Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories, Inc., 31622 [2019-14028]
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31622
Federal Register / Vol. 84, No. 127 / Tuesday, July 2, 2019 / Notices
Administration (DEA) as importer of
schedule I controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as an importer of basic class
of controlled substances. Information on
previously published notice is listed in
the table below. No comments or
objections were submitted and no
requests for a hearing were submitted
for this notice.
FR
Docket
Company
Sharp (Bethlehem),
LLC.
84 FR
9837.
Published
March 18,
2019
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrant to import the applicable
basic class of schedule I 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 the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I controlled substances to the
above listed company.
Dated: June 3, 2019.
John J. Martin,
Assistant Administrator.
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 April 17, 2019,
Bellwyck Clinical Services, 8946 Global
Way, West Chester, Ohio 45069 applied
to be registered as an importer of the
following basic class of controlled
substances:
Controlled
substance
Drug code
Amphetamine ...
Methylphenidate
Oxycodone .......
1100
1724
9143
Schedule
II
II
II
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Drug Enforcement Administration
Importer of Controlled Substances
Application: Bellwyck Clinical Services
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 August 1, 2019. Such persons
may also file a written request for a
hearing on the application on or before
August 1, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
khammond on DSKBBV9HB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:00 Jul 01, 2019
Jkt 247001
Controlled
substance
Drug code
Difenoxin ...........
Diphenoxylate ...
Levorphanol ......
Meperidine intermediate-B.
9168
9170
9220
9233
Schedule
I
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Dated: June 19, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–14028 Filed 7–1–19; 8:45 am]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Pisgah
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 September 3, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
DATES:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Lipomed
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 August 1, 2019. Such persons
may also file a written request for a
hearing on the application on or before
August 1, 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
DATES:
[FR Doc. 2019–14027 Filed 7–1–19; 8:45 am]
Drug Enforcement Administration
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 5, 2019, Pisgah
Laboratories, Inc., 3222 Old
Hendersonville Highway, Pisgah Forest,
North Carolina 28768 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
The company plans to import the
listed controlled substances in dosage
form to conduct clinical trials. Approval
of permit applications will occur only
when the registrant’s 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 nonapproved finished dosage forms for
commercial sale.
Dated: June 18, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–14023 Filed 7–1–19; 8:45 am]
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Page 31622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14028]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Pisgah
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 September 3, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on March 5, 2019, Pisgah Laboratories, Inc., 3222 Old
Hendersonville Highway, Pisgah Forest, North Carolina 28768 applied to
be registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Difenoxin.......................... 9168 I
Diphenoxylate...................... 9170 II
Levorphanol........................ 9220 II
Meperidine intermediate-B.......... 9233 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for distribution to its customers.
Dated: June 19, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-14028 Filed 7-1-19; 8:45 am]
BILLING CODE 4410-09-P
