[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Notices]
[Pages 34360-34364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14006]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Roy S. Schwartz; Decision and Order

    On October 7, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Roy S. Schwartz, D.D.S. (hereinafter, Registrant), of 
Tacoma, Washington. The Show Cause Order proposed the revocation of 
Registrant's DEA Certificate of Registration, which authorizes him to 
dispense controlled substances as a practitioner, and the denial of any 
pending applications to renew or modify his registration, on the ground 
that his ``continued registration is inconsistent with the public 
interest.'' GX 1, at 1.
    More specifically, the Show Cause Order alleged Registrant had 
procured controlled substances for one Dr. Raymond Wilkinson, who had 
previously held a DEA registration but which he had surrendered for 
cause, and that Registrant distributed controlled substances to Dr. 
Wilkinson who used them to sedate a patient at Registrant's registered 
address. Id. at 1-2. The Show Cause Order also alleged Dr. Wilkinson 
removed the controlled substances from Registrant's registered address 
and administered them ``to individuals with whom [Registrant] did not 
establish a doctor patient relationship.'' Id. at 2 (citations 
omitted).
    Next, the Show Cause Order alleged that Registrant had made 
``material false and misleading statements to investigators during the 
initial phase of the investigation, including denying [that he knew] 
where Dr. Wilkinson obtained the controlled substances, denying 
ordering controlled substances, and stating that [he was] unfamiliar 
with DEA Forms-222.'' Id. The Order then set forth various statements 
Registrant allegedly made including that on November 2, 2012, he told 
Washington Department of Health Investigators that he ``did not know 
where Dr. Wilkinson obtained controlled substances and that [he] never 
ordered controlled substances.'' Id. Based on various statements 
Registrant made to both Washington State and DEA Investigators, the 
Government also alleged that Registrant had ``turned a willful blind 
eye to the diversion of controlled substances you obtained using your 
own DEA Certificate of Registration.'' Id. at 3.
    The Show Cause Order further alleged that during an on-site 
inspection of his registered location, DEA Investigators found that 
Registrant: (1) Did not have an initial or biennial inventory of 
controlled substances; (2) failed to properly document the receipt of 
controlled substances on DEA Form 222s; (3) failed to maintain all 
invoices of schedule II through V controlled substances and/or ``failed 
to maintain . . . records in readily retrievable form''; and 4) failed 
to maintain effective controls against diversion by ``allowing Dr. 
Wilkinson to maintain controlled substances in a locked suitcase in an 
unlocked cabinet at an unregistered location.'' Id. at 3-4 (citations 
omitted). Finally, the Show Cause Order alleged DEA Investigators 
conducted an audit, which found that Registrant had overages of two 
ampules of 2 ml. fentanyl 50mcg/ml., ten ampules of 5 ml fentanyl 
50mcg/ml., and 131 vials of 2 ml. midazolam 1mg/ml. Id. at 4.
    On October 8, 2013, a DEA Diversion Investigator (DI) personally 
served the Show Cause Order on Registrant. GX 4. While the Show Cause 
Order explained that Registrant had the right to request a hearing on 
the allegations, the procedure for requesting a hearing (by sending his 
request to the Hearing Clerk, DEA Office of Administrative Law Judges, 
at a Springfield, Va., mailing address) and that if he failed to do so 
within 30 days of receipt of the Order, he would ``be deemed to have 
waived [his] right to a hearing,'' GX 1, at 4; Registrant did nothing 
until November 20, 2013, when he wrote the DI (who was located in 
Seattle, Washington) requesting a continuance of the time for him to 
respond to the Order. GX 5, at 3. On December 4, 2013, after the letter 
to the DI was returned undelivered, Registrant wrote the Hearing Clerk 
requesting a continuance; this letter was received on December 9, 2013, 
and the matter was assigned to an Administrative Law Judge (ALJ).
    Thereafter, pursuant to the ALJ's order, the Government filed a 
notice of service and a motion to terminate the proceeding on the 
ground that Registrant had neither timely requested a hearing nor 
demonstrated good cause for failing to do so. GX 8. While Registrant 
claimed that he had inadvertently mailed his letter to the DI (as well 
as attached his previous letter in which he asserted that he had 
encountered difficulty finding an attorney to represent him), GX 7, the 
ALJ found that this did not establish good cause. GX 9, at 9. The ALJ 
therefore granted the Government's motion to terminate the proceeding.
    Thereafter, the Government submitted a Request for Final Agency 
Action to my Office. Having reviewed the record, I find that Registrant 
failed to timely request a hearing and has failed to demonstrate good 
cause to excuse his untimely filing. Accordingly, I find that 
Registrant has waived his right to a hearing and issue this Decision 
and Order based on the Investigative Record submitted by the 
Government. I make the following findings of fact.

Findings

    Registrant is the holder of DEA Certificate of Registration, 
pursuant to which he is authorized to dispense controlled substances in 
schedules II through V, as a practitioner, at the registered location 
of: 1901 S. Union Ave, Suite B4008, Allenmore Medical Center Building 
B, Tacoma, WA 98405-1804. GX 3. His registration does not expire until 
February 28, 2015. Id.
    According to the affidavit of an Investigator with the Washington 
Department of Health (hereinafter, DOH), the DOH received complaints 
that one Dr. Raymond Wilkinson had used expired fentanyl and ketamine 
to perform conscious sedation on patients at the University of 
Washington's Periodontics Clinic. GX 10, at 1. However, the drugs 
(which are schedule II and schedule III controlled substances

[[Page 34361]]

respectively \1\) were not stocked at the clinic. Id. Moreover, years 
ago, Dr. Wilkinson had surrendered his DEA registration for cause. GX 
18, at 6.
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    \1\ See 21 CFR 1308.12(c) (fentanyl) and 21 CFR 1308.13(c) 
(ketamine).
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    On November 2, 2012, DOH Investigators went to Dr. Wilkinson's 
dental practice, which was in the same office as that of Registrant. GX 
10, at 2. Upon arriving, they met Registrant who told them that Dr. 
Wilkinson was not present and only worked at the office on Mondays and 
did so as an independent contractor. Id.
    Registrant agreed to an interview, during which he stated that 
neither he nor Wilkinson provided conscious sedations at Registrant's 
office. Id. Registrant admitted, however, that he knew that Wilkinson 
was providing conscious sedation at other offices. Id. Moreover, 
Registrant stated that he had no idea as to how Wilkinson had obtained 
the drugs he used to sedate patients and ``that he did not order or use 
sedation drugs in his practice.'' Id. However, Registrant then admitted 
knowing that Wilkinson kept controlled substance in a briefcase at 
Registrant's office and that Wilkinson took the drugs offsite to 
perform conscious sedation. Id. He also stated that he was unfamiliar 
with the DEA Form which is used to order schedule II controlled 
substances (Form-222).
    Three days later, DOH Investigators returned to Registrant's office 
and interviewed Dr. Wilkinson. Id. at 3. During the interview, 
Wilkinson admitted to bringing controlled substances from Registrant's 
office to the University of Washington's Periodontics Clinic, as well 
as that he provided sedation services for multiple dentists including 
Registrant. Id. He also stated that Registrant had purchased the 
controlled substances for him from a local pharmacy, that Registrant 
completed the Form 222s, and that the latter's office manager would 
pick up the orders. Id.
    Dr. Wilkinson then showed the DOH Investigators his ``sedation 
kit,'' which according to the DOH Investigator, ``he kept in a locked 
file-box within an unlocked cabinet.'' Id. Upon opening the kit, the 
Investigator found the following items: (1) A cash receipt for a 
prescription for Registrant for 50 midazolam 2mg/ml injectable; (2) an 
un-opened box of 25 midazolam 2mg/ml vials; (3) an opened box which 
contained 11 midazolam 2mg/ml vials; (4) a blister pack of 10 ampules 
of fentanyl citrate 250mcg; and (5) a blister pack with one ampule 
remaining of fentanyl citrate 100mcg; and (6) a hand-written drug log. 
Id.
    On November 9, 2012, DEA Investigators went to Registrant's 
practice. GX 2, at 3. Registrant admitted that ``he did not make, 
maintain, or review any of the controlled substance records.'' Id. 
Registrant acknowledged that he knew that Wilkinson did not have a DEA 
registration and yet was providing sedation to patients at other 
offices; he also asserted that Wilkinson ``did not provide sedation for 
his . . . patients.'' Id. at 4. Registrant also admitted that he used 
his DEA registration to obtain the controlled substances that Wilkinson 
needed to perform sedation and acknowledged having signed several Form 
222s. Id. at 4. Registrant further stated that the controlled 
substances belonged to Wilkinson and that he was ``doing a favor for a 
friend.'' Id.
    On December 10, 2012, two DIs returned to Registrant's practice and 
conducted an on-site inspection. Id. While Registrant consented to the 
inspection, he declined to participate in it. Id. However, Dr. 
Wilkinson was present and assisted the DIs, who asked him to provide 
various records. Id.
    Dr. Wilkinson stated that Registrant ``never had access to the 
controlled substances or records'' and stated that all of the drugs 
were ordered from a local pharmacy. Id. at 5. Wilkinson also stated 
that 90 percent of the sedations he did were done at the practices of 
other dentists. Id.
    The DIs further determined that Registrant did not have either an 
initial or biennial inventory of the controlled substances. Id. 
According to a DI, while Dr. Wilkinson produced a dispensing log, which 
contained twenty-six records, ``[a]ll of the entries failed to record'' 
the ``patient address, finished form and initials of [t]he dispenser.'' 
Id. Moreover, only three of the entries ``noted the volume of the 
finished form'' which was dispensed. Id. The DI further asserted that 
``the dispensing log did not contain at least two years' worth of 
records.'' Id.
    The DI, who had previously obtained copies of the Form-222s from 
the pharmacy where Registrant purchased the drugs, determined that 
Registrant was missing at least one such form. Id. at 6. Moreover, 
Registrant had failed to record the actual number of containers 
received and the dates of receipt. Id. The DI further asserted that 
Registrant was unable to identify who had prepared several of the 
forms. Id. In addition, the DI found that Registrant ``failed to 
maintain . . . any Schedule III-V acquisitions invoices'' and that 
while the controlled substances were kept ``in a locking briefcase,'' 
they were kept in an unlocked cabinet in Wilkinson's office. Id.
    Subsequently, the DI conducted an audit ``utilizing the closing 
inventory assembled during the on-site inspection, [the] dispensing log 
entries, and the Form-222s.'' Id. The DI did not, however, ``record the 
acquisition of any [s]chedule III-V controlled substances due to the 
lack of invoices.'' Id. The DI further stated that he ``used an initial 
inventory date of January 1, 2012, beginning of business, and noted 
that the initial inventory was `zero' due to lack of an initial or 
biennial inventory.'' Id.
    According to the DI's affidavit, the audit found overages of two 
ampules of 2ml fentanyl 50mcg/ml; ten ampules of 5ml fentanyl 50mcg/ml; 
and 131 vials of 2 ml midazolam 1mg/ml. Id. at 7. However, the record 
also includes a computation chart which lists various data that were 
obtained from Dr. Wilkinson's records as well as the pharmacy which 
supplied the drugs. See GX 12, at 2. Notably, this data includes 
figures (other than 0) in the ``initial inventory'' column and which 
are listed in entries that are labeled ``Wilkinson Records,'' as well 
as data for the midazolam purchases based on both the pharmacy records 
and Wilkinson's records. Id. Moreover, using Wilkinson's figures, the 
audit found, with respect to both the fentanyl and midazolam, that all 
of the drugs which were purchased were accounted for. Id.
    The DI further declared that he had been informed by a DOH 
Investigator that one of Registrant's patients (J.F.) had received 
conscious sedation from Dr. Wilkinson at the latter's office. GX 2, at 
8. As found above, in November 2012, Registrant had stated to both DOH 
and DEA Investigators that Wilkinson had not provided conscious 
sedation at his office. According to the DI, he subpoenaed J.F.'s 
medical records and determined ``that in July 2012, Dr. Wilkinson 
utilized controlled substances to provide conscious sedation to'' J.F. 
at Registrant's practice. Id.; see also GX 17 & 20.
    As part of the record, the Government included several letters from 
Registrant to both DOH and the DI. In a letter to DOH, Registrant 
asserted ``that under the sense of friendship[,] collegiality and 
economy, I made the decision to let another doctor share my DEA 
license'' and ``[i]t did not occur to me that sharing the license with 
a dentist operating in my office and building would be illegal'' as he 
was told by the

[[Page 34362]]

DI.\2\ GX 15, at 7. Registrant further stated that he had known that 
``Dr. Wilkinson had taught [iv] [s]edation at the University of 
Washington Dental School for years,'' and that he ``had complete 
confidence that he would be well versed in the proper procedures for 
ordering and using the drugs for [iv] [s]edation.'' Id. Registrant then 
stated that Wilkinson told him ``that he would use the drugs in 
`neighboring practices' where dental sedation was required in the 
treatment of patients'' and that it was his ``understanding'' that this 
meant only ``dental practices in our immediate locality.'' Id.
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    \2\ See also GX 5, at 4 (Registrant's letter of Nov. 20, 2013 to 
DI) (``He [Wilkinson] told me, at the time that we made the 
agreement, that he had decided to `give up' his DEA license because 
of the `haggle' over it at his Puyallup practice.'').
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    Registrant then explained that Dr. Wilkinson arranged with his 
secretary ``to order the drugs he needed'' and that he ``would sign off 
on the order.'' Id. Registrant further stated that he ``never saw, 
received or handled the drugs that were ordered by Dr. Wilkinson,'' and 
that the ``drugs were given directly to Dr. Wilkinson for his use and 
maintenance'' on patients that were unknown to Registrant. Id.; see 
also id. at 9. Registrant further stated that ``Dr. Wilkinson was 
responsible for maintaining the required paperwork for using these 
drugs including receipts, dispensing, and inventory of what amount of 
the drugs remained in his possession.'' Id. at 7.
    Registrant further wrote that he was unaware that Dr. Wilkinson's 
state dental license had been suspended and that he had surrendered his 
DEA registration for cause, as Wilkinson had not informed him of this 
when they ``discussed the sharing of my DEA license.'' Id. at 8. 
Registrant further noted that he had prescribed controlled substances 
``for over fifty years without any incidents.'' Id.
    Registrant further stated that he always gives his patients a 
prescription, and that ``[i]n his over fifty years of practice, [he] 
has never stored any controlled substances in his office.'' Id. at 10. 
He also denied making false and misleading statements to either DOH or 
DEA Investigators. Id. Finally, he stated that he did not employ Dr. 
Wilkinson. Id.

Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that 
a registration to ``dispense a controlled substance . . . may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. Sec.  
824(a)(4) (emphasis added). With respect to a practitioner, the Act 
requires the consideration of the following factors in making the 
public interest determination:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State laws 
relating to the manufacture, distribution, or dispensing of controlled 
substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. Sec.  823(f).
    ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I 
``may rely on any one or a combination of factors[,] and may give each 
factor the weight [I] deem[] appropriate in determining whether a 
registration should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while 
I am required to consider each of the factors, I ``need not make 
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting 
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\3\
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    \3\ ``In short, this is not a contest in which score is kept; 
the Agency is not required to mechanically count up the factors and 
determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct.'' Jayam Krishna-Iyer, 74 FR 459, 462 (2009). 
Accordingly, as the Tenth Circuit has recognized, findings under a 
single factor can support the revocation of a registration. MacKay, 
664 F.3d at 821.
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    Even where a Registrant fails to request a hearing or to submit a 
written statement in lieu of a hearing, the Government has the burden 
of proving, by a preponderance of the evidence, that the requirements 
for revocation or suspension pursuant to 21 U.S.C. Sec.  824(a) are 
met. 21 CFR 1301.44(e). In this matter I have considered all of the 
statutory factors and deem it unnecessary to make findings with respect 
to factors one, two, three, and five. However, having considered all of 
the evidence in this matter, including the statements Registrant made 
to Investigators, I conclude that evidence with respect to factor four 
is sufficient to establish that Registrant has committed such acts as 
to render his registration inconsistent with the public interest.

Factor Four--Compliance With Applicable Laws Related to Controlled 
Substances

    Under the CSA, it is ``unlawful for any person [to] knowingly or 
intentionally . . . distribute . . . a controlled substance,'' 
``[e]xcept as authorized by this subchapter.'' 21 U.S.C. Sec.  
841(a)(1). The CSA specifically recognizes various categories of 
registration to include, inter alia, manufacturers, distributors and 
practitioners, see id. Sec.  823; and provides that a registrant may 
possess and engage in controlled substance activities ``to the extent 
authorized by their registration and in conformity with the other 
provisions of this subchapter.'' Id. Sec.  822(b); see also 21 CFR 
1301.13(e) (``Any person who is required to be registered and who is 
not so registered, shall make application for registration for one of 
the following groups of activities, which are deemed to be independent 
of each other.''). So too, the CSA limits the circumstances in which a 
person may lawfully possess a controlled substance to where the 
substance ``was obtained directly, pursuant to a valid prescription or 
order, from a practitioner, while acting in the course of his 
professional practice, or except as otherwise authorized by'' the CSA. 
21 U.S.C. Sec.  844(a).
    Under the CSA, a practitioner's registration authorizes its holder 
to dispense controlled substances, 21 U.S.C. Sec.  823(f); i.e., ``to 
deliver a controlled substance to an ultimate user . . . by, or 
pursuant to the lawful order of, a practitioner, including the 
prescribing and administering of a controlled substance.'' Id. Sec.  
802(10). Thus, except for in limited circumstances, a practitioner is 
not authorized to distribute controlled substances.\4\
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    \4\ One such exception is found at 21 CFR 1307.11(a). It 
provides that:
    (a) A practitioner who is registered to dispense a controlled 
substance may (without being registered to distribute) a quantity of 
such substance to--
    (1) Another practitioner for the purpose of general dispensing 
by the practitioner to patients provided that--
    (i) The practitioner to whom the controlled substance is to be 
distributed is registered under the Act to dispense that controlled 
substance;
    (ii) The distribution is recorded by the distributing 
practitioner in accordance with Sec.  1304.22(c) of this chapter and 
by the receiving practitioner in accordance with Sec.  1304.22(c) of 
this chapter;
    (iii) If the substance is listed in Schedule I or II, an order 
form is used as required in part 1305 of this chapter . . . .
    21 CFR 1307.11(a).
    Respondent did not, however, raise this provision as an 
affirmative defense, see 21 U.S.C. Sec.  885(a)(1), and because 
Wilkinson was not registered, could not have successfully raised it.

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[[Page 34363]]

    Here, the evidence shows that while Registrant did not physically 
possess the controlled substances, he nonetheless unlawfully 
distributed them to Dr. Wilkinson. Under the CSA, Wilkinson could not 
have lawfully obtained the controlled substances because he was not 
registered. Indeed, the whole purpose of the agreement between 
Wilkinson and Registrant was--in Registrant's own words--to ``share'' 
his DEA registration, so that Wilkinson could obtain possession of 
controlled substances. With Registrant's knowledge and consent, the 
controlled substances were ordered under Registrant's registration and 
were then delivered to Wilkinson. This constitutes a distribution under 
the CSA. See 21 U.S.C. Sec.  802(11) (``The term `distribute' means to 
deliver (other than by administering or dispensing) a controlled 
substance . . .''); id. Sec.  802(8) (``The terms `deliver' or 
`deliver' mean the actual, constructive, or attempted transfer of a 
controlled substances . . . whether or not there exists an agency 
relationship.'').
    While Registrant asserted that he was unaware that Wilkinson had 
surrendered his DEA registration years earlier, he obviously knew that 
Wilkinson was unregistered as there would have been no reason for 
Registrant to ``share'' his DEA license if Wilkinson was registered. 
Moreover, he also knew that Wilkinson was taking the controlled 
substances from his practice, which was his registered location, to 
other dental offices. Accordingly, I find that Registrant violated the 
CSA when he distributed the controlled substances to Wilkinson. See 21 
U.S.C. Sec.  841(a)(1). However, while this is technically diversion 
because Dr. Wilkinson was unregistered and thus outside the closed 
system of distribution established by the CSA, there is no evidence 
that any of the drugs were administered to patients other than in the 
course of providing legitimate dental treatment.
    The evidence also shows that Registrant failed to comply with 
various recordkeeping requirements. Under 21 U.S.C. Sec.  827(a)(1), 
``every registrant . . . shall . . . as soon . . . as such registrant 
first engaged in the manufacture, distribution, or dispensing of 
controlled substances, and every second year thereafter, make a 
complete and accurate record of all stocks thereof on hand.'' Even if 
Registrant or his Secretary (who apparently prepared the order forms) 
never physically possessed the drugs, upon the use of his registration 
for the purpose of enabling Wilkinson to obtain controlled substances, 
he engaged in the distribution of controlled substances and under DEA 
regulations, he was still required to prepare an initial inventory. See 
21 CFR 1304.11(b) (``In the event a person commences business with no 
controlled substances on hand, he/she shall record this fact as the 
initial inventory.''). The evidence showed, however, that Registrant 
had no inventories.
    Also, pursuant to 21 U.S.C. Sec.  827(a)(3), ``every registrant . . 
. manufacturing, distributing, or dispensing a controlled substance or 
substances shall maintain, on a current basis, a complete and accurate 
record of each such substances manufactured, received, sold, delivered, 
or otherwise disposed of by him.'' See also 21 CFR 1304.21(a). Thus, 
Registrant was required to keep records of the purchases he authorized 
and his subsequent distributions to Wilkinson.
    While Registrant had some DEA Form-222s for the fentanyl purchases, 
the forms were not completed to show the actual quantities received and 
the dates of receipt. See 21 CFR 1305.13(e). Nor could he produce any 
invoices or other records documenting the purchases for the other 
controlled substances that were ordered. Likewise, he had no records 
documenting the subsequent distributions of the controlled substances 
to Wilkinson. Registrant thus violated the CSA by failing to maintain 
required records.\5\ 21 U.S.C. Sec. Sec.  827(a)(3) & 842(a)(5); 21 CFR 
1304.21(a); 21 CFR 1304.22(b).
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    \5\ Notwithstanding that the Order to Show Cause alleged that 
DEA's audit found that Registrant had various overages, GX 1, at 4, 
in its discussion of the public interest factors, the Government 
made no reference to the audit results. Accordingly, I do not 
consider this evidence.
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    Accordingly, I find that Registrant ``has committed such acts as 
would render his registration . . . inconsistent with the public 
interest.'' 21 U.S.C. Sec.  824(a)(4).\6\ While I have carefully 
considered Registrant's statements in his letters, I find that 
Registrant has not acknowledged that he violated federal law by both: 
(1) Distributing controlled substances to an unregistered person, and 
(2) failing to maintain CSA-required records.\7\ Moreover, Respondent 
clearly knew that his activities were illegal as there would be no 
reason to ``share'' his DEA license if Wilkinson was himself 
registered; indeed, he even knew that Wilkinson had given up ``his DEA 
license because of the `haggle' over it at [Wilkinson's] Puyallup 
practice.'' GX 5, at 4. Registrant also knew that Wilkinson intended to 
take the controlled substance to other dental offices.
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    \6\ Because Registrant had already distributed the controlled 
substances to Wilkinson and there is no evidence that Wilkinson 
acted as Registrant's agent when he performed sedation (other than 
with the possible exception of when he sedated J.F.), I place no 
weight on the inadequacies identified by the DI regarding the 
dispensing log maintained by Dr. Wilkinson. So too, because the 
controlled substances had been distributed to Wilkinson, I place no 
weight on the evidence that they were not ``stored in a securely 
locked, substantially constructed cabinet.'' 21 CRF 1301.75
     With respect to factor five, the Government argues that 
Registrant lacked candor because he made false statements to both 
Washington DOH as well as DEA Investigators. As for his alleged 
false statements to the DOH Investigators, I conclude that the State 
of Washington is the best forum to adjudicate these allegations. As 
for his alleged false statement to DEA, in its discussion of factor 
five, the Government simply lumps all of Registrant's putatively 
false statements together without identifying which of the 
statements were made to DEA Investigators. While there is evidence 
that Registrant told DEA Investigators that Dr. Wilkinson did not 
perform conscious sedation on any of his patients even though 
Wilkinson had done so on J.F., the Government has provided no 
explanation as to why Registrant's false statement was material to 
its investigation. Accordingly, I place no weight on Registrant's 
false statement to Agency Investigators.
    \7\ In his May 21, 2013 letter to the DOH Investigator, 
Respondent stated that ``Dr Wilkinson was responsible for 
maintaining the required paperwork for using these drugs including 
receipts, dispensing, and an inventory of what amount of the drug 
remained in his possession.'' GX 15, at 7. While this may have been 
his arrangement with Wilkinson, as explained above, because 
Registrant engaged in the acquisition and distribution of controlled 
substances he was also required to maintain records.
     Moreover, on the issue of whether he allowed controlled 
substances to be taken from his registered location, Registrant 
wrote: ``Dr. Wilkinson was given the drugs he ordered. What he did 
with them after that was done without my knowledge or consent.'' GX 
18, at 8. Registrant did, however, know that Wilkinson intended to 
and did take the controlled substances out of his office.
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    In determining the appropriate sanction, the Agency also considers 
the egregiousness of the proven misconduct and the need to deter 
similar misconduct on the part of other registrants. In mitigation of 
the violations, it is noted that there is no evidence that Wilkinson 
was personally abusing the drugs or that he dispensed any of the drugs 
outside of the course of providing legitimate dental treatment. 
Moreover, the Government produced no evidence that Registrant has 
engaged in any other misconduct related to controlled substances during 
the course of his professional career, which has spanned more than 
fifty years.
    On the other hand, Registrant's statements suggest that he does not 
accept responsibility for his misconduct. Moreover, the Agency has

[[Page 34364]]

a strong interest in deterring similar acts on the part of other 
registrants. Accordingly, while I reject the Government's contention 
that Registrant's registration should be revoked, I will order that his 
registration be suspended outright for a period of one year.\8\
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    \8\ This Order does not preclude the Government from seeking 
revocation of Registrant's registration in the event the State of 
Washington suspends or revokes Registrant's dental license.
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    I further order that Registrant's registration shall be restricted 
to allow him only to prescribe controlled substances until such time as 
he completes a course in controlled substance recordkeeping. During 
this period, Registrant shall be prohibited from possessing any 
controlled substances (including those provided as samples by 
pharmaceutical manufacturers and distributors) other than those that 
are prescribed to him to treat a legitimate medical condition. Upon the 
completion of such course, Respondent shall provide a copy of his 
certificate of completion to the local DEA field office to have said 
restriction removed.

Order

    Pursuant to the authority vested in me by 21 U.S.C. Sec. Sec.  
823(f) and 824(a)(4), as well as 28 CFR 0.100(b) and 0.104, I order 
that the DEA Certificate of Registration issued to Roy S. Schwartz, 
D.D.S., be, and it hereby is, suspended for a period of one year. The 
suspension of Dr. Schwartz's registration shall be effective July 16, 
2014. I further order that Dr. Schwartz's registration shall be 
restricted as set forth above; said restrictions shall be, and hereby 
are, effective immediately.\9\
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    \9\ In the event Registrant is in possession of any controlled 
substances other than those which have been lawfully prescribed to 
him, he shall contact the DEA field office for instructions on how 
to dispose of them. Registrant shall have ten (10) business days to 
dispose of any such controlled substances.

    Dated: June 9, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-14006 Filed 6-13-14; 8:45 am]
BILLING CODE 4410-09-P