Importer of Controlled Substances Application: Wildlife Laboratories, Inc., 21809-21810 [2019-10030]

Download as PDF Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES The Emergency Restriction states that, as of the date of the Emergency Restriction, Registrant ‘‘has failed to enter into a contract with . . . [the Professionals Resource Network, (hereinafter, PRN)] that encompasses the necessary treatment to address . . . [Registrant’s] psychiatric and substance abuse issues.’’ Id. at 4. It concludes that (1) Registrant ‘‘is not capable of caring for patients in a manner that is correct and safe;’’ (2) Registrant’s continued unrestricted practice as a physician presents an immediate, serious danger to the health, welfare, and safety of the public;’’ (3) ‘‘there is a significant likelihood that . . . [Registrant’s] inability to practice medicine with reasonable skill and safety to patients will continue without appropriate treatment and monitoring;’’ and that (4) there are no less restrictive means, other than the terms of . . . [the Emergency Restriction], that will adequately protect the public from . . . [Registrant’s] continued unrestricted practice of medicine.’’ Id. at 4–5. The Emergency Restriction orders the immediate restriction of Registrant’s medical license ‘‘until PRN or a PRN-approved evaluator notifies the Department that she is safe to resume the practice of medicine.’’ Id. at 7. On July 2, 2018, the Florida Board of Medicine denied all of the Exceptions that Registrant filed concerning the Emergency Restriction, adopted the Emergency Restriction’s findings of fact, and revoked Registrant’s license to practice medicine in the State of Florida. Final Order of the Florida Board of Medicine (filed date: July 5, 2018) (hereinafter, Final Order), at 2–6. According to Florida’s online records, of which I take official notice, Registrant’s license is still revoked.3 Florida Board of Medicine Lookup, https://flboardofmedicine.gov/ (last visited May 3, 2019). Florida’s online records show that Registrant’s medical Id. at 3. According to the Emergency Restriction, Registrant ‘‘does not have a valid order for medical marijuana. Id. 3 Under the Administrative Procedure Act, an agency ‘‘may take official notice of facts at any stage in a proceeding—even in the final decision.’’ United States Department of Justice, Attorney General’s Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.’’ Accordingly, Registrant may dispute my finding by filing a properly supported motion for reconsideration within 15 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the Government. In the event Registrant files a motion, the Government shall have 15 calendar days to file a response. VerDate Sep<11>2014 22:43 May 14, 2019 Jkt 247001 license remains revoked and that she is not authorized in Florida to prescribe controlled substances. Id. Accordingly, I find that Registrant currently is neither licensed to engage in the practice of medicine nor registered to dispense controlled substances in Florida, the State in which she is registered with the DEA. 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 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); PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 21809 Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Blanton, supra, 43 FR at 27,617. According to Florida statute, ‘‘A practitioner, in good faith and in the course of his or her professional practice only, may prescribe, administer, [or] dispense . . . a controlled substance.’’ Fla. Stat. Ann. § 893.05(1)(a) (West, Westlaw current with chapters from the 2019 First Regular Session of the 26th Legislature in effect through April 26, 2019). Further, ‘‘practitioner,’’ as defined by Florida statute, includes ‘‘a physician licensed under chapter 458.’’ Fla. Stat. Ann. § 893.02(23) (West, Westlaw current with chapters from the 2019 First Regular Session of the 26th Legislature in effect through April 26, 2019).4 Here, the undisputed evidence in the record is that Registrant currently lacks authority to practice medicine in Florida. As already discussed, a physician must be a licensed practitioner to dispense a controlled substance in Florida. Thus, since Registrant lacks authority to practice medicine in Florida and, therefore, is not authorized to handle controlled substances in Florida, I will order that Registrant’s DEA registration be revoked. Order Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I order that DEA Certificate of Registration No. BS7985623 issued to Raquel Skidmore, M.D., be, and it hereby is, revoked. This Order is effective June 14, 2019. Dated: May 3, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019–10015 Filed 5–14–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Wildlife Laboratories, 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 on or before June 14, 2019. Such persons may also file a written request for a DATES: 4 Chapter 458 concerns medical practice and addresses, among other things, the licensure of physicians. E:\FR\FM\15MYN1.SGM 15MYN1 21810 Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices hearing on the application on or before June 14, 2019. 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. 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 March 12, 2019, Wildlife Laboratories, Inc., 1230 West Ash, Suite D, Windsor, Colorado 80550–4677 applied to be registered as an importer of the following basic class of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Etorphine HCL ............... Thiafentanil .................... Drug code 9059 9729 Schedule II II DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2019–10013 Filed 5–14–19; 8:45 am] [Docket No. DEA–392] jbell on DSK3GLQ082PROD with NOTICES Dated: April 27, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–10030 Filed 5–14–19; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 22:43 May 14, 2019 BILLING CODE 4410–09–P Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC Notice of application. [Docket No. DEA–392] 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 July 15, 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 March 6, 2019, AMPAC Fine Chemicals Virginia, LLC, 2820 North Normandy Drive, Petersburg, Virginia 23805 applied to be registered as a bulk manufacturer of the following basic class of controlled substances: SUPPLEMENTARY INFORMATION: Methylphenidate ............. Phenylacetone ............... Levomethorphan ............ Levorphanol ................... Morphine ........................ Thebaine ........................ Noroxymorphone ........... Tapentadol ..................... Drug code 1724 8501 9210 9220 9300 9333 9668 9780 Schedule II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Jkt 247001 DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: Controlled substance The company plans to import the listed controlled substances for distribution to its customers. Dated: April 27, 2019. John J. Martin, Assistant Administrator. PO 00000 Frm 00063 Fmt 4703 Sfmt 9990 Bulk Manufacturer of Controlled Substances Registration ACTION: Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of schedule I and II controlled substances. SUMMARY: The companies listed below applied to be registered as bulk manufacturers of schedule I or schedule II controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUPPLEMENTARY INFORMATION: Company Johnson Matthey Pharmaceutical Materials Inc. IsoSciences, LLC .............. FR docket 84 FR 2579 84 FR 2570 Published February 7, 2019. February 7, 2019. The 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 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 companies. Dated: April 27, 2019. John J. Martin, Assistant Administrator. [FR Doc. 2019–10014 Filed 5–14–19; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\15MYN1.SGM 15MYN1

Agencies

[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Pages 21809-21810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10030]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Wildlife 
Laboratories, 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 on or before June 14, 2019. Such 
persons may also file a written request for a

[[Page 21810]]

hearing on the application on or before June 14, 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 March 
12, 2019, Wildlife Laboratories, Inc., 1230 West Ash, Suite D, Windsor, 
Colorado 80550-4677 applied to be registered as an importer of the 
following basic class of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Etorphine HCL........................         9059  II
Thiafentanil.........................         9729  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
distribution to its customers.

    Dated: April 27, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-10030 Filed 5-14-19; 8:45 am]
 BILLING CODE 4410-09-P