[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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