Witold Marek Zajewski, M.D.; Decision and Order, 15630-15633 [2018-07454]
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Controlled substance
Drug code
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Phenmetrazine ........................................................................................................................................................
Methylphenidate ......................................................................................................................................................
Amobarbital .............................................................................................................................................................
Pentobarbital ...........................................................................................................................................................
Secobarbital .............................................................................................................................................................
Glutethimide ............................................................................................................................................................
Nabilone ..................................................................................................................................................................
1-Phenylcyclohexylamine ........................................................................................................................................
Phencyclidine ..........................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .............................................................................................................
Phenylacetone .........................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ........................................................................................................................
Alphaprodine ...........................................................................................................................................................
Anileridine ................................................................................................................................................................
Cocaine ...................................................................................................................................................................
Codeine ...................................................................................................................................................................
Etorphine HCl ..........................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Oxycodone ..............................................................................................................................................................
Hydromorphone .......................................................................................................................................................
Diphenoxylate ..........................................................................................................................................................
Ecgonine ..................................................................................................................................................................
Ethylmorphine ..........................................................................................................................................................
Hydrocodone ...........................................................................................................................................................
Levomethorphan ......................................................................................................................................................
Levorphanol .............................................................................................................................................................
Isomethadone ..........................................................................................................................................................
Meperidine ...............................................................................................................................................................
Meperidine intermediate-B ......................................................................................................................................
Metazocine ..............................................................................................................................................................
Methadone ...............................................................................................................................................................
Methadone intermediate ..........................................................................................................................................
Metopon ...................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................
Morphine ..................................................................................................................................................................
Thebaine ..................................................................................................................................................................
Dihydroetorphine .....................................................................................................................................................
Levo-alphacetylmethadol .........................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Phenazocine ............................................................................................................................................................
Piminodine ...............................................................................................................................................................
Racemethorphan .....................................................................................................................................................
Racemorphan ..........................................................................................................................................................
Alfentanil ..................................................................................................................................................................
Remifentanil .............................................................................................................................................................
Sufentanil .................................................................................................................................................................
Carfentanil ...............................................................................................................................................................
Tapentadol ...............................................................................................................................................................
Bezitramide ..............................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. 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 FDA
approved or non-approved finished
dosage forms for commercial sale.
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Dated: April 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–07442 Filed 4–10–18; 8:45 am]
BILLING CODE 4410–09–P
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
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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
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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
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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
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15631
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
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
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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
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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
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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. . . 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 DATAWaiver 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 § 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’’).
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
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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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
§ 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
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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
Dated: April 4, 2018.
Robert W. Patterson,
Acting Administrator.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as importers of
various classes of schedule I or II
controlled substances.
[FR Doc. 2018–07454 Filed 4–10–18; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
The companies listed below applied
to be registered as importers of various
basic classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
Company
FR docket
Sharp (Bethlehem), LLC .....................................................
Catalent Pharma Solutions, LLC ........................................
Janssen Pharmaceuticals, Inc ............................................
Mylan Pharmaceuticals, Inc ...............................................
Meridian Medical Technologies, Inc ...................................
Noramco, Inc ......................................................................
Johnson Matthey, Inc .........................................................
Mylan Technologies, Inc .....................................................
Mylan Pharmaceuticals, Inc ...............................................
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of the listed registrants to
import the applicable basic classes of
schedule I or II controlled substances is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated each company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
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with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or II controlled substances to
the above listed companies.
Dated: April 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
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Jkt 244001
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUMMARY:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
The companies listed below applied
to be registered as bulk manufacturers of
various basic classes of controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
FR docket
4 For the same reasons which led the IDFPR to
revoke Respondent’s controlled substance license, I
January 4, 2018.
January 16, 2018.
January 16, 2018.
February 9, 2018.
February 9, 2018.
February 9, 2018.
February 9, 2018.
February 9, 2018.
February 23, 2018.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–07444 Filed 4–10–18; 8:45 am]
Nanosyn, Inc .......................................................................
Janssen Pharmaceutical, Inc .............................................
Cambrex High Point, Inc ....................................................
AMPAC Fine Chemicals LLC .............................................
Organix, Inc ........................................................................
Johnson Matthey Inc ..........................................................
Chemtos, LLC .....................................................................
Alcami Wisconsin Corporation ...........................................
17:17 Apr 10, 2018
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8107 ........................................................................
Company
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conclude that the public interest necessitates that
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December 1, 2017.
December 8, 2017.
December 29, 2017.
December 29, 2017.
January 2, 2018.
January 16, 2018.
January 18, 2018.
January 18, 2018.
this Order be effective immediately. 21 CFR
1316.67.
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[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
