[Federal Register Volume 90, Number 87 (Wednesday, May 7, 2025)]
[Notices]
[Pages 19310-19313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07934]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Margaret Dennis, D.M.D.; Default Decision and Order
I. Introduction
On October 31, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to Margaret Dennis, D.M.D., of Jacksonville, FL
(Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX)
1, at 1. The OSC/ISO informed Registrant of the immediate suspension of
her DEA Certificate of Registration, No. BD1443732, 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 between at least January of 2013 until at
least July of 2024, Registrant issued numerous prescriptions for
controlled substances to at least four patients despite, among other
things: (1) failing to establish a proper medical justification for
prescribing; (2) prescribing outside the scope of her practice; and (3)
failing to appropriately address red flags of abuse or diversion. Id.
The OSC/ISO alleged that Registrant's noted prescribing practices were
in violation of the Controlled Substances Act's (CSA's) implementing
regulations and Florida state law. Id. at 2-3.\1\
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\1\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC/ISO. Ruan v. United States, 597 U.S. 450
(2022) (decided in the context of criminal proceedings).
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The OSC/ISO notified Registrant of her right to file with DEA a
written request for a 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 1, at 7-8 (citing 21 CFR 1301.43).
Here, Registrant did not request a hearing. RFAA, at 1.\2\ ``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].'' 21 CFR 1301.43(e); see also RFAAX
1, at 8 (providing notice to Registrant).
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\2\ Based on the Government's submissions in its RFAA dated
December 12, 2024, the Agency finds that service of the OSC/ISO on
Registrant was adequate. According to the included Declaration from
a DEA Diversion Investigator (DI), on November 1, 2024, after
attempting to serve Registrant at Registrant's registered location,
the DI ``reached out [to Registrant's] counsel and confirmed
representation of [Registrant] for purposes of any administrative
proceedings.'' RFAAX 2, at 1. On the same date, following the
confirmation of representation, the DI emailed Registrant's counsel
a copy of the OSC/ISO and copied Registrant on the email. Id. Here,
the Agency finds that Registrant was successfully served the OSC/ISO
by email and that the DI's efforts to serve Registrant by other
means were `` `reasonably calculated, under all the circumstances,
to apprise [Registrant] of the pendency of the action.' '' Jones v.
Flowers, 547 U.S. 220, 226 (2006) (quoting Mullane v. Central
Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)); see also
Mohammed S. Aljanaby, M.D., 82 FR 34552, 34552 (2017) (finding that
service by email satisfies due process where the email is not
returned as undeliverable and other methods have been unsuccessful).
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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] 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(c), (f), 1301.46. RFAA, at 1; see
also 21 CFR 1316.67.
II. Applicable Law
As the Supreme Court stated in Gonzales v. Raich, ``the main
objectives
[[Page 19311]]
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 . . . 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.
A. Improper Prescribing (21 CFR 1306.04(a); Fla. Stat. Secs. 456.44,
466.028; Fla. Admin. Code Ann. r. 64B8-9.003)
The OSC/ISO alleges that for over ten years, Registrant ``issued
multiple controlled substance prescriptions to patients without
undertaking actions typical of medical professionals, such as
conducting and documenting a complete medical history, properly
assessing the needs of individuals for controlled substances, and
monitoring patient medication compliance.'' RFAAX 1, at 4. According to
CSA regulations, a prescription for a controlled substance is proper
only if ``issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of his professional practice.''
21 CFR 1306.04(a).
Moreover, Florida law requires a practitioner to, among other
things: (1) prescribe controlled substances only after conducting a
complete medical history and physical examination; (2) document the
presence of one or more recognized medical indications for the use of a
controlled substance; (3) create a written treatment plan with goals
and objectives; (4) discuss the risks and benefits of the use of
controlled substances with the patient; (5) see the patient at regular
intervals and conduct periodic reviews of the effectiveness of the
treatment; (6) assess patient risk for aberrant drug-related behavior,
continue to monitor that risk on an ongoing basis, and provided special
attention to patients at risk for abusing their medication; and (7)
maintain accurate, current, and complete records that are accessible
and readily available for review. Fla. Stat. sec. 456.44.
Florida law also provides a list of acts that constitute grounds
for disciplinary action against dentists and other dental
practitioners, including, among others: ``(p) [p]rescribing . . . any
controlled substance, other than in the course of the professional
practice of the dentist . . . without regard to his or her intent'';
``(r) [p]rescribing, procuring, ordering, dispensing, administering,
supplying, selling, or giving any drug which is a Schedule II
amphetamine . . . ``; ``(x) [b]eing guilty of incompetence or
negligence by . . . the undertaking of diagnosis and treatment for
which the dentist is not qualified by training or experience . . . '';
and ``(y) [p]racticing or offering to practice beyond the scope
permitted by law or accepting and performing professional
responsibilities which the licensee knows or has reason to know that
she or he is not competent to perform.'' Id. sec. 466.028.
Finally, Florida law requires that medical records, among other
things, must have ``sufficient detail to clearly demonstrate why the
course of treatment was undertaken'' and must ``contain sufficient
information to identify the patient, support the diagnosis, justify the
treatment and document the course and results of treatment
accurately.'' Fla. Admin. Code Ann. R. 64B8-9.003.
III. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC/ISO are deemed admitted.
A. Prescribing to D.B.
Registrant admits that between June 1, 2021, and July 1, 2024,
Registrant issued to D.B. prescriptions for controlled substances
including dextroamphetamine-amphetamine (a Schedule II stimulant),
hydromorphone (a Schedule II opioid), and alprazolam (a Schedule IV
benzodiazepine). RFAAX 1, at 4. Registrant admits that she failed to
establish a proper medical justification for prescribing
dextroamphetamine-amphetamine to D.B., specifically, because Registrant
issued the prescriptions without any diagnostic workup, rationale, or
treatment plan. Id. Additionally, Registrant admits that under Florida
prescribing regulations, Registrant's prescribing of dextroamphetamine-
amphetamine was outside the scope of dental practice and facial pain
management. Id.
Registrant admits that she prescribed D.B. increasingly high daily
dosages of hydromorphone, as high as 237 MME, without proper medical
indication, rationale, or evidence of improvement in pain and function.
Id. Registrant further admits that she failed to document justification
for prescribing opioids and benzodiazepines concurrently. Id. Finally,
Registrant admits that Registrant failed to properly monitor D.B.'s
medication compliance and failed to appropriately address red flags of
abuse or diversion that D.B. presented.\3\ Id.
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\3\ For example, D.B. has a history of prior management with
Suboxone, but Registrant issued the controlled substance
prescriptions to D.B. without any diagnostic workup pertaining to
chemical dependency or substance abuse and without performing any
toxicology screening. Id.
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Registrant admits and the Agency finds substantial record evidence
that the above-referenced controlled substance prescriptions issued to
D.B. were issued outside the usual course of professional practice and
not for a legitimate medical purpose. Id. at 4-5. The Agency further
finds substantial record evidence that the prescribing of amphetamine-
dextroamphetamine to D.B. was outside the scope of Registrant's
practice.
B. Prescribing to D.G.
Registrant admits that between December 9, 2019, and January 13,
2022, Registrant issued to D.G. prescriptions for controlled substances
including oxycodone (a Schedule II opioid), morphine (a Schedule II
opioid), and alprazolam. Id. at 5. Registrant admits that she failed to
establish a proper medical justification for prescribing
benzodiazepines to D.G., specifically, because Registrant issued the
prescriptions with no pertinent medical workup. Id.
Registrant admits that she failed to maintain adequate medical
records for her treatment of D.G.; specifically, seven years of medical
charts were missing from D.G.'s records. Id. Registrant also admits
that Registrant failed to document justification for prescribing
opioids and benzodiazepines concurrently. Id. Finally, Registrant
admits that Registrant failed to properly monitor D.G.'s medication
compliance and failed to appropriately address red flags of abuse or
diversion that D.G. presented.\4\ Id.
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\4\ For example, Registrant admits that she failed to address
D.G.'s history of substance abuse and chemical dependency diagnosis,
such as by performing toxicology screening. Id. Registrant also
admits that Registrant did not attempt to obtain medical records
pertaining to D.G.'s chemical dependency diagnosis or inpatient
treatment. Id.
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Registrant admits and the Agency finds substantial record evidence
that the above-referenced controlled substance prescriptions issued to
D.G. were issued outside the usual course of
[[Page 19312]]
professional practice and not for a legitimate medical purpose. Id.
C. Prescribing to M.G.
Registrant is deemed to have admitted that between October 11,
2018, and February 22, 2019, Registrant issued to M.G. prescriptions
for controlled substances including oxycodone, tramadol (a Schedule IV
opioid), morphine sulfate (a Schedule II opioid), methadone (a Schedule
II opioid), and carisoprodol (a Schedule IV muscle relaxant). Id.
Registrant also admits that she prescribed M.G. increasingly high
daily dosages of multiple controlled substances without rationale
supporting the medical necessity or evidence of improvement in pain and
function. Id. Specifically, Registrant admits that Registrant
prescribed Patient M.G. oxycodone, tramadol, morphine sulfate,
methadone, and carisoprodol on multiple occasions, increasing Patient
M.G.'s daily dosage from 45 MME to 270 MME without supporting medical
necessity. Id. Finally, Registrant admits that she failed to properly
monitor Patient M.G.'s medication compliance.\5\ Id. at 5.
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\5\ For example, Registrant admits that she did not pursue a
chemical dependency diagnosis inquiry, did not discuss potential
substance abuse issues with M.G., and did not perform any toxicology
screening. Id. at 6.
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Registrant admits and the Agency finds substantial record evidence
that the above-referenced controlled substance prescriptions issued to
M.G. were issued outside the usual course of professional practice and
not for a legitimate medical purpose. Id. at 6.
D. Prescribing to I.R.
Registrant is deemed to have admitted that between December 19,
2019, and June 13, 2024, Registrant issued to I.R. prescriptions for
controlled substances including oxycodone, methadone, diazepam (a
Schedule IV benzodiazepine), and alprazolam. Id. Further, Registrant
admits that over a four-day period between August and September 2021,
Registrant prescribed multiple high dosage controlled substances to
I.R. with a MME as high as 1,935. Id. These prescriptions were issued
without proper medical justification and with no evidence of
improvement in pain and function. Id.
Registrant also admits that she failed to maintain adequate medical
records for the treatment of I.R., specifically, by lacking the
documentation that appropriately accounted for the initiation of
controlled substance prescriptions and their subsequent dosage
increases over the years. Id. Moreover, Registrant admits that she
failed to request pertinent and recent medical records regarding
treatment I.R. disclosed that he/she received elsewhere. Id.
Registrant admits that she failed to document justification for
prescribing opioids and benzodiazepines concurrently. Id. Finally,
Registrant admits that she failed to properly monitor I.R.'s medication
compliance and failed to appropriately address red flags of abuse or
diversion that I.R. presented.\6\ Id.
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\6\ Specifically, Registrant admits that she prescribed
controlled substances, and increased the dosages at I.R.'s request,
without performing or entertaining toxicology screening. Id.
Registrant admits that this occurred despite numerous and repeated
red flags, including, but not limited to: I.R. obtaining narcotics
from `` `other sources' ''; `` `an increased use of Valium' ''; an
admission from I.R. that I.R. `` `used to search out moms' meds' '';
I.R.'s `` `doub[ling] up [controlled substances] to have a good day'
''; a report of suicidal gesturing; admitted cocaine use; and other
``inconsistent and alarming patient statements.'' Id.
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Registrant admits and the Agency finds substantial record evidence
that the above-referenced controlled substance prescriptions issued to
I.R. were issued outside the usual course of professional practice and
not for a legitimate medical purpose. Id. at 6.
E. Expert Review
DEA retained an independent medical expert to review, among other
materials, information regarding all of the above-noted controlled
substance prescriptions as well as Registrant's patient files for D.B.,
D.G., M.G., and I.R. Id. at 7. DEA's medical expert concluded that all
of the above-noted controlled substance prescriptions violated minimal
medical standards applicable to Registrant's practice of medicine in
Florida. Id. Further, DEA's medical expert concluded that Registrant's
misconduct put D.B., D.G., M.G., and I.R. at risk for abuse, addiction,
overdose, and death. Id.
IV. Discussion
A. 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).\7\
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\7\ 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., 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.
[[Page 19313]]
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. RFAAX 1, at 4. Moreover, the Government
has the burden of proof in this proceeding. 5 U.S.C.A. 556(d); 21 CFR
1301.44.
B. Factors B and/or D--Registrant's Registration Is Inconsistent With
the Public Interest
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 the Agency finds above,
Registrant is deemed to admit and the Agency finds that for over ten
years, Registrant issued numerous prescriptions for controlled
substances to at least four patients without, among other things,
having proper medical justification, resolving red flags of abuse or
diversion, or maintaining proper medical records. Supra Section III.
The Agency further finds that each of the above-reference prescriptions
were outside the usual course of professional practice and not for a
legitimate medical purpose. Supra Section III; see also RFAAX 1, at 4-
7. The Agency further finds substantial record evidence that the
prescribing of amphetamine-dextroamphetamine to D.B. was outside the
scope of Registrant's practice. Supra Section III.A.
As such, the Agency finds substantial record evidence that the
Registrant violated 21 CFR 1306.04(a), Fla. Stat. secs. 456.44,
466.028, and Fla. Admin. Code Ann. r. 64B8-9.003. After weighing
Factors B and D, the Agency further finds that Registrant's continued
registration is outside 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).
V. 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 her controlled
substance prescribing. Accordingly, the burden shifts to Registrant to
show why she can be entrusted with a 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); supra sections III and IV.
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 at 46972-73.
Here, Registrant did not request a hearing 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 a 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.
In sum, Registrant has not offered any evidence on the record that
rebuts the Government's case for revocation of her registration, and
Registrant has not demonstrated that she can be entrusted with the
responsibility of registration. Accordingly, the Agency will order the
revocation of Respondent's registration.
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 Certificate
of Registration No. BD1443732 issued to Margaret Dennis, D.M.D.
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 Margaret Dennis, D.M.D., to renew or modify this
registration, as well as any other pending application of Margaret
Dennis, D.M.D., for additional registration in Florida. This Order is
effective June 6, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 1, 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. 2025-07934 Filed 5-6-25; 8:45 am]
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