[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10335-10337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03358]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Milad I. Shaker, M.D.; Decision and Order

    On October 5, 2020, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, Government), 
signed an Order to Show Cause (hereinafter, OSC) addressed to Milad I. 
Shaker, M.D. (hereinafter, Registrant). OSC, at 1. The OSC proposed the 
revocation of Registrant's Certificate of Registration No. FS1471818. 
Id. It alleged that Registrant is without ``authority to handle 
controlled substances in the State of Pennsylvania, the state in which 
[Registrant is] registered with DEA.'' OSC, at 2 (citing 21 U.S.C. 
824(a)(3)).

[[Page 10336]]

I. Background

    The OSC alleged that the Pennsylvania State Board of Medicine 
(hereinafter, Board) issued a Preliminary Order October 29, 2019. Id. 
This Preliminary Order, according to the OSC, indefinitely suspended 
Registrant's Pennsylvania Medical Physician and Surgeon license 
following the Board's ``finding of [Registrant's] noncompliance with 
conditions of probation approved by the Board on December 18, 2018.'' 
Id.
    The OSC notified Registrant of the right to request a hearing on 
the allegations or to submit a written statement, while waiving the 
right to a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 2 (citing 21 
CFR 1301.43). The OSC also notified Registrant of the opportunity to 
submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 
824(c)(2)(C)).

a. Adequacy of Service

    According to the declaration of a DEA Diversion Investigator 
(hereinafter, DI), DEA made arrangements for service of the OSC on 
Registrant, while he was incarcerated at the United States Penitentiary 
(USP)--Hazelton correctional facility in Bruceton, West Virginia. 
Request for Final Agency Action (hereinafter, RFAA) Exhibit 
(hereinafter, RFAAX) 10 (Declaration of DI), at 1-3. To accomplish 
service, DEA established a point of contact with Special Investigative 
Services at USP--Hazelton, and made arrangements to serve the OSC on 
Registrant by hand delivery. Id. at 3; RFAAX 5 (emails to and from 
Special Investigative Services, dated October 20-21, 2020). According 
to the emails, the OSC was served on Registrant on October 21, 2020. 
RFAAX 5, at 1; RFAAX 10, at 3.
    In its RFAA, the Government represents that ``more than 30-days 
have passed since Registrant received the [OSC]'' and that ``Registrant 
has not submitted to DEA a request for hearing.'' RFAA, at 2; see also 
RFAAX 6 (email, dated December 17, 2020, confirming no correspondence 
from Registrant). The Government also represents that DEA has not 
received ``any other written correspondence, telephonic communication, 
or any other communication from Registrant, or any representative on 
his behalf in response to the [OSC].'' RFAA, at 4. I find that more 
than thirty days have now passed since the Government accomplished 
service of the OSC. Accordingly, I find that Registrant has waived the 
right to a hearing and the right to submit a written statement and 
corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). 
I, therefore, issue this Decision and Order based on the record 
submitted by the Government, which constitutes the entire record before 
me. 21 CFR 1301.46.

II. Findings of Fact

a. Registrant's DEA Registration

    Registrant is the holder of DEA Certificate of Registration No. 
FS1471818 at the registered address of 308 Bessemer Road, Suite 100, 
Mount Pleasant, Pennsylvania 15666. RFAA, at 2; RFAAX 1 (Controlled 
Substance Registration Certificate); RFAAX 2 (Certification of 
Registration History). Pursuant to this registration, Registrant is 
authorized to dispense controlled substances in schedules II through V 
as a practitioner. Id. Registrant's registration expires on February 
28, 2021, and is ``in an active pending status.'' RFAAX 2, at 1.

b. The Status of Registrant's State License

    On October 2, 2018, Registrant was indicted by a grand jury for 
fifty-four felony charges, which appear to be related to Registrant's 
practice of medicine (hereinafter, Indictment).\1\ RFAAX 3 (Board's 
Preliminary Order with Exhibits), at 37-47. As a result of the 
Indictment, the Board petitioned for immediate temporary suspension of 
Registrant's license, alleging that Registrant was ``guilty of 
unprofessional conduct by failing to conform to the quality standard of 
the profession,'' and an Order of Temporary Suspension was issued on 
October 9, 2018. Id. at 15; see also RFAAX 3, at 12. On December 13, 
2018, Registrant and the Board entered into a Consent Agreement and 
Order (hereinafter, Consent Agreement). Id. at 11-36.
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    \1\ The felony charges included allegations that Registrant 
``issued prescriptions for controlled substances to [two patients] 
in return for sexual favors;'' issued thirty-six Schedule II 
controlled substance prescriptions ``outside of the usual course of 
professional practice and not for a legitimate medical purpose;'' 
issued 16 Schedule IV controlled substances ``outside of the usual 
course of professional practice and not for a legitimate medical 
purpose;'' and engaged in two ``[f]elony counts of Health Care 
Fraud.'' RFAAX 3, at 13-14.
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    Pursuant to the Consent Agreement, the Board indefinitely suspended 
Registrant's state license, but immediately stayed the suspension ``in 
favor of a period of indefinite probation.'' Id. at 16-17 (emphasis 
omitted). The Board required that Registrant satisfy a number of 
conditions during his indefinite probation.\2\ Id. at 17-26. On October 
29, 2019, the Board made a probable cause determination that Registrant 
violated the terms of the Consent Agreement and issued a Preliminary 
Order. Id. at 2. The Preliminary Order stated ``the stay of the 
suspension of [Registrant's] license is now VACATED, the period of 
probation is now TERMINATED, and [Registrant's] license to practice as 
a physician and surgeon, license number MD437512, along with any other 
licenses . . . are now actively indefinitely SUSPENDED.'' Id. (emphasis 
in original). Registrant was ordered to ``immediately cease practicing 
the profession.'' Id. The Preliminary Order's indefinite suspension of 
Registrant's state medical license served as the basis for the OSC's 
allegation that Registrant lacked state authority to handle controlled 
substances. RFAAX 10, at 2; OSC, at 1.
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    \2\ One of the conditions required that Registrant ``contract 
for the services of a Board Approved Practice Monitor,'' ``allow the 
Practice Monitor access to all aspects of his practice,'' and allow 
the Practice Monitor a minimum of ``[m]onthly in-person overview[s] 
. . . to determine that the monitor's directions are being 
implemented.'' RFAAX 3 22-23. On September 3, 2019, Registrant's 
practice monitor notified Registrant and the Board that they were 
``ceasing all services . . . effective immediately'' based on 
Registrant's failure to allow two of the required monthly visits and 
his failure to respond to communications. Id. at 50-51. On October 
29, 2019, a Petition for Appropriate Relief was filed with the Board 
seeking suspension of Registrant's license because ``[Registrant's] 
failure to fully cooperate and successfully comply with the 
monitoring terms and conditions of the probation [was] a violation 
of [the Consent Agreement].'' Id. at 9.
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    On April 30, 2020, the Board issued a Notice and Order of Automatic 
Suspension, which automatically suspended Registrant's license to 
practice medicine and surgery based on Registrant's ``conviction in 
Federal court for unlawful distribution of a Schedule II controlled 
substance'' (hereinafter, second suspension). RFAAX 8 (Final Order 
dated December 1, 2020 \3\), at 5. The second suspension was affirmed 
by the Board in a Final Order dated December 1, 2020. The Final Order 
was retroactive to July 28, 2020, and suspended Registrant's license to 
practice medicine and surgery for at least 10 years.\4\ Id. at 1, 18. 
Similar to the Preliminary Order, the Final Order provided that 
Registrant ``shall immediately CEASE the practice of

[[Page 10337]]

medicine and surgery.'' Id. at 18 (emphasis in original).
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    \3\ DEA obtained a copy of the Board's Final Order after the OSC 
was issued to Registrant. RFAAX 10, at 3. The Final Order is not 
material as the record is clear that Registrant's license had been 
suspended since the Preliminary Order issued on October 29, 2019.
    \4\ The suspension of the license was retroactive to May 20, 
2020. It appears that as of May 20, 2020, there were two concurrent 
suspension applied to Registrant's license. The number of 
suspensions is not material as the record is clear that Registrant's 
license had been suspended since October 29, 2019.
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    According to DI, on December 17, 2019, DI queried the Pennsylvania 
Department of State licensing verification website at https://www.pals.pa.gov/#/page/searchresult and determined that Registrant's 
medical physician license was still suspended at that time and that 
Registrant was without authorization to handle controlled substances or 
practice medicine in Pennsylvania. RFAAX 10, at 3. According to 
Pennsylvania's online records, of which I take official notice, 
Registrant's license is still revoked.\5\ Pennsylvania Licensing System 
Verification, https://www.pals.pa.gov/#/page/search (last visited date 
of signature of this Order).
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    \5\ 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). 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 my finding by filing 
a properly supported motion for reconsideration of finding of fact 
within fifteen calendar days of the date of this Order. Any such 
motion shall be filed with the Office of the Administrator and a 
copy shall be served on the Government. In the event Registrant 
files a motion, the Government shall have fifteen calendar days to 
file a response. 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 
[email protected].
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    Accordingly, I find that Registrant currently is neither licensed 
to engage in the practice of medicine nor registered to dispense 
controlled substances in Pennsylvania, the state in which Registrant is 
registered with the DEA.

III. Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (hereinafter, CSA) ``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, the 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 (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).
    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(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the CSA, the 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, M.D., 71 FR 39,130, 39,131 
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby 
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43 
FR at 27,617.
    Under the Pennsylvania Controlled Substance, Drug, Device and 
Cosmetic Act, ``no controlled substance in Schedule II shall be 
dispensed without an electronic prescription of a practitioner.'' 35 
PA. Stat. and Const. Stat. Ann. Sec.  780-111(a) (West October 24, 
2019). Further, ``no controlled substance in Schedule III, IV or V 
shall be dispensed without an electronic prescription of a 
practitioner.'' Id. at Sec.  780-111(b). The definition of 
``practitioner,'' as used in the state Act, includes a ``physician . . 
. or other person licensed, registered or otherwise permitted to 
distribute, dispense, conduct research with respect to or to administer 
a controlled substance . . . in the course of professional practice . . 
. in the Commonwealth of Pennsylvania.'' Id. at 780-102(b).
    Here, the undisputed evidence in the record is that Registrant 
currently lacks authority to practice medicine in Pennsylvania. As 
already discussed, a physician must be a licensed practitioner to 
dispense a controlled substance in Pennsylvania. Thus, because 
Registrant lacks a license to practice medicine in Pennsylvania and, 
therefore, is not authorized to handle controlled substances in 
Pennsylvania, Registrant is not eligible to maintain a DEA 
registration. Accordingly, I 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. 
FS1471818 issued to Milad I. Shaker, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of Milad I. Shaker, M.D. to renew or 
modify this registration or for any other registration in Pennsylvania. 
This Order is effective March 22, 2021.

D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-03358 Filed 2-18-21; 8:45 am]
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