[Federal Register Volume 84, Number 183 (Friday, September 20, 2019)]
[Notices]
[Pages 49551-49552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20418]



[[Page 49551]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 19-17]


Peter J. Waidzunas, D.D.S.; Decision and Order

    On March 4, 2019, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Peter J. Waidzunas, 
D.D.S. (hereinafter, Respondent), of Gurnee, Illinois. Order to Show 
Cause (hereinafter, OSC), at 1. The OSC proposed the revocation of 
Respondent's Certificate of Registration No. BW7668835 on the ground 
that Respondent does ``not have authority to handle controlled 
substances in Illinois, the state in which . . . [Respondent is] 
registered with the DEA.'' Id. (citing 21 U.S.C. 823(f) and 824(a)(3)).
    Specifically, the OSC alleged that Respondent and the Illinois 
Department of Financial and Professional Regulation (hereinafter, 
IDFPR) entered into a Consent Order with Respondent on September 10, 
2018. Id. at 1-2. According to the OSC, the Consent Order indefinitely 
suspended Respondent's Illinois dentist controlled substance license, 
because, according to joint stipulations in the Consent Order, 
Respondent ``unlawfully issued prescriptions for controlled substances 
and failed to maintain dispensing records of controlled substances in 
violation of the Illinois Dental Practice Act, 225 ILCS 25 et seq. and 
the Illinois Controlled Substances Act, 720 ILCS 570 et seq.'' Id. at 
1-2.
    The OSC notified Respondent 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 Respondent of the opportunity to 
submit a corrective action plan. OSC, at 3 (citing 21 U.S.C. 
824(c)(2)(C)).
    By letter dated April 5, 2019, Respondent, pro se, timely requested 
a hearing.\1\ Hearing Request, at 1. In his hearing request, Respondent 
did not address whether his Illinois dentist controlled substance 
license remained indefinitely suspended; however, he asserted that he 
``completely disagree[d] with the findings, compilations and 
inventories taken by the two DEA `agents' '' and argued that he has 
``at all times completely complied with all DEA and IDFPR rules and 
regulations.'' Id. Respondent's Hearing Request states that Respondent 
is ``currently on Appeal with the Federal Court over the ruling of the 
judge.'' Id. at 2. Respondent also requested that all notices and 
mailings be directed to the dental office address provided in his 
letterhead. Id.
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    \1\ The OSC was filed with the Office of Administrative Law on 
March 5. Briefing Order, at 1. With no other evidence presented to 
the contrary, I find that the Respondent's Request for a Hearing was 
timely.
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    The Office of Administrative Law Judges put the matter on the 
docket and assigned it to Chief Administrative Law Judge John J. 
Mulrooney, II (hereinafter, Chief ALJ). The Chief ALJ issued an Order 
Directing the Filing of Government Evidence Regarding Its Lack of State 
Authority Allegation and Briefing Schedule (hereinafter, Briefing 
Order) dated April 8, 2019. In his Briefing Order, the Chief ALJ 
advised Respondent that, pursuant to 21 CFR 1316.50, he has the right 
to seek representation by a qualified attorney at his own expense. Id. 
at 1, n.2. The Chief ALJ also ordered the Government to provide 
evidence to support its allegation that Respondent lacks state 
authority to handle controlled substances and to set a briefing 
schedule for any motion for summary disposition on that basis, as well 
as any reply by Respondent. Id. at 1-2. The Government timely complied 
with the Briefing Order by filing a Motion for Summary Disposition on 
April 19, 2019. Government's Motion for Summary Disposition and 
Argument in Support of Finding that Respondent Lacks State 
Authorization To Handle Controlled Substances (hereinafter, MSD). In 
its MSD, the Government stated that Respondent lacks authority to 
handle controlled substances in Illinois, the State in which he is 
registered with the DEA and argued that, therefore, DEA must revoke his 
registration. Id. Respondent did not answer the MSD, and the Chief ALJ 
deemed the Government's motion unopposed. Order Granting Summary 
Disposition and Recommended Rulings, Findings of Fact, Conclusions of 
Law, and Decision dated May 15, 2019 (hereinafter, R.D.), at 2.
    The Chief ALJ granted the Government's Motion, finding that ``there 
is no dispute of material fact in this case.'' R.D. at 4. The ALJ 
recommended that Respondent's registration be revoked because ``the 
Government submitted evidence from the IDFPR and the Consent Order 
which show that the Respondent can no longer prescribe[] controlled 
substances'' and ``[t]his fact is not challenged by the Respondent.'' 
Id. I issue this Decision and Order based on the entire record before 
me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of Fact

Respondent's DEA Registration

    Respondent is the holder of DEA Certificate of Registration No. 
BW7668835 at the registered address of 501 North Riverside Drive, Suite 
119, Gurnee, Illinois. MSD, Attachment 1 (Certificate of Registration). 
Pursuant to this registration, Respondent is authorized to dispense 
controlled substances in schedules II through V as a practitioner. Id. 
Respondent's registration expires on May 31, 2020. Id.

The Status of Respondent's State License

    On September 11, 2018, the IDFPR Division of Professional 
Regulation issued a Consent Order entered into between the IDFPR and 
Respondent.\2\ MSD, Attachment 2 (Consent Order), at 1. According to 
the Consent Order, IDFPR alleged that Respondent's actions and/or 
omissions in his practice of dentistry constitute violations of the 
Illinois Dental Practice Act and the Illinois Controlled Substances 
Act, and which, if proven true, would constitute grounds for 
discipline. Id. at 2-3. (Citations omitted.) Specifically, IDFPR 
alleged that Respondent prescribed Vicodin and Tramadol, on a monthly 
basis between 1996 and 2018, to treat a patient with temporomandibular 
joint dysfunction (``TMJ'') syndrome, and failed to obtain ongoing 
diagnostic and/or radiological studies to verify and confirm the extent 
of that patient's continued TMJ symptoms, as well as authorizing 
numerous prescriptions for controlled substances without properly 
evaluating and monitoring the patient for signs and symptoms of drug 
addiction or abuse. Id. at 1.
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    \2\ The Consent Order demonstrates that Respondent was 
represented by an attorney in the proceeding. Id.
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    The stipulations in the Consent Order also included allegations 
that DEA Diversion Investigators (DIs) conducted an inspection of 
Respondent's dental practice and discovered that he prescribed Ambien 
and Codeine to his wife without documenting the prescriptions or dental 
exam necessity for those prescriptions in her chart. Id. at 2. He also 
stipulated that the DIs conducted a count of controlled substances and 
found a substantial amount of substances unaccounted for, including: A 
shortage of 1,034 Hydrocodone 5/500mg tablets, a shortage of 500 
tablets Hydrocodone 5/325 tablets, and a shortage of 1,960 tablets 
Diazepam 5mg. Id. In addition,

[[Page 49552]]

according to the Consent Order, Respondent was unable to produce a 
biennial inventory, he failed to adequately maintain dispensing records 
for controlled substances, and he failed to maintain inventory records 
of controlled substances for two years. Id. The DIs also determined 
that: (a) Everyone in Respondent's dental office had access to the 
controlled substances cabinet; (b) Respondent kept a five-hundred count 
bottle of Vicodin, a one-hundred count bottle of Halcion, and a five-
hundred count bottle of Valium in his home, a non-registered address; 
and (c) Respondent kept a one-hundred count bottle of Vicodin in his 
desk drawer. Id.
    Respondent also failed to complete the required nine hours of 
continuing education in sedation techniques for the 2009-2012 renewal 
cycle, and failed to ensure that his staff had completed the requisite 
training to assist him in dental sedation procedures. Id.
    Respondent and the IDFPR agreed, in the Consent Order, that 
Respondent's Illinois dentist controlled substance license would be 
indefinitely suspended, and that his Illinois dentist license would be 
placed on indefinite probation with conditions for a minimum period of 
two years. Id. at 4. The Consent Order became effective on September 
11, 2018, upon the approval and signature of the Director of the 
Division of Professional Regulation for the IDFPR. Id. at 7-8.
    According to the online records for the state of Illinois, of which 
I take official notice, Respondent's Illinois dentist controlled 
substance license remains suspended.\3\ https://ilesonline.idfpr.illinois.gov/DFPR/Lookup/LicenseLookup.aspx (last 
visited September, 12, 2019).
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    \3\ 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, Respondent may dispute my finding by filing 
a properly supported motion for reconsideration within 15 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 Respondent files a motion, the Government 
shall have 15 calendar days to file a response.
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    Accordingly, I find that Respondent is not currently licensed to 
dispense controlled substances in Illinois, the State in which 
Respondent is registered with the DEA.

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 
Respondent . . . 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 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th 
Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (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., Hooper, supra, 76 
FR at 71371-72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); 
Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts, M.D., 
53 FR 11919, 11920 (1988); Blanton, supra, 43 FR at 27617.
    Pursuant to the Illinois Controlled Substances Act, a dentist is 
specifically included in the definition of a practitioner. `` 
`Practitioner' means a physician licensed to practice medicine in all 
its branches, dentist . . . or other person licensed, registered, or 
otherwise lawfully permitted by the United States or this State to 
distribute, dispense, conduct research with respect to, administer or 
use in teaching or chemical analysis, a controlled substance in the 
course of professional practice or research.'' 720 Ill. Comp. Stat. 
Ann. 570/102(kk) (Westlaw P.A. 100-863). Illinois law requires that 
``[e]very person who manufactures, distributes, or dispenses any 
controlled substances . . . must obtain a registration issued by the 
Department of Financial and Professional Regulation in accordance with 
its rules.'' Id. at 570/302(a).
    Further, under Illinois law, the Illinois Controlled Substances Act 
authorizes the IDFPR to discipline a practitioner holding a dentist 
controlled substance license. ``A registration under Section 303 to 
manufacture, distribute, or dispense a controlled substance . . . may 
be denied, refused renewal, suspended, or revoked by the Department of 
Financial and Professional Regulation.'' Id. at 570/304(a).
    Here, the undisputed evidence in the record is that Respondent 
currently lacks authority to handle controlled substances as a dentist 
in Illinois. As already discussed, a dentist must hold a valid dentist 
controlled substance license to dispense a controlled substance in 
Illinois. Thus, because Respondent lacks authority to handle controlled 
substances in Illinois, Respondent is not eligible to maintain a DEA 
registration. Accordingly, I order that Respondent'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. 
BW7668835 issued to Peter J. Waidzunas, D.D.S. This Order is effective 
October 21, 2019.

    Dated: September 9, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-20418 Filed 9-19-19; 8:45 am]
 BILLING CODE 4410-09-P