Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC, 5992-5993 [2020-01960]
Download as PDF
<![CDATA[
5992
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
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 71371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27616,
27617 (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., James L. Hooper, M.D., 76 FR at
71371–72; Sheran Arden Yeates, M.D.,
71 FR 39130, 39131 (2006); Dominick A.
Ricci, M.D., 58 FR 51104, 51105 (1993);
Bobby Watts, M.D., 53 FR 11919, 11920
(1988); Frederick Marsh Blanton, M.D.,
43 FR at 27617.
Under Michigan law, ‘‘a person who
manufactures, distributes, prescribes, or
dispenses a controlled substance in this
state . . . shall obtain a license issued
by the administrator.’’ Mich. Comp.
Laws § 333.7303(1). Here, the
3 Registrant is also authorized as a Data-Waiver
practitioner for up to 100 patients pursuant to 21
U.S.C. 823(g)(2)(a).
4 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
a practitioner.3 Registrant’s registration
expires on June 30, 2020, and is ‘‘in an
active pending status.’’ RFAA, EX 1
(Copy of Registrant’s Certificate of
Registration).
lotter on DSKBCFDHB2PROD with NOTICES
The Status of Registrant’s State License
On January 19, 2018, the Michigan
Department of Licensing and Regulatory
Affairs ‘‘executed an Order of Summary
Suspension and an Administrative
Complaint charging [Registrant] with
violating the Public Health Code, [Mich.
Comp. Laws] § 333.1101 et seq.’’ RFAA,
EX 3 (Final Order of the Board of
Pharmacy Disciplinary Subcommittee,
Bureau of Professional Licensing,
Michigan Department of Licensing and
Regulatory Affairs), at 1. On June 21,
2019, after an administrative hearing,
the Michigan Board of Pharmacy issued
a Final Order revoking Registrant’s
controlled substance license and drug
control-location licenses. Id. at 2, 4. The
Final Order became effective thirty days
from its signature, on July 21, 2019.
RFAA, EX 3, at 4.
According to Michigan’s online
records, of which I take official notice,4
Registrant’s controlled substance license
and drug control-location licenses
remain revoked. https://
aca3.accela.com/MILARA/
GeneralProperty/PropertyLookUp.aspx
(last visited January 3, 2020).
Further, the Final Order states that
reinstatement of Registrant’s revoked
licenses ‘‘is not automatic and shall be
in accordance with [Mich. Comp. Laws]
§§ 333.7315–333.7316.’’ RFAA, EX 3, at
3. It is noted that pursuant to Section
333.7315, Registrant may not apply for
reinstatement of his revoked licenses
before the expiration of five years after
the effective date of revocation. Mich.
Comp. Laws § 333.7315.
Accordingly, I find that Registrant
currently does not possess a controlled
substances license in Michigan, the
State in which he is registered with the
DEA.
VerDate Sep<11>2014
16:47 Jan 31, 2020
Jkt 250001
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
undisputed evidence in the record is
that Registrant currently lacks authority
to manufacture, distribute, prescribe, or
dispense controlled substances in
Michigan. Thus, because Registrant
lacks authority to distribute, prescribe,
or dispense controlled substances in
Michigan, Registrant is not eligible to
maintain a DEA registration.
Accordingly, 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 hereby revoke DEA Certificate
of Registration No. FA7485027 issued to
Solomon Adu-Beniako. This Order is
effective March 4, 2020.
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–01971 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–578]
Bulk Manufacturer of Controlled
Substances Application: IsoSciences,
LLC
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 April 3, 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 November 27, 2019,
IsoSciences, LLC, 340 Mathers Road,
Ambler, Pennsylvania 19002–3420
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\03FEN1.SGM
03FEN1
5993
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
Controlled substance
Drug code
lotter on DSKBCFDHB2PROD with NOTICES
Cathinone .................................................................................................................................................................
Methcathinone .........................................................................................................................................................
Lysergic acid diethylamide ......................................................................................................................................
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
3,4-Methylenedioxyamphetamine ............................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine ...............................................................................................................
3,4-Methylenedioxymethamphetamine ....................................................................................................................
5-Methoxy-N–N-dimethyltryptamine ........................................................................................................................
Alpha-methyltryptamine ...........................................................................................................................................
Bufotenine ................................................................................................................................................................
Diethyltryptamine .....................................................................................................................................................
Dimethyltryptamine ..................................................................................................................................................
Psilocybin .................................................................................................................................................................
Psilocyn ....................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ......................................................................................................................
Dihydromorphine ......................................................................................................................................................
Heroin ......................................................................................................................................................................
Nicocodeine .............................................................................................................................................................
Nicomorphine ...........................................................................................................................................................
Normorphine ............................................................................................................................................................
Thebacon .................................................................................................................................................................
Normethadone .........................................................................................................................................................
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- ......................................................................................................
phenylacrylamide) ....................................................................................................................................................
Para-Fluorofentanyl .................................................................................................................................................
3-Methylfentanyl .......................................................................................................................................................
Alpha-methylfentanyl ...............................................................................................................................................
Acetyl-alpha-methylfentanyl .....................................................................................................................................
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide ...............................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N- ...................................................................................................
phenylacetamide) .....................................................................................................................................................
Butyryl Fentanyl .......................................................................................................................................................
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N- ..................................................................................................
(1-phenethylpiperidin-4-yl)isobutyramide) ................................................................................................................
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide .................................................................................
Beta-hydroxyfentanyl ...............................................................................................................................................
Beta-hydroxy-3-methylfentanyl ................................................................................................................................
Alpha-methylthiofentanyl ..........................................................................................................................................
3-Methylthiofentanyl .................................................................................................................................................
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran- ..............................................................................
2-carboxamide) ........................................................................................................................................................
Thiofentanyl .............................................................................................................................................................
Beta-hydroxythiofentanyl .........................................................................................................................................
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2- .......................................................................................
carboxamide ............................................................................................................................................................
Amphetamine ...........................................................................................................................................................
Methamphetamine ...................................................................................................................................................
Codeine ....................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Oxycodone ...............................................................................................................................................................
Hydromorphone .......................................................................................................................................................
Hydrocodone ............................................................................................................................................................
Isomethadone ..........................................................................................................................................................
Methadone ...............................................................................................................................................................
Methadone intermediate ..........................................................................................................................................
Morphine ..................................................................................................................................................................
Thebaine ..................................................................................................................................................................
Levo-alphacetylmethadol .........................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Thiafentanil ..............................................................................................................................................................
Alfentanil ..................................................................................................................................................................
Sufentanil .................................................................................................................................................................
Carfentanil ................................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to manufacture
bulk controlled substances for use in
analytical testing. In reference to drug
codes 7360 (marihuana) and 7370
(Tetrahydrocannabinols), the company
VerDate Sep<11>2014
16:47 Jan 31, 2020
Jkt 250001
plans to bulk manufacture these drugs
as synthetics. No other activities for
these drug codes are authorized for this
registration.
PO 00000
Fmt 4703
Sfmt 9990
1235
1237
7315
7360
7370
7400
7404
7405
7431
7432
7433
7434
7435
7437
7438
7439
9145
9200
9309
9312
9313
9315
9635
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
9811
9812
9813
9814
9815
9816
I
I
I
I
I
I
9821
9822
I
I
9824
9825
9830
9831
9832
9833
I
I
I
I
I
I
9834
9835
9836
I
I
I
9843
1100
1105
9050
9120
9143
9150
9193
9226
9250
9254
9300
9333
9648
9652
9729
9737
9740
9743
9801
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Dated: January 24, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–01960 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
Frm 00067
Schedule
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5992-5993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01960]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-578]
Bulk Manufacturer of Controlled Substances Application:
IsoSciences, LLC
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 April 3, 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 November 27, 2019, IsoSciences, LLC, 340 Mathers
Road, Ambler, Pennsylvania 19002-3420 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
[[Page 5993]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone............................... 1235 I
Methcathinone........................... 1237 I
Lysergic acid diethylamide.............. 7315 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
3,4-Methylenedioxyamphetamine........... 7400 I
3,4-Methylenedioxy-N-ethylamphetamine... 7404 I
3,4-Methylenedioxymethamphetamine....... 7405 I
5-Methoxy-N-N-dimethyltryptamine........ 7431 I
Alpha-methyltryptamine.................. 7432 I
Bufotenine.............................. 7433 I
Diethyltryptamine....................... 7434 I
Dimethyltryptamine...................... 7435 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
5-Methoxy-N,N-diisopropyltryptamine..... 7439 I
Dihydromorphine......................... 9145 I
Heroin.................................. 9200 I
Nicocodeine............................. 9309 I
Nicomorphine............................ 9312 I
Normorphine............................. 9313 I
Thebacon................................ 9315 I
Normethadone............................ 9635 I
Acryl fentanyl (N-(1-phenethylpiperidin- 9811 I
4-yl)-N-...............................
phenylacrylamide).......................
Para-Fluorofentanyl..................... 9812 I
3-Methylfentanyl........................ 9813 I
Alpha-methylfentanyl.................... 9814 I
Acetyl-alpha-methylfentanyl............. 9815 I
N-(2-fluorophenyl)-N-(1- 9816 I
phenethylpiperidin-4-yl)propionamide...
Acetyl Fentanyl (N-(1-phenethylpiperidin- 9821 I
4-yl)-N-...............................
phenylacetamide)........................
Butyryl Fentanyl........................ 9822 I
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-.......................
(1-phenethylpiperidin-4-
yl)isobutyramide)......................
2-methoxy-N-(1-phenethylpiperidin-4-yl)- 9825 I
N-phenylacetamide......................
Beta-hydroxyfentanyl.................... 9830 I
Beta-hydroxy-3-methylfentanyl........... 9831 I
Alpha-methylthiofentanyl................ 9832 I
3-Methylthiofentanyl.................... 9833 I
Furanyl fentanyl (N-(1- 9834 I
phenethylpiperidin-4-yl)-N-phenylfuran-
2-carboxamide)..........................
Thiofentanyl............................ 9835 I
Beta-hydroxythiofentanyl................ 9836 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-...............
carboxamide.............................
Amphetamine............................. 1100 II
Methamphetamine......................... 1105 II
Codeine................................. 9050 II
Dihydrocodeine.......................... 9120 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Isomethadone............................ 9226 II
Methadone............................... 9250 II
Methadone intermediate.................. 9254 II
Morphine................................ 9300 II
Thebaine................................ 9333 II
Levo-alphacetylmethadol................. 9648 II
Oxymorphone............................. 9652 II
Thiafentanil............................ 9729 II
Alfentanil.............................. 9737 II
Sufentanil.............................. 9740 II
Carfentanil............................. 9743 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to manufacture bulk controlled substances for use
in analytical testing. 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.
Dated: January 24, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-01960 Filed 1-31-20; 8:45 am]
BILLING CODE 4410-09-P
