Importer of Controlled Substances Application: Patheon API Services, Inc., 13884-13885 [2025-05280]

Download as PDF 13884 Federal Register / Vol. 90, No. 58 / Thursday, March 27, 2025 / Notices Signing Authority This document of the Drug Enforcement Administration was signed on March 18, 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. 2025–05164 Filed 3–26–25; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No.1519] Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Baxter Research Lab 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 instruction at that site for lotter on DSK11XQN23PROD with NOTICES1 DATES: VerDate Sep<11>2014 17:43 Mar 26, 2025 Jkt 265001 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 therefore, may submit electronic comments on or objections of the requested registration, 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 regulation. 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 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 August 20, 2024, Baxter Research Lab, 5200 North Lake Road, Merced, California 95343–5001, applied to be registered as bulk manufacturer of the following basic class(es) of controlled substances: Controlled substance Marihuana ........................ PO 00000 Frm 00033 Fmt 4703 Drug code Schedule 7360 I Sfmt 4703 Controlled substance Tetrahydrocannabinols .... Drug code Schedule I 7370 II Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2025–05276 Filed 3–26–25; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1522] Importer of Controlled Substances Application: Patheon API Services, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Patheon API Services, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. DATES: 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 April 28, 2025. Such persons may also file a written request for a hearing on the application on or before April 28, 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. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement SUMMARY: E:\FR\FM\27MRN1.SGM 27MRN1 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

Agencies

[Federal Register Volume 90, Number 58 (Thursday, March 27, 2025)]
[Notices]
[Pages 13884-13885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-05280]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1522]


Importer of Controlled Substances Application: Patheon API 
Services, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Patheon API Services, Inc. has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplementary Information listed below for further drug information.

DATES: 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 
April 28, 2025. Such persons may also file a written request for a 
hearing on the application on or before April 28, 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. All 
requests for a hearing must be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. All requests for a hearing should also be 
sent to: Drug Enforcement

[[Page 13885]]

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):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Dimethyltryptamine......................    7435  I
Psilocybin..............................    7437  I
Psilocyn................................    7438  I
Amphetamine.............................    1100  II
Methadone...............................    9250  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 non-approved 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
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