Brewster Drug, Inc.; Decision and Order, 19020-19027 [2020-07017]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 19020-19027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07017]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Brewster Drug, Inc.; Decision and Order

    On October 26, 2017, the DEA Acting Administrator issued an Order 
to Show Cause and Immediate Suspension of Registration (hereinafter 
collectively, OSC), to Brewster Drug, Inc. (hereinafter, Registrant), 
of Brewster, Washington. The OSC informed Registrant of the immediate 
suspension of its DEA Certificate of Registration AB6785161 and 
proposed its revocation, the denial of any pending application for 
renewal or modification of such registration, and the denial of any 
applications for additional DEA registrations, on the ground that its 
``continued registration is inconsistent with the public interest.'' 
OSC, at 1 (citing 21 U.S.C. 824(a)(4) and 823(f)).
    The OSC alleged that Registrant is a corporate entity in the state 
of Washington. Id. at 2. It further alleged that ``Brian Johnson and 
Nikki Johnson are the [Registrant's] `Governing Persons'--as defined in 
the Revised Code of Washington (RCW) 23.95.105(12),'' and that ``Brian 
Johnson is listed as the Pharmacy's Registered Agent by the Washington 
State Corporation commission.'' Id. It further alleged that Brian 
Johnson is Registrant's Pharmacist-in-Charge (hereinafter, PIC). Id.
    The OSC alleged that ``DEA's investigation [of Registrant] has 
revealed separate types of misconduct, which, taken together, pose an 
imminent danger to public health or safety.'' Id. at 2. Specifically, 
DEA conducted inspections of Registrant on August 15, 2017 and 
September 13, 2017,\1\ which ``revealed that [Registrant] was unable to 
account for large volumes of controlled substances.'' Id. The Order 
also alleged that PIC Johnson ``engaged in the practice of pharmacy at 
[Registrant] while under the influence of controlled substances, 
including some of the same controlled substances for which [one of the 
audits] showed significant discrepancies.'' Id. The OSC further alleged 
that Registrant failed to maintain adequate records in violation of 21 
U.S.C. 827(a) and 21 CFR 1304.03-.04, 1304.11, 1304.21, and 1305.13(e), 
and that PIC Johnson placed customers in danger by dispensing 
controlled substances to a patient without a valid prescription. Id. at 
2-4.
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    \1\ The Government did not include any further mention of the 
September 13, 2017 audit in the record provided to me; therefore, 
the findings herein are limited to the August 15, 2017 audit.
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    Based on his ``preliminary finding that controlled substances were 
diverted from [Registrant] in connection with failure to maintain 
complete records and dispensing controlled substances without a valid 
prescription,'' the former Acting Administrator concluded that 
Registrant's registration ``is inconsistent with the public interest.'' 
Id. at 5. The former Acting Administrator also made the preliminary 
finding that Registrant's ``continued registration during the pendency 
of these proceedings would constitute an imminent danger to the public 
health and safety because of the substantial likelihood of an imminent 
threat that death, serious bodily harm or abuse of controlled 
substances will occur in the absence of this suspension.'' Id. The 
former Acting Administrator thus concluded that Registrant's continued 
registration during the pendency of the proceeding ``constitutes an 
imminent danger to the public health and safety'' and suspended its 
registration ``effective immediately.'' Id. (citing 21 U.S.C. 824(d)). 
Pursuant to 21 U.S.C. 824(f) and 21 CFR 1301.36(f), the former Acting 
Administrator authorized the DEA Special Agents and Diversion 
Investigators serving the OSC on Registrant to place under seal or to 
remove for safekeeping all controlled substances Registrant possessed 
pursuant to the immediately suspended registration. Id. The former 
Acting Administrator also directed those DEA employees to take 
possession of Registrant's Certificate of Registration AB6785161 and 
any unused order forms. Id.
    The OSC notified Registrant of its right to request a hearing on 
the allegations or to submit a written statement while waiving its 
right to a hearing, the procedures for electing either option, and the 
consequence of failing to elect either option. Id. at 5-6 (citing 21 
CFR 1301.43).
    On October 31, 2017, a DEA Diversion Investigator (DI) personally 
served the OSC on Brian Johnson, Registrant's PIC at Registrant's 
address. GX 3, at 3. On the same day, Diversion Investigators took 
custody of Registrant's DEA Certificate of Registration and removed all 
controlled substances in Registrant's possession, pursuant to the 
Immediate Suspension Order. Id. See also GX 3, Appendix 4 (Inventory of 
Seized Items).
    According to the Government, since the date of service of the 
Order, neither Registrant, nor anyone purporting to represent it, has 
filed a written statement or made any communication in writing to the 
Agency since the OSC was served. Request for Final Agency Action 
(hereinafter, RFAA), at 2; see also GX 3, at 3. Based on the 
Government's representation, I find that more than 30 days have now 
passed and Registrant has neither requested a hearing nor submitted a 
written statement while waiving its right to a hearing. I therefore 
find that Registrant has waived its right to a hearing or to submit a 
written statement, and issue this Decision and Order based on the 
record submitted by the Government, which constitutes the entire record 
before me. See 21 CFR 1301.43(e).
    On February 25, 2019, I issued an Order taking notice of the 
Agency's registration records, which showed that on January 16, 2018, 
DEA approved the registration of a different retail pharmacy, called 
``Brewster Marketplace Pharmacy & T.V. Hardware LLC'' at the same 
street address as Registrant. Order dated February 25, 2019 
(hereinafter, February Order). The February Order directed the 
Government ``to investigate and to address whether Registrant has 
discontinued its business practice as a retail pharmacy and whether its 
DEA registration has thus terminated pursuant to 21 CFR 1301.52.'' Id. 
at 2. Additionally, the Order directed the Government to determine 
whether Registrant has forfeited its right, title and interest in the 
seized controlled substances. Id. at 2-3.
    On March 25, 2019, I received the Government's Reply to 
Administrator's February Order (hereinafter, GR), which confirmed that 
Registrant discontinued business on December 29, 2017, and sold the 
business to Brewster Marketplace Pharmacy and Hardware, LLC 
(hereinafter, Marketplace). GR, at 2. The Government asserts that 
because

[[Page 19021]]

Registrant discontinued professional practice, the regulation states 
that the registration terminates `` `without any further action by the 
Administration.' '' GR, at 2 (quoting 21 CFR 1301.52). Because 
Registrant discontinued business, DEA issued a letter on March 15, 
2019, notifying Registrant that its DEA-seized controlled substances 
would be disposed of pursuant to 21 U.S.C. 824(g). Id.; GRX 1. On March 
20, 2019, DEA received an email from Marketplace claiming an ownership 
interest in the controlled substances. Id. at 3; GRX 2. Therefore, 
despite the Registrant's discontinuation of business, the Government 
requests that I affirm the ISO in order to resolve title to 
Registrant's DEA-seized property. Id. (citing ChipRX, L.L.C., d/b/a 
City Center Pharmacy, 82 FR 51433 (2017)).
    According to the Controlled Substances Act (hereinafter, CSA), the 
controlled substances inventory that DEA seized from Registrant's 
registered location on the date DEA served the OSC ``shall be forfeited 
to the United States'' and ``[a]ll right, title, and interest in such 
controlled substances shall vest in the United States upon a revocation 
order becoming final.'' 21 U.S.C. 824(f). Disposition of Registrant's 
seized controlled substances inventory remains outstanding even though 
Registrant discontinued business, and, therefore, its registration is 
terminated. 21 CFR 1301.52. I shall, therefore, adjudicate this OSC to 
finality as required by 21 U.S.C. 824(f). See also Jeffrey D. Olsen, 
M.D., 84 FR 68474 (2019) (declining to dismiss an immediate suspension 
order as moot when the registrant allowed the registration subject to 
the ISO to expire before final adjudication of the ISO).\2\
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    \2\ My implementation of these statutory and regulatory 
provisions also provides transparency given Marketplace's claim of 
an ownership in the controlled substances inventory that DEA seized 
in conjunction with its service of the OSC.
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    I make the following findings.

Findings of Fact

Registrant's DEA Registration

    Registrant, a retail pharmacy, was a corporate entity organized 
under the laws of Washington State. OSC, at 2. It was registered with 
the DEA as a retail pharmacy authorized to dispense controlled 
substances in schedules II-V pursuant to Registration AB6785161, with a 
registered address at 811 US Highway 97, P.O. Box 798, Brewster, 
Washington 98812. GX 1 (Certificate of Registration). Registrant's 
registration would have expired by its terms on July 31, 2020; however, 
it appears that the Registrant discontinued business on December 29, 
2017. Id.; GR, at 2.
    According to the DI in charge of this investigation, at the time of 
the investigation, Brian Johnson and Nikki Johnson were listed as 
Registrant's ``Governing Persons,'' under the Revised Code of 
Washington, which defines ``Governor'' as ``a director of a business 
corporation . . . or any other person under whose authority the powers 
of an entity are exercised and under whose direction the activities and 
affairs of the entity are managed pursuant to the organic law and 
organic rules of the entity.'' GX 3, at 2 (Declaration of Diversion 
Investigation) (citing Wash. Rev. Code Ann. Sec.  23.95.105(12) (West 
2019)); see also GX 3, Appendix 1 (copy of web page entitled 
``Corporations: Registration detail'' obtained from Washington 
Secretary of State website, www.sos.wa.gov/corps/search_detail). The 
same web page also listed Brian Johnson as the Registered Agent for 
Registrant.\3\
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    \3\ The website currently lists the business status as 
``administratively dissolved.''
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    According to the DI, Brian Johnson worked as Registrant's PIC and 
is married to Nikki Johnson. GX 3, at 2. Agency registration records 
show that Brian Johnson is the contact for Registrant's DEA 
registration.\4\
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    \4\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA's regulations, Registrant is ``entitled on timely request to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). To allow Registrant the opportunity to refute the 
facts of which I take official notice, Registrant may file a motion 
for reconsideration within fifteen calendar days of service of this 
order which shall commence on the date this order is mailed.
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Investigation by Washington State Pharmacy Investigator

    The Government's evidence includes a sworn Declaration, dated March 
15, 2018, by an investigator (hereinafter, Investigator V.) employed by 
the Washington State Pharmacy Quality Assurance Commission, Washington 
State Department of Health (DOH).\5\ GX 4. According to the 
Declaration, the investigation into dispensing practices at Registrant 
was initiated by a physician's complaint to the DOH, which alleged that 
a patient (hereinafter, Patient M.R.) had obtained multiple dispensings 
of oxycodone based on a single prescription presented to Registrant. GX 
4, at 1 (Declaration of Investigator V.).
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    \5\ The Government's evidence includes the Declarations of the 
State Investigator and Dr. F., including attachments, but does not 
explain how it obtained them, nor how this Agency became aware of 
the State's investigation.
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    According to the Government's evidence, a physician practicing in 
Wenatchee, Washington (hereinafter, Dr. F.) averred in a sworn 
declaration that, while she was treating Patient M.R. on February 17, 
2017, the patient showed her three bottles of oxycodone filled by 
Registrant. GX 5 (Declaration of Dr. F.), at 1. Patient M.R. told Dr. 
F. that he had obtained them from Registrant, and that he did not know 
how much he had received, but ``recalled the first bottle was for a 
smaller amount than on the prescription as they did not have enough 
pills to fill as written'' and that ``[h]e later received the remainder 
from that prescription.'' Id. Dr. F. stated, ``[e]ach of the bottles 
had a sticker indicating that the bottle was for patient M.R.'' and 
``[o]ne of the bottles was labeled for oxycodone 30 mg, and the other 
two for oxycodone 15 mg.'' Id. Dr. F. then ``reviewed M.R.'s patient 
record from a prior visit'' and found that the records showed that a 
nurse practitioner at her practice (N.P.) had issued a single 
prescription for 182 tablets of oxycodone 30mg to M.R. on January 20, 
2017. Id. The doctor also compared M.R.'s patient record with the 
Washington state Prescription Drug Monitoring Program (hereinafter, 
PMP), which showed that Registrant reported three transactions of 
dispensing oxycodone to M.R. in early February 2017, after the 
prescription written by N.P. Id. at 1-2.
    Dr. F. stated that she telephoned Registrant on February 17, 2017, 
and asked the PIC to find out how much oxycodone had been provided to 
patient M.R., but the PIC was unable to tell her. Id. Dr. F. then 
submitted a complaint to the Washington Pharmacy Commission. GX 4, at 
1.
    Investigator V. reported that he ``obtained a copy of the original 
prescription written by N.P. for Patient M.R. from [Registrant],'' 
which ``has a fill sticker from [Registrant] reflecting prescription 
number N1133568'' and indicates the ``prescription was filled on 
February 11, 2017.'' Id. ``The initials `BJ' \6\ are on the fill 
sticker indicating that the prescription was filled by PIC Brian 
Johnson.'' Id. at 1; GX 4, Appendix 1. The Investigator attached a true 
and correct copy of the prescription to his Declaration. Id. at 1; GX 
4, Appendix 1. The prescription notes ``Dispense as Written: No'' and 
includes a ``Start Date'' of January 20, 2017, but

[[Page 19022]]

the ``End Date'' is blank and there are ``0 (Zero)'' refills. GX 4, 
Appendix 1.
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    \6\ The Registrant's PIC's name is Brian Johnson (B.J.).
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    The Investigator obtained a copy of the Washington state PMP report 
for Patient M.R. ``to identify what [Registrant] reported to the PMP'' 
regarding the controlled substance prescriptions it filled for M.R. Id. 
He noted that ``a Pharmacy is required to report to the Washington 
State PMP every instance where a controlled substance is dispensed to a 
patient.'' Id. He reported and included a record demonstrating that 
Patient M.R.'s PMP report showed that in February 2017, Registrant 
reported three dispensings of oxycodone prescribed by N.P.:

    (1) 364 tablets oxycodone 15mg on February 1 under prescription 
#1132787, a 14 day supply;
    (2) 182 tablets oxycodone 30mg on February 11 under prescription 
#1133568, a 14 day supply;
    (3) 364 tablets oxycodone 15mg on February 11 under prescription 
#1132787, a 14 day supply.

Id. at 1-2; GX 4, Appendix 3 (PMP database printout). The Investigator 
stated that these were the only reports made by Registrant to the PMP, 
and all were associated with the single prescription issued by N.P. to 
Patient M.R. on January 20, 2017. GX 4, at 2; accord GX 5 (Declaration 
of Dr. F). In consideration of the DI's attestation regarding the 
report's authenticity as a true and correct copy of the Washington 
State PMP, and in the absence of any evidence to the contrary, I find 
that this report represents a true copy of the Washington State PMP and 
accurately reflects what Registrant reported as its dispensings of 
oxycodone to M.R. on the dates listed.
    The Investigator also obtained Registrant's patient profile for 
Patient M.R. for the time period February 1--February 28, 2017, which 
shows Registrant's internal dispensing record of prescriptions it 
filled for M.R. GX 4, at 2. A copy of this report was submitted to the 
Government's evidentiary record. GX 4, Appendix 2. The patient profile 
records two oxycodone dispensings on February 11, 2017, showing 
prescription number 1132787 for 364 tablets of oxycodone 15mg, and 
prescription number 1133568 for 182 tablets of oxycodone 30 mg. Id. at 
1. Registrant's patient profile does not show any oxycodone dispensing 
to Patient M.R. on February 1, 2017. Id.
    According to the Investigator, Dr. F. sent him photocopies of the 
three prescription bottles patient M.R. brought to his appointment. GX 
4, at 2. ``She [ ] informed me that her patient, M.R., had three 
bottles of various strength oxycodone that [he] reported [he] obtained 
from Registrant based on the single prescription from [N.P.].'' Id.; 
see also GX 4, Appendix 4. The photocopies attached to the 
Investigator's report are poor quality but include four pages, each 
showing three prescription bottles, each from a slightly different 
angle, depicting:

    1) One bottle labeled RX#N113278[ ] \7\ for 364 tablets of 
oxycodone dated February 1, 2017, issued to [M.R.] by Dr. [N.P.], with 
the initials ``BJ'' \8\ on the label.
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    \7\ The last digit is unclear from the photocopy, but the 
declarations indicate that this prescription was for RX #1132787 and 
I find that it is probable that the missing number is a 7.
    \8\ The evidence demonstrates that BJ is PIC Brian Johnson. See 
GX 4.
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    (2) One bottle labeled RX#N1132787 for 364 tablets of oxycodone 
dated February 1, 2017, issued to [M.R.] by Dr. [N.P.], with the 
initials ``BJ'' on the label), and
    (3) One bottle labeled RXN#113356[], for 182 tablets of oxycodone, 
dated February 11, 2017, issued to [M.R.] by [N.P.], with the initials 
``BJ'' on the label.

GX 4, Appendix 4, at 1-4.\9\ The three bottles appear to bear the name 
``Brewster Drug;'' however, corresponding dosage units are not clearly 
shown on any of the copies. Id.
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    \9\ The PMP demonstrates that there were three prescriptions, 
one on February 1st, and two on February 11th, but the copies of 
bottle labels provided by Dr. F. demonstrate two bottles on February 
1st and one on February 11th. This discrepancy is not further 
described in the Government's evidence; however, the PMP is clearly 
inaccurate, so the bottle labels seem to represent a more accurate 
depiction of what Registrant actually filled. Regardless of which is 
more accurate, the evidence is clear that Registrant filled one 
prescription in three different ways on two different dates and did 
not appropriately maintain records, as further described herein.
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    Investigator V. further attested that he spoke with PIC Brian 
Johnson regarding the Registrant's dispensing multiple bottles of 
various strength oxycodone on the basis of a single prescription, and 
he memorialized the conversation in a Memorandum, dated June 13, 2017. 
GX 4, Appendix 5. He reported, ``PIC Johnson explained that he may have 
filled the prescription for 30 mg oxycodone tablets with 15 mg tablets 
because he did not have enough supply on hand,'' but he ``was not sure 
when or what quantities he dispensed to patient M.R., and he could not 
account for prescription RX#1133568, shown in the PMP.'' GX 4, at 2. 
Investigator V. further stated he ``confronted PIC Johnson on the fact 
that he had only a record of the single issued prescription 
corresponding with prescription number 1132787,'' and ``he acknowledged 
that he had made no record of partial fills or substitute fills and had 
no other explanation'' for M.R.'s three prescription bottles. Id.; see 
also GX 4, Appendix 5 (Investigator V.'s Memorandum of Conversation 
with PIC).
    According to the Investigator, PIC Johnson ``confirm[ed] that it 
was he who was the responsible pharmacist on each of the 
dispensing[s],'' but that ``he was sure the patient wasn't given more 
medication than the doctor had prescribed but doesn't recall the exact 
amount in each bottle.'' GX 4, Appendix 5. He also told the 
Investigator that ``he [didn't] recall the exact events,'' but believed 
he ``either didn't have enough, or any, of the 30 mg Oxycodone so he 
gave him a partial quantity of the 15 mg tablets'' and that he ``didn't 
document how much he gave him at this time.'' Id. Further, according to 
the Memorandum, PIC Johnson told Investigator V. that ``when the 
patient returned for the remainder of the prescription he believe[d] he 
again didn'[t] have enough of the 30mg tablets to complete the order so 
he provided a combination of both 15mg and 30 mg tablets'' and that 
``the patient has been on this drug for quite some time and he 
believe[d] the patient [was] knowledgeable enough to take the correct 
bottle and dose and not to overdose himself.'' Id.
    Additionally, Investigator V.'s Memorandum reported that Johnson 
stated that ``he wasn't sure how the patient received a bottle dated 
[February 1, 2017] as he doesn't recall giving him that one and it's 
not listed in his computer,'' but he acknowledged that the prescription 
was entered into the system on February 1, 2017. Id. The Memorandum 
further reported that PIC Johnson ``recognize[d] that he failed to keep 
records of each time and quantity given to the patient.'' Id. The 
Investigator finally reported that he asked a pharmacy employee to 
retrieve the hard copy prescriptions for Rx#1132787 [364 oxycodone 
15mg] and Rx#1133568 [182 oxycodone 30mg], but #1132787 was not 
located. Id. According to the Memorandum, PIC Johnson also attempted to 
retrieve them and did not locate them. Id.
    Investigator V.'s Memorandum also stated that PIC Johnson 
``identified the partial adhesives near the back tag label applied to 
the [ARNP's] prescription, which he opined may have been the previous 
label [RX 1132787 for 364 oxycodone 15mg] that he put on the 
prescription and then must have removed it when he filled the 30mg 
tablets.'' Id. According to the Memorandum, PIC Johnson admitted to 
Investigator V., ``Boy I guess I shouldn't

[[Page 19023]]

have done that'' \10\ and ``I guess I [f--ed] this one up. I quit. Do 
you know anybody who wants to buy a pharmacy?'' Id.
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    \10\ Ellipses omitted from quote.
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The Diversion Investigator's Investigation

    The DI reported, in a sworn Declaration dated March 19, 2018, that 
he conducted an accountability audit for Registrant on August 15, 2017. 
GX 3, at 2. As part of the audit, he conducted a physical count and 
review of some, but not all, controlled substances on hand at 
Registrant, and ``compared that count with the [Registrant's] biennial 
inventory records, dispensing logs, DEA 222 forms, and invoices 
compared with shipping records, which [he] had subpoenaed from pharmacy 
suppliers McKesson and Amerisource Bergen.'' Id. According to the DI, 
the results of his audit showed that Registrant was short 10,594 
oxycodone 30 mg tablets and 11,125 Carisprodol 350 mg tablets, and had 
overages of hydrocodone/apap 10/325 mg by 3,717 tablets, and overages 
of Tramadol 50 mg by 5,018 tablets.\11\ Id. The DI's declaration 
explained that when he began the audit on August 15, 2017, ``DEA was 
not aware that PIC Johnson had tested positive for amphetamines, and 
did not select amphetamines as a controlled substance to audit.'' Id.
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    \11\ The Government's evidence does not include any evidence of 
the DI's audit calculations, beginning or ending inventories, 
dispensing records, receiving records, DEA 222 order forms, invoices 
or a computation chart. The DI's declaration touches on some of this 
information, and there is no evidence to contradict it, so I am 
sustaining those allegations that are adequately explained in the DI 
Declaration.
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    The DI stated that he issued an administrative subpoena to Three 
Rivers Hospital in Brewster, Washington to obtain PIC Johnson's patient 
file. Id. According to the DI, the records show that PIC Johnson had 
tested positive in urine drug screens for oxycodone and amphetamines on 
July 29, 2017, and October 7, 2017, and that he had ``made various 
admissions regarding his drug abuse during the course of his treatment 
for drug overdose.'' Id.; see also GX 3, Appendix 2 (subpoenaed Three 
Rivers Hospital records).
    The DI also obtained Emergency Medical Service records from the 
Douglas Okanogan County Fire Department,\12\ which demonstrated that on 
July 29, 2017, and October 7, 2017, Emergency Medical Services 
(hereinafter, EMS) were dispatched to Registrant to attend to PIC 
Johnson. GX 3, at 3 (citing GX 3, Appendix 3 (EMS records)).
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    \12\ The subpoenaed Fire Department records in Appendix 3 also 
included an emergency dispatch on September 29, 2017, which was not 
included in the DI's declaration.
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    The DI also reported that during an interview with PIC Johnson on 
October 31, 2017, which included two of his DEA colleagues, ``PIC 
Johnson admitted that he was diverting controlled substances from the 
pharmacy and was, on average, taking approximately 4-5 oxycodone 30 mg 
tablets at a time, twice a day,'' but he ``could not recall . . . how 
long he had been diverting controlled substances from the pharmacy.'' 
Id. Further, PIC Johnson admitted that he had abused oxycodone on the 
previous night and ``admitted that he abused amphetamines which he 
diverted from Registrant, but not as often as he abused diverted 
oxycodone.'' Id. Further, according to the DI, PIC Johnson told them 
during the interview that in spite of his regular diversion, abuse and 
impairment, ``it would be more dangerous to have a new pharmacist who 
does not know the community operating [Registrant] than it would be for 
[him] to continue operating [it].'' Id.
    The DI also interviewed PIC Johnson's wife, Nikki Johnson, who told 
them that she began noticing that PIC Johnson was using controlled 
substances ``about a year prior,'' and that ``he would `plan ahead' and 
bring home controlled substance pills [from Registrant] in his pockets 
and she would occasionally find controlled substances pills in his 
pockets at home.'' Id.

PIC Brian Johnson's Treatment for Substance Abuse

    In particular, the Government's evidence includes a copy of a 
medical incident report obtained by the DI from the Douglas Okanogan 
County Fire Department on July 29, 2017.\13\ GX 3, Appendix 3. The 
incident report states that EMS responded to a call for ``Heat/Cold 
Exposure'' at Registrant's location at 811 Highway 97, Brewster, where 
the Emergency Medical Technicians (EMTs) found PIC Johnson suffering 
from ``possible heat stroke,'' ``confused/disoriented,'' and displaying 
symptoms of ``Cognitive-Confusion/Disorientation.'' Id. at 1-2. The 
report states, ``[I]t is known to EMS crew that patient has recently 
been to rehab for opioid drug use.'' Id. at 2. The EMTs administered 
Narcan (Naloxone) and transported him to the local hospital. Id.
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    \13\ The Government's evidence does not include a subpoena for 
the medical reports obtained from Douglas Okanogan County Fire 
Department, nor is there a corresponding attestation of authenticity 
to those records, however, the DI attests that that all information 
included in his Declaration is true and correct, and specifically 
states that he attached the records obtained from the subpoenas in 
Appendix 2; therefore, I find that these records appear to be 
authentic.
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    PIC Johnson's patient records from Three Rivers Hospital (TRH) show 
that on July 29, 2017, PIC Johnson was treated in the emergency room 
after EMS documented ``[c]oncern for heatstroke vs. drug OD?'' GX 3, 
Appendix 2, at 2. The results of an administered urine drug test were 
positive for amphetamines and oxycodone. Id. at 20. The ``Nurses 
Notes'' in the hospital record state that prior to discharge from the 
hospital a ``brief intervention [was] done regarding drug use.''' Id. 
at 7.
    A document titled ``ER Note'' for PIC Johnson on that date states 
that his chief complaint was ``altered mental status'' and that ``he 
denie[d] taking any medications,'' and ``denies recreational drug 
use''; however, the reviewing doctor's assessment was ``Narcotic 
overdose.'' Id. at 19-21.
    The records attached to the DI's Declaration show that on September 
29, 2017, the EMS responded to an emergency call on Highway 97, 
Pateros, Washington, where they encountered PIC Johnson sitting ``in a 
car along the road [ ] shaking and non-respon[sive] to [rescue 
personnel] on the scene.'' GX 3, Appendix 3, at 4. The EMTs reported 
that he ``kept saying that he was late and needed to get to work.'' Id. 
The EMTs assessed him with ``altered mental status'' and transported 
him to the hospital. Id. at 3. The corresponding hospital report states 
that he ``[d]enies any drug use in the past 30 days.'' GX 3, Appendix 
2, at 41. According to the report, during his treatment in the 
emergency room, police ``received orders from a judge to obtain labs,'' 
and he was discharged into police custody and ``taken to jail for 
DUI.'' Id. at 45. The reviewing doctor's report states that he 
``reports a history of narcotic dependence in the past and though he 
denies dependency now he admits to abuse.'' Id. at 46. No urine drug 
screen was performed at the hospital but the treating doctor's report 
was amended to state, ``The main issue will be withdrawal from 
narcotics which may happen in the next 24 hours.'' Id. at 48.
    On October 7, 2017, the EMS responded to a call at Registrant in 
response to a complaint of PIC Johnson ``shaking, possibly having 
seizure while standing.'' GX 3, Appendix 3, at 8. The EMT's report 
states that, upon arrival, they encountered PIC Johnson and the field 
assessment of him was ``Substance Abuse--Opioid.'' Id. at 10.
    According to the hospital patient records for PIC Johnson on that 
date, a urine drug screen showed positive results for amphetamines and

[[Page 19024]]

oxycodone. GX 3, Appendix 2, at 69, 77. The treating physician's report 
states that PIC Johnson ``admits during ER course to problem with using 
drugs and wishes to stop but declines admission and states he knows how 
to get off drugs with Methadone or Suboxone'' and that he planned to 
enter rehab when ``able to be free from his pharmacy business for at 
least a [three] week period.'' Id. at 72. He also admitted he ``has no 
prescribed medication from a provider . . . [h]e states he is a 
pharmacist and has access to medications.'' Id. The treating 
physician's impression was ``drug intoxication, mixed substance abuse, 
narcotics and amphetamine, acute, recurrent. Illicit drug use.'' Id.

Allegation That PIC Johnson Abused Registrant's Registration To Fuel 
His Drug Addiction

    The Government has demonstrated that PIC Johnson used the 
Registrant's registration to procure drugs for his own addiction. By 
his own admission to the DI, PIC Johnson was ``diverting controlled 
substances from the pharmacy and was, on average, taking approximately 
4-5 oxycodone 30 mg tablets at a time, twice a day.'' GX 3, at 3. His 
wife, and co-owner of Registrant, confirmed this admission in stating 
to the DI that PIC Johnson ``would `plan ahead' and bring home 
controlled substance pills [from Registrant] in his pockets.'' Id. The 
evidence is clear that Registrant was enabling this drug addiction by 
dispensing to PIC Johnson without a prescription and without 
maintaining required records. Although I believe that the Government 
has provided substantial evidence regarding PIC Johnson's abuse of 
Registrant's registration through PIC Johnson's admission, this 
violation was not alleged in the OSC; therefore, I will not ultimately 
consider this violation as a basis for sanction in this case. Had this 
case gone to hearing, the violation would have likely been adequately 
noticed during the prehearing phase.\14\ In this case, I believe that 
there is enough evidence that Registrant's registration is inconsistent 
with the public interest without it.
---------------------------------------------------------------------------

    \14\ In this case, the Government has provided no evidence or 
legal arguments regarding its provision of due process to the 
Registrant related to the allegation not charged in the OSC that 
would allow me to consider PIC Johnson's admission as a basis for 
sanction.
---------------------------------------------------------------------------

Allegation That PIC Johnson Was Impaired While Working as Pharmacist-
In-Charge

    Based on the declaration of the DI and the records from EMS and 
Three Rivers Hospital, I find that the Government has established that 
PIC Johnson was impaired on at least two occasions, while working as 
the Pharmacist in Charge. GX 3, Appendix 2 & 3. Particularly, EMS was 
dispatched on July 29, 2017, and October 7, 2017, to Registrant to 
attend to PIC Johnson. GX 3, at 3 (citing GX 3, Appendix 3). Laboratory 
tests conducted at the hospital on those two occasions demonstrated 
that PIC Johnson tested positive for oxycodone and amphetamines. GX 3, 
Appendix 2, 20; id. at 69, 77.

Allegation That Registrant Failed To Keep Accurate Records

    Based on the uncontested declaration of the DI, I find that 
Registrant failed to maintain adequate records of its controlled 
substances.\15\ GX 3, at 2. I find that an accountability audit 
conducted on August 15, 2017, demonstrated that Registrant was short 
10,594 oxycodone 30 mg tablets and 11,125 Carisoprodol 350 mg tablets, 
and had overages of hydrocodone/apap 10/325 mg by 3,717 tablets, and 
overages of Tramadol 50 mg by 5,018 tablets.16 17 Id.
---------------------------------------------------------------------------

    \15\ The Government also alleged in the OSC that Registrant 
failed to record the date and quantity of controlled substances 
received on multiple copies of DEA Form 222; however, the DI's sworn 
declaration did not include confirmation of this allegation; 
therefore, this allegation is not sustained.
    \16\ The OSC also alleged that the audit showed shortages of 
morphine immediate release, morphine extended release and 
meperidine; however, the DI's sworn declaration did not include 
confirmation; therefore, this allegation is not sustained.
    \17\ The Government's evidence does not include any evidence of 
the DI's audit calculations, beginning or ending inventories, 
dispensing records, receiving records, DEA 222 order forms, invoices 
or a computation chart; however, there is no information to 
contradict the DI's sworn declaration, so I will find the facts as 
presented therein.
---------------------------------------------------------------------------

    Regarding the multiple fillings of Patient M.R.'s prescription, I 
find that the Government's evidence substantially indicates that on 
more than one occasion, PIC Johnson dispensed varying dosages of 
Oxycodone to Patient M.R. on the basis of a single prescription. 
Although the evidence is unclear as to how many bottles were filled on 
February 1, 2017, it appears that the PMP entries for the prescription 
were inaccurate, because it shows only one prescription filled on 
February 1, for the full prescription. See GX 4, Appendix 1 (PMP data 
for February 1, 2017 and February 11, 2017) (showing three dispensings 
on two different dates, one of which is for the full prescription). I 
find that both the State PMP and the labels on the bottles show that 
the Registrant filled a prescription for a prescription number that was 
entirely invented (no record from the prescriber or at the pharmacy), 
and also filled the full amount of the single prescription twice. Id.; 
GX 5, at 2.\18\
---------------------------------------------------------------------------

    \18\ The evidence also demonstrates that Registrant engaged in 
unlawful dispensing to PIC Johnson, which would provide further 
evidence of recordkeeping violations, but as explained herein, I am 
not ultimately considering violations related to PIC Johnson's self-
dispensing in my sanction determination, because these violations 
were not included in the OSC, nor was Registrant otherwise provided 
with notice that they would be a basis for sanction.
---------------------------------------------------------------------------

Discussion

Public Interest Analysis

    The Government asserts that Registrant's registration should be 
revoked because its continued registration is inconsistent with the 
public interest, and requests that I issue a final order affirming the 
Order of Immediate Suspension issued on October 26, 2017. RFAA, at 1. 
According to the Government, Registrant's pharmacist in charge 
``circumvented the CSA's prescription requirement by leapfrogging the 
doctor-patient component of the CSA's closed system, obtained [sic] a 
DEA Registration, and used the Pharmacy to order wholesale quantities 
of controlled substances for his abuse.'' RFAA, at 7. It also contends 
that PIC Johnson dispensed controlled substances to patient M.R. 
contrary to the CSA's prescription requirement, and that the PIC's 
repeated drug overdoses, while working as the Pharmacist-in-Charge at 
the Registrant, demonstrates conduct which may threaten the public 
health and safety.
    In addition, the Government requests that all controlled substances 
seized from Registrant on October 31, 2017, pursuant to the Order of 
Immediate Suspension be forfeited to the United States. Id. at 1.
    Section 304(a) of the CSA provides that ``[a] registration . . . to 
. . . dispense a controlled substance . . . may be suspended or revoked 
by the Attorney General upon a finding that the registrant . . . has 
committed such acts as would render [its] registration under section 
823 of this title inconsistent with the public interest as determined 
under such section.'' 21 U.S.C. 824(a)(4). In the case of a 
``practitioner,'' which is defined in 21 U.S.C. 802(21) and includes a 
pharmacy, the CSA requires that the Agency consider the following 
factors in making the public interest determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.

[[Page 19025]]

    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the . . . 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). These factors are considered in the disjunctive. 
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003).
    According to Agency decisions, I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether'' to revoke a registration. Id.; see 
also Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 
F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi v. Drug Enf't 
Admin., 841 F.3d 707, 711 (6th Cir. 2016); MacKay v. Drug Enf't Admin., 
664 F.3d 808, 816 (10th Cir. 2011); Volkman v. Drug Enf't Admin., 567 
F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enf't Admin., 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); see 
also Hoxie, 419 F.3d at 482. ``In short, . . . 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, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth 
Circuit has recognized, findings under a single factor can support the 
revocation of a registration. MacKay, 664 F.3d at 821.
    Also, pursuant to section 824(d), ``[t]he Attorney General may, in 
his discretion, suspend any registration simultaneously with the 
institution of proceedings under this section, in cases where he finds 
that there is an imminent danger to the public health or safety.'' 21 
U.S.C. 824(d)(1). Congress has defined ``the phrase `imminent danger to 
the public health or safety' [to] mean[ ] that, due to the failure of 
the registrant to maintain effective controls against diversion or 
otherwise comply with the obligations of a registrant under [the CSA], 
there is a substantial likelihood of an immediate threat that death, 
serious bodily harm, or abuse of a controlled substance will occur in 
the absence of an immediate suspension of the registration.'' Id. at 
(d)(2).
    Under the Agency's regulation, ``[a]t any hearing for the 
revocation or suspension of a registration, the Administration shall 
have the burden of proving that the requirements for such revocation or 
suspension pursuant to . . . 21 U.S.C. 824(a) . . . are satisfied.'' 21 
CFR 1301.44(e). In this matter, I have considered all of the factors 
and find that the Government's evidence with respect to factors two, 
four and five establishes that Registrant, through its corporate 
principal and pharmacist-in-charge, has committed acts which render its 
registration ``inconsistent with the public interest'' and which 
support the revocation of its registration. 21 U.S.C. 824(a)(4). I 
further find that the Government's evidence, supports my initial 
finding and further establishes that Registrant's misconduct satisfies 
the imminent danger standard of 21 U.S.C. 824(d), in that, Registrant's 
failure ``to maintain effective controls against diversion or otherwise 
comply with the obligations of a registrant under'' the CSA created ``a 
substantial likelihood of an immediate threat that . . . abuse of a 
controlled substance will occur in the absence of an immediate 
suspension of [its] registration.'' Id.

Factors Two and/or Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

    The Government has established that Registrant unlawfully dispensed 
controlled substances to Patient M.R. The definition of ``dispense'' 
under the CSA is ``to deliver a controlled substance to an ultimate 
user . . . pursuant to the lawful order of, a practitioner.'' Id. at 
Sec.  802(10); see also 21 CFR 1300.01(a) (``Prescription means an 
order for medication which is dispensed to or for an ultimate user . . 
. .'').
    Factor Four is demonstrated by evidence that a registrant has not 
complied with laws related to controlled substances, including 
violations of the CSA, DEA regulations, or other state or local laws 
regulating the dispensing of controlled substances. The Government's 
case relies primarily on the actions of Registrant's PIC and co-owner. 
``Agency precedent has consistently held that the registration of a 
pharmacy may be revoked as the result of the unlawful activity of the 
pharmacy's owners, majority shareholders, officers, managing 
pharmacist, or other key employee.'' Perry County Food &Drug, 80 FR 
70084, 70109 (2015) (citing EZRX, LLC, 69 FR 63178, 63181 (1988); Plaza 
Pharmacy, 53 FR 36910, 36911 (1988).
    Under the CSA, it is ``unlawful for any person knowingly or 
intentionally to possess a controlled substance unless such substance 
was obtained directly, or pursuant to a valid prescription or order, 
from a practitioner, while acting in the course of his professional 
practice, or except as otherwise authorized by this subchapter.'' 21 
U.S.C. 844(a). While PIC Johnson was authorized to order controlled 
substances for the pharmacy and to possess controlled substances in his 
capacity as the Registrant's PIC, he was authorized to do so only for 
the purpose of dispensing the controlled substances to patients 
``pursuant to the lawful order of a practitioner,'' in this case, a 
prescription. 21 U.S.C. 822(b) (``Persons registered by the Attorney 
General under this subchapter to . . . dispense controlled substances . 
. . are authorized to possess . . . distribute, or dispense such 
substance . . . to the extent authorized by their registration and in 
conformity with the other provision of this subchapter.'') (emphasis 
added); 21 U.S.C. 823(f); see also ChipRX, L.L.C., d/b/a City Center 
Pharmacy, 82 FR 51433, 51437 (2017).
    The Government asserts that not only does PIC Johnson's misconduct 
in dispensing to himself violate 21 U.S.C. 844(a) (unauthorized 
possession of controlled substances), but that such possession 
demonstrates the Registrant's violation of Sec.  829(a) and (b) 
(requiring a prescription to dispense controlled substances). RFAA, at 
8. Further, it alleges that the Registrant's conduct violates federal 
regulations mandating that a pharmacist may dispense scheduled drugs 
only pursuant to a written prescription signed by the practitioner. 21 
CFR 1306.11 (schedule II) and 1306.21 (schedules III-V). Id. The 
evidence shows that Registrant's PIC was diverting narcotic controlled 
substances from Registrant's pharmacy stock for his own misuse--taking 
approximately 4-5 oxycodone 30 mg tablets at a time, twice a day. See 
GX 3, at 3. His wife, Registrant's co-owner, also informed the DIs that 
he would bring home controlled substance pills from Registrant in his 
pockets, which demonstrated that she had knowledge of Registrant's 
unlawful activity and permitted it to continue. Although there is 
substantial evidence that PIC Johnson violated multiple laws in 
dispensing to himself, these allegations were not noticed in the OSC, 
and therefore, I am not relying on the violations of law associated 
with them in my sanction determination.

[[Page 19026]]

    There is substantial evidence that Registrant violated the 
recordkeeping requirements of the CSA. Recordkeeping is one of the 
CSA's principal tools for preventing the diversion of controlled 
substances. Grider Drug 1 & Grider Drug 2, 77 FR 44070, 44100 (citing 
Paul H. Volkman, 73 FR 30630, 30644 (2008)). Under the Act, ``every 
registrant . . . dispensing a controlled substance or substances shall 
maintain, on a current basis, a complete and accurate record of each 
such substance . . . received, sold, delivered, or otherwise disposed 
of by him.'' 21 U.S.C. 827(a). Further, DEA decisions have explained 
that ``a registrant's accurate and diligent adherence to [its 
recordkeeping] obligations is absolutely essential to protect against 
the diversion of controlled substances.'' Volkman, 73 FR at 30644. 
Here, the Government alleged, in its Order to Show Cause, that an audit 
conducted by the Diversion Investigators of Registrant showed shortages 
of more than 10,000 oxycodone 30 mg tablets and more than 11,000 
carisoprodol 350 mg tablets. OSC, at 2. In addition, the Government 
alleged that the audit showed overages for hydrocodone/apap 10/325 and 
tramadol. Id. (citing 21 CFR 1304.03, 1304.04, 1304.11, 1304.21); \19\ 
see also GX3, at 2 (DI's Declaration). It is clear from such overages 
and shortages that Registrant was not maintaining required records.
---------------------------------------------------------------------------

    \19\ Although the OSC alleged that Registrant had also violated 
21 CFR 1305.13(e), I found no mention of the underlying violations 
in the DI Declaration nor in the RFAA, so I am not sustaining that 
violation. See OSC, at 2; GX 3; RFAA. Additionally, I am not 
sustaining a violation of 21 CFR 1304.22 as alleged in the RFAA, 
because it was not alleged in the OSC and the Government has not 
provided me with a basis for considering it.
---------------------------------------------------------------------------

    In addition, as found herein, the Government's evidence 
substantially indicates that PIC Johnson filled multiple prescriptions 
for varying dosages of Oxycodone to Patient M.R. on the basis of a 
single prescription. Registrant filled the single Schedule II oxycodone 
prescription on more than one occasion in violation of 21 U.S.C. 
841(a). Further, it is clear that Registrant did not maintain adequate 
records regarding its dispensing to Patient M.R.
    On the basis of these unrefuted facts I find that Registrant, 
through its PIC, failed to maintain accurate records of its dispensing 
activities to M.R., violated federal law in dispensing to M.R. without 
a valid prescription, and Registrant's inventory overages and shortages 
further demonstrate violations of federal law and regulations. Such 
findings weigh against entrusting Registrant with a registration.

Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety

    Although factor five is broad, DEA decisions have qualified its 
breadth by limiting the considerations made under that factor to those 
where there is ``a substantial relationship between the conduct and the 
CSA's purpose of preventing drug abuse and diversion.'' Zvi H. Perper, 
M.D., 77 FR 64131, 64141 (2012), citing Tony T. Bui, 75 FR 49979, 49988 
(2010). DEA caselaw has held that registrants who self-abuse controlled 
substances may endanger public health and safety. See Tyson D. Quy, 
M.D., 78 FR 47412 (2013); Bui, 75 FR at 49988; Kenneth Wayne Green, 
Jr., 59 FR 51453 (1994). In particular, PIC Johnson abused oxycodone 
and amphetamines on two documented occasions, while acting as the 
Pharmacist-in-Charge at Registrant to such an extent that EMS had to 
take him to the hospital for a potential overdose. A practitioner, who 
is under the influence of controlled substances while practicing, 
places public health and safety in jeopardy. See Quy, 78 FR at 47418 
(holding that a physician who reported to work at a hospital while 
under the influence endangered public health and safety, because ``the 
fact that he was willing to risk such harm is inconsistent with the 
requirements of a DEA registrant.'').
    In this case, Registrant is a corporation, not an individual, but 
``misconduct of an entity's principal is properly considered in 
determining whether to revoke the entity's registration.'' ChipRX, 
L.L.C., d/b/a City Center Pharmacy, 82 FR 51438 (citing G&O Pharmacy of 
Paducah, 68 FR 43752, 43753 (2003). Although PIC Johnson's dispensing 
to Patient M.R. fortunately did not result in harm to the patient, it 
demonstrates a dangerous lack of attention to detail and violations of 
law, which resulted in PIC Johnson filling ``this single prescription 
three times,\20\ providing patient M.R. with three different 
prescription bottles with various dosage strengths, for a total of 910 
oxycodone tablets.'' OSC, at 4. As the Agency has previously held, `` 
`[c]areless or negligent handling of controlled substances creates the 
opportunity for diversion and [can] justify' the revocation of an 
existing registration or the denial of an application for a 
registration.'' Lon F. Alexander, M.D., 82 FR 49704, 49725 n.43 (2017) 
(quoting Paul J. Caragine, Jr. 63 FR 51592, 51601 (1998)).
---------------------------------------------------------------------------

    \20\ As explained herein, he appeared to fill the prescription 
twice in three bottles.
---------------------------------------------------------------------------

    Additionally, on September 29, 2017, EMS and hospital records 
demonstrate that PIC Johnson showed signs of drug abuse while operating 
his vehicle on his way to work. See GX 3, Appendix 3, at 4. The 
hospital records show that he was subsequently arrested for Driving 
Under the Influence. GX 3, Appendix 2, at 45. Once again, it appears 
that PIC Johnson was planning to practice as the Pharmacist-in-Charge 
while dangerously intoxicated, and additionally, he demonstrated an 
extreme lack of judgment and a reckless disregard for the safety of 
others by driving his car in such a state.

Summary of Factors Two, Four and Five and Imminent Danger

    Having considered all of the factors, I conclude that the evidence 
pertinent to factors two, four and five demonstrate a prima facie 
showing that Registrant ``has committed such acts as would render [its] 
registration . . . inconsistent with the public interest.'' 21 U.S.C. 
824(a)(4). I further conclude that Registrant has not rebutted the 
Government's prima facie case.
    For purposes of the imminent danger inquiry, my findings also lead 
to the conclusion that Respondent has ``fail[ed] . . . to maintain 
effective controls against diversion or otherwise comply with the 
obligations of a registrant'' under the CSA. 21 U.S.C. 824(d)(2). The 
uncontroverted, substantial evidence that Respondent was severely 
impaired while working or heading to work, as evidenced by his 
emergency room treatments for potential overdose three times in the 
course of three months, establishes that there was ``a substantial 
likelihood of an immediate threat that death, serious bodily harm, or 
abuse of a controlled substance . . . [would] occur in the absence of 
the immediate suspension'' of Registrant's registration. Id.; see also, 
ChipRX, L.L.C. d/b/a City Center Pharmacy, 82 FR 51433, 51439 (2017).

Sanction

    Where, as here, the Government has met its prima facie burden of 
showing that Registrant's continued registration is inconsistent with 
the public interest, the burden shifts to the Registrant to show why it 
can be entrusted with a registration. Garrett Howard Smith, M.D., 83 FR 
18882, 18910 (2018) (collecting cases).
    The CSA authorizes the Attorney General to ``promulgate and enforce 
any rules, regulations, and procedures which he may deem necessary and 
appropriate for the efficient execution of his functions under this 
subchapter.'' 21 U.S.C. 871(b). This authority

[[Page 19027]]

specifically relates ``to `registration' and `control,' and `for the 
efficient execution of his functions' under the statute.'' Gonzales, 
546 U.S. at 259. ``Because `past performance is the best predictor of 
future performance, ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 
452 (7th Cir. 1995), [the Agency] has repeatedly held that where a 
registrant has committed acts inconsistent with the public interest, 
the registrant must accept responsibility for [the registrant's] 
actions and demonstrate that [registrant] will not engage in future 
misconduct.' '' Jayam Krishna-Iyer, 74 FR at 463 (quoting Medicine 
Shoppe, 73 FR 364, 387 (2008)); see also Jackson, 72 FR at 23853; John 
H. Kennnedy, M.D., 71 FR 35705, 35709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62884, 62887 (1995). The issue of trust is necessarily a 
fact-dependent determination based on the circumstances presented by 
the individual registrant; therefore, the Agency looks at factors, such 
as the acceptance of responsibility, and the credibility of that 
acceptance as it relates to the probability of repeat violations or 
behavior, and the nature of the misconduct that forms the basis for 
sanction, while also considering the Agency's interest in deterring 
similar acts. See Arvinder Singh, M.D., 81 FR 8247, 8248 (2016).
    Here the Registrant failed to respond to the Government's Order to 
Show Cause and Immediate Suspension Order and did not avail itself of 
the opportunity to refute the Government's case. PIC Johnson did 
arguably accept responsibility on two occasions, one by admitting to 
the DI that he was diverting controlled substances, and the other when 
he admitted to the state investigator that he ``shouldn't have done 
that.'' GX 3, at 3; GX 4, Appendix 5. However, he also told the DI that 
``it would be more dangerous to have a new pharmacist who does not know 
the community operating [Registrant] tha[n] it would be for [him] to 
continue operating the Pharmacy notwithstanding his regular diversion, 
abuse, and impairment.'' GX 3, at 3. This statement undercuts any 
acceptance of responsibility and also highlights PIC Johnson's lack of 
judgment in believing that it would benefit the community to have a 
pharmacist under the influence of controlled substances. Furthermore, 
because neither PIC Johnson nor anyone else testified nor presented any 
evidence on behalf of the Registrant in this proceeding, the Registrant 
has not provided any assurances that it has implemented remedial 
measures to ensure such conduct is not repeated. Such silence weighs 
against the Registrant's continued registration. Zvi H. Perper, M.D., 
77 FR at 64142 (citing Medicine Shoppe, 73 FR at 387); see also Samuel 
S. Jackson, 72 FR at 23853.
    Accordingly, I find that the factors weigh in favor of sanction and 
I shall order the sanctions the Government requested, as contained in 
the Order below.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. 
AB6785161 issued to Brewster Drug, Inc. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny any pending application of Brewster Drug, Inc. to renew or modify 
this registration, as well as any other pending application of Brewster 
Drug, Inc. for additional registrations in Washington. Pursuant to the 
authority vested in me by 21 U.S.C. 824(f), as well as 28 CFR 0.100(b), 
I further order that all controlled substances seized pursuant to the 
Order of Immediate Suspension of Registration are forfeited to the 
United States. This Order is effective May 4, 2020.

    Dated: March 13, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-07017 Filed 4-2-20; 8:45 am]
BILLING CODE 4410-09-P