Importer of Controlled Substances Application: Fresenius Kabi USA, LLC, 34878-34879 [2018-15750]

Download as PDF 34878 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices defined the term ‘‘practitioner’’ to mean ‘‘a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . . , to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.’’ 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner’s registration, Congress directed that ‘‘[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess State authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner’s registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices. See, e.g., Hooper, supra, 76 FR at 71,371–72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Blanton, supra, 43 FR at 27,617. According to Mississippi statute, ‘‘Every person who desires to practice dentistry . . . in this state must obtain a license to do so.’’ Miss. Code Ann. § 73–9–1 (West, Westlaw current with laws from the 2018 Regular Session). Further, ‘‘[e]very person who . . . dispenses any controlled substance within this state . . . must obtain a registration issued by . . . the State Board of Dental Examiners . . . in accordance with its rules and the law of this state.’’ Miss. Code Ann. § 41–29– 125(1)(a) (West, Westlaw current with laws from the 2018 Regular Session).3 See also Miss. Code Ann. § 73–9–53 (West, Westlaw current with laws from the 2018 Regular Session) (authorizing Mississippi pharmacists to fill prescriptions only of ‘‘legally licensed and registered dentists of this state for any drugs to be used in the practice of dentistry’’) and Miss. Admin. Code 30–2301:1.35(1) (West, current through the Mississippi Administrative Rules Listing of Filings, dated May 2018) (legally licensed and registered dentists may write prescriptions for any drugs to be used in the practice of dentistry). Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice dentistry and handle controlled substances in Mississippi. As already discussed, only a legally licensed and registered dentist may dispense a controlled substance or any drug to be used in the practice of dentistry in Mississippi. Thus, since Registrant lacks authority to practice dentistry in Mississippi, and is not registered in Mississippi to handle controlled substances, I will order that Registrant’s DEA registration be revoked. comments on or objections to the issuance of the proposed registration on or before August 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: Order SUPPLEMENTARY INFORMATION: Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 21 U.S.C. 824(a), I order that DEA Certificate of Registration No. FB0508993 issued to Kenneth C. Beal, Jr., D.D.S., be, and it hereby is, revoked. This Order is effective August 22, 2018. The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on June 21, 2018, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072–2028 applied to be registered as an importer of the following basic class of controlled substance: Dated: July 9, 2018. Uttam Dhillon, Acting Administrator. [FR Doc. 2018–15743 Filed 7–20–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fresenius Kabi USA, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written DATES: Drug code Schedule Remifentanil ............................................................................................................................................................. amozie on DSK3GDR082PROD with NOTICES1 Controlled substance 9739 II 3 ‘‘Dispensing’’ a controlled substance includes ‘‘prescribing’’ and ‘‘administering’’ it. Miss. Code VerDate Sep<11>2014 17:59 Jul 20, 2018 Jkt 244001 Ann. § 41–29–105(j) (West, Westlaw current with laws from the 2018 Regular Session). PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1 34879 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices The company plans to import the listed controlled substance for narcotic material for bulk manufacture. Dated: July 12, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–15750 Filed 7–20–18; 8:45 am] BILLING CODE 4410–09–P In accordance with 21 CFR 1301.34(a), this is notice that on April 23, 2018, Shertech Laboratories, LLC, 1185 Woods Chapel Road, Duncan South Carolina 29334 applied to be registered as an importer of the following basic class of controlled substance: Drug Code Controlled substance DEPARTMENT OF JUSTICE Cocaine ........................ 9041 Schedule II Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Applications: Shertech Laboratories, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before August 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. amozie on DSK3GDR082PROD with NOTICES1 DATES: VerDate Sep<11>2014 19:07 Jul 20, 2018 Jkt 244001 The company plans to import synthetic derivatives of the listed controlled substance in bulk form to conduct clinical trials. Approval of permit applications will occur only when the registrant’s activity is consistent with what is authorized under to 21 U.S.C.952 (a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: July 12, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–15713 Filed 7–20–18; 8:45 am] Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on June 5, 2018, Fisher Clinical Services, 700A–C Nestle Way, Breinigsville, PA 18031– 1522 applied to be registered as an importer of the following basic class of controlled substance: BILLING CODE 4410–09–P Controlled substance Drug code Schedule DEPARTMENT OF JUSTICE Psilocybin ..................... Drug Enforcement Administration The company plans to import the listed controlled substance for clinical trials. [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: Notice of application. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 I Dated: July 12, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–15667 Filed 7–20–18; 8:45 am] Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before August 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register DATES: 7437 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration ACTION: Notice of registration. The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of various classes of schedule I or II controlled substances. SUPPLEMENTARY INFORMATION: The company listed below applied to be registered as an importer of various basic classes of controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted SUMMARY: E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34878-34879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15750]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Fresenius Kabi 
USA, LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before August 22, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before August 22, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: 
    The Attorney General has delegated his authority under the 
Controlled Substances Act to the Administrator of the Drug Enforcement 
Administration (DEA), 28 CFR 0.100(b). Authority to exercise all 
necessary functions with respect to the promulgation and implementation 
of 21 CFR part 1301, incident to the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances (other than final orders in connection with suspension, 
denial, or revocation of registration) has been redelegated to the 
Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on June 
21, 2018, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New 
York 14072-2028 applied to be registered as an importer of the 
following basic class of controlled substance:

------------------------------------------------------------------------
         Controlled substance              Drug code         Schedule
------------------------------------------------------------------------
Remifentanil..........................            9739               II
------------------------------------------------------------------------


[[Page 34879]]

    The company plans to import the listed controlled substance for 
narcotic material for bulk manufacture.

    Dated: July 12, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-15750 Filed 7-20-18; 8:45 am]
 BILLING CODE 4410-09-P