83 FR 34878 - Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 141 (July 23, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 141 (July 23, 2018)
| Page Range | 34878-34879 | |
| FR Document | 2018-15750 |
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)] [Notices] [Pages 34878-34879] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15750] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Fresenius Kabi USA, LLC ACTION: Notice of application. ----------------------------------------------------------------------- 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
![34878 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
defined the term ‘‘practitioner’’ to mean state for any drugs to be used in the comments on or objections to the
‘‘a physician . . . or other person practice of dentistry’’) and Miss. Admin. issuance of the proposed registration on
licensed, registered, or otherwise Code 30–2301:1.35(1) (West, current or before August 22, 2018. Such persons
permitted, by . . . the jurisdiction in through the Mississippi Administrative may also file a written request for a
which he practices . . . , to distribute, Rules Listing of Filings, dated May hearing on the application on or before
dispense, . . . [or] administer . . . a 2018) (legally licensed and registered August 22, 2018.
controlled substance in the course of dentists may write prescriptions for any ADDRESSES: Written comments should
professional practice.’’ 21 U.S.C. drugs to be used in the practice of be sent to: Drug Enforcement
802(21). Second, in setting the dentistry). Administration, Attention: DEA Federal
requirements for obtaining a Here, the undisputed evidence in the Register Representative/DRW, 8701
practitioner’s registration, Congress record is that Registrant currently lacks Morrissette Drive, Springfield, Virginia
directed that ‘‘[t]he Attorney General authority to practice dentistry and 22152. All requests for hearing must be
shall register practitioners . . . if the handle controlled substances in sent to: Drug Enforcement
applicant is authorized to dispense . . . Mississippi. As already discussed, only Administration, Attn: Administrator,
controlled substances under the laws of a legally licensed and registered dentist 8701 Morrissette Drive, Springfield,
the State in which he practices.’’ 21 may dispense a controlled substance or Virginia 22152. All request for hearing
U.S.C. 823(f). Because Congress has any drug to be used in the practice of should also be sent to: (1) Drug
clearly mandated that a practitioner dentistry in Mississippi. Thus, since Enforcement Administration, Attn:
possess State authority in order to be Registrant lacks authority to practice Hearing Clerk/LJ, 8701 Morrissette
deemed a practitioner under the CSA, dentistry in Mississippi, and is not Drive, Springfield, Virginia 22152; and
the DEA has held repeatedly that registered in Mississippi to handle (2) Drug Enforcement Administration,
revocation of a practitioner’s registration controlled substances, I will order that Attn: DEA Federal Register
is the appropriate sanction whenever he Registrant’s DEA registration be Representative/DRW, 8701 Morrissette
is no longer authorized to dispense revoked. Drive, Springfield, Virginia 22152.
controlled substances under the laws of
Order SUPPLEMENTARY INFORMATION:
the State in which he practices. See,
e.g., Hooper, supra, 76 FR at 71,371–72; Pursuant to 28 CFR 0.100(b) and the The Attorney General has delegated
Sheran Arden Yeates, M.D., 71 FR authority thus vested in me by 21 U.S.C. his authority under the Controlled
39,130, 39,131 (2006); Dominick A. 824(a), I order that DEA Certificate of Substances Act to the Administrator of
Ricci, M.D., 58 FR 51,104, 51,105 (1993); Registration No. FB0508993 issued to the Drug Enforcement Administration
Bobby Watts, M.D., 53 FR 11,919, 11,920 Kenneth C. Beal, Jr., D.D.S., be, and it (DEA), 28 CFR 0.100(b). Authority to
(1988); Blanton, supra, 43 FR at 27,617. hereby is, revoked. This Order is exercise all necessary functions with
According to Mississippi statute, effective August 22, 2018. respect to the promulgation and
‘‘Every person who desires to practice Dated: July 9, 2018. implementation of 21 CFR part 1301,
dentistry . . . in this state must obtain Uttam Dhillon, incident to the registration of
a license to do so.’’ Miss. Code Ann. Acting Administrator. manufacturers, distributors, dispensers,
§ 73–9–1 (West, Westlaw current with importers, and exporters of controlled
[FR Doc. 2018–15743 Filed 7–20–18; 8:45 am]
laws from the 2018 Regular Session). substances (other than final orders in
BILLING CODE 4410–09–P
Further, ‘‘[e]very person who . . . connection with suspension, denial, or
dispenses any controlled substance revocation of registration) has been
within this state . . . must obtain a DEPARTMENT OF JUSTICE redelegated to the Assistant
registration issued by . . . the State Administrator of the DEA Diversion
Board of Dental Examiners . . . in Drug Enforcement Administration Control Division (‘‘Assistant
accordance with its rules and the law of Administrator’’) pursuant to section 7 of
[Docket No. DEA–392] 28 CFR part 0, appendix to subpart R.
this state.’’ Miss. Code Ann. § 41–29–
125(1)(a) (West, Westlaw current with Importer of Controlled Substances In accordance with 21 CFR
laws from the 2018 Regular Application: Fresenius Kabi USA, LLC 1301.34(a), this is notice that on June
Session).3 See also Miss. Code Ann. 21, 2018, Fresenius Kabi USA, LLC,
§ 73–9–53 (West, Westlaw current with ACTION: Notice of application. 3159 Staley Road, Grand Island, New
laws from the 2018 Regular Session) York 14072–2028 applied to be
(authorizing Mississippi pharmacists to DATES: Registered bulk manufacturers of registered as an importer of the
fill prescriptions only of ‘‘legally the affected basic classes, and following basic class of controlled
licensed and registered dentists of this applicants therefore, may file written substance:
Controlled substance Drug code Schedule
Remifentanil ............................................................................................................................................................. 9739 II
amozie on DSK3GDR082PROD with NOTICES1
3 ‘‘Dispensing’’ a controlled substance includes Ann. § 41–29–105(j) (West, Westlaw current with
‘‘prescribing’’ and ‘‘administering’’ it. Miss. Code laws from the 2018 Regular Session).
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![Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34879
The company plans to import the In accordance with 21 CFR Representative/DRW, 8701 Morrissette
listed controlled substance for narcotic 1301.34(a), this is notice that on April Drive, Springfield, Virginia 22152.
material for bulk manufacture. 23, 2018, Shertech Laboratories, LLC, SUPPLEMENTARY INFORMATION: The
Dated: July 12, 2018. 1185 Woods Chapel Road, Duncan Attorney General has delegated his
John J. Martin, South Carolina 29334 applied to be authority under the Controlled
registered as an importer of the Substances Act to the Administrator of
Assistant Administrator.
following basic class of controlled the Drug Enforcement Administration
[FR Doc. 2018–15750 Filed 7–20–18; 8:45 am]
substance: (DEA), 28 CFR 0.100(b). Authority to
BILLING CODE 4410–09–P
exercise all necessary functions with
Drug respect to the promulgation and
Controlled substance Schedule
Code
DEPARTMENT OF JUSTICE implementation of 21 CFR part 1301,
Cocaine ........................ 9041 II incident to the registration of
Drug Enforcement Administration manufacturers, distributors, dispensers,
[Docket No. DEA–392]
The company plans to import importers, and exporters of controlled
synthetic derivatives of the listed substances (other than final orders in
Importer of Controlled Substances controlled substance in bulk form to connection with suspension, denial, or
Applications: Shertech Laboratories, conduct clinical trials. revocation of registration) has been
LLC Approval of permit applications will redelegated to the Assistant
occur only when the registrant’s activity Administrator of the DEA Diversion
ACTION: Notice of application. is consistent with what is authorized Control Division (‘‘Assistant
under to 21 U.S.C.952 (a)(2). Administrator’’) pursuant to section 7 of
DATES: Registered bulk manufacturers of Authorization will not extend to the 28 CFR part 0, appendix to subpart R.
the affected basic classes, and import of FDA approved or non- In accordance with 21 CFR
applicants therefore, may file written approved finished dosage forms for 1301.34(a), this is notice that on June 5,
comments on or objections to the commercial sale. 2018, Fisher Clinical Services, 700A–C
issuance of the proposed registration on Dated: July 12, 2018. Nestle Way, Breinigsville, PA 18031–
or before August 22, 2018. Such persons 1522 applied to be registered as an
John J. Martin,
may also file a written request for a importer of the following basic class of
Assistant Administrator.
hearing on the application on or before controlled substance:
[FR Doc. 2018–15713 Filed 7–20–18; 8:45 am]
August 22, 2018.
BILLING CODE 4410–09–P
ADDRESSES: Written comments should Drug
Controlled substance Schedule
be sent to: Drug Enforcement code
Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE Psilocybin ..................... 7437 I
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia Drug Enforcement Administration The company plans to import the
22152. All requests for hearing must be
[Docket No. DEA–392] listed controlled substance for clinical
sent to: Drug Enforcement
trials.
Administration, Attn: Administrator, Importer of Controlled Substances
8701 Morrissette Drive, Springfield, Dated: July 12, 2018.
Application: Fisher Clinical Services,
Virginia 22152. All request for hearing John J. Martin,
Inc.
should also be sent to: (1) Drug Assistant Administrator.
Enforcement Administration, Attn: ACTION: Notice of application. [FR Doc. 2018–15667 Filed 7–20–18; 8:45 am]
Hearing Clerk/LJ, 8701 Morrissette BILLING CODE 4410–09–P
Drive, Springfield, Virginia 22152; and DATES: Registered bulk manufacturers of
(2) Drug Enforcement Administration, the affected basic classes, and
Attn: DEA Federal Register applicants therefore, may file written DEPARTMENT OF JUSTICE
Representative/DRW, 8701 Morrissette comments on or objections to the
Drive, Springfield, Virginia 22152. issuance of the proposed registration on Drug Enforcement Administration
SUPPLEMENTARY INFORMATION: The or before August 22, 2018. Such persons
[Docket No. DEA–392]
Attorney General has delegated his may also file a written request for a
authority under the Controlled hearing on the application on or before Importer of Controlled Substances
Substances Act to the Administrator of August 22, 2018. Registration
the Drug Enforcement Administration ADDRESSES: Written comments should
(DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement ACTION: Notice of registration.
exercise all necessary functions with Administration, Attention: DEA Federal
respect to the promulgation and Register Representative/DRW, 8701 SUMMARY: The registrant listed below
implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia has applied for and been granted
incident to the registration of 22152. All requests for hearing must be registration by the Drug Enforcement
manufacturers, distributors, dispensers, sent to: Drug Enforcement Administration (DEA) as an importer of
importers, and exporters of controlled Administration, Attn: Administrator, various classes of schedule I or II
substances (other than final orders in 8701 Morrissette Drive, Springfield, controlled substances.
amozie on DSK3GDR082PROD with NOTICES1
connection with suspension, denial, or Virginia 22152. All requests for hearing SUPPLEMENTARY INFORMATION:
revocation of registration) has been should also be sent to: (1) Drug The company listed below applied to
redelegated to the Assistant Enforcement Administration, Attn: be registered as an importer of various
Administrator of the DEA Diversion Hearing Clerk/LJ, 8701 Morrissette basic classes of controlled substances.
Control Division (‘‘Assistant Drive, Springfield, Virginia 22152; and Information on the previously published
Administrator’’) pursuant to section 7 of (2) Drug Enforcement Administration, notice is listed in the table below. No
28 CFR part 0, appendix to subpart R. Attn: DEA Federal Register comments or objections were submitted
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Document Created: 2018-07-21 00:49:24
Document Modified: 2018-07-21 00:49:24
| 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 | Notice of application. | |
| 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. | |
| FR Citation | 83 FR 34878 |
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