Notice2025-19579
David S. Pecora, P.A.; Decision and Order
Primary source
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Published
October 17, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 199 (Friday, October 17, 2025)</title>
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[Federal Register Volume 90, Number 199 (Friday, October 17, 2025)]
[Notices]
[Pages 48357-48364]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19579]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
David S. Pecora, P.A.; Decision and Order
On August 16, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to David S. Pecora,
P.A., of Bemidji, Minnesota (Applicant). Request for Final Agency
Action (RFAA), Exhibit (RFAAX) 1, at 1, 15. The OSC proposed the denial
of Applicant's application for DEA registration, Control Number
W23054133M, alleging that he materially falsified multiple applications
for registration and that his registration would be inconsistent with
the public interest. Id. at 1 (citing 21 U.S.C. 823(g)(1),
824(a)(1)).\1\
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\1\ The Agency need not adjudicate the criminal violations
alleged in the OSC. See Ruan v. United States, 597 U.S. 450 (2022)
(decided in the context of criminal proceedings).
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On September 30, 2024, the Government submitted a RFAA to the
Administrator requesting that the Agency issue a default final order
denying Applicant's application. RFAA, at 1, 3-4. After carefully
reviewing the entire record and conducting the analysis as set forth in
detail below, the Agency grants the Government's request for final
agency action and denies Applicant's application. As a preliminary
matter, this Decision addresses whether or not Applicant is in default
and finds that he is. Thereafter, this Decision makes specific factual
findings on the alleged violations as set forth in the OSC.
Specifically, this Decision considers whether Applicant submitted a
materially false application and finds that he did. Additionally, this
Decision considers whether Applicant's registration would be
inconsistent with the public interest and finds that it would be.
Lastly, this Decision determines that the appropriate sanction is
denial of Applicant's application.
I. Default Determination
Under 21 CFR 1301.43, a registrant or applicant entitled to a
hearing who fails to file a timely hearing request ``within 30 days
after the date of receipt of the [OSC] . . . shall be deemed to have
waived their right to a hearing and to be in default'' unless ``good
cause'' is established for the failure. 21 CFR 1301.43(a), (c)(1). In
the absence of a demonstration of good cause, a registrant or applicant
who fails to timely file an answer also is ``deemed to have waived
their right to a hearing and to be in default.'' 21 CFR 1301.43(c)(2).
The OSC notified Applicant of his right to file a written request
for a hearing and an answer, and that if he failed to file such a
request and answer, he would be deemed to have waived his right to a
hearing and be in default.\2\ RFAAX 1, at 14 (citing 21 CFR 1301.43).
Here, Applicant did not request a hearing, file an answer, or respond
to the OSC in any way. RFAA, at 1-3. Accordingly, Applicant is in
default. 21 CFR 1301.43(c)(1).
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\2\ Based on the Government's submissions in its RFAA dated
September 30, 2024, the Agency finds that service of the OSC on
Applicant was adequate. Specifically, the Declaration from a DEA
Diversion Investigator (DI) indicates that on August 26, 2024, DI
served the OSC on Applicant in-person and Applicant signed and
initialed each page of the OSC. RFAAX 2, at 1; RFAAX 3. Accordingly,
the Agency finds that due process notice requirements have been
satisfied. Jones v. Flowers, 547 U.S. 220, 226 (2006).
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``A default, unless excused, shall be deemed to constitute a waiver
of the [applicant's] right to a hearing and an admission of the factual
allegations of the [OSC].'' 21 CFR 1301.43(e). Because Applicant is in
default and has not moved to excuse the default, the Agency finds that
Applicant has admitted to the factual allegations in the OSC. 21 CFR
1301.43(c)(1), (e), (f)(1).
Further, ``[i]n the event that [an applicant] . . . 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.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Applicant's
default pursuant to 21 CFR 1301.43(c)(1), (f)(1). RFAA, at 1-3; see
also 21 CFR 1316.67.
II. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Applicant is deemed to have admitted to each of the
following facts.\3\
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\3\ According to the Controlled Substances Act (CSA),
``[f]indings of fact by the [DEA Administrator], if supported by
substantial evidence, shall be conclusive.'' 21 U.S.C. 877. Here,
where Applicant is found to be in default, all the factual
allegations in the OSC are deemed to be admitted. These uncontested
and deemed admitted facts constitute evidence that exceeds the
``substantial evidence'' standard of 21 U.S.C. 877; it is unrebutted
evidence.
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A. Material Falsification
January 2012 Application, Number W12001098M
On January 6, 2012, Applicant submitted an application for DEA
registration, which was assigned control number W12001098M. RFAAX 1, at
9.
The application's Liability Question 3 asked: ``Has the applicant
ever surrendered (for cause) or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or is any such action pending?''
Id.
Applicant answered ``no'' to Liability Question 3. Id. In doing so,
Applicant failed to disclose that: (a) in July 2007, Applicant's West
Virginia registered nursing license, number 53904, was suspended; and
(b) in October 2008, Applicant's Florida registered nursing license,
number RN9221251, was suspended. Id. Applicant's January 2012
application was approved and assigned DEA registration number
MP2562432. Id.
October 2013 Application, Number W13085169M
On October 12, 2013, Applicant submitted an application for DEA
registration, which was assigned control number W13085169M. RFAAX 1, at
9.
The application's Liability Question 3 asked: ``Has the applicant
ever surrendered (for cause) or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or is any such action pending?''
Id.
Applicant answered ``no'' to Liability Question 3. Id. In doing so,
Applicant failed to disclose that: (a) in July 2007, Applicant's West
Virginia registered nursing license, number 53904, was suspended; (b)
in October 2008, Applicant's Florida registered nursing license, number
RN9221251, was suspended; and (c) in July 2012, Applicant's application
for a physician assistant license in North Dakota was denied. Id. at 9-
10. Applicant's October 2013 application was approved and assigned DEA
registration number MP3221417. Id.
[[Page 48358]]
January 2016 Application, Number W16005281M
On January 21, 2016, Applicant submitted an application for DEA
registration, which was assigned control number W16005281M. RFAAX 1, at
10.
The application's Liability Question 2 asked: ``Has the applicant
ever surrendered (for cause) or had a federal controlled substances
registration revoked, suspended, restricted, or denied, or is any such
action pending?'' Id.
Applicant answered ``yes'' to Liability Question 2. Id. In response
to the application's direction to provide the date and location of the
incident that prompted the affirmative answer, Applicant stated:
``January 30, 2015,'' and ``BEMIDJI, MINNESOTA.'' Id.
In response to the application's direction to provide the nature of
the incident, Applicant stated: ``ON 10/01/2014, I MISTAKENLY TOOK
TABLETS OF SOMA.\4\ DURING MY PREVIOUS ABUSE OF SOMA, I HAD PLACED SOME
SOMA TABLETS IN THE SAME CONTAINER AS MY ASPIRIN. ON 10/01/2014, I
DEVELOPED A HEADACHE AND WENT INTO MY BATHROOM WITHOUT TURNING ON THE
LIGHT (AS LIGHT INCREASES MY HEADACHES). I TOOK OUT THE BOTTLE OF
ASPIRIN AND POURED THEM INTO MY HAND. I TOOK TWO TABLETS. THIS WAS AN
UNINTENTIONAL INJECTION OF SOMA.'' Id.
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\4\ Soma is a brand name for carisoprodol. See infra n.7.
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In response to the application's direction to provide the result of
the incident, Applicant stated: ``I WAS BEING MOUNTED BY MINNESOTA
HEALTH PROFESSIONALS SERVICES PROGRAM. I DID A UA THE NEXT DAY. IT WAS
POSITIVE FOR SOMA. AFTER AN INVESTIGATION BY MINNESOTA BOARD OF MEDICAL
PRACTICE, THEY DETERMINED TREATMENT WAS NOT NECESSARY. FLORIDA
PROFESSIONALS RESOURCE NETWORK BEGAN MONITORING ME (I ALSO HAVE A
FLORIDA PA LICENSE). FLORIDA DID MANDATE TREATMENT. I WENT TO HAZELDEN
BETTY FORD IN CENTER CITY, MN. I WAS THERE FOR 60 DAYS OF IN-PATIENT
TREATMENT IN THE HEALTH CARE PROFESSIONALS SEC.'' Id.
These descriptions most closely resemble circumstances relating to
DEA registration number MP3221417, which Applicant surrendered for
cause on January 30, 2015. Id.
The application's Liability Question 3 asked: ``Has the applicant
ever surrendered (for cause) or had a state professional license or
controlled substance registration revoked, suspended, denied,
restricted, or placed on probation, or is any such action pending?''
Id. at 11.
Applicant answered ``yes'' to Liability Question 3. Id. In response
to the application's direction to provide the date and location of the
incident that prompted the affirmative answer, Applicant stated:
``September 15, 2013,'' and ``MINNEAPOLIS, MN.'' Id.
In response to the application's direction to provide the nature of
the incident, Applicant stated: ``SOMETIME DURING THE FALL OF 2013, AND
AFTER I COMPLETED 90-DAYS OF IN-PATIENT TREATMENT AT TALBOTT RECOVERY
CAMPUS, I MEET WITH JACK HENDERSON & ANDY BIRD WITH THE MINNESOTA DEA
AND SURRENDERED MY DEA LICENSE.'' Id.
In response to the application's direction to provide the result of
the incident, Applicant stated: ``MY DEA LICENSE WAS RE-ISSUED TO ME
ABOUT A YEAR LATER.'' Id.
These descriptions most closely resemble circumstances relating to
DEA registration number MP2562432, which Applicant surrendered for
cause on June 4, 2013, and not any state professional license or state
controlled substance registration. Id.
While Applicant made some disclosures in response to Liability
Question 3, Applicant failed to disclose that: (a) in July 2007,
Applicant's West Virginia registered nursing license, number 53904, was
suspended; (b) in October 2008, Applicant's Florida registered nursing
license, number RN9221251, was suspended; (c) in July 2012, Applicant's
application for a physician assistant license in North Dakota was
denied; (d) in January 2014, Applicant's Minnesota physician assistant
license, number 10593, was suspended and the suspension was stayed; (e)
in November 2014, Applicant's Minnesota physician assistant license,
number 10593, was suspended; (f) in January 2015, Applicant's Minnesota
physician assistant license, number 10593, was indefinitely suspended;
and (g) in November 2015, Applicant's Minnesota physician assistant
license, number 10593, was reinstated, suspended, and the suspension
was stayed. Id. Applicant's January 2016 application was approved and
assigned DEA registration number MP4140478. Id.
Renewal Application of DEA Registration, Number MP4140478
On February 11, 2020, Applicant submitted an application to renew
DEA registration number MP4140478. RFAAX 1, at 12. The application's
Liability Question 3 asked: ``Has the applicant ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on
probation, or is any such action pending?'' Id. Applicant answered
``yes'' to Liability Question 3. Id.
In response to the application's direction to provide the date and
location of the incident that prompted the affirmative answer,
Applicant stated: ``February 11, 2020,'' and ``NOTHING NEW TO REPORT.''
Id. In response to the application's direction to provide the nature of
the incident, Applicant stated: ``NOTHING NEW TO REPORT SINCE LAST
REGISTRATION.'' Id. In response to the application's direction to
provide the result of the incident, Applicant stated: ``NOTHING NEW TO
REPORT.'' Id.
Applicant's follow-up responses to Liability Question 3 were false
because Applicant again failed to disclose the incidents in West
Virginia, Florida, North Dakota, and Minnesota that made his
application, number W16005281M, false. Id. Applicant's February 2020
renewal application for registration number MP4140478 was approved. Id.
May 2023 Application, Number W23054133M
On May 2, 2023, Applicant submitted an application for DEA
registration, which was assigned control number W23054133M. RFAAX 1, at
12.
The application's Liability Question 2 asked: ``Has the applicant
ever surrendered (for cause) or had a federal controlled substances
registration revoked, suspended, restricted, or denied, or is any such
action pending?'' Id. Applicant answered ``yes'' to Liability Question
2. Id. In response to the application's direction to provide the date
and location of the incident that prompted the affirmative answer,
Applicant stated: ``February 10, 2022,'' and ``MINNESOTA.'' Id.
In response to the application's direction to provide the nature of
the incident, Applicant stated: ``MY MN PHYSICIAN ASSISTANT LICENSE WAS
SUSPENDED DUE TO MY DIVERSION OF PROPOFOL FOR SELF USE. I THEN HAD TO
SURRENDER MY MN DEA REGISTRATION DUE TO MY MN PHYSICIAN ASSISTANT
LICENSE BEING SUSPENDED.'' \5\ Id. In response to the application's
direction to provide the result of the incident, Applicant
[[Page 48359]]
stated: ``I SURRENDERED MY MN DEA REGISTRATION.'' Id.
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\5\ Propofol is a Schedule IV depressant. 21 CFR 1308.14(c)(27);
RFAAX 1, at 8.
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These descriptions most closely resemble circumstances relating to
DEA registration number MP4140478, which Applicant surrendered for
cause on November 16, 2021. Id.
Though Applicant made some disclosures, he failed to disclose that
he surrendered two additional DEA registrations. Specifically, he
failed to disclose that on June 4, 2013, he surrendered for cause DEA
registration number MP2562432, and on January 30, 2015, he surrendered
for cause DEA registration number MP3221417. Id. at 13.
Liability Question 3 asked: ``Has the applicant ever surrendered
(for cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on
probation, or is any such action pending?'' Id. Applicant answered
``yes'' to Liability Question 3. Id. In response to the application's
direction to provide the date and location, Applicant stated: ``May 1,
2021,'' and ``MINNESOTA.'' Id.
In response to the application's direction to provide the nature of
the incident, Applicant stated: ``I DIVERTED PROPOFOL FOR SELF-USE IN
AUGUST OF 2020 IN THE COUNTRY OF CURACAO WHILE ON A COVID-19 RAPID
RESPONSE TEAM. I SELF-REPORTED THIS DIVERSION TO THE MINNESOTA HEALTH
PROFESSIONALS SERVICES PROGRAM.'' Id.
In response to the application's direction to provide the result of
the incident, Applicant stated: ``MY MINNESOTA PHYSICIAN ASSISTANT
LICENSE WAS SUSPENDED.'' Id. These descriptions most closely resemble
circumstances relating to the indefinite suspension of Applicant's
Minnesota physician assistant license, number 10593, on September 11,
2021. Id.
Again, Applicant failed to disclose the incidents in West Virginia,
Florida, North Dakota, and Minnesota that made his application, number
W16005281M, and his renewal application of registration number
MP4140478, false. Id. at 13-14. Additionally, Applicant failed to
disclose that on March 11, 2023, Applicant's Minnesota physician
assistant license, number 10593, was suspended and the suspension was
stayed. Id. at 14.
B. Public Interest
Applicant is deemed to have admitted that in 2007, he was addicted
to zolpidem \6\ and underwent treatment at a chemical addiction
recovery program for sedative-hypnotic addiction. RFAAX 1, at 4.
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\6\ Zolpidem is a Schedule IV depressant. 21 CFR 1308.14(c)(58);
RFAAX 1, at 4.
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In 2013, Applicant was abusing carisoprodol \7\ and was being
monitored by the Florida Professionals Resource Network. Id. at 6. In
April 2013, Applicant wrote a prescription for a volleyball teammate
for 90 tablets of carisoprodol that authorized refills, and in
exchange, Applicant's volleyball teammate promised to fill the
prescription and provide Applicant with 30 carisoprodol tablets. Id.
Applicant's volleyball teammate supplied Applicant with 30 of the
carisoprodol tablets, which Applicant consumed. Id.
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\7\ Carisoprodol is a Schedule IV depressant. 21 CFR
1308.14(c)(7); RFAAX 1, at 6.
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Approximately one month later, Applicant wrote another prescription
for a different volleyball teammate for 90 tablets of carisoprodol that
authorized refills, and in exchange, Applicant's second volleyball
teammate promised to fill the prescription and provide Applicant with
30 carisoprodol tablets. Id. Applicant's second volleyball teammate
supplied Applicant with 30 of the carisoprodol tablets, which Applicant
consumed. Id.
In the summer of 2013, Applicant ordered carisoprodol tablets
through the internet not for a legitimate medical purpose and not
within the usual course of Applicant's professional practice. Id. The
carisoprodol tablets were delivered to Applicant while he was a patient
at a chemical addiction recovery program, which he attended from June
2013 to August 2013. Id.
On October 8, 2014, and October 20, 2014, Applicant tested positive
for carisoprodol on two separate toxicology screens, when he did not
have a prescription for carisoprodol. Id. at 7.
In November 2015, Applicant consented to a stipulation and order
issued by the Minnesota Board of Medical Practice after Applicant
demonstrated completion of in-patient chemical dependency treatment,
regular attendance at self-help program meetings, and random drug
testing administered by the Florida Professionals Resource Network. Id.
The stipulation and order required Applicant to demonstrate three years
of uninterrupted recovery from substance abuse. Id.
In November 2020, Applicant stole propofol from an operating room
for his own personal use. Id. at 8.
In September 2021, Applicant was subject to a stipulation and order
issued by the Minnesota Board of Medical Practice that required
Applicant to demonstrate six months of uninterrupted recovery from
substance abuse, negative results on twelve random toxicology screens
per quarter, regular attendance at self-help meetings in support of
recovery, completion of a neuropsychological evaluation, and
certification from medical professionals that Applicant was competent
to safely resume practice. Id.
III. Discussion
A. Material Falsification
A DEA registration may be denied, suspended, or revoked upon a
finding that the applicant or registrant materially falsified any
application filed pursuant to or required by the Controlled Substances
Act (CSA). 21 U.S.C. 824(a)(1).\8\ To present a prima facie case for
material falsification, the Government's record evidence must show (1)
the submission of an application, (2) containing a false statement and/
or omitting information that the application requires, (3) when the
submitter knew or should have known that the statement is false and/or
that the omitted information existed and the application required its
disclosure, and (4) the false statement and/or required but omitted
information is material, that is, it ``connect[s] to at least one of
[the section 823] factors that, according to the CSA, [the
Administrator] `shall' consider'' when analyzing ``whether issuing a
registration `would be inconsistent with the public interest.' '' Frank
Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21 U.S.C. 823
and Kungys, 485 U.S. at 771). The Government must establish material
falsification with record evidence that is clear, unequivocal, and
convincing. Kungys, 485 U.S. at 772; Stirlacci, 85 FR at 45230-39.
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\8\ A statutory basis to deny an application pursuant to section
823 is also a basis to revoke or suspend a registration pursuant to
section 824, and vice versa, because doing ``otherwise would mean
that all applications would have to be granted only to be revoked
the next day . . . .'' Robert Wayne Locklear, M.D., 86 FR 33738,
33744-45 (2021) (collecting cases).
The Supreme Court's decision in Kungys v. United States, 485
U.S. 759 (1988), and its progeny, guide the Agency's implementation
of these CSA provisions.
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First, the Government must prove that the applicant or registrant
submitted an application for registration pursuant to the CSA. 21
U.S.C. 824(a)(1); see also 21 U.S.C. 822 (persons required to
register); 21 U.S.C. 823(g)(1) (registration requirements).
Second, the Government must prove that the application contained a
false
[[Page 48360]]
statement or omitted information that the application required, either
of which may constitute a material falsity. See, e.g., Emed Medical
Company LLC and Med Assist Pharmacy, 88 FR 21719, 21720 (2023)
(applicant falsely answered ``no'' to Liability Question 3 on seventeen
applications when the true answer was ``yes''); Richard J. Settles,
D.O., 81 FR 64940, 64945-46 (2016) (applicant failed to disclose an
interim consent agreement restricting his license based on findings
that he issued controlled substance prescriptions without federal or
state legal authority to do so). In making this assessment, the Agency
will examine the entire application, including registrant's ``yes/no''
answers to the liability questions and any follow-up response(s).
Daniel A. Glick, D.D.S., 80 FR 74800, 74802, 74808-09 (2015). To
establish an omission, the Government must show both that omitted
information existed and that the application required inclusion of that
information. See, e.g., Richard A. Herbert, M.D., 76 FR 53942, 53956
(2011) (omission of a probation which the application required to be
identified); Michel P. Toret, M.D., 82 FR 60041, 60042 (2017)
(Voluntary Surrender Form alone is insufficient evidence to find
material falsification based on registrant's ``no'' answer to the
question regarding ``surrender[s] (for cause)'').
Third, the Government must prove that the applicant or registrant
knew or should have known that the statement is false and/or that the
omitted information existed and the application required its
disclosure. See John J. Cienki, M.D., 63 FR 52293, 52295 (1998) (``[I]n
finding that there has been a material falsification of an application,
it must be determined that the applicant knew or should have known that
the response given to the liability question was false.''); Samuel
Arnold, D.D.S., 63 FR 8687, 8688 (1998) (``It is also undisputed that
Respondent knew that his Ohio dental license had previously been
suspended.''); Bobby Watts, M.D., 58 FR 46995, 46995 (1993)
(``Respondent knew that the Tennessee Board of Medical Examiners had
suspended his medical license on May 7, 1987, and had placed his state
medical license on probation on May 2, 1988.''); see also Stirlacci, 85
FR at 45236-37 & nn.22-23 (collecting cases).
Fourth, the Government must prove that the false statement and/or
required but omitted information is ``material.'' Kungys holds that a
statement is material if it is ``predictably capable of affecting,
i.e., had a natural tendency to affect, the [Agency's] official
decision,'' or stated differently, ``had a natural tendency to
influence the decision.'' Kungys, 485 U.S. at 771-72. As already
discussed, materiality, for the purposes of the CSA, is tied to the
factors that the Administrator ``shall'' consider when determining
whether issuance of a registration ``would be inconsistent with the
public interest.'' 21 U.S.C. 823; Kungys, 485 U.S. at 771-72;
Stirlacci, 85 FR at 45234, 45238.
The Government has the burden of proof in this proceeding, and the
Agency must make its findings based on clear, unequivocal, and
convincing record evidence. 21 CFR 1301.44(d); Kungys, 485 U.S. at 772;
Stirlacci, 85 FR at 45230-39. Here, the Agency finds that the
Government's record evidence presents a prima facie case that Applicant
submitted five materially false applications. 21 U.S.C. 824(a)(1).
January 2012 Application, Number W12001098M
The Agency finds the following facts based on clear, unequivocal,
and convincing record evidence. On January 6, 2012, Applicant submitted
an application for DEA registration, which was assigned control number
W12001098M. RFAAX 1, at 9. Liability Question 3 asked whether Applicant
had ever had any adverse action against a state professional license,
to include revocation, suspension, probation, or denial. Id. Applicant
falsely answered ``no.'' Id. Applicant's ``no'' answer to Liability
Question 3 was false because he knew or should have known that
information existed that the application required to be disclosed in
response to Liability Question 3. Id. Specifically, Applicant knew or
should have known that in July 2007 his West Virginia nursing license
was suspended and that in October 2008 his Florida nursing license was
suspended. Id.
Additionally, Applicant's false answer was material. The CSA
provides that suspension of a state license is one basis by which the
Attorney General may suspend or revoke a DEA registration, and
therefore, it is a relevant statutory factor for determining whether
issuance or maintenance of a registration is inconsistent with the
CSA.\9\ 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical Company LLC and
Med Assist Pharmacy, 88 FR at 21720. Thus, whether an applicant has had
a state license suspended is a relevant factor DEA must consider when
reviewing an application, and failure to disclose such information has
``a natural tendency to influence the [Agency's] decision.'' Kungys,
485 U.S. at 771-72.
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\9\ Because the bases for revocation listed in 21 U.S.C. 824 may
also serve as bases to deny an application, see supra n.8, a finding
of materiality may also be tied to 21 U.S.C. 824(a)(1)-(5).
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Accordingly, the falsity in Applicant's January 2012 application
directly affected the statutory analysis that DEA was required to make
when it reviewed his application. 21 U.S.C. 823(g)(1), 824(a)(3). Thus,
the falsity was material because it was ``predictably capable of
affecting . . . [DEA's] official decision'' regarding whether Applicant
met ``the requirements for'' registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence that Applicant's January 6, 2012 application for DEA
registration, control number W12001098M, was materially false. 21
U.S.C. 824(a)(1); RFAAX 1, at 9.
October 2013 Application, Number W13085169M
The Agency finds the following based on clear, unequivocal, and
convincing record evidence. On October 12, 2013, Applicant submitted an
application for DEA registration, which was assigned control number
W13085169M. RFAAX 1, at 9. Liability Question 3 asked whether Applicant
had ever had any adverse action against a state professional license,
to include revocation, suspension, probation, or denial. Id. Applicant
falsely answered ``no.'' Id. Applicant's ``no'' answer to Liability
Question 3 was false because he knew or should have known that
information existed that the application required to be disclosed in
response to Liability Question 3. Id.
Specifically, Applicant knew or should have known that in July 2007
his West Virginia nursing license was suspended, in October 2008 his
Florida nursing license was suspended, and in 2012 his application for
a physician assistant license was denied in North Dakota. Id. at 9-10.
Additionally, Applicant's false answer was material. The CSA
provides that suspension or lack of a state license is one basis by
which the Attorney General may suspend, revoke, or deny a DEA
registration, and therefore, it is a relevant statutory factor for
determining whether issuance or maintenance of a registration is
inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical
Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an
applicant has had a state license suspended or denied is a relevant
factor DEA must consider when reviewing an application, and failure to
disclose such information has ``a natural tendency to influence the
[Agency's] decision.'' Kungys, 485 U.S. at 771-72.
[[Page 48361]]
Accordingly, the falsity in Applicant's October 2013 application
directly affected the statutory analysis that DEA was required to make
when it reviewed his application. 21 U.S.C. 823(g)(1), 824(a)(3). Thus,
the falsity was material because it was ``predictably capable of
affecting . . . [DEA's] official decision'' regarding whether Applicant
met ``the requirements for'' registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence that Applicant's October 12, 2013 application for DEA
registration, control number W13085169M, was materially false. 21
U.S.C. 824(a)(1); RFAAX 1, at 9-10.
January 2016 Application, Number W16005281M
The Agency finds the following based on clear, unequivocal, and
convincing record evidence. On January 21, 2016, Applicant submitted an
application for DEA registration, which was assigned control number
W16005281M. RFAAX 1, at 10. Liability Question 2 asked, in part,
whether Applicant has ever surrendered for cause a federal controlled
substances registration. Id. Liability Question 3 asked whether
Applicant had ever had any adverse action against a state professional
license, to include revocation, suspension, probation, or denial. Id.
at 11. Applicant answered ``yes'' to Liability Questions 2 and 3 and
provided additional information to the follow-up prompts regarding
date, location, nature, and result. Id. at 10-11.
Despite truthfully answering ``yes,'' Applicant failed to disclose
all the required information in response to Liability Question 3.
Specifically, Applicant's follow-up responses failed to disclose that
in July 2007 his West Virginia nursing license was suspended; in
October 2008 his Florida nursing license was suspended; in 2012 his
application for a physician assistant license was denied in North
Dakota; and in January 2014, November 2014, January 2015, and November
2015, his Minnesota physician assistant license was suspended. Id.
Accordingly, Applicant's response to Liability Question 3 was false
because he knew or should have known information existed that the
application clearly required be disclosed in response to Liability
Question 3.\10\ Id.
---------------------------------------------------------------------------
\10\ In response to Liability Question 2, Applicant noted that
the Minnesota Board of Medical Practice investigated him after a
positive urinalysis but determined that ``treatment was not
necessary.'' RFAAX 1, at 10. Applicant also noted that the Florida
Professionals Resource Network ``began monitoring [him]'' and
``mandate[d] treatment.'' Id. Although these responses indicate that
he was investigated in Minnesota and monitored and required to
undergo treatment in Florida, they fail to disclose, as Liability
Question 3 required, that his nursing license was suspended in
Florida in 2008 and his physician assistant license was suspended in
Minnesota in 2014 and 2015. Id.
---------------------------------------------------------------------------
Additionally, Applicant's false answer was material. The CSA
provides that suspension or lack of a state license is one basis by
which the Attorney General may suspend, revoke, or deny a DEA
registration, and therefore, it is a relevant statutory factor for
determining whether issuance or maintenance of a registration is
inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical
Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an
applicant has had a state license suspended or denied is a relevant
factor DEA must consider when reviewing an application, and failure to
disclose such information has ``a natural tendency to influence the
[Agency's] decision.'' Kungys, 485 U.S. at 771-72.
Accordingly, the falsity in Applicant's January 2016 application
directly affected the statutory analysis that DEA was required to make
when it reviewed his application. 21 U.S.C. 823(g)(1), 824(a)(3). Thus,
the falsity was material because it was ``predictably capable of
affecting . . . [DEA's] official decision'' regarding whether Applicant
met ``the requirements for'' registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence that Applicant's January 21, 2016 application for DEA
registration, control number W16005281M, was materially false. 21
U.S.C. 824(a)(1); RFAAX 1, at 10-11.
February 2020 Renewal Application, Registration Number MP4140478
The Agency finds the following based on clear, unequivocal, and
convincing record evidence. On February 11, 2020, Applicant submitted
an application to renew DEA registration number MP4140478. RFAAX 1, at
12. Liability Question 3 asked whether Applicant had ever had any
adverse action against a state professional license, to include
revocation, suspension, probation, or denial. Id. Applicant answered
``yes.'' Id.
Despite truthfully answering ``yes,'' Applicant failed to disclose
all the required information in response to Liability Question 3. In
response to the application's request for the date of the incident that
prompted the ``yes'' answer, Applicant stated, ``February 11, 2020,''
the date he submitted the application. Id. In response to the
application's request for the location, nature, and result of the
incident, Applicant stated: ``NOTHING NEW TO REPORT.'' Id. Applicant's
response to Liability Question 3 was false because he continued to fail
to disclose the incidents that made his January 21, 2016 application,
control number W16005281M, false. Id. Specifically, Applicant failed to
disclose that in July 2007 his West Virginia nursing license was
suspended; in October 2008 his Florida nursing license was suspended;
in 2012 his application for a physician assistant license was denied in
North Dakota; and in January 2014, November 2014, January 2015, and
November 2015, his Minnesota physician assistant license was suspended.
Id. at 11-12. Accordingly, Applicant's response to Liability Question 3
was false because he knew or should have known information existed that
the application required be disclosed in response to Liability Question
3. Id.
Additionally, Applicant's false answer was material. The CSA
provides that suspension or lack of a state license is one basis by
which the Attorney General may suspend, revoke, or deny a DEA
registration, and therefore, it is a relevant statutory factor for
determining whether issuance or maintenance of a registration is
inconsistent with the CSA. 21 U.S.C. 823(g)(1), 824(a)(3); Emed Medical
Company LLC and Med Assist Pharmacy, 88 FR at 21720. Thus, whether an
applicant has had a state license suspended or denied is a relevant
factor DEA must consider when reviewing an application, and failure to
disclose such information has ``a natural tendency to influence the
[Agency's] decision.'' Kungys, 485 U.S. at 771-72.
Accordingly, the falsity directly affected the statutory analysis
that DEA was required to make when it reviewed Applicant's application.
21 U.S.C. 823(g)(1), 824(a)(3). Further, the falsity was material
because it was ``predictably capable of affecting . . . [DEA's]
official decision'' regarding whether Applicant met ``the requirements
for'' registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence that Applicant's February 11, 2020 application to renew DEA
registration number MP4140478 was materially false. 21 U.S.C.
824(a)(1); RFAAX 1, at 12.
May 2023 Application, Number W23054133M
On May 2, 2023, Applicant submitted an application for DEA
registration, which was assigned control number W23054133M. RFAAX 1, at
12. Liability Question 2 asked, in part, whether
[[Page 48362]]
Applicant has ever surrendered for cause a federal controlled
substances registration. Id. Applicant answered ``yes.'' Id. In
response to the application's follow-up prompts, Applicant provided a
date, location, and description of events that most closely resembled
circumstances relating to the surrender of DEA registration number
MP4140478 in November 2021 in Minnesota. Id. at 4, 12.
Applicant, however, failed to disclose that he had previously
surrendered two other DEA registrations in Minnesota. Specifically, he
failed to disclose that on June 4, 2013, he surrendered for cause DEA
registration number MP2562432, and on January 30, 2015, he surrendered
for cause DEA registration number MP3221417. Id. at 3, 12-13. Although
Applicant indicated that he ``SURRENDERED [HIS] MN DEA REGISTRATION,''
the information he provided on the application related to the surrender
of only one Minnesota DEA registration, when, in fact, he previously
held two additional DEA registrations that he also surrendered. Id. at
12-13. Accordingly, Applicant's response to Liability Question 2 was
false because he knew or should have known information existed that the
application required be disclosed in response to Liability Question 2.
Id.
Liability Question 3 asked whether Applicant had ever had any
adverse action against a state professional license, to include
revocation, suspension, probation, or denial. Id. at 13. Applicant
answered ``yes.'' Id. In response to the application's follow-up
prompts, Applicant disclosed information that most closely resembled
circumstances relating to the suspension of his Minnesota physician
assistant license in September 2021. Id.
Applicant, however, failed to disclose additional adverse actions
against state licenses that he knew or should have known were required
to be disclosed in response to Liability Question 3. Specifically, he
failed to disclose that in 2007 his nursing license was suspended in
West Virginia; in 2008 his nursing license was suspended in Florida; in
2012 his application for a physician assistant license was denied in
North Dakota; and in January 2014, November 2014, January 2015,
November 2015, and March 2023, his physician assistant license was
suspended in Minnesota. Id. at 13-14. Although Applicant disclosed one
suspension of his physician assistant license in Minnesota in 2021, he
failed to disclose suspensions of his Minnesota physician assistant
license in 2014, 2015, and 2023. Id. Accordingly, Applicant's response
to Liability Question 3 was false because he knew or should have known
information existed that the application required be disclosed in
response to Liability Question 3. Id.
Additionally, Applicant's false answers to Liability Questions 2
and 3 were material. The CSA provides that suspension or lack of a
state license is one basis by which the Attorney General may suspend,
revoke, or deny a DEA registration, and therefore, it is a relevant
statutory factor for determining whether issuance or maintenance of a
registration is inconsistent with the CSA. 21 U.S.C. 823(g)(1),
824(a)(3); Emed Medical Company LLC and Med Assist Pharmacy, 88 FR at
21720. Furthermore, a surrender for cause of a DEA registration
implicates an applicant's or registrant's experience handling
controlled substances and non-compliance with controlled substances
laws, which are relevant considerations under Public Interest Factors B
and D. 21 U.S.C. 823(g)(1). Thus, whether an applicant has had a state
license suspended, an application for licensure denied, and/or has
surrendered a previous DEA registration are all relevant factors DEA
must consider when reviewing an application, and failure to disclose
such information has ``a natural tendency to influence the [Agency's]
decision.'' Kungys, 485 U.S. at 771-72.
Accordingly, the falsities directly affected the statutory analysis
that DEA was required to make when it reviewed Applicant's application.
21 U.S.C. 823(g)(1), 824(a)(3). Further, the falsities were material
because they were ``predictably capable of affecting . . . [DEA's]
official decision'' regarding whether Applicant met ``the requirements
for'' registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence that Applicant's May 2, 2023 application for DEA registration,
control number W23054133M, was materially false. 21 U.S.C. 824(a)(1);
RFAAX 1, at 12-13.
Further, although the instant OSC concerns whether Applicant's May
2023 application should be granted, the Agency's decision to deny this
application may also be based on the material falsification of
Applicant's January 2012, October 2013, January 2016, and February 2020
applications, because 21 U.S.C. 824(a)(1) provides that a registration
may be revoked or denied based on the material falsification of ``any
application filed pursuant to or required by'' the CSA. RFAAX 1, at 9-
12.
B. Public Interest
Congress enacted the CSA ``to conquer drug abuse and control the
legitimate and illegitimate traffic in controlled substances.''
Gonzales v. Raich, 545 U.S. 1, 12 (2005). A particular concern of
Congress was ``the need to prevent the diversion of drugs from
legitimate to illicit channels,'' and it ``devised a closed regulatory
system making it unlawful to manufacture, distribute, dispense, or
possess any controlled substance except in a manner authorized by the
CSA.'' Id. at 12-13. To protect the American people and ensure
compliance with the CSA, Congress empowered the Agency \11\ to deny,
suspend, or revoke a registration if it would be inconsistent with the
public interest. 21 U.S.C. 823(g)(1); 21 U.S.C. 824(a)(4); Gonzales v.
Oregon, 546 U.S. 243, 251 (2006).
---------------------------------------------------------------------------
\11\ The CSA grants this authority to the Attorney General, who
has delegated it to the Administrator of DEA (the Agency). 28 CFR
0.100.
---------------------------------------------------------------------------
In determining whether Applicant's proposed registration is
inconsistent with the public interest, the Agency analyzes five
statutorily established ``public interest factors.'' Gonzales v.
Oregon, 546 U.S. at 251; 21 U.S.C. 823(g)(1)(A)-(E). The five factors
are:
(A) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(B) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(C) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1)(A)-(E).
These five public interest factors are considered in the
disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93; Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-
case basis. David H. Gillis, M.D., 58 FR 37507, 37508 (1993). Any one
factor, or combination of factors, may be decisive, Gillis, 58 FR at
37508, and the Agency ``may give each factor the weight . . . deem[ed]
appropriate in determining whether a registration should be revoked or
an application for registration denied.'' Morall v. Drug Enf't Admin.,
412 F.3d 165, 185 n.2 (D.C. Cir. 2005) (Henderson, J., concurring)
(quoting Robert A. Smith, M.D., 70 FR 33207, 33208 (2007)); see also
Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007).
[[Page 48363]]
While the Agency is required to consider each of the factors, it
``need not make explicit findings as to each one.'' MacKay v. Drug
Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. U.
S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009)); Jones Total
Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th
Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir.
2005). ``In short, . . . the Agency is not required to mechanically
count up the factors and determine how many favor the Government and
how many favor the registrant. Rather, it is an inquiry which focuses
on protecting the public interest; what matters is the seriousness of
the registrant's misconduct.'' Jayam Krishna-Iyer, M.D., 74 FR 459, 462
(2009). Accordingly, as the Eleventh Circuit has recognized, Agency
decisions have explained that findings under a single factor can
support the denial of an application for registration. Jones Total
Health Care Pharmacy, 881 F.3d at 830; Pharmacy Doctor Enterprises,
Inc. v. Drug Enf't Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019).
In this matter, the Government's evidence is confined to Factors B,
D, and E. RFAA, at 4; RFAAX 1, at 4. Evidence is considered under
Factors B and D when it reflects experience dispensing controlled
substances and compliance or non-compliance with laws related to
controlled substances. Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022).
Evidence is considered under Factor E when it constitutes ``[s]uch
other conduct which may threaten the public health and safety.'' 21
U.S.C. 823(g)(1)(E). To determine whether Applicant's registration is
in the public interest, the Agency will evaluate the Government's
allegations that Applicant has diverted controlled substances by
issuing illegitimate prescriptions for the purpose of obtaining pills
for personal use and that Applicant has a lengthy history of abusing
controlled substances.\12\
---------------------------------------------------------------------------
\12\ Due to the numerous and egregious public interest
violations established in excess of substantial record evidence, the
Agency need not address the remaining public interest violations
alleged in the OSC.
---------------------------------------------------------------------------
The Government has the burden of proof in this proceeding and the
Agency must make its public interest findings based on substantial
record evidence. 5 U.S.C. 556(d); 5 U.S.C. 706(2)(E); 21 U.S.C. 877; 21
CFR 1301.44(d). If the Government meets its burden of establishing a
prima facie case that granting Applicant's registration application is
not in the public interest, then the burden shifts to Applicant to
rebut the Government's case. Pharmacy Doctor Enterprises, 789 Fed.
Appx. at 729 (citing Jones Total Health Care Pharmacy, 881 F.3d at
830). Here, the Agency finds that the Government's record evidence
presents a prima facie case that Applicant's registration would be
inconsistent with the public interest. 21 U.S.C. 824(a)(4).
Public Interest Factors B and D: Diversion
A lawful controlled substance order or prescription is one that is
``issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice.'' 21 CFR
1306.04(a); RFAAX 1, at 2. Therefore, ``a physician who engages in the
unauthorized practice of medicine is not a practitioner acting in the
usual course of professional practice.'' United Prescription Servs.,
Inc., 72 FR 50397, 50407 (2007).
Further, a registrant acts outside the usual course of professional
practice and in a manner inconsistent with the public interest when he
or she issues controlled substance prescriptions to individuals for the
purpose of receiving some of the pills in return. See Michael E. Smith,
D.V.M., 87 FR 4944, 4950-51 (2022) (finding registrant violated 21 CFR
1306.04(a) and his registration was inconsistent with the public
interest where he issued fraudulent prescriptions for controlled
substances in order to obtain the drugs for personal use); Roger A.
Pellmann, M.D., 76 FR 17704, 17709 (2011) (registrant violated federal
law by obtaining controlled substances for ``office use,'' when he, in
fact, was diverting the drugs to another individual and himself);
Steven B. Brown, M.D., 75 FR 65660, 65662 (2010) (finding registrant
violated 21 CFR 1306.04(a) by issuing controlled substance
prescriptions in exchange for the individual to provide the registrant
with half of the pills); Randall Relyea, D.O., 73 FR 40378, 40380
(2008) (finding registrant's registration to be inconsistent with the
public interest where he issued controlled substance prescriptions to
individuals with no medical need and instructed them to give the drugs
to him).
Here, Applicant admits that around April and May 2013, he issued
two prescriptions for carisoprodol in order to obtain some of the pills
for personal use. RFAAX 1, at 6. Accordingly, the undisputed record
evidence establishes, and the Agency finds, that Applicant has issued
controlled substance prescriptions outside the usual course of
professional practice and not for legitimate medical purposes in
violation of 21 CFR 1306.04(a). See also Smith, 87 FR at 4950-51;
Pellmann, 76 FR at 17709; Brown, 75 FR at 65662; Relyea, 73 FR at
40380.
Further, the Agency finds that this misconduct reflects poorly on
Applicant's experience handling controlled substances and demonstrates
non-compliance with Federal law governing controlled substances. 21
U.S.C. 823(g)(1)(B), (D). Accordingly, the Agency finds substantial
record evidence that Applicant's registration would be inconsistent
with the public interest. 21 U.S.C. 824(a)(4).
Public Interest Factor E: Substance Abuse
Past DEA decisions have consistently held that ``registrants who
self-abuse controlled substances may endanger public health and
safety,'' and that such misconduct may be considered under Factor E.
See Brewster Drug, Inc., 85 FR 19020, 19026 (2020) (collecting cases).
Here, Applicant's admissions establish that Applicant has a long
history of abusing controlled substances. Specifically, in 2007
Applicant was addicted to zolpidem and underwent treatment at a
chemical addiction recovery program. RFAAX 1, at 4. In addition, in
2013 Applicant was abusing carisoprodol and was in a chemical addiction
recovery program. Id. at 6. Further, despite being in treatment for
addiction to carisoprodol, Applicant ordered carisoprodol tablets
through the internet not for a legitimate medical purpose and not
within the usual course of his professional practice. Id. On two
occasions in 2014, Applicant tested positive for carisoprodol when he
did not have a prescription for carisoprodol. Id. at 7. In November
2020, Applicant stole propofol from an operating room for personal use.
Id. at 8. In 2015 and 2021, Applicant was subject to orders issued by
the Minnesota Board of Medical Practice that, among other things,
required Applicant to undergo treatment for chemical dependency, attend
self-help program meetings, undergo random drug testing, and
demonstrate sobriety. Id. at 7-8.
In sum, the Agency finds substantial record evidence that Applicant
has abused a variety of controlled substances over a period of many
years and continued to do so even after he had been monitored and
required to undergo treatment for substance abuse. Id. at 4, 6-8. The
Agency finds that this lengthy history of substance abuse constitutes
``other conduct which may threaten the public health and safety.'' 21
U.S.C. 823(g)(1)(E); Brewster Drug, Inc., 85 FR at 19026. Accordingly,
the Agency finds substantial record
[[Page 48364]]
evidence that Applicant's registration would be inconsistent with the
public interest. 21 U.S.C. 824(a)(4).
IV. Sanction
The Agency has found by clear, unequivocal, and convincing record
evidence that Applicant submitted five materially false applications
for DEA registration and substantial record evidence that his
registration would be inconsistent with the public interest due to
having committed acts of diversion and demonstrating a lengthy history
of substance abuse. 21 U.S.C. 823(g)(1)(B), (D), (E); 21 U.S.C.
824(a)(1), (4). When the Government establishes a prima facie case for
sanction, as it did here, the Agency then determines the appropriate
sanction, which may include denial of an application for registration.
21 U.S.C. 823(g)(1); see also Pharmacy Doctors Enterprises, 789 Fed.
Appx. at 734 (the Agency is entitled to choose a sanction); Jeffrey
Stein, M.D., 84 FR 46968, 46972-73 (2019); Scott Hansen, A.R.N.P., 90
FR 27338, 27341 (2025).
At this stage, the burden is on Applicant to show why he can be
entrusted with a registration. Morall, 412 F.3d at 174; Jones Total
Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D., 83
FR 18882, 18904 (2018). The issue of trust is necessarily a fact-
dependent determination based on the circumstances presented by the
individual. Stein, 84 FR at 46972; see also Jones Total Health Care
Pharmacy, 881 F.3d at 833.
As past performance is the best predictor of future performance,
the Agency requires that an applicant who has committed acts
inconsistent with the public interest accept responsibility for those
acts and demonstrate that they will not engage in future misconduct.
See Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc.
v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). Moreover, the
Agency requires an applicant's unequivocal acceptance of
responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024);
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total
Health Care Pharmacy, 881 F.3d at 830-31. The Agency also considers the
need to deter similar acts by the applicant and by the community of
registrants. Stein, 84 FR at 46972-73.
Here, Applicant failed to request a hearing and answer the
allegations contained in the OSC, and did not otherwise avail himself
of the opportunity to prove to the Agency that he can be entrusted with
a registration. See supra Section I. Thus, there is no record evidence
that Applicant takes responsibility, let alone unequivocal
responsibility, for the misconduct proven by record evidence.
Accordingly, he has not convinced the Agency that he can be entrusted
with the responsibilities of a registration.
Further, the interests of specific and general deterrence weigh in
favor of denial. Applicant's misconduct in this matter concerns the
submission of registration applications that contained material
falsities, improper prescribing for the purpose of obtaining controlled
substances for personal abuse, and a lengthy history of abusing
controlled substances. Thus, the proven misconduct goes to the heart of
the CSA's ``strict requirements regarding registration'' and its
``closed regulatory system'' specifically designed ``to conquer drug
abuse and to control the legitimate and illegitimate traffic in
controlled substances.'' Gonzales v. Raich, 545 U.S. at 12-14. If the
Agency were to issue a registration to Applicant under these
circumstances, it would send a dangerous message that compliance with
the law is not essential to obtaining a registration.
In sum, Applicant has not offered any credible evidence on the
record that rebuts the Government's case for denial of his application,
and Applicant has not demonstrated that he can be entrusted with the
responsibility of a DEA registration. Accordingly, the Agency will
order the denial of Applicant's application for registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(g)(1), I hereby deny the application for a DEA Certificate
of Registration, Control No. W23054133M, submitted by David S. Pecora,
P.A., as well as any other pending application of David S. Pecora,
P.A., for registration in Minnesota. This Order is effective November
17, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 1, 2025, by Administrator Terrance Cole. 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. 2025-19579 Filed 10-16-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on October 17, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.