Importer of Controlled Substances Application: Novitium Pharma LLC, 27245-27246 [2020-09705]
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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].’’
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16:45 May 06, 2020
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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:
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27246
Federal Register / Vol. 85, No. 89 / Thursday, May 7, 2020 / Notices
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 March 2, 2020,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as an importer
of the following basic class(es) of
controlled substances:
Controlled substance
Drug
code
Schedule
Lisdexamfetamine ....
1205
II
The company plans to import the
listed controlled substance as a raw
material for drug product development
and research.
The company may import Active
Pharmaceutical Ingredients (API) for
research purposes only but not for the
manufacturing of Food and Drug
Administration-approved products.
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).
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–09705 Filed 5–6–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Michael Thomas Watkins, M.D.;
Decision and Order
On November 4, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Michael
Thomas Watkins, M.D. (hereinafter,
Registrant) of Boston, Massachusetts.
OSC, at 1. The OSC proposed the
revocation of Registrant’s Certificate of
Registration No. BW0913132 and the
denial of ‘‘any applications for renewal
or modification of such registration and
any applications for any other DEA
registrations.’’ Id. It alleged that
Registrant is ‘‘without authority to
handle controlled substances in the
Commonwealth of Massachusetts, the
state in which . . . [he is] registered
with the DEA.’’ Id. at 2 (citing 21 U.S.C.
824(a)(3); 21 CFR 1301.37(b)).
Specifically, the OSC alleged that,
‘‘[o]n or about May 30, 2019, the
Massachusetts Board of Registration in
Medicine . . . ratified a ‘Voluntary
Agreement Not to Practice Medicine’
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Jkt 250001
that . . . [Registrant] signed on May 22,
2019, in which . . . [he] agreed to ‘cease
. . . [his] practice of medicine in the
Commonwealth of Massachusetts
effective immediately.’’’ OSC, at 1. The
OSC further alleged that Registrant’s
‘‘Massachusetts Controlled Substances
License was terminated due to the
Board action’’ and, ‘‘[t]hus, . . . [he is]
currently without authority to handle
controlled substances in . . . the state
in which . . . [he is] registered with the
DEA.’’ Id. at 2. The OSC concluded that
‘‘DEA must revoke . . . [Registrant’s]
DEA registration based on . . . [his] lack
of authority to handle controlled
substances in the Commonwealth of
Massachusetts.’’ Id.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. (citing 21 CFR
1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. OSC, at 3
(citing 21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated February 24,
2020, a Diversion Investigator
(hereinafter, DI) assigned to the New
England Division, stated that she and
another DI traveled to the address her
investigation identified to be
Registrant’s home on November 12,
2019. Request for Final Agency Action
dated February 26, 2020 (hereinafter,
RFAA), Exhibit (hereinafter, EX) 4
(Declaration of Service of Order to Show
Cause dated February 24, 2020), at 1.
The DI stated that she and the other DI
showed their credentials to the ‘‘woman
who answered the door’’ and asked if
Registrant was ‘‘available.’’ Id. The
woman, according to the DI’s
Declaration, responded that Registrant
‘‘was not home.’’ Id. After verifying the
woman’s identity as Registrant’s spouse,
DI ‘‘explained . . . that Registrant was
being served with the . . . [OSC] and
handed the . . . [OSC] to . . . [the
woman] to give to Registrant.’’ Id. The
woman signed a receipt for the OSC. Id.;
see also id. at EX 4B (signed DEA–12
receipt dated November 12, 2019), at 1.
According to the DI’s Declaration, the
woman ‘‘stated that she would give the
documents to Registrant.’’ Id. at EX 4, at
1.
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on February 26, 2020. In its
RFAA, the Government represented that
‘‘[a]t least 30 days have passed since the
time the Order was served on Registrant.
Registrant has not requested a hearing
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
and has not otherwise corresponded or
communicated with DEA regarding the
Order . . . including the filing of any
written statement in lieu of a hearing.’’
RFAA, at 2. The Government requested
that Registrant’s registration be revoked,
based on his having ‘‘no valid medical
license in Massachusetts’’ and his being
‘‘without state authority to handle
controlled substances in Massachusetts,
the state where he is registered with
DEA.’’ Id. at 3.
Based on the DI’s Declaration, the
Government’s written representations,
and my review of the record, I find that
the Government accomplished service
of the OSC on Registrant on November
12, 2019. Dale L. Taylor, M.D., 72 FR
30,855, 30,855 (2007) (concluding that
service was sufficient when OSC and
Immediate Suspension Order were left
at registrant’s residence with his wife);
Sajjan Gangappa Chikkannaiah, M.D.,
54 FR 8608, 8608 (1989) (noticing OSC
and Immediate Suspension Order to
registrant through the Federal Register
when family, wife, and staff were
unable to provide any information on
registrant’s whereabouts); Fredric J.
Sloan, M.D., 52 FR 10,957, 10,957
(1987) (serving registrant’s wife with
OSC at their residence was sufficient
notice to registrant).
I also find that more than thirty days
have now passed since the Government
accomplished service of the OSC.
Further, based on the Government’s
written representations and my review
of the record, I find that neither
Registrant, nor anyone purporting to
represent Registrant, requested a
hearing, submitted a written statement
while waiving Registrant’s right to a
hearing, or submitted a corrective action
plan. Accordingly, I find that Registrant
has waived the right to a hearing and
the right to submit a written statement
and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I,
therefore, issue this Decision and Order
based on the record submitted by the
Government, which constitutes the
entire record before me. 21 CFR
1301.43(e).
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
BW0913132 at the registered address of
Dept. of Surgery-Vascular-MGH, 15
Parkman Street, ACC 440, Boston, MA
02114. RFAA, EX 1 (Certification of
Registration Status for DEA No.
BW0913132 dated December 4, 2019), at
1. Pursuant to this registration,
Registrant is authorized to dispense
controlled substances in schedules II
E:\FR\FM\07MYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 89 (Thursday, May 7, 2020)]
[Notices]
[Pages 27245-27246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09705]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-638]
Importer of Controlled Substances Application: Novitium Pharma
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: 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,
[[Page 27246]]
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 March 2, 2020, Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520, applied to be registered as an importer
of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Lisdexamfetamine..................... 1205 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance as a
raw material for drug product development and research.
The company may import Active Pharmaceutical Ingredients (API) for
research purposes only but not for the manufacturing of Food and Drug
Administration-approved products. 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).
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09705 Filed 5-6-20; 8:45 am]
BILLING CODE 4410-09-P
