Dale Fitzpatrick, M.D.; Decision and Order, 84623-84624 [2024-24570]
Download as PDF
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
(f), 1301.46. RFAA, at 3; see also 21 CFR
1316.67.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Dale Fitzpatrick, M.D.; Decision and
Order
On July 19, 2023, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Dale Fitzpatrick, M.D.,
of Modesto, CA (Registrant). Request for
Final Agency Action (RFAA), Exhibit
(RFAAX) 2, at 1, 3. The OSC proposed
the revocation of Registrant’s Certificate
of Registration No. BF0553455, alleging
that Registrant’s registration should be
revoked because Registrant is ‘‘currently
without authority to prescribe,
administer, dispense, or otherwise
handle controlled substances in the
State of California, the state in which
[he is] registered with DEA.’’ Id. at 2
(citing 21 U.S.C. 824(a)(3)).1
The OSC notified Registrant of his
right to file with DEA a written request
for hearing, and that if he failed to file
such a request, he would be deemed to
have waived his right to a hearing and
be in default. Id. (citing 21 CFR
1301.43). Here, Registrant did not
request a hearing. RFAA, at 2.2 ‘‘A
default, unless excused, shall be
deemed to constitute a waiver of the
[registrant’s] right to a hearing and an
admission of the factual allegations of
the [OSC].’’ 21 CFR 1301.43(e).
Further, ‘‘[i]n the event that a
registrant . . . is deemed to be in
default . . . DEA may then file a request
for final agency action with the
Administrator, along with a record to
support its request. In such
circumstances, the Administrator may
enter a default final order pursuant to
[21 CFR] 1316.67.’’ Id. § 1301.43(f)(1).
Here, the Government has requested
final agency action based on Registrant’s
default pursuant to 21 CFR 1301.43(c),
khammond on DSKJM1Z7X2PROD with NOTICES
1 According
to Agency records, Registrant’s
registration expired on September 30, 2024. The
fact that a registrant allows his registration to expire
during the pendency of an OSC does not impact the
Agency’s jurisdiction or prerogative under the
Controlled Substances Act (CSA) to adjudicate the
OSC to finality. Jeffrey D. Olsen, M.D., 84 FR
68,474, 68,476–79 (2019).
2 Based on the Government’s submissions in its
RFAA dated April 18, 2024, the Agency finds that
service of the OSC on Registrant was adequate. The
included declaration from a DEA Diversion
Investigator (DI) indicates that on August 10, 2023,
the OSC was successfully delivered to Registrant’s
registered address, though an individual who was
not the Registrant signed to confirm the receipt of
the OSC. RFAAX 3, at 2, Attachment A. Further, the
DI’s Declaration indicates that on August 29, 2023,
the OSC was successfully delivered to Registrant’s
home address, however, it was never signed for. Id.
at 2, Attachment B. Finally, the DI’s Declaration
indicates that on December 8, 2023, the OSC was
emailed to Registrant’s registered email address. Id.
at 2, Attachment C.
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18:48 Oct 22, 2024
Jkt 265001
Findings of Fact
The Agency finds that, in light of
Registrant’s default, the factual
allegations in the OSC are admitted.
According to the OSC, effective January
6, 2023, Registrant surrendered his
California physician and surgeon
license. RFAAX 2, at 1. According to
California online records, of which the
Agency takes official notice, Registrant’s
California physician and surgeon
license remains surrendered.3 California
DCA License Search, https://
search.dca.ca.gov (last visited date of
signature of this Order). Accordingly,
the Agency finds that Registrant is not
licensed to practice as a physician in
California, the state in which 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 21 U.S.C. 823 ‘‘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, 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 71,371,
71,372 (2011), pet. for rev. denied, 481
F. App’x 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616,
27,617 (1978).4
3 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 the Agency’s finding by
filing a properly supported motion for
reconsideration of findings of fact within fifteen
calendar days of the date of this Order. Any such
motion and response shall be filed and served by
email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.gov.
4 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
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
84623
According to California statute,
‘‘dispense’’ means ‘‘to deliver a
controlled substance to an ultimate user
or research subject by or pursuant to the
lawful order of a practitioner, including
the prescribing, furnishing, packaging,
labeling, or compounding necessary to
prepare the substance for that delivery.’’
Cal. Health & Safety Code § 11010 (West
2024). Further, a ‘‘practitioner’’ means a
person ‘‘licensed, registered, or
otherwise permitted, to distribute,
dispense, conduct research with respect
to, or administer, a controlled substance
in the course of professional practice or
research in [the] state.’’ Id. § 11026(c).
Here, the undisputed evidence in the
record is that Registrant currently lacks
authority to practice as a physician in
California. As discussed above, an
individual must be a licensed
practitioner to dispense a controlled
substance in California. Thus, because
Registrant currently lacks authority to
practice as a physician in California
and, therefore, is not currently
authorized to handle controlled
substances in California, Registrant is
not eligible to maintain a DEA
registration. Accordingly, the Agency
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. BF0553455 issued to
Dale Fitzpatrick, M.D. Further, pursuant
to 28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications
of Dale Fitzpatrick, M.D., to renew or
modify this registration, as well as any
other pending application of Dale
Fitzpatrick, M.D., for additional
registration in California. This Order is
effective November 22, 2024.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on October 15, 2024, by Administrator
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(g)(1). 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 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, 76 FR at 71,371–72; Sheran Arden
Yeates, D.O., 71 FR 39,130, 39,131 (2006); Dominick
A. Ricci, D.O., 58 FR 51,104, 51,105 (1993); Bobby
Watts, D.O., 53 FR 11,919, 11,920 (1988); Frederick
Marsh Blanton, 43 FR at 27,617.
E:\FR\FM\23OCN1.SGM
23OCN1
84624
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2024–24570 Filed 10–22–24; 8:45 am]
BILLING CODE 4410–09–P
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on October 8, 2024, Mylan
Technologies Inc., 110 Lake Street, Saint
Albans, Vermont 05478–2266, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
DEPARTMENT OF JUSTICE
Drug
code
Controlled substance
Drug Enforcement Administration
Methylphenidate .............
Fentanyl ..........................
[Docket No. DEA–1441]
Importer of Controlled Substances
Application: Mylan Technologies Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Technologies Inc to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
listed below for further drug
information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 22, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 22, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:48 Oct 22, 2024
Jkt 265001
I
1724
9801
Schedule
II
III
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically manufactured FDF to
foreign markets. No other activities for
these drug codes are authorized for this
registration.
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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–24557 Filed 10–22–24; 8:45 am]
BILLING CODE P
listed below for further drug
information.
Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 22, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 22, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on September 11, 2024,
Halo Pharmaceutical Inc., 30 North
Jefferson Road, Whippany, New Jersey
07981–1030, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
DATES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Drug
code
Schedule
7437
I
[Docket No. DEA–1440]
Psilocybin .......................
Importer of Controlled Substances
Application: Halo Pharmaceutical Inc.
The company plans to import the
listed controlled substance to support
formulation development and use in
clinical trials. No other activity for this
drug code is authorized for this
registration.
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).
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Halo Pharmaceutical Inc. to
be registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
SUMMARY:
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
E:\FR\FM\23OCN1.SGM
23OCN1
Agencies
[Federal Register Volume 89, Number 205 (Wednesday, October 23, 2024)]
[Notices]
[Pages 84623-84624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24570]
[[Page 84623]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Dale Fitzpatrick, M.D.; Decision and Order
On July 19, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Dale Fitzpatrick,
M.D., of Modesto, CA (Registrant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 2, at 1, 3. The OSC proposed the revocation of
Registrant's Certificate of Registration No. BF0553455, alleging that
Registrant's registration should be revoked because Registrant is
``currently without authority to prescribe, administer, dispense, or
otherwise handle controlled substances in the State of California, the
state in which [he is] registered with DEA.'' Id. at 2 (citing 21
U.S.C. 824(a)(3)).\1\
---------------------------------------------------------------------------
\1\ According to Agency records, Registrant's registration
expired on September 30, 2024. The fact that a registrant allows his
registration to expire during the pendency of an OSC does not impact
the Agency's jurisdiction or prerogative under the Controlled
Substances Act (CSA) to adjudicate the OSC to finality. Jeffrey D.
Olsen, M.D., 84 FR 68,474, 68,476-79 (2019).
---------------------------------------------------------------------------
The OSC notified Registrant of his right to file with DEA a written
request for hearing, and that if he failed to file such a request, he
would be deemed to have waived his right to a hearing and be in
default. Id. (citing 21 CFR 1301.43). Here, Registrant did not request
a hearing. RFAA, at 2.\2\ ``A default, unless excused, shall be deemed
to constitute a waiver of the [registrant's] right to a hearing and an
admission of the factual allegations of the [OSC].'' 21 CFR 1301.43(e).
---------------------------------------------------------------------------
\2\ Based on the Government's submissions in its RFAA dated
April 18, 2024, the Agency finds that service of the OSC on
Registrant was adequate. The included declaration from a DEA
Diversion Investigator (DI) indicates that on August 10, 2023, the
OSC was successfully delivered to Registrant's registered address,
though an individual who was not the Registrant signed to confirm
the receipt of the OSC. RFAAX 3, at 2, Attachment A. Further, the
DI's Declaration indicates that on August 29, 2023, the OSC was
successfully delivered to Registrant's home address, however, it was
never signed for. Id. at 2, Attachment B. Finally, the DI's
Declaration indicates that on December 8, 2023, the OSC was emailed
to Registrant's registered email address. Id. at 2, Attachment C.
---------------------------------------------------------------------------
Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] 1316.67.'' Id. Sec. 1301.43(f)(1). Here, the
Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), 1301.46. RFAA, at 3; see
also 21 CFR 1316.67.
Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are admitted. According to the OSC,
effective January 6, 2023, Registrant surrendered his California
physician and surgeon license. RFAAX 2, at 1. According to California
online records, of which the Agency takes official notice, Registrant's
California physician and surgeon license remains surrendered.\3\
California DCA License Search, https://search.dca.ca.gov (last visited
date of signature of this Order). Accordingly, the Agency finds that
Registrant is not licensed to practice as a physician in California,
the state in which he is registered with DEA.
---------------------------------------------------------------------------
\3\ 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 the Agency's finding
by filing a properly supported motion for reconsideration of
findings of fact within fifteen calendar days of the date of this
Order. Any such motion and response shall be filed and served by
email to the other party and to Office of the Administrator, Drug
Enforcement Administration at [email protected].
---------------------------------------------------------------------------
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under 21 U.S.C. 823 ``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, 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 71,371, 71,372 (2011), pet. for
rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh Blanton,
M.D., 43 FR 27,616, 27,617 (1978).\4\
---------------------------------------------------------------------------
\4\ 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(g)(1). 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 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, 76 FR at 71,371-72; Sheran
Arden Yeates, D.O., 71 FR 39,130, 39,131 (2006); Dominick A. Ricci,
D.O., 58 FR 51,104, 51,105 (1993); Bobby Watts, D.O., 53 FR 11,919,
11,920 (1988); Frederick Marsh Blanton, 43 FR at 27,617.
---------------------------------------------------------------------------
According to California statute, ``dispense'' means ``to deliver a
controlled substance to an ultimate user or research subject by or
pursuant to the lawful order of a practitioner, including the
prescribing, furnishing, packaging, labeling, or compounding necessary
to prepare the substance for that delivery.'' Cal. Health & Safety Code
Sec. 11010 (West 2024). Further, a ``practitioner'' means a person
``licensed, registered, or otherwise permitted, to distribute,
dispense, conduct research with respect to, or administer, a controlled
substance in the course of professional practice or research in [the]
state.'' Id. Sec. 11026(c).
Here, the undisputed evidence in the record is that Registrant
currently lacks authority to practice as a physician in California. As
discussed above, an individual must be a licensed practitioner to
dispense a controlled substance in California. Thus, because Registrant
currently lacks authority to practice as a physician in California and,
therefore, is not currently authorized to handle controlled substances
in California, Registrant is not eligible to maintain a DEA
registration. Accordingly, the Agency 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.
BF0553455 issued to Dale Fitzpatrick, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Dale Fitzpatrick, M.D., to
renew or modify this registration, as well as any other pending
application of Dale Fitzpatrick, M.D., for additional registration in
California. This Order is effective November 22, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 15, 2024, by Administrator
[[Page 84624]]
Anne Milgram. That document with the original signature and date is
maintained by DEA. For administrative purposes only, and in compliance
with requirements of the Office of the Federal Register, the
undersigned DEA Federal Register Liaison Officer has been authorized to
sign and submit the document in electronic format for publication, as
an official document of DEA. This administrative process in no way
alters the legal effect of this document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-24570 Filed 10-22-24; 8:45 am]
BILLING CODE 4410-09-P