Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc., 56993-56994 [2017-25916]

Download as PDF Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices The Status of Respondent’s State License On May 9, 2017, the Executive Director of the Maryland State Board of Physicians signed a 34-page Order summarily suspending Respondent’s license to practice medicine. GX 3. The Order of Summary Suspension discussed numerous complaints against Respondent, including complaints about Respondent’s controlled substance prescribing practices, the conclusions of an independent peer review agency that Respondent did not meet quality standards for pain medicine, and allegations concerning Respondent’s unprofessional conduct. Id. The Order of Summary Suspension concluded that Respondent acted unprofessionally in his pain medicine practice, among other areas, and determined that the public health, safety, or welfare imperatively required the emergency action of the suspension of Respondent’s medical license. Id. at 31–32. The terms of the Order of Summary Suspension included the requirement that Respondent surrender his original Maryland license D26832 and his current license renewal certificate. Id. at 33. On July 11, 2017, the DEA Diversion Investigator assigned to the investigation of Respondent (hereinafter, DI) signed a Declaration. GX 4. In that Declaration, the DI stated that Respondent’s license to practice medicine in Maryland was suspended effective May 9, 2017 and that Respondent ‘‘currently has no authority to practice medicine in Maryland.’’ Id. at 1. Respondent’s hearing request admitted that the Maryland State Board of Physicians summarily suspended Respondent’s Maryland medical license. GX 5, at 1. Respondent did not submit any evidence that his Maryland medical license was reinstated. Respondent, thus, admitted that he currently is not authorized to practice medicine in Maryland. Accordingly, I find that Respondent currently is without authority to engage in the practice of medicine in Maryland, the State in which he is registered. sradovich on DSK3GMQ082PROD 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 the Controlled Substances Act (hereinafter, CSA), ‘‘upon a finding that the registrant . . . has had his State License or registration suspended [or] revoked by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 substances.’’ With respect to a practitioner, the DEA has also 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, M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (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 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 CSA, the 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. See, e.g., Hooper, supra, 76 FR at 71,371–72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby Watts, 53 FR 11,919, 11,920 (1988); Blanton, supra, 43 FR at 27,617. According to Maryland Department of Health regulations, a ‘‘prescription for a controlled dangerous substance may be issued only by an individual practitioner who is . . . [a]uthorized to prescribe controlled dangerous substances in the State of Maryland, in which the practitioner is licensed to practice the practitioner’s profession.’’ MD Code Regs. 10.19.03.07B(1)(a) (2017). The Maryland Department of Health regulations define an ‘‘individual practitioner’’ to be a ‘‘physician . . . or other individual licensed, registered, or otherwise permitted by . . . the jurisdiction in which the individual practitioner practices, to dispense a controlled dangerous substance in the course of professional practice.’’ MD Code Regs. 10.19.03.02C(7)(a) (2017). Under Maryland law, a ‘‘physician’’ is PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 56993 ‘‘an individual who practices medicine,’’ and a ‘‘licensed physician’’ is a physician ‘‘who is licensed by the Board [of Physicians] to practice medicine.’’ West’s MD Code Ann., Health Occupations, § 14–101(m) and (i) (2017). Further, in Maryland, to ‘‘practice medicine’’ means ‘‘to engage . . . in medical (i) Diagnosis; (ii) Healing; (iii) Treatment; or (iv) Surgery.’’ Id. at § 14–101(o)(1)(i-iv). Thus, in Maryland, a physician may be authorized to dispense controlled substances only if he is licensed to practice medicine. In this case, the Maryland State Board of Physicians suspended Respondent’s license to practice medicine. Consequently, Respondent is not currently eligible to handle controlled substances in the State of Maryland, the State in which he is registered with the Agency and, therefore, he is not entitled to maintain his DEA registration. Hooper, supra; Blanton, supra. Accordingly, I will order that Respondent’s registration be revoked and that any pending application for the renewal or modification of his registration be denied. 21 U.S.C. 824(a)(3). 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 AS2145476 issued to Kofi E. Shaw-Taylor, M.D., be, and it hereby is, revoked. I further order that any pending application of Kofi E. ShawTaylor, M.D., to renew or modify this registration, as well as any other pending application by him for registration in the State of Maryland, be, and it hereby is, denied. This order is effective immediately.2 Dated: November 20, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017–25922 Filed 11–30–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc. Drug Enforcement Administration, Department of Justice. AGENCY: 2 For the same reasons the Maryland State Board of Physicians of the Maryland Department of Health and Mental Hygiene suspended Respondent’s Maryland Medical License summarily, I find that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67. E:\FR\FM\01DEN1.SGM 01DEN1 56994 ACTION: Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices Notice of application. DEPARTMENT OF JUSTICE 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 January 30, 2018. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 August 11, 2017, Nanosyn, Inc., Nanoscale Combinatorial Synthesis, 3331–B Industrial Drive, Santa Rosa, California 95403 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Oxymorphone ................. Fentanyl .......................... Drug code Schedule 9652 9801 II II sradovich on DSK3GMQ082PROD with NOTICES The company is a contract manufacturer. At the request of the company’s customers, it manufactures derivatives of controlled substances in bulk form. Dated: November 24, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–25916 Filed 11–30–17; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: ABBVIE LTD 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 January 2, 2018. Such persons may also file a written request for a hearing on the application on or before January 2, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 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 October 27, 2016, ABBVIE, LTD, Carr. #2, KM 58.0 Cruce Davila, C/O PO Box 278, Barceloneta, Puerto Rico 00617 applied to be registered as an importer of tapentadol (9780), a basic class of controlled substance in schedule II. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol (9780) DATES: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 for distribution to its customers. Placement of this drug code onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 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: November 24, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–25921 Filed 11–30–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1110–XXXX] Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval of a New Collection Laboratory Division Federal Bureau of Investigation Laboratory Division Survey of Forensic Science Services, Federal Bureau of Investigation, Department of Justice. ACTION: 60-Day Notice. AGENCY: The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Laboratory Division (LD) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. DATES: Comments are encouraged and will be accepted for 60 days until January 30, 2018. FOR FURTHER INFORMATION CONTACT: If you have additional comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cary Oien, United States Department of Justice, Federal Bureau of Investigation, Laboratory Division, 2501 Investigation Parkway, Quantico, VA 22135 SUPPLEMENTARY INFORMATION: This process is conducted in accordance with 5 CFR. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should SUMMARY: E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56993-56994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25916]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Nanosyn, 
Inc.

AGENCY: Drug Enforcement Administration, Department of Justice.

[[Page 56994]]


ACTION: Notice of application.

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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 January 30, 2018.

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 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 August 
11, 2017, Nanosyn, Inc., Nanoscale Combinatorial Synthesis, 3331-B 
Industrial Drive, Santa Rosa, California 95403 applied to be registered 
as a bulk manufacturer for the basic classes of controlled substances:

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Oxymorphone............................    9652  II
Fentanyl...............................    9801  II
------------------------------------------------------------------------

    The company is a contract manufacturer. At the request of the 
company's customers, it manufactures derivatives of controlled 
substances in bulk form.

    Dated: November 24, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-25916 Filed 11-30-17; 8:45 am]
 BILLING CODE 4410-09-P