Alexandra R. Lovec, A.P.R.N.; Decision and Order

Issuing agencies

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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Pages 64685-64689]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20751]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Alexandra R. Lovec, A.P.R.N.; Decision and Order

    On December 22, 2025, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) to Alexandra Renee 
Lovec, A.P.R.N., of Ekalaka, Montana (Registrant). OSC, at 1, 6; 
Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1, 6. The 
OSC proposed the revocation of Registrant's DEA Certificate of 
Registration, No. ML4889347, alleging that Registrant's continued 
registration would be inconsistent with the public interest. OSC, at 1; 
RFAAX 1, at 1 (citing 21 U.S.C. 823(g)(1); 824(a)(4)).\1\
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    \1\ Based on the Government's submissions in its RFAA dated 
March 16, 2026, the Agency finds that service of the OSC on 
Registrant was adequate. Specifically, the Declaration from a DEA 
Diversion Investigator (DI) indicates that on January 7, 2026, the 
OSC was served to Registrant's counsel. RFAAX 2, at 2; see also id., 
Appendices A-C.
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    The OSC alleged that from at least June 5, 2022, to at least 
January 16, 2025, Registrant repeatedly violated federal and Montana 
state law by issuing numerous prescriptions for Schedule II-IV 
controlled substances to a patient outside the usual course of 
professional practice and not for a legitimate medical purpose, in 
violation of 21 CFR 1306.04; Mont. Admin. R. Sec.  24.159.1204(1)(a), 
24.159.1464(1), (4), 24.159.2301(2).\2\ OSC, at 2-4; RFAAX 1, at 2-
4.\3\ Specifically, the OSC alleged that, among other things, 
Registrant failed to conduct or document adequate patient evaluations 
and histories necessary to establish an objective medical diagnosis 
justifying the necessity for the prescriptions and failed to adequately 
monitor patient progress. OSC, at 3-4; RFAAX 1, at 3-4.
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    \2\ The Agency need not adjudicate the criminal violations 
alleged in the OSC. Ruan v. United States, 597 U.S. 450 (2022) 
(decided in the context of criminal proceedings).
    \3\ The OSC also alleged that Registrant violated Mont. Admin. 
R. Sec.  24.159.1204(5), but the deemed-admitted facts were 
insufficient to find a violation regarding this allegation.
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    On March 12, 2026, the Government submitted an RFAA requesting that 
the Agency issue a default final order revoking Registrant's 
registration. RFAA, at 3. 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 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).
    Here, the OSC notified Registrant of her right to file a written 
request for hearing, and that if she failed to file such a request, she 
would be deemed to have waived her right to a hearing and be in 
default. OSC, at 5; RFAAX 1, at 5 (citing 21 CFR 1301.43). According to 
the Government's RFAA, Registrant failed to request a hearing. RFAA, at 
2. Thus, the Agency finds that Registrant is in default and therefore 
has admitted to the factual allegations in the OSC. 21 CFR 1301.43(e).

II. Public Interest Determination

A. Overview of Law

    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. 243, 251 (2006) (quoting 21 U.S.C. 824(a)(4)). The Attorney 
General's ``discretion in exercising [the authority to register and 
deregister practitioners] is spelled out in very broad terms.'' Id. at 
292 (Scalia, J., dissenting); see also Neumann's Pharmacy, L.L.C. v. 
Drug Enf't Admin., 167 F.4th 320, 323 (5th Cir. 2026) (``DEA 
unquestionably has broad authority to deregister pharmacies and 
substantial discretion to shape policy within statutory bounds.''). In 
executing this broad mandate, DEA must continuously balance the CSA's 
public interest goals of curbing the ``illegal . . . distribution[ ] 
and possession[,] and improper use of controlled substances[, which 
has] a substantial and detrimental effect on the health and general 
welfare of the American people,'' while ensuring that the public has 
access to medications that ``have a useful and legitimate medical 
purpose and are necessary to maintain the health and general welfare of 
the American people.'' 21 U.S.C. 801(1), (2); see Joanna R. Lampe, 
Cong. Rsch. Serv., R45948, The Controlled Substances Act (CSA): A Legal 
Overview for the 119th Congress (2025), <a href="https://www.congress.gov/crs-product/R45948">https://www.congress.gov/crs-product/R45948</a>.
    In the case of a practitioner, Congress directed the Attorney 
General to consider five factors in making the public interest 
determination. 21 U.S.C. 823(g)(1)(A)-(E).\4\ Just as the phrase 
``inconsistent with the public interest'' is broad, the five factors 
that Congress directed DEA to consider in determining the public 
interest are similarly broad, suggesting that Congress intended for DEA 
to have discretion and flexibility to interpret this language as 
necessary to implement its critical mission to protect the public from 
drug abuse and diversion. See Loper Bright Enters. v. Raimondo, 603 U.S 
369, 394-95 (2024) (noting that ``[i]n a case involving an agency . . . 
the statute's meaning may well be that the agency is authorized to 
exercise a degree of discretion,'' such as where the statute uses terms 
or phrases like ``appropriate or reasonable'' (internal citations 
omitted)). Indeed, courts have recognized the Agency's broad discretion 
to deny applications and deregister practitioners for a wide variety of 
conduct that the Agency has determined is inconsistent with the public 
interest. See, e.g., Orusa v. Drug Enf't Admin., No. 22-3132, 2023 WL 
3886403 (6th Cir. June 8, 2023) (physician issuing prescriptions 
outside the usual course of professional practice and beneath the 
standard of care); St. Croix v. Drug Enf't Admin., No. 21-1116, 2022 WL 
2092177 (D.C. Cir. June 10, 2022) (physician failing to maintain 
adequate records, prescribing controlled substances without a 
legitimate medical purpose, storing controlled substances at an 
unregistered location, failing to provide effective controls to guard

[[Page 64686]]

against theft or diversion of these substances); Suntree Pharmacy v. 
Drug Enf't Admin., No. 20-14626, 2022 WL 444357 (11th Cir. Feb. 14, 
2022), cert. denied, 143 S. Ct. 305 (2022) (pharmacy filling 
prescriptions outside the usual course of practice).
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    \4\ 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 CSA's five public interest 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(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).
    Registrant is registered in Montana, and the OSC has alleged 
violations of state laws in Montana. RFAAX 1, at 2-5. Accordingly, the 
Agency must evaluate the Government's evidence under Montana law. See 
Henry Emery, M.D., 90 FR 46927, 46929 (2025) (explaining the Agency 
analyzes public interest allegations according to the laws in the state 
where registrant is registered with DEA); see also 21 U.S.C. 903 (``No 
provision of this subchapter shall be construed as indicating an intent 
on the part of the Congress to occupy the field in which that provision 
operates, including criminal penalties, to the exclusion of any State 
law on the same subject matter which would otherwise be within the 
authority of the State, unless there is a positive conflict between 
that provision of this subchapter and that State law so that the two 
cannot consistently stand together.'').

B. Applicable Federal and State Law

    According to the CSA's implementing regulations, a lawful 
controlled substance prescription is one that is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a); see 
Gonzales v. Oregon, 546 U.S. at 274; United States v. Hayes, 595 F.2d 
258 (5th Cir. 1979), rehearing den., 598 F.2d 620 (5th Cir. 1979), 
cert. denied, 444 U.S. 866 (1979); RFAAX 1, at 2. 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).
    As for state law, Montana regulations require nurses to ``conduct 
and document nursing assessments of the health status of individuals 
and groups by: (a) collecting objective and subjective data from 
observations, examinations, interviews, and written records in an 
accurate and timely manner.'' Mont. Admin. R. Sec.  24.159.1204(1)(a). 
Further, Montana regulations require that all prescriptions must comply 
with all applicable state and federal laws and that an advanced 
practice registered nurse (APRN) with prescriptive authority must 
comply with federal DEA requirements for controlled substances. Id. 
Sec.  24.159.1464(1), (4). Finally, Montana regulations define 
unprofessional conduct of nurses as behavior ``which fails to conform 
to the accepted standards of the nursing profession and which could 
jeopardize the health and welfare of the people'' and includes ``(i) 
diversion of a medication for any purpose; (j) violating state or 
federal laws relative to drugs; . . . [and] (v) violating a state or 
federal statute while performing or attempting to perform the practice 
of nursing.'' Id. Sec.  24.159.2301(2).

III. Findings of Fact

    In light of Registrant's default, the factual allegations in the 
OSC are deemed admitted. 21 CFR 1301.43(e). Accordingly, Registrant 
admits that from June 5, 2022, until as recently as January 16, 2025, 
Registrant unlawfully issued at least 109 prescriptions for Schedule 
II-V controlled substances to Patient M.S. that were not for a 
legitimate medical purpose. OSC, at 4. Registrant admits that these 
prescriptions included the following controlled substance medications: 
alprazolam, a Schedule IV sedative; lisdexamfetamine, a Schedule II 
stimulant; hydrocodone-acetaminophen 5-325 mg, a Schedule II narcotic; 
phentermine, a Schedule IV stimulant; and tramadol, a Schedule IV 
narcotic. Id.
    Registrant admits that she issued the above controlled substance 
prescriptions to Patient M.S. despite failing to establish a medical 
condition sufficient to support the long-term use of these controlled 
substances. Id. Registrant admits that, among other things, she: failed 
to perform or document adequate physical examinations; failed to 
document an objective medical diagnosis, supported by examination or 
functional status, to support the on-going use of controlled 
substances; failed to conduct any urine drug screenings to test for 
controlled substances and non-controlled substances in order to verify 
compliance and otherwise discover noncompliance, abuse, or diversion, 
despite Patient M.S. consenting to random drug screenings; failed to 
execute a Controlled Medication Agreement with Patient M.S. outlining 
the dangers of dangerous drug combinations until one calendar year 
after Registrant began prescribing those medications to Patient M.S.; 
and failed to keep or maintain adequate notes or documents related to 
the treatment of Patient M.S. and treatment notes were often vague or 
incomplete. Id.

[[Page 64687]]

    Registrant further admits that from at least March 2023 to October 
2024, Registrant prescribed Patient M.S. a dangerous and potentially 
lethal drug combination of a stimulant, a sedative, and a narcotic. Id. 
Specifically, Registrant admits that she prescribed tramadol, 
alprazolam, lisdexamfetamine, and phentermine to Patient M.S. Id. 
Registrant admits that this combination put Patient M.S. at a 
substantial risk of adverse health consequences, including lifelong 
drug dependence and addiction, overdose, and fatal drug poisoning. Id.
    DEA retained an independent medical expert who reviewed the 
prescribing history obtained from the Montana Prescription Drug 
Reporting system as well as the patient records for Patient M.S. Id. 
DEA's medical expert opined that Registrant's issuance of the above 
prescriptions fell below the standard of care applicable to the 
practice of medicine in Montana.
    In consideration of the above, the Agency finds substantial record 
evidence that Registrant issued at least 109 controlled substance 
prescriptions to Patient M.S., in dangerous combinations, without 
adequate and accurate documentation, that lacked a legitimate medical 
purpose and were issued outside the usual course of professional 
practice in Montana.

IV. Discussion

    While the Agency has considered all the public interest factors of 
21 U.S.C. 823(g)(1), the Government's evidence in support of its prima 
facie case primarily implicates Factors B and D. RFAA, at 2-3; RFAAX 1, 
at 3-5. Evidence is considered under Factor B when it reflects 
experience dispensing controlled substances and under Factor D when it 
reflects compliance or non-compliance with laws related to controlled 
substances. Kareem Hubbard, M.D., 87 FR 21156, 21162 (2022). Although 
Factors B and D have some overlap, such that the Agency has frequently 
analyzed them 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'').

A. Factor B

    As already discussed, the CSA gives the Attorney General authority 
to revoke a registration if he determines that the registrant ``has 
committed such acts as would render his registration . . . inconsistent 
with the public interest as determined under [section 823].'' 21 U.S.C. 
824(a). One of the five factors that the Attorney General must consider 
in making this determination is the registrant's ``experience in 
dispensing . . . controlled substances.'' 21 U.S.C. 823(g)(1)(B) 
(Factor B). Neither the statute nor the implementing regulations define 
the term ``experience'' or place any limitations on the type of conduct 
that may be considered as ``experience'' under Factor B.\5\
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    \5\ The only limitation discussed in the legislative history on 
DEA's authority under Factor B is that DEA should not ``construe 
[this factor] in any way to hinder registration of recent graduates 
of professional schools who may have no professional experience 
dispensing or conducting research with controlled substances.'' H.R. 
REP. NO. 98-835, pt. 1, at 14 (1984).
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    Historically, the Agency's Factor B \6\ analysis considered ``both 
the qualitative manner and quantitative volume of the [practitioner's] 
experience . . . as expressed through his patients and employees,'' and 
concluded that the record must contain quantitative evidence regarding 
the practitioner's experience for the Agency to find that Factor B 
weighs against a practitioner. E.g., Clair L. Pettinger, 78 FR 61592, 
61619 (2013). In 2015, the Agency abandoned this language, observing 
that the text of Factor B did not require DEA to consider the 
practitioner's ``quantity'' of prescribing. See JM Pharmacy Group, 
Inc., 80 FR 28667, 28667-68 (2015); see also Wesley Pope, M.D., 82 FR 
14944, 14982 (2017). The Agency reviewed dictionary definitions of 
``experience,'' including:
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    \6\ Historically, the Agency referred to ``Factor B'' as 
``Factor Two.'' Effective December 2, 2022, the Medical Marijuana 
and Cannabidiol Research Expansion Act, Public Law 117-215, 136 
Stat. 2257 (2022) (Marijuana Research Amendments or MRA), amended 
the CSA and other statutes. Relevant to this matter, the MRA 
redesignated the public interest factors outlined at 21 U.S.C. 
823(f)(1)-(5), which the Agency referred to as Factors One through 
Five, as 21 U.S.C. 823(g)(1)(A)-(E), which the Agency now refers to 
as Factors A through E. Accordingly, this Decision cites to the 
current designation, 21 U.S.C. 823(g)(1)(B), ``Factor B.''

    (1) The ``direct observation of or participation in events as a 
basis for knowledge,'' (2) ``the fact or state of having been 
affected by or gained knowledge through direct observation or 
participation,'' (3) ``practical knowledge, skill, or practice 
derived from direct observation of or participation in events or in 
a particular activity,'' and (4) ``the length of such 
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participation.''

    80 FR at 28667 n.2 (citing Webster's Collegiate Dictionary 409 
(10th ed. 1998); The Random House Dictionary of the English Language 
681 (2d ed. 1987)).
    The word ``dispense'' means ``to deliver a controlled substance[ ] 
to an ultimate user or research subject by, or pursuant to the lawful 
order of a practitioner, including the prescribing or administering of 
a controlled substance and the packaging, labeling or compounding 
necessary to prepare the substance for such delivery.'' 21 U.S.C. 
802(10). This definition encompasses, among other things, practitioners 
who prescribe controlled substances and pharmacies who fill controlled 
substance prescriptions. Id. The term ``controlled substance'' simply 
means ``a drug or other substance . . . included in schedule I, II, 
III, IV, or V . . . .'' 21 U.S.C. 802(6). Thus, the phrase ``experience 
in dispensing'' means the direct participation in the act of 
delivering, prescribing, dispensing, or administrating a controlled 
substance to an ultimate user.
    The phrase ``experience in dispensing'' must be considered within 
the context of DEA's broad mandate under 21 U.S.C. 824(a) to deregister 
practitioners who ``ha[ve] committed such acts as would render [their] 
registration . . . inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). In other words, in determining what type of conduct is 
relevant under Factor B, DEA's primary focus is to determine whether a 
registrant's ``experience in dispensing'' is ``inconsistent with the 
public interest'' or whether a registrant's dispensing constitutes 
``acts'' that are inconsistent with the public interest. 21 U.S.C. 
823(g)(1), 824(a)(4).
    The word ``inconsistent'' is not defined in the CSA, but it is 
commonly defined as ``lacking consistency: such as (a) not compatible 
with another fact or claim, [and] (b) containing incompatible 
elements.'' Inconsistent, Merriam-Webster, <a href="https://www.merriam-webster.com/dictionary/inconsistent">https://www.merriam-webster.com/dictionary/inconsistent</a> (last visited on the date of 
signature). ``Public interest'' is a broad, discretionary term not 
explicitly defined in the CSA, but Congress identifies the primary 
goals in the CSA's introductory section as ensuring access to 
controlled substances used for a ``legitimate medical purpose'' while 
protecting the public from the ``illegal . . . distribution . . . and 
improper use of controlled substances[, which] have a substantial and 
detrimental effect on the health and general welfare of the American 
people.'' 21 U.S.C. 801(1) & (2).
    Considering these goals, DEA's Factor B analysis primarily concerns 
whether a registrant's ``experience in dispensing'' reflects illegal 
distribution or improper use of controlled substances that is 
inconsistent with the public interest. Id. In the context of a 
practitioner, this would require the Agency to evaluate whether he or 
she has dispensed

[[Page 64688]]

controlled substances in a manner that is improper, illegal, or 
inconsistent with the public interest; for example, by issuing 
prescriptions without conducting a proper examination or developing a 
supported diagnosis; ignoring patient indications of abuse, diversion, 
or improper use; issuing a prescription in a manner that is 
inconsistent with state law or the state's standards of practice; or 
issuing prescriptions for controlled substances in a way that creates a 
risk of diversion.\7\
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    \7\ Analysis of whether a prescription is illegally dispensed 
also fits within Factor D, ``Compliance with applicable State, 
Federal, or local laws relating to controlled substances.'' 21 
U.S.C. 823(g)(1)(D).
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    Of course, the Agency is not only concerned with acts of 
intentional diversion,\8\ as DEA has explained that ``[c]areless or 
negligent handling of controlled substances creates the opportunity for 
diversion and [can] justify the revocation of an existing registration 
. . .'' Samson K. Orusa, M.D., 87 FR 2986, 3018 (2022) (quoting Paul J. 
Caragine, Jr., 63 FR 51592, 51602 (1998)); see also MacKay, 75 FR at 
49974 n.35 (``Accordingly, under the public interest standard, DEA has 
authority to consider those prescribing practices of a physician, 
which, while not rising to the level of intentional or knowing 
misconduct, nonetheless create a substantial risk of diversion.''). 
Indeed, neither 21 U.S.C. 824(a) nor 21 U.S.C. 823(g) requires DEA to 
find that a registrant has intentionally diverted controlled 
substances. Ultimately, a registrant whose dispensing practices create 
an environment that encourages or is indifferent to the abuse or 
diversion of controlled substances is acting outside the public's 
interest. 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 the CSA's safeguards to ensure 
the health and general wellness of the American public.
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    \8\ Only criminally unlawful conduct requires an act of 
intentional diversion such as proof that a physician ``used `his 
authority to prescribe controlled substances . . . not for treatment 
of a patient, but for the purpose of assisting another in the 
maintenance of a drug habit' or some other illegitimate purposes, 
such as his own `personal profit.' '' United States v. McIver, 470 
F.3d 550, 559 (4th Cir. 2006) (quoted in Laurence T. McKinney, 73 FR 
43260, 43266 (2008)). Compare 21 U.S.C. 823 and 824, with 21 U.S.C. 
841, 842, 843.
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    Registrants ``may continue to introduce evidence as to . . . lawful 
. . . dispensing activities.'' \9\ However, the Agency has found that 
``evidence that a practitioner has treated thousands of patients does 
not negate a prima facie showing that the practitioner has committed 
acts inconsistent with the public interest.'' \10\ Krishna-Iyer, 74 FR 
at 463. Accordingly, the Agency has consistently rejected registrants' 
arguments that acts of unlawful prescribing were mitigated by years of 
lawful prescribing. See, e.g., Syed-Jawed Akhtar-Zaidi, 80 FR 42961, 
42967 (2015), pet. for rev. denied, 841 F.3d 707, 713 (6th Cir. 2016) 
(rejecting respondent's argument that he was denied a ``fair 
adjudication'' because the Government seized 400 patient files but only 
proved the illegality of a handful of prescriptions issued during 
undercover visits, and finding that ``the physician's prescribings to 
thousands of other patients do not . . . render her prescribings to the 
undercover officers any less unlawful, or any less acts which are 
inconsistent with the public interest'') (internal quotations and 
citations omitted).\11\
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    \9\ Randall L. Wolff, M.D., 77 FR 5106, 5153 (2012) (finding 
that evidence of lawful prescribing is ``entitled to some 
evidentiary weight only in cases where a practitioner credibly 
demonstrates an acceptance of responsibility and reform of past 
practices''); see also Roberto Zayas, M.D., 82 FR 21410, 21422 n.27 
(2017) (``[T]he Agency properly considers a [registrant's] evidence 
of a lengthy history of compliance after the Government makes out 
its prima facie case, as determining what sanction is necessary to 
protect the public interest is the ultimate purpose of these 
provisions.''). In other words, this evidence may be relevant to the 
Agency's sanctions analysis.
    \10\ ``[E]very registrant can undoubtedly point to an extensive 
body of legitimate prescribing over the course of [their] 
professional career.'' Krishna-Iyer, 74 FR at 463. Accordingly, 
except where the Agency has found in its decision that a 
prescription was issued outside the public interest or in violation 
of law, the Agency assumes that all controlled substance 
prescriptions dispensed by a pharmacy are dispensed for a legitimate 
medical purpose and in accordance with relevant laws. See Dewey C. 
Mackay, M.D., 75 FR at 49977.
    \11\ In an unreported opinion, the Sixth Circuit affirmed DEA's 
conclusion that the respondent's acts of unlawful prescribing 
outweighed his years of work experience. Orusa v. Drug Enf't Admin., 
2023 WL 3886403 at *5 (``Orusa's credentials and years of work 
experience, which the agency acknowledged, do nothing to disturb the 
agency's detailed review of his prescribing history--the relevant 
``experience in dispensing . . . controlled substances.'').
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    Here, as found above, Registrant is deemed to have admitted, and 
the Agency finds, that Registrant issued at least 109 controlled 
substance prescriptions to a patient in dangerous combinations, without 
adequate and accurate documentation, that lacked a legitimate medical 
purpose and were issued outside the usual course of professional 
practice in Montana. RFAAX 1, at 2-4. The Agency finds that 
Registrant's failure to adhere to the minimum standards governing 
Montana practice reflects ``experience in dispensing . . . controlled 
substances'' that created an opportunity for the abuse or diversion of 
controlled substances and was outside the public interest. Registrant 
did not request a hearing and thus did not provide the Agency with any 
evidence related to her ``experience in dispensing'' that served the 
public's interest. Accordingly, the Agency finds that Factor B weighs 
strongly against Registrant's continued registration.\12\
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    \12\ While the Agency has determined that Registrant's 
dispensing conduct is relevant to Factors B and D, to the extent 
that the found conduct does not fall within these factors, it would 
nevertheless constitute ``other conduct which may threaten the 
public health and safety.'' 21 U.S.C. 823(g)(1)(E). Registrant's 
repeated issuing of controlled substances to a patient in dangerous 
combinations, without adequate and accurate documentation, that 
lacked a legitimate medical purpose and were issued outside the 
usual course of professional practice in Montana, may threaten the 
public health and safety by threatening the health and safety of 
Registrant's patient and by creating the risk that controlled 
substances may leave the CSA's closed distribution system and be 
abused or diverted.
---------------------------------------------------------------------------

B. Factor D

    Under Factor D, the Agency considers a registrant's ``[c]ompliance 
with applicable State, Federal, or local laws relating to controlled 
substances.'' 21 U.S.C. 823(g)(1)(D). Here, as found above, Registrant 
is deemed to have admitted and the Agency finds that Registrant issued 
at least 109 controlled substance prescriptions that lacked a 
legitimate medical purpose and were issued outside the usual course of 
professional practice in Montana. Accordingly, the Agency finds 
substantial record evidence that Registrant violated 21 CFR 1306.04(a); 
Mont. Admin. R. Sec.  24.159.1204(1)(a), 24.159.1464(1), (4), 
24.159.2301(2).
    The Agency finds that after considering the public interest factors 
of 21 U.S.C. 823(g)(1), Factors B and D weigh in favor of revocation of 
Registrant's registration. Accordingly, the Government has 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 also finds that there is insufficient 
mitigating evidence to rebut the Government's prima facie case. Thus, 
the only remaining issue is whether, in spite of the public interest 
determination, Registrant can be trusted with a registration.

V. Sanction

    Where, as here, the Government has met the burden of showing that 
Registrant's registration is inconsistent with the public interest, the 
burden shifts to Registrant to show why she can be entrusted with a 
registration. Morall,

[[Page 64689]]

412 F.3d. at 174; Jones Total Health Care Pharmacy, LLC v. Drug Enf't 
Admin., 881 F.3d 823, 830 (11th Cir. 2018); 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, the 
Agency requires that a registrant who has committed acts inconsistent 
with the public interest accept responsibility for those acts and 
demonstrate that he will not engage in future misconduct. See Jones 
Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug 
Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). 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 
29,569, 29,573 (2018); see also Jones Total Health Care Pharmacy, 881 
F.3d at 830-31. In addition, a registrant's candor during the 
investigation and hearing is an important factor in determining 
acceptance of responsibility and the appropriate sanction. See 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. See 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. Jeffrey Stein, M.D., 84 
FR at 46972-73.
    Here, Registrant did not request a hearing or answer the 
allegations in the OSC and was therefore deemed to be in default. See 
supra I. To date, Registrant has not filed a motion with the Office of 
the Administrator to excuse the default. 21 CFR 1301.43(c)(1). 
Registrant has thus failed to answer the allegations contained in the 
OSC and has not otherwise availed herself of the opportunity to refute 
the Government's case. As such, Registrant has not accepted 
responsibility for the proven violations, has made no representations 
regarding her future compliance with the CSA, and has not demonstrated 
that she can be trusted with registration. Accordingly, the Agency will 
order the revocation of Registrant's registration.

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. ML4889347 issued to Alexandra Renee Lovec, A.P.R.N. 
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 application of Alexandra 
Renee Lovec, A.P.R.N., to renew or modify this registration, as well as 
any other pending application of Alexandra Renee Lovec, A.P.R.N., for 
additional registration in Montana. This Order is effective November 9, 
2026.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 5, 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. 2026-20751 Filed 10-8-26; 8:45 am]
BILLING CODE 4410-09-P


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