Notice2024-23511
Janet S. Pettyjohn, D.O.; Decision and Order
Primary source
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Published
October 11, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 89 Issue 198 (Friday, October 11, 2024)</title>
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[Federal Register Volume 89, Number 198 (Friday, October 11, 2024)]
[Notices]
[Pages 82639-82641]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-23511]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Janet S. Pettyjohn, D.O.; Decision and Order
On June 21, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Janet S. Pettyjohn, D.O., of Tampa, Florida
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX)
2, at 1. The OSC/ISO informed Registrant of the immediate suspension of
her DEA registration, Control No. AP6641713,\1\ pursuant to 21 U.S.C.
824(d), alleging that Registrant's continued registration constitutes
`` `an imminent danger to the public health or safety.' '' Id. (quoting
21 U.S.C. 824(d)). The OSC/ISO also proposed the revocation of
Registrant's registration, alleging that Registrant's continued
registration is inconsistent with the public interest. Id. (citing 21
U.S.C. 823(g)(1), 824(a)(4)).
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\1\ This registration expired on March 31, 2024. RFAAX 1. The
fact that a registrant allows her registration to expire during the
pendency of an administrative enforcement proceeding does not impact
the Agency's jurisdiction or prerogative to adjudicate the OSC to
finality. Jeffrey D. Olsen, M.D., 84 FR 68474, 68479 (2019).
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The OSC/ISO notified Registrant of her right to file with DEA a
written request for hearing within 30 days after the date of receipt of
the OSC/ISO. RFAAX 2, at 6. The OSC/ISO also notified Registrant that
if she failed to file such a request, she would be deemed to have
waived her right to a hearing and be in default. Id. (citing 21 CFR
1301.43). Here, Registrant did not request a hearing. RFAA, at 1-2.\2\
``A default, unless excused, shall be deemed to constitute a waiver of
the [registrant's] right to a hearing and an admission of the factual
allegations of the [OSC/ISO].'' 21 CFR 1301.43(e).
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\2\ Based on the Government's submissions in its RFAA dated
December 18, 2023, the Agency finds that service of the OSC/ISO on
Registrant was adequate. Attached to the Government's RFAA is the
Declaration of a DEA Diversion Investigator asserting that on June
21, 2023, the OSC/ISO was served on Registrant's counsel, who
confirmed receipt. RFAAX 3, appendix A, at 1.
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Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. Sec. 1301.43(f)(1). Here,
the Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (f), because Registrant has not
timely requested a hearing nor filed an Answer to the June 21, 2023
OSC/ISO. See also id. Sec. 1316.67.
I. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are admitted. 21 CFR 1301.43(e).
Accordingly, Registrant admits that between August 2021 and February
2023, she issued 60 prescriptions for controlled substances to six
individuals without conducting
[[Page 82640]]
medical examinations, evaluating the individuals, or maintaining any
medical documentation to support the prescriptions. RFAAX 2, at 2-5.
Registrant also admits that among these 60 prescriptions, nine were
issued in response to text messages requesting the prescriptions. Id.
Registrant further admits that, for all 60 prescriptions, her conduct
reflects negative experience in prescribing controlled substances and
that her conduct was outside the usual course of professional practice.
Id. at 1-3.
A. Prescribing to S.G.
Registrant admits that from August 21, 2021, to February 9, 2023,
Registrant issued to S.G. 27 prescriptions containing hydromorphone \3\
and/or alprazolam \4\ without conducting a medical examination or
evaluation of S.G. and without maintaining any medical documentation to
support the prescriptions. RFAAX 2, at 3.
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\3\ Hydromorphone is a schedule II opioid. 21 CFR
1308.12(b)(1)(vii).
\4\ Alprazolam is a schedule IV depressant. 21 CFR
1308.14(c)(2).
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B. Prescribing to L.P.
Registrant admits that from January 5, 2022, to January 23, 2023,
Registrant issued to L.P. 12 prescriptions containing oxycodone,\5\
hydromorphone, and/or alprazolam, including one hydromorphone
prescription that was issued in response to a text message requesting
the prescription, without conducting a medical examination or
evaluation of L.P. and without maintaining any medical documentation to
support the prescriptions. RFAAX 2, at 3-4.
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\5\ Oxycodone is a schedule II opioid. 21 CFR
1308.12(b)(1)(xiv).
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C. Prescribing to C.P-C.
Registrant admits that from February 3, 2022, to February 13, 2023,
Registrant issued to C.P-C. 14 prescriptions containing oxycodone and/
or alprazolam, including one oxycodone prescription that was issued in
response to a text message requesting the prescription, without
conducting a medical examination or evaluation of C.P-C. and without
maintaining any medical documentation to support the prescriptions.
RFAAX 2, at 4.
D. Prescribing to J.A.
Registrant admits that on January 12, 2023, and February 16, 2023,
Registrant issued to J.A. two prescriptions for oxycodone, each of
which were issued in response to text messages requesting the
prescriptions, without conducting a medical examination or evaluation
of J.A. and without maintaining any medical documentation to support
the prescriptions. RFAAX 2, at 4.
E. Prescribing to DC
Registrant admits that from February 24, 2022, to January 12, 2023,
Registrant issued to DC four prescriptions containing oxycodone,
methadone,\6\ and/or alprazolam. RFAAX 2, at 4-5. Specifically,
Registrant admits that on February 24, 2022, and January 12, 2023,
Registrant issued to DC two prescriptions for oxycodone in response to
text messages requesting the prescriptions. Id. at 5. Registrant admits
that on March 5, 2022, she issued to DC a prescription for alprazolam
in response to a text message requesting the prescription. Id.
Registrant admits that on December 29, 2022, she issued to DC a
prescription for methadone in response to a text message requesting the
prescription. Id. Registrant issued each of these prescriptions to DC
without conducting a medical examination or evaluation of DC and
without maintaining any medical documentation to support the
prescriptions. Id.
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\6\ Methadone is a schedule II opioid. 21 CFR 1308.12(c)(15).
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F. Prescribing to J.D.
Registrant admits that on February 3, 2023, Registrant issued to
J.D. a prescription for oxycodone in response to a text message
requesting the prescription and without conducting a medical
examination or evaluation of J.D. or maintaining any medical
documentation to support the prescription. RFAAX 2, at 5.
II. Discussion
A. 21 U.S.C. 823(g)(1): 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)(4). In making the
public interest determination, the CSA requires consideration of the
following factors:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(g)(1).
When making this determination, DEA considers the public interest
factors in the disjunctive. Robert A. Leslie, M.D., 68 FR 15227, 15230
(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
37507, 37508 (1993).
While the Agency has considered all the public interest factors of
21 U.S.C. 823(g)(1),\7\ the Government's evidence in support of its
prima facie case for sanction is confined to Factors B and D. See
generally RFAAX 2. The Government has the burden of proof in this
proceeding. 21 CFR 1301.44.
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\7\ As to Factor A, there is no record evidence of disciplinary
action against Registrant's State medical license. 21 U.S.C.
823(g)(1)(A). 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 the [Registrant's] DEA certification is consistent
with the public interest.'' Roni Dreszer, M.D., 76 FR 19434, 19444
(2011). As to Factor C, there is no evidence in the record that
Registrant has been convicted of any Federal or State law offense
``relating to the manufacture, distribution, or dispensing of
controlled substances.'' 21 U.S.C. 823(g)(1)(C). However, as Agency
cases have noted, ``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 E, the Government's evidence fits
squarely within the parameters of Factors B and D and does not raise
``other conduct which may threaten the public health and safety.''
21 U.S.C. 823(g)(1)(E). Accordingly, Factor E does not weigh for or
against Registrant.
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Here, the Agency finds that the Government satisfied its prima
facie burden of showing that Registrant's continued registration would
be ``inconsistent with the public interest.'' 21 U.S.C. 824(a)(4).
1. Factors B and D
Evidence is considered under Factors B and D 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 21156, 21162 (2022). In the current matter, the Government
has alleged that Registrant has violated both Federal and Florida law
regulating controlled substances. RFAAX 2, at 1-2.
According to the CSA's implementing regulations, a lawful
controlled
[[Page 82641]]
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). A
``practitioner must establish and maintain a bona fide doctor-patient
relationship in order to act `in the usual course of . . . professional
practice' and to issue a prescription for a `legitimate medical
purpose.' '' Dewey C. Mackay, M.D., 75 FR at 49973. Here, Registrant
admits that her prescribing of controlled substances was outside the
usual course of professional practice and that her conduct reflects
negative experience in prescribing controlled substances. RFAAX 2, at
1-3.
Regarding the standards for adequacy of medical records, Florida
law requires that medical documentation must ``contain sufficient
information to identify the patient, support the diagnosis, justify the
treatment and document the course and results of treatment accurately,
by including, at a minimum, patient histories; examination results;
test results; records of drugs prescribed, dispensed, or administered;
reports of consultations and hospitalizations; and copies of records or
reports or other documentation obtained from other health care
practitioners. . . .'' Fla. Admin. Code section 64B8-9.003(3); RFAAX 2,
at 2. Florida law also requires that medical documentation contain
``sufficient detail to clearly demonstrate why the course of treatment
was undertaken.'' Id. section 64B8-9.003(2); RFAAX 2, at 2. Here,
Registrant admits that she issued 60 prescriptions for controlled
substances to six individuals without maintaining any medical
documentation whatsoever to justify the prescribing of controlled
substances. RFAAX 2, at 2-5.
Prior to prescribing a controlled substance for acute pain, Florida
law requires practitioners to maintain ``accurate and complete''
medical documentation that includes, but is not limited to, the
patient's medical history and physical examination; diagnostic results;
consultations; treatment objectives; discussion of risks and benefits;
treatments; medications; instructions and agreements; drug testing
results; and periodic reviews. Fla. Stat. section 456.44(3); Fla.
Admin. Code section 64B8-9.013(2); RFAAX 2, at 2. Here, not only does
Registrant admit that she issued 60 prescriptions for controlled
substances to six individuals without maintaining any medical
documentation, she admits she never conducted the physical examinations
she was required to document. RFAAX 2, at 2-5. Registrant further
admits that nine of these prescriptions were issued in response to text
messages requesting the controlled substances. Id.
Based on Registrant's admissions, the Agency finds that from August
21, 2021, to February 16, 2023, Registrant issued 60 prescriptions to
six individuals outside the usual course of professional practice and
in violation of Federal and State laws. 21 CFR 1306.04(a); Fla. Stat.
section 456.44(3); Fla. Admin. Code sections 64B8-9.003(2)-(3), 64B8-
9.013(2).
In sum, the Agency finds Registrant's continued registration to be
inconsistent with the public interest after balancing the factors of 21
U.S.C. 823(g)(1). The Agency also finds that Registrant failed to
provide sufficient mitigating evidence to rebut the Government's prima
facie case.
III. Sanction
Where, as here, the Government has established sufficient grounds
to revoke Registrant's registration, the burden shifts to the
registrant to show why she can be entrusted with the responsibility
carried by a registration. Garret Howard Smith, M.D., 83 FR 18882,
18910 (2018). ``[T]rust is necessarily a fact-dependent determination
based'' on individual circumstances; therefore, the Agency looks at
factors such as ``the acceptance of responsibility and the credibility
of that acceptance as it relates to the probability of repeat
violations or behavior.'' Robert Wayne Locklear, M.D., 86 FR 33738,
33746 (2021). To be effective, acceptance of responsibility must be
unequivocal. Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018). When a
registrant has committed acts inconsistent with the public interest,
she must both accept responsibility and demonstrate that she has
undertaken corrective measures. Holiday CVS, L.L.C., d/b/a CVS/Pharmacy
Nos. 219 and 5195, 77 FR 62316, 62339 (2012) (internal quotations
omitted).
Here, Registrant did not request a hearing, submit a corrective
action plan, respond to the OSC/ISO, or otherwise avail herself of the
opportunity to refute the Government's case. As such, Registrant has
made no representations as to her future compliance with the CSA, has
not demonstrated that she can be entrusted with registration, and has
not accepted responsibility for the misconduct. Accordingly, the Agency
will order the revocation of Registrant's registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
AP6641713 issued to Janet S. Pettyjohn, D.O. 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 applications of Janet S. Pettyjohn, D.O., to
renew or modify this registration, as well as any other pending
application of Janet S. Pettyjohn, D.O., for additional registration in
Florida. This Order is effective November 12, 2024.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 2, 2024, 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. 2024-23511 Filed 10-10-24; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on October 11, 2024.
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