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