Importer of Controlled Substances Application: Sharp (Bethlehem), LLC, 9837 [2019-05000]

Download as PDF 9837 Federal Register / Vol. 84, No. 52 / Monday, March 18, 2019 / Notices (4th Cir. 2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (‘‘State authorization to dispense or otherwise handle controlled substances is a prerequisite to the issuance and maintenance of a Federal controlled substances registration.’’). This rule derives from the text of two provisions of the CSA. First, Congress 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 Act, DEA has long held 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 engages in professional practice. See, e.g., Calvin Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR 27616 (1978). Moreover, because ‘‘the controlling question’’ in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a practitioner’s registration ‘‘is currently authorized to handle controlled substances in the [S]tate,’’ Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), the Agency has also long held that revocation is warranted even where a practitioner has lost his state authority by virtue of the State’s use of summary process and the State has yet to provide a hearing to challenge the suspension. Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, it is of no consequence that the Virginia Board of Medicine summarily suspended Registrant’s state medical license. What is consequential is my finding that Registrant is no longer currently authorized to dispense controlled substances in the Commonwealth of Virginia, the State in which he is registered. Specifically, the Virginia Board of Medicine’s decision to suspend VerDate Sep<11>2014 18:24 Mar 15, 2019 Jkt 247001 Registrant’s medical license also means that Registrant is currently without authority to dispense controlled substances under the laws of Virginia. See, e.g., Va. Code Ann. §§ 54.1–2409.1 (2017) (felony to prescribe controlled substances without a current valid license); 54.1–2900 (2017); 54.1–3401 (2016). Accordingly, Registrant is not entitled to maintain his DEA registration, and I will therefore order that his registration be revoked. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. FS4850459, issued to Joel A. Smithers, D.O., be, and it hereby is, revoked. I further order that any pending application of Joel A. Smithers to renew or modify the above registration, or any pending application of Joel A. Smithers for any other DEA registration in the Commonwealth of Virginia, be, and it hereby is, denied. This Order is effective April 17, 2019. Dated: February 27, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019–05013 Filed 3–15–19; 8:45 am] (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 January 04, 2019, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020 applied to be registered as an importer of the following basic classes of controlled substances: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sharp (Bethlehem), 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 April 17, 2019. Such persons may also file a written request for a hearing on the application on or before April 17, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and DATES: PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 Controlled substance Drug code Schedule Gamma Hydroxybutyric Acid ....... 3,4-Methylenedioxymethamphetamine. Psilocybin ..................................... 2010 7405 I I 7437 I The company plans to import the listed controlled substances for 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: March 5, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–05000 Filed 3–15–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration William A. Sanpablo, M.D.; Decision and Order On December 3, 2018, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (DEA), issued an Order to Show Cause to William A. Sanpablo, E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Notices]
[Page 9837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05000]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Sharp (Bethlehem), 
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 April 17, 2019. Such 
persons may also file a written request for a hearing on the 
application on or before April 17, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 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 
January 04, 2019, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, 
Bethlehem, Pennsylvania 18020 applied to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                            Drug
           Controlled substance             code         Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid................   2010  I
3,4-Methylenedioxymethamphe- tamine......   7405  I
Psilocybin...............................   7437  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
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 non-approved finished dosage forms for commercial sale.

    Dated: March 5, 2019.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2019-05000 Filed 3-15-19; 8:45 am]
 BILLING CODE 4410-09-P