control (Human) Levels 1-2Amber Vial: 5 mL; Box: 25 vials12/22/2011
Cerilliant Corporation(±) Pentazocine-13C3 (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant Corporation(±)-cis-11-Nor-9-carboxy-delta9-THC-D3 glucuronide (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant Corporation3,4-Methylenedioxypyrovalerone HCl (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant Corporation3,4-Methylenedioxypyrovalerone-D8 HCl (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant Corporation3-Desmethylprodine (1 mg/mL)Glass Ampule: 1 mL7/31/2012
Cerilliant Corporation3-Desmethylprodine HCl (1 mg/mL)Glass Ampule: 1 mL7/31/2012
Cerilliant Corporation6-alpha/beta-Hydroxyoxymorphone (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant Corporation6-alpha/beta-Hydroxyoxymorphone-D3 (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationBuprenorphine N-oxide (1 mg/mL)Glass Ampule: 1 mL12/22/2011
Cerilliant CorporationCannabinol-D3 (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationCarisoprodol (1 mg/mL)Glass Ampule: 2 mL12/22/2012
Cerilliant CorporationCarisoprodol-D7 (0.1 mg/mL)Glass Ampule: 2 mL12/22/2012
Cerilliant CorporationCarisoprodol-D7 (1 mg/mL)Glass Ampule: 2 mL7/31/2012
Cerilliant CorporationCocaine N-oxide HCl (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationCocaine N-oxide HCl (1 mg/mL)Glass Ampule: 2 mL3/8/2012
Cerilliant CorporationCocaine N-oxide-D3 HCl (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationCocaine N-oxide-D3 HCl (0.1 mg/mL)Glass Ampule: 2 mL3/8/2012
Cerilliant CorporationDrug Solution # 15Screw-cap Vial: 50 mL6/5/2012
Cerilliant CorporationLacosamide (1 mg/mL)Glass Ampule: 2 mL5/31/2012
Cerilliant CorporationLacosamide-13C, D3 (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationLacosamide-13C, D3 (1 mg/mL)Glass Ampule: 1 mL7/31/2012
Cerilliant CorporationLisdexamfetamine dimesylate (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationLisdexamfetamine-D4 dimesylate (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationMephedrone HCl (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationMephedrone-D3 HCl (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationMethylone HCl (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationMethylone-D3 HCl (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationMorphine (8 μg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationNaloxone N-oxide (0.1 mg/mL)Glass Ampule: 2 mL6/5/2012
Cerilliant CorporationNorcodeine-D3 (1 mg/mL)Glass Ampule: 1 mL7/31/2012
Cerilliant CorporationNormeperidine-D4 (1 mg/mL)Glass Ampule: 1 mL7/31/2012
Cerilliant CorporationNoroxycodone and Norhydrocodone Mix (0.5 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationOpiate Internal Standard Mix-15Glass Ampule: 2 mL12/22/2011
Start Printed Page 4452
Cerilliant CorporationPseudobuprenorphine dihydrochloride (1.0mg/mL)Glass Ampule: 1 mL2/1/2012
Cerilliant CorporationPyrovalerone HCl (1 mg/mL)Glass Ampule: 2 mL12/22/2011
Cerilliant CorporationSecobarbital-D5 (1 mg/mL)Glass Ampule: 1 mL7/31/2012
Cerilliant CorporationZolpidem-D7 (0.1 mg/mL)Glass Ampule: 2 mL12/22/2011
ElSohly Laboratories, IncELI Drug Standards Δ9-Tetrahydrocannabinol-glucoronide (10 μg/mL in MeOH)Glass vial: 1 ml5/31/2012
ElSohly Laboratories, IncELI Drug Standards Δ9-Tetrahydrocannabinol-glucoronide (100 μg/mL in MeOH)Glass vial: 1 ml5/31/2012
Environmental Resource Associates (ERA)Chloral Hydrate, Proficiency Testing Material, Catalog No. 853Glass Ampule: 2 mL3/8/2012
Environmental Resource Associates (ERA)Chloral Hydrate, Reference Material, Catalog No. 676Glass Ampule: 2 mL3/8/2012
Environmental Resource Associates (ERA)Waters Steroid Test Mix, Part No. 07364Glass Ampule: 2 mL3/8/2012
Immunalysis CorporationMethadone Calibrator Levels 1-4Glass vial: 10 mL6/19/2012
Immunalysis CorporationMethadone High ControlGlass vial: 10 mL6/19/2012
Immunalysis CorporationMethadone Low ControlGlass vial: 10 mL6/19/2012
Immunalysis CorporationOral Fluid Cutoff Calibrator Pain Management Prediluted in Extraction BufferGlass vial: 10 mL6/19/2012
Immunalysis CorporationOral Fluid High Positive Control Pain Management Prediluted in Extration BufferGlass vial: 10 mL6/19/2012
Immunalysis CorporationOral Fluid Low Positive Control Pain Management Prediluted in Extraction BufferGlass vial: 10 mL6/19/2012
Immunalysis CorporationZolpidem CalibratorGlass vial: 10 mL6/19/2012
Immunalysis CorporationZolpidem High ControlGlass vial: 10 mL6/19/2012
Immunalysis CorporationZolpidem Low ControlGlass vial: 10 mL6/19/2012
Insys Therapeutics, Inc.(-)-delta9-Tetrahydrocannabinol (1.0 mg/mL)Glass Ampule: 1 mL5/9/2012
Microgenics CorporationCEDIA Amphetamine OFT Assay, Catalog Number: 10014947Box: 4 bottles; 65 mL each12/22/2011
Microgenics CorporationCEDIA Cannabinoids OFT Assay, Catalog Number: 10014910Box: 4 bottles; 65 mL each12/22/2011
Microgenics CorporationCEDIA Cocaine OFT Assay, Catalog Number: 10014764Box: 4 bottles; 65 mL each12/22/2011
Microgenics CorporationCEDIA Methamphetamine OFT Assay, Catalog Number: 10014949Box: 4 bottles; 65 mL each12/22/2011
Microgenics CorporationCEDIA Methamphetamine OFT Control Set (Low and High) , Catalog #10014953Vial: 10 mL Box: 2 vials12/22/2011
Microgenics CorporationCEDIA Methamphetamine OFT Cutoff Calibrator, Catalog #10014951Vial: 5 mL Box: 1 vial12/22/2011
Microgenics CorporationCEDIA Methamphetamine OFT High Calibrator, Catalog #10014952Vial: 5 mL Box: 1 vial12/22/2011
Microgenics CorporationCEDIA Multi-Drug OFT Control Set (Low and High), Catalog #10014957Vial: 15 mL Box: 2 vials12/22/2011
Microgenics CorporationCEDIA Multi-Drug OFT Cutoff Calibrator, Catalog #10014955Vial: 10 mL Box: 1 vial12/22/2011
Microgenics CorporationCEDIA Multi-Drug OFT High Calibrator, Catalog #10014956Vial: 10 mL Box: 1 vial12/22/2011
Microgenics CorporationCEDIA Opiate OFT Assay, Catalog Number: 10014873Box: 4 bottles; 65 mL each12/22/2011
Microgenics CorporationCEDIA PCP OFT Assay, Catalog Number: 10014888Box: 4 bottles; 65 mL each12/22/2011
Microgenics CorporationCEDIA THC OFT Control Set (Low and High), Catalog #10014925Vial: 10 mL Box: 2 vials12/22/2011
Microgenics CorporationCEDIA THC OFT Cutoff Calibrator, Catalog #10014923Vial: 5 mL Box: 1 vial12/22/2011
Microgenics CorporationCEDIA THC OFT High Calibrator, Catalog #10014924Vial: 5 mL Box: 1 vial12/22/2011
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016345Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 1, Catalog Number: 10016362Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016346Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 2, Catalog Number: 10016363Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016347Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 3, Catalog Number: 10016364Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Calibrator 4, Catalog Number: 10016348Vial: 5 mL Box: 1 vial7/5/2012
Start Printed Page 4453
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016349Vial: 10 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016365Vial: 10 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Control Set (Low and High), Catalog Number: 10016808Vial: 10 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA Methamphetamine OFT Cutoff Calibrator, Catalog Number: 10016807Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016865Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 1, Catalog Number: 10016882Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016866Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 2, Catalog Number: 10016883Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016867Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 3, Catalog Number: 10016884Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Calibrator 4, Catalog Number: 10016868Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016869Vial: 15 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016885Vial: 15 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Control Set (Low and High), Catalog Number: 10016895Vial: 15 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA Multi-Drug OFT Cutoff Calibrator, Catalog Number: 10016894Vial: 10 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016644Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 1 Catalog Number: 10016700Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016646Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 2 Catalog Number: 10016701Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016647Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 3 Catalog Number: 10016702Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Calibrator 4 Catalog Number: 10016648Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016649Vial: 10 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016703Vial: 10 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Control Set (Low and High), Catalog Number: 10016731Vial: 10 mL Box: 2 vials7/5/2012
Microgenics CorporationThermo Scientific CEDIA THC OFT Cutoff Calibrator Catalog Number: 10016730Vial: 5 mL Box: 1 vial7/5/2012
Microgenics CorporationThermo Scientific DRI Fentanyl Assay Catalog Number: 10016005Vials: 500 mL5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl Assay Catalog Number: 100160063 vials, 18 mL each5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl Assay Catalog Number: 100164373 vials, 18 mL each5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl Calibrator 2 ng/mL Catalog Number: 10016023Vials: 10 mL5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl High Control 1 ng/mL Catalog Number: 10016484Box: 1 vial; 25 mL5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl High Control 2 ng/mL Catalog Number: 10016485Box: 1 vial; 10 mL5/31/2012
Start Printed Page 4454
Microgenics CorporationThermo Scientific DRI Fentanyl High Control 3 ng/mL Catalog Number: 10016024Vials: 25 mL5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl High Control 3 ng/mL Catalog Number: 10016486Box: 1 vial; 25 mL5/31/2012
Microgenics CorporationThermo Scientific DRI Fentanyl Low Control 1 ng/mL Catalog Number: 10016022Vials: 25 mL5/31/2012
Microgenics CorporationThermo Scientific MAS Omni•CORE Liquid Assayed Integrated Chemistry Control Levels 1-3Vial 5 mL; Box: 6 vials12/22/2011
Microgenics CorporationThermo Scientific MAS Omni•CORE Liquid Assayed Integrated Chemistry Control Sample PackBox: 6 vials; 5 mL each12/22/2011
Microgenics CorporationThermo Scientific MAS Omni•IMMUNE Liquid Assayed Integrated Chemistry Control Levels 1-3Vial 5 mL; Box: 6 vials12/22/2011
Microgenics CorporationThermo Scientific MAS Omni•IMMUNE Liquid Assayed Integrated Chemistry Control Sample PackBox: 6 vials; 5 mL each12/22/2011
Microgenics CorporationThermo Scientific MAS Omni•IMMUNE PRO Liquid Assayed Integrated Chemistry Control Levels 1-3Vial 5 mL; Box: 6 vials12/22/2011
Microgenics CorporationThermo Scientific MAS Omni•IMMUNE PRO Liquid Assayed Integrated Chemistry Control Sample PackBox: 6 vials; 5 mL each12/22/2011
Restek CorporationAppendix IX Mix #1, RevisedAmpule: 2 mL12/22/2011
Restek CorporationCustom a,a-Dimethylphenethylamine StandardAmpule: 2 mL12/22/2011
Restek CorporationCustom Chloral Hydrate StandardAmpule: 2 mL12/22/2011
Restek CorporationCustom LS4434 Standard 1Ampule: 2 mL7/5/2012
Restek CorporationMetabolomic Standard Mix #1Ampule: 2 mL2/1/2012
Restek CorporationUCMR3 Method 539 Calibration StandardAmpule: 2 mL12/22/2011
Restek CorporationUCMR3 Method Calibration StandardAmpule: 2 mL5/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT Cal A Levels 1-5Glass vial: 5 mL7/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT Cal B Levels 1-5Glass vial: 5 mL7/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT Control Set A Material No. 05473390190Box of 6 vials, 10 mL each7/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT Control Set B Material No. 05473411190Box of 6 vials, 10 mL each7/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT Qual Cal Material No. 05475929190Box of 4 vials, 5 mL each7/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT SQ Cal A Material No. 05475872190Box of 6 vials, 5 mL each7/31/2012
Roche Diagnostics Operations, IncOral Fluid DAT SQ Cal B Material No. 05475899190Box of 6 vials, 5 mL each7/31/2012
SAFC BiosciencesHH-4 Cell Culture MediumBag: 1L, 200L, 500L; Bottle: 1L, 2L2/3/2012
SAFC BiosciencesHH-4 Cell Culture MediumBag: 20 L, 100L, 1,000 L3/22/2012
Siemens Healthcare Diagnostics IncADVIA Chemistry Drug CAL 1Carton: 10 vials; 3 ml each11/5/2012
Siemens Healthcare Diagnostics IncADVIA Chemistry Drug CAL 1, Level 2Vial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncADVIA Chemistry Drug CAL 1, Level 3Vial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncADVIA Chemistry Drug CAL 1, Level 4Vial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncADVIA Chemistry Drug CAL 1, Level 5Vial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncBulk EII Plus THC CAL 2 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC CAL 3 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC CAL 4 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC CAL 5 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC Control 1 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC Control 2 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC Control 3 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC Control 4 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC Control 5 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncBulk EII Plus THC Control 6 MLBulk Container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncDimension Drug Calibrator, Level 2Vial: 2.5 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Drug Calibrator, Level 3Vial: 2.5 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Drug Calibrator, Level 4Vial: 2.5 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Drug Calibrator, Level 5Vial: 2.5 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Clinical Chemistry System DRUG CalibratorCarton: 10 vials; 2.5 ml each11/5/2012
Siemens Healthcare Diagnostics IncDimension Vista DRUG 1 CAL, BVial: 2.5 mL7/31/2012
Siemens Healthcare Diagnostics IncDimension Vista Drug 4 CAL, Level BVial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Vista Drug 4 CAL, Level CVial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Vista Drug 4 CAL, Level DVial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Vista Drug 4 CAL, Level EVial: 3 mL11/5/2012
Siemens Healthcare Diagnostics IncDimension Vista LOCI 8 CALBox of 10 vials; Vial: 2.5 mL3/22/2012
Siemens Healthcare Diagnostics IncDimension Vista LOCI 9 CAL Levels A-EVial: 1.5 mL12/22/2011
Start Printed Page 4455
Siemens Healthcare Diagnostics IncDimension Vista System DRUG 1 CALCarton: 6 vials; 2.5 mL each7/31/2012
Siemens Healthcare Diagnostics IncDimension Vista System Drug 4 CALCarton: 10 vials; 3 ml each11/5/2012
Siemens Healthcare Diagnostics IncDimension Vista System LOCI 9 CalibratorBox of 10 vials; Vial: 1.5 mL12/22/2011
Siemens Healthcare Diagnostics IncDimension Vista UDAT CALGlass vial: 3 mL; Carton: 6 vials12/22/2011
Siemens Healthcare Diagnostics IncDimension Vista UDAT CAL Bulk, Level BBulk Container: 20 L-25 L5/31/2012
Siemens Healthcare Diagnostics IncDimension Vista UDAT CAL Pilot, Level BPilot Container: 2 mL-125 mL5/31/2012
Siemens Healthcare Diagnostics IncDimension Vista UDAT CAL, Level BGlass vial: 3 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC CAL 2 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC CAL 3 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC CAL 4 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC CAL 5 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC Control 1 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC Control 2 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC Control 3 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC Control 4 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC Control 5 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncFC EII Plus THC Control 6 MLPlastic vial: 15 mL12/22/2011
Siemens Healthcare Diagnostics IncMP LOCI 9 TTST Cal Lvl 1-7 FCVial: 1-5 mL12/22/2011
Siemens Healthcare Diagnostics IncMP LOCI 9 TTST Lvl 1-7 BulkBulk container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncVS Drug 1 Cal Bulk Soln, Level BBulk container: 2 mL-1 L7/31/2012
Siemens Healthcare Diagnostics IncVS LOCI 9 CAL BULK SOLN Levels 1-5Bulk container: 4 mL-100 L12/22/2011
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 BULK SOLN Level 2Bulk container: 4 mL-100 L3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 BULK SOLN Level 3Bulk container: 4 mL-100 L3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 BULK SOLN Level 4Bulk container: 4 mL-100 L3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 BULK SOLN Level 5Bulk container: 4 mL-100 L3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 Vial Level EVial: 2.5 mL3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 Vial Level BVial: 2.5 mL3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 Vial Level CVial: 2.5 mL3/22/2012
Siemens Healthcare Diagnostics IncVS LOCI CAL 8 Vial Level DVial: 2.5 mL3/22/2012
Supelco, IncCustom Mix, 0.2-163.2 μg/mL in methanolGlass ampule: 1 mL7/31/2012
Ultra Scientific, IncDSA Detection Cocaine HCl StandardAmber ampule: 1 mL12/22/2011
Ultra Scientific, IncDSA Detection Cocaine HCl StandardPhenobarbital (625 μg/mL)Amber ampule: 1 mL12/22/2011
Ultra Scientific, IncDSA Detection Cocaine HCl StandardPhenobarbital (6400 μg/mL)Amber ampule: 1 mL12/22/2011
Ultra Scientific, IncGE-Ion Track 100 ng/μL TNT/Cocaine HCl Standard Rev. 1Amber ampule: 10 mL12/22/2011
Ultra Scientific, IncGE-Ion Track 100 ng/μL TNT/Cocaine HCl Standard Rev. 1Glass bottle: 100 mL12/22/2011
Ultra Scientific, IncPhenobarbital (625 μg/mL)Amber ampule: 1 mL5/31/2012
Ultra Scientific, IncPhenobarbital (6400 μg/mL)Amber ampule: 1 mL5/31/2012
Ultra Scientific, IncUltracheck WS Chloral Hydrate SampleGlass ampule: 2 mL12/22/2011

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.

Chart II

SupplierProduct nameFormDenial date
Abbott LaboratoriesARCHITECT Estradiol Assay Diluent, No. 2K25JTank: 50-500 L12/22/2011
Abbott LaboratoriesAxSYM Estradiol BufferBulk Tank: 50-500 L; Bag-in-box: 18-200 L12/22/2011
American Radiolabeled Chemicals, Inc.Lysergic acid diethylamideVial: 1 mL12/22/2011
Biochemical Diagnostics, Inc.Benzoylecgonine Bulk Solution (5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Cocaine Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Codeine Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.d-Amphetamine Bulk Solution (5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC134Glass vials: 500 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC135Glass vials: 500 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC136Glass vials: 200 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC137Glass vials: 500 ml-2 L11/15/2011
Start Printed Page 4456
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC138Glass vials: 500 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC139Glass vials: 500 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC140Glass vials: 500 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC141Glass vials: 500 ml-2 L11/15/2011
Biochemical Diagnostics, Inc.Detectabuse Custom Liquid Control Urine, MC142Glass vials: 1 ml-200 mL11/15/2011
Biochemical Diagnostics, Inc.d-Methamphetamine Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.d-Propoxyphene Bulk Solution (5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Hydrocodone Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Hydromorphone Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.MDA Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.MDEA Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.MDMA Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Methadone Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Methaqualone Bulk Solution(5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Morphine Bulk Solution (5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Oxazepam Bulk Solution (5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Biochemical Diagnostics, Inc.Secobarbital Bulk Solution (5 mg/mL)Bottle: 1 ml-1 L11/15/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control C1 MinipakAmber Vial: 20mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control C2 MinipakAmber Vial: 20mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control C3 MinipakAmber Vial: 20mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control C4 MinipakAmber Vial: 20mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control Low Opiate Level C2 MinipakAmber Vial: 20mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control Low Opiate Level C3 MinipakAmber Vial: 20mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S1 MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S1E Low Opiate MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S1E MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S1S MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S2 MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S2E Low Opiate MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S2E MinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S2SMinipakAmber Vial: 10mL12/22/2011
Bio-Rad LaboratoriesLiquichek Urine Toxicology Control S3 MinipakAmber Vial: 10mL12/22/2011
Cayman Chemical Company4-Methylmethcathinone (hydrochloride), 10 mg in 1 mL MethanolGlass vial: 1 mL7/31/2012
Cayman Chemical Company4-Methylmethcathinone (hydrochloride), 25 mg in 2.5 mL MethanolGlass vial: 2.5 mL7/31/2012
Cayman Chemical Company4-Methylmethcathinone (hydrochloride), 5 mg in 500 µL MethanolGlass vial: 500 µL7/31/2012
Cayman Chemical Company5-methoxy DMT, 10 mg in 1 mL MethanolGlass vial: 1 mL7/31/2012
Cayman Chemical Company5-methoxy DMT, 25 mg in 2.5 mL MethanolGlass vial: 2.5 mL7/31/2012
Cayman Chemical Company5-methoxy DMT, 5 mg in 500 µL MethanolGlass vial: 500 µL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone (hydrochloride), 10 mg in 1 mL MethanolGlass vial: 1 mL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone (hydrochloride), 25 mg in 2.5 mL MethanolGlass vial: 2.5 mL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone (hydrochloride), 5 mg in 500 µL MethanolGlass vial: 500 µL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone, 10 mg in 1 mL MethanolGlass vial: 1 mL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone, 25 mg in 2.5 mL MethanolGlass vial: 2.5 mL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone, 5 mg in 500 µL MethanolGlass vial: 500 µL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone-d8 (hydrochloride), 10 mg in 1 mL MethanolGlass vial: 1 mL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone-d8 (hydrochloride), 25 mg in 2.5 mL MethanolGlass vial: 2.5 mL7/31/2012
Cayman Chemical CompanyMethylenedioxy Pyrovalerone-d8 (hydrochloride), 5 mg in 500 µL MethanolGlass vial: 500 µL7/31/2012
Cayman Chemical CompanyMethylone (hydrochloride), 10 mg in 1 mL MethanolGlass vial: 1 mL7/31/2012
Cayman Chemical CompanyMethylone (hydrochloride), 25 mg in 2.5 mL MethanolGlass vial: 2.5 mL7/31/2012
Cayman Chemical CompanyMethylone (hydrochloride), 5 mg in 500 µL MethanolGlass vial: 500 µL7/31/2012
Cerilliant CorporationCodeine (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationCodeine-D3 (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationDrug Solution # 16Screw-cap Vial: 50 mL6/5/2012
Start Printed Page 4457
Cerilliant CorporationDrug Solution # 17Screw-cap Vial: 50 mL6/5/2012
Cerilliant CorporationDrug Solution # 18Screw-cap Vial: 50 mL6/5/2012
Cerilliant CorporationDrug Solution # 19Screw-cap Vial: 50 mL6/5/2012
Cerilliant CorporationDrug Solution # 20Screw-cap Vial: 50 mL6/5/2012
Cerilliant CorporationHydrocodone (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationHydrocodone-D6 (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationHydromorphone (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationHydromorphone-D3 (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationMorphine (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationMorphine-D3 (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationNoroxycodone HCl (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationNoroxycodone-D3 HCl (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationOxycodone (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationOxycodone-D3 (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationOxymorphone (1 mg/mL)Glass ampule: 5 mL7/31/2012
Cerilliant CorporationOxymorphone-D3 (1 mg/mL)Glass ampule: 5 mL7/31/2012
Environmental Resource Associates (ERA)USGS BQS LS4434 Mix 1Glass Ampule: 1-2 mL7/31/2012
Environmental Resource Associates (ERA)USGS BQS LS4434 Mix 2Glass Ampule: 1-2 mL7/31/2012
Immunalysis CorporationTapentadol Calibrator Levels 1-4Glass vial: 10 mL6/19/2012
Immunalysis CorporationTapentadol High ControlGlass vial: 10 mL6/19/2012
Immunalysis CorporationTapentadol Low ControlGlass vial: 10 mL6/19/2012
Restek CorporationCustom Cannabinoids StandardAmpule: 2 mL5/31/2012
Restek CorporationCustom Paraldehyde Standard (10 mg/mL)Ampule: 2 mL7/5/2012
Siemens Healthcare Diagnostics Inc.Dimension Vista UDAT CAL Bulk, Level BBulk Container: 4mL-100L12/22/2011
Siemens Healthcare Diagnostics Inc.Dimension Vista UDAT CAL Bulk, Level BBulk Container: 26 L-50L5/31/2012
Siemens Healthcare Diagnostics Inc.Drug CAL BULK SOLN, Level 2Bulk container: 2 L-100 L11/5/2012
Siemens Healthcare Diagnostics Inc.Drug CAL BULK SOLN, Level 3Bulk container: 2 mL-100 L11/5/2012
Siemens Healthcare Diagnostics Inc.Drug CAL BULK SOLN, Level 4Bulk container: 2 mL-100 L11/5/2012
Siemens Healthcare Diagnostics Inc.Drug CAL BULK SOLN, Level 5Bulk container: 2m L-100 L11/5/2012
Siemens Healthcare Diagnostics Inc.VS Drug 1 Cal Bulk Soln, Level BBulk container: 2 mL-100 L7/31/2012

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 Start Printed Page 4458exempt, 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.

Start Signature

Dated: January 14, 2013.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.

End Signature End Supplemental Information

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.

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[FR Doc. 2013-01133 Filed 1-18-13; 8:45 am]

BILLING CODE 4410-09-P