Importer of Controlled Substances Application: Wildlife Laboratories, Inc., 21809-21810 [2019-10030]
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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.
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22:43 May 14, 2019
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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);
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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.
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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
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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
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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]
-----------------------------------------------------------------------
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