[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.
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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, 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.
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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 [email protected].
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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.

[[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]
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