80_FR_29122 80 FR 29025 - Keith Ky Ly, D.O.; Decision and Order

80 FR 29025 - Keith Ky Ly, D.O.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 97 (May 20, 2015)

Page Range29025-29037
FR Document2015-12139

Federal Register, Volume 80 Issue 97 (Wednesday, May 20, 2015)
[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Notices]
[Pages 29025-29037]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-12139]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Keith Ky Ly, D.O.; Decision and Order

    On January 24, 2013, I, the Administrator of the Drug Enforcement 
Administration, issued an Order to Show Cause and Immediate Suspension 
of Registration (hereinafter, OTSC-ISO or Order) to Keith Ky Ly, D.O. 
(Respondent), of Mountlake Terrace, Washington. GX 2, at 1. The Order 
proposed the revocation of Respondent's DEA Certificate of 
Registration, which authorizes him to dispense controlled substances in 
schedules II through V, as a practitioner, as well as 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, as that term is defined in 21 U.S.C. 823(f).'' Id.
    More specifically, the OTSC-ISO alleged that on February 2, 2012, 
law enforcement officers arrested Respondent's girlfriend, who was then 
driving his vehicle, for driving with a suspended license and that 
during a search of the vehicle, found ``one pound of marijuana, 
approximately $3,900 cash in a vacuum sealed bag located in [her] 
purse, $5,000 cash located in a hidden compartment, and three 
prescription bottles containing controlled substances located in'' her 
backpack. Id. at 2. The Order further alleged that Respondent had 
issued one of the prescriptions found in the backpack to an employee, 
and that during an interview when he attempted to recover the vehicle, 
Respondent stated that he lived with his girlfriend, that she worked at 
his medical practice, and that she and the employee whose medication 
was found in the backpack ``often shared medications.'' Id. The Order 
then alleged that this showed that Respondent had ``knowledge of 
illegal activity occurring between [his] employees and [took] no 
corrective action.'' Id.
    Next, the OTSC-ISO alleged that law enforcement officers discovered 
that several premises owned by Respondent were being used as marijuana-
grow houses. Id. More specifically, the Order alleged that: (1) On May 
30, 2012, the Renton, Washington fire department responded to a fire at 
his Quincy

[[Page 29026]]

Avenue property and seized approximately 700 marijuana plants; (2) on 
July 5, 2012, state and local law enforcement officers obtained a 
search warrant for his property located at 20118 14th Avenue NE., 
Shoreline, Washington, and seized approximately 489 marijuana plants 
and six bags of processed marijuana; (3) on July 6, 2012, state and 
local law enforcement officers executed a search warrant at 
Respondent's personal residence in Bothell, Washington, and ``seized 
$12,000 in cash, two firearms, marijuana grow documents, approximately 
15 grams of processed marijuana, and multiple prescription bottles 
containing pills,'' including an unlabeled bottle containing 
hydrocodone, and a bottle containing clonazepam, which Respondent had 
prescribed for patient R.M.; and (4) on July 7, 2012, state and local 
law enforcement obtained a search warrant for his property located at 
5006 104th Place NE., Marysville, Washington and seized marijuana 
leaves and grow equipment. Id. at 2-3.
    Next, the OTSC-ISO alleged that on July 13, 2012, DEA personnel 
``conducted an inspection and audit at [Respondent's] registered 
address.'' Id. at 3. The Order alleged that Respondent had a 75 percent 
shortage of both testosterone 200mg/ml and phentermine 37.5mg, as well 
as a 14 percent shortage of hydrocodone 10/500mg. Id. Based on the 
audit results, the Order further alleged that Respondent ``failed to 
maintain accurate and complete records and failed to account for these 
controlled substances.'' Id. (citing 21 U.S.C. 827(a)(1) and 842(a)(5); 
21 CFR 1301.71, 1304.03, 1304.04 (a) & (g), and 1304.21). The Order 
then alleged that Respondent had committed additional recordkeeping 
violations, in that he ``failed to take and maintain an initial or 
biennial inventory of all stocks of controlled substances on hand,'' 
``failed to record essential elements on approximately 128 dispensing 
records,'' ``failed to maintain a dispensing/administration log for 
testosterone and Testim samples, located during the on-site 
inspection,'' and ``failed to maintain all Schedule III-V acquisition 
invoices and record the dates of receipt[ ] on the invoices.'' Id. at 
3-4 (citations omitted).
    Finally, the OTSC-ISO alleged that Respondent ``failed to make 
required dispensing reports'' to the Washington State Prescription 
Monitoring Program ``on approximately 45 separate occasions from 
January to July 2012.'' Id. at 4. As the legal basis for this 
allegation, the Government noted that Washington State ``requires a 
dispensing physician to report to the . . . PMP all instances in which 
he or she dispenses more than a 24-hour supply of controlled 
substances.'' Id. (citing Wash. Rev. Code Sec.  70.225.020; Wash. 
Admin. Code Sec.  246-470-030).
    Based on the above, I made a preliminary finding that Respondent 
``illegally manufactured controlled substances in violation of state 
and federal law, illegally possessed and distributed highly addictive 
controlled substances . . . and ha[d] generally failed to maintain 
effective controls to guard against theft and prevent diversion of 
controlled substances.'' Id. I therefore ordered that Respondent's 
registration be suspended effective immediately. Id. (citing 21 U.S.C. 
824(d)).
    According to the Declaration of a DEA Diversion Investigator (DI), 
on January 28, 2013, DEA Special Agents and DIs went to Respondent's 
registered location and personally served him with the OTSC-ISO, along 
with ``a sample request for hearing form.'' DI Declaration, at 9. 
According to the DI, later that same day, he also hand-delivered a copy 
of the OTSC-ISO and the hearing request form to Respondent's ``attorney 
at the time.'' \1\ Id.
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    \1\ The courts are clear that service of an initial pleading on 
an attorney does not constitute adequate service unless a party has 
granted authority to the attorney to accept process on his behalf. 
See, e.g., United States v. Ziegler Bolt & Parts Co., 111 F.3d 878, 
881 (Fed. Cir.1997). There being no such evidence showing that 
Respondent granted such authority to the attorney, I rely only on 
the DI's statement that Respondent was personally served.
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    The OTSC-ISO plainly advised that: (1) ``[w]ithin 30 days after the 
date of receipt of this Order to Show Cause and Immediate Suspension of 
Registration, you may file with the DEA a written request for a hearing 
in the form set forth in 21 CFR 1316.47''; (2) ``[i]f you fail to file 
such a request, the hearing shall be cancelled in accordance with 
paragraph 3''; (3) ``[s]hould you decline to file a request for a 
hearing . . . you shall be deemed to have waived the right to a hearing 
and the DEA may cancel such hearing''; (4) ``[c]orrespondence 
concerning this matter, including requests [for a hearing] should be 
addressed to the Hearing Clerk, Office of Administrative Law Judges 
[OALJ] . . . 8701 Morrissette Drive, Springfield, VA 22152''; and (5) 
``[m]atters are deemed filed upon receipt by the Hearing Clerk.'' GX 2, 
at 4-5 (citations omitted). Notwithstanding this, Respondent did not 
file a request for hearing with the Office of Administrative Law Judges 
until April 4, 2013. GX 4, at 1.
    The matter was then assigned to an Administrative Law Judge (ALJ), 
who ordered that the proceeding be terminated because Respondent had 
``failed to timely request a hearing and failed to assert good cause 
for his 36-day delay.'' Id. at 2. Thereafter, on April 18, 2013, 
Respondent, who was now represented by counsel (a different counsel 
than identified by the DI in his declaration), filed a motion to 
reconsider and re-open. GX 5. Therein, Respondent requested a full 
hearing on the allegations, as well as ``additional time to file his 
Request for Hearing based on this motion showing of good cause.'' Id. 
at 1.
    In the motion, Respondent did ``not contest that he was effectively 
served with a copy of the'' OTSC-ISO. Id. at 2. He also did not dispute 
that his prior attorney ``was in contact with [him] during and after 
the period for filing a timely appeal.'' Id. Rather, Respondent 
maintained that he ``sent a letter requesting appeal of the [OTSC-ISO] 
to [a] local Seattle-based DEA agent . . . by certified mail on 
February 4, 2013,'' who ``did not respond to the appeal letter or 
inform Respondent that an appeal of the [OTSC-ISO] could not be 
perfected by sending it to him.'' Id. at 2-3. Respondent further 
asserts that he ``sought the advice of and had several conversations 
with [his former] attorney,'' and that ``[b]ased on these 
conversations, [he] `filed' an appeal NOT with the DEA . . . Office of 
Administrative Law Judges, but instead with the Office of the Inspector 
General (OIG),'' and that he faxed the appeal ``to the OIG on February 
20, 2013, and again on March 8, 2013.'' Id. at 3. According to 
Respondent, ``[t]he OIG suggested [he] contact the DEA.'' Id.
    Respondent further asserted that he ``discussed the matter with an 
assistant in his office, who believed the correct place to file the 
appeal was with the office of the United States Attorney General.'' Id. 
Respondent stated that ``[a]n `appeal' was sent to that address on 
February 11, 2013.'' Id.
    Next, Respondent contended that on March 14, 2013, he was advised 
by his then-counsel that the latter ``and his partner had decided not 
to represent [him] in this . . . proceeding,'' but that ``[t]his was 
after the request for hearing deadline had expired.'' Id. Respondent 
then contended that on March 28, he spoke with two Seattle-based DEA 
agents, ``who told him he needed to file the request for hearing right 
away.'' Id. According to Respondent, he then ``filed his request for 
hearing on April 4, 2013 with the DEA'' OALJ. Id.
    Respondent asserted that he ``was confused about how and where to 
file his request for a hearing'' and that ``[t]he source of his 
confusion came from his

[[Page 29027]]

contacts with [his former] attorney . . ., with his office assistant, 
and from the lack of response by [a DEA Agent], although a late effort 
to clarify the correct means to request a hearing was provided by the 
DEA agents.'' Id. at 3-4. He further maintained that he attempted ``in 
good faith to ask for a hearing'' and that ``[n]one of the alternatives 
employed by [him] were done for purposes of delay.'' Id. at 4.
    Respondent argued that his case is similar to that of Steven J. 
Watterson, 67 FR 67413 (2002). Therein, the Agency set aside a final 
order where a party had failed to file a request for a hearing based on 
``conflicting guidance'' having been ``given to'' an Applicant by an 
Agency ``official concerning how and when the matter would be 
resolved.'' Id. at 67414. Respondent argued that Watterson stands for 
the proposition that `` `[g]ood cause' . . . to set aside and rescind a 
decision terminating a proceeding . . . require[s] a showing of both 
excusable neglect and a meritorious defense.'' GX 5, at 5. He then 
argued that ``[t]he acceptance and retention by'' the DI of his appeal 
request ``was misleading, particularly when [the DIs] actively 
encouraged [him] to file his appeal correctly AFTER the appeal period 
had lapsed,'' and that ``[t]his was a source of conflicting guidance 
for Respondent.'' Id. at 6.
    Respondent also relied on Pincay v. Andrews, 389 F.3d 853 (9th Cir. 
2004) (en banc). There, a lawyer failed to file a notice of appeal 
within the thirty-day period provided for doing so in the Federal Rules 
of Appellate Procedure, based on his reliance on the erroneous advice 
of a paralegal that the notice of appeal need not be filed until sixty 
days after the issuance of a judgment, rather than the thirty days 
provided in the applicable Federal Rule of Appellate Procedure. Id. at 
855. The Ninth Circuit held that the failure to timely file the notice 
of appeal constituted excusable neglect, notwithstanding its 
conclusions that the lawyer's reliance on the paralegal's reading of 
the rule was ``negligent'' and that the ``lawyer's failure to read an 
applicable rule is one of the least compelling excuses that can be 
offered.'' Id. at 859. The court nonetheless held that the district 
court did not abuse its discretion in concluding that the lawyer's 
untimely filing was the result of excusable neglect. Id. The court 
further noted that ``the decision whether to grant or deny an extension 
of time to file a notice of appeal should be entrusted to the 
discretion of the district court because the district court is in a 
better position than'' the appeals court to evaluate the relevant 
factors, and that the decision was to be determined ``within the 
context of the particular case,'' which, in Pincay, had gone on for 
fifteen years. Id. However, the court also observed that ``[h]ad the 
district court declined to permit the filing of the notice, we would be 
hard pressed to find any rationale requiring us to reverse.'' Id.
    Based on Pincay, Respondent argued that: (1) There is no prejudice 
to the Agency because his registration remains suspended; (2) the 
thirty-six day delay in filing his hearing request had no impact on the 
proceeding; (3) ``the reason for the delay was confusion on his part,'' 
that his conduct is no worse than that found excusable in Pincay and 
was ``based in part on omissions by'' the DI, and was not made in bad 
faith; and (4) that he acted promptly to rectify his untimely filing. 
GX 5, at 8-9. Accordingly, Respondent argued that he has shown good 
cause for setting aside the ALJ's termination order. Id. at 9.
    The ALJ granted Respondent's motion for reconsideration but then 
denied his motion to reopen the proceedings. Order Granting 
Respondent's Motion for Reconsideration and Denying Respondent's Motion 
to Reopen the Case, at 10 (Order on Reconsideration) (GX 7). While 
concluding that she had jurisdiction to consider Respondent's motion 
for reconsideration, the ALJ rejected Respondent's contention that he 
had shown good cause for his untimely filing.
    First, the ALJ rejected Respondent's contention that under 
Watterson, he had demonstrated good cause because he had received 
``conflicting guidance'' from the DI to whom he sent his ``appeal'' 
letter. Id. at 7. The ALJ found that Watterson was not controlling 
because, during the period in which Respondent could have filed his 
hearing request, the DI did not provide conflicting guidance but rather 
no guidance at all. Id. at 8. Indeed, the DI did not provide any advice 
to Respondent regarding his hearing request until he met with the DI on 
March 28, 2013. Id.
    Next, the ALJ rejected Respondent's contention that ``good cause'' 
existed to excuse his untimely filing because his former attorney 
``committed `excusable neglect.' '' Id. More specifically, the ALJ 
noted that the excusable neglect standard of the Federal Rules of 
Appellate Procedure, see Pincay, and the Federal Rules of Bankruptcy 
Procedure (Rule 9006(b)(1)), which was discussed by the Supreme Court 
in Pioneer Inv. Servs. v. Brunswick Assoc., 507 U.S. 380, 396 (1993), 
``do not govern our [DEA] proceedings.'' \2\ Order on Reconsideration, 
GX 7, at 8. The ALJ further noted that even under Pioneer, 
``respondents can `be held accountable for the acts and omissions of 
their chosen counsel.' '' Id. (quoting Pioneer, 507 U.S. at 397).
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    \2\ While it true that DEA has not adopted any of the various 
federal rules of procedure, it has frequently looked to those rules 
for guidance in interpreting its procedural rules. See Bio 
Diagnostic Inc., 78 FR 39327, 39328-29 & n.1 (2013) (applying 
federal court decisions interpreting Fed. R. Civ. P. 56 (governing 
summary judgment), in determining whether summary disposition was 
appropriately granted in Agency proceeding); Glenn D. Kreiger, 76 FR 
20020, 20021 n.3 (2011) (applying federal court decisions and 
holding that a challenge to the sufficiency of service of a Show 
Cause Order is waived if not raised in a respondent's first 
responsive pleading). In this regard, it is noted that the Federal 
Rules of Civil Procedure have expressly adopted the ``excusable 
neglect'' standard for determining whether ``good cause'' exists to 
extend the time for ``[w]hen an act may or must be done'' when a 
``motion [is] made after the time has expired.'' Fed. R. Civ. P. 
6(b)(1). As agency decisions make clear, the good cause standard is 
not limited to those instances where a respondent or his attorney 
are blameless in failing to timely file a pleading. See, e.g., Tony 
T. Bui, 75 FR 49979, 49980 (2010) (finding good cause existed to 
excuse untimely filed hearing request where attorney used an 
incomplete address to mail the request but when the request was 
returned, promptly proceeded to mail it to the correct address).
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    The ALJ found that Respondent was represented by another attorney 
``at the time [he] was served with the Order to Show Cause,'' and that 
this attorney did not inform him that he would not represent him in the 
DEA proceeding until after the deadline had passed for filing his 
hearing request. Id. at 8-9. The ALJ then concluded that while the 
``[a]ttorney was negligent in failing to tell Respondent in a timely 
fashion that he would no longer represent [him], . . . Respondent 
cannot argue that he detrimentally relied on [the attorney] to send out 
the request for hearing.'' Id. at 9. This was so because ``Respondent, 
himself, sent out the letters to [the DI],\3\ OIG, and [the] Attorney 
General.'' Id. The ALJ thus concluded ``that Respondent was ultimately 
responsible for filing a timely request for hearing, despite his former 
attorney's shortcomings.'' Id.
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    \3\ Regarding the letter to the DI, the ALJ noted that 
Respondent wrote: ``I am writing to you as an appeal for the 
immediate and urgent help in the matter of my DEA license 
reinstatement.'' Termination Order, at 9 n.8 (quoting Motion for 
Reconsideration, Ex. 29, at 1). The ALJ further noted that ``[w]hile 
Respondent's intent may have been to request a hearing, Respondent 
did not explicitly express this intent in the letters he sent before 
April 4, 2013.'' Id.
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    Finally, the ALJ rejected Respondent's contention that his 
``confusion . . . support[ed] a finding of `good cause.' '' Id. As the 
ALJ explained, ``[t]he clear language of the Order to Show Cause states 
that `[c]orrespondence concerning

[[Page 29028]]

this matter, including requests referenced in paragraphs 1 [i.e., a 
hearing request] and 2 above, should be addressed to the Hearing Clerk, 
Office of Administrative Law, Drug Enforcement Administration, 8701 
Morrissette Drive, Springfield, VA 22152.' '' Id. (quoting OTSC-ISO, at 
5). Finding ``that this language is an unmistakably clear explanation 
of where to send a request for hearing, especially for an educated 
professional, such as the Respondent,'' the ALJ held that 
``Respondent's confusion does not justify a finding of `good cause.' '' 
Id.
    The ALJ thus rejected Respondent's contention that he had shown 
good cause to excuse his untimely filing. Id. She further concluded 
that ``Respondent's failure to file a timely request [constituted] a 
waiver of his right to a hearing under 21 CFR 1301.43(d).'' Id. at 9-
10. The ALJ thus denied Respondent's motion to reopen the matter.
    Thereafter, the Government forwarded a Request for Final Agency 
Action and the Investigative Record to me. Having reviewed the record, 
I adopt the ALJ's finding that Respondent did not demonstrate good 
cause for his failure to file his hearing request within the thirty-day 
period as required by 21 CFR 1301.43(a).
    As the ALJ explained, the OTSC-ISO provided a clear explanation as 
to the procedure to be followed for filing a hearing request. That 
procedure required that Respondent or his representative file his 
hearing request with the ``Hearing Clerk, Office of Administrative Law 
Judges, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, VA 22152,'' and that ``[m]atters are deemed filed upon 
receipt by the Hearing Clerk.'' GX 2, at 5.
    Moreover, the OTSC-ISO included an attachment entitled: ``REQUEST 
FOR HEARING.'' Id. at 6. The attachment states that ``[a]ny person 
desiring a hearing with regard to an Order to Show Cause must, within 
thirty (30) days from receipt of the Order to Show Cause, file a 
request for a hearing in the following format.'' Id. The attachment 
then provides a sample form, with the following address block: DEA 
Headquarters, Office of the Administrative Law Judges, Hearing Clerk, 
8701 Morrissette Drive, Springfield, Virginia 22152.

Id. Notably, neither the OTSC-ISO, nor the attachment, directed 
Respondent, if he desired a hearing, to file his hearing request with 
DEA field personnel, the Office of Inspector General, or the Attorney 
General himself.
    Also unavailing is Respondent's reliance on Pincay v. Andrews to 
argue ``good cause'' exists to excuse his untimely filing because 
either he or his lawyer committed ```excusable neglect.' '' \4\ Motion 
for Reconsideration, GX 5, at 7. As the Supreme Court explained in 
Pioneer, ``inadvertence, ignorance of the rules, or mistakes construing 
the rules do not usually constitute excusable neglect.'' 507 U.S. at 
392. Moreover, as the Ninth Circuit noted in Pincay, the ``failure to 
read an applicable rule is one of the least compelling excuses that can 
be offered.'' 389 F.3d at 859. Indeed, as the Ninth Circuit noted in 
Pincay, ``had the district court declined to permit'' the appellant to 
file his notice late, it ``would [have] be[en] hard pressed to find any 
rationale requiring us to reverse.'' Id.
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    \4\ While the ALJ interpreted Respondent's excusable neglect 
argument as being based on his former attorney's failure to tell him 
that he would not represent Respondent until after the deadline had 
passed, Respondent's argument appears to rely on his own confusion 
as to where to file the hearing request and not on the aforesaid 
conduct of the attorney.
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    In his affidavit, Respondent asserts that he ``sought the advice of 
and had several conversations with'' his former attorney ``concerning 
the OSC and filing an appeal,'' and that ``[b]ased on these 
conversations, I `filed' an appeal NOT with the DEA . . . Office of the 
Administrative Law Judges, but instead with the Office of the Inspector 
General.'' Respondent's Declaration, at 9. To the extent Respondent 
seeks to rely on the advice he received from his former attorney to 
support a showing of good cause, his vague assertions do not establish 
that he was ever told not to comply with the instructions on the OTSC-
ISO. Nor does Respondent assert that his former attorney ever agreed to 
represent him in this matter, let alone that he agreed to file a 
request for a hearing on Respondent's behalf. To the extent Respondent 
relies on his own confusion as the reason for his untimely filing, see 
Mot. For Recon., at 8; there is no reason to excuse his neglect when 
the OTSC-ISO was personally served on him and set forth, with 
unmistakable clarity, the procedures to be followed for requesting a 
hearing.\5\
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    \5\ As for Respondent's letters to the OIG and the Attorney 
General, Respondent did not submit a copy of any of these letters 
with his motion. See generally Attachments to Respondent's Motion. 
Indeed, the only letter relevant to this issue which Respondent 
submitted for the record (other than his appeal request) was a copy 
of an April 4, 2013 letter he received from the OIG, which 
``acknowledge[d] receipt of [his] correspondence dated July 11, 
2011'' and explained that his ``complaint has been forwarded to'' 
the DEA ``Office of Professional Responsibility.'' Id. at Ex. 31. 
Obviously, this letter could not have been a response to a misfiled 
hearing request given that it referenced his correspondence, which 
was dated approximately eighteen months before he was even served 
with the OTSC-ISO. Nor, even if the OIG's letter was misdated, does 
it seem likely that it was prepared in response to a hearing 
request, given that it referred to his ``complaint'' and referred it 
to the ``Office of Professional Responsibility.'' Id.
    As for Respondent's assertion that he ``discussed the matter . . 
. with an assistant in [his] office, who believed that the correct 
place to send the appeal was to the office of the Attorney 
General,'' Resp. Decl., at 9; this begs the question of why he did 
not discuss where to file his appeal with the attorney (who had also 
received a copy of the OTSC-ISO) he was then consulting with.
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    Respondent further argues that ``[t]he acceptance and retention by 
[the DI] of the appeal request . . . was misleading, particularly when 
he and [another DI] actively encouraged [him] to file his appeal 
correctly AFTER the appeal period had lapsed'' and that [t]his was a 
source of conflicting guidance for'' him. Id. at 6. However, as the ALJ 
noted, this argument goes nowhere because Respondent does not claim 
that he had any discussion with the DI regarding the manner for 
properly filing his hearing request within the thirty-day period, let 
alone that he was given misleading advice as to how to file his 
request.\6\ Indeed, nothing prevented Respondent from filing a separate 
hearing request with the Office of Administrative Law Judges during the 
thirty-day period. I therefore reject Respondent's contention that his 
untimely filing should be excused because he relied on ``conflicting 
guidance'' he received from agency personnel. See Watterson, 67 FR at 
67413.
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    \6\ So too, if there was evidence that the DI had told 
Respondent that he would forward his hearing request to the Office 
of Administrative Law Judges and failed to do, I would order that a 
hearing be granted. Respondent, however, makes no such claim, but 
rather, relies only on the DI's silence during the period for 
requesting a hearing.
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    Accordingly, I hold that Respondent has failed to demonstrate good 
cause to excuse his failure to timely file his hearing request. I 
therefore find that Respondent has waived his right to a hearing on the 
allegations and issue this Decision and Order based on the 
Investigative Record (including Respondent's Declaration) submitted by 
the Government. I make the following findings.

Findings of Fact

    Respondent was the holder of DEA Certificate of Registration 
#BL6283927, pursuant to which he was authorized, prior to the Immediate 
Suspension of his registration, to dispense controlled substances in 
schedules II through V as a practitioner, at the registered address of 
6603 220th Street SW., Mountlake Terrace, Washington 98043. GX 1.

[[Page 29029]]

Respondent's registration was due to expire on March 31, 2014. Id. 
However, according to the registration records of the Agency, on March 
13, 2014, Respondent submitted an application to renew his 
registration. While under the Agency's regulation, his renewal 
application was untimely because he was subject to an Order to Show 
Cause and Immediate Suspension of Registration and did not submit the 
application ``at least 45 days before the date on which [his] 
registration [wa]s due to expire,'' 21 CFR 1301.36(i), and thus his 
registration has expired, his application remains pending before the 
Agency.
    Respondent is also licensed by the State of Washington (as well as 
by the States of Texas and California) as an Osteopathic Physician. 
Resp. Declaration, at 1. According to Respondent, he has never been 
subject to discipline by any state licensing body. Id. However, 
Respondent has been subject to discipline by the Texas Medical Board. 
Moreover, while this matter was pending, the Washington Board of 
Osteopathic Medicine and Surgery issued Respondent an Ex Parte Order of 
Summary Action which suspended his state license to practice as an 
osteopathic physician and surgeon. In re Keith Ky Ly (Wash. Bd. 
Osteopathic Med. & Surg., Sep. 22, 2014) (Ex Parte Order of Summary 
Action, at 1).
    With respect to the Texas Medical Board, on May 20, 2011, 
Respondent entered into an Agreed Order. See In re Application for 
Licensure By Keith Ly, D.O., at 6 (Tx. Med. Bd. 2011). Therein, the 
Texas Board found that Respondent failed to report on his application 
for a Texas Medical License that in February 1990, while undergoing his 
``residency training,'' he had been ``placed on probation'' for being 
late and missing shifts, as well as for failing to report a 2007 
arrest. Id. at 2. While the Board granted Respondent a license, it also 
assessed an administrative penalty of $5,000 and placed him on 
probation for two years.\7\ Id. at 3-4.
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    \7\ Based on the Texas Board's action, the Washington Board 
filed a Statement of Allegations against Respondent. See In re Keith 
K. Ly, No. M2010-1665, Statement of Allegations and Summary of 
Evidence (Wash. Dept. Health, Oct. 12, 2012). However, these 
allegations were settled in a Stipulation To Informal Disposition, 
the terms of which included that it ``is not [a] formal disciplinary 
action.'' See Stipulation To Informal Disposition, In re Ly, at 2. 
However, the proceeding was still subject to reporting to the Health 
Integrity and Protection Databank and the National Practitioner 
Databank. Id.
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    Accordingly, I find that notwithstanding his statement, Respondent 
has been subject to discipline by a state licensing body. While the 
basis of the Texas Board's action does not provide a reason under the 
CSA for DEA to take any action against Respondent's registration, 
Respondent's statement was nonetheless false and clearly offered to 
influence the decision of the Agency to grant him a hearing on the 
allegations. Accordingly, I consider Respondent's lack of candor in 
assessing the credibility of the various assertions contained in his 
declaration.

The Arrest of Respondent's Girlfriend

    According to the DI, on February 2, 2012, Respondent's girlfriend 
(TB),\8\ who was driving his Mercedez Benz SL 65,\9\ was stopped by 
local police, cited for driving under a suspended license, and 
arrested. DI Decl., at 1; Resp. Decl., at 3. Respondent corroborated 
that the car was his, when in his declaration he addressed the 
allegation and stated, inter alia, that on January 24, 2012, he had 
withdrawn $5000 from his bank account to pay for the remodeling of his 
clinic and left the money ``in the small hidden compartment space of 
the car.'' Resp. Decl., at 3. Accordingly, I find that Respondent's 
statements corroborate the DI's assertion that the car was owned by 
Respondent.
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    \8\ According to Respondent, TB has lived with him ``for the 
past 2 years'' and ``is now [his] wife.'' Resp. Decl., at 5. 
Moreover, TB worked in Respondent's clinic. Resp. Decl., at Ex. 4.
    \9\ According to the DI's affidavit, the car was registered to 
Respondent. DI's Decl., at 1. While the DI's affidavit offers no 
explanation as to the basis of knowledge for this assertion, 
Respondent, in his declaration, stated that a friend of TB ``had 
borrowed the car the previous day without my knowledge.'' Resp. 
Decl., at 3. I further note that in a March 3, 2012 letter to a 
local narcotic task force and the King County Prosecuting Attorney's 
Office, Respondent claimed that he owned the car and sought its 
return. Resp. Decl., at Ex.4. Accordingly, I find that Respondent 
owned the car that TB was driving when she was stopped and arrested.
---------------------------------------------------------------------------

    Following the arrest of Respondent's girlfriend, the police 
apparently impounded his car, and upon searching it, found one pound of 
marijuana,\10\ the aforesaid $5000, and a backpack which contained pain 
medication. Id.; DI Decl., at 2.\11\ As for the marijuana, Respondent 
asserted that it belonged to a medical marijuana patient (LHE) who was 
a friend of TB, and points to a statement from the purported owner of 
the marijuana. Resp. Decl., at 3; see also Resp. Mot., at Ex.1. 
Therein, LHE stated that she had an engine problem with her car and 
that she borrowed Respondent's car from TB ``for a few hours to pick-up 
. . . one [m]arijuana prescription bag'' from a marijuana collective. 
Resp. Mot., at Ex. 1. According to LHE, she ``was in a hurry to return 
the car to [TB and] forget [sic] to remove the bag behind the driver 
seat.'' Id. However, LHE's statement is unsworn, and given that the 
purported reason for borrowing Respondent's car was to obtain the 
marijuana, I find her story that she left a one pound bag of marijuana 
\12\ in the car because she was in such a hurry to return it to be 
utterly ludicrous.\13\
---------------------------------------------------------------------------

    \10\ In his statement, Respondent does not dispute that the 
arresting authorities found a one pound bag of marijuana. Resp. 
Decl., at 3.
    \11\ According to the DI, the police also found $3900 in cash in 
a vacuum sealed bag in TB's purse. DI Decl., at 2.
    \12\ According to data collected by the Agency, during the 
period in which TB was stopped, one pound of marijuana had a street 
value of $1500 to $1800 in the Seattle area. At .5 grams per joint, 
one pound would be enough to make approximately 900 joints.
    \13\ I further note that in his March 3, 2012 letter to a local 
narcotics task force and the King County Prosecuting Attorney's 
Office, in which he sought the return of his car, while Respondent 
again denied knowledge of the marijuana, he made no mention of the 
story that LHE had borrowed the car from his girlfriend.
---------------------------------------------------------------------------

    As for the cash, Respondent offered two explanations for its 
source. First, he maintained that the day before, a patient paid him 
$5000 cash as a deposit for a liposuction procedure. Resp. Decl., at 3. 
Respondent also produced an unsworn letter from the purported patient 
to this effect and a form entitled: ``SmartLipo & Coolsculpting Price 
Quote.'' Id. at Ex. 2. While the latter purports to show that the 
patient paid a $5000 deposit in cash, the date of the deposit clearly 
appears to have been altered. See id.
    Second, as found above, Respondent maintained that he had withdrawn 
$5,000 from his bank account on January 24, 2012 to pay for clinic 
remodeling, and that he had placed the money ``in the small hidden 
compartment space of the car.'' Resp. Decl., at 3. To support his 
claim, Respondent produced a bank statement showing that he made a cash 
withdrawal of $5,000. Resp. Ex. 3. However, numerous entries in the 
statement, including Respondent's various balances for both his 
checking and savings account, are blacked out. Id.
    Putting aside that Respondent offered two different stories as for 
why so much cash was found in his car, I find neither explanation 
credible. As for the claim that the money was from a patient who had 
paid $5,000 cash the day before for a procedure, the patient's 
statement is unsworn and thus lacks even the most basic indicia of 
reliability. Moreover, on the price quote form, the date of the 
patient's deposit was clearly written over. Also, even acknowledging 
that the patient's procedure was likely not covered by insurance, it 
seems most unlikely that the patient would pay this

[[Page 29030]]

amount in cash rather than by check or credit card.
    As for his second story, it also seems most unlikely that 
Respondent would pay to remodel his clinic with cash (rather than check 
or credit card), let alone be carrying that much cash around in his car 
for nine days. By contrast, carrying large sums of cash is consistent 
with engaging in the distribution of marijuana.
    In his declaration, the DI also asserted that the search of the 
vehicle found ``multiple prescription bottles containing pills,'' and 
that one of the bottles bore a label indicating that the drugs had been 
prescribed to T.V., ``an office employee of'' Respondent. DI's Decl., 
at 2 (citing GX 9). The DI further stated that ``[t]wo of the bottles 
found in the vehicle . . . were unlabeled and contained phentermine and 
phendimetrazine.'' Id. (citing GX 10). Finally, the DI asserted that 
when Respondent ``attempted to recover his vehicle, he told law 
enforcement officers that his employees often shared their 
medication.'' Id.
    Respondent did not dispute that drugs were found in TB's backpack. 
Rather, he asserted that they ``belonged to my office manager,'' that 
he had prescribed the drugs ``for her liposuction procedure pain a few 
months prior,'' and that the drugs were ``left at my house when she 
visited for [a] dinner party.'' Resp. Decl., at 3. Respondent then 
maintained that ``[a]s a medical doctor, I do not encourage nor allow 
any patients to share medication'' and that he ``would absolutely 
terminate my employee if found engaging in sharing medication and would 
report them to the authorities.'' Id. Respondent did not, however, 
explain when the purported dinner party had occurred.
    Consistent with Respondent's admission, the record does include a 
photograph of a prescription vial; its label lists the patient as a 
person whose name corresponds with the initials T.V., the drug as 
hydrocodone/acetaminophen, and Respondent as the prescriber. See GX 9, 
at 1.\14\ Moreover, while the photograph does not show whether there 
were pills remaining in the vial, in his declaration, Respondent does 
not dispute that the vial contained pain medication, which hydrocodone 
is. I thus find that substantial evidence supports a finding that 
Respondent's girlfriend unlawfully possessed hydrocodone, which had 
been prescribed to another person.
---------------------------------------------------------------------------

    \14\ Government Exhibit 9, however, contains seven additional 
photographs, including: (1) A photograph of two unlabeled vials 
(only one of which clearly contains tablets); (2) a photograph of 
two plastic bags, which purportedly contain phentermine and a red 
document, the date of which is unclear; (3) a photograph of a 
plastic bag containing a drug similar in appearance to the drug in 
the previous photograph; (4) a photograph of a vial containing 
yellow capsules and orange tablets, the label of which had been 
removed; (5) a vial bearing a label for a prescription issued by 
Respondent for clonazepam to a patient whose initials are R.M.; (6) 
six bottles bearing manufacturer's labels (several of which are 
labelled as professional samples) for Viagra, Topiramate, Ultram ER, 
and Meridia; and (7) two vials, whose labels list Respondent as the 
prescriber, his girlfriend T.B. as the patient, and the drugs as 
lorazepam and hydrocodone/acetaminophen, with pills being visible 
only in the latter vial. Generally, the DI's declaration offers no 
statements linking these photographs to the various items which were 
purportedly seized during the various searches of Respondent's car 
and properties he owned.
    Moreover, Government Exhibits 8, 9, 10, 11a, 11b, 13, 14, and 15 
each contain the exact same set of eight photographs, although not 
necessarily in the same order. Providing multiple copies of the 
exact same set of photographs does not, however, make the first set 
of photographs any more probative of the facts for which they were 
offered.
---------------------------------------------------------------------------

    In support of the DI's assertion that two unlabeled vials which 
contained phentermine and phendimetrazine were also seized, the DI 
cited Government Exhibit 10, but without regard to the specific page. 
However, in his declaration, the DI offered no statement to the effect 
that he participated in the search of Respondent's car, nor otherwise 
set forth the basis of his knowledge for making this assertion. Nor 
does the record contain any affidavits or police reports prepared by 
those officers who did participate in the arrest and search, nor other 
documents such as an inventory of the search, a chain of custody, and 
lab test results, which would support the DI's assertion.\15\
---------------------------------------------------------------------------

    \15\ Even giving weight to the DI's assertion that Respondent 
``purchased these items [i.e., phentermine and phendimetrazine] on 
August 5, 2011 from Distributor A.F. Hauser,'' DI's Decl., at 5 (] 
34), this is not enough to overcome the insufficiency of the 
evidence with respect to the assertion that these drugs were seized 
during the February 2, 2012 search.
---------------------------------------------------------------------------

    Indeed, while Government Exhibit 10 contains eight photographs, in 
reviewing this matter it is apparent that the exhibit is not limited to 
the evidence that was seized following the search of Respondent's car, 
but also contained photographs of evidence that may well have been 
seized during several of the searches described below. Most 
significantly, the Exhibit contains two photographs of vials (one 
showing two vials, the other showing a single vial) which were missing 
their labels, with no identification of when and from whom the vials 
were seized. Finally, while at least two of the vials appear to contain 
tablets (the third vial being murky), the Government provided no 
evidence (such as lab test results) explaining the basis for the DI's 
assertion that these vials contained phentermine and phendimetrazine.

The Searches of Respondent's Properties

    As noted above, the Show Cause Order also alleged that state and 
local law enforcement officers conducted searches of four different 
premises which Respondent owned, and found marijuana plants at his 
properties which were located in Renton and Shoreline, Washington, as 
well as six bags of processed marijuana at the latter property. GX 2, 
at 2. In addition, the Show Cause Order alleged that marijuana grow 
documents and ``15 grams of processed marijuana'' were found at 
Respondent's personal residence, and that both marijuana grow equipment 
and marijuana leaves were found at a fourth property he owns. Id. at 3.
    In his declaration, the DI made various assertions with respect to 
each of the searches. For example, with respect to the May 30, 2012 
search of the Renton residence, the DI stated that the Renton Fire 
Department had responded to an electrical fire at the premises, which 
``is owned by'' Respondent and ``discovered a large marijuana grow,'' 
and that thereafter, ``[t]he Renton Police Department executed a search 
warrant of the residence and seized approximately 700 marijuana 
plants.'' DI Decl., at 2. The DI further stated that Respondent ``told 
law enforcement that he rented the [premises] to [one] Jack Tran,'' but 
that the police ``were unable to locate and/or identify Mr. Tran.'' Id. 
at 3. While all of this may be true, here again, the DI's declaration 
offers no statement to the effect that he participated in the search, 
nor otherwise sets forth the basis of his knowledge.
    With respect to the July 5, 2012 search of the Shoreline residence, 
the DI stated that it was owned by Respondent, and that during the 
search by state and local law enforcement, ``approximately 489 
marijuana plants and six (6) bags of processed marijuana'' were seized. 
Id. at 3. The DI further stated that TB and three other ``marijuana 
tenders were arrested leaving the Shoreline residence,'' that TB 
``admitted'' to the police ``that she was learning to grow marijuana at 
the Shoreline residence,'' and that two ``of the marijuana tenders 
arrested at the Shoreline residence possessed loose phentermine tablets 
in their pockets.'' Id. (citing GX 11).\16\ Here

[[Page 29031]]

too, all of this may be true, but the DI's affidavit offers nothing 
bordering on substantial evidence to support any of these 
assertions.\17\
---------------------------------------------------------------------------

    \16\ As explained below, while Respondent denies knowledge as to 
how his properties were being used, he does not dispute that 
marijuana was being grown at the various properties. Thus, his 
declaration corroborates the basic thrust of the DI's assertions.
    That being said, the DI's affidavit contains numerous assertions 
for which there is no foundation to conclude that they are based on 
the DI's ``personal knowledge'' as that term is commonly understood. 
Indeed, many of the DI's assertions regarding the searches of 
Respondent's properties appear to be based on hearsay statements, 
the reliability of which cannot be assessed because the DI did not 
identify the source of the information and the Government did not 
include various documents (such as police reports, search 
inventories, and test results) in the record.
    More specifically, the DI asserts that TB and three other 
persons were arrested during the search of the Shoreline residence; 
that during an interview with law enforcement, TB admitted that she 
was learning how to grow marijuana; and that two of the persons had 
loose phentermine tablets in their pockets. Again, the DI offered no 
statement to the effect that he participated in either the search of 
the Shoreline residence or the interview of TB. Nor did he set forth 
any other basis for these assertions.
    As for the two marijuana tenders who purportedly possessed loose 
phentermine, the DI further asserted that ``[s]tate law requires the 
labeling of dispensed medication'' and that ``[t]he lack of labeled 
prescription bottles suggests the controlled substances were 
diverted.'' DI's Decl., at 3. This too may be true, but there is no 
evidence in the record establishing the names of these individuals 
and that they obtained the controlled substances from Respondent. 
Indeed, while the DI cited GX 11 as support for his assertion that 
these individuals possessed phentermine, this exhibit simply 
contains a series of photographs including two of white tablets (one 
of which contains a red form which is illegible), various 
prescription vials (some of which contain pills, others which it is 
unclear if they do) and bottles containing various drug samples. 
Even assuming that the white tablets are phentermine (even though 
there is no evidence they were tested), nothing in the record 
establishes from whom and when these tablets were seized.
    \17\ Here too, even giving weight to the DI's assertion that 
Respondent ``purchased this exact item [i.e., more phentermine] on 
March 16, 2012 from Distributor A.F. Hauser,'' DI Decl., at 5 (] 
35), this evidence does not overcome the insufficiency of the 
evidence with respect to the assertion that these drugs were seized 
from the marijuana tenders during the search of the Shoreline 
residence. And because the evidence is insufficient to establish 
that loose phentermine was seized from the two marijuana tenders who 
were purportedly at the Shoreline residence, the assertions of the 
DI that: (1) One of the tenders ``was never seen by'' Respondent, 
and (2) that while one of the tenders was seen by Respondent, he was 
not prescribed any controlled substance, id. at 5-6 (] 36), is 
insufficient to establish that Respondent unlawfully distributed the 
phentermine to either person.
---------------------------------------------------------------------------

    The DI further asserted that L.E. was one of the marijuana tenders 
arrested during this search, and that using the Washington State 
Prescription Monitoring Program, ``[i]t was discovered . . . that in 
June 2012, [Respondent] prescribed 30 dosage units of 10/500 mg 
hydrocodone to L.E.'' Id. Citing Government Exhibit 12, the DI further 
stated that he ``verified the prescriptions [sic] by obtaining a hard 
copy of the prescription through'' the pharmacy which filled it. Id. at 
3-4. The DI then stated that on July 13, 2012, he subpoenaed ``L.E.'s 
patient chart from'' Respondent, but that ``[t]he office staff could 
not locate a patient chart for L.E., nor could they find his/her name 
in the electronic medical records.'' Id. at 4.
    Government Exhibit 12 is a copy of a prescription issued by 
Respondent on June 28, 2012 for thirty (30) tablets of Lortab 
(hydrocodone/acetaminophen) 10/500. See GX 12. However, the 
prescription was issued to a patient whose initials are H.L., and not 
L.E. See id. Thus, the prescription does not support the DI's 
assertion, and the Government points to no other evidence that 
Respondent prescribed a controlled substance to a patient whose name 
corresponds with the initials of L.E., let alone that he violated the 
CSA's prescription requirement in doing so. See GX 2, at 2, ] 3-b. 
(OTSC-ISO).
    Regarding the July 6, 2012 search of Respondent's and TB's 
residence (which is owned by the former), the DI asserted that state 
and local law enforcement seized ``firearms, marijuana grow documents, 
approximately 15 grams of processed marijuana, and multiple 
prescription bottles containing pills.'' DI Decl., at 4. The DI then 
stated that Investigators found ``an unlabeled'' vial, ``which 
contained hydrocodone''; one labeled vial, ``which contained clonazepam 
that [Respondent] prescribed to patient R.M. in 2010''; and two ``stock 
bottles that contained Meridia and diazepam''; even though Respondent 
``was not, nor has ever been, registered with DEA at his Bothell 
residence.'' Id. (citing GXs 13, 14, and 15).
    As for the unlabeled prescription bottle which purportedly 
contained hydrocodone, here again, the DI's Declaration is devoid of 
any statement that he was present during the search and there is no 
other evidence establishing that the vials were seized from 
Respondent's residence. And while GX 13 contains a photograph of two 
vials, with pills that are barely visible in the vials, there is no 
photograph of the pills outside of the vials, which might have shown 
that the pills bore the NDC Code for hydrocodone. Nor is there any 
evidence establishing that the pills were tested by a laboratory and 
found to be hydrocodone.\18\
---------------------------------------------------------------------------

    \18\ Even giving weight to the DI's assertion that Respondent 
``purchased this item [i.e., hydrocodone] on March 16, 2012 from 
Distributor A.F. Hauser, Inc.,'' DI Decl., at 6 (] 37); this 
statement likewise does not overcome the lack of substantial 
evidence establishing that these drugs were seized during the search 
of Respondent's residence.
---------------------------------------------------------------------------

    As for the DI's assertion that the police also seized a vial 
containing clonazepam, here again, there is no evidence either that the 
DI was present during the search of Respondent's residence or that a 
vial containing this drug was seized during that search. And while the 
record contains a photograph of a vial, which bears a label listing 
Respondent as the prescriber, the drug as clonazepam, and the patient's 
name corresponding with the initials R.M., there is no evidence 
establishing that any pills were in the vial, let alone that the pills 
were clonazepam.\19\
---------------------------------------------------------------------------

    \19\ In his Declaration, Respondent denied that he ``ha[s] or 
store[s] any [h]ydrocodone or [c]lonazepam at home.'' Resp. Decl., 
at 5. He further stated that ``[t]he prescription bottles are 
prescribed for my wife for her liposuction procedures post-
operational pain where she had four liposuction procedures performed 
from 7/9/11 to 11/3/12.'' Id.
---------------------------------------------------------------------------

    Turning to the DI's assertion that Respondent ``also possessed two 
(2) stock bottles that contained Meridia and diazepam,'' here again, 
there is no evidence establishing that the DI participated in the 
search of Respondent's residence, or any other evidence establishing 
that these drugs were seized during that search. To be sure, the 
Government cites to an exhibit, which contains several photographs, 
including one which shows six white bottles (several of which are 
clearly marked as professional samples) which bear the manufacturer's 
label for such drugs as Viagra, Topiramate, Ultram ER, and Meridia. See 
GX 15, at 1. However, of these drugs, only Meridia (sibutramine) is a 
controlled substance under federal law, 21 CFR 1308.14(e), and putting 
aside the absence of any evidence as to where and when this drug was 
seized, here again, there is no evidence that there actually was any of 
the drug in the bottle at the time it was seized. As for the DI's 
assertion that a stock bottle of diazepam was also seized during the 
search of Respondent's residence, here too, there is no evidence 
(indeed, not even a photograph of the bottle) to support the DI's 
contention.
    Finally, the DI stated that on July 7, 2012, state and local law 
enforcement executed a search warrant at a fourth residence which is 
owned by Respondent and located in Marysville, Washington. DI Decl., at 
5. The DI further stated that during the search, the officers ``seized 
some marijuana grow equipment and marijuana leaves.'' Id. Here again, 
the DI's affidavit does not establish the basis of his knowledge.
    Regarding the searches of the properties other than his residence, 
Respondent acknowledged that he owned ``three rental properties.'' 
Resp. Decl., at 3. He also acknowledged that

[[Page 29032]]

``one of the rental houses had an electrical burn that shed light on 
the others that had illegal activities.'' Id. at 4. He then asserted 
that he ``had irresponsible tenants that took advantage of the 
locations by cultivating [m]arijuana for 6 months without [his] 
knowledge'' and that he ``do[es] not personally inspect, supervise, or 
manage the rentals on a regular basis,'' because he works six days a 
week in his medical practice, and that ``[w]hen the rent is timely paid 
with no complaints that need repair, [he has] no need to bother tenants 
at their home.'' Id. at 3-4. Later in his declaration, Respondent 
stated that ``[i]f something is broke they send me a bill for repair 
and I deduct it from the rent.'' Id. at 5.
    On May 22, 2013, Respondent was indicted in United States District 
Court for the Western District of Washington and charged with 
conspiracy to manufacture and distribute marijuana. DI Decl., at 11; 
see also GX 31. Moreover, on October 22, 2013, a superseding indictment 
was filed against Respondent and his girlfriend.
    The superseding indictment alleged that Respondent and others 
conspired to grow marijuana at several residential properties and that 
Respondent ``made at least three of those properties available . . . 
for the purpose of manufacturing marijuana,'' that he ``purport[ed] to 
rent [the houses] to others, knowing that the persons listed as 
`tenants' for these properties did not, in fact, reside there and/or 
did not pay rent,'' that he and his co-conspirators ``set up large-
scale marijuana grows for the purpose of manufacturing marijuana within 
the houses'' and ``caused the electrical power in these houses to be 
diverted around the meters, thus stealing power to run the marijuana 
grows,'' and that he and his co-conspirators ``recruited and directed 
others to help grow and harvest the marijuana plants, and maintain the 
houses and yards at these properties.'' Superseding Indictment, at 2, 
United States v. Thi Nguyen Tram Bui and Keith Ky Ly, No CR13-157JCC 
(W.D. Wash. 2013) (citing, inter alia, 21 U.S.C. 841(a)(1) and 
(b)(1)(A), 846). The Indictment further charged Respondent with three 
counts of manufacturing marijuana at his properties in Renton, 
Shoreline and Marysville, Washington, as well as three counts of 
maintaining drug-involved premises. Id. at 4-7 (citing 21 U.S.C. 
841(a)(1) and (b)(1)(B); 856(a)(1) and 856(b)). The indictment also set 
forth additional allegations regarding the quantities of marijuana 
plants and/or harvested marijuana that were seized during the searches 
of his Renton and Shoreline properties, as well as the quantity of 
marijuana which was seized from his girlfriend. Id. at 3.
    Respondent went to trial; the jury found him guilty on all 
counts.\20\ On December 19, 2014, the United States District Court 
convicted Respondent on each of the above counts and sentenced him to 
60 months of imprisonment, imposed a four-year term of supervised 
release following his release from imprisonment, imposed an assessment 
of $1,000, and ordered that various property be forfeited. Judgment, at 
1-6, United States v. Keith K. Ly (W.D. Wash. Dec. 19, 2014).
---------------------------------------------------------------------------

    \20\ Respondent was also charged and convicted of three counts 
of wire fraud, based on claims he made to an insurance company.
---------------------------------------------------------------------------

The DEA Investigation

    According to the DI's affidavit, on July 13, 2012, DEA 
Investigators visited Respondent's registered location and upon 
obtaining his consent, conducted an inspection. DI's Decl., at 6; see 
also GX 20 (Notice of Inspection manifesting Respondent's consent to 
the inspection and witnessed by the DI). As part of the inspection, the 
Investigators asked Respondent to produce his records, including his 
controlled substance inventories, dispensing and administration logs, 
invoices, returns, distributions, as well as theft and loss reports. 
Id.
    The DIs determined that Respondent ``failed to take and maintain an 
initial or biennial inventory of all stocks of controlled substances on 
hand.'' Id. While Respondent produced a dispensing log, which covered 
the period from December 23, 2010 to July 11, 2012, according to the 
DI, 128 of the entries lacked required information. Id. More 
specifically, the DI asserted that 82 entries did not have the 
patient's address, the name of the controlled substance, the finished 
form, and the dispenser's initials. Id. at 6-7. According to the DI, 
another 46 entries lacked the patient's address, name of the controlled 
substance, the quantity dispensed, and the dispenser's initials. Id. at 
7.
    As part of the record, the Government submitted a copy of 
Respondent's dispensing log. GX 21. A review of the log corroborates 
the DI's assertion that many of the entries which record the dispensing 
of controlled substances lack various items of information required by 
federal law, including the patient's address and the dispenser's 
initials. See id. at 6-9. As for the contention that numerous entries 
did not contain the name of the controlled substance that was 
dispensed, it is true that numerous entries were missing the 
``Medication ID Sticker.'' Id. at 1-5. Yet the Government produced no 
evidence to prove that these dispensings actually involved controlled 
substances as opposed to non-controlled drugs.
    The DI also asserted that Respondent ``failed to maintain or 
provide any dispensing/administration records for Testosterone and 
Testim samples located at the registered location.'' DI Decl., at 7. 
The DI further asserted that Respondent did not ``maintain[ ] at least 
four Schedule III-V acquisition invoices and by not recording the dates 
of receipt on at least five invoices.'' Id.\21\
---------------------------------------------------------------------------

    \21\ The DI also stated that during the inspection, Respondent 
did not provide any ``Report[s] of Theft or Loss of Controlled 
Substances'' (DEA Form 106). DI Decl., at 7. He also reviewed all of 
the hard copy Theft and Loss Reports on file with the Seattle Field 
Office, as well as queried the Drug Theft Loss database, which 
gathers all of the Form 106s which are submitted online, and 
determined that Respondent had not submitted any such reports. Id.
---------------------------------------------------------------------------

    The DIs also conducted an audit of the controlled substances which 
were located at Respondent's registered location. Id. In his 
declaration, the DI stated that ``DEA used an initial inventory date of 
January 1, 2012, beginning of business, and noted that the initial 
inventory was `zero' due to the lack of an initial or biennial 
inventory.'' Id. To determine the amounts of the various drugs 
Respondent purchased, the DIs relied on ``a summary of the invoices 
provided by distributor A.F. Hauser''; they also used his dispensing 
log to determine the amounts that he dispensed. Id. The DI further 
stated that he used ``the closing inventory assembled by DEA 
investigators during the on-site inspection.'' Id.
    The DI then asserted that the ``audit revealed large shortages of 
testosterone, phentermine, phendimetrazine, and a 14% shortage or[sic] 
hydrocodone.'' Id. More specifically, the DI asserted that Respondent 
had a shortage of 300 mg of Testosterone 200 mg/ml, 6,028 tablets of 
phentermine 37.5 mg,\22\ 2,102 tablets of phendimetrazine 35 mg, and 71 
tablets of hydrocodone 10/500 mg. Id. at 8.
---------------------------------------------------------------------------

    \22\ According to the DI's declaration, the shortage was 6.028 
tablets. DI Decl., at 8. Based on the audit chart, which lists the 
shortage as 6,028 tablets, GX 23, I conclude that the former figure 
is a typographical error.
---------------------------------------------------------------------------

    The Government also submitted a document which appears to be the 
aforesaid summary of Respondent's controlled substance purchases from 
A.F. Hauser between January 1, 2010 and July 24, 2012, see GX 16, as 
well as the audit computation chart. GX 23. Significantly, the audit 
chart lists the initial inventory date as ``1-1-2010 COB'' and not 
January 1, 2012 as set

[[Page 29033]]

forth in the DI's declaration. Compare GX 23 with DI Decl., at 7.
    This disparity has a material impact on the accuracy of the audit 
results. For example, according to the DI's declaration (and the 
computation chart), Respondent was short more than 6,000 dosage units 
of phentermine. Yet, according to the summary of Respondent's purchases 
and the invoices, Respondent only purchased 3,000 dosage units of 
phentermine during 2012. Thus, if--as stated by the DI--the beginning 
date of the audit period was January 1, 2012 and zero was assigned as 
the opening inventory, Respondent could not have been short 6,000 
dosage units.
    So too, in his declaration, the DI asserted that Respondent was 
short more than 2,100 phendimetrazine tablets (the same figure listed 
on the computation chart, which also lists 3,000 dosage units as having 
been purchased). However, the Government's other evidence shows that 
Respondent did not purchase any phendimetrazine during 2012. See GX 16. 
Here again, Respondent could not have been short 3,000 dosage units if 
the beginning date of the audit period was January 1, 2012, as stated 
by the DI in his sworn declaration.
    As for the testosterone, while there is evidence that Respondent 
also purchased testosterone in February 2012, the data as presented in 
the computation chart suggests that he purchased 400 10ml bottles and 
that he could not account for 300 bottles. See GX 23 (listing drug as 
``Testosterone 200mg/ml--10 ml bottle'' and listing the ``[t]otal 
purchased'' as 400.) However, the Government's other evidence, i.e., 
the listing of Respondent's purchases, which according to the DI was 
prepared by A.F. Hauser, lists the quantity of Respondent's purchases 
as only ``2.00.'' GX 19. Thus, here again, there is reason to question 
the reliability of the audit results.\23\
---------------------------------------------------------------------------

    \23\ Moreover, even if the entry in the computation chart was 
actually intended to be 400mg (or two bottles) as opposed to 400 
bottles, at most Respondent would not be able to account for 1.5 
bottles.
---------------------------------------------------------------------------

    With respect to the remaining drugs, there is evidence that 
Respondent purchased 500 dosage units of hydrocodone during 2012 (GX 
19) and was short 71 tablets. GX 23. There is also evidence that at the 
time of the July 2012 inspection, Respondent had on hand 21 Testim 1% 
samples. While the DIs concluded that Respondent had an overage of 
these 21 samples, there is no evidence as to who distributed the 
samples to him and there is no evidence the DIs asked Respondent for 
any of the documentation establishing the amount of Testim that was 
distributed to him.\24\ Finally, the Government's evidence shows that 
in March 2012, Respondent purchased 1,000 dosage units of Lorazepam, GX 
16, and the computation chart indicates that the audit balanced with 
respect to this drug. GX 23.
---------------------------------------------------------------------------

    \24\ It is further noted that while the computation chart 
contains a column for the ``Total Purchased,'' which was added to 
the ``Initial Inventory'' to arrive at the ``Amount Accountable 
For,'' samples are not typically purchased and the chart contains no 
column for other means of acquisition. GX 23.
---------------------------------------------------------------------------

    In his declaration, the DI further asserted that Respondent failed 
to report to the State of Washington's Prescription Monitoring Program 
(PMP), ``at least 45 occasions from January through July 2012'' in 
which he ``dispensed more than a 24-hour supply of controlled 
substances.'' DI Decl., at 8. According to the DI, this was a violation 
of Washington law. Id. The Government did not, however, submit the PMP 
reports which establish the basis for its assertion.
    Regarding this allegation, Respondent stated that he ``was not 
aware of this Washington State law requirement . . . [and] thus cannot 
have . . . repeatedly failed'' to comply or to have shown a 
``consistent disregard'' for this requirement. Resp. Decl., at 8. 
Respondent then stated that ``I am now made fully aware and will comply 
with the law. This is not an intentional violation.'' Id.\25\
---------------------------------------------------------------------------

    \25\ Based on the DI's Declaration, the Government proposes that 
I make a factual finding that following the issuance of the 
Immediate Suspension Order, Respondent ``issued at least three (3) 
prescriptions to two (2) separate patients on February 1, March 2, 
and March 30, 2013, in violation of the Order.'' Request for Final 
Agency Action, at 5 (citing DI's Declaration at 9-10). However, in 
its Request for Final Agency Action, the Government does not propose 
that I make any conclusion of law based on this conduct. See id. at 
6-12. Accordingly, I do not consider this conduct.
---------------------------------------------------------------------------

Discussion

    Under the CSA, ``[a] registration pursuant to section 823 of this 
title to manufacture, distribute, or 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.'' \26\ 21 U.S.C. 
824(a)(4). The Act further provides that in determining ``the public 
interest'' with respect to a practitioner's application, the following 
factors be considered:
---------------------------------------------------------------------------

    \26\ Pursuant to 28 CFR 0.100(b), this authority has been 
delegated by the Attorney General to the Administrator of the Drug 
Enforcement Administration.

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing, or conducting 
research with respect to controlled substances.
    (3) The [registrant'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.

21 U.S.C. 823(f).

    ``[T]hese 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)).\27\
---------------------------------------------------------------------------

    \27\ ``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. See 
MacKay, 664 F.3d at 821.
---------------------------------------------------------------------------

    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. 824(a) are met. 21 CFR 1301.44(e). This is so even in a 
non-contested case.
    In this matter, I have considered all of the factors. While I find 
that some of the allegations are not supported by substantial evidence, 
I nonetheless find that the Government's evidence with respect to 
factors one, two, three, and four establishes that he has committed 
acts which render his registration ``inconsistent with the public 
interest.'' 21 U.S.C. 823(f). While I have also considered Respondent's 
declaration with respect to the various allegations, I conclude that he 
has not presented sufficient evidence to rebut this conclusion. 
Accordingly, I will affirm the suspension of his registration and

[[Page 29034]]

further order that his pending application be denied.

Factor One--The Recommendation of the State Licensing Board

    As found above, on September 22, 2014, the Washington Board of 
Osteopathic Medicine and Surgery issued Respondent an Ex Parte Order of 
Summary Action, pursuant to which, his authority to practice medicine 
in the State was suspended. Under the CSA, a practitioner's possession 
of authority to dispense controlled substances under the laws of the 
State in which he seeks registration is a prerequisite to obtaining a 
registration. See 21 U.S.C. 823(f) (``The Attorney General shall 
register practitioners . . . to dispense . . . controlled substances . 
. . if the applicant is authorized to dispense . . . controlled 
substances under the laws of the State in which he practices.''); see 
also id. Sec.  802(21) (defining ``[t]he term `practitioner' [to] 
mean[] a physician . . . licensed, registered, or otherwise permitted, 
by the United States or the jurisdiction in which he practices . . . to 
. . . dispense . . . [or] administer . . . a controlled substance in 
the course of professional practice'').
    Because Respondent is no longer authorized by the State of 
Washington to practice medicine and dispense controlled substances, he 
is not authorized to hold a registration in that State. This provides 
reason alone to deny his application. However, because the Government 
also seeks a final order based on the allegations of the Order to Show 
Cause and Immediate Suspension of Registration, I address the evidence 
with respect to the other public interest factors.

Factor Two--Respondent's Experience in Dispensing Controlled Substances

    The Government contends that Respondent unlawfully distributed 
controlled substances to various persons who were arrested during the 
search of his Shoreline property. Req. for Final Agency Action, at 10 
(citing, inter alia, 21 U.S.C. 841(a)(1)). More specifically, the 
Government contends that Respondent ``prescribed hydrocodone . . . to 
an individual arrested at the Shoreline'' property and could ``not 
locate a patient file at [his] registered location for this particular 
individual.'' Id. Based on the Investigators' ``determin[ation] that 
[Respondent] also purchased the loose phentermine tablets located on 
individuals at the Shoreline residence on March 16, 2012, despite the 
fact that he could not produce patient records when requested by law 
enforcement,'' the Government also apparently contends that Respondent 
unlawfully distributed the tablets to these individuals. Id. at 11.
    Neither of these allegations is proved by substantial evidence. As 
for the allegation regarding the hydrocodone prescription, as found 
above, in his Declaration, the DI repeatedly referred to this person as 
L.E. Yet to support the allegation, the Government offered a copy of a 
prescription which was issued to a patient whose initials are H.L. and 
not L.E. Moreover, the Government points to no other evidence that 
Respondent even prescribed hydrocodone (or any controlled substance for 
that matter) to a person whose initials are L.E. Thus, the allegation 
is unsupported by substantial evidence.
    As for the allegation that the phentermine was found on two persons 
who were arrested during the Shoreline search and was distributed to 
them by Respondent, while the Government produced evidence that 
Respondent had ordered phentermine from his distributor several months 
earlier, the evidence offered to establish that phentermine was found 
on these individuals was limited to the DI's assertion that it was. The 
DI did not, however, offer any basis for concluding that he personally 
participated in the search--notwithstanding his assertion that his 
declaration was based on ``personal knowledge''--nor otherwise explain 
the basis for his statement. Finally, the Government offered no other 
evidence to prove this assertion such as a police report, an affidavit 
of the arresting officer, or an inventory of the items found during the 
search conducted incident to the purported arrest of these individuals. 
The allegation therefore fails for lack of substantial evidence.
    The evidence further shows that Respondent purchased controlled 
substances including hydrocodone with acetaminophen, phentermine, 
phendimetrazine, testosterone, and lorazepam, which he dispensed 
directly to his patients. Under federal law, Respondent was required 
upon ``first engag[ing] in the . . . dispensing of controlled 
substances, and every second year thereafter, [to] make a complete and 
accurate record of all stocks thereof on hand.'' 21 U.S.C. 827(a)(1). 
Also, under federal law, because he engaged in the dispensing of the 
controlled substances, Respondent was required to ``maintain, on a 
current basis, a complete and accurate record of each such substance . 
. . received, sold, delivered, or otherwise disposed of by him.'' Id. 
Sec.  827(a)(3). DEA regulations further require that a dispenser 
maintain a record ``of the number of units or volume of such finished 
form dispensed, including the name and address of the person to whom it 
was dispensed, the date of dispensing, the number of units or volume 
dispensed, and the written or typewritten name or initials of the 
individual who dispensed or administered the substance on behalf of the 
dispenser.'' 21 CFR 1304.22(c). Finally, under this regulation, 
Respondent was required to maintain records of the controlled 
substances he acquired, to include ``[t]he name of the substance''; 
``[e]ach finished form . . . and the number of units or volume of 
finished form in each commercial container''; and ``[t]he number of 
units of finished forms and/or commercial containers acquired from 
other persons, including the date of and number of units and/or 
commercial containers in each acquisition to inventory and the name, 
address, and registration number of the person from the units were 
acquired.'' Id. Sec.  1304.22(a)(2)(i), (ii), and (iv).
    Here, I give no weight to the audit results given the numerous 
problems found above, including the conflict in the Government's 
evidence as to what the DIs used as the beginning date for the audit 
period. Nonetheless, I find that the DI's declaration establishes that 
during the July 2012 inspection, Respondent could not produce the 
required inventories for the controlled substances he was handling, and 
was thus in violation of 21 U.S.C. 827(a)(1).\28\ Moreover, the DI's 
declaration establishes that while Respondent was engaged in dispensing 
controlled substances, many of the entries for his phentermine 
dispensings lacked the patient's address and the name or initials of 
the person who did the actual dispensing.\29\ Thus, Respondent violated 
the CSA and DEA regulations for these reasons as well.\30\ See 21 
U.S.C. 827(a)(3); 21 CFR

[[Page 29035]]

1304.22(c). Finally, the DI's declaration establishes that Respondent 
lacked complete records of the controlled substances he acquired from 
his distributor, in violation of 21 U.S.C. 827(a)(3), as well as 21 CFR 
1304.22(c). See also 21 CFR 1304.22(a)(2)(i), (ii), and (iv).
---------------------------------------------------------------------------

    \28\ Regarding the lack of inventories, Respondent stated that 
he ``ha[d] invoices from [his distributor] as my initial 
inventory.'' Resp. Decl., at 7. Contrary to Respondent's contention, 
under the CSA, the requirement to take and maintain complete and 
accurate inventories is separate from the requirement to maintain 
records of the controlled substances a registrant acquires. Compare 
21 U.S.C. 827(a)(1) with id. Sec.  827(a)(3); compare also 21 CFR 
1304.11 with id. Sec.  1304.22. I therefore reject Respondent's 
contention. I further note that during the inspection, the DI found 
that Respondent did not have all of the invoices.
    \29\ While in his declaration Respondent states that this 
information was in the patient charts and that there is only limited 
space in his dispensing log, see Resp. Decl., at 7; DEA regulations 
require that the patient's address be documented in the dispensing 
log. 21 CFR 1304.22(c).
    \30\ As for the various entries in the dispensing log which 
lacked the name of the drug, because the Government provided no 
evidence that the dispensings involved controlled substances, I 
place no weight on this evidence. As for the Government's assertion 
that Respondent failed to maintain a ``dispensing/administration log 
for testosterone and Testim samples,'' Request for Final Agency 
Action, at 8; there is no evidence that he dispensed any Testim 
samples. As for the testosterone, the evidence does suggest that 
Respondent administered approximately 300 mg or 1.5 vials without 
documenting the administrations in his dispensing log. See 21 CFR 
1304.03(d).
---------------------------------------------------------------------------

    As both the Agency and the federal courts have explained, 
recordkeeping is one of the CSA's fundamental features for preventing 
the diversion of controlled substances. See Gonzales v. Raich, 545 U.S. 
1, 14 (2005) (``The CSA and its implementing regulations set forth 
strict requirements regarding . . . recordkeeping.''); United States v. 
Poulin, 926 F. Supp. 246, 250 (D. Mass. 1996) (``The [CSA] focuses on 
recordkeeping, in an attempt to regulate closely the distribution of 
certain substances determined by Congress to pose dangers, if freely 
available, to the public at large.'') (int. quotations and citation 
omitted); Paul H. Volkman, 73 FR 30630, 30644 (2008) (``Recordkeeping 
is one of the CSA's central features; a registrant's accurate and 
diligent adherence to this obligation is absolutely essential to 
protect against the diversion of controlled substances.'').
    Respondent's recordkeeping violations alone are sufficiently 
egregious to support the conclusion that he ``has committed such acts 
[which] render[ed] his registration . . . inconsistent with the public 
interest.'' 21 U.S.C. 824(a)(4); see also Volkman, 73 FR at 30644 
(holding that recordkeeping violations alone can support revocation or 
denial of an application).

Factor Three--Respondent's Conviction Record Under Federal and State 
Laws Related to the Manufacture, Distribution, and Dispensing of 
Controlled Substances

    As found above, following a jury trial, on December 19, 2014, 
Respondent was convicted by the United States District Court on seven 
felony counts related to the manufacture and distribution of marijuana, 
including conspiracy to distribute or manufacture marijuana, three 
counts of manufacturing marijuana, and three counts of maintaining drug 
involved premises.\31\ Each of these convictions provides reason alone 
to deny his application. And under the doctrine of collateral estoppel, 
the convictions also preclude any challenge to the allegations that he 
was engaged in the unlawful manufacture of marijuana. See Robert L. 
Daugherty, 76 FR 16823, 16830 (2011).
---------------------------------------------------------------------------

    \31\ As to the latter offense, the CSA renders it unlawful to 
``knowingly use[] or maintain any place, whether permanently or 
temporarily, for the purpose of manufacturing, distributing, or 
using any controlled substance.'' 21 U.S.C. 856(a)(1). As the 
evidence shows that Respondent used and maintained the three 
properties for the purpose of manufacturing marijuana and not simply 
as places to use the drugs, I conclude that his convictions for 
maintaining drug-involved premises fall within factor three.
---------------------------------------------------------------------------

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

    With respect to this factor, the Government raises three main 
allegations. First, based on the various searches, the Government 
argues that Respondent possessed and was engaged in the manufacture of 
marijuana, a schedule I controlled substance. Request for Final Agency 
Action, at 8-9 (citing 21 U.S.C. 841(a)(1), 844(a); 812(c)). Second, 
the Government alleges that during the search of Respondent's 
residence, several vials of controlled substances were found including 
one each of clonazepam and hydrocodone, the latter being in an 
unlabeled vial, as well as stock bottles of Meridia and diazepam, and 
that Respondent's possession of the drugs violated federal law because 
he was not registered at his residence. Id. (citing 21 U.S.C. 844(a); 
21 CFR 1301.75(b)). Third, the Government alleges that Respondent 
violated state law by failing to report to the Washington Prescription 
Monitoring Program some 45 instances in which he dispensed more than a 
twenty-four hour supply of a controlled substance. Id. at 9.
    As for the latter allegation, Respondent did not dispute that he 
had failed to report various dispensings to the State's PMP. Resp. 
Decl., at 8. Rather, he claimed his violations were unintentional 
because he was unaware of the law but would now comply. Id.
    However, this is not a valid defense as the Washington courts 
follow the traditional rule that ignorance of the law is no excuse. See 
State v. Reed, 928 P.2d 469, 471 (Wash. Ct. App. 1997) (other citation 
omitted). Accordingly, I find that Respondent violated Washington law 
by failing to report various dispensings to the State's PMP. See Wash. 
Rev. Code Sec.  70.225.020(2).
    As for the allegations pertaining to the controlled substances that 
the police found during the search of Respondent's residence, I 
conclude that the Government did not provide substantial evidence to 
support the allegations with respect to any of the four drugs (Meridia, 
diazepam, clonazepam (in a vial indicating that Respondent had 
prescribed the drug to R.M.) or hydrocodone (in an unlabeled vial)). 
With respect to the diazepam, the Government produced absolutely no 
evidence that the drug was even seized during the search. With respect 
to the Meridia, the Government's evidence was limited to a photograph 
of a white professional sample bottle and the DI's unsupported 
assertion, with no other evidence to establish that the bottle was 
seized from Respondent's residence, let alone that there were any pills 
in the bottle when it was seized.
    So too, with respect to the hydrocodone and clonazepam, there is no 
evidence other than photographs and the DI's unsupported assertion that 
these drugs were seized during the search of Respondent's residence. To 
be sure, in his declaration, Respondent stated that he prescribed the 
hydrocodone and clonazepam to his wife for several procedures. However, 
Respondent explicitly denied having or storing clonazepam or 
hydrocodone at his home and his statements do not constitute an 
admission of any part of this allegation. Accordingly, these 
allegations fail for lack of substantial evidence.
    I also find that substantial evidence supports the remaining 
marijuana-related allegation--that on February 2, 2012, Respondent 
violated federal law by possessing marijuana, and that he did so with 
the intent to distribute. Most significantly, it is undisputed that 
upon the February 2, 2012 arrest of TB, (Respondent's then live-in 
girlfriend and now wife), who was then driving his car, the police 
impounded his vehicle and during the subsequent search of the vehicle 
found one pound of marijuana and $5,000 in cash; the police also found 
$3,900 in cash in TB's purse.
    As found above, the street value of the marijuana was approximately 
$1,500 to $1,800, and the quantity would provide approximately 900 
joints. Respondent denied having any knowledge of the marijuana, 
asserting that it had been left in his car by LHE, a friend of TB and a 
purported medical marijuana patient who TB allowed to borrow his car, 
and provided an unsworn statement from LHE to this effect. However, as 
I found above, her statement (that she left the marijuana in the car 
because she was in

[[Page 29036]]

such a hurry to return the car to TB and forgot it) is utterly 
ludicrous.\32\ I therefore reject Respondent's explanation for why the 
police found one pound of marijuana in his car.
---------------------------------------------------------------------------

    \32\ As also noted, in a March 3, 2012 letter to the local 
prosecutor in which Respondent sought the return of his car, he 
denied having any knowledge of the marijuana that was found therein. 
See Resp. Decl., at Ex. 4. Yet he made no mention of LHE's story. 
See id.
---------------------------------------------------------------------------

    Moreover, given the closeness of the relationship between 
Respondent and TB in that they were living together and that TB also 
worked for him, I find it implausible that Respondent lacked knowledge 
of the marijuana. Rather, I find that Respondent had the ability to 
exercise dominion or control over the marijuana through TB and thus 
constructively possessed the drug. See United States v. Sanders, 341 
F.3d 809, 816 (8th Cir. 2003) (`` `To prove constructive possession, 
the government had to present evidence that appellants had knowledge 
and ownership, dominion or control over the contraband itself, or 
dominion over the vehicle in which the contraband is concealed.' '') 
(quoting Ortega v. United States, 270 F.3d 540, 545 (8th Cir. 2001)).
    So too, Respondent's attempt to explain the presence of the large 
sum of cash (nearly $9,000) that was found in his car and on his wife's 
person does not persuade. As for the money which was purportedly paid 
by a patient the day before as a deposit on a liposuction procedure, as 
found previously, while the ``Price Quote'' document indicates that the 
patient paid a $5,000 cash deposit, the date was clearly written over. 
And while the purported patient provided a letter to support 
Respondent, it too was unsworn.
    As an additional explanation for why so much money was found in his 
car, Respondent stated that the money had been withdrawn to pay for 
remodeling his clinic. To support this claim, Respondent submitted a 
copy of a bank statement (on which the various balances are blacked 
out), which documents that he made a withdrawal nine days before his 
girlfriend was arrested. However, Respondent offered no further 
evidence to support this contention, and in any event, his explanation 
begs the question of why he would risk the potential theft or loss of a 
large sum of cash, rather than pay for the purported remodeling with a 
check or credit card.
    I therefore find that both the quantity of the marijuana (which 
would provide a single person with three joints a day for approximately 
ten months), and the large amount of cash which was found in 
Respondent's vehicle, support a finding that the marijuana was intended 
for distribution. See United States v. Collins, 412 F.3d 515, 519 (4th 
Cir. 2005) (holding that ``intent to distribute can be inferred from a 
number of factors, including . . . the quantity of drugs'' and ``the 
amount of cash seized with the drugs.''). I further find that 
Respondent ``had the right to exercise dominion and control over'' the 
marijuana ``either directly or through'' TB. United States v. Staten, 
581 F.2d 878, 883 (D.C. Cir. 1978). I therefore find that Respondent 
knowingly possessed marijuana with the intent to distribute it.\33\ See 
21 U.S.C. 841(a)(1).
---------------------------------------------------------------------------

    \33\ In his Declaration, Respondent disputed that he owned the 
marijuana plants, the processed marijuana, and related items that 
were seized in the searches of his three properties. See Resp. 
Decl., at 3 (``I have three rental properties. I had irresponsible 
tenants that took advantage of the locations by cultivating 
Marijuana for 6 months without my knowledge.''). He also claimed 
that because he was a busy physician, who did not bother his tenants 
if they paid their rent and did not request repairs, he ``did not 
know of . . . nor . . . in any way participate in the growing of 
marijuana at these rental houses.'' Id. at 4. Based on Respondent's 
convictions for conspiracy to manufacture marijuana, unlawful 
manufacture of marijuana at each of the three grow houses, and 
maintaining drug-involved premises at each of the three residences, 
I reject his assertions as utterly false.
---------------------------------------------------------------------------

    Based on Respondent's violation of federal law by possessing 
marijuana with the intent to distribute, as well as his admitted 
failure to report multiple dispensings of controlled substances to the 
Washington PMP, I find that factor four also supports a finding that he 
has committed acts which rendered his registration ``inconsistent with 
the public interest.'' \34\ 21 U.S.C. 823(f) & 824(a)(4).
---------------------------------------------------------------------------

    \34\ Having already addressed the various false statements 
regarding the marijuana-related allegations which Respondent has 
made in his declaration, I deem it unnecessary to repeat this 
discussion under factor five.
---------------------------------------------------------------------------

Sanction

    Under Agency precedent, where, as here, ``the Government has proved 
that a registrant has committed acts inconsistent with the public 
interest, the registrant must ` ``present sufficient mitigating 
evidence to assure the Administrator that [he] can be entrusted with 
the responsibility carried by such a registration.'' ' '' Medicine 
Shoppe--Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 
72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 
(1988))). ``Moreover, because `past performance is the best predictor 
of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 
Cir. 1995), [DEA] has repeatedly held that where a registrant has 
committed acts inconsistent with the public interest, the registrant 
must accept responsibility for [his] actions and demonstrate that [he] 
will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; 
see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 
(2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also 
Hoxie, 419 F.3d at 483 (``admitting fault'' is ``properly 
consider[ed]'' by DEA to be an ``important factor[]'' in the public 
interest determination). So too, in making the public interest 
determination, ``this Agency also places great weight on an 
[applicant's] candor, both during an investigation and in [a] 
subsequent proceeding.'' Robert F. Hunt, 75 FR 49995, 50004 (2010) 
(citing The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy, 72 FR 
74334, 74338 (2007) (quoting Hoxie, 419 F.3d at 483) (``Candor during 
DEA investigations properly is considered by the DEA to be an important 
factor when assessing whether a . . . registration is consistent with 
the public interest.'')).
    Moreover, while a registrant must accept responsibility and 
demonstrate that he will not engage in future misconduct in order to 
establish that granting his application for registration is consistent 
with the public interest, DEA has repeatedly held these are not the 
only factors that are relevant in determining whether to grant or deny 
an application. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); 
Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, 
the egregiousness and extent of a registrant's misconduct are 
significant factors in determining the appropriate disposition. Cf. 
Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a 
respondent can ``argue that even though the Government has made out a 
prima facie case, his conduct was not so egregious as to warrant 
revocation''); see also Paul H. Volkman, 73 FR 30630, 30644 (2008); 
Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009).
    Moreover, as I have noted in several cases, `` `[n]either Jackson, 
nor any other agency decision, holds . . . that the Agency cannot 
consider the deterrent value of a sanction in deciding whether a 
registration should be [suspended or] revoked,' '' or whether an 
application should be denied. Gaudio, 74 FR at 10094 (quoting 
Southwood, 72 FR at 36503 (2007)); see also Robert Raymond Reppy, 76 FR 
61154, 61158 (2011); Michael S. Moore, 76 FR 45867, 45868 (2011). This 
is so, both with respect to the respondent in a particular case and the 
community of registrants. See Gaudio, 74 FR at 10095 (quoting

[[Page 29037]]

Southwood, 71 FR at 36504). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 
(2d Cir. 2005) (upholding SEC's express adoption of ``deterrence, both 
specific and general, as a component in analyzing the remedial efficacy 
of sanctions'').
    As found above, the Government has established that Respondent: 1) 
committed multiple recordkeeping violations in that he did not have 
required inventories, was missing invoices, and his dispensing log 
lacked required information; 2) was engaged in the manufacture and 
distribution of marijuana; and 3) failed to report multiple dispensings 
of controlled substances to the Washington PMP. I find that the proven 
misconduct is sufficiently egregious to affirm the Order of Immediate 
Suspension and to deny his pending application to renew his 
registration. See, e.g., Moore, 76 FR at 45870 (imposing one-year 
suspension on physician who manufactured marijuana, notwithstanding 
ALJ's finding that physician accepted responsibility and demonstrated 
he would not engage in future misconduct).\35\ I further find that the 
Agency's interest in deterring similar acts on the part of both 
Respondent and others supports the denial of his pending application.
---------------------------------------------------------------------------

    \35\ In Moore, I agreed with the ALJ's finding that the 
physician's conduct in manufacturing and distributing marijuana 
supported revocation of his registration. 76 FR at 45868. However, I 
also agreed with the ALJ's finding that the physician had accepted 
responsibility for his misconduct and demonstrated that he would not 
engage in future misconduct. Id. By contrast, here, the record 
establishes that in addition to his marijuana-related misconduct, 
for which he disingenuously denies any responsibility, Respondent 
also committed multiple recordkeeping violations and violated state 
law by failing to report numerous dispensings to the State PMP. 
Also, in contrast to Moore, I find that Respondent has not accepted 
responsibility for his misconduct.
---------------------------------------------------------------------------

    Having carefully reviewed Respondent's declaration, I further find 
that Respondent has not accepted responsibility for his misconduct. 
Regarding his recordkeeping violations, Respondent entirely denied that 
he failed to keep the required inventories and that he was missing 
various invoices. Moreover, he further claimed that the reason his 
dispensing log was missing essential information such as patient 
addresses was because there was no room to make these entries. Yet in 
DEA's experience, thousands of other registrants who engage in 
dispensing have no problem complying with the latter requirements.
    With respect to the marijuana allegations, Respondent offered the 
far-fetched story that the marijuana belonged to an acquaintance of his 
wife, who had borrowed his car to obtain her medical marijuana but who 
was in such a hurry to return the car that she forgot to retrieve it 
even though it was her medicine. So too, Respondent's alternative 
explanations for why thousands of dollars of cash were found in his car 
defy credulity. Similarly, his claim that he was unaware of the 
marijuana growing activities which were being conducted at not one, not 
two, but three of his properties, is clearly disingenuous.\36\ 
Accordingly, based on his various false statements regarding the 
marijuana-related activity, as well as his blatantly false assertion 
that he has never been subject to discipline by a state licensing 
authority (all of which are clearly material to the outcome of this 
proceeding), I further find that Respondent lacks candor.
---------------------------------------------------------------------------

    \36\ With regard to his failure to report dispensings to the 
Washington PMP, Respondent claimed that he was unaware of the law. 
However, the legislation which created the Washington PMP was 
enacted in 2007, more than four years earlier, and as a physician 
who engaged in the highly regulated activity of dispensing 
controlled substances, Respondent was obligated to keep abreast of 
legislation and regulatory developments applicable to his medical 
practice. Moreover, while Respondent asserted that he is now aware 
of the requirement and will comply in the future, his various 
statements regarding the events at issue (including that he had 
never been disciplined by a state board) support a finding that he 
lacks candor. Accordingly, I give no weight to his statement that he 
would comply with the State's PMP reporting requirement in the 
future.
---------------------------------------------------------------------------

    Based on his failure to acknowledge his misconduct, his failure to 
offer any credible evidence of remedial efforts, and his lack of 
candor, I conclude that Respondent has failed to present sufficient 
evidence to rebut the Government's prima facie showing that his 
registration would be ``inconsistent with the public interest.'' 21 
U.S.C 823(f); see also id. 824(a)(4). Therefore, I will affirm the 
issuance of the Order of Immediate Suspension and order that any 
pending application to renew Respondent's registration be denied.

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 affirm the Order of Immediate 
Suspension of DEA Certificate of Registration BL6283927, issued to 
Keith Ky Ly, D.O. I further order that the application of Keith Ky Ly, 
D.O., to renew his registration, be, and it hereby is, denied. This 
Order is effective June 19, 2015.

    Dated: May 11, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-12139 Filed 5-19-15; 8:45 am]
BILLING CODE 4410-09-P



                                                                               Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                   29025

                                                  The reasons for withdrawal are not material,            Government meets its burden of establishing             Date: October 7, 2014.
                                                  given the statutory language set forth above.           grounds to deny an application for                    Christopher B. Mcneil,
                                                                                                          registration upon sufficient proof establishing
                                                  Analysis, Findings of Fact and Conclusions                                                                    Administrative Law Judge.
                                                                                                          the applicant does not possess a state
                                                  of Law                                                  pharmacy license. That proof is in the record         [FR Doc. 2015–12128 Filed 5–19–15; 8:45 am]
                                                     In determining whether to grant the                  before me, and it warrants the summary                BILLING CODE 4410–09–P
                                                  Government’s Motion for Summary                         denial of Respondent’s application for a DEA
                                                  Disposition, I am required to apply the                 Certificate of Registration.
                                                  principle of law that holds such a motion                  I am mindful of the arguments raised by            DEPARTMENT OF JUSTICE
                                                  may be granted in an administrative                     Respondent in its Answer to Movant’s
                                                  proceeding if no material question of fact              Motion, including the fact that Respondent’s          Drug Enforcement Administration
                                                  exists:                                                 lack of a pharmacy license is based on
                                                     It is settled law that when no fact question         Respondent’s voluntary withdrawal of its              Keith Ky Ly, D.O.; Decision and Order
                                                  is involved or the facts are agreed, a plenary,         pharmacy license to avoid state sanctions as
                                                  adversary administrative proceeding                     a result of delays by the DEA.49 These                   On January 24, 2013, I, the
                                                  involving evidence, cross-examination of                difficulties do not, however, change the fact         Administrator of the Drug Enforcement
                                                  witnesses, etc., is not obligatory—even                 that without a state pharmacy license,                Administration, issued an Order to
                                                  though a pertinent statute prescribes a                 Respondent is not a ‘‘practitioner’’ and              Show Cause and Immediate Suspension
                                                  hearing. In such situations, the rationale is           cannot be granted a Certificate of                    of Registration (hereinafter, OTSC–ISO
                                                  that Congress does not intend administrative            Registration. Equitable principles, even were
                                                                                                                                                                or Order) to Keith Ky Ly, D.O.
                                                  agencies to perform meaningless tasks                   they available in this forum, fail to lead to
                                                  (citations omitted).43                                  a different outcome. As made clear in Potter          (Respondent), of Mountlake Terrace,
                                                     In this context, I am further guided by prior        and Halil, the lack of timeliness in processing       Washington. GX 2, at 1. The Order
                                                  decisions before the DEA involving                      an application for a DEA Certificate of               proposed the revocation of
                                                  certificate holders who lacked licenses to              Registration does not overcome the public             Respondent’s DEA Certificate of
                                                  distribute or dispense controlled substances.           interest.                                             Registration, which authorizes him to
                                                  On the issue of whether an evidentiary                     Some care should be taken to assure the            dispense controlled substances in
                                                  hearing is required, ‘‘it is well settled that          parties that the actions taken in this                schedules II through V, as a practitioner,
                                                  when there is no question of material fact              administrative proceeding conform to                  as well as the denial of any pending
                                                  involved, there is no need for a plenary,               constitutional requirements. I have examined
                                                  administrative hearing.’’ 44 Under this
                                                                                                                                                                applications to renew or modify his
                                                                                                          the parties’ contentions with an eye towards
                                                  guidance, the Government’s motion must be               ensuring all tenets of due process have been          registration, on the ground that his
                                                  sustained unless a material fact question has           adhered to. There is, however, no authority           ‘‘continued registration is inconsistent
                                                  been presented.                                         for me to evaluate the facts that underlie            with the public interest, as that term is
                                                     The sole determinative fact now before me            Respondent’s contentions. In the proceedings          defined in 21 U.S.C. 823(f).’’ Id.
                                                  is that Respondent lacks a Texas pharmacy               now before me, the only material question                More specifically, the OTSC–ISO
                                                  license. In order for a pharmacy to receive a           was answered by Respondent in its Request             alleged that on February 2, 2012, law
                                                  DEA registration authorizing it to dispense             for Hearing. Further, while the Order to              enforcement officers arrested
                                                  controlled substances under 21 U.S.C. 823(f),           Show Cause sets forth a non-exhaustive                Respondent’s girlfriend, who was then
                                                  it must meet the definition of ‘‘practitioner’’         summary of facts and law relevant to a
                                                  as found in the Controlled Substances Act.45                                                                  driving his vehicle, for driving with a
                                                                                                          determination that granting this application
                                                  Such an entity must be ‘‘licensed, registered,          would be inconsistent with the public
                                                                                                                                                                suspended license and that during a
                                                  or otherwise permitted by . . . the                     interest under 21 U.S.C. 823(f), the                  search of the vehicle, found ‘‘one pound
                                                  jurisdiction in which he practices . . . to             conclusion, order and recommendation that             of marijuana, approximately $3,900 cash
                                                  distribute, dispense, [or] administer . . . a           follow are based solely on a finding that             in a vacuum sealed bag located in [her]
                                                  controlled substance in the course of                   Respondent is not a ‘‘practitioner’’ as that          purse, $5,000 cash located in a hidden
                                                  professional practice.’’ 46 Delegating to the           term is defined by 21 U.S.C. 802(21), and I           compartment, and three prescription
                                                  Attorney General the authority to determine             make no finding regarding whether granting            bottles containing controlled substances
                                                  who may or may not be registered to perform             this application would or would not be
                                                  these duties, Congress permitted such
                                                                                                                                                                located in’’ her backpack. Id. at 2. The
                                                                                                          inconsistent with the public interest.                Order further alleged that Respondent
                                                  registration only to ‘‘practitioners’’ as defined
                                                  by the Controlled Substances Act.47                     Order Granting the Government’s Motion for            had issued one of the prescriptions
                                                     As cited by the Government in its Motion             Summary Disposition and Recommendation                found in the backpack to an employee,
                                                  for Summary Disposition, there is substantial              I find there is no genuine dispute regarding       and that during an interview when he
                                                  authority both through agency precedent and             whether Respondent is a ‘‘practitioner’’ as           attempted to recover the vehicle,
                                                  through decisions of courts in review of that           that term is defined by 21 U.S.C. 802(21), and        Respondent stated that he lived with his
                                                  precedent, holding that an application for a            that based on the record the Government has           girlfriend, that she worked at his
                                                  retail pharmacy DEA registration is                     established that Respondent is not a                  medical practice, and that she and the
                                                  dependent upon the applicant having a state             practitioner and is not authorized to dispense
                                                  license to dispense controlled substances.48
                                                                                                                                                                employee whose medication was found
                                                                                                          controlled substances in the state in which it
                                                  Under the doctrine before me, the                       seeks to operate under a DEA Certificate of
                                                                                                                                                                in the backpack ‘‘often shared
                                                                                                          Registration. I find no other material facts at       medications.’’ Id. The Order then
                                                     43 NLRB v. International Assoc. of Bridge, 549       issue, for the reasons set forth in the               alleged that this showed that
                                                  F.2d 634, 638 (9th Cir. 1977) (quoting United States    Government’s Motion for Summary                       Respondent had ‘‘knowledge of illegal
                                                  v. Consolidated Mines & Smelting Co., Ltd., 455         Disposition. Accordingly, I GRANT the                 activity occurring between [his]
                                                  F.2d 432, 453 (9th Cir. 1971)).                         Government’s Motion for Summary                       employees and [took] no corrective
                                                     44 See Michael G. Dolin, M.D., 65 FR 5661 (DEA
                                                                                                          Disposition.                                          action.’’ Id.
                                                  February 4, 2000); Jesus R. Juarez, M.D., 62 FR
                                                                                                             Upon this finding, I ORDER that this case
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                                                  14945 (DEA March 28, 1997); see also Philip E.                                                                   Next, the OTSC–ISO alleged that law
                                                  Kirk, M.D., 48 FR 32887 (DEA July 19, 1983), aff’d      be forwarded to the Administrator for final           enforcement officers discovered that
                                                  sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir.         disposition and I RECOMMEND the
                                                                                                                                                                several premises owned by Respondent
                                                  1984).                                                  Administrator DENY Respondent’s
                                                     45 21 U.S.C. 802(21).                                application for a DEA Certificate of                  were being used as marijuana-grow
                                                     46 Id.                                               Registration.                                         houses. Id. More specifically, the Order
                                                     47 21 U.S.C. 823(f).                                                                                       alleged that: (1) On May 30, 2012, the
                                                     48 Government’s Motion for Summary Disposition         49 Respondent’s Answer to Movant’s Motion for       Renton, Washington fire department
                                                  at 7 and cases cited therein.                           Summary Disposition at 2.                             responded to a fire at his Quincy


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                                                  29026                        Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  Avenue property and seized                              more than a 24-hour supply of                         ordered that the proceeding be
                                                  approximately 700 marijuana plants; (2)                 controlled substances.’’ Id. (citing Wash.            terminated because Respondent had
                                                  on July 5, 2012, state and local law                    Rev. Code § 70.225.020; Wash. Admin.                  ‘‘failed to timely request a hearing and
                                                  enforcement officers obtained a search                  Code § 246–470–030).                                  failed to assert good cause for his 36-day
                                                  warrant for his property located at                        Based on the above, I made a                       delay.’’ Id. at 2. Thereafter, on April 18,
                                                  20118 14th Avenue NE., Shoreline,                       preliminary finding that Respondent                   2013, Respondent, who was now
                                                  Washington, and seized approximately                    ‘‘illegally manufactured controlled                   represented by counsel (a different
                                                  489 marijuana plants and six bags of                    substances in violation of state and                  counsel than identified by the DI in his
                                                  processed marijuana; (3) on July 6, 2012,               federal law, illegally possessed and                  declaration), filed a motion to
                                                  state and local law enforcement officers                distributed highly addictive controlled               reconsider and re-open. GX 5. Therein,
                                                  executed a search warrant at                            substances . . . and ha[d] generally                  Respondent requested a full hearing on
                                                  Respondent’s personal residence in                      failed to maintain effective controls to              the allegations, as well as ‘‘additional
                                                  Bothell, Washington, and ‘‘seized                       guard against theft and prevent                       time to file his Request for Hearing
                                                  $12,000 in cash, two firearms, marijuana                diversion of controlled substances.’’ Id.             based on this motion showing of good
                                                  grow documents, approximately 15                        I therefore ordered that Respondent’s                 cause.’’ Id. at 1.
                                                  grams of processed marijuana, and                       registration be suspended effective                      In the motion, Respondent did ‘‘not
                                                  multiple prescription bottles containing                immediately. Id. (citing 21 U.S.C.                    contest that he was effectively served
                                                  pills,’’ including an unlabeled bottle                  824(d)).                                              with a copy of the’’ OTSC–ISO. Id. at 2.
                                                  containing hydrocodone, and a bottle                       According to the Declaration of a DEA              He also did not dispute that his prior
                                                  containing clonazepam, which                            Diversion Investigator (DI), on January               attorney ‘‘was in contact with [him]
                                                  Respondent had prescribed for patient                   28, 2013, DEA Special Agents and DIs                  during and after the period for filing a
                                                  R.M.; and (4) on July 7, 2012, state and                went to Respondent’s registered location              timely appeal.’’ Id. Rather, Respondent
                                                  local law enforcement obtained a search                 and personally served him with the                    maintained that he ‘‘sent a letter
                                                  warrant for his property located at 5006                OTSC–ISO, along with ‘‘a sample                       requesting appeal of the [OTSC–ISO] to
                                                  104th Place NE., Marysville,                            request for hearing form.’’ DI                        [a] local Seattle-based DEA agent . . .
                                                  Washington and seized marijuana leaves                  Declaration, at 9. According to the DI,               by certified mail on February 4, 2013,’’
                                                  and grow equipment. Id. at 2–3.                         later that same day, he also hand-                    who ‘‘did not respond to the appeal
                                                     Next, the OTSC–ISO alleged that on                   delivered a copy of the OTSC–ISO and                  letter or inform Respondent that an
                                                  July 13, 2012, DEA personnel                            the hearing request form to                           appeal of the [OTSC–ISO] could not be
                                                  ‘‘conducted an inspection and audit at                  Respondent’s ‘‘attorney at the time.’’ 1              perfected by sending it to him.’’ Id. at
                                                  [Respondent’s] registered address.’’ Id.                Id.                                                   2–3. Respondent further asserts that he
                                                  at 3. The Order alleged that Respondent                    The OTSC–ISO plainly advised that:                 ‘‘sought the advice of and had several
                                                  had a 75 percent shortage of both                       (1) ‘‘[w]ithin 30 days after the date of              conversations with [his former]
                                                  testosterone 200mg/ml and phentermine                   receipt of this Order to Show Cause and               attorney,’’ and that ‘‘[b]ased on these
                                                  37.5mg, as well as a 14 percent shortage                Immediate Suspension of Registration,                 conversations, [he] ‘filed’ an appeal
                                                  of hydrocodone 10/500mg. Id. Based on                   you may file with the DEA a written                   NOT with the DEA . . . Office of
                                                  the audit results, the Order further                    request for a hearing in the form set                 Administrative Law Judges, but instead
                                                  alleged that Respondent ‘‘failed to                     forth in 21 CFR 1316.47’’; (2) ‘‘[i]f you             with the Office of the Inspector General
                                                  maintain accurate and complete records                  fail to file such a request, the hearing              (OIG),’’ and that he faxed the appeal ‘‘to
                                                  and failed to account for these                         shall be cancelled in accordance with                 the OIG on February 20, 2013, and again
                                                  controlled substances.’’ Id. (citing 21                 paragraph 3’’; (3) ‘‘[s]hould you decline             on March 8, 2013.’’ Id. at 3. According
                                                  U.S.C. 827(a)(1) and 842(a)(5); 21 CFR                  to file a request for a hearing . . . you             to Respondent, ‘‘[t]he OIG suggested
                                                  1301.71, 1304.03, 1304.04 (a) & (g), and                shall be deemed to have waived the                    [he] contact the DEA.’’ Id.
                                                  1304.21). The Order then alleged that                   right to a hearing and the DEA may                       Respondent further asserted that he
                                                  Respondent had committed additional                     cancel such hearing’’; (4)                            ‘‘discussed the matter with an assistant
                                                  recordkeeping violations, in that he                    ‘‘[c]orrespondence concerning this                    in his office, who believed the correct
                                                  ‘‘failed to take and maintain an initial or             matter, including requests [for a                     place to file the appeal was with the
                                                  biennial inventory of all stocks of                     hearing] should be addressed to the                   office of the United States Attorney
                                                  controlled substances on hand,’’ ‘‘failed               Hearing Clerk, Office of Administrative               General.’’ Id. Respondent stated that
                                                  to record essential elements on                         Law Judges [OALJ] . . . 8701                          ‘‘[a]n ‘appeal’ was sent to that address
                                                  approximately 128 dispensing records,’’                 Morrissette Drive, Springfield, VA                    on February 11, 2013.’’ Id.
                                                  ‘‘failed to maintain a dispensing/                      22152’’; and (5) ‘‘[m]atters are deemed                  Next, Respondent contended that on
                                                  administration log for testosterone and                 filed upon receipt by the Hearing                     March 14, 2013, he was advised by his
                                                  Testim samples, located during the on-                  Clerk.’’ GX 2, at 4–5 (citations omitted).            then-counsel that the latter ‘‘and his
                                                  site inspection,’’ and ‘‘failed to maintain             Notwithstanding this, Respondent did                  partner had decided not to represent
                                                  all Schedule III–V acquisition invoices                 not file a request for hearing with the               [him] in this . . . proceeding,’’ but that
                                                  and record the dates of receipt[ ] on the               Office of Administrative Law Judges                   ‘‘[t]his was after the request for hearing
                                                  invoices.’’ Id. at 3–4 (citations omitted).             until April 4, 2013. GX 4, at 1.                      deadline had expired.’’ Id. Respondent
                                                     Finally, the OTSC–ISO alleged that                      The matter was then assigned to an                 then contended that on March 28, he
                                                  Respondent ‘‘failed to make required                    Administrative Law Judge (ALJ), who                   spoke with two Seattle–based DEA
                                                  dispensing reports’’ to the Washington                                                                        agents, ‘‘who told him he needed to file
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                                                                                                            1 The courts are clear that service of an initial
                                                  State Prescription Monitoring Program                                                                         the request for hearing right away.’’ Id.
                                                                                                          pleading on an attorney does not constitute
                                                  ‘‘on approximately 45 separate                          adequate service unless a party has granted
                                                                                                                                                                According to Respondent, he then ‘‘filed
                                                  occasions from January to July 2012.’’                  authority to the attorney to accept process on his    his request for hearing on April 4, 2013
                                                  Id. at 4. As the legal basis for this                   behalf. See, e.g., United States v. Ziegler Bolt &    with the DEA’’ OALJ. Id.
                                                  allegation, the Government noted that                   Parts Co., 111 F.3d 878, 881 (Fed. Cir.1997). There      Respondent asserted that he ‘‘was
                                                                                                          being no such evidence showing that Respondent
                                                  Washington State ‘‘requires a dispensing                granted such authority to the attorney, I rely only
                                                                                                                                                                confused about how and where to file
                                                  physician to report to the . . . PMP all                on the DI’s statement that Respondent was             his request for a hearing’’ and that ‘‘[t]he
                                                  instances in which he or she dispenses                  personally served.                                    source of his confusion came from his


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                                                                               Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                        29027

                                                  contacts with [his former] attorney . . .,              was to be determined ‘‘within the                     our [DEA] proceedings.’’ 2 Order on
                                                  with his office assistant, and from the                 context of the particular case,’’ which,              Reconsideration, GX 7, at 8. The ALJ
                                                  lack of response by [a DEA Agent],                      in Pincay, had gone on for fifteen years.             further noted that even under Pioneer,
                                                  although a late effort to clarify the                   Id. However, the court also observed                  ‘‘respondents can ‘be held accountable
                                                  correct means to request a hearing was                  that ‘‘[h]ad the district court declined to           for the acts and omissions of their
                                                  provided by the DEA agents.’’ Id. at                    permit the filing of the notice, we would             chosen counsel.’ ’’ Id. (quoting Pioneer,
                                                  3–4. He further maintained that he                      be hard pressed to find any rationale                 507 U.S. at 397).
                                                  attempted ‘‘in good faith to ask for a                  requiring us to reverse.’’ Id.                           The ALJ found that Respondent was
                                                  hearing’’ and that ‘‘[n]one of the                                                                            represented by another attorney ‘‘at the
                                                                                                             Based on Pincay, Respondent argued                 time [he] was served with the Order to
                                                  alternatives employed by [him] were
                                                  done for purposes of delay.’’ Id. at 4.                 that: (1) There is no prejudice to the                Show Cause,’’ and that this attorney did
                                                     Respondent argued that his case is                   Agency because his registration remains               not inform him that he would not
                                                  similar to that of Steven J. Watterson, 67              suspended; (2) the thirty-six day delay               represent him in the DEA proceeding
                                                  FR 67413 (2002). Therein, the Agency                    in filing his hearing request had no                  until after the deadline had passed for
                                                  set aside a final order where a party had               impact on the proceeding; (3) ‘‘the                   filing his hearing request. Id. at 8–9. The
                                                  failed to file a request for a hearing                  reason for the delay was confusion on                 ALJ then concluded that while the
                                                  based on ‘‘conflicting guidance’’ having                his part,’’ that his conduct is no worse              ‘‘[a]ttorney was negligent in failing to
                                                  been ‘‘given to’’ an Applicant by an                    than that found excusable in Pincay and               tell Respondent in a timely fashion that
                                                  Agency ‘‘official concerning how and                    was ‘‘based in part on omissions by’’ the             he would no longer represent [him],
                                                  when the matter would be resolved.’’ Id.                DI, and was not made in bad faith; and                . . . Respondent cannot argue that he
                                                  at 67414. Respondent argued that                        (4) that he acted promptly to rectify his             detrimentally relied on [the attorney] to
                                                  Watterson stands for the proposition                    untimely filing. GX 5, at 8–9.                        send out the request for hearing.’’ Id. at
                                                  that ‘‘ ‘[g]ood cause’ . . . to set aside and           Accordingly, Respondent argued that he                9. This was so because ‘‘Respondent,
                                                  rescind a decision terminating a                        has shown good cause for setting aside                himself, sent out the letters to [the DI],3
                                                  proceeding . . . require[s] a showing of                the ALJ’s termination order. Id. at 9.                OIG, and [the] Attorney General.’’ Id.
                                                  both excusable neglect and a                               The ALJ granted Respondent’s motion                The ALJ thus concluded ‘‘that
                                                  meritorious defense.’’ GX 5, at 5. He                   for reconsideration but then denied his               Respondent was ultimately responsible
                                                  then argued that ‘‘[t]he acceptance and                 motion to reopen the proceedings. Order               for filing a timely request for hearing,
                                                  retention by’’ the DI of his appeal                     Granting Respondent’s Motion for                      despite his former attorney’s
                                                  request ‘‘was misleading, particularly                  Reconsideration and Denying                           shortcomings.’’ Id.
                                                  when [the DIs] actively encouraged                      Respondent’s Motion to Reopen the                        Finally, the ALJ rejected Respondent’s
                                                  [him] to file his appeal correctly AFTER                Case, at 10 (Order on Reconsideration)                contention that his ‘‘confusion . . .
                                                  the appeal period had lapsed,’’ and that                (GX 7). While concluding that she had                 support[ed] a finding of ‘good cause.’ ’’
                                                  ‘‘[t]his was a source of conflicting                    jurisdiction to consider Respondent’s                 Id. As the ALJ explained, ‘‘[t]he clear
                                                  guidance for Respondent.’’ Id. at 6.                                                                          language of the Order to Show Cause
                                                                                                          motion for reconsideration, the ALJ
                                                     Respondent also relied on Pincay v.                                                                        states that ‘[c]orrespondence concerning
                                                  Andrews, 389 F.3d 853 (9th Cir. 2004)                   rejected Respondent’s contention that
                                                  (en banc). There, a lawyer failed to file               he had shown good cause for his                          2 While it true that DEA has not adopted any of

                                                  a notice of appeal within the thirty-day                untimely filing.                                      the various federal rules of procedure, it has
                                                  period provided for doing so in the                        First, the ALJ rejected Respondent’s               frequently looked to those rules for guidance in
                                                                                                          contention that under Watterson, he had               interpreting its procedural rules. See Bio Diagnostic
                                                  Federal Rules of Appellate Procedure,                                                                         Inc., 78 FR 39327, 39328–29 & n.1 (2013) (applying
                                                  based on his reliance on the erroneous                  demonstrated good cause because he                    federal court decisions interpreting Fed. R. Civ. P.
                                                  advice of a paralegal that the notice of                had received ‘‘conflicting guidance’’                 56 (governing summary judgment), in determining
                                                  appeal need not be filed until sixty days               from the DI to whom he sent his                       whether summary disposition was appropriately
                                                  after the issuance of a judgment, rather                                                                      granted in Agency proceeding); Glenn D. Kreiger, 76
                                                                                                          ‘‘appeal’’ letter. Id. at 7. The ALJ found            FR 20020, 20021 n.3 (2011) (applying federal court
                                                  than the thirty days provided in the                    that Watterson was not controlling                    decisions and holding that a challenge to the
                                                  applicable Federal Rule of Appellate                    because, during the period in which                   sufficiency of service of a Show Cause Order is
                                                  Procedure. Id. at 855. The Ninth Circuit                Respondent could have filed his hearing               waived if not raised in a respondent’s first
                                                  held that the failure to timely file the                                                                      responsive pleading). In this regard, it is noted that
                                                                                                          request, the DI did not provide                       the Federal Rules of Civil Procedure have expressly
                                                  notice of appeal constituted excusable                  conflicting guidance but rather no                    adopted the ‘‘excusable neglect’’ standard for
                                                  neglect, notwithstanding its conclusions                guidance at all. Id. at 8. Indeed, the DI             determining whether ‘‘good cause’’ exists to extend
                                                  that the lawyer’s reliance on the                       did not provide any advice to                         the time for ‘‘[w]hen an act may or must be done’’
                                                  paralegal’s reading of the rule was                                                                           when a ‘‘motion [is] made after the time has
                                                                                                          Respondent regarding his hearing                      expired.’’ Fed. R. Civ. P. 6(b)(1). As agency
                                                  ‘‘negligent’’ and that the ‘‘lawyer’s                   request until he met with the DI on                   decisions make clear, the good cause standard is not
                                                  failure to read an applicable rule is one               March 28, 2013. Id.                                   limited to those instances where a respondent or his
                                                  of the least compelling excuses that can                                                                      attorney are blameless in failing to timely file a
                                                  be offered.’’ Id. at 859. The court                        Next, the ALJ rejected Respondent’s                pleading. See, e.g., Tony T. Bui, 75 FR 49979, 49980
                                                  nonetheless held that the district court                contention that ‘‘good cause’’ existed to             (2010) (finding good cause existed to excuse
                                                                                                          excuse his untimely filing because his                untimely filed hearing request where attorney used
                                                  did not abuse its discretion in                                                                               an incomplete address to mail the request but when
                                                  concluding that the lawyer’s untimely                   former attorney ‘‘committed ‘excusable                the request was returned, promptly proceeded to
                                                  filing was the result of excusable                      neglect.’ ’’ Id. More specifically, the ALJ           mail it to the correct address).
                                                                                                          noted that the excusable neglect                         3 Regarding the letter to the DI, the ALJ noted that
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                                                  neglect. Id. The court further noted that
                                                  ‘‘the decision whether to grant or deny                 standard of the Federal Rules of                      Respondent wrote: ‘‘I am writing to you as an
                                                                                                          Appellate Procedure, see Pincay, and                  appeal for the immediate and urgent help in the
                                                  an extension of time to file a notice of                                                                      matter of my DEA license reinstatement.’’
                                                  appeal should be entrusted to the                       the Federal Rules of Bankruptcy                       Termination Order, at 9 n.8 (quoting Motion for
                                                  discretion of the district court because                Procedure (Rule 9006(b)(1)), which was                Reconsideration, Ex. 29, at 1). The ALJ further
                                                                                                          discussed by the Supreme Court in                     noted that ‘‘[w]hile Respondent’s intent may have
                                                  the district court is in a better position                                                                    been to request a hearing, Respondent did not
                                                  than’’ the appeals court to evaluate the                Pioneer Inv. Servs. v. Brunswick Assoc.,              explicitly express this intent in the letters he sent
                                                  relevant factors, and that the decision                 507 U.S. 380, 396 (1993), ‘‘do not govern             before April 4, 2013.’’ Id.



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                                                  29028                        Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  this matter, including requests                            Also unavailing is Respondent’s                           Respondent further argues that ‘‘[t]he
                                                  referenced in paragraphs 1 [i.e., a                     reliance on Pincay v. Andrews to argue                    acceptance and retention by [the DI] of
                                                  hearing request] and 2 above, should be                 ‘‘good cause’’ exists to excuse his                       the appeal request . . . was misleading,
                                                  addressed to the Hearing Clerk, Office of               untimely filing because either he or his                  particularly when he and [another DI]
                                                  Administrative Law, Drug Enforcement                    lawyer committed ‘‘‘excusable                             actively encouraged [him] to file his
                                                  Administration, 8701 Morrissette Drive,                 neglect.’ ’’ 4 Motion for Reconsideration,                appeal correctly AFTER the appeal
                                                  Springfield, VA 22152.’ ’’ Id. (quoting                 GX 5, at 7. As the Supreme Court                          period had lapsed’’ and that [t]his was
                                                  OTSC–ISO, at 5). Finding ‘‘that this                    explained in Pioneer, ‘‘inadvertence,                     a source of conflicting guidance for’’
                                                  language is an unmistakably clear                       ignorance of the rules, or mistakes                       him. Id. at 6. However, as the ALJ noted,
                                                  explanation of where to send a request                  construing the rules do not usually                       this argument goes nowhere because
                                                  for hearing, especially for an educated                 constitute excusable neglect.’’ 507 U.S.                  Respondent does not claim that he had
                                                  professional, such as the Respondent,’’                 at 392. Moreover, as the Ninth Circuit                    any discussion with the DI regarding the
                                                  the ALJ held that ‘‘Respondent’s                        noted in Pincay, the ‘‘failure to read an                 manner for properly filing his hearing
                                                  confusion does not justify a finding of                 applicable rule is one of the least                       request within the thirty-day period, let
                                                  ‘good cause.’ ’’ Id.                                    compelling excuses that can be offered.’’                 alone that he was given misleading
                                                     The ALJ thus rejected Respondent’s                   389 F.3d at 859. Indeed, as the Ninth                     advice as to how to file his request.6
                                                  contention that he had shown good                       Circuit noted in Pincay, ‘‘had the                        Indeed, nothing prevented Respondent
                                                  cause to excuse his untimely filing. Id.                district court declined to permit’’ the                   from filing a separate hearing request
                                                  She further concluded that                              appellant to file his notice late, it                     with the Office of Administrative Law
                                                  ‘‘Respondent’s failure to file a timely                 ‘‘would [have] be[en] hard pressed to                     Judges during the thirty-day period. I
                                                  request [constituted] a waiver of his                   find any rationale requiring us to                        therefore reject Respondent’s contention
                                                  right to a hearing under 21 CFR                         reverse.’’ Id.                                            that his untimely filing should be
                                                  1301.43(d).’’ Id. at 9–10. The ALJ thus                    In his affidavit, Respondent asserts                   excused because he relied on
                                                  denied Respondent’s motion to reopen                    that he ‘‘sought the advice of and had                    ‘‘conflicting guidance’’ he received from
                                                  the matter.                                             several conversations with’’ his former                   agency personnel. See Watterson, 67 FR
                                                     Thereafter, the Government forwarded                 attorney ‘‘concerning the OSC and filing                  at 67413.
                                                  a Request for Final Agency Action and                   an appeal,’’ and that ‘‘[b]ased on these                     Accordingly, I hold that Respondent
                                                  the Investigative Record to me. Having                  conversations, I ‘filed’ an appeal NOT                    has failed to demonstrate good cause to
                                                  reviewed the record, I adopt the ALJ’s                  with the DEA . . . Office of the                          excuse his failure to timely file his
                                                  finding that Respondent did not                         Administrative Law Judges, but instead                    hearing request. I therefore find that
                                                  demonstrate good cause for his failure to               with the Office of the Inspector                          Respondent has waived his right to a
                                                  file his hearing request within the                     General.’’ Respondent’s Declaration, at                   hearing on the allegations and issue this
                                                  thirty-day period as required by 21 CFR                 9. To the extent Respondent seeks to                      Decision and Order based on the
                                                  1301.43(a).                                             rely on the advice he received from his                   Investigative Record (including
                                                     As the ALJ explained, the OTSC–ISO                   former attorney to support a showing of                   Respondent’s Declaration) submitted by
                                                  provided a clear explanation as to the                  good cause, his vague assertions do not                   the Government. I make the following
                                                  procedure to be followed for filing a                   establish that he was ever told not to                    findings.
                                                  hearing request. That procedure                         comply with the instructions on the                       Findings of Fact
                                                  required that Respondent or his                         OTSC–ISO. Nor does Respondent assert
                                                  representative file his hearing request                 that his former attorney ever agreed to                     Respondent was the holder of DEA
                                                  with the ‘‘Hearing Clerk, Office of                     represent him in this matter, let alone                   Certificate of Registration #BL6283927,
                                                  Administrative Law Judges, Drug                         that he agreed to file a request for a                    pursuant to which he was authorized,
                                                  Enforcement Administration, 8701                        hearing on Respondent’s behalf. To the                    prior to the Immediate Suspension of
                                                  Morrissette Drive, Springfield, VA                      extent Respondent relies on his own                       his registration, to dispense controlled
                                                  22152,’’ and that ‘‘[m]atters are deemed                confusion as the reason for his untimely                  substances in schedules II through V as
                                                  filed upon receipt by the Hearing                       filing, see Mot. For Recon., at 8; there is               a practitioner, at the registered address
                                                  Clerk.’’ GX 2, at 5.                                    no reason to excuse his neglect when                      of 6603 220th Street SW., Mountlake
                                                     Moreover, the OTSC–ISO included an                   the OTSC–ISO was personally served on                     Terrace, Washington 98043. GX 1.
                                                  attachment entitled: ‘‘REQUEST FOR                      him and set forth, with unmistakable
                                                                                                                                                                    could not have been a response to a misfiled
                                                  HEARING.’’ Id. at 6. The attachment                     clarity, the procedures to be followed                    hearing request given that it referenced his
                                                  states that ‘‘[a]ny person desiring a                   for requesting a hearing.5                                correspondence, which was dated approximately
                                                  hearing with regard to an Order to Show                                                                           eighteen months before he was even served with the
                                                  Cause must, within thirty (30) days from                   4 While the ALJ interpreted Respondent’s               OTSC–ISO. Nor, even if the OIG’s letter was
                                                                                                          excusable neglect argument as being based on his          misdated, does it seem likely that it was prepared
                                                  receipt of the Order to Show Cause, file                                                                          in response to a hearing request, given that it
                                                                                                          former attorney’s failure to tell him that he would
                                                  a request for a hearing in the following                not represent Respondent until after the deadline         referred to his ‘‘complaint’’ and referred it to the
                                                  format.’’ Id. The attachment then                       had passed, Respondent’s argument appears to rely         ‘‘Office of Professional Responsibility.’’ Id.
                                                  provides a sample form, with the                        on his own confusion as to where to file the hearing         As for Respondent’s assertion that he ‘‘discussed
                                                  following address block: DEA                            request and not on the aforesaid conduct of the           the matter . . . with an assistant in [his] office, who
                                                                                                          attorney.                                                 believed that the correct place to send the appeal
                                                  Headquarters, Office of the                                5 As for Respondent’s letters to the OIG and the       was to the office of the Attorney General,’’ Resp.
                                                  Administrative Law Judges, Hearing                      Attorney General, Respondent did not submit a             Decl., at 9; this begs the question of why he did not
                                                  Clerk, 8701 Morrissette Drive,                          copy of any of these letters with his motion. See         discuss where to file his appeal with the attorney
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                                                  Springfield, Virginia 22152.                            generally Attachments to Respondent’s Motion.             (who had also received a copy of the OTSC–ISO)
                                                                                                          Indeed, the only letter relevant to this issue which      he was then consulting with.
                                                  Id. Notably, neither the OTSC–ISO, nor                  Respondent submitted for the record (other than his          6 So too, if there was evidence that the DI had told

                                                  the attachment, directed Respondent, if                 appeal request) was a copy of an April 4, 2013 letter     Respondent that he would forward his hearing
                                                  he desired a hearing, to file his hearing               he received from the OIG, which ‘‘acknowledge[d]          request to the Office of Administrative Law Judges
                                                                                                          receipt of [his] correspondence dated July 11, 2011’’     and failed to do, I would order that a hearing be
                                                  request with DEA field personnel, the                   and explained that his ‘‘complaint has been               granted. Respondent, however, makes no such
                                                  Office of Inspector General, or the                     forwarded to’’ the DEA ‘‘Office of Professional           claim, but rather, relies only on the DI’s silence
                                                  Attorney General himself.                               Responsibility.’’ Id. at Ex. 31. Obviously, this letter   during the period for requesting a hearing.



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                                                                                 Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                         29029

                                                  Respondent’s registration was due to                     discipline by a state licensing body.                     . . . one [m]arijuana prescription bag’’
                                                  expire on March 31, 2014. Id. However,                   While the basis of the Texas Board’s                      from a marijuana collective. Resp. Mot.,
                                                  according to the registration records of                 action does not provide a reason under                    at Ex. 1. According to LHE, she ‘‘was in
                                                  the Agency, on March 13, 2014,                           the CSA for DEA to take any action                        a hurry to return the car to [TB and]
                                                  Respondent submitted an application to                   against Respondent’s registration,                        forget [sic] to remove the bag behind the
                                                  renew his registration. While under the                  Respondent’s statement was nonetheless                    driver seat.’’ Id. However, LHE’s
                                                  Agency’s regulation, his renewal                         false and clearly offered to influence the                statement is unsworn, and given that the
                                                  application was untimely because he                      decision of the Agency to grant him a                     purported reason for borrowing
                                                  was subject to an Order to Show Cause                    hearing on the allegations. Accordingly,                  Respondent’s car was to obtain the
                                                  and Immediate Suspension of                              I consider Respondent’s lack of candor                    marijuana, I find her story that she left
                                                  Registration and did not submit the                      in assessing the credibility of the                       a one pound bag of marijuana 12 in the
                                                  application ‘‘at least 45 days before the                various assertions contained in his                       car because she was in such a hurry to
                                                  date on which [his] registration [wa]s                   declaration.                                              return it to be utterly ludicrous.13
                                                  due to expire,’’ 21 CFR 1301.36(i), and                                                                               As for the cash, Respondent offered
                                                                                                           The Arrest of Respondent’s Girlfriend
                                                  thus his registration has expired, his                                                                             two explanations for its source. First, he
                                                  application remains pending before the                      According to the DI, on February 2,
                                                                                                                                                                     maintained that the day before, a patient
                                                  Agency.                                                  2012, Respondent’s girlfriend (TB),8
                                                                                                                                                                     paid him $5000 cash as a deposit for a
                                                     Respondent is also licensed by the                    who was driving his Mercedez Benz SL
                                                                                                                                                                     liposuction procedure. Resp. Decl., at 3.
                                                  State of Washington (as well as by the                   65,9 was stopped by local police, cited
                                                                                                                                                                     Respondent also produced an unsworn
                                                  States of Texas and California) as an                    for driving under a suspended license,
                                                                                                                                                                     letter from the purported patient to this
                                                  Osteopathic Physician. Resp.                             and arrested. DI Decl., at 1; Resp. Decl.,
                                                                                                                                                                     effect and a form entitled: ‘‘SmartLipo &
                                                  Declaration, at 1. According to                          at 3. Respondent corroborated that the
                                                                                                                                                                     Coolsculpting Price Quote.’’ Id. at Ex. 2.
                                                  Respondent, he has never been subject                    car was his, when in his declaration he
                                                                                                                                                                     While the latter purports to show that
                                                  to discipline by any state licensing                     addressed the allegation and stated,
                                                                                                                                                                     the patient paid a $5000 deposit in cash,
                                                  body. Id. However, Respondent has                        inter alia, that on January 24, 2012, he
                                                                                                           had withdrawn $5000 from his bank                         the date of the deposit clearly appears
                                                  been subject to discipline by the Texas                                                                            to have been altered. See id.
                                                  Medical Board. Moreover, while this                      account to pay for the remodeling of his
                                                                                                           clinic and left the money ‘‘in the small                     Second, as found above, Respondent
                                                  matter was pending, the Washington
                                                                                                           hidden compartment space of the car.’’                    maintained that he had withdrawn
                                                  Board of Osteopathic Medicine and
                                                                                                           Resp. Decl., at 3. Accordingly, I find that               $5,000 from his bank account on
                                                  Surgery issued Respondent an Ex Parte
                                                                                                           Respondent’s statements corroborate the                   January 24, 2012 to pay for clinic
                                                  Order of Summary Action which
                                                                                                           DI’s assertion that the car was owned by                  remodeling, and that he had placed the
                                                  suspended his state license to practice
                                                                                                           Respondent.                                               money ‘‘in the small hidden
                                                  as an osteopathic physician and
                                                                                                              Following the arrest of Respondent’s                   compartment space of the car.’’ Resp.
                                                  surgeon. In re Keith Ky Ly (Wash. Bd.
                                                                                                           girlfriend, the police apparently                         Decl., at 3. To support his claim,
                                                  Osteopathic Med. & Surg., Sep. 22,
                                                                                                           impounded his car, and upon searching                     Respondent produced a bank statement
                                                  2014) (Ex Parte Order of Summary
                                                                                                           it, found one pound of marijuana,10 the                   showing that he made a cash
                                                  Action, at 1).
                                                                                                           aforesaid $5000, and a backpack which                     withdrawal of $5,000. Resp. Ex. 3.
                                                     With respect to the Texas Medical
                                                                                                           contained pain medication. Id.; DI Decl.,                 However, numerous entries in the
                                                  Board, on May 20, 2011, Respondent
                                                                                                           at 2.11 As for the marijuana, Respondent                  statement, including Respondent’s
                                                  entered into an Agreed Order. See In re
                                                                                                           asserted that it belonged to a medical                    various balances for both his checking
                                                  Application for Licensure By Keith Ly,
                                                                                                           marijuana patient (LHE) who was a                         and savings account, are blacked out. Id.
                                                  D.O., at 6 (Tx. Med. Bd. 2011). Therein,
                                                  the Texas Board found that Respondent                    friend of TB, and points to a statement                      Putting aside that Respondent offered
                                                  failed to report on his application for a                from the purported owner of the                           two different stories as for why so much
                                                  Texas Medical License that in February                   marijuana. Resp. Decl., at 3; see also                    cash was found in his car, I find neither
                                                  1990, while undergoing his ‘‘residency                   Resp. Mot., at Ex.1. Therein, LHE stated                  explanation credible. As for the claim
                                                  training,’’ he had been ‘‘placed on                      that she had an engine problem with her                   that the money was from a patient who
                                                  probation’’ for being late and missing                   car and that she borrowed Respondent’s                    had paid $5,000 cash the day before for
                                                  shifts, as well as for failing to report a               car from TB ‘‘for a few hours to pick-up                  a procedure, the patient’s statement is
                                                  2007 arrest. Id. at 2. While the Board                                                                             unsworn and thus lacks even the most
                                                  granted Respondent a license, it also
                                                                                                              8 According to Respondent, TB has lived with
                                                                                                                                                                     basic indicia of reliability. Moreover, on
                                                                                                           him ‘‘for the past 2 years’’ and ‘‘is now [his] wife.’’   the price quote form, the date of the
                                                  assessed an administrative penalty of                    Resp. Decl., at 5. Moreover, TB worked in
                                                  $5,000 and placed him on probation for                   Respondent’s clinic. Resp. Decl., at Ex. 4.               patient’s deposit was clearly written
                                                  two years.7 Id. at 3–4.                                     9 According to the DI’s affidavit, the car was         over. Also, even acknowledging that the
                                                     Accordingly, I find that                              registered to Respondent. DI’s Decl., at 1. While the     patient’s procedure was likely not
                                                                                                           DI’s affidavit offers no explanation as to the basis      covered by insurance, it seems most
                                                  notwithstanding his statement,                           of knowledge for this assertion, Respondent, in his
                                                  Respondent has been subject to                           declaration, stated that a friend of TB ‘‘had
                                                                                                                                                                     unlikely that the patient would pay this
                                                                                                           borrowed the car the previous day without my
                                                    7 Based on the Texas Board’s action, the               knowledge.’’ Resp. Decl., at 3. I further note that in       12 According to data collected by the Agency,

                                                  Washington Board filed a Statement of Allegations        a March 3, 2012 letter to a local narcotic task force     during the period in which TB was stopped, one
                                                  against Respondent. See In re Keith K. Ly, No.           and the King County Prosecuting Attorney’s Office,        pound of marijuana had a street value of $1500 to
                                                  M2010–1665, Statement of Allegations and                 Respondent claimed that he owned the car and              $1800 in the Seattle area. At .5 grams per joint, one
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                                                  Summary of Evidence (Wash. Dept. Health, Oct. 12,        sought its return. Resp. Decl., at Ex.4. Accordingly,     pound would be enough to make approximately 900
                                                  2012). However, these allegations were settled in a      I find that Respondent owned the car that TB was          joints.
                                                  Stipulation To Informal Disposition, the terms of        driving when she was stopped and arrested.                   13 I further note that in his March 3, 2012 letter
                                                                                                              10 In his statement, Respondent does not dispute
                                                  which included that it ‘‘is not [a] formal                                                                         to a local narcotics task force and the King County
                                                  disciplinary action.’’ See Stipulation To Informal       that the arresting authorities found a one pound bag      Prosecuting Attorney’s Office, in which he sought
                                                  Disposition, In re Ly, at 2. However, the proceeding     of marijuana. Resp. Decl., at 3.                          the return of his car, while Respondent again
                                                  was still subject to reporting to the Health Integrity      11 According to the DI, the police also found          denied knowledge of the marijuana, he made no
                                                  and Protection Databank and the National                 $3900 in cash in a vacuum sealed bag in TB’s purse.       mention of the story that LHE had borrowed the car
                                                  Practitioner Databank. Id.                               DI Decl., at 2.                                           from his girlfriend.



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                                                  29030                        Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  amount in cash rather than by check or                  while the photograph does not show                        assertion that these vials contained
                                                  credit card.                                            whether there were pills remaining in                     phentermine and phendimetrazine.
                                                     As for his second story, it also seems               the vial, in his declaration, Respondent
                                                  most unlikely that Respondent would                                                                               The Searches of Respondent’s
                                                                                                          does not dispute that the vial contained
                                                  pay to remodel his clinic with cash                                                                               Properties
                                                                                                          pain medication, which hydrocodone is.
                                                  (rather than check or credit card), let                 I thus find that substantial evidence                        As noted above, the Show Cause
                                                  alone be carrying that much cash                        supports a finding that Respondent’s                      Order also alleged that state and local
                                                  around in his car for nine days. By                     girlfriend unlawfully possessed                           law enforcement officers conducted
                                                  contrast, carrying large sums of cash is                hydrocodone, which had been                               searches of four different premises
                                                  consistent with engaging in the                         prescribed to another person.                             which Respondent owned, and found
                                                  distribution of marijuana.                                 In support of the DI’s assertion that                  marijuana plants at his properties which
                                                     In his declaration, the DI also asserted             two unlabeled vials which contained                       were located in Renton and Shoreline,
                                                  that the search of the vehicle found                    phentermine and phendimetrazine were                      Washington, as well as six bags of
                                                  ‘‘multiple prescription bottles                         also seized, the DI cited Government                      processed marijuana at the latter
                                                  containing pills,’’ and that one of the                 Exhibit 10, but without regard to the                     property. GX 2, at 2. In addition, the
                                                  bottles bore a label indicating that the                specific page. However, in his                            Show Cause Order alleged that
                                                  drugs had been prescribed to T.V., ‘‘an                 declaration, the DI offered no statement                  marijuana grow documents and ‘‘15
                                                  office employee of’’ Respondent. DI’s                   to the effect that he participated in the                 grams of processed marijuana’’ were
                                                  Decl., at 2 (citing GX 9). The DI further               search of Respondent’s car, nor                           found at Respondent’s personal
                                                  stated that ‘‘[t]wo of the bottles found in             otherwise set forth the basis of his                      residence, and that both marijuana grow
                                                  the vehicle . . . were unlabeled and                    knowledge for making this assertion.                      equipment and marijuana leaves were
                                                  contained phentermine and                               Nor does the record contain any                           found at a fourth property he owns. Id.
                                                  phendimetrazine.’’ Id. (citing GX 10).                  affidavits or police reports prepared by                  at 3.
                                                  Finally, the DI asserted that when                      those officers who did participate in the                    In his declaration, the DI made
                                                  Respondent ‘‘attempted to recover his                   arrest and search, nor other documents                    various assertions with respect to each
                                                  vehicle, he told law enforcement                        such as an inventory of the search, a                     of the searches. For example, with
                                                  officers that his employees often shared                chain of custody, and lab test results,                   respect to the May 30, 2012 search of
                                                  their medication.’’ Id.                                 which would support the DI’s                              the Renton residence, the DI stated that
                                                     Respondent did not dispute that drugs                assertion.15                                              the Renton Fire Department had
                                                  were found in TB’s backpack. Rather, he                    Indeed, while Government Exhibit 10                    responded to an electrical fire at the
                                                  asserted that they ‘‘belonged to my                     contains eight photographs, in                            premises, which ‘‘is owned by’’
                                                  office manager,’’ that he had prescribed                reviewing this matter it is apparent that                 Respondent and ‘‘discovered a large
                                                  the drugs ‘‘for her liposuction procedure               the exhibit is not limited to the evidence                marijuana grow,’’ and that thereafter,
                                                  pain a few months prior,’’ and that the                 that was seized following the search of                   ‘‘[t]he Renton Police Department
                                                  drugs were ‘‘left at my house when she                  Respondent’s car, but also contained                      executed a search warrant of the
                                                  visited for [a] dinner party.’’ Resp. Decl.,            photographs of evidence that may well                     residence and seized approximately 700
                                                  at 3. Respondent then maintained that                   have been seized during several of the                    marijuana plants.’’ DI Decl., at 2. The DI
                                                  ‘‘[a]s a medical doctor, I do not                       searches described below. Most                            further stated that Respondent ‘‘told law
                                                  encourage nor allow any patients to                     significantly, the Exhibit contains two                   enforcement that he rented the
                                                  share medication’’ and that he ‘‘would                  photographs of vials (one showing two                     [premises] to [one] Jack Tran,’’ but that
                                                  absolutely terminate my employee if                     vials, the other showing a single vial)                   the police ‘‘were unable to locate and/
                                                  found engaging in sharing medication                    which were missing their labels, with                     or identify Mr. Tran.’’ Id. at 3. While all
                                                  and would report them to the                            no identification of when and from                        of this may be true, here again, the DI’s
                                                  authorities.’’ Id. Respondent did not,                  whom the vials were seized. Finally,                      declaration offers no statement to the
                                                  however, explain when the purported                     while at least two of the vials appear to                 effect that he participated in the search,
                                                  dinner party had occurred.                              contain tablets (the third vial being                     nor otherwise sets forth the basis of his
                                                     Consistent with Respondent’s                         murky), the Government provided no                        knowledge.
                                                  admission, the record does include a                    evidence (such as lab test results)                          With respect to the July 5, 2012 search
                                                  photograph of a prescription vial; its                  explaining the basis for the DI’s                         of the Shoreline residence, the DI stated
                                                  label lists the patient as a person whose                                                                         that it was owned by Respondent, and
                                                  name corresponds with the initials T.V.,                labels list Respondent as the prescriber, his
                                                                                                                                                                    that during the search by state and local
                                                  the drug as hydrocodone/                                girlfriend T.B. as the patient, and the drugs as
                                                                                                          lorazepam and hydrocodone/acetaminophen, with             law enforcement, ‘‘approximately 489
                                                  acetaminophen, and Respondent as the                    pills being visible only in the latter vial. Generally,   marijuana plants and six (6) bags of
                                                  prescriber. See GX 9, at 1.14 Moreover,                 the DI’s declaration offers no statements linking         processed marijuana’’ were seized. Id. at
                                                                                                          these photographs to the various items which were
                                                     14 Government Exhibit 9, however, contains seven     purportedly seized during the various searches of         3. The DI further stated that TB and
                                                  additional photographs, including: (1) A                Respondent’s car and properties he owned.                 three other ‘‘marijuana tenders were
                                                  photograph of two unlabeled vials (only one of             Moreover, Government Exhibits 8, 9, 10, 11a, 11b,      arrested leaving the Shoreline
                                                  which clearly contains tablets); (2) a photograph of    13, 14, and 15 each contain the exact same set of         residence,’’ that TB ‘‘admitted’’ to the
                                                  two plastic bags, which purportedly contain             eight photographs, although not necessarily in the
                                                                                                          same order. Providing multiple copies of the exact
                                                                                                                                                                    police ‘‘that she was learning to grow
                                                  phentermine and a red document, the date of which
                                                  is unclear; (3) a photograph of a plastic bag           same set of photographs does not, however, make           marijuana at the Shoreline residence,’’
                                                  containing a drug similar in appearance to the drug     the first set of photographs any more probative of        and that two ‘‘of the marijuana tenders
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                                                  in the previous photograph; (4) a photograph of a       the facts for which they were offered.                    arrested at the Shoreline residence
                                                  vial containing yellow capsules and orange tablets,        15 Even giving weight to the DI’s assertion that
                                                                                                                                                                    possessed loose phentermine tablets in
                                                  the label of which had been removed; (5) a vial         Respondent ‘‘purchased these items [i.e.,
                                                  bearing a label for a prescription issued by            phentermine and phendimetrazine] on August 5,             their pockets.’’ Id. (citing GX 11).16 Here
                                                  Respondent for clonazepam to a patient whose            2011 from Distributor A.F. Hauser,’’ DI’s Decl., at
                                                  initials are R.M.; (6) six bottles bearing              5 (¶ 34), this is not enough to overcome the                16 As explained below, while Respondent denies

                                                  manufacturer’s labels (several of which are labelled    insufficiency of the evidence with respect to the         knowledge as to how his properties were being
                                                  as professional samples) for Viagra, Topiramate,        assertion that these drugs were seized during the         used, he does not dispute that marijuana was being
                                                  Ultram ER, and Meridia; and (7) two vials, whose        February 2, 2012 search.                                  grown at the various properties. Thus, his



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                                                                                Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                       29031

                                                  too, all of this may be true, but the DI’s               DI then stated that on July 13, 2012, he                As for the DI’s assertion that the
                                                  affidavit offers nothing bordering on                    subpoenaed ‘‘L.E.’s patient chart from’’             police also seized a vial containing
                                                  substantial evidence to support any of                   Respondent, but that ‘‘[t]he office staff            clonazepam, here again, there is no
                                                  these assertions.17                                      could not locate a patient chart for L.E.,           evidence either that the DI was present
                                                     The DI further asserted that L.E. was                 nor could they find his/her name in the              during the search of Respondent’s
                                                  one of the marijuana tenders arrested                    electronic medical records.’’ Id. at 4.              residence or that a vial containing this
                                                  during this search, and that using the                      Government Exhibit 12 is a copy of a              drug was seized during that search. And
                                                  Washington State Prescription                            prescription issued by Respondent on                 while the record contains a photograph
                                                  Monitoring Program, ‘‘[i]t was                           June 28, 2012 for thirty (30) tablets of             of a vial, which bears a label listing
                                                  discovered . . . that in June 2012,                      Lortab (hydrocodone/acetaminophen)                   Respondent as the prescriber, the drug
                                                  [Respondent] prescribed 30 dosage units                  10/500. See GX 12. However, the                      as clonazepam, and the patient’s name
                                                  of 10/500 mg hydrocodone to L.E.’’ Id.                   prescription was issued to a patient                 corresponding with the initials R.M.,
                                                  Citing Government Exhibit 12, the DI                     whose initials are H.L., and not L.E. See            there is no evidence establishing that
                                                  further stated that he ‘‘verified the                    id. Thus, the prescription does not                  any pills were in the vial, let alone that
                                                  prescriptions [sic] by obtaining a hard                  support the DI’s assertion, and the                  the pills were clonazepam.19
                                                  copy of the prescription through’’ the                   Government points to no other evidence                  Turning to the DI’s assertion that
                                                  pharmacy which filled it. Id. at 3–4. The                that Respondent prescribed a controlled              Respondent ‘‘also possessed two (2)
                                                                                                           substance to a patient whose name                    stock bottles that contained Meridia and
                                                  declaration corroborates the basic thrust of the DI’s
                                                                                                           corresponds with the initials of L.E., let           diazepam,’’ here again, there is no
                                                  assertions.                                                                                                   evidence establishing that the DI
                                                     That being said, the DI’s affidavit contains          alone that he violated the CSA’s
                                                                                                           prescription requirement in doing so.                participated in the search of
                                                  numerous assertions for which there is no
                                                  foundation to conclude that they are based on the        See GX 2, at 2, ¶ 3–b. (OTSC–ISO).                   Respondent’s residence, or any other
                                                  DI’s ‘‘personal knowledge’’ as that term is                                                                   evidence establishing that these drugs
                                                  commonly understood. Indeed, many of the DI’s               Regarding the July 6, 2012 search of              were seized during that search. To be
                                                  assertions regarding the searches of Respondent’s        Respondent’s and TB’s residence (which               sure, the Government cites to an exhibit,
                                                  properties appear to be based on hearsay                 is owned by the former), the DI asserted
                                                  statements, the reliability of which cannot be                                                                which contains several photographs,
                                                  assessed because the DI did not identify the source
                                                                                                           that state and local law enforcement                 including one which shows six white
                                                  of the information and the Government did not            seized ‘‘firearms, marijuana grow                    bottles (several of which are clearly
                                                  include various documents (such as police reports,       documents, approximately 15 grams of                 marked as professional samples) which
                                                  search inventories, and test results) in the record.     processed marijuana, and multiple
                                                     More specifically, the DI asserts that TB and three                                                        bear the manufacturer’s label for such
                                                  other persons were arrested during the search of the
                                                                                                           prescription bottles containing pills.’’ DI          drugs as Viagra, Topiramate, Ultram ER,
                                                  Shoreline residence; that during an interview with       Decl., at 4. The DI then stated that                 and Meridia. See GX 15, at 1. However,
                                                  law enforcement, TB admitted that she was learning       Investigators found ‘‘an unlabeled’’ vial,           of these drugs, only Meridia
                                                  how to grow marijuana; and that two of the persons       ‘‘which contained hydrocodone’’; one
                                                  had loose phentermine tablets in their pockets.                                                               (sibutramine) is a controlled substance
                                                  Again, the DI offered no statement to the effect that
                                                                                                           labeled vial, ‘‘which contained                      under federal law, 21 CFR 1308.14(e),
                                                  he participated in either the search of the Shoreline    clonazepam that [Respondent]                         and putting aside the absence of any
                                                  residence or the interview of TB. Nor did he set         prescribed to patient R.M. in 2010’’; and            evidence as to where and when this
                                                  forth any other basis for these assertions.              two ‘‘stock bottles that contained
                                                     As for the two marijuana tenders who
                                                                                                                                                                drug was seized, here again, there is no
                                                  purportedly possessed loose phentermine, the DI
                                                                                                           Meridia and diazepam’’; even though                  evidence that there actually was any of
                                                  further asserted that ‘‘[s]tate law requires the         Respondent ‘‘was not, nor has ever                   the drug in the bottle at the time it was
                                                  labeling of dispensed medication’’ and that ‘‘[t]he      been, registered with DEA at his Bothell             seized. As for the DI’s assertion that a
                                                  lack of labeled prescription bottles suggests the        residence.’’ Id. (citing GXs 13, 14, and
                                                  controlled substances were diverted.’’ DI’s Decl., at                                                         stock bottle of diazepam was also seized
                                                  3. This too may be true, but there is no evidence
                                                                                                           15).                                                 during the search of Respondent’s
                                                  in the record establishing the names of these               As for the unlabeled prescription                 residence, here too, there is no evidence
                                                  individuals and that they obtained the controlled        bottle which purportedly contained                   (indeed, not even a photograph of the
                                                  substances from Respondent. Indeed, while the DI
                                                  cited GX 11 as support for his assertion that these
                                                                                                           hydrocodone, here again, the DI’s                    bottle) to support the DI’s contention.
                                                  individuals possessed phentermine, this exhibit          Declaration is devoid of any statement                  Finally, the DI stated that on July 7,
                                                  simply contains a series of photographs including        that he was present during the search                2012, state and local law enforcement
                                                  two of white tablets (one of which contains a red        and there is no other evidence                       executed a search warrant at a fourth
                                                  form which is illegible), various prescription vials
                                                  (some of which contain pills, others which it is         establishing that the vials were seized              residence which is owned by
                                                  unclear if they do) and bottles containing various       from Respondent’s residence. And                     Respondent and located in Marysville,
                                                  drug samples. Even assuming that the white tablets       while GX 13 contains a photograph of                 Washington. DI Decl., at 5. The DI
                                                  are phentermine (even though there is no evidence        two vials, with pills that are barely                further stated that during the search, the
                                                  they were tested), nothing in the record establishes
                                                  from whom and when these tablets were seized.            visible in the vials, there is no                    officers ‘‘seized some marijuana grow
                                                     17 Here too, even giving weight to the DI’s           photograph of the pills outside of the               equipment and marijuana leaves.’’ Id.
                                                  assertion that Respondent ‘‘purchased this exact         vials, which might have shown that the               Here again, the DI’s affidavit does not
                                                  item [i.e., more phentermine] on March 16, 2012          pills bore the NDC Code for                          establish the basis of his knowledge.
                                                  from Distributor A.F. Hauser,’’ DI Decl., at 5 (¶ 35),
                                                  this evidence does not overcome the insufficiency        hydrocodone. Nor is there any evidence                  Regarding the searches of the
                                                  of the evidence with respect to the assertion that       establishing that the pills were tested by           properties other than his residence,
                                                  these drugs were seized from the marijuana tenders       a laboratory and found to be                         Respondent acknowledged that he
                                                  during the search of the Shoreline residence. And        hydrocodone.18                                       owned ‘‘three rental properties.’’ Resp.
                                                  because the evidence is insufficient to establish that
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                                                  loose phentermine was seized from the two                                                                     Decl., at 3. He also acknowledged that
                                                  marijuana tenders who were purportedly at the              18 Even giving weight to the DI’s assertion that

                                                  Shoreline residence, the assertions of the DI that:      Respondent ‘‘purchased this item [i.e.,                 19 In his Declaration, Respondent denied that he

                                                  (1) One of the tenders ‘‘was never seen by’’             hydrocodone] on March 16, 2012 from Distributor      ‘‘ha[s] or store[s] any [h]ydrocodone or
                                                  Respondent, and (2) that while one of the tenders        A.F. Hauser, Inc.,’’ DI Decl., at 6 (¶ 37); this     [c]lonazepam at home.’’ Resp. Decl., at 5. He further
                                                  was seen by Respondent, he was not prescribed any        statement likewise does not overcome the lack of     stated that ‘‘[t]he prescription bottles are prescribed
                                                  controlled substance, id. at 5–6 (¶ 36), is              substantial evidence establishing that these drugs   for my wife for her liposuction procedures post-
                                                  insufficient to establish that Respondent unlawfully     were seized during the search of Respondent’s        operational pain where she had four liposuction
                                                  distributed the phentermine to either person.            residence.                                           procedures performed from 7/9/11 to 11/3/12.’’ Id.



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                                                  29032                        Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  ‘‘one of the rental houses had an                       well as the quantity of marijuana which               Sticker.’’ Id. at 1–5. Yet the Government
                                                  electrical burn that shed light on the                  was seized from his girlfriend. Id. at 3.             produced no evidence to prove that
                                                  others that had illegal activities.’’ Id. at              Respondent went to trial; the jury                  these dispensings actually involved
                                                  4. He then asserted that he ‘‘had                       found him guilty on all counts.20 On                  controlled substances as opposed to
                                                  irresponsible tenants that took                         December 19, 2014, the United States                  non-controlled drugs.
                                                  advantage of the locations by cultivating               District Court convicted Respondent on                   The DI also asserted that Respondent
                                                  [m]arijuana for 6 months without [his]                  each of the above counts and sentenced                ‘‘failed to maintain or provide any
                                                  knowledge’’ and that he ‘‘do[es] not                    him to 60 months of imprisonment,                     dispensing/administration records for
                                                  personally inspect, supervise, or manage                imposed a four-year term of supervised                Testosterone and Testim samples
                                                  the rentals on a regular basis,’’ because               release following his release from                    located at the registered location.’’ DI
                                                  he works six days a week in his medical                 imprisonment, imposed an assessment                   Decl., at 7. The DI further asserted that
                                                  practice, and that ‘‘[w]hen the rent is                 of $1,000, and ordered that various                   Respondent did not ‘‘maintain[ ] at least
                                                  timely paid with no complaints that                     property be forfeited. Judgment, at 1–6,              four Schedule III–V acquisition invoices
                                                  need repair, [he has] no need to bother                 United States v. Keith K. Ly (W.D. Wash.              and by not recording the dates of receipt
                                                  tenants at their home.’’ Id. at 3–4. Later              Dec. 19, 2014).                                       on at least five invoices.’’ Id.21
                                                  in his declaration, Respondent stated
                                                                                                          The DEA Investigation                                    The DIs also conducted an audit of
                                                  that ‘‘[i]f something is broke they send
                                                                                                                                                                the controlled substances which were
                                                  me a bill for repair and I deduct it from                  According to the DI’s affidavit, on July
                                                                                                                                                                located at Respondent’s registered
                                                  the rent.’’ Id. at 5.                                   13, 2012, DEA Investigators visited
                                                     On May 22, 2013, Respondent was                                                                            location. Id. In his declaration, the DI
                                                                                                          Respondent’s registered location and
                                                  indicted in United States District Court                                                                      stated that ‘‘DEA used an initial
                                                                                                          upon obtaining his consent, conducted
                                                  for the Western District of Washington                                                                        inventory date of January 1, 2012,
                                                                                                          an inspection. DI’s Decl., at 6; see also
                                                  and charged with conspiracy to                                                                                beginning of business, and noted that
                                                                                                          GX 20 (Notice of Inspection manifesting
                                                  manufacture and distribute marijuana.                                                                         the initial inventory was ‘zero’ due to
                                                                                                          Respondent’s consent to the inspection
                                                  DI Decl., at 11; see also GX 31.                                                                              the lack of an initial or biennial
                                                                                                          and witnessed by the DI). As part of the
                                                  Moreover, on October 22, 2013, a                                                                              inventory.’’ Id. To determine the
                                                                                                          inspection, the Investigators asked
                                                  superseding indictment was filed                                                                              amounts of the various drugs
                                                                                                          Respondent to produce his records,
                                                  against Respondent and his girlfriend.                                                                        Respondent purchased, the DIs relied on
                                                                                                          including his controlled substance
                                                     The superseding indictment alleged                                                                         ‘‘a summary of the invoices provided by
                                                                                                          inventories, dispensing and
                                                  that Respondent and others conspired to                                                                       distributor A.F. Hauser’’; they also used
                                                                                                          administration logs, invoices, returns,
                                                  grow marijuana at several residential                                                                         his dispensing log to determine the
                                                                                                          distributions, as well as theft and loss
                                                  properties and that Respondent ‘‘made                                                                         amounts that he dispensed. Id. The DI
                                                                                                          reports. Id.
                                                  at least three of those properties                         The DIs determined that Respondent                 further stated that he used ‘‘the closing
                                                  available . . . for the purpose of                      ‘‘failed to take and maintain an initial or           inventory assembled by DEA
                                                  manufacturing marijuana,’’ that he                      biennial inventory of all stocks of                   investigators during the on-site
                                                  ‘‘purport[ed] to rent [the houses] to                   controlled substances on hand.’’ Id.                  inspection.’’ Id.
                                                  others, knowing that the persons listed                 While Respondent produced a                              The DI then asserted that the ‘‘audit
                                                  as ‘tenants’ for these properties did not,              dispensing log, which covered the                     revealed large shortages of testosterone,
                                                  in fact, reside there and/or did not pay                period from December 23, 2010 to July                 phentermine, phendimetrazine, and a
                                                  rent,’’ that he and his co-conspirators                 11, 2012, according to the DI, 128 of the             14% shortage or[sic] hydrocodone.’’ Id.
                                                  ‘‘set up large-scale marijuana grows for                entries lacked required information. Id.              More specifically, the DI asserted that
                                                  the purpose of manufacturing marijuana                  More specifically, the DI asserted that               Respondent had a shortage of 300 mg of
                                                  within the houses’’ and ‘‘caused the                    82 entries did not have the patient’s                 Testosterone 200 mg/ml, 6,028 tablets of
                                                  electrical power in these houses to be                  address, the name of the controlled                   phentermine 37.5 mg,22 2,102 tablets of
                                                  diverted around the meters, thus                        substance, the finished form, and the                 phendimetrazine 35 mg, and 71 tablets
                                                  stealing power to run the marijuana                     dispenser’s initials. Id. at 6–7.                     of hydrocodone 10/500 mg. Id. at 8.
                                                  grows,’’ and that he and his co-                        According to the DI, another 46 entries                  The Government also submitted a
                                                  conspirators ‘‘recruited and directed                   lacked the patient’s address, name of the             document which appears to be the
                                                  others to help grow and harvest the                     controlled substance, the quantity                    aforesaid summary of Respondent’s
                                                  marijuana plants, and maintain the                      dispensed, and the dispenser’s initials.              controlled substance purchases from
                                                  houses and yards at these properties.’’                 Id. at 7.                                             A.F. Hauser between January 1, 2010
                                                  Superseding Indictment, at 2, United                       As part of the record, the Government              and July 24, 2012, see GX 16, as well as
                                                  States v. Thi Nguyen Tram Bui and                       submitted a copy of Respondent’s                      the audit computation chart. GX 23.
                                                  Keith Ky Ly, No CR13–157JCC (W.D.                       dispensing log. GX 21. A review of the                Significantly, the audit chart lists the
                                                  Wash. 2013) (citing, inter alia, 21 U.S.C.              log corroborates the DI’s assertion that              initial inventory date as ‘‘1–1–2010
                                                  841(a)(1) and (b)(1)(A), 846). The                      many of the entries which record the                  COB’’ and not January 1, 2012 as set
                                                  Indictment further charged Respondent                   dispensing of controlled substances lack
                                                  with three counts of manufacturing                      various items of information required by                21 The DI also stated that during the inspection,
                                                  marijuana at his properties in Renton,                  federal law, including the patient’s                  Respondent did not provide any ‘‘Report[s] of Theft
                                                  Shoreline and Marysville, Washington,                   address and the dispenser’s initials. See             or Loss of Controlled Substances’’ (DEA Form 106).
                                                  as well as three counts of maintaining                                                                        DI Decl., at 7. He also reviewed all of the hard copy
                                                                                                          id. at 6–9. As for the contention that                Theft and Loss Reports on file with the Seattle Field
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                                                  drug-involved premises. Id. at 4–7                      numerous entries did not contain the                  Office, as well as queried the Drug Theft Loss
                                                  (citing 21 U.S.C. 841(a)(1) and (b)(1)(B);              name of the controlled substance that                 database, which gathers all of the Form 106s which
                                                  856(a)(1) and 856(b)). The indictment                   was dispensed, it is true that numerous               are submitted online, and determined that
                                                  also set forth additional allegations                   entries were missing the ‘‘Medication ID
                                                                                                                                                                Respondent had not submitted any such reports. Id.
                                                                                                                                                                  22 According to the DI’s declaration, the shortage
                                                  regarding the quantities of marijuana
                                                                                                                                                                was 6.028 tablets. DI Decl., at 8. Based on the audit
                                                  plants and/or harvested marijuana that                    20 Respondent was also charged and convicted of     chart, which lists the shortage as 6,028 tablets, GX
                                                  were seized during the searches of his                  three counts of wire fraud, based on claims he made   23, I conclude that the former figure is a
                                                  Renton and Shoreline properties, as                     to an insurance company.                              typographical error.



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                                                                               Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                          29033

                                                  forth in the DI’s declaration. Compare                  documentation establishing the amount                    application, the following factors be
                                                  GX 23 with DI Decl., at 7.                              of Testim that was distributed to him.24                 considered:
                                                     This disparity has a material impact                 Finally, the Government’s evidence                         (1) The recommendation of the appropriate
                                                  on the accuracy of the audit results. For               shows that in March 2012, Respondent                     State licensing board or professional
                                                  example, according to the DI’s                          purchased 1,000 dosage units of                          disciplinary authority.
                                                  declaration (and the computation chart),                Lorazepam, GX 16, and the computation                      (2) The [registrant’s] experience in
                                                  Respondent was short more than 6,000                    chart indicates that the audit balanced                  dispensing, or conducting research with
                                                  dosage units of phentermine. Yet,                       with respect to this drug. GX 23.                        respect to controlled substances.
                                                  according to the summary of                                                                                        (3) The [registrant’s] conviction record
                                                                                                             In his declaration, the DI further                    under Federal or State laws relating to the
                                                  Respondent’s purchases and the
                                                  invoices, Respondent only purchased                     asserted that Respondent failed to report                manufacture, distribution, or dispensing of
                                                  3,000 dosage units of phentermine                       to the State of Washington’s                             controlled substances.
                                                                                                          Prescription Monitoring Program (PMP),                     (4) Compliance with applicable State,
                                                  during 2012. Thus, if—as stated by the                                                                           Federal, or local laws relating to controlled
                                                  DI—the beginning date of the audit                      ‘‘at least 45 occasions from January
                                                                                                          through July 2012’’ in which he                          substances.
                                                  period was January 1, 2012 and zero                                                                                (5) Such other conduct which may threaten
                                                  was assigned as the opening inventory,                  ‘‘dispensed more than a 24-hour supply
                                                                                                                                                                   the public health and safety.
                                                  Respondent could not have been short                    of controlled substances.’’ DI Decl., at 8.
                                                                                                                                                                   21 U.S.C. 823(f).
                                                  6,000 dosage units.                                     According to the DI, this was a violation
                                                     So too, in his declaration, the DI                   of Washington law. Id. The Government                       ‘‘[T]hese factors are . . . considered
                                                  asserted that Respondent was short                      did not, however, submit the PMP                         in the disjunctive.’’ Robert A. Leslie,
                                                  more than 2,100 phendimetrazine                         reports which establish the basis for its                M.D., 68 FR 15227, 15230 (2003). It is
                                                  tablets (the same figure listed on the                  assertion.                                               well settled that I ‘‘may rely on any one
                                                  computation chart, which also lists                        Regarding this allegation, Respondent                 or a combination of factors, and may
                                                  3,000 dosage units as having been                       stated that he ‘‘was not aware of this                   give each factor the weight [I] deem
                                                  purchased). However, the Government’s                   Washington State law requirement . . .                   appropriate in determining whether a
                                                  other evidence shows that Respondent                    [and] thus cannot have . . . repeatedly                  registration should be revoked.’’ Id.; see
                                                  did not purchase any phendimetrazine                    failed’’ to comply or to have shown a                    also MacKay v. DEA, 664 F.3d 808, 816
                                                  during 2012. See GX 16. Here again,                     ‘‘consistent disregard’’ for this                        (10th Cir. 2011); Volkman v. DEA, 567
                                                  Respondent could not have been short                    requirement. Resp. Decl., at 8.                          F.3d 215, 222 (6th Cir. 2009); Hoxie v.
                                                  3,000 dosage units if the beginning date                Respondent then stated that ‘‘I am now                   DEA, 419 F.3d 477, 482 (6th Cir. 2005).
                                                  of the audit period was January 1, 2012,                made fully aware and will comply with                    Moreover, while I am required to
                                                  as stated by the DI in his sworn                        the law. This is not an intentional                      consider each of the factors, I ‘‘need not
                                                  declaration.                                            violation.’’ Id.25                                       make explicit findings as to each one.’’
                                                     As for the testosterone, while there is                                                                       MacKay, 664 F.3d at 816 (quoting
                                                  evidence that Respondent also                           Discussion                                               Volkman, 567 F.3d at 222 (quoting
                                                  purchased testosterone in February                                                                               Hoxie, 419 F.3d at 482)).27
                                                  2012, the data as presented in the                        Under the CSA, ‘‘[a] registration                         The Government has the burden of
                                                  computation chart suggests that he                      pursuant to section 823 of this title to                 proving, by a preponderance of the
                                                  purchased 400 10ml bottles and that he                  manufacture, distribute, or dispense a                   evidence, that the requirements for
                                                  could not account for 300 bottles. See                  controlled substance . . . may be                        revocation or suspension pursuant to 21
                                                  GX 23 (listing drug as ‘‘Testosterone                   suspended or revoked by the Attorney                     U.S.C. 824(a) are met. 21 CFR
                                                  200mg/ml—10 ml bottle’’ and listing the                 General upon a finding that the                          1301.44(e). This is so even in a non-
                                                  ‘‘[t]otal purchased’’ as 400.) However,                 registrant . . . has committed such acts                 contested case.
                                                  the Government’s other evidence, i.e.,                  as would render his registration under                      In this matter, I have considered all of
                                                  the listing of Respondent’s purchases,                  section 823 of this title inconsistent                   the factors. While I find that some of the
                                                  which according to the DI was prepared                  with the public interest as determined                   allegations are not supported by
                                                  by A.F. Hauser, lists the quantity of                   under such section.’’ 26 21 U.S.C.                       substantial evidence, I nonetheless find
                                                  Respondent’s purchases as only ‘‘2.00.’’                824(a)(4). The Act further provides that                 that the Government’s evidence with
                                                  GX 19. Thus, here again, there is reason                in determining ‘‘the public interest’’                   respect to factors one, two, three, and
                                                  to question the reliability of the audit                with respect to a practitioner’s                         four establishes that he has committed
                                                  results.23                                                                                                       acts which render his registration
                                                     With respect to the remaining drugs,                    24 It is further noted that while the computation
                                                                                                                                                                   ‘‘inconsistent with the public interest.’’
                                                  there is evidence that Respondent                       chart contains a column for the ‘‘Total Purchased,’’     21 U.S.C. 823(f). While I have also
                                                                                                          which was added to the ‘‘Initial Inventory’’ to arrive
                                                  purchased 500 dosage units of                           at the ‘‘Amount Accountable For,’’ samples are not       considered Respondent’s declaration
                                                  hydrocodone during 2012 (GX 19) and                     typically purchased and the chart contains no            with respect to the various allegations,
                                                  was short 71 tablets. GX 23. There is                   column for other means of acquisition. GX 23.            I conclude that he has not presented
                                                  also evidence that at the time of the July                 25 Based on the DI’s Declaration, the Government
                                                                                                                                                                   sufficient evidence to rebut this
                                                  2012 inspection, Respondent had on                      proposes that I make a factual finding that following
                                                                                                          the issuance of the Immediate Suspension Order,
                                                                                                                                                                   conclusion. Accordingly, I will affirm
                                                  hand 21 Testim 1% samples. While the                    Respondent ‘‘issued at least three (3) prescriptions     the suspension of his registration and
                                                  DIs concluded that Respondent had an                    to two (2) separate patients on February 1, March
                                                  overage of these 21 samples, there is no                2, and March 30, 2013, in violation of the Order.’’         27 ‘‘In short, this is not a contest in which score

                                                  evidence as to who distributed the                      Request for Final Agency Action, at 5 (citing DI’s       is kept; the Agency is not required to mechanically
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                                                                                                          Declaration at 9–10). However, in its Request for        count up the factors and determine how many favor
                                                  samples to him and there is no evidence                 Final Agency Action, the Government does not             the Government and how many favor the registrant.
                                                  the DIs asked Respondent for any of the                 propose that I make any conclusion of law based          Rather, it is an inquiry which focuses on protecting
                                                                                                          on this conduct. See id. at 6–12. Accordingly, I do      the public interest; what matters is the seriousness
                                                    23 Moreover, even if the entry in the computation     not consider this conduct.                               of the registrant’s misconduct.’’ Jayam Krishna-Iyer,
                                                  chart was actually intended to be 400mg (or two            26 Pursuant to 28 CFR 0.100(b), this authority has    74 FR 459, 462 (2009). Accordingly, as the Tenth
                                                  bottles) as opposed to 400 bottles, at most             been delegated by the Attorney General to the            Circuit has recognized, findings under a single
                                                  Respondent would not be able to account for 1.5         Administrator of the Drug Enforcement                    factor can support the revocation of a registration.
                                                  bottles.                                                Administration.                                          See MacKay, 664 F.3d at 821.



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                                                  29034                        Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  further order that his pending                          unlawfully distributed the tablets to                 volume of such finished form
                                                  application be denied.                                  these individuals. Id. at 11.                         dispensed, including the name and
                                                                                                             Neither of these allegations is proved             address of the person to whom it was
                                                  Factor One—The Recommendation of                        by substantial evidence. As for the                   dispensed, the date of dispensing, the
                                                  the State Licensing Board                               allegation regarding the hydrocodone                  number of units or volume dispensed,
                                                     As found above, on September 22,                     prescription, as found above, in his                  and the written or typewritten name or
                                                  2014, the Washington Board of                           Declaration, the DI repeatedly referred               initials of the individual who dispensed
                                                  Osteopathic Medicine and Surgery                        to this person as L.E. Yet to support the             or administered the substance on behalf
                                                  issued Respondent an Ex Parte Order of                  allegation, the Government offered a                  of the dispenser.’’ 21 CFR 1304.22(c).
                                                  Summary Action, pursuant to which,                      copy of a prescription which was issued               Finally, under this regulation,
                                                  his authority to practice medicine in the               to a patient whose initials are H.L. and              Respondent was required to maintain
                                                  State was suspended. Under the CSA, a                   not L.E. Moreover, the Government                     records of the controlled substances he
                                                  practitioner’s possession of authority to               points to no other evidence that                      acquired, to include ‘‘[t]he name of the
                                                  dispense controlled substances under                    Respondent even prescribed                            substance’’; ‘‘[e]ach finished form . . .
                                                  the laws of the State in which he seeks                 hydrocodone (or any controlled                        and the number of units or volume of
                                                  registration is a prerequisite to obtaining             substance for that matter) to a person                finished form in each commercial
                                                  a registration. See 21 U.S.C. 823(f) (‘‘The             whose initials are L.E. Thus, the                     container’’; and ‘‘[t]he number of units
                                                  Attorney General shall register                         allegation is unsupported by substantial              of finished forms and/or commercial
                                                  practitioners . . . to dispense . . .                   evidence.                                             containers acquired from other persons,
                                                  controlled substances . . . if the                         As for the allegation that the                     including the date of and number of
                                                  applicant is authorized to dispense . . .               phentermine was found on two persons                  units and/or commercial containers in
                                                  controlled substances under the laws of                 who were arrested during the Shoreline                each acquisition to inventory and the
                                                  the State in which he practices.’’); see                search and was distributed to them by                 name, address, and registration number
                                                  also id. § 802(21) (defining ‘‘[t]he term               Respondent, while the Government                      of the person from the units were
                                                  ‘practitioner’ [to] mean[] a physician                  produced evidence that Respondent had                 acquired.’’ Id. § 1304.22(a)(2)(i), (ii), and
                                                  . . . licensed, registered, or otherwise                ordered phentermine from his                          (iv).
                                                  permitted, by the United States or the                  distributor several months earlier, the                  Here, I give no weight to the audit
                                                  jurisdiction in which he practices . . .                evidence offered to establish that                    results given the numerous problems
                                                  to . . . dispense . . . [or] administer                 phentermine was found on these                        found above, including the conflict in
                                                  . . . a controlled substance in the                     individuals was limited to the DI’s                   the Government’s evidence as to what
                                                  course of professional practice’’).                     assertion that it was. The DI did not,                the DIs used as the beginning date for
                                                     Because Respondent is no longer                      however, offer any basis for concluding               the audit period. Nonetheless, I find that
                                                  authorized by the State of Washington                   that he personally participated in the                the DI’s declaration establishes that
                                                  to practice medicine and dispense                       search—notwithstanding his assertion                  during the July 2012 inspection,
                                                  controlled substances, he is not                        that his declaration was based on                     Respondent could not produce the
                                                  authorized to hold a registration in that               ‘‘personal knowledge’’—nor otherwise                  required inventories for the controlled
                                                  State. This provides reason alone to                    explain the basis for his statement.                  substances he was handling, and was
                                                  deny his application. However, because                  Finally, the Government offered no                    thus in violation of 21 U.S.C.
                                                  the Government also seeks a final order                 other evidence to prove this assertion                827(a)(1).28 Moreover, the DI’s
                                                  based on the allegations of the Order to                such as a police report, an affidavit of              declaration establishes that while
                                                  Show Cause and Immediate Suspension                     the arresting officer, or an inventory of             Respondent was engaged in dispensing
                                                  of Registration, I address the evidence                 the items found during the search                     controlled substances, many of the
                                                  with respect to the other public interest               conducted incident to the purported                   entries for his phentermine dispensings
                                                  factors.                                                arrest of these individuals. The                      lacked the patient’s address and the
                                                                                                          allegation therefore fails for lack of                name or initials of the person who did
                                                  Factor Two—Respondent’s Experience
                                                                                                          substantial evidence.                                 the actual dispensing.29 Thus,
                                                  in Dispensing Controlled Substances                        The evidence further shows that                    Respondent violated the CSA and DEA
                                                     The Government contends that                         Respondent purchased controlled                       regulations for these reasons as
                                                  Respondent unlawfully distributed                       substances including hydrocodone with                 well.30 See 21 U.S.C. 827(a)(3); 21 CFR
                                                  controlled substances to various persons                acetaminophen, phentermine,
                                                  who were arrested during the search of                  phendimetrazine, testosterone, and                      28 Regarding the lack of inventories, Respondent

                                                  his Shoreline property. Req. for Final                  lorazepam, which he dispensed directly                stated that he ‘‘ha[d] invoices from [his distributor]
                                                  Agency Action, at 10 (citing, inter alia,               to his patients. Under federal law,                   as my initial inventory.’’ Resp. Decl., at 7. Contrary
                                                                                                                                                                to Respondent’s contention, under the CSA, the
                                                  21 U.S.C. 841(a)(1)). More specifically,                Respondent was required upon ‘‘first                  requirement to take and maintain complete and
                                                  the Government contends that                            engag[ing] in the . . . dispensing of                 accurate inventories is separate from the
                                                  Respondent ‘‘prescribed hydrocodone                     controlled substances, and every second               requirement to maintain records of the controlled
                                                  . . . to an individual arrested at the                  year thereafter, [to] make a complete                 substances a registrant acquires. Compare 21 U.S.C.
                                                                                                                                                                827(a)(1) with id. § 827(a)(3); compare also 21 CFR
                                                  Shoreline’’ property and could ‘‘not                    and accurate record of all stocks thereof             1304.11 with id. § 1304.22. I therefore reject
                                                  locate a patient file at [his] registered               on hand.’’ 21 U.S.C. 827(a)(1). Also,                 Respondent’s contention. I further note that during
                                                  location for this particular individual.’’              under federal law, because he engaged                 the inspection, the DI found that Respondent did
                                                  Id. Based on the Investigators’                         in the dispensing of the controlled                   not have all of the invoices.
                                                                                                                                                                  29 While in his declaration Respondent states that
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                                                  ‘‘determin[ation] that [Respondent] also                substances, Respondent was required to
                                                                                                                                                                this information was in the patient charts and that
                                                  purchased the loose phentermine tablets                 ‘‘maintain, on a current basis, a                     there is only limited space in his dispensing log, see
                                                  located on individuals at the Shoreline                 complete and accurate record of each                  Resp. Decl., at 7; DEA regulations require that the
                                                  residence on March 16, 2012, despite                    such substance . . . received, sold,                  patient’s address be documented in the dispensing
                                                  the fact that he could not produce                      delivered, or otherwise disposed of by                log. 21 CFR 1304.22(c).
                                                                                                                                                                  30 As for the various entries in the dispensing log
                                                  patient records when requested by law                   him.’’ Id. § 827(a)(3). DEA regulations               which lacked the name of the drug, because the
                                                  enforcement,’’ the Government also                      further require that a dispenser maintain             Government provided no evidence that the
                                                  apparently contends that Respondent                     a record ‘‘of the number of units or                  dispensings involved controlled substances, I place



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                                                                               Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                29035

                                                  1304.22(c). Finally, the DI’s declaration               maintaining drug involved premises.31                      As for the allegations pertaining to the
                                                  establishes that Respondent lacked                      Each of these convictions provides                      controlled substances that the police
                                                  complete records of the controlled                      reason alone to deny his application.                   found during the search of Respondent’s
                                                  substances he acquired from his                         And under the doctrine of collateral                    residence, I conclude that the
                                                  distributor, in violation of 21 U.S.C.                  estoppel, the convictions also preclude                 Government did not provide substantial
                                                  827(a)(3), as well as 21 CFR 1304.22(c).                any challenge to the allegations that he                evidence to support the allegations with
                                                  See also 21 CFR 1304.22(a)(2)(i), (ii),                 was engaged in the unlawful                             respect to any of the four drugs
                                                  and (iv).                                               manufacture of marijuana. See Robert L.                 (Meridia, diazepam, clonazepam (in a
                                                     As both the Agency and the federal                   Daugherty, 76 FR 16823, 16830 (2011).                   vial indicating that Respondent had
                                                  courts have explained, recordkeeping is                                                                         prescribed the drug to R.M.) or
                                                                                                          Factor Four—Compliance With                             hydrocodone (in an unlabeled vial)).
                                                  one of the CSA’s fundamental features                   Applicable Laws Related to Controlled
                                                  for preventing the diversion of                                                                                 With respect to the diazepam, the
                                                                                                          Substances                                              Government produced absolutely no
                                                  controlled substances. See Gonzales v.
                                                                                                             With respect to this factor, the                     evidence that the drug was even seized
                                                  Raich, 545 U.S. 1, 14 (2005) (‘‘The CSA
                                                                                                          Government raises three main                            during the search. With respect to the
                                                  and its implementing regulations set
                                                                                                          allegations. First, based on the various                Meridia, the Government’s evidence
                                                  forth strict requirements regarding . . .
                                                                                                          searches, the Government argues that                    was limited to a photograph of a white
                                                  recordkeeping.’’); United States v.
                                                                                                          Respondent possessed and was engaged                    professional sample bottle and the DI’s
                                                  Poulin, 926 F. Supp. 246, 250 (D. Mass.
                                                                                                          in the manufacture of marijuana, a                      unsupported assertion, with no other
                                                  1996) (‘‘The [CSA] focuses on
                                                                                                          schedule I controlled substance. Request                evidence to establish that the bottle was
                                                  recordkeeping, in an attempt to regulate
                                                                                                          for Final Agency Action, at 8–9 (citing                 seized from Respondent’s residence, let
                                                  closely the distribution of certain
                                                                                                          21 U.S.C. 841(a)(1), 844(a); 812(c)).                   alone that there were any pills in the
                                                  substances determined by Congress to
                                                                                                          Second, the Government alleges that                     bottle when it was seized.
                                                  pose dangers, if freely available, to the                                                                          So too, with respect to the
                                                  public at large.’’) (int. quotations and                during the search of Respondent’s
                                                                                                          residence, several vials of controlled                  hydrocodone and clonazepam, there is
                                                  citation omitted); Paul H. Volkman, 73                                                                          no evidence other than photographs and
                                                  FR 30630, 30644 (2008)                                  substances were found including one
                                                                                                          each of clonazepam and hydrocodone,                     the DI’s unsupported assertion that
                                                  (‘‘Recordkeeping is one of the CSA’s                                                                            these drugs were seized during the
                                                  central features; a registrant’s accurate               the latter being in an unlabeled vial, as
                                                                                                          well as stock bottles of Meridia and                    search of Respondent’s residence. To be
                                                  and diligent adherence to this obligation                                                                       sure, in his declaration, Respondent
                                                  is absolutely essential to protect against              diazepam, and that Respondent’s
                                                                                                          possession of the drugs violated federal                stated that he prescribed the
                                                  the diversion of controlled                                                                                     hydrocodone and clonazepam to his
                                                  substances.’’).                                         law because he was not registered at his
                                                                                                          residence. Id. (citing 21 U.S.C. 844(a);                wife for several procedures. However,
                                                     Respondent’s recordkeeping                           21 CFR 1301.75(b)). Third, the                          Respondent explicitly denied having or
                                                  violations alone are sufficiently                       Government alleges that Respondent                      storing clonazepam or hydrocodone at
                                                  egregious to support the conclusion that                violated state law by failing to report to              his home and his statements do not
                                                  he ‘‘has committed such acts [which]                    the Washington Prescription Monitoring                  constitute an admission of any part of
                                                  render[ed] his registration . . .                       Program some 45 instances in which he                   this allegation. Accordingly, these
                                                  inconsistent with the public interest.’’                dispensed more than a twenty-four hour                  allegations fail for lack of substantial
                                                  21 U.S.C. 824(a)(4); see also Volkman,                  supply of a controlled substance. Id. at                evidence.
                                                  73 FR at 30644 (holding that                                                                                       I also find that substantial evidence
                                                                                                          9.
                                                  recordkeeping violations alone can                                                                              supports the remaining marijuana-
                                                                                                             As for the latter allegation,                        related allegation—that on February 2,
                                                  support revocation or denial of an                      Respondent did not dispute that he had
                                                  application).                                                                                                   2012, Respondent violated federal law
                                                                                                          failed to report various dispensings to                 by possessing marijuana, and that he
                                                  Factor Three—Respondent’s Conviction                    the State’s PMP. Resp. Decl., at 8.                     did so with the intent to distribute. Most
                                                  Record Under Federal and State Laws                     Rather, he claimed his violations were                  significantly, it is undisputed that upon
                                                  Related to the Manufacture,                             unintentional because he was unaware                    the February 2, 2012 arrest of TB,
                                                  Distribution, and Dispensing of                         of the law but would now comply. Id.                    (Respondent’s then live-in girlfriend
                                                  Controlled Substances                                      However, this is not a valid defense                 and now wife), who was then driving
                                                                                                          as the Washington courts follow the                     his car, the police impounded his
                                                    As found above, following a jury trial,               traditional rule that ignorance of the law              vehicle and during the subsequent
                                                  on December 19, 2014, Respondent was                    is no excuse. See State v. Reed, 928 P.2d               search of the vehicle found one pound
                                                  convicted by the United States District                 469, 471 (Wash. Ct. App. 1997) (other                   of marijuana and $5,000 in cash; the
                                                  Court on seven felony counts related to                 citation omitted). Accordingly, I find                  police also found $3,900 in cash in TB’s
                                                  the manufacture and distribution of                     that Respondent violated Washington                     purse.
                                                  marijuana, including conspiracy to                      law by failing to report various                           As found above, the street value of the
                                                  distribute or manufacture marijuana,                    dispensings to the State’s PMP. See                     marijuana was approximately $1,500 to
                                                  three counts of manufacturing                           Wash. Rev. Code § 70.225.020(2).                        $1,800, and the quantity would provide
                                                  marijuana, and three counts of                                                                                  approximately 900 joints. Respondent
                                                                                                            31 As to the latter offense, the CSA renders it       denied having any knowledge of the
                                                  no weight on this evidence. As for the                  unlawful to ‘‘knowingly use[] or maintain any
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                                                                                                                                                                  marijuana, asserting that it had been left
                                                  Government’s assertion that Respondent failed to        place, whether permanently or temporarily, for the
                                                  maintain a ‘‘dispensing/administration log for          purpose of manufacturing, distributing, or using
                                                                                                                                                                  in his car by LHE, a friend of TB and
                                                  testosterone and Testim samples,’’ Request for Final    any controlled substance.’’ 21 U.S.C. 856(a)(1). As     a purported medical marijuana patient
                                                  Agency Action, at 8; there is no evidence that he       the evidence shows that Respondent used and             who TB allowed to borrow his car, and
                                                  dispensed any Testim samples. As for the                maintained the three properties for the purpose of      provided an unsworn statement from
                                                  testosterone, the evidence does suggest that            manufacturing marijuana and not simply as places
                                                  Respondent administered approximately 300 mg or         to use the drugs, I conclude that his convictions for
                                                                                                                                                                  LHE to this effect. However, as I found
                                                  1.5 vials without documenting the administrations       maintaining drug-involved premises fall within          above, her statement (that she left the
                                                  in his dispensing log. See 21 CFR 1304.03(d).           factor three.                                           marijuana in the car because she was in


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                                                  29036                         Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices

                                                  such a hurry to return the car to TB and                in Respondent’s vehicle, support a                      registrant has committed acts
                                                  forgot it) is utterly ludicrous.32 I                    finding that the marijuana was intended                 inconsistent with the public interest, the
                                                  therefore reject Respondent’s                           for distribution. See United States v.                  registrant must accept responsibility for
                                                  explanation for why the police found                    Collins, 412 F.3d 515, 519 (4th Cir.                    [his] actions and demonstrate that [he]
                                                  one pound of marijuana in his car.                      2005) (holding that ‘‘intent to distribute              will not engage in future misconduct.’’
                                                     Moreover, given the closeness of the                 can be inferred from a number of                        Medicine Shoppe, 73 FR at 387; see also
                                                  relationship between Respondent and                     factors, including . . . the quantity of                Jackson, 72 FR at 23853; John H.
                                                  TB in that they were living together and                drugs’’ and ‘‘the amount of cash seized                 Kennedy, 71 FR 35705, 35709 (2006);
                                                  that TB also worked for him, I find it                  with the drugs.’’). I further find that                 Prince George Daniels, 60 FR 62884,
                                                  implausible that Respondent lacked                      Respondent ‘‘had the right to exercise                  62887 (1995). See also Hoxie, 419 F.3d
                                                  knowledge of the marijuana. Rather, I                   dominion and control over’’ the                         at 483 (‘‘admitting fault’’ is ‘‘properly
                                                  find that Respondent had the ability to                 marijuana ‘‘either directly or through’’                consider[ed]’’ by DEA to be an
                                                  exercise dominion or control over the                   TB. United States v. Staten, 581 F.2d                   ‘‘important factor[]’’ in the public
                                                  marijuana through TB and thus                           878, 883 (D.C. Cir. 1978). I therefore find             interest determination). So too, in
                                                  constructively possessed the drug. See                  that Respondent knowingly possessed                     making the public interest
                                                  United States v. Sanders, 341 F.3d 809,                 marijuana with the intent to distribute                 determination, ‘‘this Agency also places
                                                  816 (8th Cir. 2003) (‘‘ ‘To prove                       it.33 See 21 U.S.C. 841(a)(1).                          great weight on an [applicant’s] candor,
                                                  constructive possession, the government                    Based on Respondent’s violation of                   both during an investigation and in [a]
                                                  had to present evidence that appellants                 federal law by possessing marijuana                     subsequent proceeding.’’ Robert F.
                                                  had knowledge and ownership,                            with the intent to distribute, as well as               Hunt, 75 FR 49995, 50004 (2010) (citing
                                                  dominion or control over the                            his admitted failure to report multiple                 The Lawsons, Inc., t/a The Medicine
                                                  contraband itself, or dominion over the                 dispensings of controlled substances to                 Shoppe Pharmacy, 72 FR 74334, 74338
                                                  vehicle in which the contraband is                      the Washington PMP, I find that factor                  (2007) (quoting Hoxie, 419 F.3d at 483)
                                                  concealed.’ ’’) (quoting Ortega v. United               four also supports a finding that he has                (‘‘Candor during DEA investigations
                                                  States, 270 F.3d 540, 545 (8th Cir.                     committed acts which rendered his                       properly is considered by the DEA to be
                                                  2001)).                                                 registration ‘‘inconsistent with the                    an important factor when assessing
                                                     So too, Respondent’s attempt to                      public interest.’’ 34 21 U.S.C. 823(f) &                whether a . . . registration is consistent
                                                  explain the presence of the large sum of                824(a)(4).                                              with the public interest.’’)).
                                                  cash (nearly $9,000) that was found in                                                                             Moreover, while a registrant must
                                                  his car and on his wife’s person does                   Sanction                                                accept responsibility and demonstrate
                                                  not persuade. As for the money which                       Under Agency precedent, where, as                    that he will not engage in future
                                                  was purportedly paid by a patient the                   here, ‘‘the Government has proved that                  misconduct in order to establish that
                                                  day before as a deposit on a liposuction                a registrant has committed acts                         granting his application for registration
                                                  procedure, as found previously, while                   inconsistent with the public interest, the              is consistent with the public interest,
                                                  the ‘‘Price Quote’’ document indicates                  registrant must ‘ ‘‘present sufficient                  DEA has repeatedly held these are not
                                                  that the patient paid a $5,000 cash                     mitigating evidence to assure the                       the only factors that are relevant in
                                                  deposit, the date was clearly written                   Administrator that [he] can be entrusted                determining whether to grant or deny an
                                                  over. And while the purported patient                   with the responsibility carried by such                 application. See, e.g., Joseph Gaudio, 74
                                                  provided a letter to support Respondent,                a registration.’’ ’ ’’ Medicine Shoppe—                 FR 10083, 10094 (2009); Southwood
                                                  it too was unsworn.                                     Jonesborough, 73 FR 364, 387 (2008)                     Pharmaceuticals, Inc., 72 FR 36487,
                                                     As an additional explanation for why                 (quoting Samuel S. Jackson, 72 FR                       36504 (2007). Obviously, the
                                                  so much money was found in his car,                     23848, 23853 (2007) (quoting Leo R.                     egregiousness and extent of a
                                                  Respondent stated that the money had                    Miller, 53 FR 21931, 21932 (1988))).                    registrant’s misconduct are significant
                                                  been withdrawn to pay for remodeling                    ‘‘Moreover, because ‘past performance is                factors in determining the appropriate
                                                  his clinic. To support this claim,                      the best predictor of future                            disposition. Cf. Jacobo Dreszer, 76 FR
                                                  Respondent submitted a copy of a bank                   performance,’ ALRA Labs, Inc. v. DEA,                   19386, 19387–88 (2011) (explaining that
                                                  statement (on which the various                         54 F.3d 450, 452 (7th Cir. 1995), [DEA]                 a respondent can ‘‘argue that even
                                                  balances are blacked out), which                        has repeatedly held that where a                        though the Government has made out a
                                                  documents that he made a withdrawal                                                                             prima facie case, his conduct was not so
                                                  nine days before his girlfriend was                        33 In his Declaration, Respondent disputed that he   egregious as to warrant revocation’’); see
                                                  arrested. However, Respondent offered                   owned the marijuana plants, the processed               also Paul H. Volkman, 73 FR 30630,
                                                  no further evidence to support this                     marijuana, and related items that were seized in the    30644 (2008); Gregory D. Owens, 74 FR
                                                  contention, and in any event, his                       searches of his three properties. See Resp. Decl., at   36751, 36757 n.22 (2009).
                                                                                                          3 (‘‘I have three rental properties. I had
                                                  explanation begs the question of why he                 irresponsible tenants that took advantage of the
                                                                                                                                                                     Moreover, as I have noted in several
                                                  would risk the potential theft or loss of               locations by cultivating Marijuana for 6 months         cases, ‘‘ ‘[n]either Jackson, nor any other
                                                  a large sum of cash, rather than pay for                without my knowledge.’’). He also claimed that          agency decision, holds . . . that the
                                                  the purported remodeling with a check                   because he was a busy physician, who did not            Agency cannot consider the deterrent
                                                                                                          bother his tenants if they paid their rent and did
                                                  or credit card.                                         not request repairs, he ‘‘did not know of . . . nor
                                                                                                                                                                  value of a sanction in deciding whether
                                                     I therefore find that both the quantity              . . . in any way participate in the growing of          a registration should be [suspended or]
                                                  of the marijuana (which would provide                   marijuana at these rental houses.’’ Id. at 4. Based     revoked,’ ’’ or whether an application
                                                  a single person with three joints a day                 on Respondent’s convictions for conspiracy to           should be denied. Gaudio, 74 FR at
                                                                                                          manufacture marijuana, unlawful manufacture of
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                                                  for approximately ten months), and the                  marijuana at each of the three grow houses, and
                                                                                                                                                                  10094 (quoting Southwood, 72 FR at
                                                  large amount of cash which was found                    maintaining drug-involved premises at each of the       36503 (2007)); see also Robert Raymond
                                                                                                          three residences, I reject his assertions as utterly    Reppy, 76 FR 61154, 61158 (2011);
                                                    32 As also noted, in a March 3, 2012 letter to the    false.                                                  Michael S. Moore, 76 FR 45867, 45868
                                                  local prosecutor in which Respondent sought the            34 Having already addressed the various false
                                                                                                                                                                  (2011). This is so, both with respect to
                                                  return of his car, he denied having any knowledge       statements regarding the marijuana-related
                                                  of the marijuana that was found therein. See Resp.      allegations which Respondent has made in his
                                                                                                                                                                  the respondent in a particular case and
                                                  Decl., at Ex. 4. Yet he made no mention of LHE’s        declaration, I deem it unnecessary to repeat this       the community of registrants. See
                                                  story. See id.                                          discussion under factor five.                           Gaudio, 74 FR at 10095 (quoting


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                                                                                Federal Register / Vol. 80, No. 97 / Wednesday, May 20, 2015 / Notices                                                       29037

                                                  Southwood, 71 FR at 36504). Cf.                         who had borrowed his car to obtain her                   DEPARTMENT OF JUSTICE
                                                  McCarthy v. SEC, 406 F.3d 179, 188–89                   medical marijuana but who was in such
                                                  (2d Cir. 2005) (upholding SEC’s express                 a hurry to return the car that she forgot                Drug Enforcement Administration
                                                  adoption of ‘‘deterrence, both specific                 to retrieve it even though it was her                    [Docket No. 11–71]
                                                  and general, as a component in                          medicine. So too, Respondent’s
                                                  analyzing the remedial efficacy of                      alternative explanations for why                         Cove Inc., D/B/A Allwell Pharmacy;
                                                  sanctions’’).                                           thousands of dollars of cash were found                  Decision and Order
                                                     As found above, the Government has                   in his car defy credulity. Similarly, his
                                                  established that Respondent: 1)                         claim that he was unaware of the                            On April 23, 2013, Administrative
                                                  committed multiple recordkeeping                        marijuana growing activities which                       Law Judge Christopher B. McNeil
                                                  violations in that he did not have                      were being conducted at not one, not                     (hereinafter, ALJ) issued the attached
                                                  required inventories, was missing                       two, but three of his properties, is                     Recommended Decision.1 Neither party
                                                  invoices, and his dispensing log lacked                 clearly disingenuous.36 Accordingly,                     filed exceptions to the ALJ’s
                                                  required information; 2) was engaged in                 based on his various false statements                    Recommended Decision.
                                                  the manufacture and distribution of                     regarding the marijuana-related activity,                   Having reviewed the record in its
                                                  marijuana; and 3) failed to report                      as well as his blatantly false assertion                 entirety and the Recommended
                                                  multiple dispensings of controlled                      that he has never been subject to                        Decision, I have decided to adopt the
                                                  substances to the Washington PMP. I                     discipline by a state licensing authority                ALJ’s findings of fact and conclusions of
                                                  find that the proven misconduct is                      (all of which are clearly material to the                law, except as discussed below. I further
                                                  sufficiently egregious to affirm the                    outcome of this proceeding), I further                   adopt the ALJ’s recommended order that
                                                  Order of Immediate Suspension and to                    find that Respondent lacks candor.                       Respondent’s application be denied.
                                                  deny his pending application to renew                      Based on his failure to acknowledge                      As explained in the ALJ’s
                                                  his registration. See, e.g., Moore, 76 FR               his misconduct, his failure to offer any                 Recommended Decision, in making the
                                                  at 45870 (imposing one-year suspension                  credible evidence of remedial efforts,                   public interest determination, Congress
                                                  on physician who manufactured                           and his lack of candor, I conclude that                  directed the Agency to consider ‘‘the
                                                  marijuana, notwithstanding ALJ’s                        Respondent has failed to present                         applicant’s experience in dispensing
                                                  finding that physician accepted                         sufficient evidence to rebut the                         . . . controlled substances.’’ 21 U.S.C.
                                                  responsibility and demonstrated he                      Government’s prima facie showing that                    823(f)(2). The evidence showed that
                                                  would not engage in future                              his registration would be ‘‘inconsistent                 Respondent’s President and majority
                                                  misconduct).35 I further find that the                  with the public interest.’’ 21 U.S.C                     owner is Mrs. Ogechi Abalihi, and that
                                                  Agency’s interest in deterring similar                  823(f); see also id. 824(a)(4). Therefore,               while Mrs. Abalihi is a registered nurse,
                                                  acts on the part of both Respondent and                 I will affirm the issuance of the Order                  she is not a pharmacist and has no
                                                  others supports the denial of his                       of Immediate Suspension and order that                   experience working in a retail
                                                  pending application.                                    any pending application to renew                         pharmacy. Moreover, when questioned
                                                     Having carefully reviewed                                                                                     both during the pre-registration
                                                                                                          Respondent’s registration be denied.
                                                  Respondent’s declaration, I further find                                                                         investigation and at the hearing as to
                                                  that Respondent has not accepted                        ORDER                                                    whether she was familiar with the
                                                  responsibility for his misconduct.                         Pursuant to the authority vested in me                federal controlled-substance
                                                  Regarding his recordkeeping violations,                 by 21 U.S.C. 823(f) and 824(a), as well                  recordkeeping and security
                                                  Respondent entirely denied that he                      as 28 CFR 0.100(b), I affirm the Order                   requirements for retail pharmacies, Mrs.
                                                  failed to keep the required inventories                 of Immediate Suspension of DEA                           Abalihi responded by stating, in
                                                  and that he was missing various                         Certificate of Registration BL6283927,                   essence, that those matters would be
                                                  invoices. Moreover, he further claimed                                                                           addressed by the pharmacist she would
                                                                                                          issued to Keith Ky Ly, D.O. I further
                                                  that the reason his dispensing log was                                                                           retain. Tr. 143–46. In her testimony,
                                                                                                          order that the application of Keith Ky
                                                  missing essential information such as                                                                            Mrs. Abalihi also made clear that she
                                                                                                          Ly, D.O., to renew his registration, be,
                                                  patient addresses was because there was                                                                          lacks knowledge of these requirements
                                                                                                          and it hereby is, denied. This Order is
                                                  no room to make these entries. Yet in                                                                            as they pertain to retail pharmacies,
                                                                                                          effective June 19, 2015.
                                                  DEA’s experience, thousands of other                                                                             stating that ‘‘if there’s a requirement for
                                                  registrants who engage in dispensing                     Dated: May 11, 2015.
                                                                                                                                                                   me to do anything, know these things,
                                                  have no problem complying with the                      Michele M. Leonhart,                                     study them, I will do them. But when
                                                  latter requirements.                                    Administrator.                                           I applied I was not made to understand
                                                     With respect to the marijuana                        [FR Doc. 2015–12139 Filed 5–19–15; 8:45 am]              that I need to know all this.’’ Id. at 144.
                                                  allegations, Respondent offered the far-                BILLING CODE 4410–09–P                                      This is truly a remarkable answer,
                                                  fetched story that the marijuana                                                                                 which fully demonstrates why granting
                                                  belonged to an acquaintance of his wife,                   36 With regard to his failure to report dispensings
                                                                                                                                                                   Respondent’s application ‘‘would be
                                                                                                          to the Washington PMP, Respondent claimed that           inconsistent with the public interest.’’
                                                    35 In Moore, I agreed with the ALJ’s finding that     he was unaware of the law. However, the legislation
                                                  the physician’s conduct in manufacturing and            which created the Washington PMP was enacted in          21 U.S.C. 823(f). Notwithstanding that
                                                  distributing marijuana supported revocation of his      2007, more than four years earlier, and as a             the Order to Show Cause specifically
                                                  registration. 76 FR at 45868. However, I also agreed    physician who engaged in the highly regulated            alleged that the Agency’s investigation
                                                  with the ALJ’s finding that the physician had           activity of dispensing controlled substances,            found Mrs. Abalihi ‘‘had no knowledge
                                                  accepted responsibility for his misconduct and          Respondent was obligated to keep abreast of
                                                  demonstrated that he would not engage in future         legislation and regulatory developments applicable       of DEA regulations pertaining to the
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  misconduct. Id. By contrast, here, the record           to his medical practice. Moreover, while                 handling of controlled substances and
                                                  establishes that in addition to his marijuana-related   Respondent asserted that he is now aware of the          related security requirements,’’ ALJ Ex.
                                                  misconduct, for which he disingenuously denies          requirement and will comply in the future, his           1, at 1; she still lacked knowledge of
                                                  any responsibility, Respondent also committed           various statements regarding the events at issue
                                                  multiple recordkeeping violations and violated state    (including that he had never been disciplined by a       these requirements when she testified
                                                  law by failing to report numerous dispensings to the    state board) support a finding that he lacks candor.
                                                  State PMP. Also, in contrast to Moore, I find that      Accordingly, I give no weight to his statement that        1 The ALJ’s Recommended Decision is cited as

                                                  Respondent has not accepted responsibility for his      he would comply with the State’s PMP reporting           R.D.; all citations to the Recommended Decision are
                                                  misconduct.                                             requirement in the future.                               to the slip opinion issued by the ALJ.



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Document Created: 2018-02-21 10:29:34
Document Modified: 2018-02-21 10:29:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 29025 

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