Notice2025-18172
Haroon Hameed, M.D.; Decision and Order
Primary source
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Published
September 19, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 180 (Friday, September 19, 2025)</title>
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45251-45257]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18172]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Haroon Hameed, M.D.; Decision and Order
I. Introduction
On March 25, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Haroon Hameed, M.D.,
of Stevensville, Maryland (Respondent). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 1, Attachment C, at 1, 5. The OSC proposed the
revocation of Respondent's DEA Certificate of Registration No.
FH8064204 and denial of any applications, alleging that Respondent has
``committed such acts as would render [his] continued registration
inconsistent with the public interest'' and ``materially falsified
[his] application for renewal of [his] registration.'' \1\ Id. at 1
(citing 21 U.S.C. 824(a)(1), (a)(4)).
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\1\ In the RFAA, the Government identified the renewal
application at issue as being Control No. W18129086C. RFAA at 1-4,
7, 12-13.
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More specifically, the OSC alleged that between October 2019 and
May 2020, Respondent abused controlled substances and saw patients and
performed medical procedures while abusing controlled substances. Id.
at 2-3. Further, the OSC alleged that Respondent's renewal application
contained material falsifications. Id. at 3-4. The OSC alleged that
Respondent's above-described misconduct violated both the implementing
regulations of the Controlled Substances Act (CSA) and Maryland state
law. Id. at 2-4.
On April 28, 2022, Respondent filed a waiver of his right to a
hearing along with a written statement and a proposed Corrective Action
Plan, which DEA denied by letter dated May 5, 2022. RFAA, at 3; see
also RFAAX 2-3. The Agency has considered Respondent's written
statement and addresses the arguments made therein throughout this
Decision.
After carefully reviewing the entire record and conducting the
analysis as set forth in more detail below, the Agency grants the
Government's request for final agency action and revokes Respondent's
registration and denies pending applications as his continued
registration is inconsistent with the public interest.
II. Public Interest
A. Applicable Law
As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1
(2005), ``the main objectives of the CSA were to conquer drug abuse and
control the legitimate and illegitimate traffic in controlled
substances.'' 545 U.S. at 12. Gonzales explained that:
Congress was particularly concerned with the need to prevent the
diversion of drugs from legitimate to illicit channels. To
effectuate these goals, Congress 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 .
. . . The CSA and its implementing regulations set forth strict
requirements regarding registration, labeling and packaging,
production quotas, drug security, and recordkeeping.
Id. at 12-14.
The OSC is addressed to Respondent at his registered address in
Maryland; therefore, the Agency also evaluates Respondent's actions
according to Maryland law. Gonzales v. Oregon, 546 U.S. 243, 269-71
(2006). Pursuant to Maryland law, a Maryland medical licensee may be
subject to disciplinary measures if, among other reasons, the licensee
engages in any of the following: unprofessional conduct in the practice
of medicine; habitual intoxication; addiction to or habitual abuse of a
controlled substance; and providing professional services while under
the influence of alcohol or while abusing a controlled substance. Md.
Code Ann., Health Occ. Sec. 14-404(a)(3)(ii), (7)-(9).
B. Findings of Fact
The Agency finds substantial record evidence for the following
findings of fact based on the uncontroverted evidence submitted by the
Government in its RFAA dated August 16, 2024. Respondent was a board-
certified practitioner of physical medicine and rehabilitation who
provided pain management consultations for patients, prescriptions for
pain medications, and surgical interventions to relieve pain. RFAAX 1,
Attachment G, at 3.
On or about November 5, 2020, the Maryland State Board of
Physicians (Board) summarily suspended Respondent's Maryland medical
license following a Board investigation finding that Respondent had
seen patients and performed medical procedures while under the
influence of controlled substances and alcohol. RFAAX 1, Attachment F,
at 2-6. One such incident occurred on August 28, 2019, when Respondent
performed a radiofrequency ablation instead of a cervical facet block
which had been ordered and consented to in writing. Id. at 4. On
February 17, 2020, Respondent was observed to be swaying while he
performed a procedure on a patient, and staff suspected that he was
impaired due to slurred speech, bloodshot eyes, and the smell of
alcohol on his person. Id. at 5. On May 5, 2020, Respondent was
observed at work with disheveled clothing and appearance, glassy and
heavy eyes, slurred speech, and a lack of coordination. Id. at 6.
On November 6, 2020, the Board issued charges against Respondent
under the Maryland Medical Practice Act, with the allegations
including: (1) unprofessional conduct in the practice of medicine; (2)
professional, physical, or mental incompetence; (3) habitual
intoxication; (4) addiction to or habitual abuse of narcotics or
controlled substances; and (5) providing professional services while
under the influence of alcohol or while abusing narcotics or controlled
dangerous substances or other drugs. RFAAX 1, at 3.
On or about November 1, 2021, the Board issued a Final Decision and
Order regarding Respondent's Maryland medical license, finding, inter
alia, that: (1) every night between October 2019 and May 2020,
Respondent consumed a combination of oxycodone (a Schedule II opioid),
eszopiclone (a Schedule IV sedative), and alcohol, RFAAX 1, Attachment
G, at 2; (2) on May 5, 2020, Respondent reported to work
[[Page 45252]]
intoxicated following consumption of alcohol, oxycodone, and
eszopiclone in excess of the prescribed dose, Id. at 6-8; and (3) on
multiple occasions, including on February 17, 2020, Respondent saw
patients and performed medical procedures while under the influence of
a combination of an opioid, sedative, and alcohol. Id. at 5-6, 8.
Respondent, in this matter, admitted that he was ``intoxicated''
and ``unable to perform [his] job on May 5[, 2020]'' because he had
taken ``an extra dose of both the oxycodone [he] was prescribed for
pain and [eszopiclone], which [he] was prescribed for insomnia.'' RFAAX
2, at 23. As for February 17, 2020, Respondent admitted that he
``combined [his] prescription medication with alcohol the night before
. . . [and] was not in proper physical condition to work on that
date.'' Id. at 23-24.
Ultimately, the Board affirmed the suspension of Respondent's
Maryland medical license and ordered that the suspension remain in
effect until he completed the Maryland Professional Rehabilitation
Program.\2\ Id. at 15. It found that Respondent: (1) was guilty of
unprofessional conduct in the practice of medicine; (2) was habitually
intoxicated; (3) was addicted to, or habitually abused, a controlled
substance; and (4) provided professional services while under the
influence of alcohol or while abusing a controlled substance. Id. at
14. Respondent does not contest the Board's findings and admits that
``his actions rightfully led to the temporary suspension of his medical
license.'' Id.
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\2\ On or about November 30, 2021, the Board ended the
suspension of Respondent's Maryland medical license, reinstated
Respondent's Maryland medical license, and placed Respondent's
Maryland medical license on probation for a period of three years.
RFAAX 1, Attachment H, at 3.
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Accordingly, the Agency finds substantial record evidence that
between October 2019 and May 2020, Respondent habitually abused a
combination of controlled substances and alcohol resulting in habitual
intoxication, consumed controlled substances in excess of the
prescribed dose, and on multiple occasions saw patients and performed
medical procedures while under the influence of controlled substances
and/or alcohol. RFAAX 1, Attachment C, at 2-3.
C. Discussion
i. The Controlled Substances Act's Public Interest Factors
The Attorney General ``may deny, suspend, or revoke [a]
registration if . . . the [registrant's] registration would be
`inconsistent with the public interest.' '' Gonzales v. Oregon, 546
U.S. at 251 (quoting 21 U.S.C. 824(a)(4)). In the case of a
``practitioner,'' Congress directed the Attorney General to consider
five factors in making the public interest determination. Id.; 21
U.S.C. 823(g)(1)(A-E).\3\
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\3\ The five factors are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant'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).
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive'' (quoting In re Arora, 60 FR 4447, 4448 (1995))); 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);
see Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005)
(describing the Agency's adjudicative process as ``applying a multi-
factor test through case-by-case adjudication'' (quoting LeMoyne-Owen
Coll. v. N.L.R.B., 357 F.3d 55, 61 (D.C. Cir. 2004))). Any one factor,
or combination of factors, may be decisive, David H. Gillis, M.D., 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, 412 F.3d.
at 185 n.2 (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).
Moreover, 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 Tenth Circuit has
recognized, Agency decisions have explained that findings under a
single factor can support the revocation of a registration. MacKay, 664
F.3d at 821.
The Government has the burden of proof in this proceeding. 21 CFR
1301.44(d)-(e).
ii. Respondent's Registration Is Inconsistent With the Public Interest
While the Agency has considered all the public interest factors of
21 U.S.C. 823(g)(1),\4\ the Agency finds that the Government's evidence
in support of its prima facie case is confined to Factors B and D.\5\
RFAA, at 9-12. Evidence is considered under Factors B and/or D when it
reflects experience in dispensing and/or compliance or non-compliance
with federal and local laws related to controlled substances. 21 U.S.C.
823(g)(1)(B) and (D); see also Kareem Hubbard, M.D., 87 FR 21156, 21162
(2022).
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\4\ As to Factor A, the record contains no evidence of a
recommendation from any State licensing board or professional
disciplinary authority. 21 U.S.C. 823(g)(1)(A). Nonetheless, an
absence of such evidence ``does not weigh for or against a
determination as to whether continuation of [or granting of a] DEA
certification is consistent with the public interest.'' Roni
Dreszer, M.D., 76 FR 19434, 19444 (2011). As to Factor C, there is
no evidence in the record that Respondent has been convicted of an
offense under either Federal or State law ``relating to the
manufacture, distribution, or dispensing of controlled substances.''
21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, ``the
absence of such a conviction is of considerably less consequence in
the public interest inquiry'' and is therefore not dispositive.
Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010).
\5\ The Government alleged in the RFAA that Factor E, ``[s]uch
other conduct which may threaten the public health and safety,''
weighed in favor of revocation. 21 U.S.C. 823(g)(1)(E) (emphasis
added); RFAA, at 10-11. The Agency notes that Respondent
``stipulate[ed]'' that he had ``engaged in other conduct which may
threaten the public health and safety.'' RFAAX 2, at 10. While the
Agency agrees that Respondent's conduct, particularly his
performance of procedures while under the influence of alcohol and
controlled substances, threatened the public health and safety, the
same conduct fits squarely under Factor B and D as reflecting
experience in dispensing and/or establishing violations of Maryland
law. Accordingly, the Agency evaluates the conduct under Factor B
and D. As to Factor B, Respondent argues that his experience in
dispensing controlled substances is unblemished. RFAAX 2, at 9. The
Agency disagrees; Respondent's admission that he took more
controlled substances than he was prescribed is relevant to his
experience in dispensing. Id., at 23-24; see also 21 U.S.C. 802(10).
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Here, as found above, the Agency finds that between at least
October 2019 and May 2020, Respondent habitually abused a combination
of controlled substances and alcohol resulting in habitual
intoxication, consumed
[[Page 45253]]
controlled substances in excess of the prescribed dose, and on multiple
occasions, saw patients and performed medical procedures while under
the influence of controlled substances and alcohol. Supra, I.B.
As such, the Agency finds substantial record evidence that
Respondent engaged in unprofessional conduct in the practice of
medicine in violation of Md. Code Ann., Health Occ. Sec. 14-
404(a)(3)(ii); was habitually intoxicated in violation of Md. Code
Ann., Health Occ. Sec. 14-404(a)(7); was addicted to or a habitual
abuser of a narcotic or controlled dangerous substance in violation of
Md. Code Ann., Health Occ. Sec. 14-404(a)(8); and provided
professional services while under the influence of alcohol or while
abusing any narcotic or controlled dangerous substance in violation of
Md. Code Ann., Health Occ. Sec. 14-404(a)(9).\6\
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\6\ Any one of these found violations of Maryland law standing
alone is a sufficient basis for the Agency to revoke Respondent's
registration on the grounds that it is outside the public interest.
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The Agency further finds that after considering the factors of 21
U.S.C. 823(g)(1), Respondent's continued registration is ``inconsistent
with the public interest.'' 21 U.S.C. 824(a)(4). Accordingly, the
Government satisfied its prima facie burden of showing that
Respondent's continued registration would be ``inconsistent with the
public interest.'' Id. The Agency also finds that there is insufficient
mitigating evidence to rebut the Government's prima facie public
interest case. Thus, the Agency must determine whether, in spite of the
public interest determination, Respondent can be trusted with a
registration. Infra, IV.
III. Material Falsification
A. Findings of Fact
The Agency finds clear, unequivocal, and convincing record evidence
for each of the following facts. On October 31, 2021, Respondent
applied for renewal of his DEA Certificate of Registration. RFAAX 1, at
5; see also RFAAX 1, Attachment B. All applications for a DEA
registration contain four liability questions that an applicant must
answer. RFAAX 1, Attachment B, at 1. For each question the applicant
answers in the affirmative, he or she must provide additional details
regarding the answer, including the date, location, nature, and result
of the incident. Id. at 2. The OSC alleges that Respondent materially
falsified his answers to both Liability Question 1 and Liability
Question 3. RFAAX 1, Attachment C, at 3.
The Agency finds clear, unequivocal, and convincing record evidence
that Liability Question 1 asks: ``Has the applicant ever been convicted
of a crime in connection with controlled substance(s) under state or
federal law, or been excluded or directed to be excluded from
participation in a Medicare or state health care program, or [is] any
such action pending?'' RFAAX 1, at 5; RFAAX 1, Attachment B, at 1. On
his October 31, 2021 application, Respondent answered ``No'' to
Liability Question 1. RFAAX 1, at 5; RFAAX 1, Attachment B, at 1. The
OSC alleges that this answer was false. RFAAX 1, Attachment C, at 3.
The Agency finds clear, unequivocal, and convincing record evidence
that by letter dated June 24, 2021, the Maryland Department of Health
notified Respondent that ``in accordance with General Medical
Assistance Provider Participation Criteria Regulation 10.09.36.02
License Requirements [he was] terminated as a Medicaid provider for all
items and services rendered, ordered, or prescribed effective December
11, 2020.'' RFAAX 1, at 5; RFAAX 1, Attachment I. The June 24, 2021
notification letter does not use the word ``excluded.'' RFAAX 1,
Attachment I. Respondent, in his Declaration, states that he knew as of
September 2021 that his Medicaid privileges were ``revoked'' due to
``the suspension of his [medical] license.'' \7\ Respondent's
Statement, Exhibit 2, at 6.
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\7\ See also Respondent's Statement, Exhibit 2, at 14 (``Dr.
Hameed's Medicaid privileges were revoked . . . on June 24, 2021, .
. . His Medicare privileges were likewise revoked on September 18,
2021.'').
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The Agency finds clear, unequivocal, and convincing record evidence
that Liability Question 3 asks: ``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?'' RFAAX 1, at 5; RFAAX 1,
Attachment B, at 1. On his October 31, 2021 renewal application,
Respondent answered ``Yes'' to Liability Question 3. RFAAX 1,
Attachment B, at 1-2. When prompted to explain the ``Nature'' of the
incident Respondent disclosed: ``I had my Maryland license suspended
after a complaint regarding that I presented to work drowsy for 30-45
min a few weeks after having a hip replacement.'' Id. at 2
(capitalization edited). Respondent went on to state that he has
``complied with the Maryland Physician Health Program'' and that his
Maryland license is being considered for reinstatement; he also stated
that his Florida license was unrestricted. Id. Finally, Respondent
stated that ``[he] did not have any issues that were pertinent to DEA
licensure including improper prescribing of controlled substance
prescriptions.'' Id. Regarding the ``Result'' of the state action
against him, Respondent wrote ``awaiting expected Maryland license
reinstatement within the next 2 weeks.'' Id. (capitalization edited).
The record evidence establishes that Respondent in fact had ``[his]
Maryland license suspended,'' and that the suspension occurred ``after
a complaint.'' RFAAX 2, at 3. The record evidence also indicates that
Respondent's hip ``required surgical intervention on February 20,
2020.'' Id. at 36. The record evidence further establishes that a few
weeks later, Respondent presented to work drowsy. Id. Specifically, the
record establishes that on May 5, 2020, ``[Respondent] overslept and
arrived at work ten to fifteen minutes late.'' Id. Respondent admitted
that he had taken oxycodone and eszopiclone and had consumed alcohol
the night before ``to aid with sleep and pain.'' Id. Respondent further
admitted ``that when he arrived at the facility on the morning of May
5, 2020, he was impaired by sleep deprivation, use of a sleep aid in
excess of the prescribed dose, and use of a Schedule II narcotic pain
medication prescribed to alleviate his chronic pain.'' Id. at 37. On
November 30, 2021, about a month after Respondent submitted the
application, the Maryland Board terminated his suspension and
reinstated his state medical license (and placed it on probation).
RFAAX 1, Attachment C, at 2.
B. Discussion
i. Legal Elements of Material Falsification and Government's Burden
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.
[[Page 45254]]
823 and Kungys v. United States, 485 U.S. 759, 771 (1988)). 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.
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 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.'' 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.
Here, the Agency finds that the Government's evidence fails to meet
the prima facie burden of showing that Respondent submitted a
materially false application. 21 U.S.C. 824(a)(1).
ii. Determining Whether the Government's Evidence Establishes a Prima
Facie Case of Material Falsification
The first element of the Government's prima facie case of material
falsification under 21 U.S.C. 824(a)(1) is that the applicant or
registrant submitted an application for DEA registration pursuant to
the CSA. 21 U.S.C. 824(a)(1). Here, the Government has shown by clear,
unequivocal, and convincing record evidence that Respondent applied for
renewal of his DEA Certificate of Registration on October 31, 2021.
RFAAX 1, Attachment B.
Second, the Government must show that the application contained a
false statement or omitted information that the application required,
either of which can constitute a falsity. Here, the Government's
allegations concern both--that Respondent made a false statement with
regard to Liability Question 1 and that he made a false statement and
omitted required information with regard to Liability Question 3.
As discussed above, Liability Question 1 asks whether Respondent
has ever ``been excluded or directed to be excluded from participation
in a . . . state health care program . . . ?'' Supra, III.A; RFAAX 1,
Attachment B. Liability Question 1 is meant to obtain information
necessary to conduct the analysis in 21 U.S.C. 824(a)(5) \8\ which
allows for denial, revocation, or suspension of a registration if the
registrant ``has been excluded (or directed to be excluded) from
participation in a program pursuant to section [42 U.S.C.] 1320a-
7(a).'' ``Exclusion'' is a specific, but undefined, statutory term used
in 42 U.S.C. 1320a-7 which governs exclusion of certain individuals and
entities from participation in Medicare and state health care programs.
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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).
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Prior to submitting his renewal application, the state notified
Respondent that pursuant to ``[Maryland] regulation 10.09.36.02 License
Requirements, [he was] terminated as a Medicaid provider.'' Supra,
III.A; RFAAX 1, Attachment I. The notice did not use the word
``excluded'' or cite to 42 U.S.C. 1320a-7(a).\9\ RFAAX 1, Attachment I.
Put another way, there is no evidence in the record that Respondent's
``termination'' meant that he was ``excluded'' from a state health care
program pursuant to 42 U.S.C. 1320a-7(a). Accordingly, the Government
has not established by clear, unequivocal, and convincing record
evidence that Respondent's ``no'' answer in response to Liability
Question 1 was false. Because the record evidence does not prove that
Respondent provided a false answer to Liability Question 1, the Agency
need not reach the issue of materiality regarding the answer to
Liability Question 1.\10\
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\9\ Both the OSC and the RFAA appear to conflate the terms
``termination'' and ``exclusion'' without providing any evidence or
argument supporting the position that the two terms mean the same
thing. See RFAA, at 12-13; RFAAX 1, Attachment C, at 3. However,
comparing Maryland regulation 10.09.36.02, the authority relied upon
to ``terminate'' Respondent's participation, to 42 U.S.C. 1320a-7,
the authority discussing ``exclusions'' from participation in
Medicare and state health care programs, suggests that the two terms
are not synonymous.
\10\ The Agency notes that only mandatory exclusions under 42
U.S.C. 1320a-7(a) are grounds for potential denial, revocation, or
suspension of a registration by DEA. 21 U.S.C. 824(a)(5). Respondent
argues that his ``answer to liability question one cannot have been
material because his exclusion from the government programs in
question was permissive rather than mandatory,'' and DEA is only
permitted to take action when a registrant's exclusion is mandatory.
Respondent's Response, RFAAX 2, at 15. While Respondent's Response
states that he was permissively excluded pursuant to 42 U.S.C.
1320a-7, the only evidence supporting the suggestion is Respondent's
declaration stating ``my Medicare privileges were also later
revoked.'' RFAAX 2, at 25. ``Revoked'' is yet another term that may
or may not mean ``excluded'' in this context. Ultimately, since
there is not clear, unequivocal, and convincing record evidence of a
falsification, the Agency need not reach the issue of materiality.
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[[Page 45255]]
Continuing the analysis, Respondent truthfully answered Liability
Question 3 in the affirmative, stating that his state license had been
suspended. Supra, III.A. Thereafter, Respondent was prompted to explain
the ``Nature'' and ``Result'' of the state action against him. Id. The
Government argued that Respondent's explanation falsified and/or
omitted required information such that the narrative response was
``materially false.'' More specifically, the Government argued that
Respondent ``provided a false response as to why his Maryland state
license was suspended'' and that there is a ``vast[ ]'' difference
between what Respondent wrote about being ``drowsy'' and the finding
that Respondent provided professional services while abusing controlled
substances.\11\ RFAA, at 13, 17; RFAAX 1, Attachment C, at 3. The
Government also argued that Respondent falsely stated that his ``issues
were not pertinent to DEA licensure.'' RFAA, at 13.
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\11\ The Agency notes that Respondent did not receive the
Board's Final Order finding habitual abuse of a narcotic or
controlled dangerous substance until after he submitted his renewal
application. RFAAX 2, at 22.
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In determining whether Respondent made a false statement and/or
omitted required information, the Agency looks carefully at the exact
language used in the application itself and the exact language used by
the applicant. See JM Pharmacy Group, Inc. d/b/a Farmacia Nueva and
Best Pharma Corp., 80 FR 28667, 28681 (2015) (stating that a falsity
must be analyzed in the context of the application requirements sought
by DEA and provided by the applicant). Regarding ``Nature'' and
``Result'' Respondent wrote:
Nature: I had my Maryland license suspended after a complaint
regarding that I presented to work drowsy for 30-45 minutes a few
weeks after having a hip replacement. I have complied with the
Maryland Physician Health Program to their full extent, and my
license has been recommended for reinstatement by the Administrative
Law Judge [B.W.], and I have had a hearing and expect reinstatement
in Maryland in the next week. My Florida license was not suspended
and the Florida Department of Health is aware of the process and has
been kept up to date, and my license is full and unrestricted there.
I did not have any issues that were pertinent to DEA licensure
including improper prescribing of controlled substance
prescriptions.
Result: Awaiting expected Maryland license reinstatement within
the next 2 weeks.
RFAAX 1, Attachment B, at 2 (capitalization edited).
Regarding falsity, two of Respondent's statements in his
application are untrue. See also supra, III.A. First, Respondent wrote
that the complaint that resulted in his Maryland suspension alleged
that Respondent was drowsy. RFAAX 1, Attachment B, at 2. However, the
record evidence establishes that the anonymous complaint that led to
Respondent's summary suspension actually ``alleg[ed] that [Respondent]
had performed the wrong surgical procedure on a patient and had
appeared at the Facility for work under the influence of unknown
intoxicants.'' RFAAX 1, Attachment F, at 2. Respondent's description of
the complaint and the actual complaint differ significantly.
Additionally, the record evidence establishes that Respondent knew or
should have known that the complaint made against him alleged more than
just drowsiness as the complaint was included in Maryland's November 5,
2020 ``Order for Summary Suspension of License to Practice Medicine.''
RFAAX 1, Attachment F, at 2. Based on the above, the Agency finds
clear, unequivocal, and convincing record evidence that Respondent's
description of the complaint made against him was false.
Second, regarding the suspension of his Maryland license,
Respondent wrote that he ``did not have any issues that were pertinent
to DEA licensure including improper prescribing of controlled substance
prescriptions.'' RFAAX 1, Attachment B, at 2 (capitalization edited).
The mere fact that Respondent's license (as stated in the first
sentence of the same paragraph) was suspended is pertinent to DEA
licensure pursuant to 21 U.S.C. 824(a)(3) and (4). Moreover, the record
evidence establishes that Respondent admitted, and therefore knew, that
he used controlled substances in excess of the dose prescribed to him
which, as discussed above, is pertinent to his DEA licensure. See
supra, II.B. Accordingly, the Agency finds clear, unequivocal, and
convincing record evidence that Respondent's statement that he ``did
not have any issues pertinent to DEA licensure'' is also false. RFAAX
1, Attachment B, at 2 (capitalization edited).
In addition to the two falsities above, the Government alleges an
omission; specifically, that Respondent's application failed to
disclose that his medical license was suspended based on, among other
reasons, ``a finding that he habitually abused a narcotic or controlled
dangerous substance.'' RFAA, at 13. This argument fails for two
reasons, first the ``habitual intoxication'' charge was not found until
November 1, 2021, after Respondent submitted the application. RFAAX 1,
Attachment G, at 9, 13-14, 20. The record does not contain any evidence
regarding an applicant's duty, if any, to supplement the application
after the date it is submitted to DEA. Second, there is no evidence in
the record regarding specific instructions, if any exist, included with
the application that specify the level of detail the Government
requires in response to the prompts for ``Nature'' and ``Result'' of
the state action. Certainly some detail is required, as the prompts are
follow up questions asking for an explanation, and Respondent did
provide details about the complaint, problems with drowsiness at work
following surgery, and the suspension of his license. Respondent argued
that he ``could have provided a more detailed explanation of the
specific charges brought before the Maryland Board, his summary
suspension, and the ALJ's recommendation . . . [if he was] aware that
it was expected, let alone required, to do so.'' RFAAX 2, at 18. Under
the circumstances, the Agency finds that the Government has failed to
establish by clear, unequivocal, and convincing record evidence that
Respondent falsified his application by omitting information regarding
the Maryland Board's Final Decision and Order (which had not yet been
issued). However, the two false statements found by the Agency require
further analysis.
Next, the Agency analyzes whether the two false statements in
Respondent's application were material, ``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.
Liability Question 3 is relevant to the Agency analysis under 21
U.S.C. 824(a)(3) and 823(g), because possession of authority to
dispense controlled substances under the laws of the state in which
Respondent engages in professional practice is a fundamental condition
for obtaining and maintaining a registration. Gonzales v. Oregon, 546
U.S. 243, 270 (2006). Furthermore, Liability Question 3 is also
relevant because it could lead to information relevant to the public
interest analysis that the Agency is required to conduct when making
registration decisions. 21 U.S.C. 824(a)(4), 823(g)(1)(A-E).
Here, Respondent disclosed on the application that there was a
complaint made against him that resulted in a suspension of his
Maryland medical license on November 5, 2020. RFAAX 1,
[[Page 45256]]
Attachment B, at 2. He disclosed that the complaint was made because he
reported to work ``drowsy'' after having surgery. Id. He explained that
he had participated in the Maryland Physician Health Program. Id. He
explained that he was expecting reinstatement of his Maryland license
in the near future and that he has already had a hearing on the matter.
Id. He explained that the Florida Department of Health was also aware
of the events in Maryland, yet he maintained his license in Florida.
Id.
In other words, Respondent provided DEA with a significant amount
of truthful information--enough to alert the Agency to allegations of
misconduct involving his practice of medicine and the adverse action
against his state license. Given the significant amount of truthful
information that was provided, and the fact that the truthful
information informed DEA that his state license had been suspended due
to allegations of misconduct at work, the two false statements'
capability to affect the official decision is not shown by clear,
unequivocal, and convincing evidence.\12\ Kungys, 485 U.S. at 771-72.
---------------------------------------------------------------------------
\12\ Regarding the first falsity, whether the initial complaint
that led to the Maryland suspension alleged ``drowsiness'' (as
Applicant wrote) or ``being under the influence'' (as the record
established) was unlikely to impact the Agency's ultimate decision
in light of Respondent's disclosure that he was found to have
engaged in misconduct which resulted in a suspension of his Maryland
license. Put another way, the CSA makes clear that the Maryland
Board's findings and suspension of Respondent's license impact the
Agency's decision making, but the record does not make clear how the
characterization of the complaint itself could impact the decision.
Regarding the second falsity, DEA, not an applicant for
registration, is charged with conducting the public interest
analysis under 21 U.S.C. 823(g) and cannot and would not sidestep
its statutorily mandated duty just because the applicant says his
misconduct is not ``pertinent'' to the analysis. Moreover,
Respondent's statement that he had no issues pertinent to DEA
licensure could not be relied upon by DEA because in the same
statement he discloses one or more issues that were clearly
pertinent to DEA licensure.
---------------------------------------------------------------------------
In sum, because the Government is unable to establish by clear,
unequivocal, and convincing record evidence that Respondent's
application contained falsities that were also material, the Government
has not established a prima facie case of material falsification.
However, as previously discussed, the Government has established that
Respondent's registration is inconsistent with the public interest.
IV. Sanction
Here, the Government has met its prima facie burden of showing that
Respondent's continued registration is inconsistent with the public
interest due to his violations of state law relating to controlled
substances and experience in dispensing with respect to controlled
substances. Accordingly, the burden shifts to Respondent 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 registrant.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, DEA Administrators have
required that a registrant who has committed acts inconsistent with the
public interest must accept responsibility for those acts and
demonstrate that he will not engage in future misconduct. 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). A registrant's acceptance of
responsibility must be unequivocal. Jones Total Health Care Pharmacy,
881 F.3d at 830-31. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id. Further,
the Agency has found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 & n.4. The Agency has also considered the need to
deter similar acts by the registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Here, Respondent asserts in his written statement responding to the
OSC that he ``has accepted full responsibility.'' RFAAX 2, at 12.
Specifically, he expressed ``great regret and deep remorse for the
unprofessional conduct demonstrated by [his] actions . . . [which were]
detrimental not only to [his] medical practice, but to [his] life as a
whole.'' RFAAX 2, at 25. Respondent also asserts that he ``is thankful
to have the ability and chance, through continued work on [his]
sobriety, to ensure that substance abuse never again threatens [his]
license, [his] practice, [his] patients, or [him]self.'' RFAAX 2, at
25-26. While Respondent has generally accepted responsibility as to his
controlled substance abuse, his acceptance of specific violative acts
has not been unequivocal.
In his Declaration, Respondent swore to all the ways he believed he
was in compliance with the CSA. He claimed that he had ``never
prescribed any substance for myself[,] . . . sought nor received
prescriptions for pain medicine from more than one treating physician
at a time[,] . . . never diverted any controlled substances[, and] . .
. never been accused of dispensing controlled substances in an
unethical or illegal manner.'' RFAAX 2, at 23. Immediately after,
Respondent admits that on or about May 5, 2020, he ``[took] an extra
dose of both the oxycodone [he] was prescribed for pain and
[eszopiclone], which [he] was prescribed for insomnia.'' Id.
Respondent's failure to appreciate that taking more controlled
substances than prescribed is drug abuse, which the CSA was enacted to
prevent, calls into question whether the Agency can trust Respondent
with a registration.\13\ This is especially true where Respondent
deemphasizes his drug abuse by emphasizing that the extra doses he took
were for ``medicine that was lawfully prescribed to him for existing
and documented medical conditions.'' RFAAX 2, at 10. Trying to downplay
the seriousness of his drug abuse further demonstrates that he cannot
be trusted with registration. See, e.g., Phong H. Tran, M.D., 90 FR
14383, 14385 (2025) (``Respondent's attempts to minimize this egregious
misconduct undermine any purported acceptance of responsibility.'').
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\13\ The CSA was ``[e]nacted in 1970 with the main objectives of
combating drug abuse and controlling the legitimate and illegitimate
traffic in controlled substances.'' Gonzales, 546 U.S. at 250.
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Also of concern is Respondent's failure to fully accept
responsibility for his misconduct on February 17, 2020. In his
Declaration, Respondent swore that ``[he] did not believe that [he] was
intoxicated at work on that date, [but he] did combine [his]
prescription medication with alcohol the night before . . . [and]
admit[s] that [he] was not in proper physical condition to work.''
RFAAX 2, at 23-24. While Respondent swore that he ``accept[ed] the
factual conclusions of the . . . Maryland Board regarding [his]
intoxication,'' id., his refusal to admit to anything more than not
being in a ``proper physical condition to work'' prohibits a finding of
unequivocal acceptance of responsibility.
Accordingly, the Agency finds that Respondent has not demonstrated
unequivocal acceptance of responsibility for the totality of the
founded violations in this matter. When a registrant fails to make the
threshold showing of acceptance of responsibility, the Agency need not
address the registrant's remedial measures. Ajay S. Ahuja, M.D., 84 FR
5479, 5498 n.33 (2019) (citing Jones Total Health Care
[[Page 45257]]
Pharmacy, L.L.C. & SND Health Care, L.L.C., 81 FR 79188, 79202-79203
(2016)); Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015).\14\
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\14\ Even so, in the current matter, the Agency has considered
that Respondent has taken various measures to remedy his misconduct
regarding his controlled substance and alcohol abuse, as detailed in
his written submission to DEA. See RFAAX 2, at 3-4, 5-6, 9, 11-12.
Respondent stated that he completed all of the actions recommended
by the Maryland Physician Health Program (MPHP), and ``has remained
sober and abstinent from controlled substances'' since December 2020
(except for a two-week period following surgery in 2021). RFAAX 2,
at 24-25. The Agency has acknowledged that ``[i]n self-abuse cases,
. . . successful rehabilitation efforts are an important
consideration in determining whether a respondent can be trusted
with a registration.'' Trenton F. Horst, D.O., 80 FR 41079, 41091
(2015); see also Abbas E. Sina, M.D., 80 FR 53191, 53201 (2015)
(``[T]he risk of relapse becomes critical in determining what steps
are warranted when determining the public interest.''). Here,
Respondent explained what he had done to obtain sobriety, but many
of his actions were required by the Maryland Board as part of his
probation. See Mary A. Vreeke, M.D., 89 FR 75567, 75571 (2024). And
though Respondent has not explained what he planned to do to remain
sober if his probationary period with the Maryland Board ended, the
Agency appreciates that Respondent has committed to continue working
on his sobriety for himself and not just for his career. RFAAX 2, at
25-26. Still, these remedial measures do not overcome the fact that
Respondent did not unequivocally accept responsibility for his
actions or convince the Agency that he can be trusted with the
responsibility of a registration. See, e.g., George D. Gowder, III,
89 FR 76152, 76154-55 (2024) (the Agency found that registrant could
be trusted in light of his acceptance of responsibility and
extensive remedial measures (both past and future), including his
decision to not seek registration to handle the controlled
substances he formerly abused, and nine years of sobriety).
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Further, the interests of specific and general deterrence weigh in
favor of revocation. Here, Respondent has not unequivocally accepted
responsibility for, and even tried to minimize, his actions related to
abuse of controlled substances. Accordingly, the interests of specific
deterrence weigh in favor of revocation. Given the foundational nature
of Respondent's violations, a sanction less than revocation would send
a message to the existing and prospective registrant community that
compliance with the law is not essential to maintaining a registration.
V. Conclusion
In sum, Respondent has not offered sufficient evidence on the
record to rebut the Government's case for revocation on public interest
grounds, and Respondent has not demonstrated that he can be entrusted
with the responsibility of registration. Accordingly, the Agency will
order that Respondent's registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate
of Registration No. FH8064204 issued to Haroon Hameed, M.D. Further,
pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C.
824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending applications
of Haroon Hameed, M.D., to renew or modify this registration, as well
as any other pending application of Haroon Hameed, M.D., for additional
registration in Maryland. This Order is effective October 20, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 10, 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. 2025-18172 Filed 9-18-25; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on September 19, 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.