Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 18321-18322 [2019-08702]
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18321
Federal Register / Vol. 84, No. 83 / Tuesday, April 30, 2019 / Notices
amozie on DSK9F9SC42PROD with NOTICES
www.pharmacy.texas.gov/ (last visited
April 5, 2019).
Accordingly, I find that Registrant
currently does not have a license to
operate a pharmacy in Texas, the State
in which he 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.’’ A pharmacy is a
‘‘practitioner’’ under the CSA. 21 U.S.C.
802(21). 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); Roots Pharmaceuticals, Inc., 76
FR 51,430 (2011); Ideal Pharmacy Care,
Inc., d/b/a Esplanade Pharmacy, 76 FR
51,415 (2011); Bourne Pharmacy, Inc.,
72 FR 18,273 (2007); Frederick Marsh
Blanton, M.D., 43 FR 27,616 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a physician, . . . pharmacy, . . . 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., James L. Hooper, supra, 76 FR at
71,371–72; Roots Pharmaceuticals, Inc.,
supra, 76 FR at 51,430; Ideal Pharmacy
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18:54 Apr 29, 2019
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Care, Inc., d/b/a Esplanade Pharmacy,
supra, 76 FR at 51,416 n.1; Bourne
Pharmacy, Inc., supra, 72 FR at 18,274;
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, M.D., 53 FR 11,919, 11,920
(1988); Frederick Marsh Blanton, supra,
43 FR at 27,617.
According to Texas statute, ‘‘A person
may not operate a pharmacy in this state
unless the pharmacy is licensed by the
board.’’ Tex. Occupations Code Ann.
§ 560.001(a) (West, Westlaw current
through the end of the 2017 Regular and
First Called Sessions of the 85th
Legislature). Further, ‘‘a person who is
not registered with or exempt from
registration with the Federal Drug
Enforcement Administration may not
manufacture, distribute, prescribe,
possess, analyze, or dispense a
controlled substance in this state.’’ 5
Tex. Health and Safety Code Ann.
§ 481.061(a) (West, Westlaw current
through the end of the 2017 Regular and
First Called Sessions of the 85th
Legislature).
The undisputed evidence in the
record before me is that Registrant
currently lacks authority to operate a
pharmacy in Texas. As such, Registrant
is not qualified to dispense controlled
substances as a ‘‘practitioner.’’ I will,
therefore, 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. FP1305564 issued to
Palafox Pharmacy be, and it hereby is,
revoked. This Order is effective May 30,
2019.
Dated: April 5, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–08703 Filed 4–29–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Inc.
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 30, 2019. Such persons
may also file a written request for a
hearing on the application on or before
May 30, 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 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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
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
November 13, 2018, Mylan
Pharmaceuticals Inc., 3711 Collins Ferry
Road, Morgantown, West Virginia 26505
applied to be registered as an importer
of the following basic classes of
controlled substances:
DATES:
Controlled substance
ACTION:
Notice of application.
5A
‘‘dispenser’’ includes a pharmacy that
dispenses a controlled substance. Tex. Health and
Safety Code Ann. § 481.002(13) (West, Westlaw
current through the end of the 2017 Regular and
First Called Sessions of the 85th Legislature).
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
Amphetamine ................
Methylphenidate ............
Oxycodone ....................
Hydromorphone .............
Methadone .....................
Morphine ........................
E:\FR\FM\30APN1.SGM
30APN1
Drug
code
1100
1724
9143
9150
9250
9300
Schedule
II
II
II
II
II
II
18322
Federal Register / Vol. 84, No. 83 / Tuesday, April 30, 2019 / Notices
Controlled substance
Fentanyl .........................
Drug
code
9801
Schedule
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domestically
manufactured FDF to foreign markets.
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial use.
Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–08702 Filed 4–29–19; 8:45 am]
BILLING CODE 4410–09–P
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[Notice: (19–022)]
NASA Federal Advisory Committee;
Notice of Committee Re-Establishment
Pursuant to the Federal Advisory
Committee Act
National Aeronautics and
Space Administration.
The Administrator of the National
Aeronautics and Space Administration
(NASA) has determined that the reestablishment of the following advisory
committee under the Federal Advisory
Committee Act (FACA) is necessary for
the conduct of agency business and in
the public interest: The NASA Human
Exploration and Operations Research
Advisory Committee (HEORAC). This
determination follows consultation with
the Committee Management Secretariat,
General Services Administration. The
HEORAC was originally established and
its charter filed by NASA on January 17,
2017. The HEORAC and its charter
expired on January 17, 2019, during the
partial shutdown of the U.S.
Government.
Name of Federal Advisory Committee:
Human Exploration and Operations
Research Advisory Committee
(HEORAC).
Purpose and Objectives: The purpose
of the HEORAC is to provide advice and
make recommendations to the Director,
Space Life and Physical Sciences
Research and Applications Division,
Human Exploration and Operations
Mission Directorate, NASA
Headquarters, on programs, policies,
amozie on DSK9F9SC42PROD with NOTICES
AGENCY:
VerDate Sep<11>2014
18:08 Apr 29, 2019
Jkt 247001
plans, and priorities pertaining to space
life and physical sciences research. The
HEORAC will function solely as an
advisory body and will comply fully
with the provisions of FACA.
Membership: HEORAC membership
shall consist of individual subject
matter experts who will serve as Special
Government Employees (unless they are
Regular Government Employees). They
will be chosen from among academia,
industry and government with
demonstrated and well-recognized
knowledge, expertise and experience in
fields relevant to their respective
scientific disciplines. The membership
will be fairly balanced in terms of points
of view represented and functions to be
performed. Diversity shall be considered
as well.
Duration: The HEORAC is a NASA
discretionary committee and is
envisioned to be continuing entity
subject to charter renewals every two
years.
Responsible NASA Official: Dr.
Bradley Carpenter, Designated Federal
Officer, Human Exploration and
Operations Mission Directorate, NASA
Headquarters, (202) 358–0826 or
brad.carpenter@nasa.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Bradley Carpenter, Designated Federal
Officer, Human Exploration and
Operations Mission Directorate, NASA
Headquarters, (202) 358–0826 or
brad.carpenter@nasa.gov.
Patricia Rausch,
Advisory Committee Management Officer,
National Aeronautics and Space
Administration.
[FR Doc. 2019–08688 Filed 4–29–19; 8:45 am]
BILLING CODE 7510–13–P
NATIONAL ARCHIVES AND RECORDS
ADMINISTRATION
[NARA–2019–020]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
National Archives and Records
Administration (NARA).
ACTION: Notice.
AGENCY:
NARA is providing notice
that we have submitted to OMB for
approval the information collection
described in this notice. We invite you
to comment on the proposed
information collection, pursuant to the
Paperwork Reduction Act of 1995.
DATES: Submit comments in writing to
OMB at the address below on or before
May 30, 2019.
SUMMARY:
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
Send comments to Nicholas
Fraser, Desk Officer for NARA, by mail
to Office of Management and Budget;
New Executive Office Building;
Washington, DC 20503, by fax to 202–
395–5167, or by email to Nicholas_A._
Fraser@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
Tamee Fechhelm by phone at
301.837.1694 or by fax at 301.837.7409,
with requests for additional information
or copies of the proposed information
collection and supporting statement.
SUPPLEMENTARY INFORMATION: Pursuant
to the Paperwork Reduction Act of 1995
(Pub. L. 104–13), we invite the public
and other Federal agencies to comment
on proposed information collections.
We published a notice of proposed
collection for this information collection
on February 15, 2019 (84 FR 4542) and
received no comments. We have
therefore submitted the described
information collection to OMB for
approval.
In response to this notice, comments
and suggestions should address one or
more of the following points: (a)
Whether the proposed information
collection is necessary for proper
performance of NARA’s functions; (b)
the accuracy of our estimate of the
proposed information collection’s
burden; (c) ways to enhance the quality,
utility, and clarity of the information
we’re proposing to collect; (d) ways to
minimize the information collection’s
burden on respondents, including use of
information technology; and (e) whether
the collection affects small. In this
notice, we are soliciting comments
concerning the following information
collection:
Title: Facility Access Media (FAM)
Request (changing from Identification
Card Request).
OMB number: 3095–0057.
Agency form numbers: NA Form
6006.
Type of review: Regular.
Affected public: Individuals or
households.
Estimated number of respondents:
1,500.
Estimated time per response: 3
minutes.
Frequency of response: On occasion.
Estimated total annual burden hours:
75.
Abstract: All people requiring
recurring access to non-public areas of
NARA’s facilities and IT network
(‘‘applicants’’) use the Facility Access
Media (FAM) Request, NA Form 6006,
to request and obtain NARA facility
access media (FAM). This includes
NARA employees, contractors,
volunteers, NARA-related foundation
ADDRESSES:
E:\FR\FM\30APN1.SGM
30APN1
]]>Agencies
[Federal Register Volume 84, Number 83 (Tuesday, April 30, 2019)]
[Notices]
[Pages 18321-18322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08702]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mylan
Pharmaceuticals 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 May 30, 2019. Such
persons may also file a written request for a hearing on the
application on or before May 30, 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
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/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. Comments and requests for hearings on
applications to import narcotic raw material are not appropriate. 72 FR
3417, (January 25, 2007).
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
November 13, 2018, Mylan Pharmaceuticals Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505 applied to be registered as an importer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Methylphenidate........................ 1724 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Methadone.............................. 9250 II
Morphine............................... 9300 II
[[Page 18322]]
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically-manufactured FDF. This analysis is required
to allow the company to export domestically manufactured FDF to foreign
markets. Authorization will not extend to the import of FDA approved or
non-approved finished dosage forms for commercial use.
Dated: January 29, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-08702 Filed 4-29-19; 8:45 am]
BILLING CODE 4410-09-P
