Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 27245 [2020-09706]
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27245
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 89 / Thursday, May 7, 2020 / Notices
denied, 481 Fed. Appx. 826 (4th Cir.
2012); Frederick Marsh Blanton, M.D.,
43 FR 27,616, 27,617 (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,
DEA has held repeatedly that revocation
of a practitioner’s registration is the
appropriate sanction whenever she is no
longer authorized to dispense controlled
substances under the laws of the state in
which she practices. See, e.g., James L.
Hooper, M.D., 76 FR at 71,371–72;
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, M.D.,
43 FR at 27,617.
According to Nevada statute, ‘‘[e]very
person desiring to practice medicine
must, before beginning to practice,
procure from the Board a license
authorizing the person to practice.’’
Nev. Rev. Stat. § 630.160(1) (Westlaw,
current through the end of the 80th
Regular Session (2019)). Further, the
phrase ‘‘practice medicine’’ includes
prescribing ‘‘for any human
disease.’’Nev. Rev. Stat. § 630.020(1)
(Westlaw, current through the end of the
80th Regular Session (2019)). As already
discussed, Registrant’s medical license
is currently revoked. Thus, Registrant
currently is not authorized to practice
medicine, including to prescribe
controlled substances, in Nevada.
Nevada statute requires that ‘‘[e]very
practitioner . . . who dispenses any
controlled substance within this State
. . . shall obtain biennially a
registration issued by the Board in
accordance with its regulations.’’ Nev.
Rev. Stat. § 453.226(1) (Westlaw, current
through the end of the 80th Regular
Session (2019)). ‘‘Practitioner’’ means ‘‘a
physician . . . who holds a license to
practice his or her profession in this
State and is registered pursuant to [the
Uniform Controlled Substances Act].’’
VerDate Sep<11>2014
16:45 May 06, 2020
Jkt 250001
Nev. Rev. Stat. § 453.126(1) (Westlaw,
current through the end of the 80th
Regular Session (2019)). ‘‘Dispense’’
means ‘‘to deliver a controlled
substance to an ultimate user . . .,
including the prescribing . . . for that
delivery.’’ Nev. Rev. Stat. § 453.056(1)
(Westlaw, current through the end of the
80th Regular Session (2019)). As already
discussed, Registrant’s Nevada medical
license is currently revoked. Thus,
Registrant is not a ‘‘practitioner’’ under
Nevada law and, therefore, he is not
eligible to dispense or prescribe a
controlled substance in Nevada.
Here, the undisputed evidence in the
record is that Registrant is not currently
authorized to practice medicine or to
prescribe controlled substances in
Nevada. Registrant, therefore, is not
currently 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. BH7844500 issued to
Isaac J. Hearne, M.D. This Order is
effective June 8, 2020.
Controlled
substance
Drug code
Amphetamine .........
Lisdexamfetamine ..
Cathinone ...............
Methylphenidate .....
Morphine-N-Oxide ..
Normophine ............
Oripavine ................
Thebaine .................
Opium Tincture .......
Oxymorphone .........
Noroxymorphone ....
Alfentanil .................
Sufentanil ................
Carfentanil ..............
Tapentadol ..............
Fentanyl ..................
1100
1205
1235
1724
9307
9313
9330
9333
9630
9652
9668
9737
9740
9743
9780
9801
Schedule
II
II
I
II
I
I
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances to
produce active pharmaceutical
ingredients (API) for their prescription
drug products and manufacture
analytical reference standards for
distribution to customers. The company
also plans to use these substances for
lab scale research and development
activities.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–09706 Filed 5–6–20; 8:45 am]
BILLING CODE 4410–09–P
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–09722 Filed 5–6–20; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–638]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–628]
ACTION:
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
ACTION:
Notice of application.
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 July 6, 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 January 30, 2020,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
DATES:
PO 00000
Frm 00042
Fmt 4703
Importer of Controlled Substances
Application: Novitium Pharma LLC
Sfmt 4703
Notice of application.
Registered bulk manufacturer 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 8, 2020. Such persons
may also file a written request for a
hearing on the application on or before
June 8, 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,
DATES:
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 85, Number 89 (Thursday, May 7, 2020)]
[Notices]
[Page 27245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09706]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-628]
Bulk Manufacturer of Controlled Substances Application: Purisys,
LLC
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 July 6, 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 January 30, 2020, Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601, applied to be registered as a bulk manufacturer
of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Amphetamine.......................... 1100 II
Lisdexamfetamine..................... 1205 II
Cathinone............................ 1235 I
Methylphenidate...................... 1724 II
Morphine-N-Oxide..................... 9307 I
Normophine........................... 9313 I
Oripavine............................ 9330 II
Thebaine............................. 9333 II
Opium Tincture....................... 9630 II
Oxymorphone.......................... 9652 II
Noroxymorphone....................... 9668 II
Alfentanil........................... 9737 II
Sufentanil........................... 9740 II
Carfentanil.......................... 9743 II
Tapentadol........................... 9780 II
Fentanyl............................. 9801 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances to produce active pharmaceutical ingredients (API) for their
prescription drug products and manufacture analytical reference
standards for distribution to customers. The company also plans to use
these substances for lab scale research and development activities.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09706 Filed 5-6-20; 8:45 am]
BILLING CODE 4410-09-P
