[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1095-1098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00011]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Sualeh Ashraf, M.D.; Decision and Order

    On September 30, 2021, the Drug Enforcement Administration (DEA) 
issued an Order to Show Cause (OSC) to Sualeh Ashraf, M.D. 
(Registrant), of Kissimmee, Florida. Request for Final Agency Action 
(RFAA), Exhibit (RFAAX) 1, at 1, 6. The OSC proposed the revocation of 
Registrant's DEA Certificate of Registration, Control No. BA2668183, 
and the denial of Registrant's pending application for an additional 
DEA Certificate of Registration, Application No. W21001036C, alleging 
that Registrant has ``committed such acts that would render [his] 
registration inconsistent with the public interest.'' Id. at 1-2 
(citing 21 U.S.C. 824(a)(4) and 823(f)).\1\
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    \1\ On November 3, 2021, Registrant submitted a signed document 
titled ``Corrective Action Plan'' in response to the OSC; however, 
the document appears to be primarily a written response to the 
Government's allegations with a brief Corrective Action Plan and 
several attachments. See RFAAX 16. The document did not indicate 
that Registrant intended to request a hearing. RFAAX 16. On April 
21, 2022, the DEA issued a letter to Registrant denying his proposed 
Corrective Action Plan and advising him of his retained procedural 
and due process rights. RFAAX 14. On May 10, 2022, Registrant 
responded by email, in which he again did not request a hearing, and 
the Government did not otherwise receive any hearing request from 
Registrant. RFAAX 15; RFAA, at 1-3; see also RFAA, at 3 n.1.
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    The Agency makes the following findings of fact based on the 
uncontroverted evidence submitted by the Government in its RFAA, dated 
July 21, 2022.

I. Findings of Fact

A. Investigation of Registrant

    According to the DEA Diversion Investigator assigned to investigate 
Registrant (DI), Registrant issued at least 33 prescriptions for 
controlled substances--specifically, oxycodone, Adderall, hydrocodone, 
and zolpidem--to three individuals identified as J.L., D.L., and J.L.2 
between September 27, 2016, and May 24, 2018. RFAAX 17, at 1-2; see 
also RFAAX 2. As part of the investigation, DI obtained a transcript of 
an interview that the Polk County Sheriff's Office conducted with 
Registrant on June 12, 2018. RFAAX 17, at 3; see also RFAAX 12. During 
the interview, Registrant stated that he could not recall issuing any 
of the prescriptions for oxycodone,\2\ although he admitted to issuing 
prescriptions for zolpidem to J.L. as recently as the month prior to 
the interview. RFAAX 17, at 3; see also RFAAX 12, at 54-57. DI made 
numerous attempts to obtain patient records for J.L., D.L., and J.L.2, 
including serving multiple Administrative Subpoenas to Registrant as 
well as contacting both the Polk County Sheriff's Office and the 
Florida Department of Health.\3\ Id. at 3-4. Ultimately, Registrant was 
unable to produce any records regarding the prescriptions in question. 
Id. at 2.
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    \2\ Registrant stated that he did not recall prescribing 
oxycodone with acetaminophen to J.L. but left open the possibility 
that he did, stating: ``. . . years ago if she had a headache or she 
had something she asked me I given [sic] 5 or 6 but not on a regular 
basis that I would remember . . .'' RFAAX 12, at 58-59.
    \3\ On April 3, 2019, DI sent an initial Administrative Subpoena 
to Registrant at Registrant's residential address. RFAAX 17, at 3. 
According to the DI, on May 1, 2019, Registrant's attorney responded 
by email, writing that while Registrant recognized the names of the 
individuals listed in the subpoena as relatives of J.L., he did not 
have any independent knowledge that they were patients at the weight 
management clinic (Dr. Drop it Like it's Hot, ``DDILIH'') where 
Registrant worked as a physician and of which J.L. was the manager 
and registered agent. Id. at 2-3; see also RFAAX 11. Registrant's 
attorney also wrote that Registrant was positive that none of the 
individuals listed in the subpoena were ever patients of his 
separately located primary private practice and that even if they 
had been patients at the clinic where Registrant was employed 
(DDILIH), ``all patient records at that office were confiscated by 
law enforcement at the time the office was raided and both 
[Registrant] and [J.L.] were arrested.'' RFAAX 17, at 3; see also 
infra I.C. (regarding the arrest of Registrant and J.L. for a 
separate matter). Registrant's attorney concluded that none of the 
records were returned to Registrant and so Registrant had no records 
to provide in response to the subpoena. RFAAX 17, at 3. On May 1, 
2019, DI emailed Registrant's attorney informing him that he had not 
provided any information regarding the requested medical file for 
J.L. to which Registrant's attorney responded by email the next day 
stating that Registrant ``did not have possession of any patient 
charts for any of the individuals identified in the subpoena.'' Id.
     However, when DI contacted both the Polk County Sheriff's 
Office and the Florida Department of Health, he was informed that no 
patient records had been seized from DDILIH during the execution of 
a search warrant on June 12, 2018. Id. at 4. On July 19, 2019, DI 
served an Administrative Subpoena to the Florida Department of 
Health and was informed on August 27, 2019, that the Florida 
Department of Health did not have any patient files for J.L., D.L., 
or J.L.2. Id. On June 11, 2021, DI served additional Administrative 
Subpoenas to Registrant at Registrant's DEA registered address to 
which Registrant responded on June 25, 2021, again stating that 
every document from his place of business had been confiscated and 
thus he had no records to produce. Id.
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    Regarding Registrant's dispensing records, on July 26, 2017, DI 
made two visits to the clinic where Registrant was employed, DDILIH. 
Id. at 4. According to DI, Registrant stated that he began dispensing 
controlled substances in March 2017 and admitted to dispensing 
phentermine directly to uninsured patients. Id. Nonetheless, Registrant 
failed to produce an initial inventory of controlled substances and 
failed to produce any dispensing records of controlled substances in 
violation of 21 CFR 1304.03(b), 1304.22(c), and 1304.11(b).\4\ RFAAX 
17, at 5. After conducting an audit of DDILIH's supply of phentermine 
in comparison to Registrant's purchase invoices, DI concluded that 
24,349 tablets of 37.5 mg units and 250 tablets of 8 mg units were 
unaccounted for.\5\ RFAAX 17, at 5. After obtaining records from the 
Florida Prescription Drug Monitoring Program, DI also determined that 
Registrant failed to report his dispensing of phentermine to the 
Program as required by Florida law (Fla. Stat. Sec.  893.055(3)(a)). 
Id.; see also RFAAX 9.
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    \4\ According to DI, Registrant stated that the inventory was in 
J.L.'s possession and that his dispensing records were annotated in 
his patients' medical records; however, when asked to produce a 
patient medical record with an included dispensing record, 
Registrant presented ``a folder containing a document titled `New 
patient information form,' a blank form with nothing to indicate 
that it pertained to a particular patient.'' RFAAX 17, at 5; see 
also RFAAX 4. The only other record that Registrant produced was ``a 
form dated July 26 (no year specified) which associated just 30 37.5 
mg dosage units of phentermine with a patient identified as Y.G.'' 
RFAAX 17, at 5; see also RFAAX 7.
    \5\ When asked by DI to produce his purchase invoices for 
phentermine, Registrant produced invoices indicating that he had 
purchased 20,000 37.5 mg dosage units of phentermine over five 
different dates. Id.; see also RFAAX 6. Upon contacting Registrant's 
distributor, DI determined that on two additional dates, Registrant 
purchased an additional 5000 37.5 mg dosage units of phentermine and 
250 8 mg dosage units of phentermine for which he did not have any 
records. RFAAX 17, at 5. Upon conducting an audit of DDILIH's supply 
of phentermine, DI initially determined that Registrant only had 621 
37.5 mg dosage units on the premises, with an additional 30 dosage 
units later discovered. Id.; see also RFAAX 5.
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    Additionally, DEA's investigation determined that Registrant failed 
to report the theft of 14 bottles of phentermine to DEA within one 
business day of discovery in violation of 21 CFR 1301.76(b), although 
the theft was reported to local police. RFAAX 17, at 5-6; see also 
RFAAX 10. Further, DEA's investigation determined that Registrant was 
dispensing phentermine in containers without warning labels that 
conformed to 21 CFR 290.5. RFAAX 17, at 6; see also RFAAX 8. Finally, 
DI determined that Registrant failed to properly store phentermine in a 
``securely locked, substantially constructed cabinet,'' in violation of 
21 CFR 1301.75(b), with Registrant admitting that J.L., who is not a 
DEA

[[Page 1096]]

registrant, ``stored controlled substances in her home during the hours 
when [DDILIH] was not open.'' RFAAX 17, at 6.

B. The Government Expert's Review of Registrant's Prescriptions

    The DEA hired Dr. Mark Rubenstein, M.D., to opine on Registrant's 
controlled substance prescribing based on the prescription and 
dispensing information described above (RFAAX 2). RFAAX 17, at 4; see 
also RFAAX 18, at 1. The Agency finds that Dr. Rubenstein is an expert 
in the standard of care for prescribing controlled substances in 
Florida and gives his expert report, see RFAAX 3, and his Declaration 
full credit in this Decision. See RFAAX 13; RFAAX 18, at 1.
    Dr. Rubenstein reviewed seven prescriptions for oxycodone issued by 
Registrant to J.L. from March 17, 2017, through April 26, 2018, and 
found that on at least four of the prescriptions, Registrant wrote that 
the prescription was issued for ```pain.''' RFAAX 18, at 2; see also 
RFAAX 2, at 17-24, 27-32. According to Dr. Rubenstein, although there 
were no corresponding medical records, ``the pattern, number, and 
frequency of these prescriptions indicate that [Registrant] issued 
[them] in order to treat some type of chronic nonmalignant pain.'' \6\ 
RFAAX 18, at 2. Dr. Rubenstein explained the standard of care for the 
treatment of chronic nonmalignant pain with controlled substances in 
the State of Florida and concluded that ``[b]ecause there were no 
medical records to review, none of the requirements for treating 
chronic nonmalignant pain [were] satisfied with respect to the 
oxycodone prescriptions issued [by Registrant] to J.L.'' Id. Further, 
Dr. Rubenstein reviewed the prescriptions for Adderall that Registrant 
issued to J.L., D.L., and J.L.2 and concluded that ``because there 
[were] no medical records to review, there [was] no evidence that 
[Registrant] issued these prescriptions for a medical purpose permitted 
by Florida law,'' nor was there ``any evidence that the prescriptions 
were issued for any legitimate medical purpose.'' Id.; see also RFAAX 
2.
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    \6\ Dr. Rubenstein noted that if Registrant had actually issued 
these four prescriptions to treat acute pain, Registrant would have 
been in violation of Florida regulations because the prescriptions 
were for 30-day supplies and Florida regulations provide that a 
prescription for a Schedule II opioid for acute pain may not exceed 
a seven-day supply. RFAAX 18, at 2 n.1; see also RFAAX 2, at 17-20, 
27-32.
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    Ultimately, Dr. Rubenstein found that there was ``no evidence that 
[Registrant] kept any medical records to justify the course of 
treatment of [patients J.L., D.L., and J.L.2].'' RFAAX 18, at 2. Based 
on his expert medical opinion, Dr. Rubenstein concluded, and the Agency 
agrees, that ``[Registrant] engaged in a pattern or practice of 
prescribing [that] demonstrated a lack of reasonable skill or safety to 
[the] patients, that [Registrant] failed to document an appropriate 
physician-patient relationship with [the patients], and that 
[Registrant's] prescribing of controlled substances was not within the 
usual scope of professional practice and cannot be deemed issued for a 
legitimate medical purpose.'' Id.; see also RFAAX 3, at 4.

C. Registrant's Case

    As previously noted, Registrant responded to the OSC through a 
signed document entitled, ``Corrective Action Plan.'' See RFAAX 16. The 
document includes a Corrective Action Plan and also details 
Registrant's position on the Government's allegations with supporting 
documentation.\7\ Id.
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    \7\ The Agency considers RFAAX 15 and 16 collectively as a 
written response. See Creekbend Community Pharmacy, 86 FR 40,627, 
40,627-29, 40,636 (2021) (the Agency considered an ambiguous 
document submitted by the Respondent Pharmacy that contained both a 
written response to the OSC, not submitted in lieu of a hearing, and 
a Corrective Action Plan).
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    Within the ``Corrective Action Plan,'' Registrant offered 
explanation of his misconduct. RFAAX 16, at 2-6, 7-9. Registrant 
described how he began working with J.L. at their weight loss clinic, 
where J.L. was the business owner and Registrant was the doctor of 
record.\8\ Id.\9\ Regarding the at least 33 controlled substance 
prescriptions at issue, Registrant argued that he ``did nothing wrong 
intentionally or otherwise,'' and repeatedly claimed that he did not 
issue the prescriptions.\10\ RFAAX 16, at 2-6. Registrant suggested 
that it was likely that J.L. forged his signature and issued the 
prescriptions to herself.\11\ RFAAX 16, at 2-6. Registrant also claimed 
that he had never met D.L., J.L.'s husband, that he had never met 
J.L.2, J.L.'s son, and that he did not even know that J.L. had a son. 
Id. at 3-4. Registrant argued that, because he did not issue the 
controlled substance prescriptions in question, he did not violate any 
state or federal laws nor did he fail to adhere to the Florida standard 
of care. Id. at 2-6. Finally, Registrant concluded that ``[i]t should 
be obvious to the DEA that the criminal mind and the criminal muscle 
behind the endeavors described on the [OSC] are the works of J.L.'' Id. 
at 9.
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    \8\ Registrant further described how J.L. ``had alleged to be a 
nurse'' and had a good reputation, but was later revealed to be 
unlicensed. Id. at 7-8.
    \9\ See also id. at 18-25. According to Registrant, in June 
2018, J.L. was arrested for practicing health care without a license 
and Registrant was arrested for employing J.L. as an unlicensed 
nurse. Id. at 8, 13. According to Registrant, everything was 
investigated by Polk County Police over a period of years and 
``[t]he Polk County State Attorney's Office dismissed all of the 
charges against [him]'' and that ``the Court granted expungement of 
[his] arrest and criminal charges.'' Id. at 9; see also id. at 12-
17.
    \10\ Compare this unequivocal denial to his statement to local 
police that he ``[did not] recall'' prescribing oxycodone with 
acetaminophen to J.L. while leaving open the possibility that ``. . 
.years ago if she had a headache or she had something she asked me I 
given [sic] 5 or 6 but not on a regular basis that I would remember 
. . . .'' RFAAX 12, at 58-59.
    \11\ However, in his recorded statement for the Polk County 
Sheriff's Office, Registrant seems to admit that he left pre-signed 
prescriptions for J.L. to fill out for patients when he was not 
available. RFAAX 12, at 15-18.
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    Registrant proposed that, going forward, he would not leave his 
prescription pads outside of his briefcase or purview and would not 
allow anyone else to handle his prescriptions; that he would not allow 
anyone else to call in his prescriptions to pharmacies and would not 
give anyone else access to his passwords; and that he would monitor the 
prescription activity taking place under his name on the Florida 
Prescription Drug Monitoring Program online database. Id. at 2.\12\
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    \12\ On April 21, 2022, the DEA issued a letter to Registrant 
denying his proposed Corrective Action Plan to which Registrant 
expressed his disagreement in an email dated May 10, 2022. RFAAX 14; 
RFAAX 15. Registrant wrote, ``In terms of the public safety: [J.L.] 
was not public as she was part of the employ [sic] apparatus that 
betrayed my trust in her as she prescribed to herself and family. It 
was not rampant public safety [sic]. Moreover, all I can think of in 
my plan to prevent future breach of trust is to keep my prescription 
pads locked under my control.'' RFAAX 15, at 1-2.
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II. Discussion

A. The Five Public Interest Factors

    Under the Controlled Substances Act (CSA), ``[a] registration . . . 
to . . . dispense a controlled substance . . . may be suspended or 
revoked by the Attorney General upon a finding that the registrant . . 
. has committed such acts as would render his registration under 
section 823 of this title inconsistent with the public interest as 
determined under such section.'' 21 U.S.C. 824(a). An application for a 
practitioner's registration may be denied upon a determination that 
``the issuance of such registration . . . would be inconsistent with 
the public interest.'' 21 U.S.C. 823(f). In making the public interest 
determination, the CSA requires consideration of the following factors:


[[Page 1097]]


    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

21 U.S.C. 823(f).

    The DEA considers these public interest factors in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each factor is 
weighed on a case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 
165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of 
factors, may be decisive. David H. Gillis, M.D., 58 FR 37,507, 37,508 
(1993).
    While the Agency has considered all of the public interest factors 
in 21 U.S.C. 823(f),\13\ the Government's evidence in support of its 
prima facie case for revocation of Registrant's registration and denial 
of Registrant's application is confined to Factors Two and Four. See 
RFAA, at 9-14. Moreover, the Government has the burden of proof in this 
proceeding. 21 CFR 1301.44. The Agency finds that the Government's 
evidence satisfies its prima facie burden of showing that Registrant's 
continued registration would be ``inconsistent with the public 
interest.'' 21 U.S.C. 824(f). The Agency further finds that Registrant 
failed to provide sufficient evidence to rebut the Government's prima 
facie case.
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    \13\ As to Factor One, there is no record evidence of 
disciplinary action against Registrant's state medical license. 21 
U.S.C. 823(f)(1). State authority to practice medicine is ``a 
necessary, but not a sufficient condition for registration . . . .'' 
Robert A. Leslie, M.D., 68 FR at 15230. Therefore, ``[t]he fact that 
the record contains no evidence of a recommendation by a state 
licensing board does not weigh for or against a determination as to 
whether continuation of [or granting of a] DEA certification is 
consistent with the public interest.'' Roni Dreszer, M.D., 76 FR 
19434, 19444 (2011). As to Factor Three, there is no evidence in the 
record that Registrant has been convicted of an offense under either 
federal or state law ``relating to the manufacture, distribution, or 
dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, 
``the absence of such a conviction is of considerably less 
consequence in the public interest inquiry'' and is therefore not 
dispositive. Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). As to 
Factor Five, the Government's evidence fits squarely within the 
parameters of Factors Two and Four and does not raise ``other 
conduct which may threaten the public health and safety.'' 21 U.S.C. 
823(f)(5). Accordingly, Factor Five does not weigh for or against 
Registrant.
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B. Factors Two and Four

    Evidence is considered under Public Interest Factors Two and Four 
when it reflects compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances. 
See Kareem Hubbard, M.D., 87 FR 21,156, 21,162 (2022). The Government 
has alleged that Registrant's prescribing practices violated both 
federal and Florida state law. RFAAX 1, at 2-4. According to the CSA's 
implementing regulations, a lawful controlled substance order or 
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). Moreover, among the listed 
acts in Florida law that ``shall constitute grounds'' for which 
disciplinary action may be taken are: ``[e]ngaging in a pattern of 
practice when prescribing . . . controlled substances which 
demonstrates a lack of reasonable skill or safety to patients,'' Fla. 
Stat. Sec.  456.072(gg) (July 1, 2016 to June 30, 2020); 
14 15 and violating a standard of practice for the treatment 
of chronic nonmalignant pain with a controlled substance,\16\ Fla. 
Stat. Sec.  456.44(3)(a), (b), (c), and (f) (July 1, 2016 to June 30, 
2020). See also Fla. Stat. Sec.  458.331(1)(m) and (q) (July 1, 2016 to 
Dec. 31, 2019) (setting out grounds for denial of a license or 
disciplinary action, including failing to keep legible medical records 
that justify the course of treatment of the patient and prescribing, 
dispensing, administering, mixing, or otherwise preparing a controlled 
substance other than in the course of the physician's professional 
practice, without regard to his or her intent).
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    \14\ By regulation, Florida states the purposes for maintaining 
medical records, including to ``furnish documentary evidence of the 
course of the patient's medical evaluation, treatment, and change in 
condition.'' Admin. Code Ann. r. 64B8-9.003(1)(b).
    \15\ Relevant years' iterations of the provisions of Florida law 
cited in this Decision are either identical to or do not deviate 
substantively from the cited texts.
    \16\ Such standards of practice include: before beginning any 
treatment, conducting a documented and complete medical history and 
physical examination proportionate to the diagnosis that justifies 
treatment; developing a written individualized treatment plan for 
each patient; discussing, with the patient or specified associated 
individual, the risks and benefits of the use of controlled 
substances, including the risks of abuse and addiction, as well as 
physical dependence and its consequences; and maintaining accurate, 
current, and complete records that are accessible and readily 
available for review and that comply with legal requirements.
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    Based on the credible and unrebutted opinion of the Government's 
expert, the Agency found above that Registrant's prescribing of at 
least 33 controlled substance prescriptions to at least three different 
patients was not within the usual scope of professional practice, that 
the prescriptions could not be deemed issued for a legitimate medical 
purpose, that Registrant failed to document an appropriate physician-
patient relationship with the patients, and that Registrant engaged in 
a pattern or practice of prescribing that demonstrated a lack of 
reasonable skill or safety to his patients. See supra I.B. Further, 
there is no evidence in the record that Registrant adhered to the 
requirements under Florida state law for issuing controlled substances 
to treat nonmalignant pain.
    In addition, the Government has alleged that Registrant violated 
various federal regulations applicable to his dispensing of controlled 
substances. RFAAX 1, at 4 (citing 21 CFR 1304.03(b), 1304.22(c), 
1304.11(b), 290.5, 1301.76(b), 1301.75(b)). Based on the DI's 
Declaration and the entire record, the Agency found above that 
Registrant failed to produce dispensing records in violation of 21 CFR 
1304.03(b) and 1304.22(c); failed to produce an initial inventory of 
controlled substances in violation of 21 CFR 1304.11(b); failed to 
report the theft of phentermine to DEA in violation of 21 CFR 
1301.76(b); and failed to store phentermine in a ``securely locked, 
substantially constructed cabinet'' in violation of 21 CFR 1301.75(b). 
See supra I.A. Further, there is also substantial record evidence that 
Registrant dispensed phentermine, a Schedule IV controlled substance, 
in violation of the requirements of 21 CFR 290.5. Accordingly, 
Registrant violated ``applicable . . . Federal . . . law [ ] relating 
to controlled substances,'' which supports the Government's case for 
revocation. 21 U.S.C. 823(f)(4).\17\
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    \17\ The Government has also alleged that Registrant violated 
Fla. Stat. Sec.  893.055(3)(a), which requires a dispensing 
practitioner to report to the Florida Prescription Drug Monitoring 
Program specific information about every controlled substance 
dispensed. RFAAX 1, at 3-4. Based on the DI's Declaration and RFAAX 
9, the Agency found above that Registrant failed to report his 
dispensing of phentermine to the Florida Prescription Drug 
Monitoring Program in violation of Fla. Stat. Sec.  893.055(3)(a). 
See supra I.A.
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    In sum, the Agency finds that the record contains substantial 
evidence that Registrant prescribed and dispensed controlled substances 
in violation of both federal and state law. The Agency, therefore, 
finds that Factors Two and Four weigh in favor of revocation of 
Registrant's registration and denial of Registrant's application and 
thus finds Registrant's registration to be inconsistent with the public

[[Page 1098]]

interest in balancing the factors of 21 U.S.C. 823(f).\18\
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    \18\ Regarding Registrant's claim in his ``Corrective Action 
Plan'' document that he did not issue the controlled substance 
prescriptions in question and that, rather, it was J.L. who 
improperly issued them to herself and her family members using 
Registrant's registration, the Agency has long held that a 
registrant is liable for the misuse of his registration by any 
person to whom he entrusts his registration. See Kevin Dennis, M.D., 
78 FR 52787, 52799 (2013) (collecting cases). During his interview 
with the Polk County Sheriff's Office conducted on June 12, 2018, 
Registrant admitted to leaving pre-signed prescription pads with 
J.L. for her to use his registration and stated that he and J.L. 
``[had] the trust.'' RFAAX 12, at 15-18. Thus, even if it is true 
that J.L. was the one who misused Registrant's registration, 
Registrant bears responsibility for her misuse because he entrusted 
her with his registration. See Brian Thomas Nichol, M.D., 83 FR 
47352, 47363 (2018) (collecting cases); see also supra n.11.
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III. Sanction

    Where, as here, the Government has established grounds to revoke 
Registrant's registration and deny Registrant's application, the burden 
shifts to the registrant to show why he can be entrusted with the 
responsibility carried by a registration. Garret Howard Smith, M.D., 83 
FR 18882, 18910 (2018). When a registrant has committed acts 
inconsistent with the public interest, he must both accept 
responsibility and demonstrate that he has undertaken corrective 
measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR 
62316, 62339 (2012) (internal quotations omitted). Trust is necessarily 
a fact-dependent determination based on individual circumstances; 
therefore, the Agency looks at factors such as the acceptance of 
responsibility, the credibility of that acceptance as it relates to the 
probability of repeat violations or behavior, the nature of the 
misconduct that forms the basis for sanction, and the Agency's interest 
in deterring similar acts. See, e.g., Robert Wayne Locklear, M.D., 86 
FR 33738, 33746 (2021).
    Here, Registrant has failed to accept responsibility, arguing that 
he ``did nothing wrong intentionally or otherwise,'' and repeatedly 
insisting that J.L. was to blame for the improper prescriptions at 
issue because she was the ``criminal mind and the criminal muscle.'' 
RFAAX 16, at 2-9. Even if J.L. did improperly issue the prescriptions 
in question, Registrant failed to admit any fault for allowing her to 
improperly use his registration which, as its holder, Registrant would 
be ultimately responsible for. Further, Registrant did not address, let 
alone accept responsibility for, any of his numerous dispensing 
violations. As such, Registrant has failed to establish that he 
unequivocally accepts responsibility such that the Agency can entrust 
him with registration.
    When a registrant fails to make the threshold showing of acceptance 
of responsibility, the Agency need not address the registrant's 
remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 (2019); 
Daniel A. Glick, D.D.S., 80 FR 74800, 74801, 74810 (2015). Even so, 
Registrant has not offered adequate remedial measures to assure the 
Agency that he can be entrusted with registration. See Carol 
Hippenmeyer, M.D., 86 FR 33748, 33773 (2021). Here, although Registrant 
offered to ``keep [his] prescription pads locked under [his] control'' 
and to take other measures to ensure that nobody else would be able to 
use his registration, he did not offer a plan to address the numerous 
dispensing violations nor to ensure his future compliance with federal 
and state law regarding the dispensing of controlled substances. RFAAX 
15, at 1-2; RFAAX 16, at 2.
    In addition to acceptance of responsibility, the Agency looks to 
the egregiousness and extent of the misconduct, Garrett Howard Smith, 
M.D., 83 FR at 18910 (collecting cases), and considers both specific 
and general deterrence when determining an appropriate sanction. Daniel 
A. Glick, D.D.S., 80 FR at 74810. Here, the record contains substantial 
evidence that Registrant improperly issued at least 33 prescriptions 
for controlled substances to at least three different patients beneath 
the applicable standard of care and outside the usual course of 
professional practice and committed numerous violations of federal and 
state law. As such, revocation of Registrant's registration and denial 
of Registrant's application would deter Registrant and the general 
registrant community from the improper prescribing of controlled 
substances as well as from ignoring their obligations to comply with 
federal and state laws regarding the dispensing of controlled 
substances.
    In sum, there is simply no evidence that Registrant's behavior is 
unlikely to recur in the future such that the Agency can entrust him 
with a CSA registration, and when considered with the scope of 
Registrant's misconduct as well as considerations of deterrence, the 
balance of factors weighs in favor of revocation and denial as 
sanctions. Accordingly, the Agency will order the revocation of 
Registrant's registration and the denial of Registrant's application.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(f) and 21 U.S.C. 824(a), I hereby revoke DEA Certificate of 
Registration No. BA2668183 issued to Sualeh Ashraf, M.D., deny the 
pending application for a DEA Certificate of Registration No. 
W21001036C submitted by Sualeh Ashraf, M.D., and deny any other pending 
applications submitted by Sualeh Ashraf, M.D in Florida. This Order is 
effective February 6, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
December 27, 2022, by Administrator Anne Milgram. 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. 2023-00011 Filed 1-5-23; 8:45 am]
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