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###### Department of Justice

###### Drug Enforcement Administration

                    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)).                

                    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                           ( print 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.                

### 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.                

### 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.*

### 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.                

                    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                           ( print 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.

# Footnotes

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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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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3.                             Hydromorphone is a schedule II opioid. 21 CFR 1308.12(b)(1)(vii).                    
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4.                             Alprazolam is a schedule IV depressant. 21 CFR 1308.14(c)(2).                    
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5.                             Oxycodone is a schedule II opioid. 21 CFR 1308.12(b)(1)(xiv).                    
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6.                             Methadone is a schedule II opioid. 21 CFR 1308.12(c)(15).                    
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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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[FR Doc. 2024-23511 Filed 10-10-24; 8:45 am]

BILLING CODE 4410-09-P