[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63579-63583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22216]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Wayne Pharmacy; Decision and Order

    On March 30, 2018, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause (hereinafter, OSC) to Wayne Pharmacy (hereinafter, 
Registrant), which proposed the revocation of its DEA Certificate of 
Registration BW8625785. Government's Request for Final Agency Action 
Exhibit (hereinafter, RFAAX) 2 (OSC). The OSC alleged that Registrant's 
``continued registration is inconsistent with the public interest.'' 
OSC, at 1 (citing 21 U.S.C. 824(a)(4) and 823(f)). The OSC also 
proposed to deny any pending application by Registrant for renewal as

[[Page 63580]]

well as applications for new DEA registrations. Id.
    In response to the OSC, Registrant issued a timely request for an 
administrative hearing, RFAAX 14 (Order Terminating Proceedings), and a 
hearing was scheduled for July 17, 2018. Id. On July 6, 2018, DEA and 
Registrant reached an administrative settlement, which required, among 
other things, for Registrant to admit to Paragraphs 2 through 8 of the 
OSC and to withdraw its request for a hearing. RFAAX 12 (Memorandum of 
Agreement), at 2-3. On July 9, 2018, pursuant to the settlement, 
Registrant withdrew its request for an administrative hearing. RFAAX 
14.
    On September 21, 2018, the Government forwarded a Request for Final 
Agency Action, along with the evidentiary record for this matter, to my 
office. Having considered the record in its entirety, I find that the 
record establishes, by substantial evidence, that Registrant committed 
acts rendering its continued registration inconsistent with the public 
interest. Accordingly, I conclude that the appropriate sanction is for 
Registrant's DEA registration to be revoked.

I. Findings of Fact

A. DEA Registration

    Registrant is registered with DEA as a retail pharmacy authorized 
to handle controlled substances in schedules II-V under DEA 
Registration No. BW8625785, with a registered location of 1055 Hamburg 
Turnpike, Wayne, New Jersey, 07470. RFAAX 1 (DEA Certificate of 
Registration). Registrant is owned by Barbara Kleiber (hereinafter, the 
Owner). Id.; RFAAX 13 (May 31, 2018 Prehearing Ruling), at Stipulation 
No. 2.

B. Administrative Settlement and Registrant's Admissions

    In lieu of an administrative hearing on this matter, Registrant and 
the Government came to an administrative settlement, the terms of which 
were memorialized in a Memorandum of Agreement (hereinafter, MOA). 
RFAAX 12. As part of the settlement, Registrant, and its Owner, both 
``accepted responsibility for their misconduct and for their failure to 
comply with federal laws pertaining to controlled substances as alleged 
in the [OSC].'' Id. at 2. Specifically, the Owner, both in her 
individual capacity and in her capacity as the owner of Registrant, 
admitted to the following factual allegations made in paragraphs 2 
through 8 of the OSC against Registrant:
    (1) Registrant is owned by Barbara Kleiber. M.B.\1\ is a former 
employee of Registrant and the son of the Owner;
---------------------------------------------------------------------------

    \1\ I have used initials to refer to all of Registrant's 
employees except for the Pharmacist in Charge.
---------------------------------------------------------------------------

    (2) In May 2017, Registrant's Pharmacist-in-Charge (``PIC'') 
Deborah Clark reported to the Wayne Police Department that in the 
course of investigating the loss of a bottle of oxycodone 30mg, she had 
conducted an audit and discovered that approximately 47,000 tablets of 
oxycodone 30mg were missing.
    (3) Although Registrant became aware of the loss of 47,000 tablets 
of oxycodone 30mg in May 2017, Registrant did not file a DEA 106 notice 
of theft or loss until June 14, 2017, after DEA conducted its own 
inspection of Registrant, and in violation of 21 CFR 1301.76(b).
    (4) On June 1, 2017, DEA inspected Registrant's records pursuant to 
a Notice of Inspection. During this inspection, an audit was conducted 
covering the May 1, 2015 to June 1, 2017 time period. DEA's audit of 
Registrant's records found that Registrant committed systematic 
violations of the Controlled Substances Act (hereinafter, CSA), 21 
U.S.C. 801 et seq., and DEA regulations, including the following:
    a. Registrant's inventories resulted in inaccurate inventories in 
violation of 21 CFR 1304.22(c).
    i. For the audit period, Registrant was accountable for 543,575 
tablets of oxycodone 30 mg, but could only account for 510,994 tablets, 
a shortfall of 32,581 tablets.
    ii. For the audit period, Registrant was accountable for 120,102 
tablets of oxycodone/acetaminophen 10/325 mg, but could only account 
for 96,102, a shortfall of 24,000 tablets.
    iii. For the audit period, Registrant was accountable for 41,004 
tablets of Morphine IR 30 mg, but could only account for 34,487 
tablets, a shortfall of 6,517 tablets.
    (5) On September 18, 2017, DEA conducted an additional review of 
Registrant's records pursuant to an Administrative Inspection Warrant. 
DEA's audit of Registrant's records found that Registrant continued to 
commit systematic violations of the CSA and DEA regulations.
    a. The five controlled substances that were audited on June 1, 
2017, were again audited with an audit period of June 1, 2017 to 
September 18, 2017. Registrant's inventory continued to be inaccurate 
in violation of 21 CFR 1304.22(c).
    i. For the audit period, Registrant was accountable for 44,954 
tablets of oxycodone 30 mg, but could only account for 44,626 tablets, 
a shortfall of 328 tablets.
    ii. For the audit period, Registrant was accountable for 12,389 
tablets of oxycodone/acetaminophen 10/325 mg, but could only account 
for 12,193 a shortfall of 196 tablets.
    iii. For the audit period, Registrant was accountable for 2,557 
tablets of Morphine IR 30 mg, but could only account for 2,354 tablets, 
a shortfall of 203 tablets.
    b. In addition to auditing the same controlled substances that were 
audited on June 1, 2017, DEA conducted an audit of additional 
controlled substances. For these additional controlled substances, the 
audit period was May 1, 2017 to September 18, 2017. Registrant's 
inventory was inaccurate with respect to these controlled substances in 
violation of 21 CFR 1304.22(c).
    i. For the audit period, Registrant was accountable for 4,428 
tablets of alprazolam 2 mg, but could only account for 3,318 tablets, a 
shortfall of 573 tablets.
    ii. For the audit period, Registrant was accountable for 880 
tablets of Tylenol with codeine #4, but could only account for 812 
tablets, a shortfall of 68 tablets.
    iii. For the audit period, Registrant was accountable for 2,487 
tablets of Adderall IR 30 mg, but could only account for 2,292 tablets, 
a shortfall of 195 tablets.
    (6) In December 2017, Registrant hired its own auditor to inspect 
its records. Using the audit period of January 1, 2017, to December 19, 
2017, Registrant's own auditor found significant shortages. 
Specifically, Registrant's auditor found that during this time period, 
Registrant could not account for 15,264 tablets of oxycodone 30 mg, 
13,966 tablets of oxycodone 15 mg, 4,140 tablets of alprazolam 2 mg, 
and 1,192 tablets of Adderall (generic) 30 mg.
    (7) When the DEA conducted its audit on June 1, 2017, the Owner 
told DEA that Registrant was in the process of improving its practices 
since discovering the massive shortages that caused Registrant to 
report missing oxycodone to the Wayne Police Department. Specifically, 
the Owner advised DEA that Registrant was in the process of taking 
additional security measures; namely (1) ordering of a safe to store 
controlled substances (as opposed to the locked glass cabinet currently 
in use); and (2) tallying daily inventories of controlled substances. 
Neither of these alleged additional safeguards were effective, as the 
controlled substances continued to be stored in such a way that all 
employees

[[Page 63581]]

had access to them, and the daily inventories were conducted in such a 
way that any employee could alter the inventory. As such Registrant, on 
an ongoing basis, failed to adequately secure its controlled substances 
in violation of 21 CFR 1301.71.
    The Owner and Registrant also both admitted that ``[the Owner] was 
given notice by DEA that there was reasonable basis to believe that 
[M.B.] was diverting controlled substances, but [the Owner] did not 
terminate [M.B.]'s employment for at least four months.'' RFAAX 12, at 
2-3.

C. Government's Allegations

    In addition to the factual allegations the Registrant admitted in 
the MOA, the Government has also alleged that M.B., the son of 
Registrant's owner and a former employee of Registrant, was involved in 
the theft of controlled substances from Registrant and that Registrant 
failed to terminate M.B. in the face of evidence that he was diverting 
controlled substances. OSC, at 4-5; RFAA, at 9-10. To support this 
allegation, the Government submitted recordings and transcripts of 
interviews the Wayne Police Department conducted with one of 
Registrant's Pharmacists and its PIC (which were also attended by DEA 
officers and investigators), RFAAX 5-9; text messages between 
Registrant's PIC and a DEA Task Force Officer (hereinafter, TFO One), 
RFAAX 11, 16; and the declaration of a DEA Diversion Investigator 
(hereinafter, DI One), who recounted conversations he had with 
Registrant's employees, owner, and representatives. RFAAX 15.
    On June 1, 2017, DEA conducted an inspection at Registrant. DI One 
stated that he interviewed one of Registrant's pharmacy technicians, 
who recounted to him an incident from 2016, in which she discovered a 
trail of oxycodone tablets leading toward the restroom immediately 
after M.B. was involved in counting oxycodone tablets and then left for 
the restroom. GX 15, at 2.
    On June 2, 2017, the Wayne Police Department interviewed a former 
pharmacist at Registrant, C.R. RFAAX 6 (Recording of C.R. Interview) 
and 7 (Transcript of C.R. Interview); see also RFAAX 16 (Declaration of 
TFO One). TFO One attended and participated in the interview. RFAAX 16. 
During the interview, C.R. described an incident he had with M.B. when 
C.R. was working as a pharmacist at Registrant and M.B. was working as 
a pharmacy technician. RFAAAX 7, at 12-13. C.R. stated that he caught 
M.B. putting a bottle of morphine sulfate 30 mg in his pocket. Id. C.R. 
said he confronted M.B., and M.B. produced the bottle from his pocket. 
Id. C.R. stated that after the pharmacy closed that night, he told the 
Owner about the incident. Id.
    The Wayne Police Department interviewed Registrant's PIC, Deborah 
Clark, on June 9, 2017 and June 14, 2017. RFAAX 5 (Recordings of PIC 
interviews), 8 (Transcript of June 9 PIC Interview), 9 (Transcript of 
June 14 PIC Interview); see also RFAAX 15, at 2. DI One attended the 
June 9 interview. RFAAX 15, at 2. During the June 9 interview, PIC 
Clark reported an incident from May 4, 2017, where M.B. was involved in 
putting away an order at the pharmacy, which included six bottles of 
oxycodone. RFAAX 8, at 12. According to PIC Clark, M.B. abruptly left 
the pharmacy, and, after he left the pharmacy, a bottle of oxycodone 
was found to be missing. Id. When M.B. returned to the pharmacy, he 
appeared, in PIC Clark's opinion, to be ``spacey.'' Id. PIC Clark 
reported the missing bottle to the Owner. Id.
    DI One also declared that DEA repeatedly told Registrant that there 
was a reasonable basis to believe that M.B. was diverting controlled 
substances. RFAAX 15, at 4. DI One stated that he told the Owner during 
the September 2017 audit that DEA believed her son, M.B., was diverting 
controlled substances. Id. DI One also said he was present ``at a 
meeting between representatives of the Department of Justice, DEA and 
[Registrant] which took place on January 8, 2018 and February 7, 
2018,'' and ``[a]t both of those meetings [Registrant]'s 
representatives were told that [M.B.] was involved in diversion of 
controlled substances'' and at both of those meetings ``[Registrant]'s 
representatives indicated that [M.B.] still worked at Wayne Pharmacy.'' 
Id.

II. Discussion

A. Registrant's Registration Is Inconsistent With the Public Interest

    Under the Controlled Substances Act, ``[a] registration . . . to . 
. . 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.'' 21 U.S.C. 
824(a)(4). In the case of a ``practitioner,'' which is defined in 21 
U.S.C. 802(21) to include a ``physician,'' Congress directed the 
Attorney General to consider the following factors in making the public 
interest determination:
    (1) The recommendation of the appropriate State licensing board or 
professional disciplinary authority.
    (2) The [registrant]'s experience in dispensing . . . controlled 
substances.
    (3) The [registrant]'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 15,227, 15,230 (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 Pharm., 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, findings under a single factor can 
support the revocation of a registration. MacKay, 664 F.3d at 821.
    The Government has the burden of proving that the requirements for 
revocation of a DEA registration in 21 U.S.C. 824(a) are satisfied. 21 
CFR 1301.44(e). When the Government has met its prima facie case, the 
burden then shifts to the registrant to show that revoking registration 
would not be appropriate, given the totality of the facts and 
circumstances on the record. Med. Shoppe-Jonesborough, 73 FR 364, 387 
(2008).
    In this matter, while I have considered all of the Factors, the 
Government's evidence in support of its prima facie case is confined to 
Factors Two, Four, and Five. I find the

[[Page 63582]]

Government has satisfied its prima facie burden of showing that 
Registrant's continued registration would be ``inconsistent with the 
public interest.'' 21 U.S.C. 824(a)(4).
1. Factors Two and/or Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances
    As already discussed, pursuant to section 304 of the CSA, in 
conjunction with section 303 of the CSA, I am to consider evidence of 
Registrant's compliance (or non-compliance) with laws related to 
controlled substances and experience dispensing controlled substances 
in determining whether Registrant's continued registration is 
``consistent with the public interest.'' 21 U.S.C. 824(a)(4). ``[A] 
registrant's `ignorance of the law is no excuse' for actions that are 
inconsistent with responsibilities attendant upon a registration.'' 
Daniel A. Glick, D.D.S., 80 FR 74,800, 74,809 (2015) (quoting Sigrid 
Sanchez, M.D., 78 FR 39,331, 39,336 (2013)). Instead, ``[a]ll 
registrants are charged with knowledge of the CSA, its implementing 
regulations, as well as applicable state laws and rules.'' Id. at 
74,809 (internal citations omitted). Further, the Agency has 
consistently concluded that a pharmacy's registration is subject to 
revocation due to the unlawful activity of the pharmacy's owners, 
majority shareholders, officers, managing pharmacist, or other key 
employee. EZRX, LLC, 69 FR 63,178, 63,181 (2004); Plaza Pharmacy, 53 FR 
36,910, 36,911 (1988).
    In support of its contention that Registrant's continued 
registration is inconsistent with the public interest, the Government 
has alleged that Registrant violated several federal laws related to 
controlled substances. Specifically, the Government has alleged that 
Registrant violated its recordkeeping obligations under the CSA, as 
implemented in 21 CFR 1304.22(c), to maintain accurate inventories of 
its controlled substances. The Government also alleged that Registrant 
violated 21 CFR 1301.71 and 1301.76 by failing to adequately secure its 
controlled substances and failing to timely notify DEA after Registrant 
discovered it was missing controlled substances.

A. Recordkeeping Allegations

    Recordkeeping is one of the CSA's principal tools for preventing 
the diversion of controlled substances. Grider Drug 1 & Grider Drug 2, 
77 FR 44,070, 44,100 (citing Paul H. Volkman, 73 FR 30,630, 30,644 
(2008)). 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 30,644. 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). The CSA's implementing regulations specify at 21 CFR 
1304.22(c) the records that a dispenser, such as Registrant, is 
required to maintain regarding the controlled substances it receives 
and dispenses.
    Registrant's records were audited twice by DEA--on June 1, 2017 and 
September 18, 2017--and once by an auditor hired by Registrant in 
December 2017. As Registrant admitted in its MOA with the Government, 
each audit found significant shortages in Registrant's inventories of 
controlled substances. A shortage in an inventory audit of controlled 
substances occurs when a pharmacy is unable to account for all of the 
controlled substances it should have in its inventory.
    It is clear from the shortages that Registrant was not maintaining 
required records. Accordingly, I find the unrefuted evidence supports a 
finding that Registrant violated its recordkeeping obligations under 
the CSA. This finding weighs against entrusting Registrant with a 
registration.

B. Security Controls Allegations

    The Government alleged that Registrant violated 21 CFR 1301.71 and 
1301.76(b) by failing to promptly report the loss of 47,000 tablets of 
oxycodone 30mg to DEA. 21 1301.76(b) requires registrants to notify its 
area DEA Field Division Office of ``the theft or significant loss of 
any controlled substances within one business day of discovery of such 
loss or theft'' and to submit a DEA Form 106 regarding the loss or 
theft. The regulation provides factors to determine whether a loss is 
``significant,'' which include ``the actual quantity of controlled 
substances lost in relation to the type of business,'' and ``[w]hether 
the loss of the controlled substances can be associated with access to 
those controlled substances by specific individuals.'' 21 CFR 
1301.76(b).
    Registrant admitted that it became aware of the loss of 47,000 
tablets of oxycodone 30mg in May 2017. The loss of such a large number 
of tablets of oxycodone, a schedule II controlled substance, is clearly 
significant under the factors listed in 21 CFR 1301.76(a). Registrant 
was required to report this significant loss of controlled substances 
within one business day of discovering the loss. Registrant, however, 
did not file a DEA 106 notice of theft or loss until June 14, 2017, 
after DEA conducted its own inspection of Registrant. Registrant's 
failure to notify DEA of the significant loss of controlled substances 
within one business day of discovering the loss was a violation of 21 
CFR 1301.76(b) and a violation of 21 CFR 1301.71, which requires all 
registrants to provide ``effective controls and procedures to guard 
against theft and diversion of controlled substances'' as set forth in 
1301.72-76.
2. Factor Five--Such Other Conduct Which May Threaten Public Health and 
Safety
    Under Factor Five, the Administrator is authorized to consider 
``[s]uch other conduct which may threaten the public health and 
safety.'' 5 U.S.C. 823(f)(5). 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 64,131, 64,141 
(2012) (citing Tony T. Bui, 75 FR 49,979, 49,988 (2010)). As the Agency 
has previously stated, ```[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 49,704, 
49,725 n.43 (2017) (quoting Paul J. Caragine, Jr. 63 FR 51,592, 51,601 
(1998)).
    The uncontested evidence in this case shows that Registrant was 
losing large quantities of controlled substances from its inventory and 
that these losses continued even when Registrant knew about the losses 
and therefore could have taken measures to stop them. After the DEA's 
June 2017 audit, Registrant was unquestionably aware that it was losing 
large quantities of controlled substances, but the DEA's September 2017 
audit and the December 2017 audit conducted by Registrant's auditor 
show that Registrant continued to lose significant quantities of 
controlled substances throughout 2017. Furthermore, Registrant's 
employees had reported at least three incidents to Registrant's owner 
where it appeared to the employee that M.B. had stolen controlled 
substances from Registrant or where the employee had thwarted M.B.'s 
attempt to steal controlled

[[Page 63583]]

substances from the pharmacy. DEA also told Registrant on three 
separate occasions that there was a reasonable basis to believe that 
M.B. was diverting controlled substances. Despite these reports, 
Registrant continued to employ M.B. until at least February 2018.
    There is also no evidence on the record that Registrant took any 
real measures to increase security at the pharmacy or otherwise stop 
the losses. Registrant's owner told DEA on June 1, 2017, that 
Registrant was in the process of taking additional security measures--
namely ordering a safe to store controlled substances and taking daily 
inventories of controlled substances--and that M.B. no longer worked at 
Registrant. RFAAX 15, at 2. Registrant's PIC, however, told DEA on July 
27, 2017, that Registrant's narcotics were being stored in an unlocked 
case and that any pharmacy employee could change the inventory 
quantities in Registrant's computer. RFAAX 11 (text messages between 
PIC and DEA TFO). Registrant also admitted that ``[n]either of these 
alleged additional safeguards were effective, as the controlled 
substances continued to be stored in such a way that all employees have 
access to them, and the daily inventories were conducted in such a way 
that any employee could alter the inventory.'' RFAAX 12, at 2 
(admitting to the factual allegations in paragraphs 2-8 of the OSC); 
OSC, at 4. Furthermore, PIC Clark told the DEA that, as of July 27, 
2017, M.B. was working as a pharmacy tech at Registrant. RFAA 11. 
Registrant confirmed that M.B. was still employed by Registrant in 
meetings with DEA on January 8, 2018 and February 7, 2018. RFAAX 15, at 
4.
    ``[A] DEA registrant is obligated at all times to act in the public 
interest.'' Peter F. Kelly, D.P.M., 82 FR 28,676, 28,688 (2017). 
Registrant's failure to take action to stop the illicit flow of 
controlled substances out of the pharmacy was a breach of its duty as a 
registrant to act in the public interest. Moreover, it likely permitted 
the additional diversion of hundreds (if not thousands) of units of 
controlled substances. I, therefore, find that Registrant's failure to 
stem the known diversion of controlled substances from its inventory 
constitutes ``conduct which may threaten the public health and 
safety.'' 21 U.S.C. 823(f)(5).
    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.

III. 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 
18,882, 18,910 (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 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 23,853; John 
H. Kennnedy, M.D., 71 FR 35,705, 35,709 (2006); Prince George Daniels, 
D.D.S., 60 FR 62,884, 62,887 (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).
    Registrant accepted responsibility for most of its misconduct in 
the MOA, in which it admitted to many of the factual allegations in the 
OSC in exchange for certain agreements from the Government. Registrant, 
however, did not present any evidence of remorse for its past 
misconduct and did not provide any assurances that it would not engage 
in such conduct in the future. Further, it provided no evidence of 
rehabilitative actions taken to correct its past unlawful behavior, 
except an agreement from the Owner, in her individual capacity, that 
``she will not serve as an officer, partner, stockholder, proprietor, 
owner, partial owner, or pharmacist in charge of any entity that either 
possesses or is seeing a DEA Certificate of Registration'' for so long 
as the MOA between the Government and Registrant remains in effect. 
Absent such evidence and such assurances in this matter, I find that 
continued registration of Registrant is inconsistent with the public 
interest. Registrant's silence weighs against its continued 
registration. Zvi H. Perper, M.D., 77 FR 64,131, 64,142 (2012) (citing 
Med. Shoppe-Jonesborough, 73 FR at 387); see also Samuel S. Jackson, 72 
FR 23,848, 23,853 (2007).
    Accordingly, I find that the factors weigh in favor of sanction and 
I shall order the sanction the Government requested, as contained in 
the Order below.

IV. 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 
BW8625785 issued to Wayne Pharmacy. This Order is effective November 9, 
2020.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-22216 Filed 10-7-20; 8:45 am]
BILLING CODE 4410-09-P