Importer of Controlled Substances Application: Unither Manufacturing LLC, 13961-13962 [2019-06850]
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Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
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at 3.2 The GCMB found that Registrant
had not been examined since 2014
‘‘with regard to whether he suffers from
a mental or physical condition that
would affect his ability to practice
medicine.’’ Id. The GCMB also found
that Registrant ‘‘has not been treated for
alcohol use disorder nor has a physician
with expertise in addiction psychiatry
determined that [Registrant] does not
suffer from that condition or that [his]
condition is in remission.’’ Id. As a
result of these findings, the GCMB
‘‘SUMMARILY SUSPENDED’’
Registrant’s license to practice medicine
in Georgia because the GCMB
concluded that Registrant’s ‘‘continued
practice of medicine poses a threat to
the public health, safety, and welfare
and imperatively requires emergency
action.’’ Id. at 4. Finally, the Suspension
Order further states that Registrant’s
Georgia medical license ‘‘will expire on
January 31, 2019.’’ Id. at 2.
In addition, I take official notice of the
results of a search of the GCMB’s license
verification web page showing that, as
of the date of this Decision, Registrant’s
Georgia medical license remains
‘‘suspended.’’ 3 Accordingly, I find that
Registrant currently does not possess a
license to practice medicine in the State
of Georgia, the State in which he is
registered with the DEA—both because
the GCMB suspended his Georgia
medical license on June 12, 2018 and
because his Georgia license expired on
January 31, 2019.
2 Specifically, the Suspension Order states that
the North Carolina Medical Board (NCMB)
‘‘summarily suspended’’ Registrant’s North Carolina
medical license in December 2015 ‘‘based on, in
part, a determination by a healthcare provider that
[Registrant] suffered from severe alcohol use
disorder, that [Registrant’s] condition was untreated
and unmonitored, and that [Registrant] continued to
practice medicine.’’ Id. Registrant eventually
‘‘agreed to have his [North Carolina medical]
license placed on inactive status . . . effective
March 18, 2016’’ after the NCMB ‘‘concluded that
[Registrant] was unable to practice medicine with
reasonable skill and safety to patients.’’ Id.
3 See https://gcmb.mylicense.com/verification/
SearchResults.aspx. Under the Administrative
Procedure Act (APA), an agency ‘‘may take official
notice of facts at any stage in a proceeding—even
in the final decision.’’ U.S. Dept. of Justice,
Attorney General’s Manual on the Administrative
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons,
Inc., Reprint 1979). In accordance with the APA
and DEA’s regulations, Registrant is ‘‘entitled on
timely request to an opportunity to show to the
contrary.’’ 5 U.S.C. 556(e); see also 21 CFR
1316.59(e). To allow Registrant the opportunity to
refute the facts of which I take official notice,
Registrant may file a motion for reconsideration
within 15 calendar days of service of this order
which shall commence on the date this order is
mailed. The Government also attached an
unverified copy of the GCMB’s license verification
page as an exhibit to its Request for Final Agency
Action that also shows that Registrant’s Georgia
medical license is suspended. See GX 5 to RFAA.
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Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (CSA), ‘‘upon a finding
that the registrant . . . has had his State
license . . . suspended [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ Also, DEA has
long held that the possession of
authority to dispense controlled
substances under the laws of the State
in which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a practitioner’s registration. See, e.g.,
James L. Hooper, 76 FR 71371 (2011),
pet. for rev. denied, 481 Fed. Appx. 826
(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
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13961
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 GCMB 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 State of Georgia, the
State in which he is registered.
Specifically, the GCMB’s decision to
suspend Registrant’s medical license
also means that Registrant is currently
without authority to dispense controlled
substances under the laws of Georgia.
See, e.g., Ga. Code Ann. §§ 43–34–21
(2009) (defining ‘‘practice of medicine’’
to include prescribing any form of
treatment); 43–34–26(a) (2010)
(requiring state license to obtain the
right to practice medicine). 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.
AC2515596, issued to Richard Carter,
M.D., be, and it hereby is, revoked. I
further order that any pending
application of Richard Carter to renew
or modify the above registration, or any
pending application of Richard Carter
for any other DEA registration in the
State of Georgia, be, and it hereby is,
denied. This Order is effective May 8,
2019.
Dated: March 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–06835 Filed 4–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Unither Manufacturing
LLC
ACTION:
E:\FR\FM\08APN1.SGM
Notice of application.
08APN1
13962
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
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 May 8, 2019. Such persons
may also file a written request for a
hearing on the application on or before
May 8, 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.
DATES:
In accordance with 21 CFR
1301.34(a), this is notice that on
February 4, 2019, Unither
Manufacturing LLC, 331 Clay Road,
Rochester, New York 14623–3226
applied to be registered as an importer
of the following basic class of controlled
substance:
Controlled
substance
Drug code
Methylphenidate ...
1724
Schedule
II
The company plans to import the
listed substance solely for updated
analytical testing purposes for EU
customer requirements. This analysis is
required to allow the company to export
domestically-manufactured finished
dosage forms to foreign markets.
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 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–06850 Filed 4–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Synthcon,
LLC
ACTION:
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 June 7, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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
1301.33(a), this is notice that on
February 1, 2019, Synthcon, LLC, 770
Wooten Road, Unit 101, Colorado
Springs, Colorado 80915 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Notice of application.
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Controlled substance
Drug code
Amphetamine .......................................................................................................................................................................
Methamphetamine ................................................................................................................................................................
3-Fluoro-N-methylcathinone (3-FMC) ...................................................................................................................................
Cathinone .............................................................................................................................................................................
Methcathinone ......................................................................................................................................................................
4-Fluoro-N-methylcathinone (4-FMC) ...................................................................................................................................
Pentedrone (a-methylaminovalerophenone) ........................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) .........................................................................................................................
4-Methyl-N-ethylcathinone (4-MEC) .....................................................................................................................................
Naphyrone ............................................................................................................................................................................
N-Ethylamphetamine ............................................................................................................................................................
N,N-Dimethylamphetamine ..................................................................................................................................................
Aminorex ..............................................................................................................................................................................
4-Methylaminorex (cis isomer) .............................................................................................................................................
Gamma Hydroxybutyric Acid ................................................................................................................................................
Methaqualone .......................................................................................................................................................................
Mecloqualone .......................................................................................................................................................................
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ........................................................................................................
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .......................................
JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ...................................................................................
JWH-073 (1-Butyl-3-(1-naphthoyl)indole) .............................................................................................................................
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1233
1235
1237
1238
1246
1248
1249
1258
1475
1480
1585
1590
2010
2565
2572
6250
7035
7118
7173
Schedule
II
II
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]]>Agencies
[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13961-13962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06850]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Unither
Manufacturing LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
[[Page 13962]]
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 May 8, 2019. Such
persons may also file a written request for a hearing on the
application on or before May 8, 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
February 4, 2019, Unither Manufacturing LLC, 331 Clay Road, Rochester,
New York 14623-3226 applied to be registered as an importer of the
following basic class of controlled substance:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Methylphenidate..................... 1724 II
------------------------------------------------------------------------
The company plans to import the listed substance solely for updated
analytical testing purposes for EU customer requirements. This analysis
is required to allow the company to export domestically-manufactured
finished dosage forms to foreign markets.
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 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06850 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P
