Harvey Leslie, M.D.; Decision and Order, 13885-13886 [2025-05165]

Download as PDF 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 VerDate Sep<11>2014 17:43 Mar 26, 2025 Jkt 265001 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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. E:\FR\FM\27MRN1.SGM 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 VerDate Sep<11>2014 17:43 Mar 26, 2025 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 27MRN1

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]


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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


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