[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15630-15633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07454]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-46]


Witold Marek Zajewski, M.D.; Decision and Order

    On July 27, 2017, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Witold Marek Zajewski, M.D. (Respondent), of 
Mount Prospect, Illinois. The Show Cause Order proposed the revocation 
of Respondent's DEA Certificate of Registration No. BZ5641419 on the 
ground that he has ``no state authority to handle controlled 
substances.'' Order to Show Cause, at 1 (citing 21 U.S.C. 824(a)(3)). 
For the same reason, the Order also proposed the denial of any of 
Respondent's ``applications for renewal or modification of such 
registration and any applications for any other DEA registrations. Id.
    With respect to the Agency's jurisdiction, the Show Cause Order

[[Page 15631]]

alleged that Respondent is the holder of Certificate of Registration 
No. BZ5641419, pursuant to which he is authorized to dispense 
controlled substances as a practitioner in schedules II through V, at 
the registered address of 609 N. Main Street, Suite 102, Mount 
Prospect, Illinois. Id. The Order also alleged that this registration 
does not expire until May 31, 2018. Id.
    Regarding the substantive grounds for the proceeding, the Show 
Cause Order alleged that on June 29, 2017, the Illinois Department of 
Financial and Professional Regulation, Division of Professional 
Regulation (IDFPR), ``issued an Order suspending [his] Illinois 
Physician and Surgeon License No. 036.096849 and suspending [his] 
Illinois Controlled Substance License No. 336.063325,'' and he is 
therefore ``without authority to practice medicine or handle controlled 
substances in the State of Illinois, the [S]tate in which [he is] 
registered with the DEA.'' Id. at 1-2. Based on his ``lack of authority 
to [dispense] controlled substances in . . . Illinois,'' the Order 
asserted that ``DEA must revoke'' his registration. Id. at 2 (citing 21 
U.S.C. 824(a)(3)); 21 CFR 1301.37(b)).
    The Show Cause Order notified Respondent of (1) his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, (2) the procedure for electing either option, and 
(3) the consequence for failing to elect either option. Id. (citing 21 
CFR 1301.43). The Show Cause Order also notified Respondent of his 
right to submit a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 
824(c)(2)(C)).
    On August 21, 2017, Respondent, through counsel, filed a letter 
requesting a hearing on the allegations. Letter from Respondent's 
Counsel to Hearing Clerk (dated Aug. 18, 2017) (hereinafter, Hearing 
Request). In this letter, Respondent ``objects to the statement that 
his licenses have been suspended'' because the IDFPR ``entered only a 
temporary order of suspension of his license'' until ``an informal 
hearing'' scheduled in December 2017.'' Id. at 1. Respondent also 
requested to ``continue this matter to in or after January 2018.'' Id. 
at 1 (emphasis omitted).
    The matter was placed on the docket of the Office of Administrative 
Law Judges and assigned to Administrative Law Judge Mark M. Dowd 
(hereinafter, ALJ). On August 25, 2017, the ALJ ordered the Government 
to ``file evidence to support the allegation that the Respondent lacks 
state authority to handle controlled substances,'' ``respond to the 
Respondent's request for continuance,'' and file ``any motion for 
summary disposition'' no later than September 6, 2017. Order Directing 
the Filing of Government Evidence of Lack of State Authority and 
Briefing Schedule, at 1. The ALJ also directed Respondent to file his 
response to any summary disposition motion no later than September 15, 
2017. Id. at 2.
    On September 1, 2017, the Government filed its Motion for Summary 
Disposition. In its Request, the Government argued that it is 
undisputed that Respondent lacks authority to handle controlled 
substances in Illinois because the IDFPR suspended Respondent's medical 
license and his controlled substance license. Government's Motion for 
Summary Disposition (hereinafter Government's Motion or Govt. Mot.) at 
2. The Government also noted that, in his Hearing Request, Respondent 
did not dispute that the IDFPR had suspended these licenses. Id. at 3 
n.1. The Government further argued that, ``[a]bsent authority by the 
State of Illinois to dispense controlled substances, Respondent is not 
authorized to possess a DEA registration in that state.'' Id. at 3. 
Lastly, the Government argued that under Agency precedent, revocation 
is warranted even where a State has temporarily suspended a 
practitioner's state authority and has yet to provide the practitioner 
with a hearing where he may prevail. Govt. Mot., at 3-4 (citations 
omitted). As support for its summary disposition request, the 
Government attached, inter alia, a copy of the IDFPR's June 29, 2017 
Order directing that (1) Respondent's medical and controlled substance 
licenses ``be SUSPENDED, pending proceedings before an Administrative 
Law Judge at'' IDFPR and (2) Respondent to ``immediately surrender all 
indicia of licensure(s) to'' IDFPR. Government Exhibit (GX) 2 to Govt. 
Mot., at 1.
    In his responsive pleading, Respondent did not dispute that the 
IDFPR ``temporarily suspended'' his medical and controlled substance 
licenses. Respondent's Sept. 15, 2017 Motion for Extension of Time to 
Respond to Government's Motion for Summary Disposition (hereinafter, 
Resp. Reply), at 1. Instead, he argued that the suspensions were 
``pending proceedings'' before a state administrative law judge and 
that he ``believe[s] this matter may be resolved'' at an ``informal 
hearing'' in December 2017. Id. Respondent also argued that the ALJ 
should grant him an extension of time to respond to the Government's 
Motion in ``the interest of administrative/judicial economy'' until 
then. Id. at 1-2 (quoting Robert Clark Maiocco, M.D., 82 FR 19383, 
19384 (2017)).
    The ALJ denied ``Respondent's request for an extension of time--in 
essence to stay these proceedings,'' noting that ``revocation of a 
practitioner's registration is warranted whenever his (or its) state 
authority to dispense controlled substances has been suspended or 
revoked.'' Order Denying the Respondent's Request for an Extension of 
Time, Granting the Government's Motion for Summary Disposition, and 
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge (R.D.), at 2 (internal quotations and 
citations omitted), 3. While he was ``not unmindful of the Respondent's 
argument that granting an extension of time has been used in the past'' 
in Maiocco, the ALJ nevertheless ``disagree[d]'' that the same 
``interest of administrative/judicial economy'' that was present in 
Maiocco was present in this case. Id. at 2-3, 3 n.3. Specifically, the 
ALJ in Maiocco granted that respondent's three-week extension of time 
request because the Colorado Board of Medicine was scheduled to 
consider Respondent's proposed ``Stipulation and Final Agency Order'' 
``two weeks after the Respondent submitted his Motion for Extension of 
Time to the ALJ.'' Id. at 3 n.3 (citing Maiocco, 82 FR at 19384). Here, 
the ALJ reasoned, Respondent lacked the same ``interest of 
administrative/judicial economy'' because ``Respondent has submitted 
no[ ] proposed stipulation, Respondent only `anticipates' an informal 
hearing to take place.'' Id. (citing Resp. Reply at 1). Finally, the 
ALJ concluded that the DEA has previously held ``that a stay in 
administrative enforcement proceedings is `unlikely to ever be 
justified' due to ancillary proceedings involving the Respondent.'' Id. 
at 3 (quoting Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44104 n.97 
(2012)).\1\
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    \1\ I agree with this statement of the Agency's precedents. 
However, the ALJ also cited Odette L. Campbell, 80 FR 41062 (2015), 
as contrary authority. See id. The ALJ characterized Campbell as 
``holding revocation proceedings in abeyance at the post-hearing 
adjudication level for a lengthy period pending the resolution of 
both criminal fraud charges and concurrent state administrative 
proceedings against the respondent,'' id. Notably, Campbell involved 
an application for registration, not a revocation of an existing 
registration, at the time the proceeding was held in abeyance. This 
is significant, as an applicant, like Campbell, does not have the 
current authority to handle controlled substances during any stay of 
the proceedings, while a registrant does.
    Moreover, one week before the evidentiary hearing, the 
respondent was indicted on 30 counts of Health Care Fraud, as well 
as five counts of altering records during a federal investigation. 
80 FR at 41063. Had the respondent been convicted of Health Care 
Fraud, she would have been subject to mandatory exclusion from 
federal healthcare programs under 42 U.S.C. 1320a-7(a) and her 
application would have been subject to denial on that basis as well. 
Id. at 41064 (citing 21 U.S.C. 824(a)(5)). Furthermore, even after 
the respondent successfully completed pre-trial diversion and the 
charges were dismissed, the state medical board brought a proceeding 
against her license, and had the board suspended or revoked her 
medical license, denial of her application would have been required 
under the CSA. Id. (citing 21 U.S.C. 802(21) & 823(f)). Given the 
pending proceedings, Campbell was the rare case where withholding 
the issuance of a final decision was warranted. For these reasons, 
and those set forth in other final orders, I hold that Campbell does 
not support the issuance of stay of proceedings involving the 
suspension or revocation of DEA registrations. See, e.g., Judson H. 
Somerville, 82 FR 21408, 21409 n.3 (2017).

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[[Page 15632]]

    The ALJ then found that there was no dispute over the fact that 
``Respondent currently lacks state authority to handle controlled 
substances in Illinois due to [the IDFPR's] Order dated July 29, 2017, 
which suspended his state licenses to practice medicine and distribute 
controlled substances.'' Id. at 5. Reasoning that ``[b]ecause the 
Respondent lacks state authority at the present time . . . he is not 
entitled to maintain his DEA registration,'' the ALJ granted the 
Government's motion and recommended that his registration be revoked 
and that any pending renewal applications be denied. Id. at 5-6.
    Neither party filed exceptions to the ALJ's Recommended Decision. 
Thereafter, the record was forwarded to my Office for Final Agency 
Action. Having reviewed the record, I adopt the ALJ's finding that by 
virtue of the IDFPR's Order, Respondent is currently without authority 
to handle controlled substances in Illinois, the State in which he 
holds his registration with the Agency, and is thus not entitled to 
maintain his registration. I further adopt the ALJ's recommendation 
that I revoke his registration and deny any pending renewal 
application. I make the following factual findings.

Findings of Fact

    Respondent is the holder of DEA Certificate of Registration No. 
BZ5641419, pursuant to which he is authorized to dispense controlled 
substances in schedules II through V as a practitioner. GX 1. Although 
not alleged in the Show Cause Order, I also find that Respondent is the 
holder of DATA-Waiver Identification Number XZ5641419, see id., which 
authorizes Respondent to dispense or prescribe schedule III-V narcotic 
controlled substances which ``have been approved by the Food and Drug 
Administration . . . specifically for use in maintenance or 
detoxification treatment'' for up to 100 patients. 21 CFR 1301.28(a) & 
(b)(1)(iii). Respondent's registered address is 609 N. Main Street, 
Suite 102, Mount Prospect, Illinois. GX 1. Respondent's registration 
and DATA-Waiver authority do not expire until May 31, 2018. Id.
    On June 29, 2017, the IDFPR issued an Order suspending Respondent's 
Illinois Physician and Surgeon License No. 036.096849 and his Illinois 
Controlled Substance License No. 336.063325 ``pending proceedings 
before an Administrative Law Judge at the'' IDFPR. GX 2, at 2. The 
Order also directed Respondent to ``immediately surrender all indicia 
of licensure(s) to the'' IDFPR. Id.
    In January 2018, the IDFPR announced another enforcement action 
regarding Respondent's state licenses, stating that his ``physician and 
surgeon license [is] restored to indefinite probation for a minimum of 
three years and [his] controlled substance license, 336063325, [is] 
indefinitely suspended, 12 months minimum, effective retroactive to 
June 29, 2017 for inappropriately prescribing controlled substances to 
patients of his practice.'' \2\ I take official notice of the IDFPR's 
January 2018 enforcement action \3\ and find that Respondent currently 
does not possess a controlled substance license in the State of 
Illinois, and thus does not possess authority to dispense controlled 
substances in the State in which he is registered with the DEA. See 77 
Ill. Adm. Code Sec.  3100.370(a) (``A prescription for a controlled 
substance may be issued only by an individual practitioner who: (1) 
Holds an active professional license in Illinois as an individual 
practitioner; and (2) Holds an active controlled substances license 
under the Act or is exempted from licensure pursuant to Section 
3100.80'').
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    \2\ See www.idfpr.com/Forms/DISCPLN/2018_01enf.pdf.
    \3\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA's regulations, Respondent is ``entitled on timely request to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). To allow Respondent the opportunity to refute the 
facts of which I take official notice, Respondent may file a motion 
for reconsideration within 15 calendar days of service of this order 
which shall commence on the date this order is mailed.
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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 
CSA, ``upon a finding that the registrant . . . has had his State 
license . . . suspended [or] revoked . . . by competent State authority 
and is no longer authorized by State law to engage in the . . . 
dispensing of controlled substances.'' Also, DEA has 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, 76 FR 71371 
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see 
also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization 
to dispense or otherwise handle controlled substances is a prerequisite 
to the issuance and maintenance of a Federal controlled substances 
registration.'').
    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).
    Thus, ``the controlling question'' in a proceeding brought under 21 
U.S.C. 824(a)(3) is whether the holder of a DEA registration ``is 
currently authorized to handle controlled substances in the [S]tate'' 
in which the practitioner is registered. Hooper, 76 FR at 71371 
(quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)). Here, there is 
no dispute over the material fact that Respondent is no longer 
currently authorized to dispense controlled substances in Illinois, the 
State in which he is registered. See 77 Ill. Adm. Code Sec.  
3100.370(a). Accordingly, he is not entitled to maintain his 
registration.
    I will therefore adopt the ALJ's recommendation that I revoke 
Respondent's registration and deny any pending applications to renew 
his registration. R.D. at 6. I will also deny any pending application 
to modify his registration, or any pending application for any other 
registration in Illinois, as requested in the Show Cause Order. Order 
to Show Cause, at 1. Finally, because Respondent's DATA-Waiver

[[Page 15633]]

authority is contingent on Respondent being a practitioner with a valid 
DEA registration, see 21 U.S.C. 823(g)(2)(A); 21 CFR 1301.28(a), I will 
revoke his DATA-Waiver authority as well.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration No. BZ5641419 and DATA-Waiver Identification Number 
XZ5641419, issued to Witold Marek Zajewski, M.D., be, and they hereby 
are, revoked. I further order that any pending application of Witold 
Marek Zajewski to renew or modify the above registration, or any 
pending application of Witold Marek Zajewski for any other registration 
in the State of Illinois, be, and it hereby is, denied. This Order is 
effective immediately.\4\
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    \4\ For the same reasons which led the IDFPR to revoke 
Respondent's controlled substance license, I conclude that the 
public interest necessitates that this Order be effective 
immediately. 21 CFR 1316.67.

    Dated: April 4, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-07454 Filed 4-10-18; 8:45 am]
 BILLING CODE 4410-09-P