82 FR 8433 - Bulk Manufacturer of Controlled Substances Application: Organix, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 15 (January 25, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 15 (January 25, 2017)
| Page Range | 8433-8434 | |
| FR Document | 2017-01582 |
[Federal Register Volume 82, Number 15 (Wednesday, January 25, 2017)] [Notices] [Pages 8433-8434] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 82, No. 15 / Wednesday, January 25, 2017 / Notices 8433
relevant evidence contained in the 76 FR 71371 (2011) (collecting cases), therefore order that his registration be
record submitted by the Government. 21 pet. for rev. denied, 481 Fed. Appx. 826 revoked.
CFR 1301.43(d) & (e). I make the (4th Cir. 2012); see also Frederick Marsh
Order
following findings of fact. Id. Sec. Blanton, 43 FR 27616 (1978) (‘‘State
1301.43(e). authorization to dispense or otherwise Pursuant to the authority vested in me
handle controlled substances is a by 21 U.S.C. § 824(a), as well as 28 CFR
Findings of Fact 0.100(b), I order that DEA Certificate of
prerequisite to the issuance and
Registrant is the holder of DEA maintenance of a Federal controlled Registration BD0874378, issued to
Certificate of Registration BD0874378, substances registration.’’). Gentry Reeves Dunlop, M.D., be, and it
pursuant to which he is authorized to This rule derives from the text of two hereby is, revoked. Pursuant to the
dispense controlled substances in provisions of the CSA. First, Congress authority vested in me by 21 U.S.C.
Schedules II through V as a practitioner, defined ‘‘the term ‘practitioner’ [to] § 823(f), I further order that any pending
at the registered address of 4745 S. mean[] a . . . physician . . . or other application of Gentry Reeves Dunlop,
Helena Way, Aurora, Colorado. GX 2. person licensed, registered or otherwise M.D., to renew or modify his
His registration does not expire until permitted, by . . . the jurisdiction in registration, be, and it hereby is, denied.
June 30, 2019. Id. which he practices . . . to distribute, This Order is effective immediately.2
Registrant is also the holder of a Date: January 17, 2017.
dispense, [or] administer . . . a
license to practice medicine (DR–28729)
controlled substance in the course of Chuck Rosenberg,
issued by the Colorado Medical Board
professional practice.’’ 21 U.S.C. Acting Administrator.
(the Board). GX 4, at 1. However, on July
§ 802(21). Second, in setting the [FR Doc. 2017–01690 Filed 1–24–17; 8:45 am]
19, 2016, the Board issued Registrant an
requirements for obtaining a BILLING CODE 4410–09–P
Order of Suspension effective the same
day which ‘‘shall remain in effect until practitioner’s registration, Congress
resolution of this matter.’’ 1 Id. at 2. As directed that ‘‘[t]he Attorney General
Registrant did not respond to the Show shall register practitioners . . . if the DEPARTMENT OF JUSTICE
Cause Order, let alone submit any applicant is authorized to dispense . . .
controlled substances under the laws of Drug Enforcement Administration
evidence to show that his state license
has been reinstated, I find that he does the State in which he practices.’’ 21 [Docket No. DEA–392]
not possess authority to dispense U.S.C. § 823(f). Because Congress has
controlled substances under the laws of clearly mandated that a practitioner Bulk Manufacturer of Controlled
Colorado, the State in which he is possess state authority in order to be Substances Application: Organix, Inc.
registered with the Agency. deemed a practitioner under the Act,
DEA has held repeatedly that revocation ACTION: Notice of application.
Discussion of a practitioner’s registration is the
appropriate sanction whenever he is no DATES: Registered bulk manufacturers of
Pursuant to 21 U.S.C. § 824(a)(3), the the affected basic classes, and
Attorney General is authorized to longer authorized to dispense controlled
applicants therefore, may file written
suspend or revoke a registration issued substances under the laws of the State
comments on or objections to the
under section 823 of Title 21, ‘‘upon a in which he practices medicine. See,
issuance of the proposed registration in
finding that the registrant . . . has had e.g., Calvin Ramsey, 76 FR 20034, 20036
accordance with 21 CFR 1301.33(a) on
his State license . . . suspended [or] (2011); Sheran Arden Yeates, M.D., 71
or before March 27, 2017.
revoked . . . by competent State FR 39130, 39131 (2006); Dominick A.
Ricci, 58 FR 51104, 51105 (1993); Bobby ADDRESSES: Written comments should
authority and is no longer authorized by
State law to engage in the . . . Watts, 53 FR 11919, 11920 (1988); see be sent to: Drug Enforcement
dispensing of controlled substances.’’ also Frederick Marsh Blanton, 43 FR Administration, Attention: DEA Federal
Moreover, with respect to a practitioner, 27616 (1978). Register Representative/DRW, 8701
DEA has long held that the possession Morrissette Drive, Springfield, Virginia
Moreover, because ‘‘the controlling
of authority to dispense controlled 22152.
question’’ in a proceeding brought
substances under the laws of the State under 21 U.S.C. § 824(a)(3) is whether SUPPLEMENTARY INFORMATION: The
in which a practitioner engages in the holder of a DEA registration ‘‘is Attorney General has delegated her
professional practice is a fundamental currently authorized to handle authority under the Controlled
condition for obtaining and maintaining controlled substances in the [S]tate,’’ Substances Act to the Administrator of
a registration. See, e.g., James L. Hooper, Hooper, 76 FR at 71371 (quoting Anne the Drug Enforcement Administration
Lazar Thorn, 62 FR 12847, 12848 (DEA), 28 CFR 0.100(b). Authority to
1 As the basis for its order, the Board found that
(1997)), the Agency has also long held exercise all necessary functions with
Registrant signed several hundred certifications respect to the promulgation and
recommending the medical use of marijuana and
that revocation is warranted even where
authorizing the possession of increased plant a practitioner has lost his state authority implementation of 21 CFR part 1301,
counts, and that these certifications were ‘‘for by virtue of the State’s use of summary incident to the registration of
conditions other than cancer.’’ GX 4, at 1. The process and the State has yet to provide manufacturers, distributors, dispensers,
Board further found that ‘‘signing the . . . importers, and exporters of controlled
certifications . . . in the absence of cancer
a hearing to challenge the suspension.
diagnosis and treatment falls below generally Bourne Pharmacy, 72 FR 18273, 18274 substances (other than final orders in
accepted standards of medical practice and lacks (2007); Wingfield Drugs, 52 FR 27070, connection with suspension, denial, or
medical necessity’’ and was ‘‘unprofessional 27071 (1987). Thus, it is of no revocation of registration) has been
mstockstill on DSK3G9T082PROD with NOTICES
conduct’’ in violation of the Colorado Revised redelegated to the Assistant
Statute § 12–36–117(l)(p) and (mm). Id. Based on its
consequence that the Colorado Medical
review of information relevant to three Board has employed summary process Administrator of the DEA Diversion
investigations pertaining to Registrant, the Board in suspending Registrant’s state license.
found ‘‘reasonable grounds to believe that the 2 For the same reasons that led the Colorado
What is consequential is that Registrant
public health, safety or welfare imperatively Board to summarily suspend Registrant’s medical
requires emergency action and/or that [Registrant]
is no longer currently authorized to license, I find that the public interest necessitates
was guilty of a deliberate and willful violation of dispense controlled substances in the that this Order be effective immediately. 21 CFR
law.’’ Id. at 1–2. State in which he is registered. I will 1316.67.
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Control Division (‘‘Assistant Registration No. FL2413297, at the Findings
Administrator’’) pursuant to section 7 of registered address of 707 Third Street, Respondent is the holder of
28 CFR part 0, appendix to subpart R. Horseshoe Bend, Arkansas. Id. The practitioner’s registration FL2413297,
In accordance with 21 CFR Order also alleged that his registration pursuant to which he is authorized to
1301.33(a), this is notice that on does not expire until March 31, 2017. dispense controlled substances in
September 14, 2016, Organix, Inc., 240 Id. schedules II through V at the registered
Salem Street, Woburn, Massachusetts The Show Cause Order then alleged address of 707 Third Street, Horseshoe
01801, applied to be registered as a bulk that Registrant’s Arkansas medical Bend, Arkansas; this registration does
manufacturer of the following basic license expired on April 30, 2015, and not expire until March 31, 2017.
classes controlled substances: that he is currently without authority to Declaration of the Diversion Investigator
dispense controlled substances in (DI), at 1. According to the DI,
Controlled substance Drug Schedule
Arkansas, the State in which he is Registrant’s license to practice medicine
code registered with the DEA. Id. at 1–2. in Arkansas lapsed on April 30, 2015,
Based upon Registrant’s lack of and he currently has no authority to
Gamma Hydroxybutyric 2010 I authority to handle controlled
Acid. practice medicine in that State. Id. at 1.
Lysergic acid 7315 I
substances in the State of Arkansas, the As further support for the action, the
diethylamide. Government asserts that his registration DI obtained, and the Government
Marihuana ..................... 7360 I is subject to revocation. Id. at 2 (citing submitted, a license verification from
Tetrahydrocannabinols 7370 I 21 U.S.C. §§ 802(21), 823(f) and the Arkansas State Medical Board along
Psilocybin ...................... 7437 I 824(a)(3)). with a Certification from the Board’s
Psilocyn ........................ 7438 I The Show Cause Order also notified
Executive Secretary that the license
Heroin ........................... 9200 I Registrant of his right to request a
Morphine ....................... 9300 II verification was true and correct as of
hearing on the allegations or to submit
September 15, 2016. Appendix 2, at 1;
a written statement in lieu of a hearing,
The company plans to manufacture Appendix 3, at 1. This document shows
the procedures for electing either
reference standards for distribution to that as of September 14, 2016, the Board
option, and the consequence for failing
its research and forensics customers. In listed the expiration date of Registrant’s
to elect either option. Id. at 2 (citing 21
reference to drug code 7360 (marihuana) medical license as ‘‘April 30, 2015’’ and
CFR 1301.43). In addition, the Order
and 7370 (THC) the company plans to the status of his license as ‘‘Inactive’’; it
notified Registrant of his right to submit
manufacture these drugs as synthetic. also includes the notation: ‘‘License
a Corrective Action Plan. Id. at 2–3.
No other activities for these drug codes On September 19, 2016, the Show Category: Felony Conviction.’’
are authorized for this registration. Cause Order was sent via certified mail Appendix 3, at 2. Also, the document
to Registrant at his current residence, contains the following Board History
Dated: December 22, 2016. notes, which include that:
Louis J. Milione, the Federal Correctional Institution,
Butner, North Carolina, 27509. 1. On February 9, 2015, the Board issued
Assistant Administrator. an Emergency Order of Suspension to
Government Request for Final Agency
[FR Doc. 2017–01582 Filed 1–24–17; 8:45 am] Registrant;
Action (RFAA), Appendix 4,
BILLING CODE 4410–09–P Declaration, at 1. As evidenced by a 2. On April 10, 2015, the Board voted ‘‘to
continue the disciplinary hearing until after
copy of the signed return receipt card, [Registrant’s] [] trial date’’;
service was accomplished on September 3. On July 2, 2015, the Board voted ‘‘to
DEPARTMENT OF JUSTICE 22, 2016. Id.; See also Appendix 4, at 3– block [Registrant’s] access to renew his
Drug Enforcement Administration 4. license should he wish to renew’’; and
On November 1, 2016, the 4. On December 3, 2015, Registrant’s
Donald W. Lamoureaux, M.D.; Decision Government forwarded to my Office a ‘‘medical license lapsed subsequent to the
Request for Final Agency Action and an felony criminal conviction.’’
and Order
evidentiary record. In its Request, the Appendix 3, at 4–5. As Registrant did
On September 16, 2016, the Assistant Government represents that it has not not respond to the Show Cause Order,
Administrator, Division of Diversion received a request for a hearing or any let alone submit any evidence to show
Control, Drug Enforcement other reply from Registrant. RFAA, at 2. that his state license has been
Administration (DEA), issued an Order The Government thus seeks the reinstated, I find that he does not
to Show Cause to Donald W. revocation of Registrant’s Registration possess authority to dispense controlled
Lamoureaux, M.D. (Registrant), of on the ground that he lacks state substances under the laws of Arkansas,
Horseshoe Bend, Arkansas. The Show authority. Id. at 4. the State in which he is registered with
Cause Order proposed the revocation of Based upon the Government’s the Agency.
his DEA Certificate of Registration, representation and the record, I find that
pursuant to which he is authorized to more than 30 days have now passed Discussion
dispense controlled substances in since the date of service of the Show Pursuant to 21 U.S.C. 824(a)(3), the
schedules II through V, as a practitioner, Cause Order, and neither Registrant, nor Attorney General is authorized to
on the ground that he ‘‘do[es] not have anyone purporting to represent him, has suspend or revoke a registration issued
authority to handle controlled requested a hearing or submitted a under section 823 of Title 21, ‘‘upon a
substances in Arkansas, the [S]tate in written statement in lieu of a hearing. I finding that the registrant . . . has had
which he is registered with the DEA.’’ therefore find that Registrant has waived his State license . . . suspended [or]
mstockstill on DSK3G9T082PROD with NOTICES
Show Cause Order, at 1. his right to a hearing or to submit a revoked . . . by competent State
As grounds for the proceeding, the written statement in lieu of a hearing authority and is no longer authorized by
Show Cause Order alleged that and issue this Decision and Final Order State law to engage in the . . .
Registrant is registered with the DEA as based on relevant evidence contained in dispensing of controlled substances.’’
a practitioner authorized to dispense the record submitted by the With respect to a practitioner, DEA has
controlled substances in schedules II Government. 21 CFR 1301.43(d) & (e). I repeatedly held that the possession of
through V, pursuant to Certificate of make the following findings of fact. authority to dispense controlled
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Document Created: 2017-01-25 00:08:48
Document Modified: 2017-01-25 00:08:48
| 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 in accordance with 21 CFR 1301.33(a) on or before March 27, 2017. | |
| FR Citation | 82 FR 8433 |
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