Janet S. Pettyjohn, D.O.; Decision and Order, 82639-82641 [2024-23511]
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Federal Register / Vol. 89, No. 198 / Friday, October 11, 2024 / Notices
California, the state in which he is
registered with DEA.
ddrumheller on DSK120RN23PROD with NOTICES1
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under 21 U.S.C. 823 ‘‘upon a finding
that the registrant . . . has had his State
license or registration suspended . . .
[or] revoked . . . by competent State
authority and is no longer authorized by
State law to engage in the . . .
dispensing of controlled substances.’’
With respect to a practitioner, DEA has
also long held that the possession of
authority to dispense controlled
substances under the laws of the state in
which a practitioner engages in
professional practice is a fundamental
condition for obtaining and maintaining
a practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71371,
71372 (2011), pet. for rev. denied, 481
F. App’x 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27616,
27617 (1978).3
According to California statute,
‘‘dispense’’ means ‘‘to deliver a
controlled substance to an ultimate user
or research subject by or pursuant to the
lawful order of a practitioner, including
the prescribing, furnishing, packaging,
labeling, or compounding necessary to
prepare the substance for that delivery.’’
Cal. Health & Safety Code sec. 11010
(West 2024). Further, a ‘‘practitioner’’
means a person ‘‘licensed, registered, or
otherwise permitted, to distribute,
dispense, conduct research with respect
to, or administer, a controlled substance
in the course of professional practice or
research in [the] state.’’ Id. sec. 11026(c).
Here, the undisputed evidence in the
record is that Registrant currently lacks
authority to practice as a physician in
3 This rule derives from the text of two provisions
of the Controlled Substances Act (CSA). First,
Congress defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . or other person licensed,
registered, or otherwise permitted, by . . . the
jurisdiction in which he practices . . . , to
distribute, dispense, . . . [or] administer . . . a
controlled substance in the course of professional
practice.’’ 21 U.S.C. 802(21). Second, in setting the
requirements for obtaining a practitioner’s
registration, Congress directed that ‘‘[t]he Attorney
General shall register practitioners . . . if the
applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he
practices.’’ 21 U.S.C. 823(g)(1). Because Congress
has clearly mandated that a practitioner possess
state authority in order to be deemed a practitioner
under the CSA, DEA has held repeatedly that
revocation of a practitioner’s registration is the
appropriate sanction whenever he is no longer
authorized to dispense controlled substances under
the laws of the state in which he practices. See, e.g.,
James L. Hooper, 76 FR 71371–72; Sheran Arden
Yeates, D.O., 71 FR 39130, 39131 (2006); Dominick
A. Ricci, D.O., 58 FR 51104, 51105 (1993); Bobby
Watts, D.O., 53 FR 11919, 11120 (1988); Frederick
Marsh Blanton, 43 FR 27617.
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California. As discussed above, an
individual must be a licensed
practitioner to dispense a controlled
substance in California. Thus, because
Registrant currently lacks authority to
practice as a physician in California
and, therefore, is not currently
authorized to handle controlled
substances in California, Registrant is
not eligible to maintain a DEA
registration. Accordingly, the Agency
will order that Registrant’s DEA
registration be revoked.
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. BH4921727 issued to
Robert P. Hansen, M.D. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(g)(1), I hereby deny any pending
applications of Robert P. Hansen, M.D.,
to renew or modify this registration, as
well as any other pending application of
Robert P. Hansen, M.D., for additional
registration in California. 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. 2024–23514 Filed 10–10–24; 8:45 am]
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82639
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)).
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).
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] § 1316.67.’’ Id. § 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. § 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
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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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).
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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Federal Register / Vol. 89, No. 198 / Friday, October 11, 2024 / Notices
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.
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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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
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).
5 Oxycodone is a schedule II opioid. 21 CFR
1308.12(b)(1)(xiv).
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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.
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
6 Methadone is a schedule II opioid. 21 CFR
1308.12(c)(15).
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Frm 00076
Fmt 4703
Sfmt 4703
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.
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
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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Federal Register / Vol. 89, No. 198 / Friday, October 11, 2024 / Notices
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
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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.
PO 00000
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82641
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
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request, Sectoral
Strategies and Employer Engagement
Portfolio, New Collection
Office of the Assistant
Secretary for Policy, Chief Evaluation
Office, Department of Labor.
ACTION: Notice of information collection;
request for comment.
AGENCY:
The Department of Labor
(DOL), as part of its continuing effort to
reduce paperwork and respondent
burden, conducts a preclearance
consultation program to provide the
general public and federal agencies with
an opportunity to comment on proposed
and/or continuing collections of
information in accordance with the
Paperwork Reduction Act of 1995
(PRA95). This program helps to ensure
that requested data can be provided in
the desired format, reporting burden
(time and financial resources) is
minimized, collection instruments are
clearly understood, and the impact of
collection requirements on respondents
SUMMARY:
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Agencies
[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)).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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