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Notice

Exempt Chemical Preparations Under the Controlled Substances Act

Document Details

Information about this document as published in the Federal Register.

Published Document

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

Start Preamble

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.
Start Further Info

FOR FURTHER INFORMATION CONTACT:

Michael J. Lewis, Diversion Control Start Printed Page 26945Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

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

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

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

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.

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.

Chart I

SupplierProduct nameFormApplication date
Aalto Scientific, LtdEndocrine ProgramAmber vial: 5 mL8/23/2016
Aalto Scientific, LtdEndocrinologyAmber vial: 5 mL8/23/2016
Aalto Scientific, LtdLinearity FD Testosterone, Siemens CentaurKit: 5 vials; 3 mL each12/7/2016
Absolute Standards, IncISO G34 Calibrator Spike HighGlass ampoule: 1 mL8/3/2016
Absolute Standards, IncISO G34 Calibrator Spike LowGlass ampoule: 1 mL8/3/2016
Absolute Standards, IncISO G34 Calibrator Spike SolutionGlass ampoule: 1 mL8/3/2016
Start Printed Page 26946
Absolute Standards, IncISO G34 Internal StandardGlass ampoule: 1 mL8/3/2016
Accriva Diagnostics, IncHemochron PTBox: 45 cuvettes; 7.5μL each5/17/2016
Arbor AssaysTestosterone 5-pack Enzyme Immunoassay Kit (K032-H5)Kit: 400 μL vial10/18/2016
Arbor AssaysTestosterone Enzyme Immunoassay Kit (ISWE001)Kit: 1 mL vial10/18/2016
Arbor AssaysTestosterone Enzyme Immunoassay Kit (K032-H1)Kit: 90 μL vial10/18/2016
Arbor AssaysTestosterone Standard (1,000 ng/mL)Plastic vial: 1 mL10/18/2016
Arbor AssaysTestosterone Standard (200,000 pg/mL)Plastic vial: 90 μL10/18/2016
Arbor AssaysTestosterone Standard (200,000 pg/mL)Plastic vial: 400 μL10/18/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC252Glass vial: 1 mL-200 mL7/29/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC253Glass vials: 1 ml-200 mL9/30/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC254Glass vial: 1 mL-200 mL7/29/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC255Glass vial: 1 mL-200 mL7/29/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC256Glass vials: 1 ml-200 mL12/19/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC257Glass vials: 1 ml-200 mL12/19/2016
Cayman Chemical Company11-Keto Testosterone CRM; 1 mg/mL in AcetonitrileGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyAB-CHMINACA (CRM); 1 mg/mL in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyAB-CHMINACA (CRM); 1 mg/mL in MethanolGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyAB-CHMINACA (CRM); 100 µg/mL in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyAB-CHMINACA (CRM); 100 µg/mL in MethanolGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyAB-PINACA CRM; 1 mg/mL in MethanolGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyAcetyl Fentanyl CRM; 1 mg/mL in MethanolGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyAcetyl Fentanyl CRM; 100 µg/mL in MethanolGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyCocaine CRM; 1 mg/mL in AcetonitrileGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyCocaine/Heroin/Methamphetamine Mixture CRM; 1 mg/mL each in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyCocaine/Heroin/Methamphetamine Mixture CRM; 100 µg/mL each in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyCocaine/Heroin/Methamphetamine Mixture CRM; 250 µg/mL each in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyCocaine/Heroin/Methamphetamine Mixture CRM; 500 µg/mL each in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyGC-MS Drug Standard Mixture 1 in AcetonitrileGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyPhytocannabinoid Mixture 1; 1 mg/mL in AcetonitrileGlass ampule: 1 mL6/28/2016
Cayman Chemical CompanyTapentadol (hydrochloride) CRM; 1 mg/mL in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTapentadol (hydrochloride) CRM; 1 mg/mL in MethanolGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTapentadol (hydrochloride) CRM; 100 µg/mL in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTapentadol (hydrochloride) CRM; 100 µg/mL in MethanolGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTHJ2201 (CRM); 1 mg/mL in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTHJ2201 (CRM); 1 mg/mL in MethanolGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTHJ2201 (CRM); 100 µg/mL in AcetonitrileGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyTHJ2201 (CRM); 100 µg/mL in MethanolGlass ampule: 1 mL8/26/2016
Cayman Chemical CompanyToxBox THC/THC Metabolite Plate48-well plate6/28/2016
Cerilliant Corporation(±)-11-Hydroxy-delta9-THC glucuronide (0.01 mg/mL)Glass ampule: 1 mL11/11/2016
Cerilliant Corporation(±)-Cannabicyclol (1.0 mg/mL)Glass ampule: 1.0 mL7/18/2016
Cerilliant Corporation(±)-cis-3-Methylfentanyl HCl (0.05 mg/mL)Glass ampule: 1 mL6/21/2016
Cerilliant Corporation(±)-cis-3-Methylfentanyl HCl (0.1 mg/mL)Glass ampule: 0.5 mL7/18/2016
Cerilliant Corporation5alpha-Dihydrotestosterone-D3 [16, 16, 17-D3]; 10 µg/mLGlass ampule: 1 mL9/28/2016
Cerilliant Corporation6beta-Naltrexol (1 mg/mL)Glass ampule: 1 mL5/6/2016
Cerilliant CorporationAH-7921 HCl (1 mg/mL)Glass ampule: 1 mL5/20/2016
Cerilliant CorporationAH-7921-D3 HCl (0.1 mg/mL)Glass ampule: 1 mL5/20/2016
Cerilliant CorporationBrivaracetam-D3 (0.1 mg/mL)Glass ampule: 1 mL11/30/2016
Cerilliant CorporationButyryl fentanyl (0.05 mg/mL)Glass ampule: 1 mL6/21/2016
Cerilliant CorporationButyryl fentanyl (0.1 mg/mL)Glass ampule: 0.5 mL7/18/2016
Cerilliant CorporationCannabichromenic acid (CBCA) (1.0 mg/mL)Glass ampule: 1 mL11/30/2016
Cerilliant CorporationCannabicyclolic acid (CBLA) (1.0 mg/mL)Glass ampule: 1 mL11/30/2016
Cerilliant CorporationCarfentanil (0.1 mg/mL)Glass ampule: 0.5 mL9/28/2016
Cerilliant CorporationCarfentanil oxalate (0.1 mg/mL)Glass ampule: 0.5 mL11/30/2016
Cerilliant CorporationCarfentanil-D5 oxalate (0.1 mg/mL)Glass ampule: 0.5 mL11/30/2016
Cerilliant CorporationClorazepate dipotassium (1 mg/mL)Glass ampule: 1 mL5/6/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 1 (20 pg/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 2 (50 pg/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 3 (100 pg/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 4 (500 pg/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 5 (1000 pg/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 6 (2500 pg/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDihydrotestosterone Calibrator Level 7 (10 ng/mL)Cryovial: 1 mL8/12/2016
Cerilliant CorporationDiphenoxylate HCl (1 mg/mL)Glass ampule: 1 mL5/20/2016
Cerilliant CorporationFuranyl fentanyl (0.1 mg/mL)Glass ampule: 0.5 mL11/30/2016
Cerilliant CorporationNorhydromorphone-D3 HCl (0.1 mg/mL)Glass ampule: 1.0 mL7/18/2016
Cerilliant CorporationNoroxymorphone-D3 HCl (0.1 mg/mL)Glass ampule: 1.0 mL7/18/2016
Start Printed Page 26947
Cerilliant CorporationPholcodine (1 mg/mL)Glass ampule: 1 mL5/6/2016
Cerilliant CorporationTapentadol-D3 HCl (1 mg/mL)Glass ampule: 1 mL11/11/2016
Cerilliant CorporationU-47700 (1.0 mg/mL)Glass ampule: 1 mL11/30/2016
IDEXX LaboratoriesCoag Dx PTBox: 10 cartridges; 7.5μL each10/21/2016
IDEXX LaboratoriesCoag Dx PT CartridgeCartridges: 7.5μL each10/21/2016
Immunalysis CorporationcTHC Urine Calibrator 1 (20 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationcTHC Urine Calibrator 2 (50 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationcTHC Urine Calibrator 3 (100 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationcTHC Urine Calibrator 4 (200 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationcTHC Urine Control HIGH (62.5 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationcTHC Urine Control LOW (37.5 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationFentanyl Urine Calibrator 1 (1 ng/mL)Dropper bottle: 5 mL5/27/2016
Immunalysis CorporationFentanyl Urine Calibrator 2 (2 ng/mL)Dropper bottle: 5 mL5/27/2016
Immunalysis CorporationFentanyl Urine Calibrator 3 (4 ng/mL)Dropper bottle: 5 mL5/27/2016
Immunalysis CorporationFentanyl Urine Control HIGH (1.5 ng/mL)Dropper bottle: 5 mL5/27/2016
Immunalysis CorporationFentanyl Urine Control LOW (0.5 ng/mL)Dropper bottle: 5 mL5/27/2016
Immunalysis CorporationMDC Calibrator 1Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Calibrator 2Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Calibrator 3Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Calibrator 4Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Control HIGH Set 1Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Control HIGH Set 1Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Control LOW Set 1Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationMDC Control LOW Set 2Dropper bottle: 15 mL, 25 mL5/27/2016
Immunalysis CorporationOpiates Urine Calibrator 2000 1 (1000 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationOpiates Urine Calibrator 2000 2 (2000 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationOpiates Urine Calibrator 2000 3 (4000 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationOpiates Urine Calibrator 2000 4 (6000 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationOxazepam Urine Control HIGH (125 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Immunalysis CorporationOxazepam Urine Control LOW (75 ng/mL)Dropper bottle: 5 mL, 15 mL5/27/2016
Instrumentation LaboratoryGem Test PTBox: 45 cuvettes; 7.5μL each10/6/2016
IsoSciences, LLCCodeine-[13C4, 15N], 1000 μg/mL in methanolAmber ampule: 1 mL10/20/2016
IsoSciences, LLCCodeine-6β-Glucuronide-[13C10, 15N], 1000 μg/mL in methanol:water (2:8)Amber ampule: 1 mL10/20/2016
IsoSciences, LLCMorphine-[13C4, 15N], 1000 μg/mL in methanolAmber ampule: 1 mL10/20/2016
IsoSciences, LLCMorphine-6β-Glucuronide-[13C10, 15N], 1000 μg/mL in methanol:water (2:8)Amber ampule: 1 mL10/20/2016
IsoSciences, LLCTestosterone-[2H8], 100 µg/mL in methanolAmber Ampule: 1 mL8/10/2016
IsoSciences, LLCTestosterone-[2H8], 1000 µg/mL in methanolAmber Ampule: 1 mL8/10/2016
ITCHemochron JrBox: 45 cuvettes; 7.5μL each7/1/2016
Lipomed Inc25B-NB2OMe (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc25C-NB2OMe (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc25I-NB2OMe (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc25I-NB2OMe-D9 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc25I-NB2OMe-D9 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc3,4-Methylendioxypyrovalerone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc3,4-Methylenedioxy-α-pyrrolidinopropiophenone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Start Printed Page 26948
Lipomed Inc3-Desmethylprodine (1 mg/mL acetonitrile)Glass ampule: 1 mL10/28/2016
Lipomed Inc4-Ethylmethcathinone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc4-Methylethcathinone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc4-Methylmethcathinone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc4-Methylmethcathinone-D3 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Inc4-Methylmethcathinone-D3 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncBenzodiazepines mixture (.001 mg free base/ml acetonitrile)Glass ampule: 1 mL10/28/2016
Lipomed IncBenzodiazepines mixture 5 (1 mg free base/mL acetonitrile)Glass ampule: 1 mL10/28/2016
Lipomed IncBufotenine.oxalate.monohydrate (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncButabarbital (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncButalbital (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncButalbital-D5 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncButylone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncCannabidiol-D3 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncCannabidiol-D3 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncCannabinol-D3 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncCannabinol-D3 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncCarisoprodol (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncClotiazepam (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncCocaethylene-D3 (1 mg/mL acetonitrile)Glass ampule: 1 mL10/28/2016
Lipomed IncCocaine mixture 2 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncDesomorphine (1 mg/mL acetonitrile)Glass ampule: 1 mL10/28/2016
Lipomed IncEthylone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-018 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-018 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-018-D11 metabolite (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-018-D11 metabolite (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-019 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-019 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-081 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-081 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-122 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-122 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-200 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncJWH-200 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncL-Methamphetamine (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncLoprazolam (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncMazindol (1 mg/mL Dimethylformamide)Glass ampule: 1 mL10/28/2016
Lipomed IncMeprobamate (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncMethandienone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncMethylone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncMethylone-D3 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncMethylone-D3 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncN,N-Dimethylamphetamine (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncNaphyrone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncNimetazepam (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncNorbuprenorphine (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncNormeperidine (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPentedrone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPentylone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPhenobarbital-D5 (side chain) (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPhenobarbital-D5 (side chain) (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPregabalin (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPropoxyphen-D5 (0.1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPropoxyphen-D5 (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed IncPyrovalerone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Incα-Pyrrolidinopropiophenone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Lipomed Incα-Pyrrolidinovalerophenone (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Microgenics CorporationCascadion SM Total Testosterone Internal StandardBox: 8 bottles, 29 mL each12/16/2016
Microgenics CorporationCedia Buprenorphine OFT Control Set (Low and High) Catalog Number: 10022377Vial: 10 mL; Box: 2 vials11/15/2016
Microgenics CorporationCedia Buprenorphine OFT Cutoff Calibrator Catalog Number: 10022376Vial: 5 mL; Box: 1 vial11/15/2016
Microgenics CorporationCedia Multi-Drug OFT Cutoff Calibrator Set B Catalog Number: 10022355Vial: 10 mL; Box: 1 vial10/20/2016
Microgenics CorporationCedia Multi-Drug OFT Cutoff Control Set B (Low and High) Catalog Number: 10022356Vial: 15 mL; Box: 2 vials10/20/2016
Microgenics CorporationIntercept i2he Multi-Drug Oral Fluid Cutoff Calibrator Set B Catalog Number: 1001-0419Vial: 10 mL; Box: 1 vial10/19/2016
Microgenics CorporationIntercept i2he Multi-Drug Oral Fluid Cutoff Control Set B (Low and High) Catalog Number: 1001-0420Vial: 15 mL; Box: 2 vials10/19/2016
Start Printed Page 26949
Microgenics CorporationThermo Scientific CEDIA Buprenorphine II Calibrator 10 ng/mL Catalog Number: 10020799Vial: 5 mL Box: 1 vial8/30/2016
Microgenics CorporationThermo Scientific CEDIA Buprenorphine II Calibrator 100 ng/mL Catalog Number: 10020802Vial: 5 mL Box: 1 vial8/30/2016
Microgenics CorporationThermo Scientific CEDIA Buprenorphine II Calibrator 20 ng/mL Catalog Number: 10020800Vial: 5 mL Box: 1 vial8/30/2016
Microgenics CorporationThermo Scientific CEDIA Buprenorphine II Calibrator 50 ng/mL Catalog Number: 10020801Vial: 5 mL Box: 1 vial8/30/2016
Microgenics CorporationThermo Scientific CEDIA Buprenorphine II Controls (Low and High) Catalog Number: 10020804Vial: 5 mL Box: 4 vials8/30/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Oxycodone Negative Control 100Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Oxycodone Negative Control 100Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Oxycodone Negative Control 300Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Oxycodone Positive Control 100Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Oxycodone Positive Control 300Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Specialty Multi Drug Calibrator/Control Level 1Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Specialty Multi Drug Calibrator/Control Level 2Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Specialty Multi Drug Calibrator/Control Level 3Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncEmit II Plus Specialty Multi Drug Calibrator/Control Level 4Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Oxycodone Negative Control 100Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Oxycodone Negative Control 300Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Oxycodone Positive Control 100Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Oxycodone Positive Control 300Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Specialty Multi Drug Calibrator/Control Level 1Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Specialty Multi Drug Calibrator/Control Level 2Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Specialty Multi Drug Calibrator/Control Level 3Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncFC Emit II Plus Specialty Multi Drug Calibrator/Control Level 4Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Oxycodone Negative Control 100Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Oxycodone Negative Control 300Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Oxycodone Positive Control 100Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Oxycodone Positive Control 300Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Specialty Multi Drug Calibrator/Control LVL 1Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Specialty Multi Drug Calibrator/Control LVL 2Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Specialty Multi Drug Calibrator/Control LVL 3Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncMP FC Emit Specialty Multi Drug Calibrator/Control LVL 4Vial: 10 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Oxycodone Negative Control 100Pilot container: 4 mL-200 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Oxycodone Negative Control 300Pilot container: 4 mL-200 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Oxycodone Positive Control 100Pilot container: 4 mL-200 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Oxycodone Positive Control 300Pilot container: 4 mL-200 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 1Pilot container: 4 mL-200 mL8/23/2016
Start Printed Page 26950
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 2Pilot container: 4 mL-200 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 3Pilot container: 4 mL-200 mL8/23/2016
Siemens Healthcare Diagnostics, IncPilot Emit II Plus Specialty Multi Drug Calibrator/Control LVL 4Pilot container: 4 mL-200 mL8/23/2016
USPUSP Levomethorphan Solution Reference StandardBox: 3 vials, 1.2 mL each9/13/2016
UTAK Laboratories, IncAED II HR Serum Control, Ref: 72740Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncAED II MR Serum Control, Ref: 72741Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncBenzodiazepines 2 Serum Control HR, Ref: 22615Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncBenzodiazepines 2 Serum Control MR, Ref: 22616Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncBenzodiazepines Plus 100 Urine Control, Ref: 12090Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncBenzodiazepines Plus 100 Whole Blood Control, Ref: 12092Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncBenzodiazepines Plus 400 ng/mL Urine Control, Ref: 12091Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncClonazepam Serum Control HR, Ref: 22610Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncClonazepam Serum Control MR, Ref: 22611Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncDHEA Plus High Serum Control, Ref: 51411Carton: 5 bottles, 3 mL each12/27/2016
UTAK Laboratories, IncDHEA Plus Low Serum Control, Ref: 51410Carton: 5 bottles, 3 mL each12/27/2016
UTAK Laboratories, IncPentobarbital Serum Control, Ref: 66319Carton: 5 bottles, 5 mL each12/27/2016
UTAK Laboratories, IncSteroids Level 1 SMx Serum Control, Ref: 51401Carton: 5 bottles, 3 mL each12/27/2016
UTAK Laboratories, IncSteroids Level 2 SMx Serum Control, Ref: 51402Carton: 5 bottles, 3 mL each12/27/2016
UTAK Laboratories, IncSteroids Level 3 SMx Serum Control, Ref: 51403Carton: 5 bottles, 3 mL each12/27/2016
UTAK Laboratories, IncSteroids Level 4 SMx Serum Control, Ref: 51404Carton: 5 bottles, 3 mL each12/27/2016

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.

Chart II

SupplierProduct nameFormApplication date
Aalto Scientific, LtdGeneral Chemistry SerumBox: 1056 vials; 5 mL each6/20/2016
Biochemical Diagnostics, IncDetectabuse Custom Liquid Control Urine, MC253Glass vial: 1 mL-200 mL7/29/2016
Cerilliant Corporation(±)-cis-3-Methylfentanyl HCl (0.1 mg/mL)Glass ampule: 1 mL6/21/2016
Cerilliant Corporation(±)-cis-3-Methylfentanyl HCl (1 mg/mL)Glass ampule: 1 mL5/6/2016
Cerilliant CorporationButyryl fentanyl (0.1 mg/mL)Glass ampule: 1 mL6/21/2016
Cerilliant CorporationButyryl fentanyl HCl (1 mg/mL)Glass ampule: 1 mL5/20/2016
Lipomed IncBenzodiazepines mixture 8 (0.25 mg free base/mL acetonitrile)Glass ampule: 1 mL10/28/2016
Lipomed IncEstazolam (1 mg/mL methanol)Glass ampule: 1 mL10/28/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Oxycodone Negative Control 300Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Oxycodone Positive Control 100Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Oxycodone Positive Control 300Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 1Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 2Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 3Bulk Container: 1 L-50 L8/23/2016
Siemens Healthcare Diagnostics, IncBK Emit II Plus Specialty Multi Drug Calibrator/Control LVL 4Bulk Container: 1 L-50 L8/23/2016
Start Printed 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.

Start Signature

Dated: May 24, 2017.

Louis J. Milione,

Assistant Administrator.

End Signature End Supplemental Information

Footnotes

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

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

BILLING CODE 4410-09-P