[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77890-77892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27480]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 22-5]


Jennings Staley, M.D.; Decision and Order

    On October 8, 2021, the Drug Enforcement Administration (DEA or 
Government) issued an Order to Show Cause (OSC) to Jennings Staley, 
M.D., (Respondent) of California,\1\ alleging that Respondent 
``committed such acts that would render [his] registration inconsistent 
with the public interest.'' OSC, at 2 (citing 21 U.S.C. 823(f) and 
824(a)(4)).
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    \1\ The Government sought to revoke Respondent's Certificates of 
Registration Nos. FS8992794 (909 Prospect Street, Suite 100C, La 
Jolla, CA 92037), FS7111519 (31888 Del Obispo Street, Suite C2, San 
Juan Capistrano, CA 92675), FS7522508 (420 Palladio Parkway, Suite 
123, Folsom, CA 95630), FS4937922 (5016 Chesebro Road, Suite 210, 
Agoura Hills, CA 91301), and FS7568718 (23600 Rockfield Boulevard, 
Suite 2N, Lake Forest, CA 92630) and sought to deny Respondent's 
pending applications for new DEA Registrations Control Nos. 
W21025364C (24251 Town Center Drive, Suite 175, Valencia, CA 91355) 
and W21018406C (corrected) (13728 Hesperia Rd., Suite 7, 
Victorville, CA 92395). OSC, at 1-2.
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    A hearing was held before DEA Administrative Law Judge Paul E. 
Soeffing (the ALJ) who, on June 10, 2022, issued his Recommended 
Rulings, Findings of Fact, Conclusions of Law, and Decision 
(RD).2 3 Having reviewed

[[Page 77891]]

the entire record, the Agency adopts and hereby incorporates by 
reference the entirety of the ALJ's rulings, credibility findings,\4\ 
findings of fact, conclusions of law, sanctions analysis, and 
recommended sanction found in the RD.
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    \2\ The RD, which is summarized herein, found in favor of the 
Government and neither party filed exceptions.
    \3\ After the RD was issued, but before the deadline for filing 
exceptions had passed, Respondent notified the ALJ that he 
voluntarily surrendered his five DEA Certificates of Registration, 
but that the two applications were still pending. See Notice of 
Surrender dated June 30, 2022. Where a registration is terminated 
pursuant to 21 CFR 1301.52 after an ALJ has transmitted a 
recommended decision for final agency action (or, as here, after the 
ALJ had made all of the findings and recommendations), the Agency 
determines, on a case-by-case basis, if a final adjudication is 
warranted or if the matter should be dismissed. See Steven M. 
Kotsonis, M.D., 85 FR 85,667, 85,668-69 (2020); The Pharmacy Place, 
86 FR 21,008 (2021); Creekbend Community Pharmacy, 86 FR 40,627 n.4 
(2021). Here, the Agency will continue to adjudicate this case 
because the final official record of the allegations, the evidence, 
and the final agency decision will all support the Agency's future 
interactions with Respondent; further, adjudication is necessary to 
address the two pending applications. See Cypress Creek Pharmacy 
LLC, 86 FR 71,927 n.2 (2021) (citing Lawrence E. Stewart, M.D., 86 
FR 15,257 (2021)).
    \4\ The Agency agrees that the assigned DEA Diversion 
Investigator's (DI) testimony was credible; Respondent's testimony 
was not fully credible and at times irrelevant, conflicting, and 
defensive; and Amanda Staley's (Respondent's wife and medical 
assistant) testimony was largely irrelevant. RD, at 4, 10, 12.
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I. Findings of Fact

    The material facts in this case are narrow and undisputed. At the 
start of the COVID-19 pandemic, Respondent began a ``concierge medicine 
program'' providing telemedicine, home visits, and delivery of COVID-19 
medication packages to people at risk of developing COVID-19. Tr. 92, 
180; see also Id. at 93-96, 106, 181, 185, 192. In April 2020, an 
undercover FBI agent (UC) asked for six COVID-19 medication packages 
for himself and his family. Government Exhibit (GX) 8, at 2-3. At that 
point, Respondent, unsolicited, offered to dispense Xanax \5\ to UC. 
Id. at 4-5 (``Resp: And then you need any Xanax? UC: Yeah, um why not? 
Yeah, I mean sounds great.''). Respondent testified that he offered to 
dispense Xanax ``as a courtesy'' because UC seemed anxious. Tr. 143. UC 
later told Respondent's wife that he had talked to Respondent, that he 
was approved for the concierge medical program, and that Respondent had 
said that he could have Xanax.\6\ Tr. 172. Respondent's wife then 
packaged the order, including the Xanax, and shipped it to UC's home. 
Id. at 172-73. Respondent testified that he believed he had no further 
conversations with UC after the Xanax shipped. Id. at 35-41, 173, 187, 
207; GX 8, 10, 11, 12. Respondent admitted that he had not completed a 
medical evaluation nor diagnosed \7\ UC with a condition that would 
warrant dispensing Xanax, but still provided UC with the Xanax. Id.; 
see also, GX 10.\8\
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    \5\ The parties stipulated that Xanax is a brand name for 
alprazolam, a Schedule IV controlled substance. RD, at 2.
    \6\ DI testified that during the course of his investigation, he 
did not become ``aware of any prescription that was written by 
[Respondent] for this medication,'' id. at 51, nor has Respondent 
argued that there was a prescription for the Xanax. See Resp 
Posthearing, at 8.
    \7\ When asked, ``Had you diagnosed patient BM with any 
condition that would warrant taking alprazolam?'' Tr. 207, 
Respondent answered, ``No sir. I had not done a medical evaluation 
on patient BM.'' Id. Respondent then answered ``Yes,'' to the 
question ``but you nonetheless provided him with alprazolam, 
correct?'' Id. at 207-08.
    \8\ On July 21, 2021, Respondent entered a guilty plea in the 
United States District Court for the Southern District of California 
for violating 18 U.S.C. 541, wherein he admitted that he ``offered 
[UC] Viagra and Xanax without collecting any medical information 
about the undercover agent or the agent's purported family members . 
. . and his staff then mailed six treatment packs to the undercover 
agent, which included . . . Xanax . . . .'' GX 10, at 4.
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II. Discussion

    The Government has the burden of proving that the requirements for 
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21 
CFR 1301.44(e). Having reviewed the record, the Agency agrees with the 
RD that the Government has proven by substantial evidence that 
Respondent committed acts which render his continued registration 
inconsistent with the public interest. RD, at 12-18, 22. Specifically, 
the Agency agrees with the RD that the record established multiple 
instances where Respondent failed to comply with applicable federal and 
state law and dispensed controlled substances in a manner inconsistent 
with the public interest.
    DEA regulations require that for a prescription for a controlled 
substance to be effective, it must be issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
professional practice. 21 CFR 1306.04(a). CA Bus. & Prof. Code Sec.  
2242(a) prohibits prescribing or dispensing \9\ dangerous drugs \10\ 
absent an appropriate physical exam and medical indication. Here, 
Respondent admitted that he mailed Xanax, a ``dangerous drug'' under 
California law, to UC without conducting any physical examination or 
diagnosing UC ``with any condition that would warrant taking [Xanax].'' 
Tr. 207; see also CA Bus. & Prof. Code Sec.  4022. This admitted 
conduct clearly violated California law and rendered Respondent's 
dispensing outside the usual course of professional practice. 
Furthermore, DEA regulations state that a practitioner may only provide 
Schedule IV controlled substances to a patient without a prescription 
where the practitioner administers or dispenses the controlled 
substance directly to the patient. 21 CFR 1306.21(b). Here, the record 
evidence shows that Respondent violated 21 CFR 1306.21(b) because he 
neither issued a valid prescription for nor directly dispensed the 
Xanax pills that he mailed to UC. See supra n.6.
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    \9\ California law defines the term ``dispense'' to mean ``the 
furnishing of drugs or devices upon a prescription from a physician 
. . .'' and states that ``[f]urnish means to supply by any means, by 
sale or otherwise.'' CA Bus. & Prof. Code Sec. Sec.  4024, 4026.
    \10\ CA Bus. & Prof. Code Sec.  4022 defines the term 
``dangerous drug'' to ``mean any drug . . . that bears the legend . 
. . ``Rx only'' . . . [or] that by federal or state law can be 
lawfully dispensed only on prescription.'' Here, the alprazolam 
bottle that Respondent mailed to UC contained the marking ``RX 
Only.'' GX 9.
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    Accordingly, the Agency agrees with the RD that the Government has 
established by substantial evidence that Respondent issued Xanax to 
Respondent in violation of CA Bus. & Prof. Code Sec.  2242, and 21 CFR 
1306.04(a) and 1306.21(b). RD, 17-18. As such, the Agency finds that 
Respondent's continued registration is inconsistent with the public 
interest and, thus, that the Government has established a prima facie 
case for revocation and denial. Id.

III. Sanction

    Here, the Government has established grounds to revoke Respondent's 
registration, so the burden shifts to Respondent to show why he can be 
entrusted with the responsibility carried by a registration. Garret 
Howard Smith, M.D., 83 FR 18,882, 18,910 (2018). When a registrant has 
committed acts inconsistent with the public interest, he must both 
accept responsibility and demonstrate that he has undertaken corrective 
measures. Holiday CVS, L.L.C., dba CVS Pharmacy Nos 219 and 5195, 77 FR 
62,316, 62,339 (2012).
    Here, Respondent has failed to unequivocally accept responsibility. 
See RD, at 19-20. Instead, Respondent justified his conduct and even 
attempted, unsuccessfully, to establish that his shipping of Xanax to 
UC was proper.\11\ Id. at 19-20. Respondent's misconduct was also 
egregious.\12\ See

[[Page 77892]]

Garrett Howard Smith, M.D., 83 FR at 18,910 (collecting cases). 
Respondent, unsolicited, offered free Xanax to UC and then shipped it 
for UC and his whole family to use \13\ without a prior medical 
examination or valid prescription. GX 8, at 4. This conduct lacks even 
a veneer of a legitimate medical purpose and is more closely aligned 
with that of a drug dealer than that of a doctor. Any sanction less 
than revocation would send a message to the current and prospective 
registrant community that serious violations of the core principals of 
the CSA will not result in revocation, so long as the violation 
represents only a single incident. See Daniel A. Glick, D.D.S., 80 FR 
74,800, 74,810 (2015).
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    \11\ The Respondent even seemed incredulous that DEA was 
pursuing this matter. See RD, at 19-20 (citing Tr. 75-76). Moreover, 
when a registrant fails to make the threshold showing of acceptance 
of responsibility, the Agency need not address the registrant's 
remedial measures. Ajay S. Ahuja, M.D., 84 FR 5479, 5498 n.33 
(2019). Even so, here, ``Respondent made no showing of any remedial 
measures he has undertaken.'' RD, at 20.
    \12\ Respondent argued that his misconduct was not egregious 
enough to support revocation because the Government only established 
``a single incident, involving an anti-anxiety medication which is 
not prone to abuse or overdose,'' and pointed out that he did not 
profit from shipping the Xanax. Resp Posthearing, at 7. The Agency 
disagrees and finds that Respondent's blatant disregard for the laws 
relating to controlled substances warrants a sanction.
    \13\ Respondent testified that though the Xanax was only 
dispensed in UC's name, it was for all ``eligible members of the 
family . . . him, his wife, his [father-in-law], and in an unusual 
situation, possibly a child.'' Tr. 214-15.
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    Having reviewed the record in its entirety, the Agency finds that 
Respondent cannot be entrusted with a DEA registration and orders that 
his 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 Certificates of Registration Nos. 
FS8992794, FS7111519, FS7522508, FS4937922, and FS7568718 issued to 
Jennings Staley, M.D. Further, pursuant to 28 CFR 0.100(b) and 21 
U.S.C. 823(f), I hereby deny any pending applications for renewal or 
modification of these registrations, deny Respondent's applications for 
new DEA Registrations Control Nos. W21025364C and W21018406C, and deny 
any other pending application of Jennings Staley, M.D., for 
registration in California. This order is effective January 19, 2023.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
December 12, 2022, by Administrator Anne Milgram. That document with 
the original signature and date is maintained by DEA. For 
administrative purposes only, and in compliance with requirements of 
the Office of the Federal Register, the undersigned DEA Federal 
Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-27480 Filed 12-19-22; 8:45 am]
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