2013-01133. 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: [phone].

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 narcotic substance cannot in practice be removed.

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

Chart I

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,β-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	γ-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 Δ9-Tetrahydrocannabinol-glucoronide (10 μg/mL in MeOH)	Glass vial: 1 ml	5/31/2012
ElSohly Laboratories, Inc	ELI Drug Standards Δ9-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.

Chart II

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.

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.