Harvey Leslie, M.D.; Decision and Order, 13885-13886 [2025-05165]
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Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on February 4, 2025,
Patheon API Services, Inc., 101
Technology Place, Florence, South
Carolina 29501 applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
Controlled substance
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Amphetamine ..................
Methadone ......................
Drug
code
Schedule
7435
7437
7438
1100
9250
I
I
I
II
II
The company plans to import the
listed controlled substances as reference
standards for research and development
as part of API Manufacturing. No other
activities for these drug codes are
authorized for this registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05280 Filed 3–26–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
lotter on DSK11XQN23PROD with NOTICES1
Harvey Leslie, M.D.; Decision and
Order
On August 19, 2024, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Harvey Leslie, M.D., of
Decatur, Georgia (Registrant). Request
for Final Agency Action (RFAA),
Exhibit (RFAAX) 2, at 1, 3. The OSC
proposed the revocation of Registrant’s
Certification of Registration (COR) No.
FL2241305, alleging that Registration’s
registration should be revoked because
Registrant is ‘‘currently without
authority to prescribe, administer,
dispense, or otherwise handle
controlled substances in the State of
Georgia, the state in which [he is]
registered with DEA.’’ Id. at 2 (citing 21
U.S.C. 824(a)(3)).
The OSC notified Registrant of his
right to file a written request for hearing,
and that if he failed to file such a
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17:43 Mar 26, 2025
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request, he would be deemed to have
waived his right to a hearing and be in
default. Id. (citing 21 CFR 1301.43).
Here, Registrant did not request a
hearing. RFAA, at 3.1 ‘‘A default, unless
excused, shall be deemed to constitute
a waiver of the registrant’s/applicant’s
right to a hearing and an admission of
the factual allegations of the [OSC].’’ 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] § 1316.67.’’ Id. § 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 4; see also 21 CFR
1316.67.
Findings of Fact
The Agency finds that, in light of
Registrant’s default, the factual
allegations in the OSC are admitted.
According to the OSC, on February 9,
2024, Registrant’s Georgia medical
license was revoked. RFAAX 2, at 2.
According to Georgia online records, of
which Agency takes official notice,
Registrant’s Georgia medical license
remains revoked.2 Georgia Composite
Medical Board License Search, https://
gcmb.mylicense.com/verification (last
visited date of signature of this Order).
Accordingly, the Agency finds that
Registrant is not licensed to practice
medicine in Georgia, the state in which
he is registered with DEA.3
1 Based on the Government’s submissions in its
RFAA dated October 24, 2024, the Agency finds
that service of the OSC on Registrant was sufficient.
Specifically, the included Declaration from a DEA
Diversion Investigator indicates that on August 28,
2024, a copy of the OSC was personally served on
Registrant at his registered address. RFAAX 6, at 2;
see also RFAAX 4 (Report of Investigation
indicating issuance of OSC).
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979).
3 Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency
decision rests on official notice of a material fact
not appearing in the evidence in the record, a party
is entitled, on timely request, to an opportunity to
show the contrary.’’ The material fact here is that
Registrant, as of the date of this decision, is not
licensed to practice medicine in Georgia.
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 the DEA Office of
the Administrator, Drug Enforcement
Administration at dea.addo.attorneys@dea.gov.
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13885
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. § 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).4
According to Georgia statute,
‘‘dispense’’ means ‘‘to deliver a
controlled substance to an ultimate user
or research subject by or pursuant to the
lawful order of a practitioner, including
the prescribing, administering,
packaging, labeling, or compounding
4 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 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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27MRN1
13886
Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices
necessary to prepare the substance for
that delivery.’’ Ga. Code Ann.
section 16–13–21(9) (2024). Further, a
‘‘practitioner’’ means a ‘‘physician . . .
or other person licensed, registered, or
otherwise authorized under the laws of
[Georgia] to distribute, dispense,
conduct research with respect to, or
administer a controlled substance in the
course of professional practice or
research in [Georgia].’’ Id. at section 16–
13–21(23)(A).
Here, the undisputed evidence in the
record is that Registrant lacks authority
to practice medicine in Georgia. As
discussed above, a physician must be a
licensed practitioner to dispense a
controlled substance in Georgia. Thus,
because Registrant lacks authority to
practice medicine in Georgia and,
therefore, is not authorized to handle
controlled substances in Georgia,
Registrant is not eligible to maintain a
DEA registration. Accordingly, the
Agency will order that Registrant’s DEA
registration be revoked.
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. FL2241305, issued to
Harvey Leslie, 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 Harvey Leslie, M.D., to renew or
modify this registration, as well as any
other pending application of Harvey
Leslie, M.D., for additional registration
in Georgia. This Order is effective April
28, 2025.
lotter on DSK11XQN23PROD with NOTICES1
Signing Authority
This document of the Drug
Enforcement Administration was signed
on March 20, 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. 2025–05165 Filed 3–26–25; 8:45 am]
BILLING CODE 4410–09–P
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Jkt 265001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1523]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Ohana Bio
Pharma, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 27, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.’’
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
submit electronic comments on or
objections of the requested registration,
DATES:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
as provided in this notice. This notice
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on December 6, 2024, Ohana Bio
Pharma, LLC, 22 Frontage Road,
Westerly, Rhode Island 02891 applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substances:
Controlled substance
Drug
code
Schedule
Marihuana Extract .............
Marihuana .........................
Tetrahydrocannabinol .......
7350
7360
7370
I
I
I
I
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2025–05277 Filed 3–26–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1524]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Royal
Beverages, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
SUMMARY:
E:\FR\FM\27MRN1.SGM
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Agencies
[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Notices]
[Pages 13885-13886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05165]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Harvey Leslie, M.D.; Decision and Order
On August 19, 2024, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Harvey Leslie, M.D.,
of Decatur, Georgia (Registrant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 2, at 1, 3. The OSC proposed the revocation of
Registrant's Certification of Registration (COR) No. FL2241305,
alleging that Registration's registration should be revoked because
Registrant is ``currently without authority to prescribe, administer,
dispense, or otherwise handle controlled substances in the State of
Georgia, the state in which [he is] registered with DEA.'' Id. at 2
(citing 21 U.S.C. 824(a)(3)).
The OSC notified Registrant of his right to file a written request
for hearing, and that if he 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). Here, Registrant did not request a hearing.
RFAA, at 3.\1\ ``A default, unless excused, shall be deemed to
constitute a waiver of the registrant's/applicant's right to a hearing
and an admission of the factual allegations of the [OSC].'' 21 CFR
1301.43(e).
---------------------------------------------------------------------------
\1\ Based on the Government's submissions in its RFAA dated
October 24, 2024, the Agency finds that service of the OSC on
Registrant was sufficient. Specifically, the included Declaration
from a DEA Diversion Investigator indicates that on August 28, 2024,
a copy of the OSC was personally served on Registrant at his
registered address. RFAAX 6, at 2; see also RFAAX 4 (Report of
Investigation indicating issuance of OSC).
---------------------------------------------------------------------------
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), 1301.46. RFAA, at 4; see
also 21 CFR 1316.67.
Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are admitted. According to the OSC, on
February 9, 2024, Registrant's Georgia medical license was revoked.
RFAAX 2, at 2. According to Georgia online records, of which Agency
takes official notice, Registrant's Georgia medical license remains
revoked.\2\ Georgia Composite Medical Board License Search, https://gcmb.mylicense.com/verification (last visited date of signature of this
Order). Accordingly, the Agency finds that Registrant is not licensed
to practice medicine in Georgia, the state in which he is registered
with DEA.\3\
---------------------------------------------------------------------------
\2\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979).
\3\ Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision
rests on official notice of a material fact not appearing in the
evidence in the record, a party is entitled, on timely request, to
an opportunity to show the contrary.'' The material fact here is
that Registrant, as of the date of this decision, is not licensed to
practice medicine in Georgia. 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 the DEA Office of the
Administrator, Drug Enforcement Administration at
[email protected].
---------------------------------------------------------------------------
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).\4\
---------------------------------------------------------------------------
\4\ 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 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.
---------------------------------------------------------------------------
According to Georgia statute, ``dispense'' means ``to deliver a
controlled substance to an ultimate user or research subject by or
pursuant to the lawful order of a practitioner, including the
prescribing, administering, packaging, labeling, or compounding
[[Page 13886]]
necessary to prepare the substance for that delivery.'' Ga. Code Ann.
section 16-13-21(9) (2024). Further, a ``practitioner'' means a
``physician . . . or other person licensed, registered, or otherwise
authorized under the laws of [Georgia] to distribute, dispense, conduct
research with respect to, or administer a controlled substance in the
course of professional practice or research in [Georgia].'' Id. at
section 16-13-21(23)(A).
Here, the undisputed evidence in the record is that Registrant
lacks authority to practice medicine in Georgia. As discussed above, a
physician must be a licensed practitioner to dispense a controlled
substance in Georgia. Thus, because Registrant lacks authority to
practice medicine in Georgia and, therefore, is not authorized to
handle controlled substances in Georgia, Registrant is not eligible to
maintain a DEA registration. Accordingly, the Agency will order that
Registrant's DEA registration be revoked.
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.
FL2241305, issued to Harvey Leslie, 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 Harvey Leslie, M.D., to renew
or modify this registration, as well as any other pending application
of Harvey Leslie, M.D., for additional registration in Georgia. This
Order is effective April 28, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
March 20, 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. 2025-05165 Filed 3-26-25; 8:45 am]
BILLING CODE 4410-09-P