Notice2025-06424
David Israel, M.D.; Decision and Order
Primary source
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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 16005-16008]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06424]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
David Israel, M.D.; Decision and Order
On August 28, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause and Immediate Suspension of
Registration (OSC/ISO) to David Israel, M.D., of Bronx, New York
(Registrant).\1\ Request for Final Agency Action (RFAA), Exhibit
(RFAAX) 1, at 1, 6. The OSC/ISO proposed the revocation of Registrant's
DEA Certification of Registration (registration), No. BI8368828,
alleging that he is currently without authority to handle controlled
substances in the State of New York, the state in which he is
registered with DEA. Id. at 4-5 (citing 21 U.S.C. 824(a)(3)). The OSC/
ISO further proposed the revocation of Registrant's registration on the
basis that Registrant has committed such acts as would render his
registration inconsistent with the public interest. Id. at 3 (citing 21
U.S.C. 823(g)(1), 824(a)(4)).\2\
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\1\ Based on the Government's submissions in its RFAA dated
April 18, 2024, the Agency finds that service of the OSC/ISO on
Registrant was adequate. Specifically, the Declaration from a DEA
Diversion Investigator (DI) indicates that Registrant was
successfully mailed a copy of the OSC/ISO at both his mail-to
address and registered address on December 1, 2023, and December 4,
2023, respectively. RFAAX 2, at 3; see also RFAAX 2, Attachment A.
\2\ According to Agency records, Registrant's registration No.
BI8368828 expired on November 30, 2023. The fact that a registrant
allows his registration to expire during the pendency of an OSC does
not impact the Agency's jurisdiction or prerogative under the
Controlled Substances Act (hereinafter, CSA) to adjudicate the OSC
to finality. Jeffrey D. Olsen, M.D., 84 FR 68474, 68476-79 (2019).
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Specifically, the OSC/ISO alleges that ``between . . . October 9,
2020, until at least . . . June 11, 2023, [Registrant] violated federal
and New York state law by issuing prescriptions for controlled
substances outside the usual course of professional practice and for
other than a legitimate medical purpose, in violation of 21 CFR
1306.04(a) and N.Y. Comp. Codes R. & Regs. Tit. 10, Sec. 80.65.''
RFAAX 1, at 3.
The OSC notified Registrant of his right to file with DEA a written
request for hearing within 30 days after the date of receipt of the
OSC. Id. at 5-6 (citing 21 CFR 1301.43(a)). The OSC also notified
Registrant that if it failed to file such a request, he would be deemed
to have waived his right to a hearing and be in default. Id. (citing 21
CFR 1301.43(c), (d), (e)). Here, Registrant did not request a hearing.
RFAA, at 2. ``A default, unless excused, shall be deemed to constitute
a waiver of the [registrant's] right to a hearing and an admission of
the factual allegations of the [OSC/ISO].'' 21 CFR 1301.43(e).
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(c), (f), because Registrant has not
timely requested a hearing nor filed an Answer to the OSC/ISO. See also
id. Sec. 1316.67.
I. 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. According to
the OSC/ISO, on August 23, 2023, the New York Department of Health
suspended Registrant's medical license. RFAAX 1, at 4. According to New
York online records, of which the Agency takes official notice,
Registrant's medical license has since been revoked.\3\ New York Office
of the Professions Verification Search, <a href="https://eservices.nysed.gov/professions/verification-search">https://eservices.nysed.gov/professions/verification-search</a> (last visited date of signature of this
Order). Accordingly, the Agency finds substantial record evidence that
Registrant is not licensed to practice medicine in New York, 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 Registrant, as of the date of this decision, is not licensed to
practice medicine in New York. Accordingly, Registrant may dispute
the Agency's finding by filing a properly supported motion for
reconsideration of findings of fact within fifteen calendar days of
the date of this Order. Any such motion and response shall be filed
and served by email to the other party and to DEA Office of the
Administrator, Drug Enforcement Administration at
<a href="/cdn-cgi/l/email-protection#e4808185ca8580808bca8590908b968a819d97a4808185ca838b92"><span class="__cf_email__" data-cfemail="37535256195653535819564343584559524e447753525619505841">[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 Cir. 2012);
Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).\5\
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\5\ 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 Yeates, 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 New York statute, ``dispense'' means ``to deliver a
controlled substance to an ultimate user or research subject by lawful
means, . . . and includes the packaging, labeling, or compounding
necessary to prepare the substance for such delivery.'' N.Y. Pub.
Health Law section
[[Page 16006]]
3304(8) (McKinney 2024). Further, a ``practitioner'' means ``[a]
physician . . . or other person licensed, or otherwise permitted to
dispense, administer or conduct research with respect to a controlled
substance in the course of a licensed professional practice or
research.'' Id. section 3302(27).
Here, the undisputed evidence in the record is that Registrant
lacks authority to practice medicine in New York. As discussed above, a
physician must be a licensed practitioner to dispense a controlled
substance in New York. Thus, because Registrant currently lacks
authority to practice medicine in New York and, therefore, is not
authorized to handle controlled substances in New York, Registrant is
not eligible to maintain a DEA registration in New York. Accordingly,
the Agency will order that Registrant's DEA registration be revoked.
II. Public Interest
A. Applicable Law
As already discussed, the OSC/ISO alleges that Registrant violated
multiple 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.
The OSC/ISO's allegations concern the CSA's ``statutory and
regulatory provisions . . . mandating . . . compliance with . . .
prescription requirements'' 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,'' and ``to prevent the diversion of drugs from
legitimate to illicit channels.'' Id. at 12-14, 27.
The Allegation That Registrant Issued Prescriptions Outside the Usual
Course of Professional Practice
According to the CSA's implementing regulations, a lawful
prescription for controlled substances 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
Gonzales v. Oregon, 546 U.S. 243, 274 (2006), United States v. Hayes,
595 F.2d 258 (5th Cir. 1979), rehearing den., 598 F.2d 620 (5th Cir.
1979), cert. denied, 444 U.S. 866 (1979); RFAAX 1, at 2. New York
regulations similarly require that ``[a] prescription, in order to be
effective in legalizing the possession of controlled substances, shall
be issued for a legitimate medical purpose only.'' N.Y. Comp. Codes R.
& Regs. tit. 10, section 80.65. New York regulations also state that
practitioners may issue controlled substances only ``in good faith and
in the course of their professional practice.'' N.Y. Comp. Codes R. &
Regs. tit. 10, section 80.71(a).
DEA's implementing regulations permit registrants to issue
electronic prescriptions for controlled substances in schedules II-V.
21 CFR 1311.100(b); RFAAX 1, at 2. To issue an electronic prescription
for a controlled substance, the prescribing practitioner must
authenticate the prescription using at least two of the following
factors: a password or other knowledge factor, biometric data, and/or a
hard token. 21 CFR 1311.115(a), 1311.120(b)(5), (11); RFAAX 1, at 2.
The completion of the two-factor authentication process ``constitute[s]
the signing of the prescription by the practitioner.'' 21 CFR
1311.140(a)(5); RFAAX 1, at 2. While DEA regulations permit a non-
registered agent to enter data on the prescription, the registrant must
sign the prescription himself with the two-factor authentication
procedure. 21 CFR 1311.135(a); RFAAX 1, at 2.
DEA regulations make clear that ``[t]he practitioner must retain
sole possession of the hard token . . . and must not share the password
or other knowledge factor, or biometric information, with any other
person.'' 21 CFR 1311.102(a); RFAAX 1, at 2. The regulation further
states that ``[t]he practitioner must not allow any other person to use
. . . or enter the knowledge factor or other identification means to
sign prescriptions for controlled substances,'' and that ``[f]ailure by
the practitioner to secure the . . . knowledge factor, or biometric
information may provide a basis for revocation or suspension of
registration.'' Id. The practitioner has the ultimate responsibility
for ensuring that electronic prescriptions are accurate and issued in
the usual course of professional practice and for a legitimate medical
purpose. 21 CFR 1311.102(k); RFAAX 1, at 2.
B. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Registrant is deemed to have admitted and the Agency finds
that from at least April 2, 2020 through at least June 11, 2023,
Registrant issued numerous controlled substance prescriptions outside
the usual course of professional practice and for other than a
legitimate medical purpose. RFAAX 1, at 3.
Unlawful Prescriptions for T.C.
Registrant admits that from April 2, 2020, through May 13, 2023,
Registrant unlawfully provided his secure log-in credentials to T.C. so
that T.C. could self-issue controlled substance prescriptions. Id.
Registrant admits that T.C. self-issued prescriptions for lorazepam (a
schedule IV controlled substance), diazepam (a schedule IV controlled
substance), and dextroamphetamine-amphetamine (a schedule II controlled
substance) using Registrant's credentials.\6\ Id. Registrant admits
that these prescriptions were not issued for a legitimate medical
purpose by a practitioner acting in the usual course of professional
practice. Id. at 3-4.
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\6\ The OSC/ISO notes that between April 2, 2020 through October
31, 2021, Registrant requested that T.C. provide him with portions
of T.C.'s self-issued controlled substance prescriptions for
Registrant's personal use in violation of 21 CFR 1306.04(a) and New
York Administrative Code sections 80.65, 80.71. RFAAX 1, at 4. The
correlation between this allegation and the OSC's cited legal
authorities is unclear and, therefore, the Agency will not make
findings on it.
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Accordingly, the Agency finds substantial record evidence that
Registrant unlawfully provided his secure log-in credentials to T.C.
and that the controlled substance prescriptions that T.C. self-issued
were not issued for a legitimate medical purpose by a practitioner
acting in the usual course of professional practice.
Unlawful Prescriptions in C.G.'s Name
Registrant admits that on May 5, 2022, he fraudulently issued a
prescription for oxycodone 30 mg (a schedule II controlled substance)
in the name of individual C.G. RFAAX 1, at 4. Registrant gave this
prescription to an individual other than C.G. to settle a personal
debt. Id. Registrant issued four additional prescriptions for oxycodone
30 mg in C.G.'s name after C.G. died.\7\ Id. Registrant admits that the
five prescriptions that he issued to C.G. were not issued for a
legitimate medical
[[Page 16007]]
purpose by a practitioner acting in the usual course of professional
practice. Id.
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\7\ Individual C.G. died on December 6, 2022. RFAAX 1, at 4.
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Accordingly, the Agency finds substantial record evidence that the
five controlled substance prescriptions that Registrant issued to C.G.
were not issued for a legitimate medical purpose by a practitioner
acting in the usual course of professional practice.
Unlawful Prescriptions for C.R.
Registrant admits that on May 5, 2022, he issued a prescription for
oxycodone 30 mg in the name of individual C.R. Id. Registrant gave this
prescription to an individual other than C.R. in settlement of a
personal debt. Id. Registrant admits that this prescription was not
issued for a legitimate medical purpose by a practitioner acting in the
usual course of professional practice. Id.
Accordingly, the Agency finds substantial record evidence that the
oxycodone prescription that Registrant issued to C.R. was not issued
for a legitimate medical purpose by a practitioner acting in the usual
course of professional practice.
C. Discussion
i. The Five Public Interest Factors
Under Section 304 of 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).\8\ The five factors are considered in the disjunctive.
Gonzales v. Oregon, 546 U.S. at 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 n.2; David H. Gillis, M.D., 58 FR
37507, 37508 (1993).
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\8\ 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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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 case is confined to Factors B and D. See
RFAAX 1, at 4. Moreover, the Government has the burden of proof in this
proceeding.\9\ 21 CFR 1301.44.
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\9\ The Agency need not adjudicate the criminal violations
alleged in the instant OSC. Ruan v. United States, 597 U.S. 450
(2022) (decided in the context of criminal proceedings).
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Here, the Agency finds that the Government's evidence satisfies its
prima facie burden of showing that Registrant's registration would be
``inconsistent with the public interest.'' 21 U.S.C. 823(g)(1).
ii. Allegation That Registrant's Registration Is Inconsistent With the
Public Interest
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 Registrant unlawfully
provided his secure log-in credentials to individual T.C. and allowed
T.C. to self-issue controlled substance prescriptions utilizing his
credentials. Accordingly, the Agency finds substantial record evidence
that Registrant violated 21 CFR 1311.102(a), 1311.135(a), and
1306.04(a). See also Neeraj B. Shah, M.D., 89 FR 84195, 84196-97 & n.11
(2024); Allan Alexander Rashford, M.D., 87 FR 77637, 77637-38 (2022);
RFAAX 1, at 3.
Additionally, as found above, Registrant is deemed to have admitted
and the Agency finds that Registrant issued numerous prescriptions to
T.C., C.R., and C.G. that lacked a legitimate medical purpose and were
issued outside the usual course of professional practice. Accordingly,
the Agency finds substantial record evidence that Registrant violated
21 CFR 1306.04(a) and N.Y. Comp. Codes R. & Regs. tit. 10 sections
80.65, 80.71(a).
The Agency further finds that Factors B and D weigh in favor of
revocation of Registrant's registration and that Registrant's
registration would be inconsistent with the public interest in
balancing the factors of 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
Where, as here, the Government has met its prima facie burden of
showing that Registrant's registration is inconsistent with the public
interest due to its numerous violations pertaining to controlled
substances, the burden shifts to Registrant to show why he can be
entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total
Health Care Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882 (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 it will not
engage in future misconduct. Jones Total Health Care Pharmacy, 881 F.3d
at 833. A registrant's acceptance of responsibility must be
unequivocal. Id. 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, DEA Administrators have found that the egregiousness and
extent of the misconduct are significant factors in determining the
appropriate sanction. Id. at 834 and n.4. DEA Administrators have also
considered the need to deter similar acts by the specific registrant
and by the community of registrants. Jeffrey Stein, M.D., 84 FR 46972-
73.
Here, Registrant did not timely or properly request a hearing and
was deemed to be in default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA,
at 1-9. To date, Registrant has not filed a motion with the Office of
the Administrator to excuse the default. 21 CFR 1301.43(c)(1).
Registrant has thus failed to answer the allegations contained in the
OSC and has not otherwise availed himself of the
[[Page 16008]]
opportunity to refute the Government's case. As such, Registrant has
made no representations as to its future compliance with the CSA nor
made any demonstration that it can be entrusted with registration.
Moreover, the evidence presented by the Government shows that
Registrant violated the CSA, further indicating that Registrant cannot
be entrusted.
Accordingly, the Agency will order the revocation of Registrant's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BI8368828 issued to David Israel, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of David Israel, M.D., to renew or
modify this registration, as well as any other pending application of
David Israel, M.D., for additional registration in New York. 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. 2025-06424 Filed 4-15-25; 8:45 am]
BILLING CODE 4410-09-P
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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.