Exempt Chemical Preparations Under the Controlled Substances Act, 31961-31964 [2016-11937]

Download as PDF 31961 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Controlled substance Schedule Amobarbital (2125) ...................................................................................................................................................................................... Phencyclidine (7471) ................................................................................................................................................................................... Phenylacetone (8501) ................................................................................................................................................................................. Cocaine (9041) ............................................................................................................................................................................................ Codeine (9050) ............................................................................................................................................................................................ Dihydrocodeine (9120) ................................................................................................................................................................................ Oxycodone (9143) ....................................................................................................................................................................................... Hydromorphone (9150) ............................................................................................................................................................................... Ecgonine (9180) .......................................................................................................................................................................................... Hydrocodone (9193) .................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Metazocine (9240) ....................................................................................................................................................................................... Methadone (9250) ....................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. Morphine (9300) .......................................................................................................................................................................................... Oripavine (9330) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Oxymorphone (9652) ................................................................................................................................................................................... Phenazocine (9715) .................................................................................................................................................................................... Carfentanil (9743) ........................................................................................................................................................................................ Fentanyl (9801) ........................................................................................................................................................................................... The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. Dated: May 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–11938 Filed 5–19–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–372] Exempt Chemical Preparations Under the Controlled Substances Act Drug Enforcement Administration, Department of Justice. ACTION: Order with opportunity for comment. AGENCY: The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between January 1, 2016, and March 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 July 19, 2016. 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, mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 including any attachments. 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 https:// 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 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of Diversion Control, 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 https:// PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 II II II II II II II II II II II II II II II II II II II II II 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 https:// www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic E:\FR\FM\20MYN1.SGM 20MYN1 31962 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices submission that is not identified as directed above as confidential. An electronic copy of this document is available at https:// 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 III are referred to as the ‘‘Controlled Substances Act’’ and the ‘‘Controlled Substances Import and Export Act,’’ respectively, and are collectively referred to as the ‘‘Controlled Substances Act’’ or the ‘‘CSA’’ for the purpose of this action. 21 U.S.C. 801–971. The DEA published 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 she 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 Deputy Assistant Administrator may exempt a chemical preparation or mixture from certain provisions of the CSA. The Deputy Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or revoke the criteria by which exemptions are granted and modify the scope of exemptions at any time. Exempt Chemical Preparation Applications Submitted Between January 1, 2016, and March 31, 2016 The Deputy Assistant Administrator received applications between January 1, 2016, and March 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 Deputy Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart I below is intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or 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 nonnarcotic 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), and in accordance with 21 CFR 1308.23 and 21 CFR 1308.24, the Deputy Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by the DEA, are 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 Supplier Cayman Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Product name ....... ....... ....... ....... ....... Cayman Chemical Company ....... Cayman Chemical Company ....... mstockstill on DSK3G9T082PROD with NOTICES Cayman Chemical Company ....... Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Cayman Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Chemical Company Company Company Company Company Company Company Company Company Company Company Company Company ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... ....... D9-THC Metabolite Mixture CRM; 1 mg/mL each in Methanol ........ D9-THC Metabolite Mixture CRM; 100 μg/mL each in Methanol ..... D9-THC Metabolite Mixture CRM; 250 μg/mL each in Methanol ..... D9-THC Metabolite Mixture CRM; 500 μg/mL each in Methanol ..... D9-THC/Cannabidiol/Cannabinol Mixture CRM; 1 mg/mL each in Methanol. D9-THC/Cannabidiol/Cannabinol Mixture CRM; 100 μg/mL each in Methanol. D9-THC/Cannabidiol/Cannabinol Mixture CRM; 250 μg/mL each in Methanol. D9-THC/Cannabidiol/Cannabinol Mixture CRM; 500 μg/mL each in Methanol. Cannabicitran CRM; 1 mg/mL in Acetonitrile ................................... Cannabicitran CRM; 1 mg/mL in Methanol ...................................... Cannabicitran CRM; 100 μg/mL in Acetonitrile ................................ Cannabicitran CRM; 100 μg/mL in Methanol ................................... Cannabinodiol CRM; 1 mg/mL in Acetonitrile ................................... Cannabinodiol CRM; 1 mg/mL in Methanol ...................................... Cannabinodiol CRM; 100 μg/mL in Acetonitrile ................................ Cannabinodiol CRM; 100 μg/mL in Methanol ................................... Cannabinol monomethyl ether CRM; 1 mg/mL in Acetonitrile ......... Cannabinol monomethyl ether CRM; 1 mg/mL in Methanol ............ Cannabinol monomethyl ether CRM; 100 μg/mL in Acetonitrile ...... Cannabinol monomethyl ether CRM; 100 μg/mL in Methanol ......... Clonazepam-d4 CRM; 1 mg/mL in Acetonitrile ................................ 1 This authority has been delegated from the Attorney General to the Administrator of the DEA VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 by 28 CFR 0.100, and subsequently redelegated to PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Application date Form Glass Glass Glass Glass Glass vial: vial: vial: vial: vial: ........ ........ ........ ........ ........ 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 Glass vial: 1 mL ........ 2/10/2016 Glass vial: 1 mL ........ 2/10/2016 Glass vial: 1 mL ........ 2/10/2016 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: vial: 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ ........ the Deputy Assistant Administrator pursuant to Section 7 of 28 CFR 0.104, appendix to subpart R. E:\FR\FM\20MYN1.SGM 20MYN1 31963 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices CHART I—Continued Supplier Product name Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cayman Chemical Company ....... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... Cerilliant Corporation ................... IsoSciences, LLC ......................... IsoSciences, LLC ......................... IsoSciences, LLC ......................... IsoSciences, LLC ......................... IsoSciences, LLC ......................... Clonazepam-d4 CRM; 100 μg/mL each in Acetonitrile .................... Zaleplon CRM; 1 mg/mL in Acetonitrile ............................................ Zaleplon CRM; 1 mg/mL in Methanol ............................................... Zaleplon CRM; 100 μg/mL in Acetonitrile ......................................... Zaleplon CRM; 100 μg/mL in Methanol ............................................ Zolpidem CRM; 1 mg/mL in Acetonitrile ........................................... Zolpidem CRM; 1 mg/mL in Methanol .............................................. Zolpidem CRM; 100 μg/mL in Acetonitrile ........................................ Zolpidem CRM; 100 μg/mL in Methanol ........................................... Zopiclone CRM; 1 mg/mL in Acetonitrile .......................................... Zopiclone CRM; 1 mg/mL in Methanol ............................................. Zopiclone CRM; 100 μg/mL in Acetonitrile ....................................... Zopiclone CRM; 100 μg/mL in Methanol .......................................... delta9-Tetrahydrocannabinolic acid A (1.0 mg/mL) .......................... m-Hydroxycocaine (1 mg/mL) ........................................................... NIST SRM–971 Extract ..................................................................... Norhydromorphone HCl (1 mg/mL) .................................................. o-Hydroxycocaine (1 mg/mL) ............................................................ p-Hydroxycocaine (1 mg/mL) ............................................................ T–096 Extract .................................................................................... T–097 Extract .................................................................................... Thebaine (1 mg/mL) .......................................................................... VAC–10–1 ......................................................................................... VAC–10–2 ......................................................................................... VAC–10–3 ......................................................................................... VAC–10–4 ......................................................................................... VAC–10–5 ......................................................................................... VAC–10–6 ......................................................................................... Zolpidem (1 mg/mL) .......................................................................... (±)-Amphetamine-[13C6] • HCl, 0.1 mg/mL in methanol ................. (±)-Amphetamine-[13C6] • HCl, 1.0 mg/mL in methanol ................. (±)-Methamphetamine-[13C6] • HCl, 0.1 mg/mL in methanol ......... (±)-Methamphetamine-[13C6] • HCl, 1.0 mg/mL in methanol ......... (±)-Methylenedioxyamphetamine-[13C6] • HCl ((±)-MDA-[13C6] • HCl), 0.1 mg/mL in methanol. (±)-Methylenedioxyamphetamine-[13C6] • HCl ((±)-MDA-[13C6] • HCl), 1.0 mg/mL in methanol. (±)-Methylenedioxyethylamphetamine-[13C6] • HCl ((±)-MDEA[13C6] • HCl), 0.1 mg/mL in methanol. (±)-Methylenedioxyethylamphetamine-[13C6] • HCl ((±)-MDEA[13C6] • HCl), 1.0 mg/mL in methanol. Chlordiazepoxide-D5 (0.1 mg/1 mL acetonitrile) .............................. Chlordiazepoxide-D5 (1 mg/1 mL acetonitrile) ................................. Clotiazepam (1 mg/1 mL methanol) ................................................. d,l-Methamphetamine-D14.HCl (0.1 mg/1 mL methanol) ................. d,l-Methamphetamine-D14.HCl (1 mg/1 mL methanol) .................... d,l-threo-Methylphenidate-D10.HCl (0.1 mg/1 mL methanol) ........... d,l-threo-Methylphenidate-D10.HCl (1 mg/1 mL methanol) .............. Oxycodone-OCD3.HCl (0.1 mg/1 mL methanol) .............................. Oxycodone-OCD3.HCl (1 mg/1 mL methanol) ................................. Oxymetholone (1 mg/1 mL acetonitrile) ............................................ Prazepam-D5 (0.1 mg/1 mL acetonitrile) .......................................... Prazepam-D5 (1 mg/1 mL methanol) ............................................... Tapentadol.HCl (1 mg/1 mL methanol) ............................................ (¥)-delta8-THC, 1000 μg/mL in Methanol ....................................... (¥)-delta9-THC, 1000 μg/mL in Methanol ....................................... (¥)-delta9-THC-D3, 100 μg/mL in Methanol .................................... (¥)-delta9-THC-D3, 1000 μg/mL in Methanol .................................. (±)-11-Hydroxy-delta9-THC, 100 μg/mL in Methanol ....................... (±)-11-nor-9-Carboxy-delta9-THC-D3, 100 μg/mL in Methanol ........ (±)-11-nor-9-Carboxy-delta9-THC-D3, 1000 μg/mL in Methanol ...... (±)-delta8-THC (Qualitative use only), 100 μg/mL in Heptane ......... (±)-delta9-THC (Qualitative use only), 100 μg/mL in Heptane ......... exo-THC, 1000 μg/mL in Methanol ................................................... Custom Standard—Quote# 032116–099 .......................................... IsoSciences, LLC ......................... IsoSciences, LLC ......................... mstockstill on DSK3G9T082PROD with NOTICES IsoSciences, LLC ......................... Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... SPEX CertiPrep Group, LLC ....... Ultra Scientific, Inc ....................... The Deputy Assistant Administrator has found that each of the compounds, VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 mixtures, and preparations described in Chart II below is not consistent with the PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Application date Form Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ vial: 1 mL ........ ampule: 1 mL .. ampule: 0.3 mL ampule: 1 mL .. ampule: 1 mL .. ampule: 1 mL .. ampule: 0.2 mL ampule: 0.3 mL ampule: 1 mL .. ampule: 0.3 mL ampule: 0.3 mL ampule: 0.3 mL ampule: 0.3 mL ampule: 0.3 mL ampule: 0.3 mL ampule: 1 mL .. ampule: 1 mL .. ampule: 1 mL .. ampule: 1 mL .. ampule: 1 mL .. ampule: 1 mL .. 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/10/2016 2/5/2016 2/16/2016 1/4/2016 3/17/2016 2/16/2016 2/16/2016 1/4/2016 1/4/2016 3/17/2016 1/4/2016 1/4/2016 1/4/2016 1/4/2016 1/4/2016 1/4/2016 3/17/2016 2/18/2016 2/18/2016 2/18/2016 2/18/2016 2/18/2016 Glass ampule: 1 mL .. 2/18/2016 Glass ampule: 1 mL .. 2/18/2016 Glass ampule: 1 mL .. 2/18/2016 Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass Glass 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 1/28/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 2/25/2016 3/29/2016 ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: ampule: 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 5 mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL mL .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23. Accordingly, the E:\FR\FM\20MYN1.SGM 20MYN1 31964 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices Deputy Assistant Administrator has determined that the chemical preparations or mixtures generally described in Chart II below and specifically described in the application materials received by DEA, are not exempt from application of 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 Supplier Product name Form Lipomed Inc ................................. Lipomed Inc ................................. Lipomed Inc ................................. Naloxone N-Oxide (1 mg/1 mL ACN/H2O 1:1) ................................ HU–210 (1 mg/1 mL methanol) ........................................................ HU–210 (0.1 mg/1 mL methanol) ..................................................... Glass ampule: 1 mL .. Glass ampule: 1 mL .. Glass ampule: 1 mL .. mstockstill on DSK3G9T082PROD with NOTICES 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 January 1, 2016, and March 31, 2016, and not otherwise referenced in this order may remain under consideration until the DEA receives additional information required, in accordance with 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. VerDate Sep<11>2014 17:40 May 19, 2016 Jkt 238001 Chemical Preparations Containing Newly Controlled Substances The statutory authority for exempt chemical preparations is based on the control status of substances contained within a preparation, the intended administration of a preparation, and the packaged form of a preparation. The DEA conducts a case-by-case analysis of each application for exemption to determine whether exemption of a preparation from certain provisions of the CSA is appropriate pursuant to the specified statutory and regulatory requirements. Most exempt chemical preparations have remained effective until the holder of a specific exempt chemical preparation specifically requested that the exemption be terminated. The CSA allows for modifications to the controlled substances schedules to add, remove, or change the schedule of substances thus resulting in periodic modifications to the control status of various substances. 21 U.S.C. 811(a). Since the CSA was enacted in 1970, the DEA has on several occasions added to, removed from, or modified the schedules of controlled substances in accordance with the CSA. Such changes may result in the non-compliance of exempt chemical preparations with current statutes or regulations if chemical preparations that have already obtained exempt status contain newly controlled substances. For example, although an exempt chemical preparation may continue to be packaged in the same manner as when it was approved, non-controlled substances in the preparation may become controlled, thus prompting the need for a new application for exemption of the chemical preparation to ensure continued compliance. Other preparations that previously contained no controlled substances may contain newly controlled substances and thus would require an application for exemption. The DEA reviews applications for chemical preparation exemptions based PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 Application date 1/28/2016 1/28/2016 1/28/2016 on the statutes and regulations that are in place at the time of the application, including the control status of substances included in the preparation. The DEA must remain vigilant to ensure that exempt chemical preparations remain consistent with the standards set forth in the CSA and its implementing regulations. As such, the DEA reminds the public that any chemical preparation, regardless of whether it was previously exempt, that contains a newly controlled substance will require a new application for exemption pursuant to 21 U.S.C. 811(g)(3)(B) and 21 CFR 1308.23–1308.24. 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 Deputy Assistant Administrator will immediately suspend the effectiveness of any applicable part of this order until he may reconsider the application in light of the comments and objections filed. Approved Exempt Chemical Preparations are Posted on DEA’s Web Site A list of all current exemptions, including those listed in this order, is available on the DEA’s Web site at https://www.DEAdiversion.usdoj.gov/ schedules/exempt/exempt_chemlist.pdf. The dates of applications of all current exemptions are posted for easy reference. Dated: May 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–11937 Filed 5–19–16; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\20MYN1.SGM 20MYN1

Agencies

[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31961-31964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11937]

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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.

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SUMMARY: The applications for exempt chemical preparations received by
the Drug Enforcement Administration (DEA) between January 1, 2016, and
March 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 July
19, 2016. 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. 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 https://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 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/ODW, 8701 Morrissette Drive, Springfield,
Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of
Diversion Control, 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 https://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 https://www.regulations.gov may include
any personal identifying information (such as name, address, and phone
number) included in the text of your electronic

[[Page 31962]]

submission that is not identified as directed above as confidential.
An electronic copy of this document is available at https://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 III are referred to as
the ``Controlled Substances Act'' and the ``Controlled Substances
Import and Export Act,'' respectively, and are collectively referred to
as the ``Controlled Substances Act'' or the ``CSA'' for the purpose of
this action. 21 U.S.C. 801-971. The DEA published 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 she 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 Deputy Assistant Administrator may exempt a chemical
preparation or mixture from certain provisions of the CSA. The Deputy
Assistant Administrator may, pursuant to 21 CFR 1308.23(f), modify or
revoke the criteria by which exemptions are granted and modify the
scope of exemptions at any time.
---------------------------------------------------------------------------

\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 January 1,
2016, and March 31, 2016

The Deputy Assistant Administrator received applications between
January 1, 2016, and March 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 Deputy
Assistant Administrator has found that each of the compounds, mixtures,
and preparations described in Chart I below is intended for laboratory,
industrial, educational, or special research purposes and not for
general administration to a human being or 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), and in accordance
with 21 CFR 1308.23 and 21 CFR 1308.24, the Deputy Assistant
Administrator has determined that each of the chemical preparations or
mixtures generally described in Chart I below and specifically
described in the application materials received by the DEA, are 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
----------------------------------------------------------------------------------------------------------------
Cayman Chemical Company............ [Delta]9-THC Metabolite Mixture CRM; Glass vial: 1 mL..... 2/10/2016
1 mg/mL each in Methanol.
Cayman Chemical Company............ [Delta]9-THC Metabolite Mixture CRM; Glass vial: 1 mL..... 2/10/2016
100 [micro]g/mL each in Methanol.
Cayman Chemical Company............ [Delta]9-THC Metabolite Mixture CRM; Glass vial: 1 mL..... 2/10/2016
250 [micro]g/mL each in Methanol.
Cayman Chemical Company............ [Delta]9-THC Metabolite Mixture CRM; Glass vial: 1 mL..... 2/10/2016
500 [micro]g/mL each in Methanol.
Cayman Chemical Company............ [Delta]9-THC/Cannabidiol/Cannabinol Glass vial: 1 mL..... 2/10/2016
Mixture CRM; 1 mg/mL each in
Methanol.
Cayman Chemical Company............ [Delta]9-THC/Cannabidiol/Cannabinol Glass vial: 1 mL..... 2/10/2016
Mixture CRM; 100 [micro]g/mL each
in Methanol.
Cayman Chemical Company............ [Delta]9-THC/Cannabidiol/Cannabinol Glass vial: 1 mL..... 2/10/2016
Mixture CRM; 250 [micro]g/mL each
in Methanol.
Cayman Chemical Company............ [Delta]9-THC/Cannabidiol/Cannabinol Glass vial: 1 mL..... 2/10/2016
Mixture CRM; 500 [micro]g/mL each
in Methanol.
Cayman Chemical Company............ Cannabicitran CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Cannabicitran CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Methanol.
Cayman Chemical Company............ Cannabicitran CRM; 100 [micro]g/mL Glass vial: 1 mL..... 2/10/2016
in Acetonitrile.
Cayman Chemical Company............ Cannabicitran CRM; 100 [micro]g/mL Glass vial: 1 mL..... 2/10/2016
in Methanol.
Cayman Chemical Company............ Cannabinodiol CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Cannabinodiol CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Methanol.
Cayman Chemical Company............ Cannabinodiol CRM; 100 [micro]g/mL Glass vial: 1 mL..... 2/10/2016
in Acetonitrile.
Cayman Chemical Company............ Cannabinodiol CRM; 100 [micro]g/mL Glass vial: 1 mL..... 2/10/2016
in Methanol.
Cayman Chemical Company............ Cannabinol monomethyl ether CRM; 1 Glass vial: 1 mL..... 2/10/2016
mg/mL in Acetonitrile.
Cayman Chemical Company............ Cannabinol monomethyl ether CRM; 1 Glass vial: 1 mL..... 2/10/2016
mg/mL in Methanol.
Cayman Chemical Company............ Cannabinol monomethyl ether CRM; 100 Glass vial: 1 mL..... 2/10/2016
[micro]g/mL in Acetonitrile.
Cayman Chemical Company............ Cannabinol monomethyl ether CRM; 100 Glass vial: 1 mL..... 2/10/2016
[micro]g/mL in Methanol.
Cayman Chemical Company............ Clonazepam-d4 CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.

[[Page 31963]]

Cayman Chemical Company............ Clonazepam-d4 CRM; 100 [micro]g/mL Glass vial: 1 mL..... 2/10/2016
each in Acetonitrile.
Cayman Chemical Company............ Zaleplon CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Zaleplon CRM; 1 mg/mL in Methanol... Glass vial: 1 mL..... 2/10/2016
Cayman Chemical Company............ Zaleplon CRM; 100 [micro]g/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Zaleplon CRM; 100 [micro]g/mL in Glass vial: 1 mL..... 2/10/2016
Methanol.
Cayman Chemical Company............ Zolpidem CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Zolpidem CRM; 1 mg/mL in Methanol... Glass vial: 1 mL..... 2/10/2016
Cayman Chemical Company............ Zolpidem CRM; 100 [micro]g/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Zolpidem CRM; 100 [micro]g/mL in Glass vial: 1 mL..... 2/10/2016
Methanol.
Cayman Chemical Company............ Zopiclone CRM; 1 mg/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Zopiclone CRM; 1 mg/mL in Methanol.. Glass vial: 1 mL..... 2/10/2016
Cayman Chemical Company............ Zopiclone CRM; 100 [micro]g/mL in Glass vial: 1 mL..... 2/10/2016
Acetonitrile.
Cayman Chemical Company............ Zopiclone CRM; 100 [micro]g/mL in Glass vial: 1 mL..... 2/10/2016
Methanol.
Cerilliant Corporation............. delta9-Tetrahydrocannabinolic acid A Glass vial: 1 mL..... 2/5/2016
(1.0 mg/mL).
Cerilliant Corporation............. m-Hydroxycocaine (1 mg/mL).......... Glass ampule: 1 mL... 2/16/2016
Cerilliant Corporation............. NIST SRM-971 Extract................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. Norhydromorphone HCl (1 mg/mL)...... Glass ampule: 1 mL... 3/17/2016
Cerilliant Corporation............. o-Hydroxycocaine (1 mg/mL).......... Glass ampule: 1 mL... 2/16/2016
Cerilliant Corporation............. p-Hydroxycocaine (1 mg/mL).......... Glass ampule: 1 mL... 2/16/2016
Cerilliant Corporation............. T-096 Extract....................... Glass ampule: 0.2 mL. 1/4/2016
Cerilliant Corporation............. T-097 Extract....................... Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. Thebaine (1 mg/mL).................. Glass ampule: 1 mL... 3/17/2016
Cerilliant Corporation............. VAC-10-1............................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. VAC-10-2............................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. VAC-10-3............................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. VAC-10-4............................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. VAC-10-5............................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. VAC-10-6............................ Glass ampule: 0.3 mL. 1/4/2016
Cerilliant Corporation............. Zolpidem (1 mg/mL).................. Glass ampule: 1 mL... 3/17/2016
IsoSciences, LLC................... ()-Amphetamine-[13C6] Glass ampule: 1 mL... 2/18/2016
HCl, 0.1 mg/mL in methanol.
IsoSciences, LLC................... ()-Amphetamine-[13C6] Glass ampule: 1 mL... 2/18/2016
HCl, 1.0 mg/mL in methanol.
IsoSciences, LLC................... ()-Methamphetamine- Glass ampule: 1 mL... 2/18/2016
[13C6] HCl, 0.1 mg/mL in
methanol.
IsoSciences, LLC................... ()-Methamphetamine- Glass ampule: 1 mL... 2/18/2016
[13C6] HCl, 1.0 mg/mL in
methanol.
IsoSciences, LLC................... ()- Glass ampule: 1 mL... 2/18/2016
Methylenedioxyamphetamine-[13C6]
HCl (()-MDA-
[13C6] HCl), 0.1 mg/mL in
methanol.
IsoSciences, LLC................... ()- Glass ampule: 1 mL... 2/18/2016
Methylenedioxyamphetamine-[13C6]
HCl (()-MDA-
[13C6] HCl), 1.0 mg/mL in
methanol.
IsoSciences, LLC................... ()- Glass ampule: 1 mL... 2/18/2016
Methylenedioxyethylamphetamine-
[13C6] HCl (()-
MDEA-[13C6] HCl), 0.1 mg/
mL in methanol.
IsoSciences, LLC................... ()- Glass ampule: 1 mL... 2/18/2016
Methylenedioxyethylamphetamine-
[13C6] HCl (()-
MDEA-[13C6] HCl), 1.0 mg/
mL in methanol.
Lipomed Inc........................ Chlordiazepoxide-D5 (0.1 mg/1 mL Glass ampule: 1 mL... 1/28/2016
acetonitrile).
Lipomed Inc........................ Chlordiazepoxide-D5 (1 mg/1 mL Glass ampule: 1 mL... 1/28/2016
acetonitrile).
Lipomed Inc........................ Clotiazepam (1 mg/1 mL methanol).... Glass ampule: 1 mL... 1/28/2016
Lipomed Inc........................ d,l-Methamphetamine-D14.HCl (0.1 mg/ Glass ampule: 1 mL... 1/28/2016
1 mL methanol).
Lipomed Inc........................ d,l-Methamphetamine-D14.HCl (1 mg/1 Glass ampule: 1 mL... 1/28/2016
mL methanol).
Lipomed Inc........................ d,l-threo-Methylphenidate-D10.HCl Glass ampule: 1 mL... 1/28/2016
(0.1 mg/1 mL methanol).
Lipomed Inc........................ d,l-threo-Methylphenidate-D10.HCl (1 Glass ampule: 1 mL... 1/28/2016
mg/1 mL methanol).
Lipomed Inc........................ Oxycodone-OCD3.HCl (0.1 mg/1 mL Glass ampule: 1 mL... 1/28/2016
methanol).
Lipomed Inc........................ Oxycodone-OCD3.HCl (1 mg/1 mL Glass ampule: 1 mL... 1/28/2016
methanol).
Lipomed Inc........................ Oxymetholone (1 mg/1 mL Glass ampule: 1 mL... 1/28/2016
acetonitrile).
Lipomed Inc........................ Prazepam-D5 (0.1 mg/1 mL Glass ampule: 1 mL... 1/28/2016
acetonitrile).
Lipomed Inc........................ Prazepam-D5 (1 mg/1 mL methanol).... Glass ampule: 1 mL... 1/28/2016
Lipomed Inc........................ Tapentadol.HCl (1 mg/1 mL methanol). Glass ampule: 1 mL... 1/28/2016
SPEX CertiPrep Group, LLC.......... (-)-delta8-THC, 1000 [mu]g/mL in Glass ampule: 2 mL... 2/25/2016
Methanol.
SPEX CertiPrep Group, LLC.......... (-)-delta9-THC, 1000 [mu]g/mL in Glass ampule: 2 mL... 2/25/2016
Methanol.
SPEX CertiPrep Group, LLC.......... (-)-delta9-THC-D3, 100 [mu]g/mL in Glass ampule: 2 mL... 2/25/2016
Methanol.
SPEX CertiPrep Group, LLC.......... (-)-delta9-THC-D3, 1000 [mu]g/mL in Glass ampule: 2 mL... 2/25/2016
Methanol.
SPEX CertiPrep Group, LLC.......... ()-11-Hydroxy-delta9- Glass ampule: 2 mL... 2/25/2016
THC, 100 [mu]g/mL in Methanol.
SPEX CertiPrep Group, LLC.......... ()-11-nor-9-Carboxy- Glass ampule: 2 mL... 2/25/2016
delta9-THC-D3, 100 [mu]g/mL in
Methanol.
SPEX CertiPrep Group, LLC.......... ()-11-nor-9-Carboxy- Glass ampule: 2 mL... 2/25/2016
delta9-THC-D3, 1000 [mu]g/mL in
Methanol.
SPEX CertiPrep Group, LLC.......... ()-delta8-THC Glass ampule: 2 mL... 2/25/2016
(Qualitative use only), 100 [mu]g/
mL in Heptane.
SPEX CertiPrep Group, LLC.......... ()-delta9-THC Glass ampule: 2 mL... 2/25/2016
(Qualitative use only), 100 [mu]g/
mL in Heptane.
SPEX CertiPrep Group, LLC.......... exo-THC, 1000 [mu]g/mL in Methanol.. Glass ampule: 2 mL... 2/25/2016
Ultra Scientific, Inc.............. Custom Standard--Quote# 032116-099.. Glass ampule: 5 mL... 3/29/2016
----------------------------------------------------------------------------------------------------------------

The Deputy Assistant Administrator has found that each of the
compounds, mixtures, and preparations described in Chart II below is
not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and
in 21 CFR 1308.23. Accordingly, the

[[Page 31964]]

Deputy Assistant Administrator has determined that the chemical
preparations or mixtures generally described in Chart II below and
specifically described in the application materials received by DEA,
are not exempt from application of 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
----------------------------------------------------------------------------------------------------------------
Lipomed Inc........................ Naloxone N-Oxide (1 mg/1 mL ACN/H2O Glass ampule: 1 mL... 1/28/2016
1:1).
Lipomed Inc........................ HU-210 (1 mg/1 mL methanol)......... Glass ampule: 1 mL... 1/28/2016
Lipomed Inc........................ HU-210 (0.1 mg/1 mL methanol)....... Glass ampule: 1 mL... 1/28/2016
----------------------------------------------------------------------------------------------------------------

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
January 1, 2016, and March 31, 2016, and not otherwise referenced in
this order may remain under consideration until the DEA receives
additional information required, in accordance with 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.

Chemical Preparations Containing Newly Controlled Substances

The statutory authority for exempt chemical preparations is based
on the control status of substances contained within a preparation, the
intended administration of a preparation, and the packaged form of a
preparation. The DEA conducts a case-by-case analysis of each
application for exemption to determine whether exemption of a
preparation from certain provisions of the CSA is appropriate pursuant
to the specified statutory and regulatory requirements.
Most exempt chemical preparations have remained effective until the
holder of a specific exempt chemical preparation specifically requested
that the exemption be terminated. The CSA allows for modifications to
the controlled substances schedules to add, remove, or change the
schedule of substances thus resulting in periodic modifications to the
control status of various substances. 21 U.S.C. 811(a). Since the CSA
was enacted in 1970, the DEA has on several occasions added to, removed
from, or modified the schedules of controlled substances in accordance
with the CSA. Such changes may result in the non-compliance of exempt
chemical preparations with current statutes or regulations if chemical
preparations that have already obtained exempt status contain newly
controlled substances. For example, although an exempt chemical
preparation may continue to be packaged in the same manner as when it
was approved, non-controlled substances in the preparation may become
controlled, thus prompting the need for a new application for exemption
of the chemical preparation to ensure continued compliance. Other
preparations that previously contained no controlled substances may
contain newly controlled substances and thus would require an
application for exemption.
The DEA reviews applications for chemical preparation exemptions
based on the statutes and regulations that are in place at the time of
the application, including the control status of substances included in
the preparation. The DEA must remain vigilant to ensure that exempt
chemical preparations remain consistent with the standards set forth in
the CSA and its implementing regulations. As such, the DEA reminds the
public that any chemical preparation, regardless of whether it was
previously exempt, that contains a newly controlled substance will
require a new application for exemption pursuant to 21 U.S.C.
811(g)(3)(B) and 21 CFR 1308.23-1308.24.

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 Deputy Assistant
Administrator will immediately suspend the effectiveness of any
applicable part of this order until he may reconsider the application
in light of the comments and objections filed.

Approved Exempt Chemical Preparations are Posted on DEA's Web Site

A list of all current exemptions, including those listed in this
order, is available on the DEA's Web site at https://www.DEAdiversion.usdoj.gov/schedules/exempt/exempt_chemlist.pdf. The
dates of applications of all current exemptions are posted for easy
reference.

Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-11937 Filed 5-19-16; 8:45 am]
BILLING CODE 4410-09-P

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