Notice2025-18361
Immacula Michel, M.D.; Decision and Order
Primary source
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Published
September 23, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Full Text
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<title>Federal Register, Volume 90 Issue 182 (Tuesday, September 23, 2025)</title>
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[Federal Register Volume 90, Number 182 (Tuesday, September 23, 2025)]
[Notices]
[Pages 45813-45815]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18361]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Immacula Michel, M.D.; Decision and Order
On May 4, 2025, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Immacula Michel,
M.D., of Greenacres, Florida (Applicant). Request for Final Agency
Action (RFAA), Exhibit (RFAAX) 1, at 1, 4. The OSC proposed the denial
of Applicant's application for DEA registration, Control No.
W23121768C, alleging that Applicant's registration is inconsistent with
the public interest. Id. at 2 (citing 21 U.S.C. 823(g)(1)(B) and (D)).
More specifically, the OSC alleged that Applicant issued three
controlled substance prescriptions without a DEA registration in
violation of federal and Florida state law. Id.
On June 23, 2025, the Government submitted an RFAA requesting that
the Agency issue a default final order denying Applicant's application
for registration. RFAA, at 3.\1\ After carefully reviewing the entire
record and conducting the analysis as set forth in more detail below,
the Agency grants the Government's request for final agency action and
denies Applicant's application for registration.
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\1\ The RFAA states that ``the Administrator is authorized to
render the Agency's final order, without . . . making a finding of
fact.'' RFAA, at 3 (citing 21 CFR 1301.43(c), (f), and 1301.46).
However, 21 CFR 1316.67 requires that the Administrator's final
order ``set forth the final rule and the findings of fact and
conclusions of law upon which the rule is based.'' See JYA LLC d/b/a
Webb's Square Pharmacy, 90 FR 31244, 31246 n.7 (2025).
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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) and (c)(1). In the
absence of a demonstration of good cause, an applicant who fails to
timely file an answer is also ``deemed to have waived their right to a
hearing and to be in default.'' 21 CFR 1301.43(c)(2). Unless excused, a
default is deemed to constitute ``an admission of the factual
allegations of the [OSC].'' 21 CFR 1301.43(e).
Here, the OSC notified Applicant of her right to file a written
request for hearing, 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.<SUP>2 3</SUP> RFAAX 1, at 3 (citing 21 CFR 1301.43). Applicant
did not request a hearing. RFAA, at 1, 3. Thus, the Agency finds that
Applicant is in default and is deemed to have admitted the factual
allegations in the OSC. 21 CFR 1301.43(e).
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\2\ Based on the Government's submissions in its RFAA dated June
23, 2025, the Agency finds that service of the OSC on Applicant was
adequate. The included attachments show that on May 9, 2025, a
Diversion Investigator (DI) personally served the OSC on Applicant
and Applicant signed a receipt of service. RFAAX 2A, at 4; RFAAX 2B.
Accordingly, the Agency finds that the Government's service of the
OSC on Applicant was adequate.
\3\ The sworn statement from DI begins, ``I, [DI], under penalty
of perjury, declare and state the following.'' RFAAX 2, at 1. This
declaration omits the statutory language ``. . . that the foregoing
is true and correct.'' 28 U.S.C. 1746(2). Accordingly, the Agency
will give less weight to DI's sworn statement as evidence, but notes
that DI's declaration is uncontroverted.
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II. Applicable Law
As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1
(2005), ``the main objectives of the [Controlled Substances Act (CSA)]
were to conquer drug abuse and control the legitimate and illegitimate
traffic in controlled substances.'' Id. at 12. This case explained
that:
Congress was particularly concerned with the need to prevent the
diversion of drugs from legitimate to illicit channels. To
effectuate these goals, Congress devised a closed regulatory system
making it unlawful to manufacture, distribute, dispense, or possess
any controlled substance except in a manner authorized by the CSA .
. . . The CSA and its implementing regulations set forth strict
requirements regarding registration, labeling and packaging,
production quotas, drug security, and recordkeeping.
Id. at 12-14.
The CSA requires that ``every person who dispenses, or who proposes
to dispense, any controlled substance, shall obtain from the [DEA] a
registration.'' 21 U.S.C. 822(a)(2); see also Gonzales v. Raich, 545
U.S. at 27-28. Under the CSA, ``[t]he very definition of a
`practitioner' eligible to prescribe includes physicians `licensed,
registered, or otherwise permitted, by the . . . jurisdiction in which
he practices' to dispense controlled
[[Page 45814]]
substances.'' Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (citing 21
U.S.C. 802(21)). According to DEA regulations, a prescription may only
be issued by an individual practitioner who is ``[a]uthorized to
prescribe controlled substances by the jurisdiction in which he is
licensed to practice his profession'' and has been issued a DEA
registration.\4\ 21 CFR 1306.03. Additionally, 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); see
also United Prescription Servs., Inc., 72 FR 50397, 50,407 (2007) (``a
physician who engages in the unauthorized practice of medicine is not a
practitioner acting in the usual course of professional practice.'');
Salman Akbar, M.D., 89 FR 82259 (2024) (the Agency determined that
issuing prescriptions without a DEA registration is outside of the
usual course of practice); Linda Sue Cheek, M.D., 76 FR 66972, 66974
(2011) (``It is also unlawful to dispense a controlled substance
without first obtaining a [DEA] registration to do so.'').
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\4\ While there are exemptions to the registration requirements,
see 21 CFR 1301.22-.23, none apply to Applicant.
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III. Findings of Fact
In light of Applicant's default, the factual allegations in the OSC
are deemed admitted. 21 CFR 1301.43(e). Accordingly, Applicant admits
that ``[b]etween November 2024 and February 2025, [she] issued three
(3) controlled substance prescriptions for phentermine (a Schedule IV
controlled substance) under DEA [registration] No. BM6676449, despite
having surrendered this DEA [registration] on August 4, 2022.'' RFAAX
1, at 2. Therefore, the Agency finds substantial record evidence that
Applicant issued three controlled substance prescriptions without a DEA
registration. Id.
IV. Public Interest Determination
A. Legal Background on Public Interest Determinations
When the CSA's requirements are not met, the Agency \5\ ``may deny,
suspend, or revoke [an application] if . . . the physician's
registration would be `inconsistent with the public interest.' ''
Gonzales v. Oregon, 546 U.S. at 251 (quoting 21 U.S.C. 824(a)(4)).\6\
In the case of a ``practitioner,'' the Agency is directed to consider
five factors in making the public interest determination. Id.; 21
U.S.C. 823(g)(1)(A-E).\7\
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\5\ The CSA delegates this power to the Attorney General, who
has delegated it to the Administrator of the DEA (the Agency) by 28
CFR 0.100.
\6\ The Government has the burden of proof in this proceeding.
21 CFR 1301.44(d).
\7\ The five factors are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(C) The applicant'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.
21 U.S.C. 823(g)(1)(A-E).
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The five factors are considered in the disjunctive. Gonzales v.
Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It is well
established that these factors are to be considered in the
disjunctive'' (quoting 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. David H. Gillis, M.D., 58 FR 37507, 37508 (1993);
see Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005)
(describing the Agency's adjudicative process as ``applying a multi-
factor test through case-by-case adjudication'' (quoting LeMoyne-Owen
Coll. v. N.L.R.B., 357 F.3d 55, 61 (D.C. Cir. 2004))). Any one factor,
or combination of factors, may be decisive, David H. Gillis, M.D., 58
FR at 37508, and the Agency ``may give each factor the weight . . .
deem[ed] appropriate in determining whether a registration should be
revoked or an application for registration denied.'' Morall, 412 F.3d.
at 185 n.2 (Henderson, J., concurring) (quoting Robert A. Smith, M.D.,
70 FR 33207, 33208 (2007)); see also Penick Corp. v. Drug Enf't Admin.,
491 F.3d 483, 490 (D.C. Cir. 2007).
Moreover, while the Agency is required to consider each of the
factors, it ``need not make explicit findings as to each one.'' MacKay
v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting
Volkman v. U. S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009));
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d
823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477,
482 (6th Cir. 2005). ``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 Eleventh Circuit has
recognized, Agency decisions have explained that findings under a
single factor can support the denial of an application for
registration. Jones Total Health Care Pharmacy, 881 F.3d at 830.
B. Applicant's Registration Is Inconsistent With the Public Interest
While the Agency has considered all the public interest factors of
21 U.S.C. 823(g)(1),\8\ the Government's evidence in support of its
prima facie case is confined to Factors B and D. RFAAX 1, at 2.
Evidence is considered under Factors B and D when it reflects
experience dispensing controlled substances and compliance or non-
compliance with laws related to controlled substances. Kareem Hubbard,
M.D., 87 FR 21156, 21162 (2022).
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\8\ As to Factor A, there is no record evidence of disciplinary
action against Applicant's state medical license. 21 U.S.C.
823(g)(1)(A). However, ``[t]he fact that the record contains no
evidence of a recommendation by a state licensing board does not
weigh for or against a determination as to whether continuation of
the Respondent's DEA certification is consistent with the public
interest.'' Roni Dreszer, M.D., 76 FR 19434, 19444 (2011). As to
Factor C, there is no evidence in the record that Applicant has been
convicted of any federal or state law offense ``relating to the
manufacture, distribution, or dispensing of controlled substances.''
21 U.S.C. 823(g)(1)(C). However, as Agency cases have noted, ``the
absence of such a conviction is of considerably less consequence in
the public interest inquiry'' and is therefore not dispositive.
Dewey C. Mackay, M.D., 75 FR 49956, 49973 (2010). As to Factor E,
the Government's evidence fits squarely within the parameters of
Factors B and D and does not raise ``other conduct which may
threaten the public health and safety.'' 21 U.S.C. 823(g)(1)(E).
Accordingly, Factor E does not weigh for or against Applicant.
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Here, the Agency found substantial record evidence that between
November 2024 and February 2025, Applicant issued three prescriptions
for a controlled substance without a DEA registration.\9\ See supra
Section III. Accordingly, the Agency finds substantial record evidence
that Applicant violated both federal and state law, namely 21 CFR
1306.03(a)(2), 1306.04(a), and Florida Statutes Sec. 458.331(1)(g)
(2025).\10\ Applicant's misconduct, therefore, reflects negative
experience in prescribing with respect to controlled substances and
non-compliance with laws related to controlled substances. 21 U.S.C.
823(g)(1)(B), (D); see also Richard J. Settles, D.O., 81 FR 64940,
64947 (2016) (finding respondent's registration would be inconsistent
with the public interest where he prescribed controlled
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substances without a DEA registration); John V. Scalera, 78 FR 12092,
12098 (2013) (same); Belinda R. Mori, N.P., 78 FR 36582, 36588 (2013)
(same); Leo A. Farmer, M.D., 78 FR 27997, 27999 (2013) (same); Glenn D.
Krieger, M.D., 76 FR 20020, 20024 (2011) (same).
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\9\ There is no record evidence indicating that Applicant
qualified for an exemption when these prescriptions were issued.
See, e.g., 21 CFR 1301.22-.23.
\10\ This Florida statute is violated whenever a licensed
physician fails to perform any other statutory or legal obligation
placed on them.
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Accordingly, the Agency finds that after considering the factors of
21 U.S.C. 823(g)(1), the Government satisfied its prima facie burden
showing that Applicant's registration would be ``inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4); see also 21 U.S.C. 823(g)(1).
The Agency further finds that there is insufficient mitigating evidence
to rebut the Government's prima facie case. Thus, the only remaining
issue is whether, in light of the Agency's finding that Applicant
violated the law, Applicant can be trusted with a registration.
V. Sanction
Where, as here, the Government has met the burden of showing that
Applicant's proposed registration is inconsistent with the public
interest, the burden shifts to Applicant to show why she can be
entrusted with a registration. Morall, 412 F.3d at 174; Jones Total
Health Care Pharmacy, 881 F.3d at 830; 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. 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, the Agency
requires that a registrant or an applicant who has committed acts
inconsistent with the public interest accept responsibility for those
acts and demonstrate that they will not engage in future misconduct.
See 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). The Agency
requires an applicant's unequivocal acceptance of responsibility. 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. The Agency also considers the need to deter similar
acts by an applicant and by the community of registrants. Jeffrey
Stein, M.D., 84 FR at 46972-73.
Here, Applicant failed to answer the allegations contained in the
OSC and did not otherwise avail herself of the opportunity to refute
the Government's case. See supra Section I. Thus, there is no record
evidence that Applicant takes responsibility, let alone unequivocal
responsibility, for the misconduct. Accordingly, she has not convinced
the Agency that her future controlled-substance-related actions will
comply with the CSA such that she can be entrusted with the
responsibilities of a registration.
Further, the interests of specific and general deterrence weigh in
favor of denial. Applicant's conduct in this matter concerns the CSA's
``strict requirements regarding registration'' and, therefore, goes 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.'' Gonzales v. Raich, 545
U.S. at 12-14. If the Agency were to issue a registration to Applicant
under these circumstances, it would send a dangerous message that
compliance with the law is not essential to obtaining a registration.
In sum, Applicant has not offered any credible evidence on the
record that rebuts the Government's case for denial of her application,
and Applicant has not demonstrated that she can be entrusted with the
responsibility of registration. Accordingly, the Agency will order the
denial of Applicant's application for registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(g)(1), I hereby deny the application for a DEA Certificate
of Registration, Control No. W23121768C, submitted by Immacula Michel,
M.D., as well as any other pending application of Immacula Michel,
M.D., for registration in Florida. This Order is effective October 23,
2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 17, 2025, by Administrator Terrance Cole. 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. 2025-18361 Filed 9-22-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 23, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.