Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc., 21890 [2020-08330]
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21890
Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices
A, Red Lion, Pennsylvania 17356–1436,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled substance
marihuana ........................
tetrahydrocannabinols .....
Drug
code
Schedule
7360
7370
I
I
The applicant’s notice above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2016 DEA policy
statement that provided information on
how it intended to expand the number
of registrations, and described in general
terms the way it would oversee those
additional growers. In order to complete
the evaluation and registration process
for applicants to grow marihuana, DEA
has proposed regulations that, if
finalized, would supersede the 2016
policy statement and govern persons
seeking to become registered with DEA
to grow marihuana as a bulk
manufacturer, consistent with
applicable law. The proposed
regulations are available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
Controlled substance
Marihuana ........................
Tetrahydrocannabinols ....
Amphetamine ..................
Lisdexamfetamine ...........
Pentobarbital ...................
ANPP (4-Anilino-Nphenethyl-4-piperidine).
Codeine ...........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Meperidine .......................
Morphine ..........................
Fentanyl ...........................
Drug
code
Schedule
7360
7370
1100
1205
2270
8333
I
I
II
II
II
II
9050
9143
9150
9193
9230
9300
9801
II
II
II
II
II
II
II
The company plans to manufacture
the above controlled substances as bulk
active pharmaceutical ingredients (APIs)
for use in product development and for
distribution to its customers. In
reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetics. No other activities for
these drug codes are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–08330 Filed 4–17–20; 8:45 am]
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[FR Doc. 2020–08334 Filed 4–17–20; 8:45 am]
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DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–609]
[Docket No. DEA–622]
Importer of Controlled Substances
Application: Purisys, LLC
Bulk Manufacturer of Controlled
Substances Application: AMRI
Rensselaer, Inc.
ACTION:
ACTION:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before June 19, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 9, 2020, AMRI
Rensselaer, Inc., 33 Riverside Avenue,
Rensselaer, New York 12144–2951,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
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VerDate Sep<11>2014
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Jkt 250001
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before May 20, 2020. Such persons
may also file a written request for a
hearing on the application on or before
May 20, 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 request 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,
DATES:
Notice of application.
SUPPLEMENTARY INFORMATION:
Notice of application.
PO 00000
Frm 00069
Fmt 4703
Sfmt 9990
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 30, 2020,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602 applied to
be registered as an importer of the
following basic class(es) of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Nabilone .........................
Phenylacetone ................
Levorphanol ....................
Thebaine .........................
Poppy Straw Concentrate.
Tapentadol ......................
Drug
code
Schedule
7350
7360
7370
7379
8501
9220
9333
9670
I
I
I
II
II
II
II
II
9780
II
The company plans to import drug
code 8501, Phenylacetone and drug
code 9670, Poppy Straw Concentrate to
bulk manufacture other controlled
substances for distribution to its
customers. The company plans to
import impurities of buprenorphine that
have been determined by DEA to be
captured under drug code 9333,
Thebaine. In reference to drug codes
7360, Marihuana and 7370,
Tetrahydrocannabinols the company
plans to import a Synthetic Cannabidiol
and a Synthetic Tetrahydrocannabinol.
No other activity for these drug codes is
authorized for this registration.
Placement of these drugs codes on the
company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substances. Approval
of permit applications will occur only
when the registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDAapproved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–08270 Filed 4–17–20; 8:45 am]
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[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Page 21890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08330]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-622]
Bulk Manufacturer of Controlled Substances Application: AMRI
Rensselaer, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before June 19, 2020.
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 9, 2020, AMRI Rensselaer, Inc., 33 Riverside
Avenue, Rensselaer, New York 12144-2951, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Pentobarbital........................... 2270 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
Codeine................................. 9050 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Meperidine.............................. 9230 II
Morphine................................ 9300 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to manufacture the above controlled substances as
bulk active pharmaceutical ingredients (APIs) for use in product
development and for distribution to its customers. In reference to drug
codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs as synthetics. No other
activities for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-08330 Filed 4-17-20; 8:45 am]
BILLING CODE 4410-09-P
