Notice2025-06427
Lona Bibbs-Walker, D.D.S.; Decision and Order
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Published
April 16, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 72 (Wednesday, April 16, 2025)</title>
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[Federal Register Volume 90, Number 72 (Wednesday, April 16, 2025)]
[Notices]
[Pages 15999-16002]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06427]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Lona Bibbs-Walker, D.D.S.; Decision and Order
I. Introduction
On May 13, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registrations (OSC/ISO) to Lona Bibbs-Walker, D.D.S., of Fayetteville,
Georgia (Registrant). Request for Final Agency Action (RFAA), Exhibit
(RFAAX) 1, at 1. The OSC/ISO informed Registrant of the immediate
suspension of her DEA Certificates of Registration, Nos. FB3395806 and
FB9305891, 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. (quoting 21 U.S.C. 824(d)). The OSC/ISO also
proposed the revocation of Registrant's registration, alleging that
Registrant's continued registration is inconsistent with the public
interest. Id. (citing 21 U.S.C. 823(g)(1), 824(a)(4)).
The OSC/ISO alleged that from May 19, 2020, through February 16,
2024, Registrant failed to maintain adequate records relating to her
handling of controlled substances. Id. The OSC/ISO also alleged that
Registrant was unable to account for hundreds of dosage units of highly
diverted controlled substances. Id. Finally, the OSC/ISO alleged that
Registrant does not have state authority to practice dentistry since on
or about March 5, 2024. Id. The OSC/ISO alleged that Registrant's
above-described misconduct violated both the implementing regulations
of the Controlled Substances Act (CSA) and Georgia state law. Id. at 2.
The OSC/ISO notified Registrant of her right to file with DEA a
written request for hearing and an answer, and that if she failed to
file such a request, she would be deemed to have waived her right to a
hearing and be in default. RFAAX 2, at 5 (citing 21 CFR 1301.43). Here,
Registrant did not request a hearing. RFAA, at 2.\1\ ``A default,
unless excused, shall be deemed to constitute a waiver of the
registrant's/applicant's right to a hearing and an admission of the
factual allegations of the [OSC/ISO].'' 21 CFR 1301.43(e); see also
RFAAX 2, at 5 (providing notice to Registrant).
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\1\ Based on the Government's submissions in its RFAA dated
August 20, 2024, the Agency finds that service of the OSC/ISO on
Registrant was adequate. Specifically, the included Declaration from
a DEA Diversion Investigator (DI) indicates that on May 14, 2024,
the DI and other DEA personnel traveled to Registrant's registered
address and personally served the OSC/ISO on an individual
authorized by Registrant's attorney to accept service on
Registrant's behalf. RFAAX 2, at 2. Further, on the same date, the
DI served a copy of the OSC/ISO via email to Registrant's registered
email address, with Registrant's attorney courtesy copied. Id.
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Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. Sec. 1301.43(f)(1). Here,
the Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(a), (c), (f), 1301.46. RFAA, at 1;
see also 21 CFR 1316.67.
II. Lack of State Authority
A. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are deemed admitted. Accordingly,
Registrant admits that on March 5, 2024, the Georgia Board of Dentistry
revoked Registrant's authority to practice dentistry in Georgia. Id. at
4. According to Georgia online records, of which the Agency takes
official notice,\2\ Registrant's authority to practice dentistry in
Georgia remains revoked. Georgia Department of Community Health License
Verification, <a href="https://gadch.mylicense.com/verification">https://gadch.mylicense.com/verification</a> (last visited
date of signature of this Order). Accordingly, the Agency finds that
Registrant is not licensed to practice dentistry in Georgia, the state
in which she is registered with DEA.\3\
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\2\ 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).
\3\ 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.'' The material fact here is
that Registrant, as of the date of this decision, is not licensed to
practice dentistry in Georgia. 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 DEA Office of the Administrator,
Drug Enforcement Administration at <a href="/cdn-cgi/l/email-protection#85e1e0e4abe4e1e1eaabe4f1f1eaf7ebe0fcf6c5e1e0e4abe2eaf3"><span class="__cf_email__" data-cfemail="0e6a6b6f206f6a6a61206f7a7a617c606b777d4e6a6b6f20696178">[email protected]</span></a>.
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under 21 U.S.C. 823 ``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, 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.
Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (``The Attorney General
can register a physician to dispense controlled substances `if the
applicant is authorized to dispense . . . controlled substances under
the laws of the State in which he practices.' . . . The very definition
of a `practitioner' eligible to prescribe includes physicians
`licensed, registered, or otherwise permitted, by the United States or
the jurisdiction in which he practices' to dispense controlled
substances. Sec. 802(21).''). The Agency has applied these principles
consistently. See, e.g., James L. Hooper, M.D., 76 FR 71371, 71372
(2011), pet. for rev. denied, 481 F. App'x 826 (4th
[[Page 16000]]
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617
(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(g)(1). Because
Congress has clearly mandated that a practitioner possess state
authority in order to be deemed a practitioner under the CSA, 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, M.D., 76 FR 71371-72;
Sheran Arden Yeats, 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, M.D., 43 FR 27617.
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According to Georgia 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, including the
prescribing, administering, packaging, labeling, or compounding
necessary to prepare the substance for that delivery . . . .'' Ga. Code
Ann. section 16-13-21(9) (2024). Further, a ``practitioner'' means a
``physician . . . or other person licensed, registered, or otherwise
authorized under the laws of [Georgia] to distribute, dispense, conduct
research with respect to, or administer a controlled substance in the
course of professional practice or research in [Georgia].'' Id. section
16-13-21(23)(A).
Here, the undisputed evidence in the record is that Registrant
lacks authority to practice dentistry in Georgia, supra II.A. As
discussed, an individual must be a licensed practitioner to dispense a
controlled substance in Georgia. Thus, because Registrant lacks
authority to practice dentistry in Georgia and, therefore, is not
authorized to handle controlled substances in Georgia, Registrant is
not eligible to maintain a DEA registration. Accordingly, the Agency
will order that the Registrant's registration be revoked.
III. Public Interest
A. Applicable Law
As discussed above, the OSC/ISO alleges that Registrant violated
provisions of the Controlled Substances Act (CSA) and its implementing
regulations. As the Supreme Court stated in Gonzales v. Raich, ``the
main objectives of the CSA were to conquer drug abuse and to control
the legitimate and illegitimate traffic in controlled substances. . . .
To effectuate these goals, Congress devised a closed regulatory system
making it unlawful to . . . dispense[ ] or possess any controlled
substance except in a manner authorized by the CSA.'' 545 U.S. 1, at
12-13 (2005). In maintaining this closed regulatory system, ``[t]he CSA
and its implementing regulations set forth strict requirements
regarding registration, . . . drug security, and recordkeeping.'' Id.
at 14.
Here, the OSC/ISO's allegations concern the CSA's ``strict
requirements regarding registration . . . drug security, and
recordkeeping'' and, therefore, go to the heart of the CSA's ``closed
regulatory system'' specifically designed ``to conquer drug abuse and
to control the legitimate and illegitimate traffic in controlled
substances.'' Id.
Inadequate Recordkeeping and Missing Controlled Substances (21 CFR
1304.04(a), 1304.11(a)-(c), 1304.21(a) and Ga. Comp. R. & Regs. section
480-28-.04(4), (5)(a)-(b))
The OSC/ISO alleges that from May 19, 2020, through February 16,
2024, Registrant failed to maintain adequate records relating to her
handling of controlled substances. RFAAX 1, at 1. The OSC/ISO also
alleges that Registrant was unable to account for hundreds of dosage
units of highly diverted controlled substances. Id.
Under the CSA, registrants are required to keep current and
accurate records of all controlled substances handled. 21 CFR
1304.21(a). Further, registrants are required to take a complete and
accurate inventory of all controlled substances on hand from the date
they first engage in the dispensing of controlled substances and,
thereafter, must take biennial inventories; such inventories must be
kept for at least two years from the date of their creation. Id.
Sec. Sec. 1304.04(a), 1304.11(a)-(c).
Similarly, Georgia regulations require that practitioners maintain
prescription records for two years from the date the prescriptions are
filled, and such records must be kept available for inspection. Ga.
Comp. R. & Regs. section 480-28-.04(4). Further, Georgia regulations
require that practitioners maintain records of ``all controlled
substance drugs received and disposed of'' as well as maintain an
inventory of all controlled substances, which must be taken biennially.
Id. section 480-28-.04(5)(a)-(b).
B. Findings of Fact
Registrant is deemed to have admitted that from May 19, 2020,
through at least February 16, 2024, she failed to maintain proper
records regarding her inventory, purchasing, and dispensing of
controlled substances. RFAAX 1, at 3. Further, Registrant is deemed to
have admitted that she failed to adequately maintain an initial or
biennial inventory of controlled substances. Id. Finally, Registrant is
deemed to have admitted that between May 19, 2020, through at least
February 16, 2024, she was unable to account for at least the following
controlled substances: 200 dosage units of hydrocodone acetaminophen (a
Schedule II opioid) 5/325 mg; 100 dosage units of hydrocodone
acetaminophen 7.5/325 mg; 500 dosage units of hydrocodone acetaminophen
10/325 mg; 600 dosage units of oxycodone (a Schedule II opioid) 10 mg;
100 dosage units of oxycodone 15 mg; 700 dosage units of oxycodone 30
mg; and 118 bottles of promethazine with Codeine (a Schedule V opioid),
with each bottle typically including 473 to 480 ml. Id.
Accordingly, the Agency finds substantial record evidence that
Registrant failed to maintain proper records regarding her purchasing
and dispensing of controlled substances, and her initial or biennial
inventory of controlled substances. RFAAX 1, at 3. These failures
resulted in Registrant being unable to account for hundreds of dosage
units of controlled substances.
C. Discussion
The Controlled Substances Act's Public Interest Factors
Pursuant to the CSA, ``[a] registration . . . to . . . distribute[
] or 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 . . . [21
U.S.C. 823] inconsistent with the public interest as determined by such
section.'' 21 U.S.C. 824(a)(4). In the case of a ``practitioner,''
Congress directed the Attorney General to consider five factors in
making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).\5\
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\5\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are: (A) The
recommendation of the appropriate State licensing board or
professional disciplinary authority. (B) The [registrant's]
experience in dispensing, or conducting research with respect to
controlled substances. (C) The [registrant'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.
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. 243, 292-93 (2006) (Scalia, J.,
[[Page 16001]]
dissenting) (``It is well established that these factors are to be
considered in the disjunctive,'' citing In re Arora, 60 FR 4447, 4448
(1995)); 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. Penick Corp. v. Drug Enf't Admin., 491 F.3d
483, 490 (D.C. Cir. 2007); Morall, 412 F.3d. at 185 n.2; David H.
Gillis, M.D., 58 FR 37507, 37508 (1993).
According to Agency decisions, the Agency ``may rely on any one or
a combination of factors and may give each factor the weight [it] deems
appropriate in determining whether'' to revoke a registration. Id.; see
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't
Admin., 841 F.3d 707, 711 (6th Cir. 2016)); MacKay v. Drug Enf't
Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enf't
Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin.,
419 F.3d 477, 482 (6th Cir. 2005).
Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay,
664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419
F.3d at 482. ``In short, . . . the Agency is not required to
mechanically count up the factors and determine how many favor the
Government and how many favor the registrant. Rather, it is an inquiry
which focuses on protecting the public interest; what matters is the
seriousness of the registrant's misconduct.'' Jayam Krishna-Iyer, M.D.,
74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has
recognized, findings under a single factor can support the revocation
of a registration. MacKay, 664 F.3d at 821.
In this matter, while all of the 21 U.S.C. 823(g)(1) factors have
been considered, the Agency finds that the Government's evidence in
support of its prima facie public interest revocation case regarding
Registrant's violations of the CSA's implementing regulations is
confined to Factors B and D. See RFAAX 1, at 3-4. Moreover, the
Government has the burden of proof in this proceeding. 5 U.S.C.A.
556(d); 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. 823(g)(1)
Factors B and/or D--Registrant Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
Evidence is considered under Public Interest Factors B and D when
it reflects compliance or non-compliance with federal and local laws
related to controlled substances and experience dispensing controlled
substances. 21 U.S.C. 823(g)(1)(B) and (D); see also Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022). Here, as found above, Registrant is
deemed to have admitted and the Agency finds that from May 19, 2020,
through February 16, 2024, Registrant failed to maintain adequate
records relating to her handling of controlled substances and was
unable to account for hundreds of dosage units of controlled
substances. RFAAX 1, at 1.
As such, the Agency finds substantial record evidence that
Registrant violated 21 CFR 1304.04(a), 1304.11(a)-(c), 1304.21(a) and
Ga. Comp. R. & Regs. section 480-28-.04(4), (5)(a)-(b). After weighing
Factors B and D, the Agency further finds that Registrant's continued
registration is inconsistent with the public interest. 21 U.S.C.
823(g)(1). Accordingly, the Agency finds that the Government
established a prima facie case, that Registrant did not rebut that
prima facie case, and that there is substantial record evidence
supporting the revocation of Registrant's registration. 21 U.S.C.
823(g)(1).
D. Sanction
Here, the Government has met its prima facie burden of showing that
Registrant's continued registration is inconsistent with the public
interest due to her numerous violations pertaining to controlled
substance dispensing and recordkeeping. Accordingly, the burden shifts
to Registrant to show why she can be entrusted with registration.
Morall, 412 F.3d. at 174; Jones Total Health Care Pharmacy, LLC v. Drug
Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith,
M.D., 83 FR 18882, 18904 (2018).
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual registrant.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, DEA Administrators have
required that a registrant who has committed acts inconsistent with the
public interest must accept responsibility for those acts and
demonstrate that he will not engage in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't
Admin., 54 F.3d 450, 452 (7th Cir. 1995). A registrant's acceptance of
responsibility must be unequivocal. Jones Total Health Care Pharmacy,
881 F.3d at 830-31. In addition, a registrant's candor during the
investigation and hearing has been an important factor in determining
acceptance of responsibility and the appropriate sanction. Id. Further,
the Agency has found that the egregiousness and extent of the
misconduct are significant factors in determining the appropriate
sanction. Id. at 834 & n.4. The Agency has also considered the need to
deter similar acts by the registrant and by the community of
registrants. Jeffrey Stein, M.D., 84 FR 46972-73.
Here, Registrant failed to answer the allegations contained in the
OSC/ISO and did not otherwise avail herself of the opportunity to
refute the Government's case. As such, there is no record evidence that
Registrant takes responsibility, let alone unequivocal responsibility,
for the founded violations, meaning, among other things, that it is not
reasonable to believe that Registrant's future controlled substance-
related actions will comply with legal requirements. Accordingly,
Registrant did not convince the Agency that she can be entrusted with
registration.
Further, the interests of specific and general deterrence weigh in
favor of revocation. Given the foundational nature of Registrant's
violations, a sanction less than revocation would send a message to the
existing and prospective registrant community that compliance with the
law is not a condition precedent to maintaining a registration.
E. Conclusion
Accordingly, I shall order the sanction the Government requested,
as contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificates
of Registration Nos. FB3395806 and FB9305891 issued to Lona Bibbs-
Walker, D.D.S. Further, pursuant to 28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny
any pending applications of Lona Bibbs-Walker, D.D.S., to renew or
modify the named registrations, as well as any other pending
application of Lona Bibbs-Walker, D.D.S., for
[[Page 16002]]
additional registration in Georgia. This Order is effective May 16,
2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
April 10, 2025, by Acting Administrator Derek Maltz. 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. 2025-06427 Filed 4-15-25; 8:45 am]
BILLING CODE 4410-09-P
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