Muhamad Aly Rifai, M.D.; Decision and Order

Issuing agencies

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<title>Federal Register, Volume 91 Issue 200 (Monday, October 19, 2026)</title>
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[Federal Register Volume 91, Number 200 (Monday, October 19, 2026)]
[Notices]
[Pages 66156-66163]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21258]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Muhamad Aly Rifai, M.D.; Decision and Order

I. Introduction

    On November 30, 2023, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) to Muhamad Aly Rifai, 
M.D. (Respondent). Request for Final Agency Action (RFAA), Exhibit 
(RFAAX) 3, at 1, 7. The OSC proposed the revocation of Respondent's DEA 
Certificate of Registration, No. BR7552272, in Easton, Pennsylvania. 
Id. at 3. The OSC alleged that Respondent's registration should be 
revoked because his ``continued registration is inconsistent with the 
public interest.'' Id. at 1 (citing 21 U.S.C. 823(g)(1)). The OSC also 
proposed the revocation of Respondent's registration, alleging that the 
``falsification of patient medical records to conceal the unlawful 
prescribing of controlled substances may be considered by the Agency as 
conduct that threatens the public health or safety and grounds to 
revoke or deny a DEA Registration.'' Id. at 3.

A. Procedural Background

    On December 28, 2023, Respondent filed a timely hearing request 
with the Office of the Administrative Law Judges (ALJs). Id. at 2; see 
RFAAX 25, at 17-19. A hearing on the merits was initially scheduled for 
April 29, 2024. RFAAX 5, at 5. After some lengthy procedural exchanges 
between the parties and the ALJ,\1\ the matter was terminated because 
the ALJ found that Respondent ``desires delay, during which time he can 
continue to prescribe schedule II controlled substances despite very 
serious allegations against him.'' RFAAX 2, at 16. The ALJ then 
terminated the hearing proceedings on August 20, 2024, and concluded 
that the ``Respondent, in fact, does not desire a hearing before this 
tribunal.'' RFAAX 2, at 16. The ALJ did not find that Respondent was in 
default. RFAAX 2.
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    \1\ The lengthy procedural history in this matter is set forth 
fully in the ALJ's August 20, 2024, Order Vacating Stay and 
Terminating Proceedings. RFAAX 2, at 1-17.
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    Thereafter, on September 5, 2024, the Government submitted a 
request for final agency action arguing that the Administrator may 
enter a default final revoking Respondent's registration. RFAAX 25, at 
1, 4. On July 8, 2025, the Administrator denied the Government's 
request to find Respondent in default because Respondent ``continued to 
defend his case and contest the allegation on their merits.'' RFAAX 26, 
at 8; see RFAA, at 6. Instead, the Administrator found that the ALJ's 
Termination Order arose from her duties ``to take all necessary action 
to avoid delay, and to maintain order.'' RFAAX 26, at 2 (citing 21 CFR 
1316.52). The Administrator then returned the matter to the Government 
for further action, including an opportunity to file a new RFAA that 
contains substantial record evidence supporting the revocation of 
Respondent's registration. RFAAX 26, at 8-9.
    On August 25, 2025, the Government submitted another RFAA and 
requested that the Agency revoke Respondent's registration because his 
prescribing patterns were ``outside the usual course of professional 
practice and not for a legitimate medical purpose'' and Respondent 
falsified patient medical records. RFAA, at 18 (citing 21 CFR 
1306.04(a) and multiple state laws).\2\ The Government contended that 
these violations demonstrated that Respondent's continued registration 
is inconsistent with the public interest. RFAA, at 19 (citing 21 U.S.C. 
824(a)(4), 823(g)(1)(B), (D)).\3\
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    \2\ 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).
    \3\ The Government cited to 21 U.S.C. 823(f)(2), (4), which is 
not the current designation of the public interest factors. 
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 Controlled 
Substances Act (CSA) and other statutes. Relevant to this matter, 
the MRA redesignated 21 U.S.C. 823(f), cited in the OSC, as 21 
U.S.C. 823(g)(1). Accordingly, this Decision cites to the current 
designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA 
throughout.
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    After carefully reviewing the entire record and conducting the 
analysis as set forth in more detail below, the Agency grants the 
Government's RFAA and revokes Respondent's registration.

II. Law Applicable to Public Interest Determination

A. Legal Background on Public Interest Determinations

    Congress enacted the Controlled Substances Act (CSA) ``to conquer 
drug abuse and control the legitimate and illegitimate traffic in 
controlled substances.'' Gonzales v. Raich, 545 U.S. 1, 12 (2005). A 
particular concern of Congress was ``the need to prevent the diversion 
of drugs from legitimate to illicit channels,'' and it ``devised a 
closed regulatory system making it unlawful to manufacture, distribute, 
dispense, or possess any controlled substance except in a manner 
authorized by the CSA.'' Id. at 12-13.
    The CSA's requirements under this closed regulatory system include 
that ``[e]very person who dispenses, or who proposes to dispense, any 
controlled substance, shall obtain from the [DEA] a registration.'' 21 
U.S.C. 822(a)(2); see also Gonzales v. Raich, 545 U.S. at 27-28. To 
protect the American people and ensure compliance with the CSA, 
Congress empowered the Agency \4\ to deny, suspend, or revoke a 
registration if it would be inconsistent with the public interest. 21 
U.S.C. 823(g)(1); 21

[[Page 66157]]

U.S.C. 824(a)(4); Gonzales v. Oregon, 546 U.S. 243, 251 (2006).
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    \4\ The CSA delegates this power to the Attorney General, who 
has delegated it to the Administrator of the DEA (the Agency) by 28 
CFR 0.100.
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    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. 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,'' which is defined in 21 U.S.C. 
802(21) to include a ``physician,'' Congress directed the Attorney 
General to consider five factors in making the public interest 
determination. Gonzales v. Oregon, 546 U.S. at 251; 21 U.S.C. 
823(g)(1)(A-E). The five factors are:

    (A) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (B) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (C) The applicant'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).

    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 purposes, 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).
    These 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).

B. Law Applicable to Falsified Medical Records

    The OSC alleges that Respondent acted outside the public interest 
when he falsified the medical records of an undercover law enforcement 
officer (UC) purporting to seek medical treatment. RFAAX 3, at 3. The 
OSC notes that falsification of medical records to conceal the true 
nature of prescribing practices is conduct that may threaten the public 
health and safety. RFAAX 3, at 3; see Jerry Neil Rand, M.D., 61 FR 
28895, 28897 (1996) (finding that falsifying patient charts in which 
Respondent had prescribed controlled substances is inconsistent with 
the public interest).
    Regarding recordkeeping, under Pennsylvania law, ``[a] physician 
shall maintain medical records for patients which accurately, legibly 
and completely reflect the evaluation and treatment of the patient'' 
and ``[t]he medical record shall contain information sufficient to 
clearly identify the patient, the person making the entry if the person 
is not the physician--such as a physician assistant or a certified 
registered nurse practitioner--the date of the medical record entry and 
patient complaints and symptoms.'' 49 Pa. Code Sec.  16.95(a)-(b); see 
RFAAX 3, at 2-3. Moreover, Pennsylvania law provides that ``[t]he 
medical record shall also include diagnoses, the findings and results 
of pathologic or clinical laboratory examination, radiology

[[Page 66158]]

examination, medical and surgical treatment and other diagnostic, 
corrective or therapeutic procedures.'' Id. at Sec.  16.95(d). 
Pennsylvania law also instructs practitioners to follow certain minimal 
standards when prescribing controlled substances, including 
recordkeeping: ``[a]ccurate and complete medical records must document 
the evaluation and care received by patients.'' 49 Pa. Code Sec.  
16.92(a)(4) (emphasis added); see RFAAX 3, at 2.\5\
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    \5\ The OSC erroneously cites to 49 Pa. Code Sec.  16.92(b) 
instead of (a). RFAAX 3, at 2.
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C. Law Applicable to Improper Prescribing of Controlled Substances

    The OSC also alleges that Respondent acted outside the public 
interest when he improperly issued controlled substance prescriptions 
to UC. RFAAX 3, at 3-5. According to the CSA's implementing 
regulations, a lawful prescription for controlled substances 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). Pennsylvania 
state law similarly requires that ``[a] prescription for a controlled 
substance must be issued for a legitimate medical purpose by a licensed 
practitioner in the usual course of professional practice.'' 28 Pa. 
Code Sec.  25.52(a); see RFAAX 3, at 2.
    Pennsylvania law also requires practitioners to take ``an initial 
medical history'' and conduct ``an initial physical examination'' prior 
to prescribing controlled substances, make ``[r]eevaluations of the 
patient's condition and efficacy of the controlled substance . . . 
consistent with the condition diagnosed, the controlled substance or 
substances involved, expected results and possible side effects,'' and 
counsel ``[t]he patient . . . regarding the condition diagnosed and the 
controlled substance prescribed, administered or dispensed.'' 49 Pa. 
Code Sec.  16.92(a)(1)-(3); see RFAAX 3, at 2.
    A practitioner in Pennsylvania may prescribe, administer, or 
dispense a controlled substance or other drug or device only under the 
following conditions: ``(i) in good faith in the course of his 
professional practice, (ii) within the scope of the patient 
relationship, and (iii) in accordance with treatment principles 
accepted by a responsible segment of the medical profession.'' 35 Pa. 
Const. Stat. Sec.  780-111(d); see RFAAX 3, at 3.

III. Findings of Fact

    Respondent is a Pennsylvania-licensed psychiatrist who prescribed 
dextroamphetamine-amphetamine, a Schedule II stimulant, to UC on three 
separate occasions. RFAA, at 7-8; RFAAX 2, at 1 n. 1; RFAAX 3, at 3-
5.\6\ Specifically, on May 17, 2021, Respondent prescribed 30 tablets 
of dextroamphetamine-amphetamine 5 mg and instructed that UC take one 
tablet two times per day for fifteen days. RFAAX 3, at 4. On June 11, 
2021, Respondent issued UC a prescription for 60 tablets of 
dextroamphetamine-amphetamine 10 mg and instructed that UC take one 
tablet two times per day for thirty days. RFAAX 3, at 4. Finally, on 
August 9, 2021, Respondent issued to UC a prescription for 60 tablets 
of dextroamphetamine-amphetamine 15 mg to be taken two times per day 
for thirty days. RFAAX 3, at 5.
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    \6\ The parties stipulated, in part, to allegations 4, 5, and 6 
as stated in the OSC, to the extent that the Respondent prescribed 
UC a specified quantity of the controlled substance on the 
identified date. RFAAX 5, at 2 n.1.
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    UC provided a declaration under penalty of perjury, pursuant to 28 
U.S.C. 1746.\7\ RFAAX 28, at 1-7.
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    \7\ 28 U.S.C. 1746 allows a written unsworn declaration in 
proper form as true under penalty of perjury to substitute for an 
affidavit. While the Federal Rules of Evidence (FRE) do not apply 
directly to DEA administrative hearings, it may be used for 
guidance, where they do not conflict with agency regulations. In the 
Matter of Rosalind A. Cropper, M.D., 66 FR 41040, 41041. The 
Advisory Committee Notes on FRE 56(c)(4) state that a declaration 
can be used to support a motion as long as it is made under penalty 
of perjury and dated. See Fed. R. Civ. P. 56(c), advisory 
committee's note to 2010 amendment.
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A. Falsifying Medical Records

    In September 2023, DEA subpoenaed Respondent for all medical 
patient records related to UC. RFAAX 31, at 1. Respondent provided the 
following documentation dated May 17, 2021: Patient Information Sheet; 
Patient Symptom Intake Form; History and Personal Data Questionnaire; 
Authorization for Release of Confidential Information; Patient 
Cancellation Policy; Acknowledgement; Notice of Privacy Practices; 
Patient Financial Responsibility for Healthcare Services; Medication 
Refill Policy; Patient Laboratory Screening; Disability and Related 
Paperwork Protocol; Patient Medication Risk; Psychiatric Evaluation; 
Consent to Contract to Participate in treatment using Stimulant 
Medication; Urine Drug Screen--12 Panel Integrated Test Cup; The Test 
of Variables Attention; Audit-C; Patient Health Questionnaire (PHQ-9); 
GAD-7 Anxiety; and Adult ADHD Self-Report Scale Symptom Checklist. 
RFAAX 32, at 1-38. Additionally, Respondent submitted the following 
documentation: Psychiatric Progress Notes indicating an in-person 
appointment on May 17, 2021; a video telemedicine follow-up on June 11, 
2021; and a telehealth appointment on August 9, 2021; Urine Drug 
Screen--12 Panel Integrated Test Cup with results dated August 9, 2021; 
a letter dated August 9, 2021, to UC informing her that Respondent can 
no longer provide UC with psychiatric services because she has been 
approved for medical cannabis treatment; and a patient controlled 
substance report showing prescriptions for ``amphetamine salt combo'' 
issued by Respondent on May 17, 2021, June 11, 2021, and August 9, 
2021. RFAAX 32, at 39-50; see RFAAX 35, at 1-3.
    In her declaration under penalty of perjury pursuant to 28 U.S.C. 
1746, which was signed and dated, UC attested that she did not produce 
or disclose any medical documentation from previous providers, 
diagnostic or testing results, or laboratory test results to 
Respondent. RFAAX 28, at 3. UC stated under penalty of perjury that she 
did not complete or orally answer questions to the following forms: 
Patient Symptom Intake Form, History and Personal Data Questionnaire, 
Patient Medical Risk, Consent and Contract to Participate in Treatment 
Using Stimulant Medication, Urine Drug Screen--12 Panel Integrated Test 
Cup dated May 17, 2021, Audit C, Patient Health Questionnaire (PHQ-9), 
GAD-7 Anxiety, and Adult ADHD Self-Report Scale (ASR-v1.1) Symptom 
Checklist. RFAAX 28, at 3-4.
    UC clarified that she never provided a urine specimen during her 
psychiatric visit and evaluation on May 7, 2021. RFAAX 28, at 4. UC 
also attested that she never provided a urine specimen on August 9, 
2021. RFAAX 28, at 6. Moreover, contrary to the contents of the 
psychiatric evaluation dated May 8, 2021, UC declared under penalty of 
perjury that she never stated that she needed help, had problems with 
low mood, low concentration or anxiety, that she had a history of 
antidepressants, that she was worried about harming her customers due 
to lack of focus, that she had a family history of siblings with 
depression or anxiety, that her maternal aunt committed suicide, she 
had a family history of alcoholism, that her sister had ADD, that her 
mom stated she was ``all hyper,'' that her family has a poor 
relationship, that she experienced physical and mental abuse by parents

[[Page 66159]]

while growing up, or that she had sporadic cannabis use. RFAAX 28, at 
4; see RFAAX 32, at 16-19; RFAAX 39, at 1-26; RFAAX 40, at 1-8; RFAAX 
41, at 1-4.
    UC stated that on June 11, 2021, she had telephone conversations 
with staff members at Respondent's practice but did not interact with 
Respondent. RFAAX 28, at 4; see RFAAX 40, at 1-8. However, Respondent's 
progress note shows that the appointment was with a ``secure video.'' 
RFAAX 32, at 41-42. UC also stated that on August 9, 2021, she spoke 
with a nurse practitioner via telephone and asked that her prescription 
for dextroamphetamine-amphetamine be increased in strength and 
refilled. RFAAX 28, at 5; see RFAAX 41, at 1-4. But Respondent's 
progress note shows that the appointment was via ``telehealth'' and 
``Office Visit in person.'' RFAAX 32, at 43, 44.
    Contrary to Respondent's progress notes, UC stated that she never 
expressed to Respondent that she struggled with ADHD symptoms, that she 
requested an increase in the strength of her prescription so that she 
would be able to focus on work, that she used cannabis periodically to 
alleviate anxiety or alcohol use, or that she possessed a medical 
marijuana card. RFAAX 28, at 6; but see RFAAX 32, 39-45. Notably, UC 
stated that Respondent had copied her signature from a form that she 
had filled out to the other medical records that she never completed, 
and the copy of the signature was done without her knowledge or 
consent. RFAAX 28, at 4.
    Where Respondent's medical documents conflict with UC's statements, 
the Agency credits UC's statements, which have more weight than 
Respondent's forged and falsified medical documentation.\8\ Here, the 
Agency finds substantial record evidence that Respondent falsified UC's 
medical records documenting telehealth examinations, in-person 
evaluations, diagnostic tests, and patient-doctor discussions that did 
not occur and falsified medical records that were not filled out or 
completed by UC. RFAAX 28, at 3-5; see RFAAX 32, at 2-4, 15-21, 22-29, 
30-37, 46-47. In contrast, UC's declaration was signed and dated under 
penalty of perjury pursuant to 28 U.S.C. 1746. RFAAX 28, at 7; see U.S. 
ex rel. Doe v. Heart Solution, P.C., 923 F.3d 308, 315 (3d Cir. 2019) 
(an unsworn statement pursuant to 28 U.S.C. 1746 may be considered on 
summary judgment). Significantly, there is no contrary evidence 
discrediting UC's signed declaration. See Edge Pharmacy, 81 FR 72092, 
72101-72102 n. 23 (2016) (accepting a declaration pursuant to 28 U.S.C. 
1746 as credible because it was signed and dated under the penalty of 
perjury).
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    \8\ When comparing the documents that UC stated that she did not 
complete with the ones that she did, the signatures of the two sets 
of documents appear to be different. For example, UC completed the 
Authorization For Release of Confidential Information and the 
Patient Cancellations forms, and her signature shows a space between 
her first name and last name. RFAAX 32, at 6, 8. But on the forms 
that UC declared that she did not complete, such as the Patient 
Medication Risk form and the Consent and Contract to Participate in 
treatment using Stimulant Medication form, her signature is devoid 
of the space between the first and last name. RFAAX 32, at 15, 20; 
see RFAAX 28, at 3-4. In fact, UC attested in her declaration that 
Respondent had copied her signature from the Disability Related 
Paperwork Protocol form, which she had signed, to other forms that 
she never filled out. RFAAX 28, at 4; see RFAAX 32, at 14. In this 
case, when comparing the documents and reviewing the evidence of 
record, the Agency finds that UC's statement regarding her forged 
signature is true and correct.
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    Accordingly, based on UC's declaration pursuant to section 1746, 
which is signed and dated under the penalty of perjury, Agency finds 
substantial record evidence that Respondent's medical records for UC, 
including numerous diagnostic tests, were falsified.

B. Improper Prescribing

    As mentioned above, UC was prescribed dextroamphetamine-amphetamine 
on three separate occasions. RFAAX 35, at 1-3; see RFAAX 28, at 1-2. 
Specifically, on May 17, 2021, UC paid $300 in cash for the first 
visit, at which time she was interviewed by ``students'' regarding her 
medical history. RFAAX 28, at 2; see RFAAX 39, at 1-26. At that time, 
UC indicated that she had been previously prescribed medication that 
contained dextroamphetamine-amphetamine and another drug to help her 
with sleeping but that she did not remember the name of her previous 
practitioner. RFAAX 28, at 2; see RFAAX 39, at 5-6. UC told the 
students that she did not know whether she had a history of attention-
deficient/hyperactivity disorder (ADHD), and that she did not possess 
an identification card because it had been revoked due to a driving 
under the influence (DUI) arrest. RFAAX 28, at 2; see RFAAX 39, at 4-
11. On that day, UC also interacted with Respondent and informed him 
that UC had been prescribed dextroamphetamine-amphetamine by another 
doctor two to three years prior, and that she was again seeking 
prescriptions of dextroamphetamine-amphetamine because it helps her 
``g[e]t along better.'' RFAAX 28, at 2; RFAAX 39, at 16. She witnessed 
Respondent check the state prescription drug monitor program (PDMP) for 
prior prescription of dextroamphetamine-amphetamine, but he was not 
able to find a record of any controlled substance prescribed to UC in 
the past five years. RFAAX 28, at 2-3; see RFAAX 39, at 19. UC also 
explained to Respondent that she had been arrested for DUI, and 
Respondent then discussed the seriousness of alcoholism. RFAAX 28, at 
3; RFAAX 39, at 23-24. Thereafter, without diagnosing or specifying the 
nature of UC's condition and without counseling UC regarding any 
condition, Respondent prescribed 30 tablets of dextroamphetamine-
amphetamine 5mg to be taken two times per day for 15 days. RFAAX 28, at 
3; see RFAAX 35, at 1.
    Regarding the June 11, 2021, interaction, UC noted that she engaged 
in telephone conversations with staff members at the practice but not 
directly with Respondent. RFAAX 28, at 4; see RFAAX 40, at 1-8. UC 
communicated with one of the students working at the practice and 
informed her that she was taking two tablets once a day instead of one 
tablet twice a day. RFAAX 28, at 4; RFAAX 40, at 5. The only comment 
that UC made to the student was that the medication ``just did not last 
throughout the day.'' RFAAX 40, at 5; RFAAX 28, at 4. The student then 
informed UC that she would speak to Respondent and check if UC's 
prescription strength could be increased. RFAAX 28, at 4-5; RFAAX 40, 
at 6. The student then called back and informed UC that Respondent 
would increase UC's prescription strength to 10mg of dextroamphetamine-
amphetamine two times per day for two weeks. RFAAX 28, at 5; RFAAX 40, 
at 7-8. Ultimately, without speaking to or reevaluating UC, Respondent 
prescribed 60 tablets of dextroamphetamine-amphetamine and increased 
the prescription strength to 10 mg to be taken two times per day for 30 
days. RFAAX 28, at 5; RFAAX 35, at 2.
    Regarding UC's third interaction with Respondent's office on August 
9, 2021, UC spoke to a student working for Respondent about again 
increasing the strength of dextroamphetamine-amphetamine. RFAAX 28, at 
5; see RFAAX 41, at 1-4. When the student inquired about the reason for 
the request to increase the prescription strength, UC responded that 
``I just think it doesn't last long enough.'' RFAAX 41, at 2; RFAAX 28, 
at 5. The student called back and informed UC that Respondent, who did 
not speak to UC or reevaluate UC in person, was increasing the 
dextroamphetamine-amphetamine prescription to 15 mg for two times per 
day for 30 days. RFAAX 28, at 5; see RFAAX 41, at 3; RFAAX 35, at 3. 
The

[[Page 66160]]

student also mentioned to UC that Respondent had requested an in-office 
visit for the next appointment to perform a urine drug screen. RFAAX 
28, at 5; RFAAX 41, at 3.
    Supporting UC's statements regarding the prescriptions, the record 
shows that a DEA diversion investigator also provided a declaration 
under penalty of perjury pursuant to 28 U.S.C. 1746 that he generated a 
spreadsheet report from Pennsylvania PDMP, which is a state-run program 
that includes a computerized platform administered by the Pennsylvania 
Department of Health. RFAAX 29, at 2-3. The Pennsylvania PDMP shows 
that prescriptions for amphetamine salt combo in tablet forms were 
written and filled by Respondent on May 17, 2021, June 11, 2021, and 
August 9, 2021. RFAAX 34, 1-3; RFAAX 32, 48-50.
    As previously mentioned, there was substantial evidence that UC 
never completed the above-mentioned medical documents or underwent 
diagnostic tests. Based on the transcript of UC's initial visit and two 
phone conversations and UC's signed and dated declaration, there is 
substantial record evidence that Respondent improperly prescribed 
controlled substances by failing to diagnose UC or counsel UC regarding 
the medical condition prior to issuing the three prescriptions.\9\ 
Furthermore, the Agency finds substantial record evidence that 
Respondent prescribed controlled substances to UC on three separate 
occasions without providing an accurate and complete initial evaluation 
or any reevaluation.
---------------------------------------------------------------------------

    \9\ The August 9, 2021, prescription shows diagnoses of major 
depressive disorder and ADHD. RFAAX 35, at 3. However, the 
transcripts of one in-person visit and two phone conversations do 
not reflect Respondent's diagnoses of such disorders or any 
counseling regarding the conditions that were diagnosed. See RFAAX 
39, at 1-26; RFAAX 40, at 1-8; RFAAX 41, at 1-4.
---------------------------------------------------------------------------

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 11-19. 
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).\10\
---------------------------------------------------------------------------

    \10\ Historically, the Agency has analyzed Factors B and D 
together. However here, the Agency will analyze Factors B and D 
separately to capture the conduct Congress intended the Agency to 
consider under Factor B 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 D: Compliance With Applicable State, Federal, or Local Laws 
Relating to Controlled Substances

    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). In the current matter, the 
Government has alleged that Respondent violated Pennsylvania laws and 
federal law related to controlled substances. RFAAX 3, at 1-7. 
Specifically, the OSC alleges that Respondent did not comply with 49 
Pa. Code Sec.  16.92(a)(4) and 49 Pa. Code Sec.  16.95(a)-(e) because 
he failed to maintain medical records that are accurate, legible, and 
complete, and thereby failed to meet minimum Pennsylvania standards 
involving the prescribing of controlled substances. RFAAX 3, at 2-5. 
The OSC also alleges that Respondent was not compliant with 21 CFR 
1306.04(a) when he issued the prescription without a legitimate medical 
purpose. RFAAX 3, at 1.
1. False Medical Records
    Specifically, the Agency finds that Respondent submitted multiple 
documentations that were not completed or filled out by UC. See RFAA, 
at 15-18. UC attested that she never filled out the Patient Symptom 
Intake Form, History and Personal Data Questionnaire, Patient 
Medication Risk, Consent and Contract to Participate in Treatment Using 
Stimulant Medication, Urine Drug Screen--12 Panel Integrated Test Cup 
dated May 17, 2021, Audit C, Patient Health Questionnaire (PHQ-9), GAD-
7 Anxiety, and Adult ADHD Self-Report Scale Symptom Checklist. RFAAX 
28, at 3-4. However, Respondent produced those documents pursuant to 
DEA's subpoena. See RFAXX 32, at 2-4, 15-21, 30-38. Crediting UC's 
attestation, it appears that Respondent submitted numerous falsified 
documents to give the appearance that he was in compliance with the 
law.
    Not only were the relevant documents not completed by UC as they 
purported to be, but the contents of the documents are inaccurate. For 
example, UC stated that she never told Respondent that she had used 
cannabis to alleviate anxiety or lessen alcohol use, or that she 
possessed a medical marijuana card. RFAAX 28, at 6. The transcripts of 
UC's interaction with Respondent and his staff confirm UC's statement 
that she never told Respondent that she had used cannabis or possessed 
a marijuana card. See RFAAX 39, at 1-26; see also RFAAX 28, at 1-7. 
However, Respondent's records include an evaluation stating that ``[UC] 
admits to periodic cannabis use to help anxiety, less alcohol use. 
Reports Medical Marijuana Card. Could not find her name in the Medical 
Cannabis Registry.'' RFAAX 32, at 43. The records also include a letter 
indicating that Respondent had to terminate his ``professional 
relationship'' with UC because of her cannabis use. RFAAX 32, at 47. UC 
never received the purported patient termination letter or other notice 
that she was discharged as a patient. RFAAX 26, at 6.
    Based on the entire record, including UC's credible declaration, 
the Respondent's falsification of medical records displays a clear 
violation of state law. Specifically, the Agency finds substantial 
record evidence that Respondent violated 49 Pa. Code Sec.  16.92(a)(4) 
by failing to maintain medical records that were accurate and complete 
when prescribing controlled substances. See RFAAX 28, at 1-7; RFAAX 39, 
at 1-26; RFAAX 40, at 1-8; RFAAX 41, at 1-4. Similarly, the Agency 
finds substantial record evidence that Respondent violated 49 Pa. Code 
Sec.  16.95(a) by failing to provide accurate, legible and complete 
records regarding the evaluation and treatment of UC. See RFAAX 28, 1-
7. Therefore, the Agency finds that Respondent failed to comply with 
applicable state laws involving the recordkeeping of controlled 
substances.
2. Improper Prescribing
    Moreover, as discussed above, the Agency found that Respondent 
prescribed dextroamphetamine-amphetamine on three separate occasions 
without performing an initial examination that included a diagnostic 
test or an objective evaluation, conducting a reevaluation when 
increasing the strength of the controlled substances, and counseling 
the patient regarding the diagnosed condition. See RFAAX 28, at 1-7; 
RFAAX 39, at 1-26; RFAAX 40, at 1-8; RFAAX 41, 1-4. For instance, UC 
never completed a form related to her medical history or her symptoms 
and did not undergo any diagnostic tests. RFAAX 28, at 3-6; see RFAAX 
39, at 1-26; RFAAX 40, at 1-8; RFAAX 41, 1-4. Respondent did not 
reevaluate UC's condition when she requested that her prescription be 
refilled with a higher dosage. See RFAAX 40, at 1-8; RFAAX 41, at 1-4.
    Additionally, Respondent never counseled UC regarding the condition 
diagnosed and the controlled substance

[[Page 66161]]

prescribed; instead, he merely stated, ``[h]opefully[,] you'll be able 
to uh focus and concentrate and work on your sobriety.'' RFAAX 39, at 
23. As such, the Agency finds substantial record evidence that 
Respondent's prescribing practices violated Pennsylvania's minimum 
standards required to be carried out when prescribing controlled 
substances. 49 Pa. Code Sec.  16.92(a)(1)-(3).
    Furthermore, the Agency finds that Respondent's improper 
prescribing violated both federal and state law, namely 21 CFR 
1306.04(a) and 28 Pa. Code Sec.  25.52(a), when he prescribed 
controlled substances without a proper examination and diagnosis,\11\ 
RFAAX 35, at 1-3, and falsified medical records in an attempt to 
conceal the unlawful prescribing practices. See RFAAX 32, at 21, 22-38, 
46. Respondent seems to have falsified medical records and fabricated 
diagnostic test results and the urine test result because he knew that 
he lacked a legitimate medical purpose \12\ for prescribing 
dextroamphetamine-amphetamine. See Hunt, 75 FR at 50003 (finding that 
falsifying medical records demonstrates a practitioner's knowledge or 
awareness of a lack of legitimate medical purpose when prescribing 
controlled substances).
---------------------------------------------------------------------------

    \11\ The Government typically establishes that a practitioner 
issued prescriptions without a legitimate medical purpose or outside 
the usual course of professional practice in violation of 21 CFR 
1306.04(a) through, or with the support of, expert testimony. 
However, prior DEA decisions have found that the nature of the 
allegations and the evidence on the record can establish violations 
of Section 1306.04(a) without necessitating the support of expert 
opinion. Zeljko Stjepanovic, M.D., 85 FR 80152, 80155-56 (2020) 
(citing DEA decisions that found that even without expert testimony, 
prescriptions can lack a legitimate medical purpose). For example, a 
prior DEA decision found that a physician lacked legitimate medical 
purpose based on statements made during undercover visits and 
falsification of patient chart. Robert F. Hunt, D.O., 75 FR 49995, 
50003 (2010).
---------------------------------------------------------------------------

    Accordingly, because Respondent was not in compliance with state 
and federal laws relating to controlled substances, the Agency finds 
that Factor D weighs in favor of revoking Respondent's registration 
and, thus, finds Respondent's continued registration to be inconsistent 
with the public interest. See John X. Qian, 87 FR 8039, 8055 (2022) 
(``DEA's ability to assess whether controlled substances registrations 
are consistent with the public interest is predicated upon the ability 
to consider the evidence and rationale of the practitioner at the time 
that he prescribed a controlled substance--adequate documentation is 
critical to that assessment.'').
    As Respondent's case was properly terminated by the ALJ, he has 
waived the opportunity to present evidence and, therefore, to rebut the 
Government's prima facie case.\13\ See RFAAX 26, 1-9.\14\ The 
Government's prima facie case was established by substantial record 
evidence. Accordingly, the Agency finds that there is substantial and 
uncontroverted record evidence supporting the revocation of 
Respondent's registration based on Factor D alone. 21 U.S.C. 
823(g)(1)(D); see John X. Qian, 87 FR 8039, 8055 (revoking the 
respondent's registration, in part, because the Agency found that 
``recordkeeping is not only important for compliance, but also for the 
safety of the patients'').
---------------------------------------------------------------------------

    \13\ The Administrative Procedure Act (APA) provides that 
``administrative law judges'' can ``preside at the taking of 
evidence.'' 5 U.S.C. 556(b)(3). Furthermore, 21 CFR 1316.52 provides 
that a ``presiding officer,'' such as this ALJ, has a ``duty to 
conduct a fair hearing, to take all necessary action to avoid delay, 
and to maintain order.'' Id.
    \14\ The Agency issued an interim order indicating that the ALJ 
had the authority to terminate the case.
---------------------------------------------------------------------------

3. Factor B: The Applicant's Experience in Dispensing With Respect to 
Controlled Substances
    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.\15\
---------------------------------------------------------------------------

    \15\ 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).
---------------------------------------------------------------------------

    Historically, the Agency's Factor B \16\ 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:
---------------------------------------------------------------------------

    \16\ 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 Controlled Substances Act (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 participation.''
    JM Pharmacy Group, 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

[[Page 66162]]

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 not explicitly defined in the CSA, 
but Congress identifies the primary ``public interest'' 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.\17\
---------------------------------------------------------------------------

    \17\ 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).
---------------------------------------------------------------------------

    Of course, the Agency is not only concerned with acts of 
intentional diversion \18\ but also with acts of ``[c]areless or 
negligent handling of controlled substances[, which] 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)); 
Dewey C. MacKay, M.D., 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.\19\ 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.
---------------------------------------------------------------------------

    \18\ 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.
    \19\ Additional questionable conduct outside the public interest 
includes postdating prescriptions, issuing prescriptions despite 
concerns from other physicians or pharmacists, continuing to 
prescribe controlled substances to patients even after the 
practitioner had indicated that he would stop issuing them, ignoring 
signs that patients were abusing the controlled substances or were 
serious risk of doing so, ignoring the possibility that multiple 
accident and injuries reported by the patients could be drug-seeking 
behavior, and failing to maintain any patient file. Caragine, 63 FR 
at 51599-51600.
---------------------------------------------------------------------------

    Registrants ``may continue to introduce evidence as to . . . lawful 
. . . dispensing activities.'' \20\ 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.'' 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 the 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).\21\
---------------------------------------------------------------------------

    \20\ 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. ``[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 substances 
prescribed by a practitioner are prescribed for a legitimate medical 
purpose and in accordance with relevant laws. See Dewey C. Mackay, 
M.D., 75 FR at 49977 (citing Krishna-Iyer, 74 FR at 463) (pointing 
out that a ``registration [to prescribe controlled substances] is 
limited to those who have authority to dispense controlled 
substances in the course of professional practice.'').
    \21\ 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.'').
---------------------------------------------------------------------------

    Here, as the Agency found above, Respondent repeatedly issued 
improper prescriptions for controlled substances to UC because he did 
not order or perform diagnostic tests in order to provide a proper 
diagnosis, counsel UC regarding her condition, or reevaluate UC prior 
to increasing the dosage of the prescriptions. The Agency finds that 
Respondent's repeated issuance of prescriptions without adhering to the 
minimum standards of Pennsylvania's medical 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. Respondent also failed to maintain 
accurate and complete records of controlled substances which created 
further opportunities for abuse and diversion. Moreover, as noticed in 
the OSC, falsification of medical records to conceal the true nature of 
prescribing practices is conduct which threatens the public health and 
safety. RFAAX 3, at 3. Such questionable prescribing

[[Page 66163]]

patterns reflected in the record are outside the public interest.
    Moreover, Respondent failed to provide the Agency with any evidence 
related to its ``experience in dispensing'' that served the public's 
interest. Accordingly, the Agency finds that Factor B also weighs 
strongly against Respondent's continued registration.\22\
---------------------------------------------------------------------------

    \22\ While the Agency has determined that Respondent'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). Respondent's 
repeated dispensing of controlled substances without a proper 
diagnosis of UC's condition and without complete and accurate 
documentation of UC's treatment, and Respondent's falsification of 
medical records 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.
---------------------------------------------------------------------------

III. Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Respondent's continued registration would be inconsistent 
with the public interest, the burden shifts to Respondent 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 (2018). The issue of trust is necessarily a 
fact-dependent determination based on the circumstances presented by 
the individual respondent. 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, DEA Administrators have required that a registrant who has 
committed acts inconsistent with the public interest must accept 
responsibility for those acts and demonstrate that it will not engage 
in future misconduct. 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). A registrant's acceptance of responsibility must be unequivocal. 
Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a 
registrant's candor during the investigation and hearing has been an 
important factor in determining acceptance of responsibility and the 
appropriate sanction. Id. Further, the Agency has found that the 
egregiousness and extent of the misconduct are significant factors in 
determining the appropriate sanction. Id. at 834 n.4. The Agency has 
also considered the need to deter similar acts by the respondent and by 
the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
    Regarding these matters, there is no record evidence that 
Respondent takes responsibility, let alone unequivocal responsibility, 
for the founded violations. Therefore, it is not reasonable to believe 
that Respondent's future controlled substance-related actions will 
comply with legal requirements. In fact, instead of admitting that 
Respondent failed to adhere to federal and state laws, he falsified 
medical records to conceal his unlawful prescribing practices. 
Accordingly, Respondent did not meet his burden of convincing the 
Agency that he can be entrusted with a registration.
    Further, the interests of specific and general deterrence weigh in 
favor of revocation. Given the foundational nature of Respondent's 
noncompliance of state laws by failing to properly document UC's 
medical condition and treatment and Respondent's noncompliance of 
federal law by repeatedly issuing prescriptions without a legitimate 
medical purpose, a sanction less than revocation would send a message 
to the existing and prospective registrant community that compliance 
with the law is not essential to maintaining a registration.
    Here, Respondent has made no representation regarding his future 
compliance with the CSA nor made any demonstration that he can be 
trusted with registration. On the other hand, the evidence submitted by 
the Government shows that Respondent cannot be entrusted with a 
registration; in particular, the falsification of medical records 
during the investigation shows a complete lack of candor of Respondent. 
See Jones Total Health Care Pharmacy, 881 F.3d at 830-31.
    Accordingly, the Agency finds that the factors weigh in favor of 
sanction and will order revocation of Respondent's registration as 
contained in the Order below.

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. BR7552272, in Easton, Pennsylvania, issued to 
Muhamad Aly Rifai, M.D. Further, pursuant to 28 CFR 0.100(b) and the 
authority vested in me by 21 U.S.C. 823(g)(1), I hereby deny any 
pending application of Muhamad Aly Rifai, M.D, to renew or modify this 
registration, as well as any other pending application of Muhamad Aly 
Rifai, M.D., for additional registration in Pennsylvania. This Order is 
effective November 18, 2026.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
October 5, 2026, by DEA Administrator Terrance C. Cole. That document 
with the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-21258 Filed 10-16-26; 8:45 am]
BILLING CODE 4410-09-P


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