| Page Range | 26944-26951 | |
| FR Document | 2017-12110 |
[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)] [Notices] [Pages 26944-26951] From the Federal Register Online [www.thefederalregister.org] [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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Application Supplier Product name Form 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, Kit: 5 vials; 3 mL each.. 12/7/2016 Siemens Centaur. 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 Glass ampoule: 1 mL...... 8/3/2016 Solution. [[Page 26946]] Absolute Standards, Inc................ ISO G34 Internal Standard...... Glass ampoule: 1 mL...... 8/3/2016 Accriva Diagnostics, Inc............... Hemochron PT................... Box: 45 cuvettes; 5/17/2016 7.5[mu]L each. Arbor Assays........................... Testosterone 5-pack Enzyme Kit: 400 [mu]L vial...... 10/18/2016 Immunoassay Kit (K032-H5). Arbor Assays........................... Testosterone Enzyme Immunoassay Kit: 1 mL vial........... 10/18/2016 Kit (ISWE001). Arbor Assays........................... Testosterone Enzyme Immunoassay Kit: 90 [mu]L vial....... 10/18/2016 Kit (K032-H1). Arbor Assays........................... Testosterone Standard (1,000 ng/ Plastic vial: 1 mL....... 10/18/2016 mL). Arbor Assays........................... Testosterone Standard (200,000 Plastic vial: 90 [mu]L... 10/18/2016 pg/mL). Arbor Assays........................... Testosterone Standard (200,000 Plastic vial: 400 [mu]L.. 10/18/2016 pg/mL). Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vial: 1 mL-200 mL.. 7/29/2016 Control Urine, MC252. Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 9/30/2016 Control Urine, MC253. Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vial: 1 mL-200 mL.. 7/29/2016 Control Urine, MC254. Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vial: 1 mL-200 mL.. 7/29/2016 Control Urine, MC255. Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 12/19/2016 Control Urine, MC256. Biochemical Diagnostics, Inc........... Detectabuse Custom Liquid Glass vials: 1 ml-200 mL. 12/19/2016 Control Urine, MC257. Cayman Chemical Company................ 11-Keto Testosterone CRM; 1 mg/ Glass ampule: 1 mL....... 6/28/2016 mL in Acetonitrile. Cayman Chemical Company................ AB-CHMINACA (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016 Acetonitrile. Cayman Chemical Company................ AB-CHMINACA (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016 Methanol. Cayman Chemical Company................ AB-CHMINACA (CRM); 100 [micro]g/ Glass ampule: 1 mL....... 8/26/2016 mL in Acetonitrile. Cayman Chemical Company................ AB-CHMINACA (CRM); 100 [micro]g/ Glass ampule: 1 mL....... 8/26/2016 mL in Methanol. Cayman Chemical Company................ AB-PINACA CRM; 1 mg/mL in Glass ampule: 1 mL....... 6/28/2016 Methanol. Cayman Chemical Company................ Acetyl Fentanyl CRM; 1 mg/mL in Glass ampule: 1 mL....... 6/28/2016 Methanol. Cayman Chemical Company................ Acetyl Fentanyl CRM; 100 Glass ampule: 1 mL....... 6/28/2016 [micro]g/mL in Methanol. Cayman Chemical Company................ Cocaine CRM; 1 mg/mL in Glass ampule: 1 mL....... 6/28/2016 Acetonitrile. Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016 Mixture CRM; 1 mg/mL each in Acetonitrile. Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016 Mixture CRM; 100 [micro]g/mL each in Acetonitrile. Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016 Mixture CRM; 250 [micro]g/mL each in Acetonitrile. Cayman Chemical Company................ Cocaine/Heroin/Methamphetamine Glass ampule: 1 mL....... 8/26/2016 Mixture CRM; 500 [micro]g/mL each in Acetonitrile. Cayman Chemical Company................ GC-MS Drug Standard Mixture 1 Glass ampule: 1 mL....... 6/28/2016 in Acetonitrile. Cayman Chemical Company................ Phytocannabinoid Mixture 1; 1 Glass ampule: 1 mL....... 6/28/2016 mg/mL in Acetonitrile. Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016 1 mg/mL in Acetonitrile. Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016 1 mg/mL in Methanol. Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016 100 [micro]g/mL in Acetonitrile. Cayman Chemical Company................ Tapentadol (hydrochloride) CRM; Glass ampule: 1 mL....... 8/26/2016 100 [micro]g/mL in Methanol. Cayman Chemical Company................ THJ2201 (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016 Acetonitrile. Cayman Chemical Company................ THJ2201 (CRM); 1 mg/mL in Glass ampule: 1 mL....... 8/26/2016 Methanol. Cayman Chemical Company................ THJ2201 (CRM); 100 [micro]g/mL Glass ampule: 1 mL....... 8/26/2016 in Acetonitrile. Cayman Chemical Company................ THJ2201 (CRM); 100 [micro]g/mL Glass ampule: 1 mL....... 8/26/2016 in Methanol. Cayman Chemical Company................ ToxBox THC/THC Metabolite Plate 48-well plate............ 6/28/2016 Cerilliant Corporation................. ( )-11-Hydroxy- Glass ampule: 1 mL....... 11/11/2016 delta9-THC glucuronide (0.01 mg/mL). Cerilliant Corporation................. ( )-Cannabicyclol Glass ampule: 1.0 mL..... 7/18/2016 (1.0 mg/mL). Cerilliant Corporation................. ( )-cis-3- Glass ampule: 1 mL....... 6/21/2016 Methylfentanyl HCl (0.05 mg/ mL). Cerilliant Corporation................. ( )-cis-3- Glass ampule: 0.5 mL..... 7/18/2016 Methylfentanyl HCl (0.1 mg/mL). Cerilliant Corporation................. 5alpha-Dihydrotestosterone-D3 Glass ampule: 1 mL....... 9/28/2016 [16, 16, 17-D3]; 10 [micro]g/ mL. 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) Glass ampule: 1 mL....... 11/30/2016 (1.0 mg/mL). Cerilliant Corporation................. Cannabicyclolic acid (CBLA) Glass ampule: 1 mL....... 11/30/2016 (1.0 mg/mL). 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/ Glass ampule: 0.5 mL..... 11/30/2016 mL). Cerilliant Corporation................. Clorazepate dipotassium (1 mg/ Glass ampule: 1 mL....... 5/6/2016 mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 1 (20 pg/mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 2 (50 pg/mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 3 (100 pg/mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 4 (500 pg/mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 5 (1000 pg/mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 6 (2500 pg/mL). Cerilliant Corporation................. Dihydrotestosterone Calibrator Cryovial: 1 mL........... 8/12/2016 Level 7 (10 ng/mL). 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/ Glass ampule: 1.0 mL..... 7/18/2016 mL). Cerilliant Corporation................. Noroxymorphone-D3 HCl (0.1 mg/ Glass ampule: 1.0 mL..... 7/18/2016 mL). [[Page 26947]] 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; 10/21/2016 7.5[mu]L each. IDEXX Laboratories..................... Coag Dx PT Cartridge........... Cartridges: 7.5[mu]L each 10/21/2016 Immunalysis Corporation................ cTHC Urine Calibrator 1 (20 ng/ Dropper bottle: 5 mL, 15 5/27/2016 mL). mL. Immunalysis Corporation................ cTHC Urine Calibrator 2 (50 ng/ Dropper bottle: 5 mL, 15 5/27/2016 mL). mL. Immunalysis Corporation................ cTHC Urine Calibrator 3 (100 ng/ Dropper bottle: 5 mL, 15 5/27/2016 mL). mL. Immunalysis Corporation................ cTHC Urine Calibrator 4 (200 ng/ Dropper bottle: 5 mL, 15 5/27/2016 mL). mL. Immunalysis Corporation................ cTHC Urine Control HIGH (62.5 Dropper bottle: 5 mL, 15 5/27/2016 ng/mL). mL. Immunalysis Corporation................ cTHC Urine Control LOW (37.5 ng/ Dropper bottle: 5 mL, 15 5/27/2016 mL). mL. Immunalysis Corporation................ Fentanyl Urine Calibrator 1 (1 Dropper bottle: 5 mL..... 5/27/2016 ng/mL). Immunalysis Corporation................ Fentanyl Urine Calibrator 2 (2 Dropper bottle: 5 mL..... 5/27/2016 ng/mL). Immunalysis Corporation................ Fentanyl Urine Calibrator 3 (4 Dropper bottle: 5 mL..... 5/27/2016 ng/mL). Immunalysis Corporation................ Fentanyl Urine Control HIGH Dropper bottle: 5 mL..... 5/27/2016 (1.5 ng/mL). Immunalysis Corporation................ Fentanyl Urine Control LOW (0.5 Dropper bottle: 5 mL..... 5/27/2016 ng/mL). Immunalysis Corporation................ MDC Calibrator 1............... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Calibrator 2............... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Calibrator 3............... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Calibrator 4............... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Control HIGH Set 1......... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Control HIGH Set 1......... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Control LOW Set 1.......... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ MDC Control LOW Set 2.......... Dropper bottle: 15 mL, 25 5/27/2016 mL. Immunalysis Corporation................ Opiates Urine Calibrator 2000 1 Dropper bottle: 5 mL, 15 5/27/2016 (1000 ng/mL). mL. Immunalysis Corporation................ Opiates Urine Calibrator 2000 2 Dropper bottle: 5 mL, 15 5/27/2016 (2000 ng/mL). mL. Immunalysis Corporation................ Opiates Urine Calibrator 2000 3 Dropper bottle: 5 mL, 15 5/27/2016 (4000 ng/mL). mL. Immunalysis Corporation................ Opiates Urine Calibrator 2000 4 Dropper bottle: 5 mL, 15 5/27/2016 (6000 ng/mL). mL. Immunalysis Corporation................ Oxazepam Urine Control HIGH Dropper bottle: 5 mL, 15 5/27/2016 (125 ng/mL). mL. Immunalysis Corporation................ Oxazepam Urine Control LOW (75 Dropper bottle: 5 mL, 15 5/27/2016 ng/mL). mL. Instrumentation Laboratory............. Gem Test PT.................... Box: 45 cuvettes; 10/6/2016 7.5[mu]L each. IsoSciences, LLC....................... Codeine-[13C4, 15N], 1000 [mu]g/ Amber ampule: 1 mL....... 10/20/2016 mL in methanol. IsoSciences, LLC....................... Codeine-6[beta]-Glucuronide- Amber ampule: 1 mL....... 10/20/2016 [13C10, 15N], 1000 [mu]g/mL in methanol:water (2:8). IsoSciences, LLC....................... Morphine-[13C4, 15N], 1000 Amber ampule: 1 mL....... 10/20/2016 [mu]g/mL in methanol. IsoSciences, LLC....................... Morphine-6[beta]-Glucuronide- Amber ampule: 1 mL....... 10/20/2016 [13C10, 15N], 1000 [mu]g/mL in methanol:water (2:8). IsoSciences, LLC....................... Testosterone-[2H8], 100 Amber Ampule: 1 mL....... 8/10/2016 [micro]g/mL in methanol. IsoSciences, LLC....................... Testosterone-[2H8], 1000 Amber Ampule: 1 mL....... 8/10/2016 [micro]g/mL in methanol. ITC.................................... Hemochron Jr................... Box: 45 cuvettes; 7/1/2016 7.5[mu]L each. 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 Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ 25I-NB2OMe-D9 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ 3,4-Methylendioxypyrovalerone Glass ampule: 1 mL....... 10/28/2016 (1 mg/mL methanol). Lipomed Inc............................ 3,4-Methylenedioxy-[alpha]- Glass ampule: 1 mL....... 10/28/2016 pyrrolidinopropiophenone (1 mg/ mL methanol). [[Page 26948]] Lipomed Inc............................ 3-Desmethylprodine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 acetonitrile). Lipomed Inc............................ 4-Ethylmethcathinone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ 4-Methylethcathinone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ 4-Methylmethcathinone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ 4-Methylmethcathinone-D3 (0.1 Glass ampule: 1 mL....... 10/28/2016 mg/mL methanol). Lipomed Inc............................ 4-Methylmethcathinone-D3 (1 mg/ Glass ampule: 1 mL....... 10/28/2016 mL methanol). Lipomed Inc............................ Benzodiazepines mixture (.001 Glass ampule: 1 mL....... 10/28/2016 mg free base/ml acetonitrile). Lipomed Inc............................ Benzodiazepines mixture 5 (1 mg Glass ampule: 1 mL....... 10/28/2016 free base/mL acetonitrile). Lipomed Inc............................ Bufotenine.oxalate.monohydrate Glass ampule: 1 mL....... 10/28/2016 (1 mg/mL methanol). 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 Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Butylone (1 mg/mL methanol).... Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ Cannabidiol-D3 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Cannabidiol-D3 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Cannabinol-D3 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Cannabinol-D3 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). 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 Glass ampule: 1 mL....... 10/28/2016 acetonitrile). Lipomed Inc............................ Cocaine mixture 2 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Desomorphine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 acetonitrile). 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/ Glass ampule: 1 mL....... 10/28/2016 mL methanol). Lipomed Inc............................ JWH-018-D11 metabolite (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). 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 Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Loprazolam (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ Mazindol (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 Dimethylformamide). Lipomed Inc............................ Meprobamate (1 mg/mL methanol). Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ Methandienone (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Methylone (1 mg/mL methanol)... Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ Methylone-D3 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Methylone-D3 (1 mg/mL methanol) Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ N,N-Dimethylamphetamine (1 mg/ Glass ampule: 1 mL....... 10/28/2016 mL methanol). 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 Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Normeperidine (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). 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) Glass ampule: 1 mL....... 10/28/2016 (0.1 mg/mL methanol). Lipomed Inc............................ Phenobarbital-D5 (side chain) Glass ampule: 1 mL....... 10/28/2016 (1 mg/mL methanol). Lipomed Inc............................ Pregabalin (1 mg/mL methanol).. Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ Propoxyphen-D5 (0.1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Propoxyphen-D5 (1 mg/mL Glass ampule: 1 mL....... 10/28/2016 methanol). Lipomed Inc............................ Pyrovalerone (1 mg/mL methanol) Glass ampule: 1 mL....... 10/28/2016 Lipomed Inc............................ [alpha]- Glass ampule: 1 mL....... 10/28/2016 Pyrrolidinopropiophenone (1 mg/ mL methanol). Lipomed Inc............................ [alpha]- Glass ampule: 1 mL....... 10/28/2016 Pyrrolidinovalerophenone (1 mg/ mL methanol). Microgenics Corporation................ Cascadion SM Total Testosterone Box: 8 bottles, 29 mL 12/16/2016 Internal Standard. each. Microgenics Corporation................ Cedia Buprenorphine OFT Control Vial: 10 mL; Box: 2 vials 11/15/2016 Set (Low and High) Catalog Number: 10022377. Microgenics Corporation................ Cedia Buprenorphine OFT Cutoff Vial: 5 mL; Box: 1 vial.. 11/15/2016 Calibrator Catalog Number: 10022376. Microgenics Corporation................ Cedia Multi-Drug OFT Cutoff Vial: 10 mL; Box: 1 vial. 10/20/2016 Calibrator Set B Catalog Number: 10022355. Microgenics Corporation................ Cedia Multi-Drug OFT Cutoff Vial: 15 mL; Box: 2 vials 10/20/2016 Control Set B (Low and High) Catalog Number: 10022356. Microgenics Corporation................ Intercept i2he Multi-Drug Oral Vial: 10 mL; Box: 1 vial. 10/19/2016 Fluid Cutoff Calibrator Set B Catalog Number: 1001-0419. Microgenics Corporation................ Intercept i2he Multi-Drug Oral Vial: 15 mL; Box: 2 vials 10/19/2016 Fluid Cutoff Control Set B (Low and High) Catalog Number: 1001-0420. [[Page 26949]] Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016 Buprenorphine II Calibrator 10 ng/mL Catalog Number: 10020799. Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016 Buprenorphine II Calibrator 100 ng/mL Catalog Number: 10020802. Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016 Buprenorphine II Calibrator 20 ng/mL Catalog Number: 10020800. Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 1 vial... 8/30/2016 Buprenorphine II Calibrator 50 ng/mL Catalog Number: 10020801. Microgenics Corporation................ Thermo Scientific CEDIA Vial: 5 mL Box: 4 vials.. 8/30/2016 Buprenorphine II Controls (Low and High) Catalog Number: 10020804. Siemens Healthcare Diagnostics, Inc.... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L. 8/23/2016 Negative Control 100. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Negative Vial: 10 mL.............. 8/23/2016 Control 100. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Negative Vial: 10 mL.............. 8/23/2016 Control 300. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Positive Vial: 10 mL.............. 8/23/2016 Control 100. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Oxycodone Positive Vial: 10 mL.............. 8/23/2016 Control 300. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 1. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 2. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 3. Siemens Healthcare Diagnostics, Inc.... Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 4. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016 Negative Control 100. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016 Negative Control 300. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016 Positive Control 100. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Oxycodone Vial: 10 mL.............. 8/23/2016 Positive Control 300. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 1. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 2. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 3. Siemens Healthcare Diagnostics, Inc.... FC Emit II Plus Specialty Multi Vial: 10 mL.............. 8/23/2016 Drug Calibrator/Control Level 4. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Negative Vial: 10 mL.............. 8/23/2016 Control 100. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Negative Vial: 10 mL.............. 8/23/2016 Control 300. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Positive Vial: 10 mL.............. 8/23/2016 Control 100. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Oxycodone Positive Vial: 10 mL.............. 8/23/2016 Control 300. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016 Calibrator/Control LVL 1. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016 Calibrator/Control LVL 2. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016 Calibrator/Control LVL 3. Siemens Healthcare Diagnostics, Inc.... MP FC Emit Specialty Multi Drug Vial: 10 mL.............. 8/23/2016 Calibrator/Control LVL 4. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016 Negative Control 100. mL. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016 Negative Control 300. mL. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016 Positive Control 100. mL. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Oxycodone Pilot container: 4 mL-200 8/23/2016 Positive Control 300. mL. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016 Multi Drug Calibrator/Control mL. LVL 1. [[Page 26950]] Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016 Multi Drug Calibrator/Control mL. LVL 2. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016 Multi Drug Calibrator/Control mL. LVL 3. Siemens Healthcare Diagnostics, Inc.... Pilot Emit II Plus Specialty Pilot container: 4 mL-200 8/23/2016 Multi Drug Calibrator/Control mL. LVL 4. USP.................................... USP Levomethorphan Solution Box: 3 vials, 1.2 mL each 9/13/2016 Reference Standard. UTAK Laboratories, Inc................. AED II HR Serum Control, Ref: Carton: 5 bottles, 5 mL 12/27/2016 72740. each. UTAK Laboratories, Inc................. AED II MR Serum Control, Ref: Carton: 5 bottles, 5 mL 12/27/2016 72741. each. UTAK Laboratories, Inc................. Benzodiazepines 2 Serum Control Carton: 5 bottles, 5 mL 12/27/2016 HR, Ref: 22615. each. UTAK Laboratories, Inc................. Benzodiazepines 2 Serum Control Carton: 5 bottles, 5 mL 12/27/2016 MR, Ref: 22616. each. UTAK Laboratories, Inc................. Benzodiazepines Plus 100 Urine Carton: 5 bottles, 5 mL 12/27/2016 Control, Ref: 12090. each. UTAK Laboratories, Inc................. Benzodiazepines Plus 100 Whole Carton: 5 bottles, 5 mL 12/27/2016 Blood Control, Ref: 12092. each. UTAK Laboratories, Inc................. Benzodiazepines Plus 400 ng/mL Carton: 5 bottles, 5 mL 12/27/2016 Urine Control, Ref: 12091. each. UTAK Laboratories, Inc................. Clonazepam Serum Control HR, Carton: 5 bottles, 5 mL 12/27/2016 Ref: 22610. each. UTAK Laboratories, Inc................. Clonazepam Serum Control MR, Carton: 5 bottles, 5 mL 12/27/2016 Ref: 22611. each. UTAK Laboratories, Inc................. DHEA Plus High Serum Control, Carton: 5 bottles, 3 mL 12/27/2016 Ref: 51411. each. UTAK Laboratories, Inc................. DHEA Plus Low Serum Control, Carton: 5 bottles, 3 mL 12/27/2016 Ref: 51410. each. UTAK Laboratories, Inc................. Pentobarbital Serum Control, Carton: 5 bottles, 5 mL 12/27/2016 Ref: 66319. each. UTAK Laboratories, Inc................. Steroids Level 1 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016 Control, Ref: 51401. each. UTAK Laboratories, Inc................. Steroids Level 2 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016 Control, Ref: 51402. each. UTAK Laboratories, Inc................. Steroids Level 3 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016 Control, Ref: 51403. each. UTAK Laboratories, Inc................. Steroids Level 4 SMx Serum Carton: 5 bottles, 3 mL 12/27/2016 Control, Ref: 51404. each. ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Application Supplier Product name Form date ---------------------------------------------------------------------------------------------------------------- Aalto Scientific, Ltd................... General Chemistry Serum...... Box: 1056 vials; 5 mL each 6/20/2016 Biochemical Diagnostics, Inc............ Detectabuse Custom Liquid Glass vial: 1 mL-200 mL... 7/29/2016 Control Urine, MC253. Cerilliant Corporation.................. ( )-cis-3- Glass ampule: 1 mL........ 6/21/2016 Methylfentanyl HCl (0.1 mg/ mL). Cerilliant Corporation.................. ( )-cis-3- Glass ampule: 1 mL........ 5/6/2016 Methylfentanyl HCl (1 mg/mL). Cerilliant Corporation.................. Butyryl fentanyl (0.1 mg/mL). Glass ampule: 1 mL........ 6/21/2016 Cerilliant Corporation.................. Butyryl fentanyl HCl (1 mg/ Glass ampule: 1 mL........ 5/20/2016 mL). Lipomed Inc............................. Benzodiazepines mixture 8 Glass ampule: 1 mL........ 10/28/2016 (0.25 mg free base/mL acetonitrile). Lipomed Inc............................. Estazolam (1 mg/mL methanol). Glass ampule: 1 mL........ 10/28/2016 Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L.. 8/23/2016 Negative Control 300. Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L.. 8/23/2016 Positive Control 100. Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Oxycodone Bulk Container: 1 L-50 L.. 8/23/2016 Positive Control 300. Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016 Multi Drug Calibrator/ Control LVL 1. Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016 Multi Drug Calibrator/ Control LVL 2. Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016 Multi Drug Calibrator/ Control LVL 3. Siemens Healthcare Diagnostics, Inc..... BK Emit II Plus Specialty Bulk Container: 1 L-50 L.. 8/23/2016 Multi Drug Calibrator/ Control LVL 4. ---------------------------------------------------------------------------------------------------------------- [[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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Order with opportunity for comment. | |
| 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. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 26944 |