Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 68474 [2019-27094]
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68474
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Directorate for the quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as reference standards.
DEPARTMENT OF JUSTICE
[Docket No. DEA–553]
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 domesticallymanufactured FDF to foreign markets.
Authorization will not extend to the
import of Food and Drug
Administration approved or nonapproved finished dosage forms for
commercial sale.
Drug Enforcement Administration
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Inc.
Dated: November 14, 2019.
William T. McDermott,
Assistant Administrator.
Dated: December 2, 2019.
William T. McDermott,
Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–560]
[FR Doc. 2019–27094 Filed 12–13–19; 8:45 am]
Importer of Controlled Substances
Application: Novitium Pharma LLC
ACTION:
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 15, 2020. Such
persons may also file a written request
for a hearing on the application on or
before January 15, 2020.
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:
In accordance with 21 CFR
1301.34(a), this is notice that on July 18,
2018, Novitium Pharma, LLC., 70 Lake
Drive, East Windsor, New Jersey 08520
applied to be registered as an importer
of the following basic class of controlled
substance:
DATES:
Levorphanol ..............
Drug
code
9220
19:21 Dec 13, 2019
BILLING CODE 4410–09–P
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 15, 2020. Such
persons may also file a written request
for a hearing on the application on or
before January 15, 2020
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:
In accordance with 21 CFR
1301.34(a), this is notice that on October
17, 2019, 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:
Controlled substance
Drug
code
Schedule
Amphetamine .................
Methylphenidate .............
Oxycodone .....................
Hydromorphone ..............
Methadone ......................
Morphine .........................
Fentanyl ..........................
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
Schedule
II
The company plans to import the
controlled substance to develop the
manufacturing process for a drug
product that will in turn be used to
VerDate Sep<11>2014
Notice of application.
DATES:
Notice of application.
Controlled substance
[FR Doc. 2019–27095 Filed 12–13–19; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
ACTION:
Dated: December 3, 2019.
William T. McDermott,
Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2019–27093 Filed 12–13–19; 8:45 am]
lotter on DSKBCFDHB2PROD with NOTICES
produce a tablet equivalent to the
current brand product.
Jkt 250001
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Frm 00083
Fmt 4703
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Jeffrey D. Olsen, M.D.; Decision and
Order
On August 2, 2016, a former Acting
Administrator of the Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (OSC) and Immediate Suspension
of Registration (ISO) to Jeffrey D. Olsen,
M.D. (hereinafter, Registrant), of
Newport Beach, CA. Order to Show
Cause and Immediate Suspension of
Registration (hereinafter collectively,
OSC 2)), at 1; see also Government
Exhibit (hereinafter, GX) 26, at 1–6. OSC
2 informed Registrant of the immediate
suspension of his DEA Certificate of
Registration (hereinafter, COR)
FO6043638 pursuant to 21 U.S.C. 824(d)
‘‘because . . . [his] continued
registration constitute[d] an imminent
danger to the public health and safety.’’
Id.
The substantive ground for the
proceeding, as alleged in OSC 2, was
that Registrant’s ‘‘continued registration
is inconsistent with the public interest,
as that term is defined in 21 U.S.C.
823(f).’’ Id. (citing 21 U.S.C. 824(a)(4)).
Specifically, the OSC alleged that
Registrant issued numerous
prescriptions outside the usual course of
the professional practice of medicine in
violation of 21 U.S.C. 841(a)(1) and 21
CFR 1306.04(a) and in violation of
California law and the minimum
standards of medical practice in
California. Id. at 2–4. The OSC stated
that ‘‘[Registrant’s] conduct, viewed as a
whole, ‘completely betrayed any
semblance of legitimate medical
treatment.’’’ Id. at 4 (citing Jack A.
Danton, D.O., 76 FR 60900, 60904
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Page 68474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27094]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-553]
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 January 15, 2020.
Such persons may also file a written request for a hearing on the
application on or before January 15, 2020
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:
In accordance with 21 CFR 1301.34(a), this is notice that on
October 17, 2019, 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
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 Food and Drug
Administration approved or non-approved finished dosage forms for
commercial sale.
Dated: November 14, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27094 Filed 12-13-19; 8:45 am]
BILLING CODE 4410-09-P
