Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 84623 

1According to Agency records, Registrant’s 

registration expired on September 30, 2024. 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 (CSA) to adjudicate the 

OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 

68,474, 68,476–79 (2019). 

2Based on the Government’s submissions in its 

RFAA dated April 18, 2024, the Agency finds that 

service of the OSC on Registrant was adequate. The 

included declaration from a DEA Diversion 

Investigator (DI) indicates that on August 10, 2023, 

the OSC was successfully delivered to Registrant’s 

registered address, though an individual who was 

not the Registrant signed to confirm the receipt of 

the OSC. RFAAX 3, at 2, Attachment A. Further, the 

DI’s Declaration indicates that on August 29, 2023, 

the OSC was successfully delivered to Registrant’s 

home address, however, it was never signed for. Id. 

at 2, Attachment B. Finally, the DI’s Declaration 

indicates that on December 8, 2023, the OSC was 

emailed to Registrant’s registered email address. Id. 

at 2, Attachment C. 

3Under 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). 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.’’ 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 Office of the 

Administrator, Drug Enforcement Administration at 

dea.addo.attorneys@dea.gov. 

4This 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, 76 FR at 71,371–72; Sheran Arden 

Yeates, D.O., 71 FR 39,130, 39,131 (2006); Dominick 

A. Ricci, D.O., 58 FR 51,104, 51,105 (1993); Bobby 

Watts, D.O., 53 FR 11,919, 11,920 (1988); Frederick 

Marsh Blanton, 43 FR at 27,617. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Dale Fitzpatrick, M.D.; Decision and 

Order 

On July 19, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Dale Fitzpatrick, M.D., 

of Modesto, CA (Registrant). Request for 

Final Agency Action (RFAA), Exhibit 

(RFAAX) 2, at 1, 3. The OSC proposed 

the revocation of Registrant’s Certificate 

of Registration No. BF0553455, alleging 

that Registrant’s registration should be 

revoked because Registrant is ‘‘currently 

without authority to prescribe, 

administer, dispense, or otherwise 

handle controlled substances in the 

State of California, the state in which 

[he is] registered with DEA.’’ Id. at 2 

(citing 21 U.S.C. 824(a)(3)).1

The OSC notified Registrant of his 

right to file with DEA 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 2.2 ‘‘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].’’ 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 3; 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, effective January 

6, 2023, Registrant surrendered his 

California physician and surgeon 

license. RFAAX 2, at 1. According to 

California online records, of which the 

Agency takes official notice, Registrant’s 

California physician and surgeon 

license remains surrendered.3 California 

DCA License Search, https://

search.dca.ca.gov (last visited date of 

signature of this Order). Accordingly, 

the Agency finds that Registrant is not 

licensed to practice as a physician in 

California, the state in which he is 

registered with DEA. 

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. See, e.g., 

James L. Hooper, M.D., 76 FR 71,371, 

71,372 (2011), pet. for rev. denied, 481 

F. App’x 826 (4th Cir. 2012); Frederick 

Marsh Blanton, M.D., 43 FR 27,616, 

27,617 (1978).4

According to California 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, furnishing, packaging, 

labeling, or compounding necessary to 

prepare the substance for that delivery.’’ 

Cal. Health & Safety Code § 11010 (West 

2024). Further, a ‘‘practitioner’’ means a 

person ‘‘licensed, registered, or 

otherwise permitted, to distribute, 

dispense, conduct research with respect 

to, or administer, a controlled substance 

in the course of professional practice or 

research in [the] state.’’ Id. § 11026(c). 

Here, the undisputed evidence in the 

record is that Registrant currently lacks 

authority to practice as a physician in 

California. As discussed above, an 

individual must be a licensed 

practitioner to dispense a controlled 

substance in California. Thus, because 

Registrant currently lacks authority to 

practice as a physician in California 

and, therefore, is not currently 

authorized to handle controlled 

substances in California, 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. BF0553455 issued to 

Dale Fitzpatrick, 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 Dale Fitzpatrick, M.D., to renew or 

modify this registration, as well as any 

other pending application of Dale 

Fitzpatrick, M.D., for additional 

registration in California. This Order is 

effective November 22, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 15, 2024, by Administrator 


khammond on DSKJM1Z7X2PROD with NOTICES
84624 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

Anne Milgram. 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. 2024–24570 Filed 10–22–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1441] 

Importer of Controlled Substances 

Application: Mylan Technologies Inc 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Mylan Technologies Inc 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 November 22, 2024. Such 

persons may also file a written request 

for a hearing on the application on or 

before November 22, 2024. 

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 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on October 8, 2024, Mylan 

Technologies Inc., 110 Lake Street, Saint 

Albans, Vermont 05478–2266, applied 

to be registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Methylphenidate ............. 1724 II 

Fentanyl .......................... 9801 II 

The company plans to import the 

listed controlled substances in finished 

dosage form (FDF) from foreign sources 

for analytical testing and clinical trials 

in which the foreign FDF will be 

compared to the company’s own 

domestically manufactured FDF to 

foreign markets. 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. 2024–24557 Filed 10–22–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1440] 

Importer of Controlled Substances 

Application: Halo Pharmaceutical Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Halo Pharmaceutical Inc. 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 November 22, 2024. Such 

persons may also file a written request 

for a hearing on the application on or 

before November 22, 2024. 

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 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on September 11, 2024, 

Halo Pharmaceutical Inc., 30 North 

Jefferson Road, Whippany, New Jersey 

07981–1030, applied to be registered as 

an importer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Psilocybin ....................... 7437 I 

The company plans to import the 

listed controlled substance to support 

formulation development and use in 

clinical trials. No other activity for this 

drug code is 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). 


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I I