Importer of Controlled Substances Application: Unither Manufacturing LLC, 13961-13962 [2019-06850]

Download as PDF Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices jbell on DSK30RV082PROD with NOTICES 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. VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 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 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 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. jbell on DSK30RV082PROD with NOTICES 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) ............................................................................................................................. VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1 1100 1105 1233 1235 1237 1238 1246 1248 1249 1258 1475 1480 1585 1590 2010 2565 2572 6250 7035 7118 7173 Schedule II II I I I I I I I I I I I I I I I I I I I

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]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Unither 
Manufacturing LLC

ACTION: Notice of application.

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[[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