[Federal Register Volume 90, Number 132 (Monday, July 14, 2025)]
[Notices]
[Pages 31247-31251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-13117]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Michael Bouknight; Decision and Order
On December 2, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Michael Bouknight of
Norristown, Pennsylvania (Applicant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 3, at 1, 4. The OSC proposed the denial of
Applicant's applications for DEA registration, Control Nos. W24128628C
and W24092701C, alleging that he currently lacks state authority to
handle controlled substances in Pennsylvania and that he materially
falsified his applications for registration.\1\ Id. (citing 21 U.S.C.
824(a)(1), 824(a)(3)).
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\1\ The Government's RFAA notes that after the OSC was issued,
Applicant submitted a third application, No. W24165770C. RFAA, at 1-
2; RFAAX 4, at 2. Because the third application was not alleged in
the OSC, the Agency makes no factual findings regarding it. The OSC,
however, did allege that the factual allegations supported denial of
``any applications for any other DEA registrations.'' RFAAX 3, at 1
(emphasis added). Thus, this Agency final order is effective as to
the two applications identified in the OSC, as well as ``any other
pending applications,'' to include the third application submitted
after the OSC. See infra Order.
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On January 16, 2025, the Government submitted an RFAA to the
Administrator requesting that the Agency issue a default final order
denying Applicant's applications. RFAA, at 1, 4. After carefully
reviewing the entire record and conducting the analysis as set forth in
detail below, the Agency finds that Applicant is in default, finds that
Applicant is without state authority, and finds that Applicant
materially falsified his applications. Accordingly, the Agency grants
the Government's RFAA and denies Applicant's applications.
I. Default Determination
Under 21 CFR 1301.43, an applicant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence
of a demonstration of good cause, an applicant who fails to timely file
an answer also is ``deemed to have waived their right to a hearing and
to be in default.'' 21 CFR 1301.43(c)(2). Unless excused, a default
constitutes ``an admission of the factual allegations of the [OSC].''
21 CFR 1301.43(e).
[[Page 31248]]
The OSC notified Applicant of his right to file a written request
for hearing and answer, and that if he failed to file such a request
and answer, he would be deemed to have waived his right to a hearing
and be in default.\2\ RFAAX 3, at 3 (citing 21 CFR 1301.43). Here,
Applicant did not request a hearing, file an answer, or respond to the
OSC in any way. RFAA, at 2-4; RFAAX 4, at 2. Accordingly, Applicant is
in default. 21 CFR 1301.43(c)(1); RFAA, at 1-4.
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\2\ Based on the Government's submissions in its RFAA dated
January 16, 2025, the Agency finds that service of the OSC on
Applicant was adequate. Specifically, the Declaration from a DEA
Diversion Investigator (DI) indicates that on December 3, 2024, DI
served the OSC on Applicant in-person. RFAAX 4, at 2.
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``A default, unless excused, shall be deemed to constitute a waiver
of the [applicant's] right to a hearing and an admission of the factual
allegations of the [OSC].'' 21 CFR 1301.43(e). Because Applicant is in
default and has not moved to excuse the default, the Agency finds that
Applicant has admitted to the factual allegations in the OSC. 21 CFR
1301.43(c)(1), (e), (f)(1).
Further, ``[i]n the event that [an applicant] . . . 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] 1316.67.'' 21 CFR 1301.43(f)(1). Here, the
Government has requested final agency action based on Applicant's
default pursuant to 21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 1-2,
4; see also 21 CFR 1316.67.
II. Lack of State Authority
A. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Applicant is deemed to have admitted, in accordance with
the OSC, that there is no ``record of [Applicant] having ever been
authorized to handle controlled substances in Pennsylvania.'' RFAAX 3,
at 2. According to Pennsylvania online records, of which the Agency
takes official notice, Applicant does not possess any professional
license that authorizes him to handle controlled substances under the
laws of Pennsylvania.\3\ Pennsylvania Department of State Licensing
System Verification, https://www.pals.pa.gov/#!/page/search (last
visited date of signature of this Order). Accordingly, the Agency finds
that Applicant is not licensed to handle controlled substances in
Pennsylvania, the state in which he is registered with DEA.\4\
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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).
\4\ 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 Applicant, as of the date of this Decision and Order, is not
licensed to handle controlled substances in Pennsylvania.
Accordingly, Applicant 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 the DEA Office of the Administrator, Drug Enforcement
Administration, at [email protected].
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B. Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General may 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. [21 U.S.C.]
802(21).''). The Agency has applied these principles consistently. See,
e.g., James L. Hooper, M.D., 76 FR 71,371, 71,372 (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).\5\
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\5\ This rule derives from the text of two provisions of the
Controlled Substances Act (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 at 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 at 27617.
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According to Pennsylvania statute, ``dispense'' means ``to deliver
a controlled substance, other drug or device 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 such item for that delivery.'' 35 Pa.
Stat. Sec. 780-102(b) (West 2025). Further, a ``practitioner'' means
``a physician . . . or other person licensed, registered or otherwise
permitted to distribute, dispense, conduct research with respect to or
to administer a controlled substance, other drug or device in the
course of professional practice or research in the Commonwealth of
Pennsylvania.'' Id.
Here, the undisputed evidence in the record is that Applicant lacks
authority to handle controlled substances in Pennsylvania. As discussed
above, a person must be a licensed practitioner to dispense a
controlled substance in Pennsylvania. Thus, because Applicant lacks
authority to handle controlled substances in Pennsylvania, he is not
eligible to obtain or maintain a DEA registration in Pennsylvania.
Accordingly, the Agency will order that Applicant's applications for
DEA registration be denied.
III. Material Falsification
A. Findings of Fact
The Agency finds that, in light of Applicant's default, the factual
allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Applicant is deemed to have admitted to each of the
following facts. On July 8, 2024, and September 6, 2024, Applicant
submitted applications for DEA registration as a practitioner in
Schedules II through V. RFAAX 3, at 2. The application forms contained
the following statement from DEA: ``[Applicant] must be currently
authorized to prescribe, distribute, dispense, conduct research, or
otherwise handle the controlled
[[Page 31249]]
substances in the schedules for which [Applicant is] applying under the
laws of the state or jurisdiction in which [Applicant is] operating or
propose[s] to operate.'' Id.
When Applicant submitted his applications, he was not authorized in
Pennsylvania to handle controlled substances and there is no record
that he has ever been authorized to handle controlled substances in
Pennsylvania. Id. On each application, Applicant entered the
Pennsylvania Medical Physician and Surgeon License number belonging to
another person. Id.
B. Discussion
A DEA registration may be denied, suspended, or revoked upon a
finding that the applicant or registrant materially falsified any
application filed pursuant to or required by the Controlled Substances
Act (CSA). 21 U.S.C. 824(a)(1).\6\ To present a prima facie case for
material falsification, the Government's record evidence must show (1)
the submission of an application, (2) containing a false statement and/
or omitting information that the application requires, (3) when the
submitter knew or should have known that the statement is false and/or
that the omitted information existed and the application required its
disclosure, and (4) the false statement and/or required but omitted
information is material, that is, it ``connect[s] to at least one of
[the section 823] factors that, according to the CSA, [the
Administrator] `shall' consider'' when analyzing ``whether issuing a
registration `would be inconsistent with the public interest.' '' Frank
Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21 U.S.C. 823
and Kungys, 485 U.S. at 771). The Government must establish material
falsification with record evidence that is clear, unequivocal, and
convincing. Kungys, 485 U.S. at 772; Stirlacci, 85 FR at 45230-39.
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\6\ A statutory basis to deny an application pursuant to section
823 is also a basis to revoke or suspend a registration pursuant to
section 824, and vice versa, because doing ``otherwise would mean
that all applications would have to be granted only to be revoked
the next day . . . .'' Robert Wayne Locklear, M.D., 86 FR 33738,
33744-45 (2021) (collecting cases).
The Supreme Court's decision in Kungys v. United States, 485
U.S. 759 (1988), and its progeny, guide the Agency's implementation
of these CSA provisions.
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First, the Government must prove that the applicant or registrant
submitted an application for registration pursuant to the CSA. 21
U.S.C. 824(a)(1); see also 21 U.S.C. 822 (persons required to
register); 21 U.S.C. 823(g)(1) (registration requirements).
Second, the Government must prove that the application contained a
false statement or omitted information that the application required,
either of which may constitute a material falsity. See, e.g., Emed
Medical Company LLC and Med Assist Pharmacy, 88 FR 21719, 21720 (2023)
(applicant falsely answered ``no'' to Liability Question 3 on seventeen
applications when the true answer was ``yes''); Richard J. Settles,
D.O., 81 FR 64940, 64945-46 (2016) (applicant failed to disclose an
interim consent agreement restricting his license based on findings
that he issued controlled substance prescriptions without federal or
state legal authority to do so). In making this assessment, the Agency
will examine the entire application, including registrant's ``yes/no''
answers to the liability questions and any follow-up response(s).
Daniel A. Glick, D.D.S., 80 FR 74800, 74802, 74808-09 (2015). To
establish an omission, the Government must show both that omitted
information existed and that the application required inclusion of that
information. See, e.g., Richard A. Herbert, M.D., 76 FR 53942, 53956
(2011) (omission of a probation which the application required to be
identified); Michel P. Toret, M.D., 82 FR 60041, 60042 (2017)
(Voluntary Surrender Form alone is insufficient evidence to find
material falsification based on registrant's ``no'' answer to the
question regarding ``surrender[s] (for cause)'').
Third, the Government must prove that the applicant or registrant
knew or should have known that the statement is false and/or that the
omitted information existed and the application required its
disclosure. See John J. Cienki, M.D., 63 FR 52293, 52295 (1998) (``[I]n
finding that there has been a material falsification of an application,
it must be determined that the applicant knew or should have known that
the response given to the liability question was false.''); Samuel
Arnold, D.D.S., 63 FR 8687, 8688 (1998) (``It is also undisputed that
Respondent knew that his Ohio dental license had previously been
suspended.''); Bobby Watts, M.D., 58 FR 46995, 46995 (1993)
(``Respondent knew that the Tennessee Board of Medical Examiners had
suspended his medical license on May 7, 1987, and had placed his state
medical license on probation on May 2, 1988.''); see also Stirlacci, 85
FR at 45236-37 & nn.22-23 (collecting cases).
Fourth, the Government must prove that the false statement and/or
required but omitted information is ``material.'' Kungys holds that a
statement is material if it is ``predictably capable of affecting,
i.e., had a natural tendency to affect, the [Agency's] official
decision,'' or stated differently, ``had a natural tendency to
influence the decision.'' Kungys, 485 U.S. at 771-72. As already
discussed, materiality, for the purposes of the CSA, is tied to the
factors that the Administrator ``shall'' consider when determining
whether issuance of a registration ``would be inconsistent with the
public interest.'' 21 U.S.C. 823; Kungys, 485 U.S. at 771-72;
Stirlacci, 85 FR at 45234, 45238.
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. Here, the Agency finds that the Government's record evidence
presents a prima facie case that Applicant submitted a materially false
application. 21 U.S.C. 823, 824(a)(1).
Applicant submitted two applications for DEA registration; each
form notified Applicant that state authority to handle controlled
substances is a prerequisite to obtain a DEA registration. RFAAX 3, at
2. Both applications clearly asked for Applicant's state license
number, to which Applicant responded with a license number that did not
belong to him, and therefore, did not authorize him to handle
controlled substances. Id. Thus, Applicant falsified his applications
by representing that he was authorized ``under the laws of''
Pennsylvania to handle controlled substances and possessed state
authority that he, in fact, knew or should have known that he did not
possess. Id.
In addition, the falsifications were material. The Agency has
consistently held for decades that possessing valid state authority to
handle controlled substances is a prerequisite for obtaining a DEA
registration.\7\ See 21 U.S.C. 823(g)(1) (The Agency ``shall register
practitioners . . . to dispense . . . controlled substances . . . if
the applicant is authorized to dispense . . . controlled substances
under the laws of the State in which he practices.''). Thus, whether an
applicant possesses valid state authority to handle controlled
substances in the state for which the applicant seeks registration is a
critical factor DEA must consider when reviewing an application.\8\
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\7\ See Joely Keen, A.P.R.N., 90 FR 13882, 13883 (2025) (``DEA
has . . . 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.''); Blanton, 43 FR at 27617 (holding that ``[s]tate
authorization to dispense or otherwise handle controlled substances
is a prerequisite to'' obtaining and maintaining a DEA
registration).
\8\ See 21 U.S.C. 802(21) (defining a ``practitioner'' as one
who is ``licensed, registered, or otherwise permitted, by . . . the
jurisdiction in which he practices'' to handle controlled substances
``in the course of professional practice''); 21 U.S.C. 823(g)(1)
(``The 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.
824(a)(3) (providing a basis for revoking a registration where the
registrant lacks the requisite state authority to dispense
controlled substances); Gonzales v. Oregon, 546 U.S. 243, 270 (2006)
(``The structure and operation of the CSA presume and rely upon a
functioning medical profession regulated under the States' police
powers'' and explaining registration requirements and the definition
of ``practitioner''); Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016)
(explaining ``the possession of state authority is a prerequisite
for obtaining a registration''); Hoi Y. Kam, M.D., 78 FR 62694,
62696 (2013) (``Because possessing authority to dispense controlled
substances under the laws of the State in which a physician
practices medicine is a requirement for holding a DEA registration,
. . . a false answer to the state license question is material where
an applicant no longer holds authority to practice medicine
(regardless of the reason for the State's action) or authority to
dispense controlled substances . . . .'') (emphasis added).
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[[Page 31250]]
In Steven Bernhard, D.O., the Agency found that an application was
materially false where the applicant falsely represented that he
possessed valid state authority to handle controlled substances, when
in fact, he did not. 82 FR 23298, 23300 (2017). The Agency explained
that ``[b]ecause the possession of state authority is a prerequisite to
obtaining and maintaining a practitioner's registration, Respondent's
false representation[ ] that he currently possessed a state license . .
. [was] capable of influencing the Agency's decision to grant his . . .
application.'' Id.; see also Thomas G. Easter II, M.D., 69 FR 5579,
5580 (2004) (finding that applicant materially falsified an application
for registration by falsely representing that ``he was `currently
authorized to prescribe' controlled substances `under the laws of the
State or jurisdiction in which [he was] operating or propose[d] to
operate' '').
Here, Applicant's representations that he possessed authority in
Pennsylvania to handle controlled substances had the capacity to lead
DEA to believe that he met the qualifications for registration, when,
in fact, he did not, because those qualifications did not belong to
Applicant; they belonged to another practitioner. RFAAX 3, at 2. Thus,
the falsities directly affected the statutory analysis that DEA was
required to make when it reviewed his applications. 21 U.S.C. 802(21),
823(g)(1), 824(a)(3); Gonzales, 546 U.S. at 270; Stirlacci, 85 FR at
45238; Bernhard, 82 FR at 23300; Easter, 69 FR at 5580. Stated
differently, his false representations of possessing state authority
that he did not possess implicated DEA's statutory mandate to only
issue registrations to practitioners possessing valid state authority.
21 U.S.C. 802(21), 823(g)(1), 824(a)(3). Thus, the false
representations in Applicant's applications were material because they
were ``predictably capable of affecting . . . [DEA's] official
decision'' regarding whether Applicant met ``the requirements for''
registration. Kungys, 485 U.S. at 771.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence, and Applicant is deemed to have admitted, that he submitted
two materially false applications for registration. 21 U.S.C.
824(a)(1); 21 CFR 1301.43(e).
As a result of this established violation, the Agency finds that
the Government has established a prima facie case for sanction, that
Applicant did not rebut that prima facie case, and that there is
substantial record evidence supporting the denial of Applicant's
applications. 21 U.S.C. 824(a)(1).
C. Sanction
Where, as here, the Government has presented a prima facie case
showing that an applicant submitted a materially false application for
registration, the burden shifts to Applicant to show why he can be
trusted with a registration. Morall v. Drug Enf't Admin., 412 F.3d 165,
181 (D.C. Cir. 2005); 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 a fact-dependent
determination based on the circumstances presented by the individual
practitioner. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also
Jones Total Health Care Pharmacy, 881 F.3d at 833. Historically, the
Agency has considered acceptance of responsibility, egregiousness, and
deterrence when making this assessment.
Specifically, the Agency requires the practitioner to accept
responsibility for his or her violation. 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). Acceptance of responsibility must be
unequivocal. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024);
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total
Health Care Pharmacy, 881 F.3d at 830-31. In addition, the Agency
considers the egregiousness and extent of the misconduct in determining
the appropriate sanction. Jones Total Health Care Pharmacy, 881 F.3d at
834 & n.4. The Agency also considers the need to deter similar acts by
Applicant and by future applicants for registration. Stein, 84 FR at
46972-73.
Here, Applicant did not timely request a hearing, or timely or
properly answer the allegations, and was therefore deemed to be in
default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA, at 1-4. To date,
Applicant has not filed a motion with the Office of the Administrator
to excuse the default. 21 CFR 1301.43(c)(1). Applicant has thus failed
to answer the allegations contained in the OSC and has not otherwise
availed himself of the opportunity to refute the Government's case. As
such, Applicant has not accepted responsibility for the proven
violations, has made no representations regarding his future compliance
with the CSA, and has not made any demonstration that he can be trusted
with registration.
Moreover, the evidence presented by the Government shows that
Applicant used another person's license number on two applications to
falsely represent that he possessed state authority to handle
controlled substances, further demonstrating that Applicant cannot be
trusted with the responsibilities of holding a controlled substances
registration. To permit Applicant to receive a registration under these
circumstances would send a dangerous message that fraud is an
acceptable means of acquiring a DEA registration and that DEA does not
require truthfulness from applicants and registrants.
Accordingly, the Agency will order the denial of Applicant's
applications.\9\
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\9\ In this matter there are two separate and distinct grounds
by which the Government proposed denial, Applicant's lack of state
authority and his material falsification; each ground, standing
alone, supports the Agency's decision to deny.
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Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823 and 824, I hereby deny the pending applications for a DEA
Certificate of Registration, Control Nos. W24128628C and W24092701C,
submitted by Michael Bouknight, as well as any other pending
applications of Michael Bouknight for additional registration in
Pennsylvania. This Order is effective August 13, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 8, 2025, by Acting Administrator Robert J. Murphy. 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
[[Page 31251]]
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. 2025-13117 Filed 7-11-25; 8:45 am]
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