Notice2022-24301
George M. Douglass, M.D.; Decision and Order
Primary source
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Published
November 8, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 87 Issue 215 (Tuesday, November 8, 2022)</title>
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[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Notices]
[Pages 67497-67499]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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
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, <a href="https://omb.oregon.gov/search">https://omb.oregon.gov/search</a> (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.
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\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 <a href="/cdn-cgi/l/email-protection#593d3c3877383d3d3677382d2d362b373c202a193d3c38772c2a3d3633773e362f"><span class="__cf_email__" data-cfemail="b6d2d3d798d7d2d2d998d7c2c2d9c4d8d3cfc5f6d2d3d798c3c5d2d9dc98d1d9c0">[email protected]</span></a>.
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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.
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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
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