Bulk Manufacturer of Controlled Substances Registration, 55641-55642 [2017-25285]

Download as PDF 55641 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices to dispense controlled substances under the laws of the State of North Carolina. 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, ‘‘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 held repeatedly 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); Frederick Marsh Blanton, 43 FR 27616 (1978). 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 [s]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 [s]he practices.’’ 21 U.S.C. 823(f). Because Congress has clearly mandated that a physician possess state authority in order to be deemed a practitioner under the Act, DEA has held that revocation of a practitioner’s registration is the appropriate sanction whenever she is no longer authorized to dispense controlled substances under the laws of the State in which she 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 Hooper v. Holder, 481 Fed. Appx. at 828. As a consequence of the Consent Order which Registrant entered into with the Board, she is not currently authorized to dispense controlled substances in North Carolina, the State in which she is registered with the Agency. Because the CSA makes clear 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 both obtaining and maintaining a practitioner’s registration, it is of no consequence that the suspension is of a finite duration. See Hooper v. Holder, 481 F. App’x at 828 (upholding revocation of a physician’s registration as based on a reasonable interpretation of the CSA, notwithstanding that the physician’s medical license was subject to a suspension of known duration); see also James L. Hooper, 76 FR 71371, 71371–72 (2011). Rather, what matters for the purposes of the CSA is that Registrant is not currently authorized to dispense controlled substances in North Carolina. See Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997) (‘‘the controlling question . . . is whether the Respondent is currently authorized to handle controlled substances in the state’’)). Indeed, it is by no means clear that Registrant will even be able to resume the practice of medicine following the ending date of the suspension given the requirement that she complete the required five-day board certification review course.2 Therefore, she is not entitled to maintain her registration in that State. Accordingly, I will order that her registration and her DATA-Waiver Identification number be revoked. Order Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 CFR 0.100(b), I order that DEA Certificate of Registration No. BP4154023, issued to Linda M. Shuck, be, and it hereby is, revoked. I further order that DATAWaiver Identification No. XP4154023, issued to Linda M. Shuck, be, and it hereby is, revoked. This order is effective immediately.3 Dated: November 13, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017–25286 Filed 11–21–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Registration ACTION: Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration as bulk manufacturers of various classes of schedule I and II controlled substances. SUPPLEMENTARY INFORMATION: The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUMMARY: Company FR Docket asabaliauskas on DSKBBXCHB2PROD with NOTICES Cayman Chemical Company ....................................................................................................................... AMRI Rensselaer, Inc ................................................................................................................................. Organic Consultants, Inc ............................................................................................................................. Isosciences, LLC ......................................................................................................................................... Cody Laboratories, Inc ................................................................................................................................ Noramco, Inc ............................................................................................................................................... Stepan Company ......................................................................................................................................... 2 Indeed, as found above, even if she completes the course and returns to practice, under the Consent Order, she is prohibited from prescribing controlled substances outside of a hospital where she ‘‘has active clinical privileges.’’ GX 3, Appendix A, at 5. As this revocation does not impose any time VerDate Sep<11>2014 18:57 Nov 21, 2017 Jkt 244001 bar on Registrant’s ability to reapply, she can apply for a new registration upon being allowed to return to practice. 3 Based on the North Carolina Board’s findings that Registrant prescribed controlled substances in PO 00000 Frm 00089 Notice of registration. Fmt 4703 Sfmt 4703 82 82 82 82 82 82 82 FR FR FR FR FR FR FR 34691 34695 34696 35546 41054 41055 42119 Published July 26, 2017. July 26, 2017. July 26, 2017. July 31, 2017. August 29, 2017. August 29, 2017. September 6, 2017. violation of the Interim Partial Non-Practice Agreement, I find that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67. E:\FR\FM\22NON1.SGM 22NON1 55642 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants 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 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. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons. Dated: November 16, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–25285 Filed 11–21–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 17–35] asabaliauskas on DSKBBXCHB2PROD with NOTICES First Choice Surgery Center of Baton Rouge, L.L.C.; Decision and Order On May 24, 2017, the Assistant Administrator, Diversion Control Division, issued an Order to Show Cause to First Choice Surgery Center of Baton Rouge, L.L.C (Respondent), of Baton Rouge, Louisiana. The Show Cause Order proposed the revocation of Respondent’s DEA Certificate of Registration No. FF4394209, on the ground that ‘‘the clinic does not have authority to dispense controlled substances in Louisiana, the [S]tate in which the clinic is located.’’ Show Cause Order, at 1 (citing 21 U.S.C. 823(f) and 824(a)(3)). The Show Cause Order also proposed revocation on the ground that Respondent’s owner, ‘‘Dr. Arnold Feldman, M.D., has been found guilty by the Louisiana State Board of Medical Examiners of misconduct related to controlled substances.’’ Id. (citing 21 U.S.C. 823(f) and 824(a)(2); 21 CFR 1306.04). As to the jurisdictional basis for the proceeding, the Show Cause Order alleged that Respondent is ‘‘registered . . . as a hospital/clinic in [s]chedules II–V pursuant to [Registration No.] FF4394209 at 505 East Airport Drive, Baton Rouge, Louisiana.’’ Id. at 2. The VerDate Sep<11>2014 18:57 Nov 21, 2017 Jkt 244001 Order alleged that this registration does not expire until ‘‘September 30, 2019.’’ Id. As to the substantive grounds for the proceeding, the Show Cause Order alleged that Respondent ‘‘is without authority to dispense controlled substances in Louisiana.’’ Id. The Show Cause Order alleged that while Respondent ‘‘previously held’’ a Louisiana controlled substance license, ‘‘[t]his license expired on September 23, 2016 and has not been renewed.’’ Id. The Order then asserted that ‘‘based upon [Respondent’s] lack of [s]tate authority to dispense controlled substances in . . . Louisiana,’’ its registration must be revoked. Id. As to the allegation based on its owner’s misconduct, the Show Cause Order alleged that ‘‘[o]n August 15, 2016, the Louisiana State Board of Medical Examiners found [Respondent’s owner] guilty of violating [state law] by giving his staff pre-signed controlled substance prescriptions and/or allowing his staff to utilize a ‘Ghost writer’ to affix his signature to controlled substances prescriptions.’’ Id. The Order further alleged that its owner’s conduct violated 21 U.S.C. 841(a)(1) and 21 CFR 1306.04. Id. The Show Cause Order notified Respondent of its right to request a hearing on the allegations or to submit a written statement while waiving its right to a hearing and the procedure for electing either option. Id. (citing 21 CFR 1301.43). In addition, the Order notified Respondent of its right to submit a corrective action plan pursuant to 21 U.S.C. 824(c)(2)(C). Id. at 3–4. On June 15, 2017, Respondent, through its counsel, requested a hearing on the allegations. Letter from Respondent to Hearing Clerk, Office of Administrative Law Judges (June 15, 2017). The matter was assigned to Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ), who, on June 16, 2017, issued an order directing the Government to file evidence supporting the allegations by June 29, 2017 at 2 p.m., as well any motion for summary disposition. Briefing Schedule For Lack Of State Authority Allegations, at 1. The ALJ’s order also provided that if the Government moved for summary disposition, Respondent’s opposition was due by July 13, 2017 at 2 p.m. Id. On June 20, 2017, the Government filed its Motion for Summary Disposition. In its Motion, the Government argued that Respondent is a ‘‘practitioner’’ under the CSA and that because its ‘‘state authority has terminated, [it] no longer meets the statutory definition of a practitioner’’ and is not entitled to maintain its PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 registration. Motion, at 3. The Government thus sought a Recommendation that Respondent’s registration be revoked. Id. As support for its motion, the Government provided: (1) A copy of Respondent’s registration; (2) a letter dated May 22, 2017 from the Assistant Executive Director of the Louisiana Board of Pharmacy to a DEA Diversion Investigator (DI) stating that Respondent’s Louisiana Controlled Dangerous Substance (CDS) license expired September 23, 2016; (3) a November 16, 2016 Order of the Louisiana Board of Pharmacy indefinitely suspending the Controlled Dangerous Substance license of Arnold E. Feldman based on the suspension of his Louisiana Medical license; and (4) a declaration of the aforementioned DI that Respondent ‘‘currently has no authority to handle controlled substances in Louisiana.’’ Mot. for Summ. Disp., Appendices A, B, and C. The Government did not, however, seek summary disposition based on the allegation that Respondent’s owner had been found guilty by the Louisiana Board of misconduct related to controlled substances. Compare Mot. for Summ. Disp. with Show Cause Order, at 1–2. Respondent did not file a Reply to the Government’s Motion, and on July 25, 2017, the ALJ granted the Government’s Motion. Order Granting Summary Disposition (R.D.), at 3, 6. Noting that the Government had ‘‘provided a certified letter from the Louisiana Board of Pharmacy indicating that the Respondent held Louisiana Board of Pharmacy Number CDS.043803–ASC, but that this license expired on September 23, 2016,’’ id. at 2, the ALJ found it ‘‘undisputed that the Respondent lacks state authorization to dispense controlled substances in Louisiana, where [it] is registered.’’ Id. at 5. Applying the Agency’s longstanding rule ‘‘that a practitioner must be currently authorized to dispense controlled substances by the State in which [it] practices in order to obtain and maintain a registration,’’ id. at 4 (citation omitted), the ALJ concluded that ‘‘Respondent cannot maintain a DEA registration for any location in’’ Louisiana and recommended that I revoke its registration.1 Id. at 5–6. 1 With respect to the allegation that Respondent’s owner had been found guilty of misconduct by the Louisiana Board of Medical Examiners, the ALJ noted that [t]he Government did not provide any argument or evidence in its Motion.’’ R.D. 6 n.1. However, as the ALJ observed, ‘‘Respondent’s lack of state authority to dispense controlled substances E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Notices]
[Pages 55641-55642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25285]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: Registrants listed below have applied for and been granted 
registration by the Drug Enforcement Administration as bulk 
manufacturers of various classes of schedule I and II controlled 
substances.

SUPPLEMENTARY INFORMATION: The companies listed below applied to be 
registered as manufacturers of various basic classes of controlled 
substances. Information on previously published notices is listed in 
the table below. No comments or objections were submitted for these 
notices.

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                 Company                             FR Docket                           Published
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Cayman Chemical Company.................  82 FR 34691                     July 26, 2017.
AMRI Rensselaer, Inc....................  82 FR 34695                     July 26, 2017.
Organic Consultants, Inc................  82 FR 34696                     July 26, 2017.
Isosciences, LLC........................  82 FR 35546                     July 31, 2017.
Cody Laboratories, Inc..................  82 FR 41054                     August 29, 2017.
Noramco, Inc............................  82 FR 41055                     August 29, 2017.
Stepan Company..........................  82 FR 42119                     September 6, 2017.
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[[Page 55642]]

    The Drug Enforcement Administration (DEA) has considered the 
factors in 21 U.S.C. 823(a) and determined that the registration of 
these registrants 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 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. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer 
to the above listed persons.

    Dated: November 16, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-25285 Filed 11-21-17; 8:45 am]
 BILLING CODE 4410-09-P