Notice2022-27480
Jennings Staley, M.D.; Decision and Order
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Published
December 20, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 87 Issue 243 (Tuesday, December 20, 2022)</title>
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[Federal Register Volume 87, Number 243 (Tuesday, December 20, 2022)]
[Notices]
[Pages 77890-77892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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).<SUP>2 3</SUP> 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]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on December 20, 2022.
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