Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 8433-8434 [2017-01582]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 15 / Wednesday, January 25, 2017 / Notices
relevant evidence contained in the
record submitted by the Government. 21
CFR 1301.43(d) & (e). I make the
following findings of fact. Id. Sec.
1301.43(e).
Findings of Fact
Registrant is the holder of DEA
Certificate of Registration BD0874378,
pursuant to which he is authorized to
dispense controlled substances in
Schedules II through V as a practitioner,
at the registered address of 4745 S.
Helena Way, Aurora, Colorado. GX 2.
His registration does not expire until
June 30, 2019. Id.
Registrant is also the holder of a
license to practice medicine (DR–28729)
issued by the Colorado Medical Board
(the Board). GX 4, at 1. However, on July
19, 2016, the Board issued Registrant an
Order of Suspension effective the same
day which ‘‘shall remain in effect until
resolution of this matter.’’ 1 Id. at 2. As
Registrant did not respond to the Show
Cause Order, let alone submit any
evidence to show that his state license
has been reinstated, I find that he does
not possess authority to dispense
controlled substances under the laws of
Colorado, the State in which he is
registered with the Agency.
mstockstill on DSK3G9T082PROD with NOTICES
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 Title 21, ‘‘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.’’
Moreover, with respect to a practitioner,
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 registration. See, e.g., James L. Hooper,
1 As the basis for its order, the Board found that
Registrant signed several hundred certifications
recommending the medical use of marijuana and
authorizing the possession of increased plant
counts, and that these certifications were ‘‘for
conditions other than cancer.’’ GX 4, at 1. The
Board further found that ‘‘signing the . . .
certifications . . . in the absence of cancer
diagnosis and treatment falls below generally
accepted standards of medical practice and lacks
medical necessity’’ and was ‘‘unprofessional
conduct’’ in violation of the Colorado Revised
Statute § 12–36–117(l)(p) and (mm). Id. Based on its
review of information relevant to three
investigations pertaining to Registrant, the Board
found ‘‘reasonable grounds to believe that the
public health, safety or welfare imperatively
requires emergency action and/or that [Registrant]
was guilty of a deliberate and willful violation of
law.’’ Id. at 1–2.
VerDate Sep<11>2014
20:29 Jan 24, 2017
Jkt 241001
76 FR 71371 (2011) (collecting cases),
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 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 medicine. 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); see
also Frederick Marsh 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 DEA 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 Colorado Medical
Board has employed summary process
in suspending Registrant’s state license.
What is consequential is that Registrant
is no longer currently authorized to
dispense controlled substances in the
State in which he is registered. I will
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
8433
therefore order that his registration be
revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. § 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration BD0874378, issued to
Gentry Reeves Dunlop, M.D., be, and it
hereby is, revoked. Pursuant to the
authority vested in me by 21 U.S.C.
§ 823(f), I further order that any pending
application of Gentry Reeves Dunlop,
M.D., to renew or modify his
registration, be, and it hereby is, denied.
This Order is effective immediately.2
Date: January 17, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–01690 Filed 1–24–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Organix, Inc.
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 in
accordance with 21 CFR 1301.33(a) on
or before March 27, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
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
DATES:
2 For the same reasons that led the Colorado
Board to summarily suspend Registrant’s medical
license, I find that the public interest necessitates
that this Order be effective immediately. 21 CFR
1316.67.
E:\FR\FM\25JAN1.SGM
25JAN1
8434
Federal Register / Vol. 82, No. 15 / Wednesday, January 25, 2017 / Notices
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
September 14, 2016, Organix, Inc., 240
Salem Street, Woburn, Massachusetts
01801, applied to be registered as a bulk
manufacturer of the following basic
classes controlled substances:
Controlled substance
Gamma Hydroxybutyric
Acid.
Lysergic acid
diethylamide.
Marihuana .....................
Tetrahydrocannabinols
Psilocybin ......................
Psilocyn ........................
Heroin ...........................
Morphine .......................
Drug
code
Schedule
2010
I
7315
I
7360
7370
7437
7438
9200
9300
I
I
I
I
I
II
The company plans to manufacture
reference standards for distribution to
its research and forensics customers. In
reference to drug code 7360 (marihuana)
and 7370 (THC) the company plans to
manufacture these drugs as synthetic.
No other activities for these drug codes
are authorized for this registration.
Dated: December 22, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017–01582 Filed 1–24–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
mstockstill on DSK3G9T082PROD with NOTICES
Donald W. Lamoureaux, M.D.; Decision
and Order
On September 16, 2016, the Assistant
Administrator, Division of Diversion
Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Donald W.
Lamoureaux, M.D. (Registrant), of
Horseshoe Bend, Arkansas. The Show
Cause Order proposed the revocation of
his DEA Certificate of Registration,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V, as a practitioner,
on the ground that he ‘‘do[es] not have
authority to handle controlled
substances in Arkansas, the [S]tate in
which he is registered with the DEA.’’
Show Cause Order, at 1.
As grounds for the proceeding, the
Show Cause Order alleged that
Registrant is registered with the DEA as
a practitioner authorized to dispense
controlled substances in schedules II
through V, pursuant to Certificate of
VerDate Sep<11>2014
20:29 Jan 24, 2017
Jkt 241001
Registration No. FL2413297, at the
registered address of 707 Third Street,
Horseshoe Bend, Arkansas. Id. The
Order also alleged that his registration
does not expire until March 31, 2017.
Id.
The Show Cause Order then alleged
that Registrant’s Arkansas medical
license expired on April 30, 2015, and
that he is currently without authority to
dispense controlled substances in
Arkansas, the State in which he is
registered with the DEA. Id. at 1–2.
Based upon Registrant’s lack of
authority to handle controlled
substances in the State of Arkansas, the
Government asserts that his registration
is subject to revocation. Id. at 2 (citing
21 U.S.C. §§ 802(21), 823(f) and
824(a)(3)).
The Show Cause Order also notified
Registrant of his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedures for electing either
option, and the consequence for failing
to elect either option. Id. at 2 (citing 21
CFR 1301.43). In addition, the Order
notified Registrant of his right to submit
a Corrective Action Plan. Id. at 2–3.
On September 19, 2016, the Show
Cause Order was sent via certified mail
to Registrant at his current residence,
the Federal Correctional Institution,
Butner, North Carolina, 27509.
Government Request for Final Agency
Action (RFAA), Appendix 4,
Declaration, at 1. As evidenced by a
copy of the signed return receipt card,
service was accomplished on September
22, 2016. Id.; See also Appendix 4, at 3–
4.
On November 1, 2016, the
Government forwarded to my Office a
Request for Final Agency Action and an
evidentiary record. In its Request, the
Government represents that it has not
received a request for a hearing or any
other reply from Registrant. RFAA, at 2.
The Government thus seeks the
revocation of Registrant’s Registration
on the ground that he lacks state
authority. Id. at 4.
Based upon the Government’s
representation and the record, I find that
more than 30 days have now passed
since the date of service of the Show
Cause Order, and neither Registrant, nor
anyone purporting to represent him, has
requested a hearing or submitted a
written statement in lieu of a hearing. I
therefore find that Registrant has waived
his right to a hearing or to submit a
written statement in lieu of a hearing
and issue this Decision and Final Order
based on relevant evidence contained in
the record submitted by the
Government. 21 CFR 1301.43(d) & (e). I
make the following findings of fact.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Findings
Respondent is the holder of
practitioner’s registration FL2413297,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V at the registered
address of 707 Third Street, Horseshoe
Bend, Arkansas; this registration does
not expire until March 31, 2017.
Declaration of the Diversion Investigator
(DI), at 1. According to the DI,
Registrant’s license to practice medicine
in Arkansas lapsed on April 30, 2015,
and he currently has no authority to
practice medicine in that State. Id. at 1.
As further support for the action, the
DI obtained, and the Government
submitted, a license verification from
the Arkansas State Medical Board along
with a Certification from the Board’s
Executive Secretary that the license
verification was true and correct as of
September 15, 2016. Appendix 2, at 1;
Appendix 3, at 1. This document shows
that as of September 14, 2016, the Board
listed the expiration date of Registrant’s
medical license as ‘‘April 30, 2015’’ and
the status of his license as ‘‘Inactive’’; it
also includes the notation: ‘‘License
Category: Felony Conviction.’’
Appendix 3, at 2. Also, the document
contains the following Board History
notes, which include that:
1. On February 9, 2015, the Board issued
an Emergency Order of Suspension to
Registrant;
2. On April 10, 2015, the Board voted ‘‘to
continue the disciplinary hearing until after
[Registrant’s] [] trial date’’;
3. On July 2, 2015, the Board voted ‘‘to
block [Registrant’s] access to renew his
license should he wish to renew’’; and
4. On December 3, 2015, Registrant’s
‘‘medical license lapsed subsequent to the
felony criminal conviction.’’
Appendix 3, at 4–5. As Registrant did
not respond to the Show Cause Order,
let alone submit any evidence to show
that his state license has been
reinstated, I find that he does not
possess authority to dispense controlled
substances under the laws of Arkansas,
the State in which he is registered with
the Agency.
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 Title 21, ‘‘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.’’
With respect to a practitioner, DEA has
repeatedly held that the possession of
authority to dispense controlled
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 82, Number 15 (Wednesday, January 25, 2017)]
[Notices]
[Pages 8433-8434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01582]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Organix,
Inc.
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 in accordance with 21 CFR
1301.33(a) on or before March 27, 2017.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
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
[[Page 8434]]
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
September 14, 2016, Organix, Inc., 240 Salem Street, Woburn,
Massachusetts 01801, applied to be registered as a bulk manufacturer of
the following basic classes controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Lysergic acid diethylamide............. 7315 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Psilocybin............................. 7437 I
Psilocyn............................... 7438 I
Heroin................................. 9200 I
Morphine............................... 9300 II
------------------------------------------------------------------------
The company plans to manufacture reference standards for
distribution to its research and forensics customers. In reference to
drug code 7360 (marihuana) and 7370 (THC) the company plans to
manufacture these drugs as synthetic. No other activities for these
drug codes are authorized for this registration.
Dated: December 22, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-01582 Filed 1-24-17; 8:45 am]
BILLING CODE 4410-09-P
