Importer of Controlled Substances Application: Organic Standards Solutions International, LLC, 13958-13959 [2019-06849]

Download as PDF 13958 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices Findings of Fact jbell on DSK30RV082PROD with NOTICES Respondent is the holder of DEA Certificate of Registration No. FW3352539, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner at the registered address of Weingrow Wellness & Medical Center, 7200 Smoke Ranch Road, Suite #120, Las Vegas, Nevada. GX 2 (Certification of Registration History) to Govt. Mot., at 1. This registration does not expire until May 31, 2021. Id. On July 25, 2018, the NSBP issued an Order revoking Respondent’s Nevada ‘‘Controlled Substance Registration, Certificate No. CS20272, and his Practitioner Dispensing Registration, Certificate No. PD00502,’’ effective July 18, 2018. GX 3 (July 25, 2018 Findings of Fact, Conclusion of Law and Order of the NSBP) to Govt. Mot., at 8. The NSBP’s Order expressly prohibited Respondent from, inter alia, (1) ‘‘prescrib[ing] any controlled substance for any patient;’’ (2) ‘‘dispens[ing] any controlled substance or dangerous drug;’’ and (3) ‘‘possess[ing] any controlled substance for office use or for patient use.’’ Id. The NSBP also directed Respondent to ‘‘immediately and lawfully dispose of any and all controlled substances in his possession and/or control, other than a controlled substance lawfully prescribed and dispensed to him for his own personal use.’’ Id.1 On September 10, 2018, the NBME placed Respondent’s Nevada medical license in an ‘‘[i]nactive status’’ as part of a Settlement Agreement whereby Respondent agreed that his medical license would be subject to probation for 36 months and that he would be prohibited from prescribing or dispensing controlled substances during that time. See GX 4 (NBME-Respondent Settlement Agreement) to RFAA, at 5– 6. There is no evidence in the record that the NSBP ever reinstated Respondent’s Nevada controlled substance or practitioner dispensing registrations, nor is there any evidence that the NBME changed the status of 1 After conducting a hearing, the NSBP based its decision to revoke Respondent’s Nevada controlled substance and practitioner dispensing registrations in part on its finding that Respondent ‘‘routinely permitted unlicensed members of his office staff . . . to falsify his signature on the prescriptions for medications dispensed by his medical office’’ and ‘‘to falsify patient initials and dates of service on patients’ informed consent labels.’’ Id. at 1 & n.1, 2. The NSBP also found that Respondent ‘‘dispensed controlled substances and dangerous drugs by mail to patients who live out-of-town’’ and ‘‘used Federal Express to ship medications to patients.’’ Id. Respondent also signed a statement agreeing to these fact findings. See id. VerDate Sep<11>2014 17:45 Apr 05, 2019 Jkt 247001 Respondent’s medical license from inactive status. Accordingly, I find that Respondent currently does not possess the authority to dispense controlled substances in the State of Nevada, the State in which he is registered with the DEA, because both the NSBP and the NBME have expressly prohibited him from doing so. 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 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR 27616 (1978). Here, I find that there is no dispute over the material fact that Respondent is no longer currently authorized to dispense controlled substances in Nevada, the State in which he is registered with the Agency. Accordingly, Respondent is not entitled to maintain his DEA registration. I will therefore adopt the ALJ’s recommendation that I revoke Respondent’s registration. R.D., at 5. I will also deny any pending application to renew or to modify his registration, or any pending application for any other DEA registration in Nevada. 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. FW3352539, issued to Craig M. Weingrow, M.D., be, and it hereby is, revoked. I further order that any pending application of Craig M. Weingrow to renew or modify the above registration, or any pending application of Craig M. Weingrow for any other DEA registration in the State of Nevada, be, and it hereby is, denied. This Order is effective immediately.2 Dated: March 22, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019–06834 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: Organic Standards Solutions International, LLC 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 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. DATES: 2 For the same reasons which led the NSBP to revoke Respondent’s controlled substances and practitioner’s dispensing licenses and prescriptive authority, I conclude that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67. E:\FR\FM\08APN1.SGM 08APN1 13959 Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices 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 request 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. 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 1301.34(a), this is notice that on June 21, 2017, Organic Standards Solutions International, LLC, 2030 Savage Road, Charleston, South Carolina 29407–2940 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code jbell on DSK30RV082PROD with NOTICES Marihuana Extract Marihuana .............. Tetrahydrocannabinols. 7350 7360 7370 Schedule Bulk Manufacturer of Controlled Substances Registration ACTION: BILLING CODE 4410–09–P Jkt 247001 Notice of registration. The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of schedule II controlled substances. SUMMARY: The company listed below applied to be registered as a bulk manufacturer of schedule II controlled substances. Information on the previously published notice is listed in the table below. No comments or objections were submitted for this notice. SUPPLEMENTARY INFORMATION: Company FR docket Cambrex High Point, Inc. 83 FR 64159 Published December 13, 2018. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of this registrant to manufacture the applicable basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed company. registration by the Drug Enforcement Administration (DEA) as importers of schedule I or schedule II controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for a hearing were submitted for these notices. Company Chattem Chemicals .. Research Triangle Institute. FR docket 84 FR 2578 84 FR 2571 Published February 7, 2019. February 7, 2019. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated each of the company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has granted a registration as an importer for schedule I or schedule II controlled substances to the above listed companies. Dated: March 21, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–06842 Filed 4–5–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration BILLING CODE 4410–09–P [Docket No. DEA–392] DEPARTMENT OF JUSTICE Importer of Controlled Substances Registration Drug Enforcement Administration ACTION: [Docket No. DEA–392] SUMMARY: Importer of Controlled Substances Registration ACTION: [FR Doc. 2019–06849 Filed 4–5–19; 8:45 am] 17:45 Apr 05, 2019 [Docket No. DEA–392] [FR Doc. 2019–06844 Filed 4–5–19; 8:45 am] The company plans to import the listed controlled substances to produce analytical reference standards for distribution to its customers. Drug codes 7350 (marihuana extract) and 7360 (marihuana) will be used for the manufacture of cannabidiol only. VerDate Sep<11>2014 Drug Enforcement Administration Dated: March 21, 2019. John J. Martin, Assistant Administrator. I I I Dated: March 21, 2019. John J. Martin, Assistant Administrator. DEPARTMENT OF JUSTICE Notice of registration. The registrants listed below have applied for and been granted SUMMARY: PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 Notice of registration. The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as an importer of schedule II controlled substances. SUPPLEMENTARY INFORMATION: The company listed below applied to be registered as an importer of various E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13958-13959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06849]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Organic Standards 
Solutions International, LLC

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 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.

[[Page 13959]]


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 
request 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 June 
21, 2017, Organic Standards Solutions International, LLC, 2030 Savage 
Road, Charleston, South Carolina 29407-2940 applied to be registered as 
an importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Marihuana Extract....................         7350  I
Marihuana............................         7360  I
Tetrahydrocannabinols................         7370  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances to 
produce analytical reference standards for distribution to its 
customers. Drug codes 7350 (marihuana extract) and 7360 (marihuana) 
will be used for the manufacture of cannabidiol only.

    Dated: March 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-06849 Filed 4-5-19; 8:45 am]
BILLING CODE 4410-09-P