Document

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

Department of Justice Drug Enforcement Administration On December 22, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Alexan...

Department of Justice
Drug Enforcement Administration

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]

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. § 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.

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), www.congress.gov/​crs-product/​R45948.

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 ( printed 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).

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); see5 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 also21 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. § 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. § 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. § 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. ( printed 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]

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:

(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 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, www.merriam-webster.com/​dictionary/​inconsistent (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 ( printed 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]

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.

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]

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]

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. § 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, ( printed 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.

Footnotes

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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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).

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3.  The OSC also alleged that Registrant violated Mont. Admin. R. § 24.159.1204(5), but the deemed-admitted facts were insufficient to find a violation regarding this allegation.

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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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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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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.”

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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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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)). Compare21 U.S.C. 823 and 824, with21 U.S.C. 841, 842, 843.

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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.

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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.

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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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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.

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[FR Doc. 2026-20751 Filed 10-8-26; 8:45 am]

BILLING CODE 4410-09-P

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91 FR 64685

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“Alexandra R. Lovec, A.P.R.N.; Decision and Order,” thefederalregister.org (October 9, 2026), https://thefederalregister.org/documents/2026-20751/alexandra-r-lovec-a-p-r-n-decision-and-order.