Leila Kump, M.D.; Decision and Order

Issuing agencies

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<title>Federal Register, Volume 91 Issue 166 (Friday, August 28, 2026)</title>
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[Federal Register Volume 91, Number 166 (Friday, August 28, 2026)]
[Notices]
[Pages 55615-55620]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17589]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Leila Kump, M.D.; Decision and Order

    On December 10, 2025, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause and Immediate Suspension of 
Registration (OSC/ISO) to Leila Kump, M.D., of Great Falls, Virginia 
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 
1, at 1, 9. The OSC/ISO informed Registrant of the immediate suspension 
of her DEA registration, No. FK6611013, pursuant to 21 U.S.C. 824(d), 
alleging that her continued registration is ``an imminent danger to the 
public health or safety.'' Id. at 1. The OSC/ISO also proposed the 
revocation of her DEA registration, alleging that she currently lacks 
state authority to handle controlled substances in Virginia and that 
her continued registration is inconsistent with the public interest.\1\ 
Id. (citing 21 U.S.C. 823(g)(1), 824(a)(3)-(4)).
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    \1\ According to the OSC/ISO and Agency records, Registrant's 
registration expired on December 31, 2025. RFAAX 1, at 3. The Agency 
has previously held that it is within its jurisdiction and 
discretion to adjudicate a matter to finality where a registration 
expired after issuance of an OSC and before issuance of a final 
order. See Jeffrey D. Olsen, M.D., 84 FR 68474, 68475-79 (2019); see 
also Abdul Naushad, M.D., 89 FR 54059, 54060 (2024) (applying the 
same principle and adjudicating a matter to finality where a 
registration expired before issuance of the OSC). Here, adjudicating 
the matter to finality will achieve similar goals as in Olsen; it 
will support future interactions between the Agency and Registrant, 
inform current and prospective members of the registrant community 
about the Agency's expectations, provide continuing education to all 
DEA personnel, help coordinate law enforcement efforts, and inform 
stakeholders, such as legislators and the public, about the Agency's 
work. Olsen, 84 FR at 68479.

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[[Page 55616]]

    More specifically, the OSC/ISO alleged that Registrant currently 
lacks the requisite state authority to practice as a physician or 
prescribe controlled substances in Virginia, the state in which she is 
registered with DEA. RFAAX 1, at 4. The OSC/ISO further alleged that 
Registrant improperly prescribed opioids and benzodiazepines 
simultaneously to two patients, both of whom died of acute intoxication 
caused by the combination of controlled substances prescribed by 
Registrant.\2\ Id. at 4-7.
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    \2\ The Government also alleged that Registrant ``practiced 
medicine in Maryland . . . while [her] Maryland medical license was 
suspended,'' and that she issued concurrent prescriptions for 
opioids and benzodiazepines to eight additional patients between 
June and September 2025. RFAAX 1, at 4, 7. The OSC/ISO, however, 
does not indicate the state or federal laws that these actions 
allegedly violated. Id.; see Henry Emery, M.D., 90 FR 46927, 46929 
(2025) (holding that in a public interest case alleging state law 
violations, ``[i]t is the burden of the Government to provide . . . 
notice of the state law [Registrant is] alleged to have violated''). 
Accordingly, the Agency will not adjudicate those allegations. 
Nevertheless, even without those allegations, as discussed herein, 
the record contains substantial evidence establishing bases for 
revocation under 21 U.S.C. 824(a)(3) (lack of state authority), and 
21 U.S.C. 824(a)(4) (danger to public interest), to support granting 
the Government's RFAA.
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    On February 20, 2026, the Government submitted an RFAA requesting 
that the Agency issue a default final order revoking Registrant's 
registration. RFAA, at 1, 3. 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 
revokes Registrant's registration.

I. Default Determination

    Under 21 CFR 1301.43, a registrant 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 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). Unless excused, a default is 
deemed to constitute ``an admission of the factual allegations of the 
[OSC].'' 21 CFR 1301.43(e).
    The OSC notified Registrant of her right to file a written request 
for hearing and answer, and that if she failed to file such a request 
and answer, she would be deemed to have waived her right to a hearing 
and be in default.\3\ RFAAX 1, at 9 (citing 21 CFR 1301.43). Here, 
Registrant did not request a hearing, file an answer, or respond to the 
OSC/ISO in any way. RFAA, at 1-2. Thus, the Agency finds that 
Registrant is in default and therefore has admitted to the factual 
allegations in the OSC/ISO. 21 CFR 1301.43(c)(1), (e), (f)(1).
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    \3\ Based on the Government's submissions in its RFAA, the 
Agency finds that service of the OSC/ISO on Registrant was adequate. 
Specifically, the Declaration from a DEA Diversion Investigator (DI) 
indicates that on December 18, 2025, DI personally served the OSC/
ISO on Registrant at her registered address. RFAAX 2, at 1.
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II. Lack of State Authority

A. Findings of Fact

    The Agency finds that, in light of Registrant's default, the 
factual allegations in the OSC/ISO are deemed admitted. 21 CFR 
1301.43(e). Accordingly, Registrant is deemed to have admitted, in 
accordance with the OSC/ISO, that on September 24, 2025, the Virginia 
Board of Medicine (Board) suspended Registrant's Virginia state medical 
license. RFAAX 1, at 4. Specifically, the Board suspended Registrant's 
state medical license based on findings that her ``continued practice 
would pose a substantial danger to public health or safety.'' Id.
    According to Virginia online records, of which the Agency takes 
official notice, the status of Registrant's medical license is 
currently listed as ``Revoked.'' \4\ Virginia Department of Health 
Professions License Lookup, <a href="https://dhp.virginiainteractive.org/Lookup/Index">https://dhp.virginiainteractive.org/Lookup/Index</a> (last visited date of signature of this Order). Accordingly, the 
Agency finds that Registrant is not licensed to practice medicine in 
Virginia, the state in which she is registered with DEA.\5\
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    \4\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979).
    \5\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision 
rests on official notice of a material fact not appearing in the 
evidence in the record, a party is entitled, on timely request, to 
an opportunity to show the contrary.'' The material fact here is 
that Registrant, as of the date of this Decision and Order, is not 
licensed to practice as a physician in Virginia. Accordingly, 
Registrant may dispute the Agency's finding by filing a properly 
supported motion for reconsideration of findings of fact within 
fifteen calendar days of the date of this Order. Any such motion and 
response shall be filed and served by email to the other party and 
to the Office of the Administrator, Drug Enforcement Administration, 
at <a href="/cdn-cgi/l/email-protection#92f6f7f3bcf3f6f6fdbcf3e6e6fde0fcf7ebe1d2f6f7f3bcf5fde4"><span class="__cf_email__" data-cfemail="d1b5b4b0ffb0b5b5beffb0a5a5bea3bfb4a8a291b5b4b0ffb6bea7">[email&#160;protected]</span></a>.
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B. Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General may suspend 
or revoke a registration issued under 21 U.S.C. 823 ``upon a finding 
that the registrant . . . has had his [or her] State license or 
registration suspended . . . [or] revoked . . . by competent State 
authority and is no longer authorized by State law to engage in the . . 
. dispensing of controlled substances.'' With respect to a 
practitioner, DEA has also long held that the possession of authority 
to dispense controlled substances under the laws of the state in which 
a practitioner engages in professional practice is a fundamental 
condition for obtaining and maintaining a practitioner's registration. 
Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (``The Attorney General 
can register a physician to dispense controlled substances `if the 
applicant is authorized to dispense . . . controlled substances under 
the laws of the State in which he practices.' . . . The very definition 
of a `practitioner' eligible to prescribe includes physicians 
`licensed, registered, or otherwise permitted, by the United States or 
the jurisdiction in which he practices' to dispense controlled 
substances. [21 U.S.C.] 802(21).''). The Agency has applied these 
principles consistently. See, e.g., James L. Hooper, M.D., 76 FR 71371, 
71372 (2011), pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); 
Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).\6\
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    \6\ This rule derives from the text of two provisions of the 
Controlled Substances Act. First, Congress defined the term 
``practitioner'' to mean ``a physician . . . or other person 
licensed, registered, or otherwise permitted, by . . . the 
jurisdiction in which he practices . . . , to distribute, dispense, 
. . . [or] administer . . . a controlled substance in the course of 
professional practice.'' 21 U.S.C. 802(21). Second, in setting the 
requirements for obtaining a practitioner's registration, Congress 
directed that ``[t]he Attorney General shall register practitioners 
. . . if the applicant is authorized to dispense . . . controlled 
substances under the laws of the State in which he practices.'' 21 
U.S.C. 823(g)(1). Because Congress has clearly mandated that a 
practitioner possess state authority in order to be deemed a 
practitioner under the CSA, DEA has held repeatedly that revocation 
of a practitioner's registration is the appropriate sanction 
whenever he or she is no longer authorized to dispense controlled 
substances under the laws of the state in which he or she practices. 
See, e.g., Hooper, 76 FR at 71371-72; Sheran Arden Yeats, M.D., 71 
FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 
(1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988); Blanton, 43 FR 
at 27617.
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    According to Virginia statute, ``dispense'' means ``to deliver a 
drug to an ultimate user or research subject by or pursuant to the 
lawful order of a practitioner, including the prescribing

[[Page 55617]]

and administering, packaging, labeling, or compounding necessary to 
prepare the substance for that delivery.'' Va. Code Sec.  54.1-3401 
(2026). Additionally, Virginia law defines ``practitioner'' as ``a 
physician . . . or other person licensed, registered, or otherwise 
permitted to distribute, dispense, prescribe and administer, or conduct 
research with respect to a controlled substance in the course of 
professional practice or research in [Virginia].'' Id. Virginia law 
further defines a ``physician'' as ``a person licensed to practice 
medicine in [Virginia] or in the jurisdiction where the health care is 
to be rendered.'' Va. Code Sec.  54.1-2982 (2026).
    Here, the undisputed evidence in the record is that Registrant 
lacks authority to practice as a physician in Virginia. As discussed 
above, an individual must be a licensed practitioner to dispense a 
controlled substance in Virginia. Thus, because Registrant lacks 
authority to practice as a physician in Virginia and, therefore, is not 
authorized to handle controlled substances in Virginia, Registrant is 
not eligible to maintain a DEA registration in that state. Accordingly, 
the Agency will order that Registrant's DEA registration be revoked.
    Registrant's lack of state authority to handle controlled 
substances in Virginia is sufficient by itself to support revoking 
Registrant's DEA registration. Infra n.12. The following public 
interest ground provides an additional, independent basis for revoking 
Registrant's DEA registration.

III. Public Interest Determination

A. Overview of Law

    Congress enacted the Controlled Substances Act (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.
    The CSA's requirements under this closed regulatory system include 
that ``[e]very person who dispenses, or who proposes to dispense, any 
controlled substance, shall obtain from the [DEA] a registration.'' 21 
U.S.C. 822(a)(2); see Gonzales v. Raich, 545 U.S. at 27-28. To protect 
the American people and ensure compliance with the CSA, Congress 
empowered the Agency to deny, suspend, or revoke a registration if 
granting or continuing a registration would be inconsistent with the 
public interest. 21 U.S.C. 823(g)(1), 824(a)(4); Gonzales v. Oregon, 
546 U.S. at 251.
    In determining whether a registrant's 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 [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).
    These five public interest factors are considered in the 
disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., 
dissenting); 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 (2005)); see Penick Corp., Inc. v. Drug Enf't 
Admin., 491 F.3d 483, 490 (D.C. Cir. 2007). The Agency has taken this 
approach for decades. See Henry J. Schwarz, Jr., M.D., 54 FR 16422, 
16424 (1989) (holding, in 1989, that ``[t]he [Agency] need not make 
findings as to all of the factors . . . [and that the Agency] may give 
each factor the weight [it] deems appropriate,'' and basing denial on 
only two factors); Neveille H. Williams, D.D.S., 53 FR 23465, 23466 
(1988) (holding, in 1988, and citing a 1986 case, that ``[a]ll factors 
need not be present for the [Agency] to'' issue a sanction and that the 
Agency ``may accord each factor the weight [it] deems appropriate in 
determining the public interest'' (citing Paul Stepak, M.D., 51 FR 
17556 (1986))).
    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, 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(e), and the Agency must make its findings based on 
``substantial [record] evidence.'' 5 U.S.C. 556(d); see 5 U.S.C. 
706(2); 21 U.S.C. 877. If the Government meets its burden of 
establishing a prima facie case that Registrant's registration is not 
in the public interest, then the burden shifts to Registrant to rebut 
the Government's case. Pharmacy Doctor Enters., Inc. v. Drug Enf't 
Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019) (citing Jones Total 
Health Care Pharmacy, 881 F.3d at 830).
    In this matter, the Government's evidence is confined to Factors B 
and D. RFAA, at 2-3; RFAAX 1, at 3-4. 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). 
To determine whether Registrant's continued registration is in the 
public interest, the Agency has evaluated the Government's allegations 
of Registrant's experience dispensing controlled substances and her 
non-compliance with applicable federal and state laws.
    Registrant is registered in Virginia, and the OSC/ISO has alleged 
violations of state laws in Virginia. Accordingly, the Agency must 
evaluate the Government's evidence under Virginia's laws. See Emery, 90 
FR at 46929 (explaining the Agency analyzes public interest allegations 
according to the laws in the state where registrant is registered with 
DEA).

B. Applicable Law and Standard of Care

    According to the CSA's implementing regulations, a lawful 
controlled substance prescription is one that is ``issued for a 
legitimate medical purpose

[[Page 55618]]

by an individual practitioner acting in the usual course of his 
professional practice.'' 21 CFR 1306.04(a); see Gonzales v. Oregon, 546 
U.S. at 274; United States v. Hayes, 595 F.2d 258, 260 (5th Cir. 1979), 
rehearing den., 598 F.2d 620 (5th Cir. 1979), cert. denied, 444 U.S. 
866 (1979). ``A practitioner must establish and maintain a bona fide 
doctor-patient relationship in order to act `in the usual course of . . 
. professional practice' and to issue a prescription for a `legitimate 
medical purpose.' '' Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010).
    Similarly, Virginia law provides that ``[a] prescription shall be 
issued only to persons . . . with whom the practitioner has a bona fide 
practitioner-patient relationship.'' Va. Code Sec.  54.1-3303(B). 
Virginia law further provides that ``[a] practitioner who has 
established a bona fide practitioner-patient relationship with a 
patient in accordance with the provisions of this subsection may 
prescribe Schedule II through VI controlled substances to that 
patient.'' \7\ RFAAX 1, at 2; Va. Code Sec.  54.1-3303(B). To establish 
a bona fide practitioner-patient relationship, Virginia law requires 
the practitioner to take a medical history, examine the patient, inform 
the patient of the risks of the treatment, initiate follow-up 
intervention in the event of ``serious side effects,'' and prescribe 
the controlled substance in good faith for a ``medicinal or therapeutic 
purpose within the course of [the practitioner's] professional 
practice.'' RFAAX 1, at 2; Va. Code Sec.  54.1-3303(B) & (D).
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    \7\ As opposed to the CSA, which categorizes controlled 
substances in five schedules, I through V, Virginia law categorizes 
controlled substances in six schedules, I through VI. Va. Code 
Sec. Sec.  54.1-3446, 3448, 3450, 3452, 3454, 3455.
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    Before prescribing an opioid for pain lasting less than a month, 
Virginia law requires a physician to consider non-opioid medication, 
check the Prescription Drug Monitoring Program (PDMP), take a patient 
history, assess the patient's risk of substance abuse, and perform a 
physical examination. RFAAX 1, at 2-3; 18 Va. Admin. Code Sec.  85-21-
30(A) (B); see 18 Va. Admin. Code Sec.  85-21-20 (defining ``acute 
pain'' as ``pain of any origin that has existed less than one month''). 
If the physician determines that opioid therapy is necessary, Virginia 
law requires the physician to prescribe the opioid at the lowest 
effective dose for the fewest days possible. RFAAX 1, at 3; 18 Va. 
Admin. Code Sec.  85-21-30(A).
    Virginia law acknowledges the increased risk of overdose for 
patients who take an opioid concurrently with a benzodiazepine: ``[d]ue 
to a higher risk of fatal overdose when opioids are prescribed with 
benzodiazepines . . . , the prescriber shall only co-prescribe these 
substances when there are extenuating circumstances and shall document 
in the medical record a tapering plan to achieve the lowest possible 
effective doses if these medications are prescribed.'' RFAAX 1, at 3 
(quoting 18 Va. Admin. Code Sec.  85-21-40(C)). When a physician 
prescribes an opioid and benzodiazepine concurrently, Virginia law 
requires the physician to also prescribe an ``opioid reversal agent.'' 
RFAAX 1, at 3 (quoting 18 Va. Admin. Code Sec.  85-21-40(B)(3)).
    Virginia law allows for the discipline of a physician who engages 
in ``unprofessional conduct,'' including revocation of the physician's 
medical license. RFAAX 1, at 3; Va. Code Sec.  54.1-2915(A). Virginia 
law defines examples of unprofessional conduct to include: 
``[c]onducting [the physician's] practice in such a manner as to be a 
danger to the health and welfare of [her] patients or to the public,'' 
and ``[v]iolating any provision of statute or regulation, state or 
federal, relating to the manufacture, distribution, dispensing, or 
administration of drugs.'' RFAAX 1, at 3 (quoting Va. Code Sec.  54.1-
2915(A)(13) & (17)).

C. Findings of Fact

    In light of Registrant's default, the factual allegations in the 
OSC/ISO are deemed admitted. 21 CFR 1301.43(e). Accordingly, Registrant 
is deemed to have admitted that between March 2025 and April 2025, 
Registrant issued numerous concurrent prescriptions for opioids and 
benzodiazepines to individuals J.S. and D.S., and that both individuals 
died of acute intoxication caused by the concurrent prescriptions for 
opioids and benzodiazepines issued by Registrant. RFAAX 1, at 3-7.
i. March 2025: Individual J.S.
    On March 4, 2025, Registrant issued a prescription for oxycodone/
acetaminophen \8\ 10 mg/325 mg (12 count) and diazepam \9\ 5 mg (10 
count) to J.S. RFAAX 1, at 4. Each prescription had the instruction to 
``[t]ake 1 tablet orally every 12 hours[.] Take as needed.'' Id.
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    \8\ Oxycodone is a Schedule II opioid. 21 CFR 
1308.12(b)(1)(xiv).
    \9\ Diazepam is a Schedule IV benzodiazepine. 21 CFR 
1308.14(c)(18).
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    On March 21, 2025, Registrant directed J.S. to take three tablets 
of oxycodone/acetaminophen 10 mg/325 mg and three tablets of diazepam 5 
mg shortly before undergoing an outpatient procedure in Registrant's 
office. Id. At the beginning of the procedure, Registrant administered 
lidocaine, an unscheduled local anesthetic, to J.S. at the site of the 
procedure. Id. at 5.
    Registrant concurrently prescribed, and directed the use of, the 
opioids and benzodiazepines on March 4 and 21, 2025, as described 
above, without maintaining sufficient clinical documentation, without 
conducting an appropriate medical evaluation, and without mitigating 
the risks of concurrent prescribing of an opioid and benzodiazepine. 
Id. Specifically, Registrant prescribed J.S. an opioid treatment for 
pain concurrently with a local anesthetic, demonstrating that 
Registrant failed to meaningfully consider ``non-opioid treatment for 
pain'' as an alternative. Id. Registrant further failed to inform J.S. 
of the risks of taking oxycodone, diazepam, and combining both 
substances. Id. Registrant failed to document any ``extenuating 
circumstances'' justifying the concurrent prescribing of an opioid and 
a benzodiazepine to J.S. Id. Registrant failed to prescribe J.S. 
oxycodone in the ``lowest effective dose.'' Id. Registrant failed to 
mitigate the risks to J.S. of concurrently using an opioid and 
benzodiazepine, such as prescribing or administering an opioid reversal 
agent. Id. Registrant practiced medicine ``in such a manner as to be a 
danger to the health and welfare of [her] patients.'' Id.
    On March 21, 2025, J.S. developed respiratory distress while in 
Registrant's office after ingesting the opioids and benzodiazepines 
issued by Registrant, and died of acute intoxication due to the 
combined effects of oxycodone, diazepam, and lidocaine issued 
concurrently by Registrant. Id.
ii. April 2025: Individual D.S.
    On April 10, 2025, Registrant issued prescriptions for oxycodone/
acetaminophen 10 mg/325 mg (12 tablets) and diazepam 5 mg (10 tablets) 
to D.S. RFAAX 1, at 5. Each prescription had the instruction to 
``[t]ake 1 tablet orally every 12 hours[.] Take as needed.'' Id.
    On April 12, 2025, Registrant directed D.S. to take two tablets of 
oxycodone/acetaminophen 10 mg/325 mg and two tablets of diazepam 5 mg 
before undergoing an outpatient procedure in Registrant's office. Id. 
at 6. At the beginning of the procedure, Registrant administered 
lidocaine to D.S. at the site of the procedure. Id.
    Registrant concurrently prescribed, and directed the use of, the 
opioids and benzodiazepines on April 10 and 12, 2025, as described 
above, without maintaining sufficient clinical

[[Page 55619]]

documentation, without conducting an appropriate medical evaluation, 
and without mitigating the risks to the patient of concurrent 
prescribing of an opioid and benzodiazepine. Id. Specifically, 
Registrant prescribed to D.S. an opioid treatment for pain concurrently 
with a local anesthetic, demonstrating that she failed to meaningfully 
consider ``non-opioid treatment for pain'' as an alternative. Id. 
Registrant further failed to inform D.S. of the risks of taking 
oxycodone, diazepam, and combining the two controlled substances. Id. 
Registrant also failed to document any ``extenuating circumstances'' 
justifying the concurrent prescribing of an opioid and a benzodiazepine 
to D.S. Id. Registrant failed to prescribe D.S. oxycodone in the 
``lowest effective dose.'' Id. Registrant failed to mitigate the risks 
to D.S. of concurrently taking an opioid and benzodiazepine, such as 
prescribing or administering an opioid reversal agent. Id. Registrant 
practiced medicine ``in such a manner as to be a danger to the health 
and welfare of [her] patients.'' Id.
    On April 12, 2025, D.S. developed respiratory distress while in 
Registrant's office after ingesting the opioid and benzodiazepine 
issued by Registrant. Id. On April 15, 2025, D.S. died of acute 
intoxication due to the combined effects of oxycodone, diazepam, and 
lidocaine issued concurrently by Registrant. Id.
iii. Expert Review
    DEA retained an independent medical expert to review materials, 
including Registrant's medical records for J.S. and D.S. and the 
controlled substance prescriptions Registrant issued to J.S. and D.S. 
RFAAX 1, at 8. Based upon Registrant's deviations from the standard of 
care, the medical expert concluded that the prescriptions for 
controlled substances that Registrant issued to J.S. and D.S., as 
described herein, supra Sections III.C.i-ii., violated minimal medical 
standards applicable to the practice of medicine in Virginia. Id.

D. Conclusions of Law

    The Agency has found above that between March 2025 and April 2025, 
Registrant issued numerous concurrent prescriptions for opioids and 
benzodiazepines to individuals J.S. and D.S., and that both individuals 
died of acute intoxication caused by the concurrent use of opioids and 
benzodiazepines issued by Registrant. Supra Sections III.C.i-ii.
    Specifically, the Agency found, with respect to individuals J.S. 
and D.S., that Registrant failed to meaningfully consider ``non-opioid 
treatment for pain'' as an alternative, in violation of 18 Va. Admin. 
Code Sec.  85-21-30(A); failed to inform them of the risks of taking 
oxycodone, diazepam, and combining both substances, in violation of Va. 
Code Sec.  54.1-3303(B); failed to document any ``extenuating 
circumstances'' justifying the concurrent prescribing of an opioid and 
a benzodiazepine, in violation of 18 Va. Admin. Code Sec.  85-21-
40(B)(2); failed to prescribe oxycodone in the ``lowest effective 
dose,'' in violation of 18 Va. Admin. Code Sec.  85-21-30(A); failed to 
mitigate the risks of concurrently using an opioid and benzodiazepine, 
such as prescribing or administering an opioid reversal agent, in 
violation of 18 Va. Admin. Code Sec.  85-21-40(B)(3); and practiced 
medicine ``in such a manner as to be a danger to the health and welfare 
of [her] patients,'' in violation of Va. Code. Sec.  54.1-2915(A)(13).
    The Agency has further found that these concurrent opioid and 
benzodiazepine prescriptions issued to J.S. and D.S., that caused their 
deaths, were not for a legitimate medical purpose, were issued outside 
the usual course of professional practice, violated minimal medical 
standards applicable to the practice of medicine in Virginia, and 
violated federal and Virginia law.\10\ See 21 CFR 1306.04(a); Va. Code. 
Sec.  54.1-2915(A)(13); Va. Code Sec.  54.1-3303(B); 18 Va. Admin. Code 
Sec.  85-21-30(A); 18 Va. Admin. Code Sec.  85-21-40(B)(2), (3); RFAAX 
1, at 8; supra Section III.C.iii.
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    \10\ The Agency finds that, when viewed in totality, 
Registrant's conduct was egregious and strayed so far outside the 
bounds of conduct resembling legitimate medical practice that it 
constituted drug pushing. United States v. Moore, 423 U.S. 122, 143 
(1975); United States v. Collier, 478 F.2d 268, 274 (5th Cir. 1973). 
Specifically, Registrant's egregious misconduct, which caused the 
deaths of two individuals, included the failure to: meaningfully 
consider non-opioid treatment alternatives; inform the individuals 
of the risks of taking oxycodone, diazepam, and combining both 
substances; document ``extenuating circumstances'' justifying the 
concurrent prescribing of an opioid and a benzodiazepine; prescribe 
oxycodone in the ``lowest effective dose;'' and mitigate the risks 
of concurrently using an opioid and benzodiazepine. RFAAX 1, at 4-8. 
Further, an independent medical expert opined that Registrant's 
practice of combining oxycodone and a benzodiazepine was 
``dangerous.'' Id. at 8.
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E. Public Interest Conclusion

    While the Agency considered all the public interest factors of 21 
U.S.C. 823(g)(1), its findings are relevant to Factor B (experience 
dispensing controlled substances) and Factor D (compliance or non-
compliance with laws related to controlled substances).\11\ 21 U.S.C. 
823(g)(1); Hubbard, 87 FR at 21162. Accordingly, the Agency finds that 
after considering the public interest factors, and the facts deemed 
admitted by virtue of Registrant's default, the Government satisfied 
its prima facie burden of showing that Registrant's continued 
registration would be ``inconsistent with the public interest.'' 21 
U.S.C. 824(a)(4). The Agency further finds that there is insufficient 
mitigating evidence to rebut the Government's prima facie case. Thus, 
the only remaining issue is whether revocation of Registrant's 
registration is the appropriate sanction.
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    \11\ Although the Agency has frequently analyzed Factors B and D 
together, Congress must have intended Factor B to encompass conduct 
that is not captured under Factor D. See Kungys v. United States, 
485 U.S. 759, 778 (1988) (referencing the ``cardinal rule of 
statutory interpretation that no provision should be construed to be 
entirely redundant''); see also Syed Jawed Akhtar-Zaidi, M.D., 80 FR 
42962, 42969 n.17 (2015) (holding that ``[p]roof that a physician 
knowingly diverted controlled substances is the best evidence for 
assessing his experience in dispensing controlled substances [Factor 
B], although it is also relevant in assessing his compliance with 
applicable laws related to controlled substances [Factor D]''). 
Thus, even though the Agency has made findings under Factors B and D 
in this case, and both factors together support revocation, the 
findings under Factor B or D alone are sufficient to support the 
Agency's sanction. See MacKay v. Drug Enf't Admin., 664 F.3d 808, 
821 (10th Cir. 2011) (holding that ``findings under a single factor 
. . . are sufficient to support the revocation of a registration'' 
(quoting Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2006))); see also 
supra Section III.A. A registrant's failure to adhere to the state's 
standard of care (i.e., Factor B), as Registrant did here, creates 
an environment that encourages the abuse or diversion of controlled 
substances. As the opioid epidemic surges and other controlled 
substances, such as amphetamines, ketamine, and benzodiazepines, are 
increasingly abused, DEA must remain vigilant to protect the public 
against registrants who fail to employ adequate safeguards against 
abuse and diversion. Accordingly, basing revocation on findings 
under a single factor, such as Factor B, is consistent with the 
CSA's core purpose of protecting the public from the dangers of drug 
abuse and diversion. Gonzales v. Raich, 545 U.S. at 12-14.
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IV. Sanction

    Where, as here, the Government has met its burden of showing that 
Registrant's continued registration is inconsistent with the public 
interest, the burden shifts to Registrant to show why she 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. Jones Total Health Care Pharmacy, 881 F.3d at 
833; Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019). Moreover, as 
``past performance is the best predictor of future performance,'' the 
Agency requires that a registrant

[[Page 55620]]

who has committed acts inconsistent with the public interest accepts 
responsibility for those acts, understands the gravity and seriousness 
of the misconduct, and demonstrates that the registrant will not engage 
in future misconduct. ALRA Labs., Inc. v. Drug Enf't Admin., 54 F.3d 
450, 452 (7th Cir. 1995); Jones Total Health Care Pharmacy, 881 F.3d at 
831-33. The Agency requires a registrant's unequivocal acceptance of 
responsibility. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024); 
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); Jones Total Health 
Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor 
during the investigation and hearing, if one is requested, is an 
important factor in determining acceptance of responsibility and the 
appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at 
830-31; Hoxie, 419 F.3d at 483-84. Further, the Agency considers the 
egregiousness and extent of the misconduct as significant factors in 
determining the appropriate sanction. Jones Total Health Care Pharmacy, 
881 F.3d at 834 & n.4. The Agency also considers the need to deter 
similar acts by a registrant and by the community of registrants. 
Stein, 84 FR at 46972-73.
    Here, Registrant did not timely request a hearing, or timely answer 
the allegations, and was therefore deemed to be in default. 21 CFR 
1301.43(c)(1), (e), (f)(1); RFAA, at 1-2. Thus, there is no record 
evidence that Registrant takes responsibility, let alone unequivocal 
responsibility, for the misconduct. Accordingly, she has not convinced 
the Agency that her future controlled-substance-related actions will 
comply with the CSA such that she can be entrusted with the 
responsibilities of holding a registration.
    Further, the interests of specific and general deterrence weigh in 
favor of revocation. Registrant's misconduct in this matter concerns 
the CSA's ``strict requirements regarding registration'' and, 
therefore, goes to the heart of the CSA's ``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. Registrant's egregious misconduct 
involved using her registration to issue dangerous concurrent 
combinations of controlled substances that led to acute intoxication 
and death for two individuals. If the Agency were to allow Registrant 
to maintain her registration under these circumstances, it would send a 
dangerous message that prescribing controlled substances in accord with 
minimal state standards and compliance with state and federal law is 
not essential to maintaining a registration.
    In sum, Registrant has not offered any evidence on the record that 
rebuts the Government's case for revocation of her registration, and 
Registrant has not demonstrated that she can be entrusted with the 
responsibility of holding a DEA registration.
    Accordingly, the Agency will order the revocation of Registrant's 
registration.\12\
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    \12\ In this matter there are two separate and distinct grounds 
by which the Government proposed revocation, Registrant's lack of 
state authority and her registration being inconsistent with the 
public interest; each ground, standing alone, supports the Agency's 
decision to revoke.
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Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
FK6611013 issued to Leila Kump, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I 
hereby deny any pending applications of Leila Kump, M.D., to renew or 
modify this registration, as well as any other pending application of 
Leila Kump, M.D., for additional registration in Virginia. This Order 
is effective September 28, 2026.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
August 25, 2026, by DEA Administrator Terrance C. 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. 2026-17589 Filed 8-27-26; 8:45 am]
BILLING CODE 4410-09-P


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