George M. Douglass, M.D.; Decision and Order, 67497-67499 [2022-24301]
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Federal Register / Vol. 87, No. 215 / Tuesday, November 8, 2022 / Notices
of Registration No. BS6061345 issued to
Nicky Shah, 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 applications
of Nicky Shah, M.D., to renew or modify
this registration, as well as any other
pending application of Nicky Shah,
M.D., for additional registration in
California. This Order is effective
December 8, 2022.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on November 1, 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. 2022–24299 Filed 11–7–22; 8:45 am]
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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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George M. Douglass, M.D.; Decision
and Order
On June 28, 2022, the Drug
Enforcement Administration
(hereinafter, DEA or Government)
issued an Order to Show Cause and
Immediate Suspension of Registration
(hereinafter, OSC/ISO) to George M.
Douglass, Jr., M.D., (hereinafter,
Registrant) of Lake Oswego, Oregon.
Request for Final Agency Action
(hereinafter, RFAA), Exhibit
(hereinafter, RFAAX) 2 (OSC/ISO), at 1.
The OSC/ISO informed Registrant of the
immediate suspension of his DEA
Certificate of Registration, Control No.
BD5898575, 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 has
‘‘committed such acts as would render
[his] registration inconsistent with the
public interest’’ and that Registrant is
‘‘without authority to handle controlled
19:15 Nov 07, 2022
Jkt 259001
I. Findings of Fact
On June 2, 2022, the Oregon Medical
Board issued a Final Order Upon
Default revoking Registrant’s Oregon
medical license. RFAAX 3, at 4, 7.
According to Oregon’s online records, of
which the Agency takes official notice,
Registrant’s license is still revoked.3
Oregon Medical Board Licensee Search,
https://omb.oregon.gov/search (last
visited date of signature of this Order).
Accordingly, the Agency finds that
Registrant is not currently licensed to
engage in the practice of medicine in
Oregon, the state in which he is
registered with the DEA.
The Agency further finds that the
Government’s evidence shows that
Registrant continued to prescribe
controlled substances after his Oregon
medical license was revoked; he issued
at least six controlled substance
prescriptions from June 9–21, 2022.
RFAAX 4.
II. Discussion
BILLING CODE 4410–09–P
VerDate Sep<11>2014
substances in Oregon, the state in which
[he is] registered with DEA.’’ 1 Id. at 1,
3 (citing 21 U.S.C. 824(a)(4), 823(f),
824(a)(3)).
The Agency makes the following
findings of fact based on the
uncontroverted evidence submitted by
the Government in its RFAA dated
September 20, 2022.2
1 The registered address of Registrant’s DEA
Certificate of Registration, Control No. BD5898575,
is 17355 Boones Ferry Road, Suite C, Lake Oswego,
Oregon 97035. Id. at 2.
2 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 written statement or 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).
3 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.usdoj.gov.
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67497
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).4
According to Oregon statute,
‘‘dispense’’ means ‘‘to deliver a
controlled substance to an ultimate user
or research subject by or pursuant to the
lawful order of a practitioner, and
includes the prescribing, administering,
packaging, labeling or compounding
necessary to prepare the substance for
that delivery.’’ Or. Rev. Stat.
§ 475.005(10) (2022). Further, a
‘‘practitioner’’ means a person
‘‘licensed, registered or otherwise
permitted by law to dispense, conduct
research with respect to or to administer
a controlled substance in the course of
professional practice or research in [the]
state.’’ Id. at § 475.005(17).
Here, the undisputed evidence in the
record is that Registrant has had his
Oregon medical license revoked and
thus lacks authority to practice
medicine in Oregon. As discussed
above, an individual must be a licensed
practitioner to dispense a controlled
4 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.
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67498
Federal Register / Vol. 87, No. 215 / Tuesday, November 8, 2022 / Notices
substance in Oregon. Accordingly, the
Agency finds that Registrant is
unauthorized to handle controlled
substances in Oregon, the state in which
he is registered with the DEA.
B. 21 U.S.C. 823(f): The Five Public
Interest Factors
Section 304(a) of the CSA provides
that ‘‘[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:
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
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21 U.S.C. 823(f).
The DEA considers these public
interest factors in the disjunctive. Robert
A. Leslie, M.D., 68 FR 15,227, 15,230
(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 37,507, 37,508 (1993).
While the Agency has considered all of
the public interest factors 5 in 21 U.S.C.
823(f), the Government’s evidence in
support of its prima facie case for
revocation of Registrant’s registration is
confined to Factors One, Two, and Four.
5 As to Factor Three, 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(f)(3).
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, let alone
prosecuted for one. Dewey C. MacKay, M.D., 75 FR
49,956, 49,973 (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 Five, the Government’s evidence fits
squarely within the parameters of Factors One,
Two, and Four and does not raise ‘‘other conduct
which may threaten the public health and safety.’’
21 U.S.C. 823(f)(5). Accordingly, Factor Five does
not weigh for or against Registrant.
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18:33 Nov 07, 2022
Jkt 259001
See RFAA, at 6–8. Moreover, 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(f). The Agency
further finds that Registrant failed to
provide sufficient evidence to rebut the
Government’s prima facie case.
1. Factor One
In determining the public interest
under Factor One, the Agency considers
the recommendation of the appropriate
State licensing board or professional
disciplinary authority. Although the
record evidence demonstrates that the
Oregon Medical Board has not made a
recommendation in the current matter,
‘‘DEA has interpreted [F]actor [O]ne
more broadly and thus considers
disciplinary actions taken by a state
board as relevant in the public interest
determination when they result in a loss
of state authority.’’ Kenneth Harold Bull,
M.D., 78 FR 62,666, 62,672 (2013); see
also John O. Dimowo, 85 FR 15,800,
15,809 (2020).
Here, the record shows that the
Oregon Medical Board revoked
Registrant’s Oregon medical license and
that Registrant’s Oregon medical license
has not since been restored. As such, the
Agency finds that Factor One weighs
against Registrant’s continued
registration.
2. Factors Two and Four
Evidence is considered under Public
Interest Factors Two and Four when it
reflects compliance (or non-compliance)
with laws related to controlled
substances and experience dispensing
controlled substances. Established
violations of the CSA, DEA regulations,
or other laws regulating controlled
substances at the state or local level are
cognizable when considering whether
continuing a registration is consistent
with the public interest. Kareem
Hubbard, M.D., 87 FR 21,156, 21,162
(2022).
The Government has alleged that
Registrant has violated both federal and
Oregon state law regulating controlled
substances. RFAAX 2 (OSC/ISO), at 3–
4. 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). Oregon law prohibits the
practice of medicine in Oregon without
a license. Or. Rev. Stat. § 677.080(4)
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Frm 00063
Fmt 4703
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(2022). Here, the record demonstrates
that Registrant issued at least six
controlled substance prescriptions after
his Oregon medical license was
revoked. This conduct clearly violated
Oregon law and rendered 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) and Or. Rev. Stat.
§ 677.080(4).
In sum, the Agency finds that Factors
One, Two, and Four weigh in favor of
revocation of Registrant’s registration
and thus finds Registrant’s continued
registration to be inconsistent with the
public interest in balancing the factors
of 21 U.S.C. 823(f).
III. Sanction
Where, as here, the Government has
established grounds to revoke
Respondent’s registration, the burden
shifts to the 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) (internal quotations omitted).
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 33,738, 33,746 (2021).
Here, Registrant did not request a
hearing, submit a written statement,
submit a corrective action plan, respond
to the OSC/ISO, or otherwise avail
himself of the opportunity to refute the
Government’s case. As such, Registrant
has made no representations as to his
future compliance with the CSA or
made any demonstration that he can be
trusted with a registration. The evidence
presented by the Government clearly
shows that Registrant violated the CSA
and indicates that he cannot be
entrusted.
Accordingly, the Agency will order
the revocation of Registrant’s
registration.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
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Federal Register / Vol. 87, No. 215 / Tuesday, November 8, 2022 / Notices
824(a), I hereby revoke DEA Certificate
of Registration No. BD5898575 issued to
George M. Douglass, Jr., 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
applications of George M. Douglass, Jr.,
M.D., to renew or modify this
registration, as well as any other
pending application of George M.
Douglass, Jr., M.D., for additional
registration in Oregon. This Order is
effective December 8, 2022.
correct the table to include the
following basic class of scheduled
controlled substance:
Controlled
substance
Drug code
Schedule
Cocaine .....
9041
II
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–24105 Filed 11–7–22; 8:45 am]
BILLING CODE 4410–09–P
Signing Authority
This document of the Drug
Enforcement Administration was signed
on November 1, 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. 2022–24301 Filed 11–7–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1083]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.; Correction
Drug Enforcement
Administration, Justice.
ACTION: Notice of application;
correction.
AGENCY:
The Drug Enforcement
Administration (DEA) published a
document in the Federal Register on
October 11, 2022, concerning a notice of
application that inadvertently did not
include the controlled substance
Cocaine (9041).
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Correction
In the Federal Register on October 11,
2022, in FR Doc No: 2022–21940 (87 FR
61368), on page 61368, in the second
column, under SUPPLEMENTARY
INFORMATION, controlled substance table,
VerDate Sep<11>2014
18:33 Nov 07, 2022
Jkt 259001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–34]
Gerald M. Baltz, N.P.; Decision and
Order
On June 3, 2022, the Drug
Enforcement Administration
(hereinafter, DEA or Government),
issued an Order to Show Cause
(hereinafter, OSC) to Gerald M. Baltz,
N.P. (hereinafter, Respondent). OSC, at
1, 3. The OSC proposed the revocation
of Respondent’s Certificate of
Registration No. MB2171128 at the
registered address of 8060 Melrose Ave.,
Ste. 200, Los Angeles, CA 90046. Id. at
1. The OSC alleged that Respondent’s
registration should be revoked because
Respondent is ‘‘without authority to
handle controlled substances in the
State of California, the state in which
[he is] registered with DEA.’’ Id. at 1–
2 (citing 21 U.S.C. 824(a)(3)).1
By letter dated July 11, 2022,2
Respondent requested a hearing. On
July 12, 2022, Administrative Law Judge
Paul E. Soeffing (hereinafter, the ALJ)
issued an Order for Evidence of Lack of
State Authority and Directing the
Government to File Evidence Regarding
the Service of the Order to Show Cause
(hereinafter, Briefing Order). On July 26,
2022, the Government filed its
Submission of Evidence and Motion for
Summary Disposition (hereinafter,
Motion for Summary Disposition). On
August 10, 2022,3 Respondent filed his
1 According to Agency records, Respondent’s
Certificate of Registration No. MB2171128 expired
on July 31, 2022. The fact that a registrant allows
his registration to expire during the pendency of an
OSC does not impact the Agency’s jurisdiction or
prerogative under the Controlled Substances Act
(hereinafter, CSA) to adjudicate the OSC to finality.
Jeffrey D. Olsen, M.D., 84 FR 68,474 (2019).
2 The record demonstrates that service of the OSC
on Respondent was accomplished on or before June
28, 2022, see Government Exhibit (hereinafter, GX)
E, at 1–2, and the Government does not contest the
timeliness of the request for a hearing.
3 The record demonstrates that Respondent’s
filing was untimely. See Briefing Order, at 2; Order
Granting the Government’s Motion for Summary
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67499
Opposition to Government’s Motion for
Summary Disposition (hereinafter,
Opposition).4
On August 25, 2022, the ALJ granted
the Government’s Motion for Summary
Disposition and recommended the
revocation of Respondent’s DEA
registration, finding that because
Respondent lacks authority to handle
controlled substances in California,
there is no genuine issue of material
fact. Recommended Decision, at 6.5
The Agency issues this Decision and
Order based on the entire record before
it, 21 CFR 1301.43(e), and makes the
following findings of fact.
Findings of Fact
On November 19, 2021, an
Administrative Law Judge from the
State of California, Office of
Administrative Hearings, issued a
Proposed Decision revoking
Respondent’s California nursing
licenses. Government Exhibit
(hereinafter, GX) C, at 45. On January
21, 2022, the State of California,
Department of Consumer Affairs, Board
of Registered Nursing (hereinafter, the
Board), issued a Decision and Order
adopting the Administrative Law
Judge’s Proposed Decision, effective
February 18, 2022. Id. at 1. On February
24, 2022, the Board issued an Order
Denying Reconsideration in which
Respondent’s request for
reconsideration of the Proposed
Decision was denied and the Board’s
January 21, 2022 Decision and Order
was made effective February 28, 2022.
GX B.
According to California’s online
records, of which the Agency takes
official notice, Respondent’s nursing
licenses are revoked. 6 California DCA
Disposition, and Recommended Rulings, Findings
of Fact, Conclusions of Law, and Decision of the
Administrative Law Judge (hereinafter,
Recommended Decision), at 2 n.2. Nonetheless, the
Agency will fully consider the Respondent’s
arguments made therein.
4 In his Opposition, Respondent argued that his
DEA registration should not be revoked because he
maintains active nursing licenses in Colorado and
because he is still challenging the underlying action
against his California nursing licenses. Opposition,
at 3–6.
5 By letter dated September 21, 2022, the ALJ
certified and transmitted the record to the Agency
for final agency action and advised that neither
party filed exceptions.
6 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,
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08NON1
Agencies
[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Notices]
[Pages 67497-67499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24301]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
George M. Douglass, M.D.; Decision and Order
On June 28, 2022, the Drug Enforcement Administration (hereinafter,
DEA or Government) issued an Order to Show Cause and Immediate
Suspension of Registration (hereinafter, OSC/ISO) to George M.
Douglass, Jr., M.D., (hereinafter, Registrant) of Lake Oswego, Oregon.
Request for Final Agency Action (hereinafter, RFAA), Exhibit
(hereinafter, RFAAX) 2 (OSC/ISO), at 1. The OSC/ISO informed Registrant
of the immediate suspension of his DEA Certificate of Registration,
Control No. BD5898575, 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 has
``committed such acts as would render [his] registration inconsistent
with the public interest'' and that Registrant is ``without authority
to handle controlled substances in Oregon, the state in which [he is]
registered with DEA.'' \1\ Id. at 1, 3 (citing 21 U.S.C. 824(a)(4),
823(f), 824(a)(3)).
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\1\ The registered address of Registrant's DEA Certificate of
Registration, Control No. BD5898575, is 17355 Boones Ferry Road,
Suite C, Lake Oswego, Oregon 97035. Id. at 2.
---------------------------------------------------------------------------
The Agency makes the following findings of fact based on the
uncontroverted evidence submitted by the Government in its RFAA dated
September 20, 2022.\2\
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\2\ 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
written statement or 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 June 2, 2022, the Oregon Medical Board issued a Final Order Upon
Default revoking Registrant's Oregon medical license. RFAAX 3, at 4, 7.
According to Oregon's online records, of which the Agency takes
official notice, Registrant's license is still revoked.\3\ Oregon
Medical Board Licensee Search, https://omb.oregon.gov/search (last
visited date of signature of this Order). Accordingly, the Agency finds
that Registrant is not currently licensed to engage in the practice of
medicine in Oregon, the state in which he is registered with the DEA.
---------------------------------------------------------------------------
\3\ 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].
---------------------------------------------------------------------------
The Agency further finds that the Government's evidence shows that
Registrant continued to prescribe controlled substances after his
Oregon medical license was revoked; he issued at least six controlled
substance prescriptions from June 9-21, 2022. RFAAX 4.
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
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).\4\
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\4\ 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.
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According to Oregon statute, ``dispense'' means ``to deliver a
controlled substance to an ultimate user or research subject by or
pursuant to the lawful order of a practitioner, and includes the
prescribing, administering, packaging, labeling or compounding
necessary to prepare the substance for that delivery.'' Or. Rev. Stat.
Sec. 475.005(10) (2022). Further, a ``practitioner'' means a person
``licensed, registered or otherwise permitted by law to dispense,
conduct research with respect to or to administer a controlled
substance in the course of professional practice or research in [the]
state.'' Id. at Sec. 475.005(17).
Here, the undisputed evidence in the record is that Registrant has
had his Oregon medical license revoked and thus lacks authority to
practice medicine in Oregon. As discussed above, an individual must be
a licensed practitioner to dispense a controlled
[[Page 67498]]
substance in Oregon. Accordingly, the Agency finds that Registrant is
unauthorized to handle controlled substances in Oregon, the state in
which he is registered with the DEA.
B. 21 U.S.C. 823(f): The Five Public Interest Factors
Section 304(a) of the CSA provides that ``[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:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
The DEA considers these public interest factors in the disjunctive.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (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 37,507, 37,508
(1993). While the Agency has considered all of the public interest
factors \5\ in 21 U.S.C. 823(f), the Government's evidence in support
of its prima facie case for revocation of Registrant's registration is
confined to Factors One, Two, and Four. See RFAA, at 6-8. Moreover, the
Government has the burden of proof in this proceeding. 21 CFR 1301.44.
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\5\ As to Factor Three, 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(f)(3). 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, let alone prosecuted for one. Dewey C.
MacKay, M.D., 75 FR 49,956, 49,973 (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 Five, the
Government's evidence fits squarely within the parameters of Factors
One, Two, and Four and does not raise ``other conduct which may
threaten the public health and safety.'' 21 U.S.C. 823(f)(5).
Accordingly, Factor Five does not weigh for or against Registrant.
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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(f).
The Agency further finds that Registrant failed to provide sufficient
evidence to rebut the Government's prima facie case.
1. Factor One
In determining the public interest under Factor One, the Agency
considers the recommendation of the appropriate State licensing board
or professional disciplinary authority. Although the record evidence
demonstrates that the Oregon Medical Board has not made a
recommendation in the current matter, ``DEA has interpreted [F]actor
[O]ne more broadly and thus considers disciplinary actions taken by a
state board as relevant in the public interest determination when they
result in a loss of state authority.'' Kenneth Harold Bull, M.D., 78 FR
62,666, 62,672 (2013); see also John O. Dimowo, 85 FR 15,800, 15,809
(2020).
Here, the record shows that the Oregon Medical Board revoked
Registrant's Oregon medical license and that Registrant's Oregon
medical license has not since been restored. As such, the Agency finds
that Factor One weighs against Registrant's continued registration.
2. Factors Two and Four
Evidence is considered under Public Interest Factors Two and Four
when it reflects compliance (or non-compliance) with laws related to
controlled substances and experience dispensing controlled substances.
Established violations of the CSA, DEA regulations, or other laws
regulating controlled substances at the state or local level are
cognizable when considering whether continuing a registration is
consistent with the public interest. Kareem Hubbard, M.D., 87 FR
21,156, 21,162 (2022).
The Government has alleged that Registrant has violated both
federal and Oregon state law regulating controlled substances. RFAAX 2
(OSC/ISO), at 3-4. 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). Oregon law prohibits the practice of medicine in Oregon
without a license. Or. Rev. Stat. Sec. 677.080(4) (2022). Here, the
record demonstrates that Registrant issued at least six controlled
substance prescriptions after his Oregon medical license was revoked.
This conduct clearly violated Oregon law and rendered 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) and Or. Rev. Stat. Sec. 677.080(4).
In sum, the Agency finds that Factors One, Two, and Four weigh in
favor of revocation of Registrant's registration and thus finds
Registrant's continued registration to be inconsistent with the public
interest in balancing the factors of 21 U.S.C. 823(f).
III. Sanction
Where, as here, the Government has established grounds to revoke
Respondent's registration, the burden shifts to the 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) (internal
quotations omitted). 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 33,738, 33,746
(2021).
Here, Registrant did not request a hearing, submit a written
statement, submit a corrective action plan, respond to the OSC/ISO, or
otherwise avail himself of the opportunity to refute the Government's
case. As such, Registrant has made no representations as to his future
compliance with the CSA or made any demonstration that he can be
trusted with a registration. The evidence presented by the Government
clearly shows that Registrant violated the CSA and indicates that he
cannot be entrusted.
Accordingly, the Agency will order the revocation of Registrant's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C.
[[Page 67499]]
824(a), I hereby revoke DEA Certificate of Registration No. BD5898575
issued to George M. Douglass, Jr., 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 applications of George M. Douglass, Jr., M.D., to
renew or modify this registration, as well as any other pending
application of George M. Douglass, Jr., M.D., for additional
registration in Oregon. This Order is effective December 8, 2022.
Signing Authority
This document of the Drug Enforcement Administration was signed on
November 1, 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. 2022-24301 Filed 11-7-22; 8:45 am]
BILLING CODE 4410-09-P