[Federal Register Volume 89, Number 198 (Friday, October 11, 2024)]
[Notices]
[Pages 82639-82641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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