Debora Ryder, N.P.; Decision and Order, 55074-55076 [2023-17383]
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Federal Register / Vol. 88, No. 155 / Monday, August 14, 2023 / Notices
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. 2023–17385 Filed 8–11–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Debora Ryder, N.P.; Decision and
Order
ddrumheller on DSK120RN23PROD with NOTICES1
On August 24, 2022, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause and Immediate Suspension of
Registration (OSC/ISO) to Debora Ryder,
N.P. (Registrant) of Tarpon Springs,
Florida. Request for Final Agency
Action (RFAA), Exhibit (RFAAX) 2, at 1.
The OSC/ISO informed Registrant of the
immediate suspension of her DEA
Certificate of Registration, Control No.
MR4236584, 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. The OSC/ISO also proposed
the revocation of Registrant’s
registration, alleging that Registrant’s
continued registration is inconsistent
with the public interest and that
Registrant is without authority to handle
controlled substances in Florida, the
state in which she is registered with
DEA.1 Id. at 1 (citing 21 U.S.C. 824(a)(4),
823(g)(1),2 824(a)(3)).3
The Agency makes the following
findings of fact based on the
uncontroverted evidence submitted by
the Government in its RFAA dated
February 28, 2023.4
1 The registered address of Registrant’s DEA
Certificate of Registration, Control No. MR4236584,
is 900 Beckett Way, Tarpon Springs, Florida 34689.
Id. at 3.
2 Effective December 2, 2022, the Medical
Marijuana and Cannabidiol Research Expansion
Act, Public Law 117–215, 136 Stat. 2257 (2022)
(Marijuana Research Amendments or MRA),
amended the Controlled Substances Act (CSA) and
other statutes. Relevant to this matter, the MRA
redesignated 21 U.S.C. 823(f), cited in the OSC/ISO,
as 21 U.S.C. 823(g)(1). Accordingly, this Decision
cites to the current designation, 21 U.S.C. 823(g)(1),
and to the MRA-amended CSA throughout.
3 According to Agency records, Registrant’s
Certificate of Registration No. MR4236584 expired
on April 30, 2023. The fact that a registrant allows
her registration to expire during the pendency of an
OSC does not impact the Agency’s jurisdiction or
prerogative under the CSA to adjudicate the OSC
to finality. Jeffrey D. Olsen, M.D., 84 FR 68474,
68476–79 (2019).
4 Based on a Declaration from a DEA Diversion
Investigator, the Agency finds that the
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I. Findings of Fact
On July 31, 2022, Registrant’s Florida
advanced practice registered nurse
(APRN) license number APRN2943222
expired by its own terms. RFAAX 3,
Attachment B. According to Florida
online records, of which the Agency
takes official notice, Registrant’s Florida
APRN license number APRN2943222 is
listed as ‘‘Delinquent,’’ indicating that
‘‘[t]he licensed practitioner is not
authorized to practice in the state of
Florida.’’ 5 Florida Department of Health
License Verification, https://mqainternet.doh.state.fl.us/
MQASearchServices/ (last visited date
of signature of this Order). Accordingly,
the Agency finds that Registrant is not
currently licensed to practice as an
APRN in Florida, the state in which she
is registered with the DEA.6
The Agency further finds that the
Government’s evidence shows that from
June 11, 2021, through July 28, 2022,
Registrant issued at least 83
prescriptions for controlled substances
in the names of two deceased
Government’s service of the OSC/ISO on Registrant
was adequate. RFAAX 3, at 2. Further, based on the
Government’s assertions in its RFAA, the Agency
finds that more than thirty days have passed since
Registrant was served with the OSC/ISO and
Registrant has neither requested a hearing nor
submitted a corrective action plan and therefore has
waived any such rights. RFAA, at 2; see also 21 CFR
1301.43 and 21 U.S.C. 824(c)(2).
5 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 the Agency’s finding by
filing a properly supported motion for
reconsideration of findings 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.gov.
6 According to Florida online records, of which
the Agency takes official notice, Registrant’s Florida
registered nurse license number RN2943222 is
listed as ‘‘clear/active.’’ Florida Department of
Health License Verification, https://mqainternet.doh.state.fl.us/MQASearchServices/ (last
visited date of signature of this Order). Although
both the Government’s RFAA and an attached
Declaration from a DEA Diversion Investigator
correctly note that Registrant is a current holder of
a Florida registered nurse license number
RN2943222, the cited Attachment A of the
Diversion Investigator’s Declaration appears to be
an erroneous printout from the Florida Department
of Health License Verification database pertaining
to a different practitioner who shares Registrant’s
first and last name and whose registered nurse
license number RN3151242 is listed as null and
void. See RFAA, at 3; RFAAX 3, at 1; RFAAX 3,
Attachment A.
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individuals, Deceased Patient B.K.7 and
Deceased Patient J.R.8 RFAAX 3, at 2–
3. After Deceased Patient B.K.’s death,
from at least July 19, 2021 through July
28, 2022, Registrant issued at least 47
prescriptions for controlled substances
in Deceased Patient B.K.’s name,
including prescriptions for
hydromorphone, oxycodone,
alprazolam, and promethazine-codeine
syrup. Id.; see also RFAAX 3,
Attachment F. After Deceased Patient
J.R.’s death, from at least June 11, 2021
through July 28, 2022, Registrant issued
at least 36 prescriptions for controlled
substances in Deceased Patient J.R.’s
name, including prescriptions for
hydromorphone, oxycodone,
phendimetrazine, and promethazinecodeine syrup. RFAAX 3, at 2–3; see
also RFAAX 3, Attachment H.
Additionally, the Agency finds that
the Government’s evidence shows that
on March 1, 2022, during a probable
cause search of Registrant’s vehicle
during a traffic stop on an individual
who was driving Registrant’s vehicle at
the time, law enforcement discovered 14
pre-signed prescriptions for controlled
substances dated from March 1, 2022,
through March 4, 2022, and issued to
multiple individuals, including the
driver of the vehicle. RFAAX 4, at 1–2;
see also RFAAX 4, Attachment I. The
prescriptions were signed by Registrant
and issued for oxycodone, hydrocodone,
and Xanax, a brand name drug
containing alprazolam. Id.9
Further, the Agency finds that the
Government’s evidence shows that on
June 27, 2022, pursuant to a search
warrant of a business, law enforcement
discovered four prescriptions for
promethazine-codeine syrup pre-signed
by Registrant.10 Id. at 1; see also RFAAX
5, Attachment J. Notably, although the
controlled substance portions were
filled out on all four prescriptions, ‘‘the
patient information portion[s],
including the patient name[s] and
date[s] of birth[,] were blank.’’ Id.
7 Deceased Patient B.K. died on or about June 21,
2019. RFAAX 3, at 3; see also RFAAX 3,
Attachment D–E.
8 Deceased Patient J.R. was found deceased by
Registrant on or about October 19, 2018. RFAAX 3,
at 3; see also RFAAX 3, Attachment G.
9 As Registrant was not present at the time of the
traffic stop, law enforcement called Registrant
‘‘multiple times’’ and confirmed her identity as well
as that she had written out the 14 pre-signed
prescriptions. RFAAX 4, at 1–2. During one of the
phone calls, Registrant ‘‘advised she fills out
prescriptions for her patients ‘ahead of time’ ’’ and
that ‘‘she had given her nephew, the driver of the
vehicle, permission to bring the prescriptions to her
office.’’ Id. at 2.
10 During the execution of the search warrant, law
enforcement discovered 12 prescriptions in total
pre-signed by Registrant. RFAAX 5, at 1.
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II. Discussion
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A. 21 U.S.C. 824(a)(3): Loss of State
Authority
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 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 71371
(2011), pet. for rev. denied, 481 F. App’x
826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27616, 27617
(1978).11
According to Florida statute, ‘‘[a]
practitioner, in good faith and in the
course of his or her professional practice
only, may prescribe, administer,
dispense, mix, or otherwise prepare a
controlled substance.’’ Fla. Stat.
893.05(1)(a) (2022). Further, a
‘‘practitioner’’ as defined by Florida
statute includes ‘‘an [APRN] licensed
under chapter 464.’’ 12 Id. § 893.02(23).13
11 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(g)(1). 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
71371–72; Sheran Arden Yeates, M.D., 71 FR
39130, 39131 (2006); Dominick A. Ricci, M.D., 58
FR 51104, 51105 (1993); Bobby Watts, M.D., 53 FR
11919, 11920 (1988); Frederick Marsh Blanton, 43
FR at 27617.
12 Chapter 464 regulates nursing and applies to
Registrant; it defines an APRN as ‘‘any person
licensed in [the] state to practice professional
nursing and who is licensed in an advanced nursing
practice, including . . . certified nurse
practitioners.’’ Id. § 464.003(3).
13 A ‘‘practitioner’’ as defined by Florida statute
does not include a registered nurse. Id. Further,
Florida statute states that a registered nurse is only
authorized to administer ‘‘medications and
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Here, the undisputed evidence in the
record is that Registrant lacks authority
to practice as an APRN in Florida. As
discussed, a person must be a licensed
practitioner to dispense a controlled
substance in Florida. Accordingly, the
Agency finds that because Registrant
lacks authority to practice as an APRN
in Florida, Registrant is, therefore,
unauthorized to handle controlled
substances in Florida, the state in which
she is registered with DEA.
B. 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). 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 applicant’s experience in
dispensing, or conducting research with
respect to controlled substances.
(C) The applicant’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).
The DEA considers these public
interest factors in the disjunctive. Robert
A. Leslie, M.D., 68 FR 15227, 15230
(2003). Each factor is weighed on a caseby-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
of the public interest factors in 21 U.S.C.
823(g)(1),14 the Government’s evidence
treatments as prescribed or authorized by a duly
licensed practitioner.’’ Id. § 464.003(19)(b). As such,
the ‘‘clear/active’’ status of Registrant’s Florida
registered nurse license, see supra at n.5, does not
authorize Registrant to handle controlled
substances in the state of Florida.
14 As to Factor A, there is no record evidence of
disciplinary action against Registrant’s state APRN
license. 21 U.S.C. 823(g)(1)(A). Here, Registrant’s
Florida APRN license expired by its own terms. See
supra at I. DEA precedent establishes that where the
record contains no evidence of a recommendation
by a state licensing board, such absence does not
weigh for or against revocation. Ester Mark, M.D.,
PO 00000
Frm 00069
Fmt 4703
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55075
in support of its prima facie case for
revocation of Registrant’s registration is
confined to Factors B and D. See RFAA,
at 8–11. The Government has the
burden of proof in this proceeding. 21
CFR 1301.44. Here, the Agency finds
that the Government’s evidence satisfies
its prima facie burden of showing that
Registrant’s continued registration
would be ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 824(a). The Agency
further finds that Registrant failed to
provide sufficient evidence to rebut the
Government’s prima facie case.
1. Factors B and D
Evidence is considered under Public
Interest 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). The
Government has alleged that Registrant
violated both federal and Florida state
law regulating controlled substances.
RFAAX 2, at 2–5. According to the
CSA’s implementing regulations, a
lawful controlled 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). The CSA
also requires that all prescriptions for
controlled substances ‘‘shall be dated as
of, and signed on, the day when
issued.’’ 21 CFR 1306.05(a). Further,
Florida state law lists numerous
requirements for the prescribing of
controlled substances, including, but
not limited to, requirements that the
prescriber: conduct a complete medical
history and physical examination;
document any medical indications for
the use of a controlled substance; create
a written treatment plan; discuss with
the patient the risks and benefits of the
use of controlled substances; conduct
periodic reviews of the effectiveness of
any treatment with controlled
86 FR 16760, 16771 (2021) (citing 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 an offense under either
federal or state law ‘‘relating to the manufacture,
distribution, or dispensing of controlled
substances.’’ 21 U.S.C. 823(g)(1)(C). However, as
Agency cases have noted, there are a number of
reasons why a person who has engaged in criminal
misconduct may never have been convicted of an
offense under this factor. Dewey C. MacKay, M.D.,
75 FR 49956, 49973 (2010). Agency cases have
therefore found that ‘‘the absence of such a
conviction is of considerably less consequence in
the public interest inquiry’’ and is therefore not
dispositive. Id. 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 revocation.
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ddrumheller on DSK120RN23PROD with NOTICES1
substances; assess and monitor the
patient’s risk for aberrant drug-related
behavior; and maintain accurate,
current, complete, and accessible
records. Fla. Stat. 456.44; Fla. Admin.
Code Ann. r. 64B8–9.013. Additionally,
Florida state law requires that
prescriptions ‘‘must be signed by the
prescribing practitioner on the day
when issued.’’ Fla. Stat. 456.42(1).
Here, the record demonstrates that
Registrant issued at least 83
prescriptions for controlled substances
in the names of two deceased
individuals, as well as pre-signed at
least 18 prescriptions for controlled
substances. As discussed above, such
conduct is in clear violation of Florida
state law and thus renders Registrant’s
prescribing outside the usual course of
professional practice. As such, the
Agency sustains the Government’s
allegations that Registrant violated 21
CFR 1306.04(a), 1306.05(a); Florida
Statutes 456.44 and 456.2(1); and
Florida Administrative Code Rule
64B8–9.013.
In sum, the Agency finds that Factors
B and D weigh in favor of revocation of
Registrant’s registration and thus finds,
after considering the factors set forth in
21 U.S.C. 823(g)(1), Registrant’s
continued registration to be inconsistent
with the public interest.
III. Sanction
Where, as here, the Government has
established grounds to revoke
Registrant’s registration, the burden
shifts to the registrant to show why he
can be entrusted with the responsibility
carried by a registration. Garret Howard
Smith, M.D., 83 FR 18882, 18910 (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 62316, 62339 (2012). Trust
is necessarily a fact-dependent
determination based on individual
circumstances; therefore, the Agency
looks at factors such as the acceptance
of responsibility, the credibility of that
acceptance as it relates to the
probability of repeat violations or
behavior, the nature of the misconduct
that forms the basis for sanction, and the
Agency’s interest in deterring similar
acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33738, 33746 (2021).
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
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17:38 Aug 11, 2023
Jkt 259001
CSA nor demonstrated that she can be
entrusted with registration. Moreover,
the Agency has found that Registrant is
ineligible to maintain a DEA registration
and that the evidence presented by the
Government clearly shows that
Registrant violated the CSA. See supra
at II. Accordingly, the Agency orders 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. MR4236584 issued
to Debora Ryder, N.P. 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 Debora Ryder, N.P., to renew or
modify this registration, as well as any
other pending application of Debora
Ryder, N.P., for additional registration
in Florida. This Order is effective
September 13, 2023.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on August 7, 2023, 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. 2023–17383 Filed 8–11–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23–23]
Yogeshwar Gill, M.D.; Decision and
Order
On December 19, 2022, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Yogeshwar Gill, M.D.
(Respondent). OSC, at 1, 3. The OSC
proposed the revocation of
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Fmt 4703
Sfmt 4703
Respondent’s registration 1 because
Respondent is ‘‘without authority to
handle controlled substances in the
State of Tennessee, the state in which
[he is] registered with DEA.’’ Id. at 2
(citing 21 U.S.C. 824(a)(3)).
Respondent timely 2 requested a
hearing; thereafter, the Government
filed and the CALJ granted a Motion for
Summary Disposition recommending
the revocation of Respondent’s
registration. RD, at 9–10. Respondent
did not timely file exceptions to the
RD.3 Having reviewed the entire record,
the Agency adopts and hereby
incorporates by reference the entirety of
the CALJ’s rulings, findings of fact,
conclusions of law, and recommended
sanction and summarizes and expands
upon portions thereof herein.
Findings of Fact
On May 25, 2022, the Tennessee
Board of Medical Examiners issued an
Order of Summary Suspension that
suspended Respondent’s Tennessee
medical license. RD, at 7; see also
Government’s Notice of Filing of
Evidence and Motion for Summary
Disposition, Exhibit 1, Attachment A, at
1, 6–7. According to Tennessee online
records, of which the Agency takes
official notice, Respondent’s restricted
Tennessee medical license expired on
1 Certificate of Registration No. FG1060603 at the
registered address of 1034 McArthur Street,
Manchester, Tennessee 37355. Id. at 1.
2 Respondent’s Request for Hearing is dated
February 17, 2023, see Request for Hearing, at 1, but
was deemed filed on February 21, 2023. The
Government asserted that Respondent’s Request for
Hearing was untimely. Govt Termination Motion
dated February 24, 2023, at 1–2. Ultimately, the
Chief Administrative Law Judge (CALJ) found, and
the Agency agrees, that ‘‘resolution of this matter
is not imperative to issue a recommended decision’’
and ‘‘assumed, without deciding[,] that the service
ambiguity raised by the Respondent either
adjust[ed] the OSC service date to render the
[Request for Hearing] timely, or supplie[d]
sufficient good cause to consider a late-filed
[Request for Hearing].’’ Order Granting the
Government’s Motion for Summary Disposition and
Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision of the
Administrative Law Judge (Recommended Decision
or RD), at 4–5.
3 On April 28, 2023, after the deadline to file
exceptions passed and the CALJ certified the record
to the Administrator, Respondent submitted a
pleading entitled ‘‘Motion to Alter and Amend’’
(Respondent’s Motion). See 21 CFR 1316.66(a),
1316.67. Respondent’s Motion requests that the
CALJ ‘‘amend his ruling and merely order an
ongoing suspension until the [underlying state] case
is heard on its merits.’’ Respondent’s Motion, at 1,
4. As such, Respondent’s Motion appears to be an
untimely attempt to file exceptions to the RD.
Further, even if Respondent’s Motion had been
timely submitted, it merely reiterates arguments
raised by Respondent in earlier filings that were
addressed by the CALJ. See RD, at 8–9; see also
infra at n.5. Accordingly, the Agency finds
Respondent’s Motion to be unpersuasive.
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Agencies
[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55074-55076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17383]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Debora Ryder, N.P.; Decision and Order
On August 24, 2022, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Debora Ryder, N.P. (Registrant) of Tarpon
Springs, Florida. Request for Final Agency Action (RFAA), Exhibit
(RFAAX) 2, at 1. The OSC/ISO informed Registrant of the immediate
suspension of her DEA Certificate of Registration, Control No.
MR4236584, 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. The OSC/ISO also proposed the revocation of
Registrant's registration, alleging that Registrant's continued
registration is inconsistent with the public interest and that
Registrant is without authority to handle controlled substances in
Florida, the state in which she is registered with DEA.\1\ Id. at 1
(citing 21 U.S.C. 824(a)(4), 823(g)(1),\2\ 824(a)(3)).\3\
---------------------------------------------------------------------------
\1\ The registered address of Registrant's DEA Certificate of
Registration, Control No. MR4236584, is 900 Beckett Way, Tarpon
Springs, Florida 34689. Id. at 3.
\2\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes. Relevant to this
matter, the MRA redesignated 21 U.S.C. 823(f), cited in the OSC/ISO,
as 21 U.S.C. 823(g)(1). Accordingly, this Decision cites to the
current designation, 21 U.S.C. 823(g)(1), and to the MRA-amended CSA
throughout.
\3\ According to Agency records, Registrant's Certificate of
Registration No. MR4236584 expired on April 30, 2023. The fact that
a registrant allows her registration to expire during the pendency
of an OSC does not impact the Agency's jurisdiction or prerogative
under the CSA to adjudicate the OSC to finality. Jeffrey D. Olsen,
M.D., 84 FR 68474, 68476-79 (2019).
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The Agency makes the following findings of fact based on the
uncontroverted evidence submitted by the Government in its RFAA dated
February 28, 2023.\4\
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\4\ Based on a Declaration from a DEA Diversion Investigator,
the Agency finds that the Government's service of the OSC/ISO on
Registrant was adequate. RFAAX 3, at 2. Further, based on the
Government's assertions in its RFAA, the Agency finds that more than
thirty days have passed since Registrant was served with the OSC/ISO
and Registrant has neither requested a hearing nor submitted a
corrective action plan and therefore has waived any such rights.
RFAA, at 2; see also 21 CFR 1301.43 and 21 U.S.C. 824(c)(2).
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I. Findings of Fact
On July 31, 2022, Registrant's Florida advanced practice registered
nurse (APRN) license number APRN2943222 expired by its own terms. RFAAX
3, Attachment B. According to Florida online records, of which the
Agency takes official notice, Registrant's Florida APRN license number
APRN2943222 is listed as ``Delinquent,'' indicating that ``[t]he
licensed practitioner is not authorized to practice in the state of
Florida.'' \5\ Florida Department of Health License Verification,
https://mqa-internet.doh.state.fl.us/MQASearchServices/ (last visited
date of signature of this Order). Accordingly, the Agency finds that
Registrant is not currently licensed to practice as an APRN in Florida,
the state in which she is registered with the DEA.\6\
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\5\ 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 the Agency's finding
by filing a properly supported motion for reconsideration of
findings 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].
\6\ According to Florida online records, of which the Agency
takes official notice, Registrant's Florida registered nurse license
number RN2943222 is listed as ``clear/active.'' Florida Department
of Health License Verification, https://mqa-internet.doh.state.fl.us/MQASearchServices/ (last visited date of
signature of this Order). Although both the Government's RFAA and an
attached Declaration from a DEA Diversion Investigator correctly
note that Registrant is a current holder of a Florida registered
nurse license number RN2943222, the cited Attachment A of the
Diversion Investigator's Declaration appears to be an erroneous
printout from the Florida Department of Health License Verification
database pertaining to a different practitioner who shares
Registrant's first and last name and whose registered nurse license
number RN3151242 is listed as null and void. See RFAA, at 3; RFAAX
3, at 1; RFAAX 3, Attachment A.
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The Agency further finds that the Government's evidence shows that
from June 11, 2021, through July 28, 2022, Registrant issued at least
83 prescriptions for controlled substances in the names of two deceased
individuals, Deceased Patient B.K.\7\ and Deceased Patient J.R.\8\
RFAAX 3, at 2-3. After Deceased Patient B.K.'s death, from at least
July 19, 2021 through July 28, 2022, Registrant issued at least 47
prescriptions for controlled substances in Deceased Patient B.K.'s
name, including prescriptions for hydromorphone, oxycodone, alprazolam,
and promethazine-codeine syrup. Id.; see also RFAAX 3, Attachment F.
After Deceased Patient J.R.'s death, from at least June 11, 2021
through July 28, 2022, Registrant issued at least 36 prescriptions for
controlled substances in Deceased Patient J.R.'s name, including
prescriptions for hydromorphone, oxycodone, phendimetrazine, and
promethazine-codeine syrup. RFAAX 3, at 2-3; see also RFAAX 3,
Attachment H.
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\7\ Deceased Patient B.K. died on or about June 21, 2019. RFAAX
3, at 3; see also RFAAX 3, Attachment D-E.
\8\ Deceased Patient J.R. was found deceased by Registrant on or
about October 19, 2018. RFAAX 3, at 3; see also RFAAX 3, Attachment
G.
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Additionally, the Agency finds that the Government's evidence shows
that on March 1, 2022, during a probable cause search of Registrant's
vehicle during a traffic stop on an individual who was driving
Registrant's vehicle at the time, law enforcement discovered 14 pre-
signed prescriptions for controlled substances dated from March 1,
2022, through March 4, 2022, and issued to multiple individuals,
including the driver of the vehicle. RFAAX 4, at 1-2; see also RFAAX 4,
Attachment I. The prescriptions were signed by Registrant and issued
for oxycodone, hydrocodone, and Xanax, a brand name drug containing
alprazolam. Id.\9\
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\9\ As Registrant was not present at the time of the traffic
stop, law enforcement called Registrant ``multiple times'' and
confirmed her identity as well as that she had written out the 14
pre-signed prescriptions. RFAAX 4, at 1-2. During one of the phone
calls, Registrant ``advised she fills out prescriptions for her
patients `ahead of time' '' and that ``she had given her nephew, the
driver of the vehicle, permission to bring the prescriptions to her
office.'' Id. at 2.
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Further, the Agency finds that the Government's evidence shows that
on June 27, 2022, pursuant to a search warrant of a business, law
enforcement discovered four prescriptions for promethazine-codeine
syrup pre-signed by Registrant.\10\ Id. at 1; see also RFAAX 5,
Attachment J. Notably, although the controlled substance portions were
filled out on all four prescriptions, ``the patient information
portion[s], including the patient name[s] and date[s] of birth[,] were
blank.'' Id.
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\10\ During the execution of the search warrant, law enforcement
discovered 12 prescriptions in total pre-signed by Registrant. RFAAX
5, at 1.
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[[Page 55075]]
II. Discussion
A. 21 U.S.C. 824(a)(3): Loss of State Authority
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 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 71371 (2011),
pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27616, 27617 (1978).\11\
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\11\ 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(g)(1). 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
71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006);
Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts,
M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, 43 FR at
27617.
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According to Florida statute, ``[a] practitioner, in good faith and
in the course of his or her professional practice only, may prescribe,
administer, dispense, mix, or otherwise prepare a controlled
substance.'' Fla. Stat. 893.05(1)(a) (2022). Further, a
``practitioner'' as defined by Florida statute includes ``an [APRN]
licensed under chapter 464.'' \12\ Id. Sec. 893.02(23).\13\
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\12\ Chapter 464 regulates nursing and applies to Registrant; it
defines an APRN as ``any person licensed in [the] state to practice
professional nursing and who is licensed in an advanced nursing
practice, including . . . certified nurse practitioners.'' Id. Sec.
464.003(3).
\13\ A ``practitioner'' as defined by Florida statute does not
include a registered nurse. Id. Further, Florida statute states that
a registered nurse is only authorized to administer ``medications
and treatments as prescribed or authorized by a duly licensed
practitioner.'' Id. Sec. 464.003(19)(b). As such, the ``clear/
active'' status of Registrant's Florida registered nurse license,
see supra at n.5, does not authorize Registrant to handle controlled
substances in the state of Florida.
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Here, the undisputed evidence in the record is that Registrant
lacks authority to practice as an APRN in Florida. As discussed, a
person must be a licensed practitioner to dispense a controlled
substance in Florida. Accordingly, the Agency finds that because
Registrant lacks authority to practice as an APRN in Florida,
Registrant is, therefore, unauthorized to handle controlled substances
in Florida, the state in which she is registered with DEA.
B. 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). 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 applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(C) The applicant'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).
The DEA considers these 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 of the public interest factors
in 21 U.S.C. 823(g)(1),\14\ the Government's evidence in support of its
prima facie case for revocation of Registrant's registration is
confined to Factors B and D. See RFAA, at 8-11. The Government has the
burden of proof in this proceeding. 21 CFR 1301.44. Here, the Agency
finds that the Government's evidence satisfies its prima facie burden
of showing that Registrant's continued registration would be
``inconsistent with the public interest.'' 21 U.S.C. 824(a). The Agency
further finds that Registrant failed to provide sufficient evidence to
rebut the Government's prima facie case.
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\14\ As to Factor A, there is no record evidence of disciplinary
action against Registrant's state APRN license. 21 U.S.C.
823(g)(1)(A). Here, Registrant's Florida APRN license expired by its
own terms. See supra at I. DEA precedent establishes that where the
record contains no evidence of a recommendation by a state licensing
board, such absence does not weigh for or against revocation. Ester
Mark, M.D., 86 FR 16760, 16771 (2021) (citing 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 an offense under either
federal or state law ``relating to the manufacture, distribution, or
dispensing of controlled substances.'' 21 U.S.C. 823(g)(1)(C).
However, as Agency cases have noted, there are a number of reasons
why a person who has engaged in criminal misconduct may never have
been convicted of an offense under this factor. Dewey C. MacKay,
M.D., 75 FR 49956, 49973 (2010). Agency cases have therefore found
that ``the absence of such a conviction is of considerably less
consequence in the public interest inquiry'' and is therefore not
dispositive. Id. 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 revocation.
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1. Factors B and D
Evidence is considered under Public Interest 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). The Government has
alleged that Registrant violated both federal and Florida state law
regulating controlled substances. RFAAX 2, at 2-5. According to the
CSA's implementing regulations, a lawful controlled 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). The CSA also requires that
all prescriptions for controlled substances ``shall be dated as of, and
signed on, the day when issued.'' 21 CFR 1306.05(a). Further, Florida
state law lists numerous requirements for the prescribing of controlled
substances, including, but not limited to, requirements that the
prescriber: conduct a complete medical history and physical
examination; document any medical indications for the use of a
controlled substance; create a written treatment plan; discuss with the
patient the risks and benefits of the use of controlled substances;
conduct periodic reviews of the effectiveness of any treatment with
controlled
[[Page 55076]]
substances; assess and monitor the patient's risk for aberrant drug-
related behavior; and maintain accurate, current, complete, and
accessible records. Fla. Stat. 456.44; Fla. Admin. Code Ann. r. 64B8-
9.013. Additionally, Florida state law requires that prescriptions
``must be signed by the prescribing practitioner on the day when
issued.'' Fla. Stat. 456.42(1).
Here, the record demonstrates that Registrant issued at least 83
prescriptions for controlled substances in the names of two deceased
individuals, as well as pre-signed at least 18 prescriptions for
controlled substances. As discussed above, such conduct is in clear
violation of Florida state law and thus renders Registrant's
prescribing outside the usual course of professional practice. As such,
the Agency sustains the Government's allegations that Registrant
violated 21 CFR 1306.04(a), 1306.05(a); Florida Statutes 456.44 and
456.2(1); and Florida Administrative Code Rule 64B8-9.013.
In sum, the Agency finds that Factors B and D weigh in favor of
revocation of Registrant's registration and thus finds, after
considering the factors set forth in 21 U.S.C. 823(g)(1), Registrant's
continued registration to be inconsistent with the public interest.
III. Sanction
Where, as here, the Government has established grounds to revoke
Registrant's registration, the burden shifts to the registrant to show
why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18882, 18910 (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 62316, 62339 (2012). Trust is
necessarily a fact-dependent determination based on individual
circumstances; therefore, the Agency looks at factors such as the
acceptance of responsibility, the credibility of that acceptance as it
relates to the probability of repeat violations or behavior, the nature
of the misconduct that forms the basis for sanction, and the Agency's
interest in deterring similar acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33738, 33746 (2021).
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 nor
demonstrated that she can be entrusted with registration. Moreover, the
Agency has found that Registrant is ineligible to maintain a DEA
registration and that the evidence presented by the Government clearly
shows that Registrant violated the CSA. See supra at II. Accordingly,
the Agency orders 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.
MR4236584 issued to Debora Ryder, N.P. 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 Debora Ryder, N.P., to renew or
modify this registration, as well as any other pending application of
Debora Ryder, N.P., for additional registration in Florida. This Order
is effective September 13, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 7, 2023, 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. 2023-17383 Filed 8-11-23; 8:45 am]
BILLING CODE 4410-09-P