Timothy C. Sapp, M.D.; Decision and Order, 71921-71923 [2021-27485]
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Federal Register / Vol. 86, No. 241 / Monday, December 20, 2021 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Timothy C. Sapp, M.D.; Decision and
Order
On June 7, 2021, a former Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter,
Government), issued an Order to Show
Cause (hereinafter, OSC) to Timothy C.
Sapp, M.D. (hereinafter, Registrant) of
Phoenix, Arizona. OSC, at 1. The OSC
proposed the revocation of Registrant’s
Certificate of Registration No.
BS7608396. It alleged that Registrant is
without ‘‘authority to handle controlled
substances in Arizona, the state in
which [Registrant is] registered with
DEA.’’ Id. at 2 (citing 21 U.S.C.
824(a)(3)).
Specifically, the OSC alleged that the
Arizona Medical Board (hereinafter, the
Board) issued an Interim Findings of
Fact, Conclusions of Law and Order for
Summary Restriction of License on
April 22, 2020. Id. This Order,
according to the OSC, summarily
restricted Registrant’s Arizona state
medical license and prohibited
Registrant from prescribing controlled
substances pending the outcome of a
formal hearing following the Board’s
finding, inter alia, that Registrant’s
treatment of six patients to whom he
had prescribed controlled substances
deviated from the standard of care. Id.
On September 4, 2020, the Board issued
its Findings of Fact, Conclusions of Law
and Order finding, inter alia, that
Registrant’s prescribing of controlled
substances to six patients deviated from
the standard of care and accordingly,
the Board revoked Registrant’s Arizona
state medical license, effective October
9, 2020. Id.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2–3 (citing
21 CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. Id. at 3 (citing
21 U.S.C. 824(c)(2)(C)).
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Adequacy of Service
In a Declaration dated October 29,
2021, a Diversion Investigator
(hereinafter, the DI) assigned to the
Phoenix Field Division stated that on
June 9, 2021, she sent a copy of the OSC
via USPS certified mail to four
addresses associated with Registrant,
including: An address in Hawkinsville,
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GA where Registrant registered a new
driver’s license issued on May 14, 2021;
two of Registrant’s last-known
residential addresses, one in Phoenix,
AZ and another in Columbia, SC; and
one of Registrant’s former residential
addresses in Phoenix, AZ. Request for
Final Agency Action (hereinafter,
RFAA), Exhibit (hereinafter, RFAAX) 2,
at 1–2. The DI stated that she did not
mail a copy of the OSC to Registrant’s
registered address in Phoenix, AZ
because she had ‘‘previously learned
that the address was no longer a medical
facility.’’ Id. at 2. According to the DI,
on April 22, 2021, she had traveled with
a DEA Special Agent to Registrant’s
registered address and ‘‘discovered that
Registrant’s registered address [was]
operating as a tutoring facility called
‘The Art of Learning.’’’ Id. Further,
according to the DI, ‘‘[t]he staff at ‘The
Art of Learning’ had no knowledge of
[Registrant].’’ Id.
On or around June 30, 2021, the DI
discovered that the OSC mailings
delivered to Hawkinsville, GA and
Columbia, SC were returned as
undeliverable. Id.; see also RFAAX 2,
Appendix (hereinafter, App.) A. On or
around July 28, 2021, the DI discovered
that the OSC mailed to Registrant’s last
known residential address in Phoenix,
AZ was returned as undeliverable. Id.
The DI stated that as of the date of the
Declaration, she had not received any
returned mail in connection with the
OSC mailing to Registrant’s former
residential address in Phoenix, AZ.
RFAAX 2, at 2. The DI stated that on
October 29, 2021, she checked the status
of her mailing to Registrant’s former
residential address in Phoenix, AZ and
the USPS website ‘‘showed the status of
the mailing as ‘Delivered, Front Desk/
Reception/Mail Room’ on June 14, 2021
at 12:54 p.m.’’ Id. at 2–3; see also
RFAAX 2, App. B.
On August 9, 2021, the DI emailed
copies of the OSC to three email
addresses associated with Registrant,
including Registrant’s registered email
address and two email addresses listed
in Registrant’s comprehensive
LexisNexis report. RFAAX 2, at 3. The
DI stated that she received
undeliverable confirmations from
Registrant’s registered email address
and one of the email addresses listed in
Registrant’s comprehensive LexisNexis
report. Id.; see also RFAAX 2, App. C.
As of the date of the Declaration, the DI
did not receive any undeliverable
message or error message regarding to
other email address listed in Registrant’s
comprehensive LexisNexis report. Id.
The DI concluded that as of the date of
the Declaration, ‘‘DEA [had] not
received any correspondence or
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communication from [Registrant]
regarding the [OSC].’’ RFAAX 2, at 3.
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on November 2, 2021. In its
RFAA, the Government represents that
‘‘more than thirty days have passed
since the Government both mailed and
emailed the [OSC] to [Registrant]’’ and
‘‘[n]either [Registrant] nor his attorney
filed any Request for Hearing’’ ‘‘[n]or
has DEA received any other response,
either from [Registrant] or his attorney,
regarding the [OSC].’’ RFAA, at 2 and 4.
The Government requests that
Registrant’s DEA registration be revoked
because ‘‘[Registrant] lacks authority to
handle controlled substances in the
state of Arizona, the state where he is
registered with DEA.’’ Id. at 1.
Based on the DI’s Declaration, the
Government’s written representations,
and my review of the record, I find that
the Government accomplished service
of the OSC on Registrant on (or before)
August 9, 2021. I also find that more
than thirty days have now passed since
the Government accomplished service
of the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent the Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
right to a hearing, or submitted a
corrective action plan. Accordingly, I
find that Registrant has waived the right
to a hearing and the right to submit a
written statement and corrective action
plan. 21 CFR 1301.43(d) and 21 U.S.C.
824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.43(e).
Findings of Fact
Registrant’s DEA Registration
According to Agency records,
Registrant is the holder of DEA
Certificate of Registration No.
BS7608396 at the registered address of
1130 E Missouri Ave, Ste 206, Phoenix,
AZ 85014. See RFAAX 2, at 1 (DI
Declaration). Pursuant to this
registration, Registrant is authorized to
dispense controlled substances in
schedules II through V as a practitioner.
Registrant’s registration expires on
February 28, 2023 and is currently in an
‘‘active pending’’ status. Id.
The Status of Registrant’s State License
On April 22, 2020, the Arizona
Medical Board (hereinafter, the Board)
issued an Interim Findings of Fact,
Conclusions of Law and Order for
Summary Restriction of License
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(hereinafter, Interim Order). RFAAX 2,
App. D. According to the Interim Order,
the Board initiated a case after receiving
a complaint regarding Registrant’s care
and treatment of patient E.R. that
alleged inappropriate prescribing and
medication management. Id. at 1. Based
on the complaint, the Board requested
Medical Consultant (hereinafter, MC)
review of Registrant’s care of patient
E.R. and three other patients, which
found that Registrant had deviated from
the standard of care, including
‘‘prescribing Adderall without adequate
clinical rationale, prescribing two
benzodiazepines concurrently without
adequate clinical rationale, [and]
prescribing Lamictal for off-label use
without adequate clinical rationale.’’ Id.
at 1–3. The review concluded that
‘‘[t]here was the potential for patient
harm including that patients were at
risk for misuse of controlled substances,
dependence and addiction.’’ Id. at 3.
The Board initiated a second case
after receiving a complaint regarding
Registrant’s care and treatment of
patient W.F. that alleged inappropriate
prescribing and failing to obtain drug
screens. Id. An MC review of
Registrant’s care and treatment of W.F.
‘‘opined that [Registrant] deviated from
the standard of care by prescribing high
dose benzodiazepines and stimulants
without adequate clinical rationale, and
by prescribing a stimulant and
antidepressant concurrently in a patient
with bipolar disorder without a mood
stabilizer.’’ Id. at 4. The review
concluded that ‘‘[t]here was the
potential for patient harm in that [W.F.]
was at risk of a ‘manic switch’ due to
the lack of concurrently prescribed
mood stabilizer.’’ Id.
Finally, the Board initiated a third
case after receiving a complaint
regarding Registrant’s care and
treatment of patient R.P. that alleged
inappropriate discharge of a patient. Id.
An MC review of Registrant’s care and
treatment of R.P. ‘‘opined that
[Registrant] deviated from the standard
of care by failing to appropriately
discharge the patient.’’ Id. at 5. The
review concluded that ‘‘[t]here was
actual patient harm in that R.P.
experienced withdrawal symptoms from
abrupt cessation of benzodiazepines.’’
Id.
On April 21, 2020, the Board ‘‘voted
unanimously to offer [Registrant] an
Interim Consent Agreement for Practice
Restriction (‘ICA’), and if not accepted
by 12:00 p.m. on April 22, 2020, to
summarily restrict [Registrant’s] license,
based on a finding that the public
health, safety and welfare imperatively
required imminent action.’’ Id.
According to the Interim Order,
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‘‘[Registrant] failed to accept the
proposed ICA within the time frame
specified by the Board,’’ and thus, the
Board ordered the summary restriction
of Registrant’s Arizona medical license
and prohibited Registrant ‘‘from
prescribing controlled substances in the
State of Arizona pending the outcome of
a Formal Hearing in [the] matter.’’ Id. at
5–6. On September 4, 2020, the Board
issued its Findings of Fact, Conclusions
of Law and Order (License Revocation)
and ordered Registrant’s Arizona
medical license revoked. RFAAX 2,
App. E, at 19.
According to Arizona’s online
records, of which I take official notice,
Registrant’s license is expired.1 Arizona
Medical Board Licensee Search, https://
azbomprod.azmd.gov/glsuiteweb/
clients/azbom/public/WebVerification
Search.aspx (last visited date of
signature of this Order). Arizona’s
online records show that Registrant’s
medical license remains expired. Id.
Accordingly, I find that Registrant is
not currently licensed to engage in the
practice of medicine in Arizona, the
state in which Registrant is registered
with the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (hereinafter, CSA)
‘‘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, the 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.,
1 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Registrant may dispute my finding by filing a
properly supported motion for reconsideration of
finding of fact within fifteen calendar days of the
date of this Order. Any such motion and response
shall be filed and served by email to the other party
and to Office of the Administrator, Drug
Enforcement Administration at
dea.addo.attorneys@dea.usdoj.gov.
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James L. Hooper, M.D., 76 FR 71,371
(2011), pet. for rev. denied, 481 F. App’x
826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27,616, 27,617
(1978).
This rule derives from the text of two
provisions of the 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(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the CSA,
the 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 at 71,371–72;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 (2006); Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 (1993);
Bobby Watts, M.D., 53 FR 11,919, 11,920
(1988); Frederick Marsh Blanton, 43 FR
at 27,617.
According to Arizona statute, ‘‘[e]very
person who manufactures, distributes,
dispenses, prescribes or uses for
scientific purposes any controlled
substance within this state or who
proposes to engage in the manufacture,
distribution, prescribing or dispensing
of or using for scientific purposes any
controlled substance within this state
must first: (1) Obtain and possess a
current license or permit as a medical
practitioner as defined in § 32–1901
. . .’’ Ariz. Rev. Stat. Ann. § 36–2522(A)
(2021). Arizona Statute § 32–1901
defines a ‘‘[m]edical practitioner’’ as
‘‘any medical doctor . . . or other
person who is licensed and authorized
by law to use and prescribe drugs and
devices to treat sick and injured human
beings or animals or to diagnose or
prevent sickness in human beings or
animals in this state or any state,
territory or district of the United
States.’’ Ariz. Rev. Stat. Ann. § 32–1901
(2021). Arizona regulations further
clarify that ‘‘[a] physician who wishes to
dispense a controlled substance . . . a
prescription-only drug . . . or a
prescription-only device . . . shall be
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currently licensed to practice medicine
in Arizona.’’ Ariz. Admin. Code § R4–
16–301(A) (2021).
Here, the undisputed evidence in the
record is that Registrant currently lacks
authority to practice medicine in
Arizona, as he no longer retains a
medical license in that state. As already
discussed, a physician can only
dispense controlled substances if he is
licensed to practice medicine in
Arizona. Thus, because Registrant lacks
authority to practice medicine in
Arizona and, therefore, is not authorized
to dispense controlled substances in
Arizona, Registrant is not eligible to
maintain a DEA registration in Arizona.
Accordingly, I 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. BS7608396 issued to
Timothy C. Sapp, M.D. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny any pending
application of Timothy C. Sapp to
renew or modify this registration, as
well as any other pending application of
Timothy C. Sapp for additional
registration in Arizona. This Order is
effective January 19, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021–27485 Filed 12–17–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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Peter S. Klainer, M.D.; Decision and
Order
On August 20, 2021, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter,
Government), issued an Order to Show
Cause (hereinafter, OSC) to Peter S.
Klainer, M.D. (hereinafter, Registrant) of
Morehead City, North Carolina. OSC, at
1 and 3. The OSC proposed the
revocation of Registrant’s Certificate of
Registration No. BK4940741. It alleged
that Registrant is ‘‘without authority to
handle controlled substances in North
Carolina, the state in which [Registrant
is] registered with DEA.’’ Id. at 2 (citing
21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that on
November 13, 2020, the North Carolina
Medical Board issued an Order
suspending Registrant’s state medical
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license after finding that ‘‘there was
probable cause to believe [Registrant]
committed unprofessional conduct . . .
after [he was] arrested and charged with
nine felony counts of sexual
exploitation of a minor in the second
degree.’’ Id. The OSC notified Registrant
of the right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2 (citing 21
CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. Id. at 3 (citing
21 U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated November 10,
2021, a Diversion Investigator
(hereinafter, the DI) assigned to the
Raleigh District Office of the Atlanta
Field Division stated that on August 26,
2021, she ‘‘personally served the [OSC]
on [Registrant] at the Carteret County
Sheriff’s Office.’’ Request for Final
Agency Action (hereinafter, RFAA),
Exhibit (hereinafter, RFAAX) 3, at 1–2.
The DI stated that as of the date of the
Declaration, ‘‘neither [Registrant] nor
any attorney representing [Registrant]
has requested a hearing or submitted a
written statement.’’ Id. at 2.
The Government forwarded its RFAA,
along with the evidentiary record, to
this office on November 10, 2021. In its
RFAA, the Government represents that
‘‘[Registrant] has not submitted a timely
request for a hearing’’ and that as of
November 10, 2021, ‘‘neither
[Registrant] nor any attorney
representing [Registrant] has requested a
hearing or submitted a written
statement.’’ RFAA, at 1–2. The
Government ‘‘seeks to revoke
[Registrant’s DEA registration] because
[Registrant] lacks authority to handle
controlled substances in the State of
North Carolina, the state where
[Registrant] is registered with DEA’’ and
‘‘requests that the Administrator revoke
[Registrant’s] [DEA registration] and
deny any applications for renewal.’’ Id.
at 1 and 5.
Based on the DI’s Declaration, the
Government’s written representations,
and my review of the record, I find that
the Government accomplished service
of the OSC on Registrant on August 26,
2021. I also find that more than thirty
days have now passed since the
Government accomplished service of
the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent the Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
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right to a hearing, or submitted a
corrective action plan. Accordingly, I
find that Registrant has waived the right
to a hearing and the right to submit a
written statement and corrective action
plan. 21 CFR 1301.43(d) and 21 U.S.C.
824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.43(e).
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
BK4940741 at the registered address of
3700 Symi Cir, Morehead City, NC
28557. RFAAX 1 (Certificate of
Registration). Pursuant to this
registration, Registrant is authorized to
dispense controlled substances in
schedules II through V as a practitioner.
Id. Registrant’s registration expires on
December 31, 2022. Id.
The Status of Registrant’s State License
On November 13, 2020, the North
Carolina Medical Board (hereinafter, the
Board) issued an Order of Summary
Suspension of License (hereinafter,
Order). RFAAX 2, Appendix
(hereinafter, App.) A, at 1 and 6. In its
Order, the Board found that on or about
November 4, 2020, ‘‘[Registrant] was
arrested and charged with nine felony
counts of Sexual Exploitation of a Minor
in the Second Degree.’’ Id. at 1. The
Board found that probable cause existed
that Registrant committed the conduct
for which he was arrested and charged
and that ‘‘such conduct constitutes
unprofessional conduct within the
meaning of N.C. Gen. Stat. § 90–14(a)(6)
and grounds exist under that section of
the North Carolina General Statutes for
the Board to annul, suspend, revoke, or
limit [Registrant’s] license to practice
medicine or to deny any application he
might make in the future for a license
to practice medicine.’’ Id. at 5. As such,
the Board found that ‘‘the public health,
safety, or welfare requires emergency
action’’ and ordered Registrant’s
medical license summarily suspended.
Id. at 6.
According to North Carolina’s online
records, of which I take official notice,
Registrant’s license is still revoked.1
1 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
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[Notices]
[Pages 71921-71923]
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[FR Doc No: 2021-27485]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Timothy C. Sapp, M.D.; Decision and Order
On June 7, 2021, a former Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter,
Government), issued an Order to Show Cause (hereinafter, OSC) to
Timothy C. Sapp, M.D. (hereinafter, Registrant) of Phoenix, Arizona.
OSC, at 1. The OSC proposed the revocation of Registrant's Certificate
of Registration No. BS7608396. It alleged that Registrant is without
``authority to handle controlled substances in Arizona, the state in
which [Registrant is] registered with DEA.'' Id. at 2 (citing 21 U.S.C.
824(a)(3)).
Specifically, the OSC alleged that the Arizona Medical Board
(hereinafter, the Board) issued an Interim Findings of Fact,
Conclusions of Law and Order for Summary Restriction of License on
April 22, 2020. Id. This Order, according to the OSC, summarily
restricted Registrant's Arizona state medical license and prohibited
Registrant from prescribing controlled substances pending the outcome
of a formal hearing following the Board's finding, inter alia, that
Registrant's treatment of six patients to whom he had prescribed
controlled substances deviated from the standard of care. Id. On
September 4, 2020, the Board issued its Findings of Fact, Conclusions
of Law and Order finding, inter alia, that Registrant's prescribing of
controlled substances to six patients deviated from the standard of
care and accordingly, the Board revoked Registrant's Arizona state
medical license, effective October 9, 2020. Id.
The OSC notified Registrant of the right to request a hearing on
the allegations or to submit a written statement, while waiving the
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 2-3 (citing 21
CFR 1301.43). The OSC also notified Registrant of the opportunity to
submit a corrective action plan. Id. at 3 (citing 21 U.S.C.
824(c)(2)(C)).
Adequacy of Service
In a Declaration dated October 29, 2021, a Diversion Investigator
(hereinafter, the DI) assigned to the Phoenix Field Division stated
that on June 9, 2021, she sent a copy of the OSC via USPS certified
mail to four addresses associated with Registrant, including: An
address in Hawkinsville, GA where Registrant registered a new driver's
license issued on May 14, 2021; two of Registrant's last-known
residential addresses, one in Phoenix, AZ and another in Columbia, SC;
and one of Registrant's former residential addresses in Phoenix, AZ.
Request for Final Agency Action (hereinafter, RFAA), Exhibit
(hereinafter, RFAAX) 2, at 1-2. The DI stated that she did not mail a
copy of the OSC to Registrant's registered address in Phoenix, AZ
because she had ``previously learned that the address was no longer a
medical facility.'' Id. at 2. According to the DI, on April 22, 2021,
she had traveled with a DEA Special Agent to Registrant's registered
address and ``discovered that Registrant's registered address [was]
operating as a tutoring facility called `The Art of Learning.''' Id.
Further, according to the DI, ``[t]he staff at `The Art of Learning'
had no knowledge of [Registrant].'' Id.
On or around June 30, 2021, the DI discovered that the OSC mailings
delivered to Hawkinsville, GA and Columbia, SC were returned as
undeliverable. Id.; see also RFAAX 2, Appendix (hereinafter, App.) A.
On or around July 28, 2021, the DI discovered that the OSC mailed to
Registrant's last known residential address in Phoenix, AZ was returned
as undeliverable. Id. The DI stated that as of the date of the
Declaration, she had not received any returned mail in connection with
the OSC mailing to Registrant's former residential address in Phoenix,
AZ. RFAAX 2, at 2. The DI stated that on October 29, 2021, she checked
the status of her mailing to Registrant's former residential address in
Phoenix, AZ and the USPS website ``showed the status of the mailing as
`Delivered, Front Desk/Reception/Mail Room' on June 14, 2021 at 12:54
p.m.'' Id. at 2-3; see also RFAAX 2, App. B.
On August 9, 2021, the DI emailed copies of the OSC to three email
addresses associated with Registrant, including Registrant's registered
email address and two email addresses listed in Registrant's
comprehensive LexisNexis report. RFAAX 2, at 3. The DI stated that she
received undeliverable confirmations from Registrant's registered email
address and one of the email addresses listed in Registrant's
comprehensive LexisNexis report. Id.; see also RFAAX 2, App. C. As of
the date of the Declaration, the DI did not receive any undeliverable
message or error message regarding to other email address listed in
Registrant's comprehensive LexisNexis report. Id. The DI concluded that
as of the date of the Declaration, ``DEA [had] not received any
correspondence or communication from [Registrant] regarding the
[OSC].'' RFAAX 2, at 3.
The Government forwarded its RFAA, along with the evidentiary
record, to this office on November 2, 2021. In its RFAA, the Government
represents that ``more than thirty days have passed since the
Government both mailed and emailed the [OSC] to [Registrant]'' and
``[n]either [Registrant] nor his attorney filed any Request for
Hearing'' ``[n]or has DEA received any other response, either from
[Registrant] or his attorney, regarding the [OSC].'' RFAA, at 2 and 4.
The Government requests that Registrant's DEA registration be revoked
because ``[Registrant] lacks authority to handle controlled substances
in the state of Arizona, the state where he is registered with DEA.''
Id. at 1.
Based on the DI's Declaration, the Government's written
representations, and my review of the record, I find that the
Government accomplished service of the OSC on Registrant on (or before)
August 9, 2021. I also find that more than thirty days have now passed
since the Government accomplished service of the OSC. Further, based on
the Government's written representations, I find that neither
Registrant, nor anyone purporting to represent the Registrant,
requested a hearing, submitted a written statement while waiving
Registrant's right to a hearing, or submitted a corrective action plan.
Accordingly, I find that Registrant has waived the right to a hearing
and the right to submit a written statement and corrective action plan.
21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record submitted by the Government,
which constitutes the entire record before me. 21 CFR 1301.43(e).
Findings of Fact
Registrant's DEA Registration
According to Agency records, Registrant is the holder of DEA
Certificate of Registration No. BS7608396 at the registered address of
1130 E Missouri Ave, Ste 206, Phoenix, AZ 85014. See RFAAX 2, at 1 (DI
Declaration). Pursuant to this registration, Registrant is authorized
to dispense controlled substances in schedules II through V as a
practitioner. Registrant's registration expires on February 28, 2023
and is currently in an ``active pending'' status. Id.
The Status of Registrant's State License
On April 22, 2020, the Arizona Medical Board (hereinafter, the
Board) issued an Interim Findings of Fact, Conclusions of Law and Order
for Summary Restriction of License
[[Page 71922]]
(hereinafter, Interim Order). RFAAX 2, App. D. According to the Interim
Order, the Board initiated a case after receiving a complaint regarding
Registrant's care and treatment of patient E.R. that alleged
inappropriate prescribing and medication management. Id. at 1. Based on
the complaint, the Board requested Medical Consultant (hereinafter, MC)
review of Registrant's care of patient E.R. and three other patients,
which found that Registrant had deviated from the standard of care,
including ``prescribing Adderall without adequate clinical rationale,
prescribing two benzodiazepines concurrently without adequate clinical
rationale, [and] prescribing Lamictal for off-label use without
adequate clinical rationale.'' Id. at 1-3. The review concluded that
``[t]here was the potential for patient harm including that patients
were at risk for misuse of controlled substances, dependence and
addiction.'' Id. at 3.
The Board initiated a second case after receiving a complaint
regarding Registrant's care and treatment of patient W.F. that alleged
inappropriate prescribing and failing to obtain drug screens. Id. An MC
review of Registrant's care and treatment of W.F. ``opined that
[Registrant] deviated from the standard of care by prescribing high
dose benzodiazepines and stimulants without adequate clinical
rationale, and by prescribing a stimulant and antidepressant
concurrently in a patient with bipolar disorder without a mood
stabilizer.'' Id. at 4. The review concluded that ``[t]here was the
potential for patient harm in that [W.F.] was at risk of a `manic
switch' due to the lack of concurrently prescribed mood stabilizer.''
Id.
Finally, the Board initiated a third case after receiving a
complaint regarding Registrant's care and treatment of patient R.P.
that alleged inappropriate discharge of a patient. Id. An MC review of
Registrant's care and treatment of R.P. ``opined that [Registrant]
deviated from the standard of care by failing to appropriately
discharge the patient.'' Id. at 5. The review concluded that ``[t]here
was actual patient harm in that R.P. experienced withdrawal symptoms
from abrupt cessation of benzodiazepines.'' Id.
On April 21, 2020, the Board ``voted unanimously to offer
[Registrant] an Interim Consent Agreement for Practice Restriction
(`ICA'), and if not accepted by 12:00 p.m. on April 22, 2020, to
summarily restrict [Registrant's] license, based on a finding that the
public health, safety and welfare imperatively required imminent
action.'' Id. According to the Interim Order, ``[Registrant] failed to
accept the proposed ICA within the time frame specified by the Board,''
and thus, the Board ordered the summary restriction of Registrant's
Arizona medical license and prohibited Registrant ``from prescribing
controlled substances in the State of Arizona pending the outcome of a
Formal Hearing in [the] matter.'' Id. at 5-6. On September 4, 2020, the
Board issued its Findings of Fact, Conclusions of Law and Order
(License Revocation) and ordered Registrant's Arizona medical license
revoked. RFAAX 2, App. E, at 19.
According to Arizona's online records, of which I take official
notice, Registrant's license is expired.\1\ Arizona Medical Board
Licensee Search, https://azbomprod.azmd.gov/glsuiteweb/clients/azbom/public/WebVerificationSearch.aspx (last visited date of signature of
this Order). Arizona's online records show that Registrant's medical
license remains expired. Id.
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\1\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Registrant may dispute my finding by filing
a properly supported motion for reconsideration of finding of fact
within fifteen calendar days of the date of this Order. Any such
motion and response shall be filed and served by email to the other
party and to Office of the Administrator, Drug Enforcement
Administration at [email protected].
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Accordingly, I find that Registrant is not currently licensed to
engage in the practice of medicine in Arizona, the state in which
Registrant is registered with the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (hereinafter, CSA) ``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, the 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 71,371 (2011), pet. for rev. denied, 481 F. App'x 826 (4th
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
This rule derives from the text of two provisions of the 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(f). Because Congress has clearly mandated
that a practitioner possess state authority in order to be deemed a
practitioner under the CSA, the 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 at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43
FR at 27,617.
According to Arizona statute, ``[e]very person who manufactures,
distributes, dispenses, prescribes or uses for scientific purposes any
controlled substance within this state or who proposes to engage in the
manufacture, distribution, prescribing or dispensing of or using for
scientific purposes any controlled substance within this state must
first: (1) Obtain and possess a current license or permit as a medical
practitioner as defined in Sec. 32-1901 . . .'' Ariz. Rev. Stat. Ann.
Sec. 36-2522(A) (2021). Arizona Statute Sec. 32-1901 defines a
``[m]edical practitioner'' as ``any medical doctor . . . or other
person who is licensed and authorized by law to use and prescribe drugs
and devices to treat sick and injured human beings or animals or to
diagnose or prevent sickness in human beings or animals in this state
or any state, territory or district of the United States.'' Ariz. Rev.
Stat. Ann. Sec. 32-1901 (2021). Arizona regulations further clarify
that ``[a] physician who wishes to dispense a controlled substance . .
. a prescription-only drug . . . or a prescription-only device . . .
shall be
[[Page 71923]]
currently licensed to practice medicine in Arizona.'' Ariz. Admin. Code
Sec. R4-16-301(A) (2021).
Here, the undisputed evidence in the record is that Registrant
currently lacks authority to practice medicine in Arizona, as he no
longer retains a medical license in that state. As already discussed, a
physician can only dispense controlled substances if he is licensed to
practice medicine in Arizona. Thus, because Registrant lacks authority
to practice medicine in Arizona and, therefore, is not authorized to
dispense controlled substances in Arizona, Registrant is not eligible
to maintain a DEA registration in Arizona. Accordingly, I 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.
BS7608396 issued to Timothy C. Sapp, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending application of Timothy C. Sapp to renew or modify this
registration, as well as any other pending application of Timothy C.
Sapp for additional registration in Arizona. This Order is effective
January 19, 2022.
Anne Milgram,
Administrator.
[FR Doc. 2021-27485 Filed 12-17-21; 8:45 am]
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