Fred J. Powell, M.D.; Decision and Order, 21811-21812 [2019-10019]
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Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: AndersonBrecon Inc. DBA
PCI of Illinois
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration on or before June
14, 2019. Such persons may also file a
written request for a hearing on the
application on or before June 14, 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 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: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on March
5, 2019, AndersonBrecon Inc., DBA PCI
of Illinois, 5775 Logistics Parkway,
Rockford, Illinois 61109 applied to be
registered as an importer of the
following basic class of controlled
substance:
jbell on DSK3GLQ082PROD with NOTICES
DATES:
Controlled substance
Tetrahydrocannabinols ..
VerDate Sep<11>2014
Drug code
7370
22:43 May 14, 2019
Schedule
I
Jkt 247001
The company plans to import the
listed controlled substance for clinical
trials only. Approval of permit
application 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 FDA
approved or non-approved finished
dosage forms for commercial sale.
Dated: April 27, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–10006 Filed 5–14–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Fred J. Powell, M.D.; Decision and
Order
On January 25, 2018, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Fred J. Powell. (hereinafter,
Registrant), of St. Augustine, Florida.
Order to Show Cause (hereinafter, OSC),
at 1. The OSC proposes the revocation
of Registrant’s Certificate of Registration
(hereinafter, COR) on the ground that he
is without authority to handle
controlled substances in Florida, the
State in which he is registered with the
DEA. Id. at 2. The OSC cites the
operative statutory provisions that spell
out the requirements for registration
upon which the DEA alleges that
Registrant is deficient, and the DEA’s
authority to revoke his registration. Id.,
at 1–2 (citing 21 U.S.C. 824(a)(3)).
Jurisdiction
This Agency has jurisdiction to
decide this case based upon the OSC
allegation that Registrant holds a DEA
COR (No. AP8271138) at the registered
address of 35 Townsend Pl., St.
Augustine, FL 32092–3209. OSC, at 1.
That registration authorizes Registrant,
as a practitioner, to dispense controlled
substances in schedules II through V
and expires on March 31, 2020. Id.
Substantive Ground for Revocation of
COR Alleged in OSC
The substantive ground for the
proceeding, as alleged in the OSC, is
that Registrant agreed to a permanent
restriction prohibiting him from
prescribing and ordering Schedule I
through V controlled substances and
thus is ‘‘currently without authority to
handle controlled substances in the
State of Florida,’’ the State in which he
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Fmt 4703
Sfmt 4703
21811
is registered with the DEA under DEA
COR No. AP8271138. OSC, at 2.
The OSC notified Registrant of his
right to request a hearing on the
allegations or to submit a written
statement if he chooses to waive his
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect one of
those options. Id. (citing 21 CFR
1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan, the specific
procedures for filing a corrective action
plan, and the statutory provision that
governs such a plan. Id. at 2–3 (citing 21
U.S.C. 824(c)(2)(C)).
By letter dated March 27, 2018,
Registrant timely submitted a corrective
action plan (hereinafter, CAP). Request
for Final Agency Action dated April 10,
2018 (hereinafter, RFAA), Exhibit
(hereinafter, Exh.) 5.1 Registrant’s CAP
consists of thirteen paragraphs
containing assertions. The Assistant
Administrator of the Diversion Control
Division denied Registrant’s CAP by
letter dated April 6, 2018. Exh. 6.
In its RFAA, the Government
represents that, ‘‘At least 30 days have
passed since the time the . . . [OSC]
was served on Registrant. Registrant has
not requested a hearing.’’ RFAA, at 2.
The Government requests the issuance
of a ‘‘Final Order revoking Registrant’s
DEA registration.’’ Id. at 4.
The very existence of the CAP
evidences that service of the OSC on
Registrant was adequate. In addition,
Registrant did not dispute service.
Based on the Government’s written
representations and my review of the
record, I find that more than thirty days
have now passed since the date the
Government served the OSC. I find that
Registrant timely submitted a CAP and
that the Assistant Administrator of the
Diversion Control Division denied
Registrant’s CAP by letter dated April 6,
2018. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent him, requested a
hearing or submitted a written statement
while waiving Registrant’s right to a
hearing. Accordingly, I find that
Registrant has waived his right to a
hearing and his right to submit a written
statement. 21 CFR 1301.43(d). 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).
1 Also attached to the RFAA is a ‘‘Declaration’’ of
a DEA Diversion Investigator (hereinafter, DI
Declaration). Exh. 4. According to the DI
Declaration, two Diversion Investigators personally
served the OSC on Registrant on January 26, 2018.
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15MYN1
21812
Federal Register / Vol. 84, No. 94 / Wednesday, May 15, 2019 / Notices
Findings of Fact
jbell on DSK3GLQ082PROD with NOTICES
Registrant’s DEA Registration
Registrant is the holder of DEA COR
No. AP8271138, pursuant to which he is
authorized to dispense controlled
substances in schedules II through V as
a practitioner, at the registered address
of 35 Townsend Pl., St. Augustine,
Florida 32092–3209. Certification of
Registration History (Exh. 1), at 1.
On December 15, 2017, the State of
Florida, Board of Medicine (hereinafter,
Florida Board) issued a Final Order
approving and adopting in full the
Settlement Agreement that Registrant
entered into on October 3, 2017, with
the State of Florida, Department of
Health. Exh. 3, at 68–70. The Florida
Board’s Final Order, therefore, adopted
each provision of the Settlement
Agreement, including Registrant’s
voluntary permanent restriction from
‘‘prescribing, ordering, and/or
delegating the prescribing or ordering
of, any substances listed in Schedules I–
V, as defined in Section 893.03, Florida
Statutes (2016), and may from time-totime be redefined in Florida Statutes
and/or the Florida Administrative
Code.’’ Id. at 63. Thus, Registrant
currently lacks authority to handle
controlled substances in the State of
Florida, the State in which he is
licensed to practice medicine and where
he is registered with DEA.
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 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,
VerDate Sep<11>2014
22:43 May 14, 2019
Jkt 247001
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., Hooper, supra, 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);
Blanton, supra, 43 FR at 27617.
Registrant has voluntarily agreed
permanently to stop prescribing and
ordering controlled substances, and to
stop delegating the prescribing or
ordering of controlled substances. Exh.
3, at 63. He has also voluntarily agreed
that these permanent restrictions are
‘‘fair, appropriate and acceptable’’ to
him.2 Id. at 60.
The CSA has consistently been
interpreted to mean that the DEA does
not have statutory authority to maintain
a registration if the registrant is without
State authority to handle controlled
substances in the State in which he
practices. E.g., Alaaeldin A. Babiker,
M.D., 81 FR 50723, 50725 (2016);
Yeates, supra, 71 FR at 39131; Abraham
A. Chaplan, M.D., 57 FR 55280, 55280
(1992). Very simply, because Registrant
is not authorized to handle controlled
substances in Florida, he is not eligible
for a DEA registration. As such, I will
order that Registrant’s COR be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I order that DEA Certificate of
Registration No. AP8271138 issued to
Fred J. Powell, M.D., be, and it hereby
is, revoked. Pursuant to 28 CFR 0.100(b)
and the authority vested in me by 21
U.S.C. 823(f), I further order that any
pending application of Fred J. Powell,
M.D., to renew or modify this
registration (AP8271138), as well as any
other pending application by him for
2 Registrant also agreed to support these
permanent restrictions before the Florida Board. Id.
at 65.
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Frm 00065
Fmt 4703
Sfmt 4703
registration in the State of Florida, be,
and it hereby is, denied. This order is
effective June 14 2019.
Dated: April 23, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–10019 Filed 5–14–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
The registrants listed below
have applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as importers of
schedule I and schedule II controlled
substances.
SUMMARY:
The
companies listed below applied to be
registered as importers of various basic
classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
SUPPLEMENTARY INFORMATION:
Company
PerkinElmer, Inc .......
Stepan Company ......
FR docket
84 FR 3246
84 FR 3250
Published
February 11, 2019.
February 11, 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 registrants to import the
applicable basic classes of schedule I
and II 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
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 or schedule II controlled
substances to the above listed
companies.
E:\FR\FM\15MYN1.SGM
15MYN1
Agencies
[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Notices]
[Pages 21811-21812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10019]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Fred J. Powell, M.D.; Decision and Order
On January 25, 2018, the Acting Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause to Fred J. Powell.
(hereinafter, Registrant), of St. Augustine, Florida. Order to Show
Cause (hereinafter, OSC), at 1. The OSC proposes the revocation of
Registrant's Certificate of Registration (hereinafter, COR) on the
ground that he is without authority to handle controlled substances in
Florida, the State in which he is registered with the DEA. Id. at 2.
The OSC cites the operative statutory provisions that spell out the
requirements for registration upon which the DEA alleges that
Registrant is deficient, and the DEA's authority to revoke his
registration. Id., at 1-2 (citing 21 U.S.C. 824(a)(3)).
Jurisdiction
This Agency has jurisdiction to decide this case based upon the OSC
allegation that Registrant holds a DEA COR (No. AP8271138) at the
registered address of 35 Townsend Pl., St. Augustine, FL 32092-3209.
OSC, at 1. That registration authorizes Registrant, as a practitioner,
to dispense controlled substances in schedules II through V and expires
on March 31, 2020. Id.
Substantive Ground for Revocation of COR Alleged in OSC
The substantive ground for the proceeding, as alleged in the OSC,
is that Registrant agreed to a permanent restriction prohibiting him
from prescribing and ordering Schedule I through V controlled
substances and thus is ``currently without authority to handle
controlled substances in the State of Florida,'' the State in which he
is registered with the DEA under DEA COR No. AP8271138. OSC, at 2.
The OSC notified Registrant of his right to request a hearing on
the allegations or to submit a written statement if he chooses to waive
his right to a hearing, the procedures for electing each option, and
the consequences for failing to elect one of those options. Id. (citing
21 CFR 1301.43). The OSC also notified Registrant of the opportunity to
submit a corrective action plan, the specific procedures for filing a
corrective action plan, and the statutory provision that governs such a
plan. Id. at 2-3 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated March 27, 2018, Registrant timely submitted a
corrective action plan (hereinafter, CAP). Request for Final Agency
Action dated April 10, 2018 (hereinafter, RFAA), Exhibit (hereinafter,
Exh.) 5.\1\ Registrant's CAP consists of thirteen paragraphs containing
assertions. The Assistant Administrator of the Diversion Control
Division denied Registrant's CAP by letter dated April 6, 2018. Exh. 6.
---------------------------------------------------------------------------
\1\ Also attached to the RFAA is a ``Declaration'' of a DEA
Diversion Investigator (hereinafter, DI Declaration). Exh. 4.
According to the DI Declaration, two Diversion Investigators
personally served the OSC on Registrant on January 26, 2018.
---------------------------------------------------------------------------
In its RFAA, the Government represents that, ``At least 30 days
have passed since the time the . . . [OSC] was served on Registrant.
Registrant has not requested a hearing.'' RFAA, at 2. The Government
requests the issuance of a ``Final Order revoking Registrant's DEA
registration.'' Id. at 4.
The very existence of the CAP evidences that service of the OSC on
Registrant was adequate. In addition, Registrant did not dispute
service. Based on the Government's written representations and my
review of the record, I find that more than thirty days have now passed
since the date the Government served the OSC. I find that Registrant
timely submitted a CAP and that the Assistant Administrator of the
Diversion Control Division denied Registrant's CAP by letter dated
April 6, 2018. Further, based on the Government's written
representations, I find that neither Registrant, nor anyone purporting
to represent him, requested a hearing or submitted a written statement
while waiving Registrant's right to a hearing. Accordingly, I find that
Registrant has waived his right to a hearing and his right to submit a
written statement. 21 CFR 1301.43(d). 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).
[[Page 21812]]
Findings of Fact
Registrant's DEA Registration
Registrant is the holder of DEA COR No. AP8271138, pursuant to
which he is authorized to dispense controlled substances in schedules
II through V as a practitioner, at the registered address of 35
Townsend Pl., St. Augustine, Florida 32092-3209. Certification of
Registration History (Exh. 1), at 1.
On December 15, 2017, the State of Florida, Board of Medicine
(hereinafter, Florida Board) issued a Final Order approving and
adopting in full the Settlement Agreement that Registrant entered into
on October 3, 2017, with the State of Florida, Department of Health.
Exh. 3, at 68-70. The Florida Board's Final Order, therefore, adopted
each provision of the Settlement Agreement, including Registrant's
voluntary permanent restriction from ``prescribing, ordering, and/or
delegating the prescribing or ordering of, any substances listed in
Schedules I-V, as defined in Section 893.03, Florida Statutes (2016),
and may from time-to-time be redefined in Florida Statutes and/or the
Florida Administrative Code.'' Id. at 63. Thus, Registrant currently
lacks authority to handle controlled substances in the State of
Florida, the State in which he is licensed to practice medicine and
where he is registered with DEA.
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 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., Hooper, supra, 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); Blanton, supra, 43 FR at 27617.
Registrant has voluntarily agreed permanently to stop prescribing
and ordering controlled substances, and to stop delegating the
prescribing or ordering of controlled substances. Exh. 3, at 63. He has
also voluntarily agreed that these permanent restrictions are ``fair,
appropriate and acceptable'' to him.\2\ Id. at 60.
---------------------------------------------------------------------------
\2\ Registrant also agreed to support these permanent
restrictions before the Florida Board. Id. at 65.
---------------------------------------------------------------------------
The CSA has consistently been interpreted to mean that the DEA does
not have statutory authority to maintain a registration if the
registrant is without State authority to handle controlled substances
in the State in which he practices. E.g., Alaaeldin A. Babiker, M.D.,
81 FR 50723, 50725 (2016); Yeates, supra, 71 FR at 39131; Abraham A.
Chaplan, M.D., 57 FR 55280, 55280 (1992). Very simply, because
Registrant is not authorized to handle controlled substances in
Florida, he is not eligible for a DEA registration. As such, I will
order that Registrant's COR be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I order that DEA Certificate of Registration No.
AP8271138 issued to Fred J. Powell, M.D., be, and it hereby is,
revoked. Pursuant to 28 CFR 0.100(b) and the authority vested in me by
21 U.S.C. 823(f), I further order that any pending application of Fred
J. Powell, M.D., to renew or modify this registration (AP8271138), as
well as any other pending application by him for registration in the
State of Florida, be, and it hereby is, denied. This order is effective
June 14 2019.
Dated: April 23, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-10019 Filed 5-14-19; 8:45 am]
BILLING CODE 4410-09-P