Diversion Control Division, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Rules - 2017 > Order with Opportunity for Comment: Exempt Chemical Preparations Under the Controlled Substances Act

Rules - 2017

[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26944-26951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12110]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-372]

Exempt Chemical Preparations Under the Controlled Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Order with opportunity for comment.


SUMMARY: The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between April 1, 2016, and December 31, 2016, as listed below, were accepted for filing and have been approved or denied as indicated.

DATES: Interested persons may file written comments on this order in accordance with 21 CFR 1308.23(e). Electronic comments must be submitted, and written comments must be postmarked, on or before August 11, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-372" on all correspondence, including any attachments.

  • Electronic comments: The Drug Enforcement Administration (DEA) encourages that all comments be submitted through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a comment tracking number, your comment has been successfully submitted and there is no need to resubmit the same comment.
  • Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control

[[Page 26945]]

Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

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.

Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and II are referred to as the "Controlled Substances Act" and the "Controlled Substances Import and Export Act," or the "CSA" for the purpose of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.

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 ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. 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\ The DEA regulations at 21 CFR 1308.23 and 1308.24 further detail the criteria by which the DEA Assistant Administrator may exempt a chemical preparation or mixture from certain provisions of the CSA. The Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which exemptions are granted and modify the scope of exemptions at any time.

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\1\ This authority has been delegated from the Attorney General to the Administrator of the DEA by 28 CFR 0.100, and subsequently redelegated to the Deputy Assistant Administrator pursuant to Section 7 of 28 CFR 0.104, Appendix to Subpart R.

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Exempt Chemical Preparation Applications Submitted Between April 1, 2016, and December 31, 2016

The Assistant Administrator received applications between April 1, 2016, and December 31, 2016, requesting exempt chemical preparation status detailed in 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 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 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 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 the DEA, is exempt, to the extent described in 21 CFR 1308.24, from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA, and 21 CFR 1301.74, as of the date that was provided in the approval letters to the individual requesters.

Supplier Product Name Form Application
Date
Aalto Scientific, Ltd. Endocrine Program Amber vial: 5 mL 8/23/2016
Aalto Scientific, Ltd. Endocrinology Amber vial: 5 mL 8/23/2016
Aalto Scientific, Ltd. Linearity FD Testosterone, Siemens Centaur Kit: 5 vials; 3 mL each 12/7/2016
Absolute Standards, Inc. ISO G34 Calibrator Spike High Glass ampoule: 1 mL 8/3/2016
Absolute Standards, Inc. ISO G34 Calibrator Spike Low Glass ampoule: 1 mL 8/3/2016
Absolute Standards, Inc. ISO G34 Calibrator Spike Solution Glass ampoule: 1 mL 8/3/2016
Absolute Standards, Inc. ISO G34 Internal Standard Glass ampoule: 1 mL 8/3/2016
Accriva Diagnostics, Inc. Hemochron PT Box: 45 cuvettes; 7.5µL each 5/17/2016
Arbor Assays Testosterone 5-pack Enzyme Immunoassay Kit (K032-H5) Kit: 400 µL vial 10/18/2016
Arbor Assays Testosterone Enzyme Immunoassay Kit (ISWE001) Kit: 1 mL vial 10/18/2016
Arbor Assays Testosterone Enzyme Immunoassay Kit (K032-H1) Kit: 90 µL vial 10/18/2016
Arbor Assays Testosterone Standard (1,000 ng/mL) Plastic vial: 1 mL 10/18/2016
Arbor Assays Testosterone Standard (200,000 pg/mL) Plastic vial: 90 µL 10/18/2016
Arbor Assays Testosterone Standard (200,000 pg/mL) Plastic vial: 400 µL 10/18/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC252 Glass vial: 1 mL–200 mL 7/29/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC253 Glass vials: 1 ml–200 mL 9/30/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC254 Glass vial: 1 mL–200 mL 7/29/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC255 Glass vial: 1 mL–200 mL 7/29/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC256 Glass vials: 1 ml–200 mL 12/19/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC257 Glass vials: 1 ml–200 mL 12/19/2016
Cayman Chemical Company 11-Keto Testosterone CRM; 1 mg/mL in Acetonitrile Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company AB-CHMINACA (CRM); 1 mg/mL in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company AB-CHMINACA (CRM); 1 mg/mL in Methanol Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company AB-CHMINACA (CRM); 100 µg/mL in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company AB-CHMINACA (CRM); 100 µg/mL in Methanol Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company AB-PINACA CRM; 1 mg/mL in Methanol Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company Acetyl Fentanyl CRM; 1 mg/mL in Methanol Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company Acetyl Fentanyl CRM; 100 µg/mL in Methanol Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company Cocaine CRM; 1 mg/mL in Acetonitrile Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company Cocaine/Heroin/Methamphetamine Mixture CRM; 1 mg/mL each in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company Cocaine/Heroin/Methamphetamine Mixture CRM; 100 µg/mL each in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company Cocaine/Heroin/Methamphetamine Mixture CRM; 250 µg/mL each in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company Cocaine/Heroin/Methamphetamine Mixture CRM; 500 µg/mL each in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company GC-MS Drug Standard Mixture 1 in Acetonitrile Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company Phytocannabinoid Mixture 1; 1 mg/mL in Acetonitrile Glass ampule: 1 mL 6/28/2016
Cayman Chemical Company Tapentadol (hydrochloride) CRM; 1 mg/mL in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company Tapentadol (hydrochloride) CRM; 1 mg/mL in Methanol Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company Tapentadol (hydrochloride) CRM; 100 µg/mL in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company Tapentadol (hydrochloride) CRM; 100 µg/mL in Methanol Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company THJ2201 (CRM); 1 mg/mL in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company THJ2201 (CRM); 1 mg/mL in Methanol Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company THJ2201 (CRM); 100 µg/mL in Acetonitrile Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company THJ2201 (CRM); 100 µg/mL in Methanol Glass ampule: 1 mL 8/26/2016
Cayman Chemical Company ToxBox THC/THC Metabolite Plate 48-well plate 6/28/2016
Cerilliant Corporation (±)-11-Hydroxy-delta9-THC glucuronide (0.01 mg/mL) Glass ampule: 1 mL 11/11/2016
Cerilliant Corporation (±)-Cannabicyclol (1.0 mg/mL) Glass ampule: 1.0 mL 7/18/2016
Cerilliant Corporation (±)-cis-3-Methylfentanyl HCl (0.05 mg/mL) Glass ampule: 1 mL 6/21/2016
Cerilliant Corporation (±)-cis-3-Methylfentanyl HCl (0.1 mg/mL) Glass ampule: 0.5 mL 7/18/2016
Cerilliant Corporation 5alpha-Dihydrotestosterone-D3 [16, 16, 17-D3]; 10 µg/mL Glass ampule: 1 mL 9/28/2016
Cerilliant Corporation 6beta-Naltrexol (1 mg/mL) Glass ampule: 1 mL 5/6/2016
Cerilliant Corporation AH-7921 HCl (1 mg/mL) Glass ampule: 1 mL 5/20/2016
Cerilliant Corporation AH-7921-D3 HCl (0.1 mg/mL) Glass ampule: 1 mL 5/20/2016
Cerilliant Corporation Brivaracetam-D3 (0.1 mg/mL) Glass ampule: 1 mL 11/30/2016
Cerilliant Corporation Butyryl fentanyl (0.05 mg/mL) Glass ampule: 1 mL 6/21/2016
Cerilliant Corporation Butyryl fentanyl (0.1 mg/mL) Glass ampule: 0.5 mL 7/18/2016
Cerilliant Corporation Cannabichromenic acid (CBCA) (1.0 mg/mL) Glass ampule: 1 mL 11/30/2016
Cerilliant Corporation Cannabicyclolic acid (CBLA) (1.0 mg/mL) Glass ampule: 1 mL 11/30/2016
Cerilliant Corporation Carfentanil (0.1 mg/mL) Glass ampule: 0.5 mL 9/28/2016
Cerilliant Corporation Carfentanil oxalate (0.1 mg/mL) Glass ampule: 0.5 mL 11/30/2016
Cerilliant Corporation Carfentanil-D5 oxalate (0.1 mg/mL) Glass ampule: 0.5 mL 11/30/2016
Cerilliant Corporation Clorazepate dipotassium (1 mg/mL) Glass ampule: 1 mL 5/6/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 1 (20 pg/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 2 (50 pg/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 3 (100 pg/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 4 (500 pg/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 5 (1000 pg/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 6 (2500 pg/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Dihydrotestosterone Calibrator Level 7 (10 ng/mL) Cryovial: 1 mL 8/12/2016
Cerilliant Corporation Diphenoxylate HCl (1 mg/mL) Glass ampule: 1 mL 5/20/2016
Cerilliant Corporation Furanyl fentanyl (0.1 mg/mL) Glass ampule: 0.5 mL 11/30/2016
Cerilliant Corporation Norhydromorphone-D3 HCl (0.1 mg/mL) Glass ampule: 1.0 mL 7/18/2016
Cerilliant Corporation Noroxymorphone-D3 HCl (0.1 mg/mL) Glass ampule: 1.0 mL 7/18/2016
Cerilliant Corporation Pholcodine (1 mg/mL) Glass ampule: 1 mL 5/6/2016
Cerilliant Corporation Tapentadol-D3 HCl (1 mg/mL) Glass ampule: 1 mL 11/11/2016
Cerilliant Corporation U-47700 (1.0 mg/mL) Glass ampule: 1 mL 11/30/2016
IDEXX Laboratories Coag Dx PT Box: 10 cartridges; 7.5µL each 10/21/2016
IDEXX Laboratories Coag Dx PT Cartridge Cartridges: 7.5µL each 10/21/2016
Immunalysis Corporation cTHC Urine Calibrator 1 (20 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation cTHC Urine Calibrator 2 (50 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation cTHC Urine Calibrator 3 (100 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation cTHC Urine Calibrator 4 (200 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation cTHC Urine Control HIGH (62.5 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation cTHC Urine Control LOW (37.5 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation Fentanyl Urine Calibrator 1 (1 ng/mL) Dropper bottle: 5 mL 5/27/2016
Immunalysis Corporation Fentanyl Urine Calibrator 2 (2 ng/mL) Dropper bottle: 5 mL 5/27/2016
Immunalysis Corporation Fentanyl Urine Calibrator 3 (4 ng/mL) Dropper bottle: 5 mL 5/27/2016
Immunalysis Corporation Fentanyl Urine Control HIGH (1.5 ng/mL) Dropper bottle: 5 mL 5/27/2016
Immunalysis Corporation Fentanyl Urine Control LOW (0.5 ng/mL) Dropper bottle: 5 mL 5/27/2016
Immunalysis Corporation MDC Calibrator 1 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Calibrator 2 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Calibrator 3 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Calibrator 4 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Control HIGH Set 1 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Control HIGH Set 1 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Control LOW Set 1 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation MDC Control LOW Set 2 Dropper bottle: 15 mL, 25 mL 5/27/2016
Immunalysis Corporation Opiates Urine Calibrator 2000 1 (1000 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation Opiates Urine Calibrator 2000 2 (2000 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation Opiates Urine Calibrator 2000 3 (4000 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation Opiates Urine Calibrator 2000 4 (6000 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation Oxazepam Urine Control HIGH (125 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Immunalysis Corporation Oxazepam Urine Control LOW (75 ng/mL) Dropper bottle: 5 mL, 15 mL 5/27/2016
Instrumentation Laboratory Gem Test PT Box: 45 cuvettes; 7.5µL each 10/6/2016
IsoSciences, LLC Codeine-[13C4, 15N], 1000 µg/mL in methanol Amber ampule: 1 mL 10/20/2016
IsoSciences, LLC Codeine-6β-Glucuronide-[13C10, 15N], 1000 µg/mL in methanol:water (2:8) Amber ampule: 1 mL 10/20/2016
IsoSciences, LLC Morphine-[13C4, 15N], 1000 µg/mL in methanol Amber ampule: 1 mL 10/20/2016
IsoSciences, LLC Morphine-6β-Glucuronide-[13C10, 15N], 1000 µg/mL in methanol:water (2:8) Amber ampule: 1 mL 10/20/2016
IsoSciences, LLC Testosterone-[2H8], 100 µg/mL in methanol Amber Ampule: 1 mL 8/10/2016
IsoSciences, LLC Testosterone-[2H8], 1000 µg/mL in methanol Amber Ampule: 1 mL 8/10/2016
ITC Hemochron Jr. Box: 45 cuvettes; 7.5µL each 7/1/2016
Lipomed Inc. 25B-NB2OMe (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 25C-NB2OMe (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 25I-NB2OMe (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 25I-NB2OMe-D9 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 25I-NB2OMe-D9 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 3,4-Methylendioxypyrovalerone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 3,4-Methylenedioxy-α-pyrrolidinopropiophenone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 3-Desmethylprodine (1 mg/mL acetonitrile) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 4-Ethylmethcathinone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 4-Methylethcathinone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 4-Methylmethcathinone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 4-Methylmethcathinone-D3 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. 4-Methylmethcathinone-D3 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Benzodiazepines mixture (.001 mg free base/ml acetonitrile) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Benzodiazepines mixture 5 (1 mg free base/mL acetonitrile) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Bufotenine.oxalate.monohydrate (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Butabarbital (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Butalbital (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Butalbital-D5 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Butylone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Cannabidiol-D3 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Cannabidiol-D3 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Cannabinol-D3 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Cannabinol-D3 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Carisoprodol (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Clotiazepam (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Cocaethylene-D3 (1 mg/mL acetonitrile) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Cocaine mixture 2 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Desomorphine (1 mg/mL acetonitrile) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Ethylone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-018 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-018 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-018-D11 metabolite (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-018-D11 metabolite (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-019 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-019 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-081 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-081 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-122 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-122 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-200 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. JWH-200 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. L-Methamphetamine (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Loprazolam (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Mazindol (1 mg/mL Dimethylformamide) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Meprobamate (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Methandienone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Methylone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Methylone-D3 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Methylone-D3 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. N,N-Dimethylamphetamine (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Naphyrone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Nimetazepam (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Norbuprenorphine (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Normeperidine (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Pentedrone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Pentylone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Phenobarbital-D5 (side chain) (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Phenobarbital-D5 (side chain) (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Pregabalin (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Propoxyphen-D5 (0.1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Propoxyphen-D5 (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Pyrovalerone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. α-Pyrrolidinopropiophenone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. α-Pyrrolidinovalerophenone (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Microgenics Corporation Cascadion SM Total Testosterone Internal Standard Box: 8 bottles, 29 mL each 12/16/2016
Microgenics Corporation Cedia Buprenorphine OFT Control Set (Low and High) Catalog Number: 10022377 Vial: 10 mL; Box: 2 vials 11/15/2016
Microgenics Corporation Cedia Buprenorphine OFT Cutoff Calibrator Catalog Number: 10022376 Vial: 5 mL; Box: 1 vial 11/15/2016
Microgenics Corporation Cedia Multi-Drug OFT Cutoff Calibrator Set B Catalog Number: 10022355 Vial: 10 mL; Box: 1 vial 10/20/2016
Microgenics Corporation Cedia Multi-Drug OFT Cutoff Control Set B (Low and High) Catalog Number: 10022356 Vial: 15 mL; Box: 2 vials 10/20/2016
Microgenics Corporation Intercept i2he Multi-Drug Oral Fluid Cutoff Calibrator Set B Catalog Number: 1001-0419 Vial: 10 mL; Box: 1 vial 10/19/2016
Microgenics Corporation Intercept i2he Multi-Drug Oral Fluid Cutoff Control Set B (Low and High) Catalog Number: 1001-0420 Vial: 15 mL; Box: 2 vials 10/19/2016
Microgenics Corporation Thermo Scientific CEDIA Buprenorphine II Calibrator 10 ng/mL Catalog Number: 10020799 Vial: 5 mL Box: 1 vial 8/30/2016
Microgenics Corporation Thermo Scientific CEDIA Buprenorphine II Calibrator 100 ng/mL Catalog Number: 10020802 Vial: 5 mL Box: 1 vial 8/30/2016
Microgenics Corporation Thermo Scientific CEDIA Buprenorphine II Calibrator 20 ng/mL Catalog Number: 10020800 Vial: 5 mL Box: 1 vial 8/30/2016
Microgenics Corporation Thermo Scientific CEDIA Buprenorphine II Calibrator 50 ng/mL Catalog Number: 10020801 Vial: 5 mL Box: 1 vial 8/30/2016
Microgenics Corporation Thermo Scientific CEDIA Buprenorphine II Controls (Low and High) Catalog Number: 10020804 Vial: 5 mL Box: 4 vials 8/30/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Oxycodone Negative Control 100 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Oxycodone Negative Control 100 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Oxycodone Negative Control 300 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Oxycodone Positive Control 100 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Oxycodone Positive Control 300 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Oxycodone Negative Control 100 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Oxycodone Negative Control 300 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Oxycodone Positive Control 100 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Oxycodone Positive Control 300 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. FC Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Oxycodone Negative Control 100 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Oxycodone Negative Control 300 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Oxycodone Positive Control 100 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Oxycodone Positive Control 300 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Specialty Multi Drug Calibrator/Control LVL 1 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Specialty Multi Drug Calibrator/Control LVL 2 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Specialty Multi Drug Calibrator/Control LVL 3 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. MP FC Emit Specialty Multi Drug Calibrator/Control LVL 4 Vial: 10 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Oxycodone Negative Control 100 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Oxycodone Negative Control 300 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Oxycodone Positive Control 100 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Oxycodone Positive Control 300 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 1 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 2 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 3 Pilot container: 4 mL–200 mL 8/23/2016
Siemens Healthcare Diagnostics, Inc. Pilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 4 Pilot container: 4 mL–200 mL 8/23/2016
USP USP Levomethorphan Solution Reference Standard Box: 3 vials, 1.2 mL each 9/13/2016
UTAK Laboratories, Inc. AED II HR Serum Control, Ref: 72740 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. AED II MR Serum Control, Ref: 72741 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Benzodiazepines 2 Serum Control HR, Ref: 22615 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Benzodiazepines 2 Serum Control MR, Ref: 22616 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Benzodiazepines Plus 100 Urine Control, Ref: 12090 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Benzodiazepines Plus 100 Whole Blood Control, Ref: 12092 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Benzodiazepines Plus 400 ng/mL Urine Control, Ref: 12091 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Clonazepam Serum Control HR, Ref: 22610 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Clonazepam Serum Control MR, Ref: 22611 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. DHEA Plus High Serum Control, Ref: 51411 Carton: 5 bottles, 3 mL each 12/27/2016
UTAK Laboratories, Inc. DHEA Plus Low Serum Control, Ref: 51410 Carton: 5 bottles, 3 mL each 12/27/2016
UTAK Laboratories, Inc. Pentobarbital Serum Control, Ref: 66319 Carton: 5 bottles, 5 mL each 12/27/2016
UTAK Laboratories, Inc. Steroids Level 1 SMx Serum Control, Ref: 51401 Carton: 5 bottles, 3 mL each 12/27/2016
UTAK Laboratories, Inc. Steroids Level 2 SMx Serum Control, Ref: 51402 Carton: 5 bottles, 3 mL each 12/27/2016
UTAK Laboratories, Inc. Steroids Level 3 SMx Serum Control, Ref: 51403 Carton: 5 bottles, 3 mL each 12/27/2016
UTAK Laboratories, Inc. Steroids Level 4 SMx Serum Control, Ref: 51404 Carton: 5 bottles, 3 mL each 12/27/2016

[[Page 26950]]

The 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 Assistant Administrator has determined that the chemical preparations or mixtures generally described in Chart II below and specifically described in the application materials received by DEA, are not exempt from application of any part of the CSA or from application of any part of the CFR, with regard to the requested exemption pursuant to 21 CFR 1308.23, as of the date that was provided in the determination letters to the individual requesters.

Supplier Product Name Form Application
Date
Aalto Scientific, Ltd. General Chemistry Serum Box: 1056 vials; 5 mL each 6/20/2016
Biochemical Diagnostics, Inc. Detectabuse Custom Liquid Control Urine, MC253 Glass vial: 1 mL–200 mL 7/29/2016
Cerilliant Corporation (±)-cis-3-Methylfentanyl HCl (0.1 mg/mL) Glass ampule: 1 mL 6/21/2016
Cerilliant Corporation (±)-cis-3-Methylfentanyl HCl (1 mg/mL) Glass ampule: 1 mL 5/6/2016
Cerilliant Corporation Butyryl fentanyl (0.1 mg/mL) Glass ampule: 1 mL 6/21/2016
Cerilliant Corporation Butyryl fentanyl HCl (1 mg/mL) Glass ampule: 1 mL 5/20/2016
Lipomed Inc. Benzodiazepines mixture 8 (0.25 mg free base/mL acetonitrile) Glass ampule: 1 mL 10/28/2016
Lipomed Inc. Estazolam (1 mg/mL methanol) Glass ampule: 1 mL 10/28/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Oxycodone Negative Control 300 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Oxycodone Positive Control 100 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Oxycodone Positive Control 300 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 1 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 2 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 3 Bulk Container: 1 L–50 L 8/23/2016
Siemens Healthcare Diagnostics, Inc. BK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 4 Bulk Container: 1 L–50 L 8/23/2016

[[Page 26951]]

Scope of Approval

The exemptions are applicable only to the precise preparation or mixture described in the application submitted to DEA in the form(s) listed in this order and only for those sections of the CSA and the CFR that are specifically identified. In accordance with 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. In accordance with 21 CFR 1308.24(g), the 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, the DEA has determined that each of the exempted bulk products listed in this order may only be used in-house by the manufacturer, and may not be distributed for any purpose, or transported to other facilities.

Additional exempt chemical preparation requests received between April 1, 2016, and December 31, 2016, and not otherwise referenced in this order may remain under consideration until the DEA receives additional information required, pursuant to 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. The DEA's order on such requests will be communicated to the public in a future Federal Register publication.

The DEA also notes that these exemptions are limited to exemption from only those sections of the CSA and the CFR that are specifically identified in 21 CFR 1308.24(a). All other requirements of the CSA and the CFR apply, including registration as an importer as required by 21 U.S.C. 957.

Opportunity for Comment

Pursuant to 21 CFR 1308.23, any interested person may submit written comments on or objections to any chemical preparation in this order that has been approved or denied as exempt. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the 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 the 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: May 24, 2017.

Louis J. Milione,
Assistant Administrator.

[FR Doc. 2017-12110 Filed 6-9-17; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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