On November 10, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to Vladimir Romaniv, P.A., of Yonkers, N.Y. (Registrant). Request for Final Agency Action dated February 13, 2026 ^[1] (Public Interest (PI) RFAA), Exhibit (PI RFAAX) 1, at 1, 6. The OSC/ISO informed Registrant of the immediate suspension of his DEA Certificates of Registration Nos. MR2205602 and MR6587919, pursuant to 21 U.S.C. 824(d), alleging that Registrant's continued registration constitutes “ `an imminent danger to the public health or safety.' ” Id., at 1 (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed the revocation of Registrant's DEA registrations, alleging that Registrant's continued registration is inconsistent with the public interest. Id. (citing to 21 U.S.C. 823(g)(1), 824(a)(4)).^[2]

More specifically, the OSC/ISO alleged that from at least January 7, 2025, through at least May 7, 2025, Registrant repeatedly violated federal and state law by issuing multiple prescriptions to a patient for whom Registrant failed to conduct the necessary examination and evaluations to justify prescribing controlled substances because the patient was incarcerated at the time. Id., at 2-4. The OSC/ISO further alleged that Registrant repeatedly violated federal and state law by issuing overlapping prescriptions to this patient for the same controlled substance, as well as by issuing all of the prescriptions at issue without the contact information for Registrant's supervising physician. Id. The OSC/ISO alleged that Registrant's prescribing was in violation of 21 CFR 1306.04(a); N.Y. Pub. Health Law §§ 3331(2), 3390; N.Y. Comp. Codes R. & Regs. tit. 10, §§ 80.62(a), 80.65, 80.67(c), 94.2(e)(1)-(2). Id.^[3]

The Government's PI RFAA requests that the Agency issue a default final order revoking Registrant's registrations Nos. MR2205602 and MR6587919. PI RFAA, at 5-6.

On November 12, 2025, DEA issued an additional Order to Show Cause (OSC) to Registrant, proposing the revocation of Registrant's DEA Certificate of Registration No. MR7746184,^[4] alleging that Registrant has no state authority to handle controlled substances. Request for Final Agency Action dated February 12, 2026 ^[5] (Loss of State Authority (LSA) RFAA), Exhibit (LSA RFAAX) 2, at 1, 3 (citing 21 U.S.C. 824(a)(3)).^[6]

Specifically, the OSC alleged that Registrant is “currently without authority to prescribe, administer, dispense, or otherwise handle controlled substances in the State of Jersey, the state in which [he is] registered with DEA [under registration No. MR7746184].” Id., at 1-2 (citing 21 U.S.C. 824(a)(3)).

On February 12, 2026, the Government submitted a second RFAA requesting that the Agency issue a default final order revoking Registrant's registration, No. MR7746184, based in New Jersey. LSA RFAA, at 3-4.

After carefully reviewing the entire record and conducting analysis as set forth in more detail below, the Agency grants the Government's requests for final agency action and revokes Registrant's registrations Nos. MR2205602, MR6587919, and MR7746184.

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).

Both the OSC/ISO and the additional OSC notified Registrant of his right to file a written request for hearing, and that if he failed to file such a request, he would be deemed to have waived his right to a hearing and be in default. PI RFAAX 1, at 5-6 (citing to 21 CFR 1301.43); LSA RFAAX 2, at 2 (same). According to the Government's RFAAs, Registrant failed to request a hearing in response to either the OSC/ISO or the OSC. PI RFAA, at 1-2; LSA RFAA, at 1. Thus, the Agency finds that Registrant is in default and therefore has admitted to the factual allegations in both the OSC/ISO and OSC. 21 CFR 1301.43(e).

II. Loss of State Authority

A. Findings of Fact

According to the OSC, on November 30, 2023, Registrant's New Jersey controlled dangerous substances (CDS) license expired by its own terms. LSA RFAAX 2, at 2. According to New Jersey online records, of which the Agency takes official notice,^[7] Registrant's New ( printed page 64680) Jersey CDS license is expired. New Jersey Division of Consumer Affairs License Verification, newjersey.mylicense.com/​verification (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not licensed to handle controlled substances in New Jersey, the state in which he is registered with DEA under registration No. MR7746184.^[8]

B. Discussion

Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 “upon a finding that the registrant . . . has had his 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. § 802(21).”). The Agency has applied these principles consistently. See, e.g.,Thomas Earley, D.D.S.,91 FR 55624 (2026); Henry-Norbert O. Ndekwe, MD,90 FR 15990 (2025); Lawrence Rudolph, DMD,89 FR 79310 (2024).^[9]

According to New Jersey statute, “[e]very person who manufactures, distributes, or dispenses any controlled dangerous substance within this State or who proposes to engage in the manufacture, distribution, or dispensing of any controlled dangerous substance within this State, shall obtain a registration issued by the [Division of Consumer Affairs] in accordance with rules and regulations promulgated by it.” N.J. Rev. Stat. § 24:21-10(a) (2025). Further, “dispense” means “to deliver a controlled dangerous substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.” Id. § 24:21-2.

Here, the undisputed evidence in the record is that Registrant currently lacks authority to dispense controlled substances in New Jersey because Registrant's New Jersey CDS license is expired. As discussed, an individual must hold a New Jersey CDS license to dispense a controlled substance in New Jersey. Thus, because Registrant lacks authority to handle controlled substances in New Jersey, Registrant is not eligible to maintain DEA registration No. MR7746184 based in New Jersey. Accordingly, the Agency finds that Registrant's lack of state authority to handle controlled substances in New Jersey provides a basis for revocation of Registrant's DEA registration No. MR7746184. 21 U.S.C. 824(a)(3).

III. 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, 546 U.S. at 251 (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).^[10] 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 ( printed page 64681) 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 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, 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 New York, among other states, and the OSC/ISO has alleged violations of state laws in New York. PI RFAAX 1, at 2-4. Accordingly, the Agency must evaluate the Government's evidence under New York 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 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, 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); PI 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); PI RFAAX 1, at 2.

New York state law provides that “[a] practitioner, in good faith, and in the course of his or her professional practice only, may prescribe, administer and dispense” controlled substances. N.Y. Pub. Health Law § 3331(2); PI RFAAX 1, at 2. In addition, New York regulations provide that practitioners acting “in the course of their professional practice [ ] may dispense, administer or prescribe controlled substances for legitimate medical purposes or treatment.” N.Y. Comp. Codes R. & Regs. tit. 10, § 80.62(a); see also id. § 80.65 (“[a] prescription . . . shall be issued for a legitimate medical purpose only.”); PI RFAAX 1, at 3. Further, a practitioner's license “may be revoked . . . in whole or in part upon a finding that the licensee or certificate holder has . . . falsified any application, report, or record” or “failed to maintain effective control against diversion of controlled substances.” N.Y. Pub. Health Law § 3390; PI RFAAX 1, at 2.

Pursuant to New York regulations, a prescription for a schedule II controlled substance may not be refilled and may not exceed a 30-day supply. N.Y. Comp. Codes R. & Regs. tit. 10, § 80.67(a), (c); PI RFAAX 1, at 3. If a patient has received a 30-day supply of a schedule II controlled substance, the practitioner may not issue a new prescription for that same controlled substance until the patient has “exhausted all but a seven days' supply of that controlled substance.” Id. In other words, a practitioner may not issue overlapping prescriptions for the same controlled substance until the patient has seven or fewer days' supply remaining.

With respect to physician assistants, New York regulations state that a physician assistant may only prescribe controlled substances “in good faith and acting within his or her lawful scope of practice.” N.Y. Comp. Codes R. & Regs. tit. 10, § 94.2(e)(2); PI RFAAX 1, at 3. Further, prescriptions issued by a physician assistant must include “the name, address and telephone number of the supervising physician.” N.Y. Comp. Codes R. & Regs. tit. 10, § 94.2(e)(1); PI RFAAX 1, at 3.

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, a physician assistant, admits that on January 7, 2025, and January 8, 2025, he issued two separate prescriptions for ( printed page 64682) oxycodone-acetaminophen ^[11] 10-325 mg (a Schedule II opioid) to Patient N.A., both of which were for a 30-day supply of 59 tablets. PI RFAAX 1, at 4. Registrant admits that he issued these prescriptions without the name, address, and telephone number of his supervising physician. Id.

Registrant also admits that on February 6, 2025, he issued a prescription for promethazine with codeine 6.25-10 mg/5 ml (a Schedule V opioid) to Patient N.A. without the name, address, and telephone number of his supervising physician. ¹² Id.

Moreover, Registrant admits that between February 7, 2025, and May 8, 2025, Registrant issued at least eight prescriptions for controlled substances to Patient N.A., including oxycodone-acetaminophen 10-325 mg, oxycodone 20 mg and 15 mg (a Schedule II opioid), and promethazine with codeine 6.25-10 mg/5ml. Id. Registrant admits that Patient N.A. was incarcerated by the New York City Department of Correction during the time Registrant issued these prescriptions. Id. Registrant admits that he issued these prescriptions without having conducted any assessment or examination of Patient N.A. Id. Further, Registrant admits that he failed to conduct any verification of Patient N.A.'s location, or note that Patient N.A. was incarcerated, despite Registrant's patient charts claiming that Registrant saw Patient N.A. and that Patient N.A. was “evaluated at the clinic.” Id. Registrant also admits that, again, he issued the above prescriptions without the name, address, and telephone number of his supervising physician. Id. Registrant admits that the prescriptions issued to Patient N.A. did not result from a legitimate doctor-patient relationship. Id.

In consideration of all of the above, the Agency finds substantial record evidence that on two successive dates, Registrant issued overlapping prescriptions to N.A. for a 30-day supply of a schedule II controlled substance without having “exhausted all but a seven days' supply of that controlled substance” and that these prescriptions did not include the “name, address, and telephone number of the supervising physician.” The Agency finds substantial evidence that Registrant issued nine prescriptions for controlled substances to N.A. without the “name, address, and telephone number of the supervising physician.” The Agency also finds substantial evidence that Registrant issued eight prescriptions to N.A., while N.A. was incarcerated, without conducting an examination or establishing a legitimate doctor-patient relationship, and that Registrant falsified his patient records by noting that he evaluated N.A. “at the clinic.”

D. 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. PI 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”).

i. 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 places any limitations on the type of conduct that may be considered as “experience” under Factor B.^[13]

Historically, the Agency's Factor B ^[14] 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, MD,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 ( printed page 64683) “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 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.^[15]

Of course, the Agency is not only concerned with acts of intentional diversion ^[16] 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)); Bradley H. Chesler, MD,87 FR 4917, 4929 (2022) (citing Bienvenido Tan,76 FR 17673, 17689 (2011)); Dewey C. MacKay, MD,75 FR 49956, 49974 n.35 (2010) (“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.” ^[17] 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.” ^[18] 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).^[19]

Here, as found above, Registrant is deemed to have admitted, and the Agency finds, that Registrant issued overlapping opioid prescriptions and failed to examine or otherwise establish a bona fide doctor-patient relationship with N.A. prior to prescribing controlled substances. Registrant's prescribing 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 also falsified medical records which created further opportunities for abuse and diversion. Registrant did not request a hearing and thus did not provide the Agency with any evidence related to his “experience in dispensing” that served the public's interest. Accordingly, the Agency finds that Factor B weighs ( printed page 64684) strongly against Registrant's continued registration.^[20]

ii. 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 repeatedly violated state law by issuing overlapping prescriptions for a Schedule II opioid to N.A. (N.Y. Comp. Codes R. & Regs. tit. 10, § 80.67(c)) and failing to include the “the name, address and telephone number of the supervising physician” (N.Y. Comp. Codes R. & Regs. tit. 10, § 94.2(e)(1)). As found above, Registrant failed to examine N.A. or otherwise establish a bona fide doctor-patient relationship with N.A. prior to prescribing controlled substances. As such, the Agency finds that these controlled substance prescriptions were issued outside the usual course of professional practice, not for a legitimate medical purpose, and not in good faith, in violation of 21 CFR 1306.04(a) & 1306.06; N.Y. Pub. Health Law § 3331(2); N.Y. Comp. Codes R. & Regs. tit. 10, §§ 80.62(a), 80.65, 94.2(e)(1)-(2); see Dewey C. MacKay, 75 FR at 49973 (“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.' ”).

The Agency finds that after considering the public interest factors of 21 U.S.C. 23(g)(1), Factors B and D weigh in favor of revocation of Registrant's registrations. 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 further 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.

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 he can be entrusted with a registration. Morall, 412 F.3d at 174; Jones Total Health Care Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D.,83 FR 18882, 18904 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual registrant. Jeffrey Stein, M.D.,84 FR 46,968, 46,972 (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 29569, 29573 (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 834 & n.4. 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. Stein, 84 FR at 46972-73.

Here, Registrant did not request a hearing or answer the allegations in either the OSC/ISO or 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 either the OSC/ISO or the OSC and has not otherwise availed himself of the opportunity to refute the Government's case. Registrant's egregious misconduct involved unlawfully prescribing controlled substances to an individual with whom Registrant did not have a legitimate doctor-patient relationship, issuing prescriptions to that person without conducting an evaluation or assessment despite claiming to have done so, issuing overlapping prescriptions to that person, and issuing prescriptions without providing the information for Registrant's supervising physician. See supra III.C. As such, Registrant has not accepted responsibility for the proven violations, has made no representations regarding his future compliance with the CSA, and has not demonstrated that he can be trusted with registration. Accordingly, the Agency will order the revocation of Registrant's registrations.

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 Certificates of Registration Nos. MR2205602, MR6587919, and MR7746184 issued to Vladimir Romaniv, P.A. 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 Vladimir Romaniv, P.A., to renew or modify this registration, as well as any other pending application of Vladimir Romaniv, P.A., for additional registration in New York, Massachusetts, or New Jersey.^[21] 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 ( printed page 64685) the legal effect of this document upon publication in the Federal Register .