Vladimir Romaniv, P.A.; 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 64679-64685]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20749]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Vladimir Romaniv, P.A.; Decision and Order

    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\
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    \1\ This RFAA document is dated February 13, 2025, but this date 
appears to be a typographical error, because the RFAA was 
transmitted to the Administrator in 2026.
    \2\ Based on the Government's submissions in its PI RFAA, the 
Agency finds that service of the OSC/ISO on Registrant was adequate. 
Specifically, the Declaration from a DEA Diversion Investigator (DI) 
indicates that on November 17, 2025, Registrant was personally 
served with the OSC/ISO. PI RFAAX 2, at 1-2; see also id., Appendix 
A.
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    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 Sec. Sec.  
3331(2), 3390; N.Y. Comp. Codes R. & Regs. tit. 10, Sec. Sec.  
80.62(a), 80.65, 80.67(c), 94.2(e)(1)-(2). Id.\3\
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    \3\ The Agency need not adjudicate the criminal violations 
alleged in the OSC/ISO. Ruan v. United States, 597 U.S. 450 (2022) 
(decided in the context of criminal proceedings).
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    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\
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    \4\ According to Agency records, Registrant's registration No. 
MR7746184 expired on April 30, 2026. The fact that a registrant 
allows his registration to expire during the pendency of an OSC does 
not impact the Agency's jurisdiction or prerogative under the 
Controlled Substances Act (CSA) to adjudicate the OSC to finality. 
Jeffrey D. Olsen, MD, 84 FR 68474, 68476-79 (2019).
    \5\ The LSA RFAA is dated February 12, 2025, but this date 
appears to be a typographical error, because the LSA RFAA was 
transmitted to the Administrator in 2026.
    \6\ Based on the Government's submissions in its LSA RFAA, the 
Agency finds that service of the OSC on Registrant was adequate. 
Specifically, the Declaration from a DEA Diversion Investigator (DI) 
indicates that on November 17, 2025, Registrant was personally 
served with the OSC. LSA RFAAX 1, at 2; see also id., Appendix A.
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    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

[[Page 64680]]

Jersey CDS license is expired. New Jersey Division of Consumer Affairs 
License Verification, <a href="https://newjersey.mylicense.com/verification">https://newjersey.mylicense.com/verification</a> 
(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\
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    \7\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979).
    \8\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision 
rests on official notice of a material fact not appearing in the 
evidence in the record, a party is entitled, on timely request, to 
an opportunity to show the contrary.'' The material fact here is 
that Registrant, as of the date of this Order, is not licensed to 
handle controlled substances in New Jersey. Accordingly, Registrant 
may dispute the Agency's finding by filing a properly supported 
motion for reconsideration of findings of fact within fifteen 
calendar days of the date of this Order. Any such motion and 
response shall be filed and served by email to the other party and 
to the DEA Office of the Administrator, Drug Enforcement 
Administration, at <a href="/cdn-cgi/l/email-protection#c1a5a4a0efa0a5a5aeefa0b5b5aeb3afa4b8b281a5a4a0efa6aeb7"><span class="__cf_email__" data-cfemail="46222327682722222968273232293428233f350622232768212930">[email&#160;protected]</span></a>.
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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. Sec.  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\
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    \9\ This rule derives from the text of two provisions of the 
CSA. First, Congress defined the term ``practitioner'' to mean ``a 
physician . . . or other person licensed, registered, or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . , 
to distribute, dispense, . . . [or] administer . . . a controlled 
substance in the course of professional practice.'' 21 U.S.C. 
802(21). Second, in setting the requirements for obtaining a 
practitioner's registration, Congress directed that ``[t]he Attorney 
General shall register practitioners . . . if the applicant is 
authorized to dispense . . . controlled substances under the laws of 
the State in which he practices.'' 21 U.S.C. 823(g)(1). Because 
Congress has clearly mandated that a practitioner possess state 
authority in order to be deemed a practitioner under the CSA, DEA 
has held repeatedly that revocation of a practitioner's registration 
is the appropriate sanction whenever he or she is no longer 
authorized to dispense controlled substances under the laws of the 
state in which he or she practices. See, e.g., Benson Sergiles, 
P.A., 90 FR 32016, 32017 (2025); Jason Weakley, R.N., A.P.R.N., 90 
FR 10085 (2025); Traesa A. Brown, MD, 89 FR 24035, 24036 (2024).
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    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. Sec.  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. 
Sec.  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), 
<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).\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

[[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).
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    \10\ 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, 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 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 
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 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 Sec.  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, Sec.  80.62(a); see also id. Sec.  
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 Sec.  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, Sec.  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, Sec.  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, Sec.  
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

[[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.
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    \11\ The OSC/ISO refers to Percocet, which is a brand name for 
oxycodone-acetaminophen. See PI RFAAX 1, at 4.
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    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.
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    \12\ The OSC/ISO alleges that on February 6, 2025, and February 
7, 2025, Registrant issued two separate prescriptions for 
promethazine with codeine 6.25-10mg/5 ml to Patient N.A., both for a 
30-day supply, in violation of N.Y. Pub. Health Law Sec.  3390 and 
N.Y. Comp. Codes R. & Regs. tit. 10, Sec.  80.67(c). Id. However, 
the cited regulation only imposes the 30-day restriction on Schedule 
II controlled substances and other controlled substances identified 
by name. Promethazine with codeine is a Schedule V controlled 
substance and it is not otherwise identified as a covered substance. 
Accordingly, the Agency does not sustain this allegation.
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    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\
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    \13\ 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 \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:
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    \14\ 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

[[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, <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 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\
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    \15\ Analysis of whether a prescription is illegally filled, 
distributed, prescribed, or possessed also fit 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 \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.
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    \16\ 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.'' \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\
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    \17\ 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.
    \18\ ``[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 are dispensed or prescribed for a legitimate medical 
purpose and in accordance with relevant laws. See Dewey C. Mackay, 
M.D., 75 FR at 49977.
    \19\ 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 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

[[Page 64684]]

strongly against Registrant's continued registration.\20\
---------------------------------------------------------------------------

    \20\ While the Agency has determined that Registrant's improper 
prescribing 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 issuance of controlled substance prescriptions to a patient 
outside the usual course of professional practice and not for a 
legitimate medical purpose may threaten the public health and safety 
by creating the risk that controlled substances may leave the CSA's 
closed distribution system and be abused or diverted.
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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, 
Sec.  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, Sec.  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 Sec.  3331(2); N.Y. 
Comp. Codes R. & Regs. tit. 10, Sec. Sec.  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.
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    \21\ The Agency may revoke Respondent's Massachusetts 
registration based on Respondent's egregious misconduct in New York. 
See, e.g., Roberto Zayas, M.D., 82 FR 21410, 21430 (2017) (revoking 
the physician's Florida registration and denying his Texas renewal 
application based on misconduct in Texas). The Administrator's 
determination that Registrant may not be trusted with a registration 
disqualifies him for current DEA registration in all states. See 
Suntree Pharmacy and Suntree Medical Equipment, LLC, 85 FR 73753, 
73755 (2020) (``If a practitioner holding multiple registrations 
cannot be entrusted with one, it would be difficult to justify 
entrusting the same practitioner with another in a separate 
location.'').
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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

[[Page 64685]]

the legal effect of this document upon publication in the Federal 
Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-20749 Filed 10-8-26; 8:45 am]
BILLING CODE 4410-09-P


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