Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 8433-8434 [2017-01582]

Download as PDF 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]


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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