Ester Mark, M.D.; Decision and Order, 16760-16783 [2021-06583]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Notices]
[Pages 16760-16783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06583]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-45]


Ester Mark, M.D.; Decision and Order

    On July 7, 2017, a former Assistant Administrator of the Drug 
Enforcement Administration (hereinafter, DEA or Government), issued an 
Order to Show Cause (hereinafter, OSC) to Ester Mark, M.D., 
(hereinafter, Respondent) of Newport Beach, California. Administrative 
Law Judge Exhibit 1, (OSC) at 1. The OSC proposed to revoke her DEA 
Certificate of Registration (hereinafter, COR) No. BM5370123, and deny 
her pending application COR No. W15069021C pursuant to 21 U.S.C. 823(f) 
and 824(a)(4) for the reason that Respondent's ``continued registration 
is inconsistent with the public interest.'' Id.
    In response to the OSC, Respondent timely requested a hearing 
before an Administrative Law Judge. ALJ-2. The hearing in this matter 
was held in Santa Ana, California, on January 23-24, 2018. On April 5, 
2018, Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ) 
issued Recommended Rulings, Findings of Fact, Conclusions of Law and 
Decision (hereinafter, Recommended Decision or RD), and on May 9, 2018, 
the Respondent filed exceptions (hereinafter, Resp Exceptions) to the 
Recommended Decision. The Government did not file any exceptions to the 
Recommended Decision or a response to Respondent's exceptions. Having 
reviewed the entire record, I find the Respondent's Exceptions without 
merit and I adopt the ALJ's rulings, findings of fact, as modified, 
conclusions of law and recommended sanction with minor modifications, 
where noted herein.*A
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    \*A\ I have made minor modifications to the RD. I have 
substituted initials or titles for the names of witnesses and 
patients to protect their privacy and I have made minor, 
nonsubstantive, grammatical changes. Where I have made substantive 
changes, omitted language for brevity or relevance, or where I have 
added to or modified the ALJ's opinion, I have noted the edits with 
an asterisk, and I have included specific descriptions of the 
modifications in brackets following the asterisk or in footnotes 
marked with an asterisk and a letter.

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[[Page 16761]]

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. 
BM5370123 issued to Ester Mark, M.D. Further, pursuant to 28 CFR 
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby 
deny the pending application, control number W15069021C, for renewal or 
modification of this registration, as well as any other pending 
application by Ester Mark, M.D., for registration in Florida or 
California. This Order is effective April 30, 2021.

D. Christopher Evans,
Acting Administrator.

The Respondent's Exceptions

    Respondent filed Exceptions to the RD on May 9, 2018. Exceptions 
``shall include a statement of supporting reasons for such exceptions, 
together with evidence of record (including specific and complete 
citations of the pages of the transcript and exhibits) and citations of 
the authorities relied upon.'' 21 CFR 1316.66. For the most part, the 
Respondent's Exceptions not only fail to comply with this regulatory 
requirement, but also lack evidentiary support in the Administrative 
Record. I am addressing some of these Exceptions in the beginning and 
have included some throughout the record where relevant. Others are 
repetitive of Respondent's Post-Hearing Brief and were addressed by the 
ALJ in the adopted Recommended Decision herein.

Respondent's Exceptions to the Findings of Fact

    The Respondent lists sixty-eight ``Proposed Findings of Fact,'' 
which fall in two categories: Proposed findings that mirror those made 
by the ALJ, and those that supplement the findings of fact made by the 
ALJ. As to the former, the Respondent, in essence, adopts the ALJ's 
findings of fact. Consequently, I decline to consider those proposed 
findings, if intended as exceptions. As to the latter, I reject the 
Respondent's proposed factual findings that differ from those made by 
the ALJ.*B Those findings conflict with the Respondent's 
pre-hearing stipulations, lack evidentiary support in the 
Administrative Record, have no relevance to the allegations sustained 
by the ALJ, or constitute arguments rather than factual allegations.
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    \*B\ Specifically, I reject the following proposed findings of 
fact as there is no evidence in the record to support them or 
because they were irrelevant: Law enforcement personnel executed a 
search warrant at her residence on June 12, 2014 (Resp Exceptions, 
Proposed Finding of Fact I.6, at 5); testosterone is a Schedule IV 
controlled substance (id. at I.13.5); Respondent's office ``was a 
separate, closed of [sic] area from where patients were seen'' (id. 
at 5)(the record does not support this finding--her sworn statement 
says she sees them ``in my--you know, downstairs'' GE-12, at 34); 
the Respondent's husband agreed to purchase a safe (Resp Exceptions, 
Proposed Finding of Fact II.8, at 6); with the exception of the 
first sentence, the Respondent's discussion of patient charts (Resp 
Exceptions, Proposed Finding of Fact II.13, at 6-7); the Respondent 
provided investigators a dispensing log (Resp Exceptions, Proposed 
Finding of Fact II.14, at 7); the Government did not introduce in 
evidence a property receipt for invoices (Resp Exceptions, Proposed 
Finding of Fact II.18, at 7); investigators neglected to determine 
the expiration dates of the controlled substances they inventoried 
(Resp Exceptions, Proposed Finding of Fact II.19, at 7); reference 
to the Respondent's Medical Board interview (Resp Exceptions, 
Proposed Finding of Fact II.22, at 8); the Respondent called the 
pharmacy to order medications (Resp Exceptions, Proposed Finding of 
Fact III.3, at 8); the investigator never mentioned prescriptions 
(Resp Exceptions, Proposed Finding of Fact III.6, at 9); the 
Government did not introduce in evidence the search warrant (Resp 
Exceptions, Proposed Finding of Fact IV.1, at 9); the Government 
took an additional inventory for which it did not include a property 
receipt--the receipt is found in GE-14 for the inventory referenced 
in the cited transcript pages (Resp Exceptions, Proposed Finding of 
Fact IV.6, at 10); records of medications ordered by the Respondent 
(Resp Exceptions, Proposed Finding of Fact V.2, at 11); the 
respondent's discussion about the standard of care in California 
(Resp Exceptions, Proposed Finding of Fact V.4--V.9, at 11); the 
prescriptions in Exhibit 7 did not include any prescriptions written 
by the Respondent (Resp Exceptions, Proposed Finding of Fact V.10, 
at 11); the Respondent's discussion about dosing instructions (Resp 
Exceptions, Proposed Finding of Fact V.11, at 11); seven 
prescriptions were not obtained outside the California standard of 
care (Resp Exceptions, Proposed Finding of Fact V.12, at 12); the 
Respondent's discussion about E-Compounding and corresponding 
responsibility (Resp Exceptions, Proposed Finding of Fact V.13, at 
12); and the Respondent's discussion about Dr. Munzing's expert 
testimony (Resp Exceptions, Proposed Finding of Fact V.14, at 12).
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    Lastly, the Respondent's proposed findings of fact omit many 
factual findings made by the ALJ. To the extent Respondent intended 
such omissions as exceptions to those factual findings, I reject those 
exceptions, having concluded that the Administrative Record supports 
the ALJ's factual findings, as modified by this Decision and Order.

Storage Violations

    The ALJ sustained the allegation that Respondent violated 21 CFR 
1301.75(b). RD, at 33. Although the controlled substances observed in 
Respondent's office on two occasions were not stored in a securely 
locked, substantially constructed cabinet, as required by 21 CFR 
1301.75(b), Respondent argues that her extra security measures 
demonstrate substantial compliance with this regulation. Resp 
Exceptions, at 13-17. She further argues that DEA has not established 
prima facie case on this allegation due to the absence of evidence 
regarding whether her office door had a lock. Id. Respondent refers to 
her sworn interview, where she described a variety of security measures 
on her home and office, but the ALJ concluded that the probative value 
of such testimony is substantially diminished because the DEA was not a 
party to the proceeding. RD, at 31, n.14. The ALJ also determined that 
any evidence of an office door lock would be inconsequential, where the 
room was not set aside solely for the storage of controlled substances. 
Id. at 31. I agree with the ALJ's decision as outlined below, and I 
note that in particular, even if the Respondent could claim confusion 
as to whether her storage of controlled substances provided adequate 
security to be in compliance with the regulatory requirements, the 
record supports a finding that she was told by DEA and state 
investigators very clearly on several occasions that it was not. See 
e.g., GE-12, at 79 (transcript of sworn interview on April 4, 2014, 
``just so you know, the Federal regulations require that they be stored 
in a metal locked cabinet''); see also Tr. 23, 36, 130 (DEA and state 
investigators testifying that Respondent was told on March 14, 2014, to 
purchase a safe to store the controlled substances). Despite being told 
repeatedly that her security was not adequate, at the time that the 
search warrant was executed on June 13, 2014, Respondent had done 
nothing to further secure the controlled substances.*\C\
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    \*\ \C\ Additionally, the unrebutted evidence regarding 
Respondent's other violations of law are enough to support the 
finding that Respondent's continued registration is inconsistent 
with the public interest.
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Recordkeeping and Prescribing

    Respondent contends that state and federal investigators ``never 
told [her] or advised [her] to make sure [she] had an inventory readily 
available.'' Id. at 18. The regulations clearly require that Respondent 
maintain an inventory, and furthermore, that ``every inventory and 
other records required to be kept under this part must be kept by the 
registrant and be available, for at least 2 years from the date of such 
inventory or records, for inspection and copying by authorized 
employees of the Administration.'' 21 CFR 1304.04. Respondent never 
produced an inventory as the regulations required. Respondent contends 
in her Exceptions

[[Page 16762]]

that DEA and state investigators should have ``help[ed] her fix [her] 
mistakes or give[n her] a deadline to update [her] recordkeeping.'' 
Resp Exceptions, at 18. DEA's statutory mandate is to ensure compliance 
with the CSA and its implementing regulations. Respondent showed little 
aptitude for coming into compliance given that she did not secure her 
controlled substances after repeated notifications that the storage was 
not adequate.
    Respondent also contends that she keeps dispensing records both in 
the log that she introduced and also in her patient files; however, she 
introduced no patient files to explain the discrepancies in her stock 
of controlled substances. Id. at 19. I find that the ALJ addressed all 
of the arguments in Respondent's Exceptions related to the dispensing 
logs herein.
    Regarding her prescribing practices, Respondent contends that the 
AMA Code of Ethics ``does not forbid practitioners from treating 
themselves nor prescribing controlled substances. In general, 
physicians should not treat themselves or members of their own 
families, but it is acceptable in some circumstances.'' Id. at 23. She 
then lists circumstances where it might be appropriate to so prescribe, 
none of which have any relevance here, because she has presented no 
evidence on the record as to her rationale for issuing the 
prescriptions to her husband, and she failed to maintain proper 
documentation supporting those prescriptions by which their legitimacy 
could be assessed. See FF 45. Additionally, even if there were a 
legitimate reason for her to have prescribed to her husband, there is 
more than enough evidence that Respondent issued these prescriptions 
outside the usual course of the professional practice and beneath the 
standard of care due to the fact that she violated state law in both 
not documenting a physical examination and not maintaining a medical 
file on her husband. See infra Discussion.

Pill Count

    Respondent argues that all of the pill counts were inaccurate. Resp 
Exceptions, at 27. She states, ``For example, the agents failed to 
recognize the different dosages of the same medication, which amounted 
in a larger amount of pills for the same medication (Temazepam 15 mg & 
30 mg) in the first count compared to the second count.'' Id. However, 
Temazepam is listed on the first count, at 30 mg, see GE-3, at 1, and 
the second count for Temazepam lists both 15 mg and 30 mg, see GE-14, 
at 11, and the different dosages on GE-14 include different 
corresponding National Drug Code (NDC) numbers; therefore, I see no 
evidence to support her claim that the counts were inaccurate. Further, 
even if the two dosages had been conflated during the first search, she 
would still have an unexplained shortage. It is also noted that 
Respondent argues that the Government's Exhibit 14 is ``not signed, 
dated or witnessed;'' however, the first page of the exhibit includes a 
signed, dated and sworn statement of the ``itemized and individually 
described account of evidence seized . . . .'' GE-14, at 1.
    Finally, Respondent contends that the investigators counted more 
Apap Codeine in GE-14 than in GE-3, and that ``[o]nly mistakes could 
logically account for an in increase in the same medication at the 
second count.'' It is illogical to assume that only a mistake in the 
count could explain an overage. The record reflects other overages, so 
Respondent could have acquired additional controlled substances between 
the two searches. See infra n.30. Additionally, the reason that it is 
difficult to determine the cause for the overages is that Respondent's 
recordkeeping was inadequate, which is also the reason why the overages 
and shortages are relevant to this case.

Statute of Limitations

    The Respondent seeks to apply a five-year statute of limitations to 
this proceeding and cites 18 U.S.C. 3282, 19 U.S.C. 1621 and 28 U.S.C. 
2462.*D Resp Exceptions, at 32. However, none of these 
provisions apply. Prior agency decisions have long stated that neither 
the law nor federal regulations governing DEA administrative 
adjudications prescribe a statute of limitations. See Edmund Chein, 
M.D., 72 FR 6580, 6590 n.17 (2007) (``there is no statute of 
limitations applicable to these proceedings, which are remedial in 
nature and are instituted to protect the public interest''); see also 
Pettigrew Rexall Drugs, 64 FR 8855, 8859 (1999). Additionally, 
Respondent argues that the time lapse in the investigation ``does not 
align with the DEA being concerned with [Respondent's] prescribing 
behavior or misconduct,'' and she points out that she was allowed to 
renew her registration during the investigation. Resp Exceptions, at 
33. However, the agency has clear discretion regarding whether to bring 
an enforcement action, and it defies reason to construe the fact that 
the agency permitted Respondent to continue to prescribe during the 
pendency of the investigation, before giving her procedural due 
process, to imply that no violation occurred. See Frank Joseph 
Stirlacci M.D., 85 FR 45,229, 45,236 (2019).
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    \*D\ Respondent also cites ``USCA Sec. 525'', but it is unclear 
to which law she is referring.
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Accepting Responsibility

    Respondent contends that she ``clearly accepted responsibility and 
demonstrated remedial measures when she stopped ordering from E-
Compounding pharmacies, storing controlled substance, prescribing 
controlled substances to family members, and self-prescribing, as well 
as when she closed her practice to work as a medical director for 
another practice without prescribing controlled substances and 
improving her recordkeeping to meet the proper requirements of federal 
and state laws . . . .'' Resp Exceptions, at 2. Respondent presented no 
evidence establishing these remedial measures on the record and did not 
testify regarding the allegations. Furthermore, even in making these 
written statements, Respondent has not accepted responsibility for her 
actions. Even if I fully considered her post-hearing, off-the-record 
statement that she ``accept[s] full responsibility for being less than 
accurate in [her] recordkeeping duties during the time [she] was 
dispensing to patients,'' her recordkeeping violations were not limited 
to dispensing and she makes no attempt at taking responsibility for her 
other violations of law. Furthermore, she passes blame on DEA for not 
telling her how to comply with recordkeeping requirements, id. at 18, 
and she passes blame on the pharmacy for filling her ``office use'' 
prescriptions, id. at 26. I find that there is no adequate or credible 
acceptance of responsibility on the record and I further find that the 
ALJ appropriately considered Respondent's lack of acceptance of 
responsibility in his sanction recommendation. See Pharmacy Doctors 
Enterprises, Inc. v. Drug Enf't Admin., 789 F. App'x 724, 732 (2019); 
Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 
823, 830 (11th Cir. 2018) (citing MacKay v. Drug Enf't Admin., 664 F.3d 
808, 820 (10th Cir. 2011) (``The DEA may properly consider whether a 
physician admits fault in determining if the physician's registration 
should be revoked.'')); see also Jeffrey Stein, M.D., 84 FR 46,968, 
46,972-73 (2019) (unequivocal acceptance of responsibility); Jayam 
Krishna-Iyer, M.D., 74 FR 459, 463 (2009) (collecting cases).
    The issue before the Administrator is whether the record as a whole

[[Page 16763]]

establishes that it would be inconsistent with the public interest 
under 21 U.S.C. 824(a)(4) and 823(f) to allow Respondent to retain her 
DEA COR and/or to grant her pending application.
    The decision below is based on my consideration of the entire 
Administrative Record, including all of the testimony, admitted 
exhibits, and the oral and written arguments of counsel. I adopt the 
ALJ's Recommended Decision with noted modifications.

Paul A. Dean, Esq. and John E. Beerbower, Esq., for the Government
Ester Mark, M.D., for the Respondent

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

The Allegations

    1. On March 13, 2014, DEA investigators served an Administrative 
Inspection Warrant (``AIW'') at Respondent's then-registered address: 
22391 Sunbrook, Mission Viejo, California 92692. Then on June 13, 2014, 
DEA investigators, in conjunction with investigators from the 
California Medical Board, (``Medical Board'') *E executed a 
search warrant at the same location. On both dates, investigators found 
a variety of controlled substances located on open shelves, on top of 
the office copier, and in unlocked glass cabinets. In addition, on June 
13, 2014, the investigators also found marijuana in Respondent's home. 
Respondent's COR did not authorize her to possess marijuana. Further, 
investigators could not lock the door to Respondent's office. None of 
the controlled substances found at Respondent's registered address were 
secured in a locked cabinet, in violation of 21 CFR 1301.75(a) and (b). 
ALJ-1, at 2, para. 3, 5.
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    \*E\ The Medical Board also assisted in the execution of the 
March 13, 2014 AIW.
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    2. In association with the March 13, 2014 AIW, investigators 
attempted to conduct a physical inventory of the controlled substances 
located at Respondent's registered location. The investigators were not 
able to locate an initial inventory or a biennial inventory. The only 
records Respondent was able to provide were invoices from May 23, 2013, 
through March 13, 2014. Therefore, Respondent did not maintain complete 
and accurate records, including receiving records (such as DEA 222 
Forms), dispensing logs, or the required inventories, in violation of 
state and federal law. In addition, at the time of the execution of the 
search warrant on June 13, 2014, Respondent did not maintain any of 
these required records. ALJ-1, at 2, para. 4, 5.
    3. There were differences in the inventories of the controlled 
substances found in Respondent's office on March 13, 2014, and June 13, 
2014. Specifically, the following items were missing without any record 
of their dispensation: 25 Alprazolam 1 mg, 30 count bottles; 10 
Clonazepam 1 mg, 30 count bottles; 3 Diethylpropion HCI 25 mg, 28 count 
bottles; 3 Hydrocodone 10/325 mg, 30 count bottles; 2 Hydrocodone/IBU 
7.5/200 mg, 30 count bottles; 64 Phentermine 37.5 mg, 30 count bottles; 
3 Temazepam 30 mg, 30 count bottles; 12 Zolpidem 10 mg, 30 count 
bottles; and 10 vials of various anabolic steroid and testosterone-
related products. Respondent was unable to account for the 
discrepancies through the production of required dispensing logs. ALJ-
1, at 3, para. 6.
    4. During the search on June 13, 2014, investigators found 
prescription bottles in Respondent's possession bearing the names of at 
least five other individuals. The bottles were located on her office 
desk, in violation of the California Health and Safety Code Sec.  
11350, and 21 CFR 1306.04. Specifically, the following controlled 
substances issued to other individuals were discovered: Alprazolam 2 mg 
(90 dosage units) issued to L.F.; Testosterone cypionate (1 bottle 2500 
mg/10 mL) issued to B.S.; Testosterone cypionate (1 bottle 1000 mg/10 
mL) issued to B.S.; Testosterone cypionate (1 vial 200 mg) issued to 
B.S.; Testosterone cypionate (3 bottles 2500 mg/10 mL) issued to D.V.; 
Xanax 2 mg (15 dosage units) issued to J.W.; Testosterone cypionate (1 
vial 200 mg/10 mL) issued to J.W.; and Xanax 2 mg (15 dosage units) 
issued to D.D. ALJ-1, at 3, para. 7.
    5. Between February 16, 2010, and July 13, 2015, Respondent 
unlawfully issued over 75 prescriptions for controlled substances that 
were for other than a legitimate medical purpose or outside the usual 
course of professional practice. Specifically, Respondent illegally 
prescribed controlled substances to herself and to her current husband, 
S.P., as set forth below:
    a. Between February 16, 2010, and November 29, 2012, Respondent 
unlawfully issued at least 40 prescriptions to herself for controlled 
substances ``for office use'' in violation of the California Health and 
Safety Code Sec.  11170 and 21 CFR 1306.04(a) and (b). ALJ-1, at 3, 
para. 8(a).
    b. Respondent issued at least 35 prescriptions to her husband, 
S.P., outside the usual course of professional practice or for other 
than legitimate medical purposes in violation of state and federal law. 
From April 21, 2012, through June 12, 2014, Respondent issued 
prescriptions to S.P. without any documentation or examination. 
California regulations explicitly provide that the failure to medically 
evaluate a patient to determine his or her need for a controlled 
substance before prescribing a controlled substance, or to document 
such an evaluation in the patient's records, means that the physician 
is not prescribing in the usual course of professional practice. 
Respondent's actions violated state and federal law. ALJ-1, at 3-4, 
para. 8(b).
    6. Respondent also engaged in other conduct which may threaten the 
public health and safety in violation of 21 U.S.C. 823(f)(5). 
Specifically, Respondent displayed a lack of candor during DEA's 
investigation. In March 2014, Respondent told DEA investigators that 
patient files they requested ``were not there,'' and that at least some 
of the missing files were at a location in Lake Forest, California, for 
which she did not know the address. During subsequent questioning, 
Respondent again stated that the charts requested by the DEA were at 
another location, but she did not know the location. Respondent also 
stated that the dispensing log that DEA requested was actually with the 
missing charts. In fact, the charts in question, and the dispensing 
log, did not exist. Then in June 2014, Respondent told a Medical Board 
investigator that she did not know who owned the marijuana that was 
found in a suitcase in the garage of her registered location. She made 
this statement despite the fact that additional stashes of marijuana 
and large amounts of cash were discovered throughout her registered 
location, and she and her husband were the only individuals who lived 
there. ALJ-1, at 4, para. 9.

Witnesses

I. The Government's Witnesses

    The Government presented its case through the testimony of five 
witnesses. First, the Government presented the testimony of a Diversion 
Investigator (hereinafter, DI 1). Tr. 13-61, 317-319. DI 1 has been a 
Diversion Investigator for 14 years, and has been assigned to the DEA 
office in Riverside, California, for the past 7 years. Id. at 14. DI 1 
provided testimony concerning her training and duties as a Diversion 
Investigator. Id. at 14-17. DI 1 began an investigation of Respondent 
after the DEA had received a complaint. Id. at 18. In the initial 
stages of the investigation, DI 1 conducted a search of the California 
prescription monitoring program (``PMP''), called CURES. Id.

[[Page 16764]]

That search revealed that Respondent had written prescriptions to 
herself and to her family members. Id. DI 1 then contacted the Medical 
Board and requested the issuance of an Administrative Inspection 
Warrant (``AIW''). Id. at 19. Subsequently, DI 1 participated in the 
execution of the AIW, and later the execution of a search warrant at 
Respondent's home, which also doubled as her registered location. Id. 
at 19, 37. DI 1 provided testimony concerning the execution of the AIW 
and the search warrant and what was requested of Respondent, and what 
was found at Respondent's home during the AIW and the search warrant. 
Id. at 19.
    I find DI 1's testimony to be thorough, detailed, and internally 
consistent. Therefore, I merit it as credible in this Recommended 
Decision.
    Second, the Government presented the testimony of a Special Agent 
of the California Department of Justice (hereinafter, SA 1). Id. at 63-
101. SA 1 has held her current position since July 2014. Id. at 63. 
Prior to her current position, and during the relevant period of this 
case, SA 1 had been an investigator for the Medical Board from October 
2009 until July 2014. Id. SA 1 received specialized training to serve 
as an investigator for the Medical Board. Id. at 64. SA 1 provided 
testimony concerning her participation with the DEA during the 
execution of the AIW and the search warrant. Id. at 65-68, 80-99. SA 1 
also testified concerning an interview she conducted with Respondent on 
April 4, 2014. Id. at 69-80.
    I find SA 1's testimony to be thorough and internally consistent. 
Therefore, I merit SA 1's testimony as credible in this Recommended 
Decision.
    The third Government witness was a Special Agent with the 
California Department of Justice (hereinafter, SA 2). Id. at 103-19. SA 
2 had been a Special Agent for three years, and prior to that he served 
as an investigator with the Medical Board. Id. at 104. SA 2 provided 
testimony concerning his participation in the execution of the AIW as 
well as the execution of the search warrant. Id. at 105-12, 116-17. SA 
2 also testified concerning records he obtained from the E-Compounding 
Pharmacy and other pharmacies concerning prescriptions Respondent had 
written. Id. at 113-16.
    I find SA 2's testimony to be thorough and internally consistent. 
Therefore, I merit SA 2's testimony as credible in this Recommended 
Decision.
    The fourth witness the Government called to testify was a second 
Diversion Investigator (hereinafter, DI 2). Id. at 120-36, 321. DI 2 
has been a diversion investigator for five years, after having been 
employed by DEA in other capacities. Id. at 120-21. DI 2 attended 12 
weeks of diversion investigator training at Quantico, Virginia, 
following that training he was assigned to the DEA office in Riverside, 
California. Id. at 121. DI 2 provided testimony concerning his 
participation in the execution of the AIW, noting what he observed and 
statements made by Respondent during the AIW. Id. at 121-30. He also 
testified concerning his participation in the execution of the search 
warrant, noting what he observed and statements made by Respondent 
during the search. Id. at 130-32.
    I find DI 2's testimony to be thorough and internally consistent. 
Therefore, I merit DI 2's testimony as credible in this Recommended 
Decision.
    Finally, the Government presented the testimony of Dr. Timothy 
Munzing, M.D. (hereinafter, Dr. Munzing). Id. at 158-295. Dr. Munzing 
is currently a family physician and the Director of the Family Medicine 
Residency Program at Kaiser Permanente Orange County. Id. at 158-59. 
Government Exhibit 9 is a copy of Dr. Munzing's curriculum vitae. Id. 
at 163-64. Dr. Munzing obtained his medical degree from the UCLA School 
of Medicine in 1982, followed by a three-year residency in family 
medicine. Id. at 159. Dr. Munzing is licensed to practice medicine in 
California and he is board-certified in family medicine. Id. at 159, 
163. Dr. Munzing is a full clinical professor at UC-Irvine College of 
Medicine, where he has taught medical students for 25 years. Id. at 
160-61, 166. Dr. Munzing was accepted as an expert, without objection, 
in the field of ``primary care and family medicine, pain management and 
prescribing controlled substances with respect to the standard of care 
in the state of California.'' Id. at 171.
    Dr. Munzing testified about the standard of care in California. Id. 
at 174-80. He specifically testified that a doctor who does not 
maintain a medical record of his or her patient violates the standard 
of care in California by issuing a prescription for a controlled 
substance to that patient. Id. at 176, 178-80. Thus, the prescriptions 
Respondent wrote to her husband, without having a medical chart for her 
husband, fell outside the standard of care. Id. at 182-99. Dr. Munzing 
also testified that the California standard of care provides that a 
doctor cannot self-prescribe or issue prescriptions for office use. Id. 
at 200-01, 229, 289. Thus, the prescriptions that Respondent wrote to 
herself or for office use also fell outside the standard of care. Id. 
at 203-23, 225-28, 243-44.
    I find Dr. Munzing's testimony to be thorough, detailed, and 
internally consistent.*F Therefore, I merit it as credible 
in this Recommended Decision.
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    \*F\ [Respondent questioned Dr. Munzing's credibility in her 
Exceptions. Resp Exceptions, at 31. The fact that Dr. Munzing has 
testified for DEA in previous cases does not alter the finding that 
his testimony in this case was credible and unrebutted. Most of the 
allegations in this case were proven by Respondent's recordkeeping 
failures, and were not reliant solely on Dr. Munzing's testimony 
regarding the standard of care. Her prescribing to her husband 
lacked any documentation at all on which to assess the legitimacy of 
those prescriptions. She alleged that the ``Government did not 
provide sufficient evidence for the expert witness to conclude if 
[Respondent's] prescribing [was] unlawful,'' id., but her failure to 
maintain records resulted in no evidence to conclude that her 
prescribing was lawful and that failure by itself violated state law 
and the standard of care. I reject her Exceptions as to Dr. 
Munzing's credibility and the basis of his opinions.]
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II. The Respondent's Witness

    Respondent presented her case through her own testimony, which she 
limited to the identification of two documents. Id. at 302-13. Through 
her testimony, Respondent offered a copy of her dispensing log that was 
seized during the search of her home on June 13, 2014. Id. at 306; RE-
1. Respondent also offered a copy of her Florida medical license, which 
had expired in January 2017. Tr. 307; RE-2.
    While Respondent's testimony laid the foundation for the admission 
of her two exhibits, on cross-examination her answers were somewhat 
combative, confusing, and evasive. For example, Respondent was asked in 
several different ways whether she had provided DEA with her dispensing 
log in March 2014, and she avoided actually answering the question, 
finally stating ``I don't recall.'' Tr. 309-12. Respondent also clearly 
distorted the facts when she testified that Respondent's Exhibit 1 
concerned prescriptions between March 13, 2014, and June 13, 2014, 
because the first entry on the dispensing log is January 21, 2014. Id. 
at. 310-11; RE-1.*G Combativeness, confusion, and 
evasiveness tend to undermine the credibility of a witness, and they 
did with respect to Respondent's testimony that she was asked no 
questions by DEA on June 13, 2014. Tr. 312.
---------------------------------------------------------------------------

    \*G\ [Respondent took exception to this description of her 
statement, claiming that the earlier date coverage shows that the 
log ``is actually more inclusive.'' Resp Exceptions, at 20. However, 
she misses the ALJ's point that because the logs were created at an 
earlier date, they should have been made available to DEA in March 
of 2014.]
---------------------------------------------------------------------------

    When Respondent was asked if investigators requested a dispensing 
log on June 13, 2014, Respondent answered, ``[N]obody asked me 
anything. They broke down my door, I was detained. So there was no--
nobody asked me

[[Page 16765]]

anything.'' Id. at 312. DI 1, however, testified that she did ask 
Respondent for a dispensing log on that date. Id. at 39. DI 2 also 
believed that the DEA asked Respondent for her dispensing log on that 
date. Id. at 132. SA 1 also testified that Respondent had been asked 
questions about the location of the patient chart for Respondent's 
husband, and Respondent stated that the chart was in pieces around the 
house. Id. at 91. Thus, while I find Respondent's testimony credible on 
issues related to laying the foundation for the admission of 
Respondent's Exhibits 1 and 2, I do not find it credible concerning 
whether she was asked any relevant questions during the search of her 
home on June 13, 2014.
    The factual findings below are based on a preponderance of the 
evidence, including the detailed, credible, and competent testimony of 
the aforementioned witnesses, the exhibits entered into evidence, and 
the record before me.

The Facts

I. Stipulations

    The parties agreed to 14 stipulations (``Stip.''), which are 
accepted as facts in these proceedings:
    1. Respondent is registered with the DEA as a practitioner to 
handle Controlled Substances in Schedules II-V under DEA COR #BM5370123 
at Beautymark Wellness Center, 361 Hospital Road, Suite 324, Newport 
Beach, California 92663. This DEA COR is due to expire by its terms on 
January 31, 2018. ALJ-9, 24, 25.
    2. On August 5, 2015, Respondent sought to transfer her DEA 
registration to 8409 N. Military Trail, Suite 126, West Palm Beach, 
Florida 33410. DEA assigned control number W15069021C to Respondent's 
pending application for transfer. ALJ-9, 24, 25.
    3. Respondent is licensed to practice medicine in California under 
license number 55272. Respondent's California medical license is due to 
expire May 31, 2019. ALJ-9, 24, 25.
    4. On or about September 26, 2013, Respondent changed her DEA 
registration address to Beautymark Wellness Center, 22391 Sunbook 
(sic), Mission Viejo, California. On or about August 19, 2014, 
Respondent changed her DEA registration address to 361 Hospital Road, 
Suite 324, Newport Beach, California. ALJ-9, 24, 25.
    5. On or about March 13, 2014, law enforcement officials (including 
DEA investigators) served an administrative inspection warrant (AIW) at 
Respondent's then-registered address and residence, Beautymark Wellness 
Center, 22391 Sunbrook, Mission Viejo, California 92692. ALJ-9, 24, 25.
    6. On or about June 13, 2014, law enforcement officials (including 
DEA investigators) executed a search warrant at Respondent's then-
registered address and residence, Beautymark Wellness Center, 22391 
Sunbrook, Mission Viejo, California 92692. ALJ-9, 24, 25.
    7. DEA lists Alprazolam (Xanax) as a Schedule IV controlled 
substance. ALJ-44; Tr. 6.
    8. DEA lists Clonazepam (Klonopin) as a Schedule IV controlled 
substance. ALJ-44; Tr. 6.
    9. DEA lists Diethylpropion hydrochloride as a Schedule IV 
controlled substance. ALJ-44; Tr. 6.
    10. During the events at issue, DEA listed Hydrocodone as a 
Schedule III controlled substance. ALJ-44; Tr. 6.
    11. DEA lists Phentermine as a Schedule IV controlled substance. 
ALJ-44; Tr. 6.
    12. DEA lists Temazepam as Schedule IV controlled substance. ALJ-
44; Tr. 6.
    13. DEA lists Testosterone as a Schedule III controlled substance. 
ALJ-44; Tr. 6.
    14. DEA lists Zolpidem as a Schedule IV controlled substance. ALJ-
44; Tr. 6.

II. Findings of Fact

Administrative Inspection Warrant (``AIW'')

    1. DEA and Medical Board personnel participated in the execution of 
the AIW on March 13, 2014, at Respondent's home. Tr. 20, 65, 94.
    2. DI 1, SA 1, SA 2, and DI 2 participated in the execution of the 
AIW on March 13, 2014, at Respondent's home. Id. at 19, 65, 105, 121-
22.
    3. During the execution of the AIW, Respondent identified the area 
of her home that she used as her office. Id. at 22.
    4. During the execution of the AIW, multiple bottles of controlled 
substances were found on the desk, on the shelf, and on the printer in 
Respondent's office. Id. at 22, 66, 105-06, 123.
    5. The controlled substances found in Respondent's office were not 
secured in any way, and there did not appear to be any place to secure 
them in her office. Id. at 22, 66, 106, 124.
    6. Some of the controlled substances found in Respondent's home 
during the AIW were in prescription bottles that bore labels from 
commercial pharmacies, indicating that the prescriptions were for 
individuals who did not live in Respondent's home. Id. at 123-24.
    7. DI 1 did not notice a lock on Respondent's door. Tr. 39. SA 1 
does not believe there was a lock on Respondent's office door.\1\ Id. 
at 66-67.
---------------------------------------------------------------------------

    \1\ DI 2 testified that there may have been a lock on the door, 
but the door was wide open. Tr. 124.
---------------------------------------------------------------------------

    8. The DEA investigators requested that Respondent purchase some 
type of safe in which to store the controlled substances,\2\ and 
Respondent indicated that one would be purchased that day. Id. at 23, 
36, 130.
---------------------------------------------------------------------------

    \2\ DI 1 testified that she told Respondent she needed to 
purchase a safe to store controlled substances. Id. at 23, 35. I 
asked DI 1 at the hearing why she advised Respondent to obtain a 
safe when the regulation only refers to a ``cabinet.'' Id. at 51. DI 
1 then acknowledged that DEA regulations do not specifically mandate 
that controlled substances be stored in a safe. Id. at 51. Thus, the 
fact that Respondent did not purchase a safe to store her controlled 
substances does not by itself necessitate a finding that Respondent 
violated 21 CFR 1301.75(b). I note, however, that DEA regulations do 
include heightened security for thiafentanil, carfentanil, etorphine 
hydrochloride, and diprenorphine. Those controlled substances must 
be kept ``in a safe or steel cabinet equivalent to a U.S. Government 
Class V security container.'' 21 CFR 1301.75(e). Those substances, 
however, are not involved in this case.
---------------------------------------------------------------------------

    9. DEA investigators took an inventory of the controlled substances 
they found in Respondent's office. Id. at 25, 125. Government Exhibit 3 
is a copy of that physical inventory. Id. at 25-26, 125.
    10. DEA investigators asked Respondent to provide them with patient 
charts during the execution of the AIW. Id. at 21, 54, 127.
    11. Some patient charts were located in Respondent's garage, a 
location where the investigators looked while trying to locate the 
charts of specific patients. Id. at 66, 95-96, 106.
    12. Respondent did not provide all of the patient records requested 
by DEA during the AIW. Tr. 23, 54. Respondent told the DEA 
investigators that the patient records were at a storage facility in 
Lake Forest, California, but she did not know the address of the 
facility or where it was located.\3\ Id. at 23-24, 54, 56, 67, 127-28, 
135-36.
---------------------------------------------------------------------------

    \3\ DI 1 attributed these statements to Respondent. Tr. 23-24, 
54, 56. SA 1 testified that she asked Respondent about the missing 
charts and she deferred to her husband, who stated that the charts 
might be in a storage facility. Tr. 67. There is no evidence, 
however, that Respondent corrected her husband's statement. *[See 
also GE-12, at 82-83. Respondent told the state investigator that 
the dispensing logs and charts were all in her garage during the 
sworn interview and seemed reluctant to speak about her mother-in-
law's house or to confirm where it was. Id. at 27-28]
---------------------------------------------------------------------------

    13. Respondent never provided to DEA copies of all of the patient 
charts that DEA had requested. Id. at 31-32, 35, 54, 128.
    14. The DEA investigators asked Respondent for her dispensing logs 
and Respondent told them that her dispensing logs were with her patient 
charts in the storage facility. Tr. 24, 54,

[[Page 16766]]

128. The storage facility was at her mother-in-law's house. Id. at 55.
    15. The DEA investigators asked Respondent to provide them with an 
initial inventory and a biennial inventory, but Respondent did not 
provide either of them to the DEA. Id. at 24.
    16. Without an initial or biennial inventory it is not possible to 
conduct a reasonable inventory of controlled substances. Id. at 25.
    17. The DEA investigators asked Respondent for copies of invoices 
for controlled substances that she had received and Respondent provided 
some. Id. at 28. Government Exhibit 2 contains copies of the invoices 
Respondent provided. Id. at 29-30.
    18. Respondent should have had more invoices than she provided to 
the DEA investigators because the invoices she provided did not account 
for all the controlled substances that were found in her office on 
March 13, 2014. Id. at 31.
    19. An invoice for controlled substances needs to be kept for two 
years. Id. at 51. DEA does not know if any of the controlled substances 
found in Respondent's home were more than two years old. Id.
    20. At the conclusion of the execution of the AIW, DI 1 had a 
discussion with Respondent concerning the missing patient charts and 
dispensing logs, as well as the security of controlled substances. Id. 
at 35. Respondent was informed that controlled substances needed to be 
locked in a cabinet or safe. Id. at 35, 129-30.
    21. As an investigator for the Medical Board, SA 1 was concerned 
about how Respondent was storing her controlled substances, and on 
March 13, 2014, SA 1 informed Respondent that controlled substances 
needed to be locked-up. Id. at 67, 94.
    22. During the AIW, Respondent told SA 1 that she ordered 
prescriptions in her own name for office use and that she dispensed 
them to her patients. Id. at 68.
    23. During the AIW, it was determined that only two individuals 
lived in Respondent's home; those individuals were Respondent and her 
husband, S.P. Id. at 107-08.
    24. During the AIW, three pistols were found in Respondent's home, 
two of them belonged to Respondent, but the ownership of the third was 
undetermined. Id. at 109.
    25. During the AIW, SA 1 asked Respondent if she would be willing 
to be interviewed regarding the Medical Board case that SA 1 was 
investigating. Id. at 68-69.

Interview

    26. Government Exhibit 12 is a copy of the transcript of the 
interview SA 1 conducted with Respondent on April 4, 2014. Id. at 69. 
During the interview, Respondent was represented by counsel and 
Respondent was under oath. Id. at 68-69.
    27. During the interview, Respondent stated that she stored some 
office equipment and furniture in her mother-in-law's garage, but all 
of her patient charts were in her own garage. Tr. 71, 78; GE-12, at 28, 
82-84.
    28. During the interview, Respondent stated that she had prescribed 
an antibiotic to herself. Tr. 73; GE-12, at 55. Respondent also said 
that she prescribed testosterone in her own name, but that the 
medication was for office use. Id.
    29. During the interview, Respondent also stated that she 
prescribed phentermine and alprazolam to herself *[for office use.] 
*H Tr. 74; GE-12, at 60.
---------------------------------------------------------------------------

    \*H\ [I agree with Respondent that this finding of fact as 
stated could be misleading, and that in her interview, she implied 
that these prescriptions were also for office use, so I have changed 
it accordingly. See Resp Exceptions, at 9 (citing GE-12, at 60).]
---------------------------------------------------------------------------

    30. During the interview, Respondent explained that she would often 
dispense medication to her patients if they were using it for the first 
time. Tr. 74; GE-12, at 62. Respondent also stated that if the 
medication worked well for the patient she would then possibly write 
the patient a prescription for the medicine. Id.
    31. During the interview, SA 1 had a discussion with Respondent 
concerning the fact that when Respondent dispensed controlled 
substances to patients those prescriptions would not show up in the PMP 
report. Tr. 74-75; GE-12, at 63. SA 1 also explained to Respondent that 
a patient could be placed in danger because the prescriptions 
Respondent provided to patients would not be in the PMP system. Id. In 
response, Respondent indicated that she did not see that to be a 
problem.\4\ Id.
---------------------------------------------------------------------------

    \4\ See also Tr. 202 (Dr. Munzing testifying that there is a 
potential of placing the patient at risk when a doctor dispenses 
controlled substances to a patient without entering that 
prescription in the PMP system).
---------------------------------------------------------------------------

    32. During the interview, SA 1 asked Respondent if she had taken 
any steps to secure the controlled substances in her home, and 
Respondent indicated that she had not. Tr. 77; GE-12, at 77-78.

Search Warrant

    33. After the interview, SA 1 believed that she had sufficient 
probable cause to draft a search warrant for Respondent's residence. 
Tr. 80. After drafting the search warrant, SA 1 had it signed by a 
judge. Tr. 81.
    34. DI 1, SA 1, SA 2, and DI 2 returned to Respondent's home on 
June 13, 2014, when the Medical Board executed a search warrant of 
Respondent's office and residence. Id. at 38, 82, 110, 129.
    35. Government Exhibit 5 consists of photographs taken at 
Respondent's home on June 13, 2014, when the search warrant was 
executed. Id. at 82. Some of the bottles depicted in Government Exhibit 
5 are bottles of controlled substances. Id. at 83.
    36. The condition of Respondent's office on June 13, 2014, looked 
the same as it did on March 13, 2014, with controlled substances being 
found all over the office area. Id. at 38, 111, 130-31. There was no 
safe in Respondent's office on June 13, 2014. Id. at 38-39, 131. A 
bottle of controlled substances was also found in Respondent's kitchen. 
Id. at 41, 58-59.
    37. Some of the controlled substances found in Respondent's home on 
June 13, 2014, were in prescription bottles that bore labels from 
commercial pharmacies, indicating that the prescriptions were for 
individuals who did not live in Respondent's home. Id. at 40, 53-54; 
GE-14, at 11-12.
    38. On June 13, 2014, DEA asked Respondent for her dispensing 
log.\5\ Tr. 39, 132.
---------------------------------------------------------------------------

    \5\ Both DI 1 and DI 2 testified that Respondent was asked about 
her dispensing log at the time the search warrant was executed on 
June 13, 2014, and that Respondent did not provide it. Tr. 39, 132. 
Respondent, however, was in no position to ``provide'' anything 
during the search, she was handcuffed. Tr. 110; see also Tr. 312 
(Respondent testifying that she was detained at the time). The 
search, however, resulted in locating a dispensing log in 
Respondent's home office. GE-14, at 9; RE-1.
---------------------------------------------------------------------------

    39. On June 13, 2014, DEA took another inventory of the controlled 
substances that were found in Respondent's home and that inventory 
revealed a significant difference from the March 13, 2014 inventory. 
Id. at 40-41, 131-32. The June 13, 2014 inventory showed that 
Respondent was missing controlled substances that had been present on 
March 13, 2014. Id. at 41.
    40. On June 13, 2014, marijuana was discovered in a suitcase in 
Respondent's garage. Tr. 45, 111. Marijuana was also found in 
Respondent's kitchen and bedroom. Id. at 112, 132. Marijuana is a 
Schedule I controlled substance. Id. at 46.
    41. Government Exhibit 10 contains photographs taken at 
Respondent's home during the execution of the search warrant that 
depict marijuana that was found there. Id. at 84.

[[Page 16767]]

    42. On June 13, 2014, SA 1 asked both Respondent and her husband 
whether either of them had a valid recommendation for medical 
marijuana. Id. at 90. Respondent told SA 1 that her recommendation had 
expired, and Respondent's husband said that his had probably expired as 
well. Id.
    43. Respondent was questioned about the marijuana and she denied 
knowledge of how it came to be in her house. Id. at 91.
    44. Government Exhibit 11 contains photographs taken at 
Respondent's home during the execution of the search warrant that 
depict the patient charts that were found there. Id. at 86.
    45. SA 1 questioned Respondent about the location of missing 
patient charts, to include the chart for Respondent's husband. Id. at 
91. Respondent stated that her husband's chart was in pieces around the 
house, but she had no explanation for where two other missing charts 
were located. Id. Respondent, however, stated that all of her charts 
were in her home. Id. at 92.
    46. During the June 13, 2014 search of Respondent's home, the 
investigators found $26,100 in cash. Id. at 91.
    47. Government Exhibit 14 is the search warrant return that SA 1 
filed with the Orange County Superior Court after the search warrant 
was executed, along with property receipts of the items that were 
seized from Respondent's home during the search. Id. at 87-88. 
Government Exhibit 14 also contains a full accounting of the controlled 
substances found within Respondent's home on June 13, 2014. Id. at 89.

Prescriptions

    48. Government Exhibit 13 is a copy of a PMP report that the DEA 
obtained from the California Department of Justice concerning 
prescriptions written by Respondent. Id. at 32-34. The inclusive dates 
of the PMP report are February 27, 2014 through February 27, 2017. GE-
13, at 1.
    49. Government Exhibit 7 contains copies of records from the E-
Compounding Pharmacy concerning prescriptions written by Respondent for 
herself. Tr. 113.
    50. Government Exhibit 8 contains copies of prescriptions and 
related documents concerning prescriptions that Respondent wrote for 
her husband, S.P., that were obtained from various pharmacies. Id. at 
115-16.
    51. The standard of care in California requires that during an 
initial visit with a patient a doctor must: Obtain a history from the 
patient concerning the patient's current complaint; review the symptoms 
of the patient's current complaint; determine the cause of the 
patient's current condition and how long the patient has had the 
condition; obtain a medical history from the patient; determine what 
medications the patient has been taking, both prescriptions and over-
the-counter medications; determine the patient's drug and alcohol 
history; perform a general overall physical examination of the patient, 
and a detailed examination of the area of the patient's body that is 
the focus of the current complaint; determine whether any laboratory or 
other type of testing is needed; determine whether a referral to a 
specialist is needed; advise the patient of the risks and benefits of 
prescribed medications; and document what had been performed. Id. at 
174-76.
    52. The standard of care in California requires that during a 
follow-up visit with a patient that a doctor must: Get an updated 
history to determine if there have been changes in the patient's 
condition; determine whether the treatment is working; determine 
current drug and alcohol usage; and monitor the patient through use of 
PMP reports and urine screening. Id. at 178-79.
    53. The standard of care in California requires that a doctor have 
a medical record for a patient to whom prescriptions are issued. Id. at 
180.
    54. The standard of care in California requires that a doctor 
include the following items in a patient's medical record: History, 
exam, consent, diagnosis, management plan; results of laboratory 
testing; results of imaging studies; prescriptions issued; PMP reports 
run for the patient; and/or results of urine screening. Id. at 179-80.
    55. Assuming there is no medical record for S.P., the 27 
prescriptions \6\ for controlled substances written by Respondent to 
S.P. between April 21, 2012 and June 12, 2014, contained in Government 
Exhibit 8, are outside the standard of care in California. Id. at 182-
99; GE-8, at 3, 12 (2 prescriptions), 28-29, 34, 38-39, 76, 78, 80, 82, 
83, 85, 87, 89, 91, 93, 95, 97, 99, 111, 113, 125, 128, 130, 132-34.
---------------------------------------------------------------------------

    \6\ The Government presented testimony concerning 32 
prescriptions that Respondent issued to S.P., but 5 of those 
prescriptions fell outside the date range contained in the OSC. Tr. 
182-86, 194; ALJ-1, at 3, para. 8(b); GE-8, at 10, 27, 31 and 37, 67 
(2 prescriptions).
---------------------------------------------------------------------------

    56. The prescriptions in Government Exhibit 8 are outside the 
standard of care because of the absence of a medical record that 
documents that the doctor has performed the type of medical examination 
that must be performed before the doctor issues a prescription. Id. at 
184.
    57. The California standard of care and California Health and 
Safety Code Sec.  11170 provide that a doctor may not self-prescribe 
controlled substances. Tr. 134, 200. In addition, the American Medical 
Association Code of Ethics says that a doctor cannot self-prescribe or 
prescribe to close relatives. Id. at 200.
    58. Unless a California doctor follows the proper procedures for 
obtaining a controlled substance ``for office use,'' it is outside the 
standard of care in California as well as the course of professional 
practice for a doctor to write a prescription for a controlled 
substance ``for office use.'' Id. at 200-01, 229, 289.
    59. A prescription for 300, 450, or 600 tablets of phentermine 
would be a very large quantity if the prescription was for office use. 
Tr. 207, 212-13, 247. If a patient needed that much phentermine, the 
patient could be issued a prescription that would then be reported to 
the PMP system. Tr. 207, 210-11, 215, 242. A prescription written for 
office use of such large quantity of phentermine would be outside the 
standard of care in California. Id. at 247.
    60. A prescription for office use of 300 tablets of Ambien would be 
an excessive number of tablets and outside the standard of care in 
California. Id. at 245-46; GE-7, at 35.
    61. Respondent wrote four prescriptions for hydrocodone for office 
use. GE-7, at 12, 13, 36 (2 prescriptions). Hydrocodone should not be 
dispensed from the office because it would not provide immediate 
relief, but might cause the patient to become drowsy. Tr. 241-42. Thus, 
prescribing hydrocodone for office use is outside the standard of care 
in California. Id. at 242.
    62. The 69 prescriptions for controlled substances written by 
Respondent to herself, contained in Government Exhibit 7, are outside 
the standard of care in California. Tr. 203-23, 225-28, 243-44; GE-7, 
at 5, 23, 25, 26, 29, 31 (4 prescriptions), 33, 34, 37, 40 (2 
prescriptions), 41 (4 prescriptions), 42-45, 47, 49, 51, 52, 54, 57, 
59-61, 63 (2 prescriptions), 64, 67-70, 72-74, 86, 87, 89, 95 (4 
prescriptions), 99, 101, 107, 110, 112-14, 122, 130, 133, 135, 139, 140 
(3 prescriptions), 153 (2 prescriptions), 158, 169, 179 (2 
prescriptions).
    63. Four prescriptions that Respondent wrote to herself for 
controlled substances also included dosing instructions. Tr. 226-28; 
GE-7, at 40 (2 prescriptions), 47, 158. Dosing instructions on a 
prescription would be inconsistent with a prescription issued for 
office use because dosing instructions would be determined at the time 
the medication was prescribed to a

[[Page 16768]]

patient, not when it was being ordered for the office. Tr. 226.
    64. Seven prescriptions that Respondent wrote for controlled 
substances contain no patient name, nor do they indicate that they were 
for office use. Tr. 224-25; GE-7, at 16, 22, 24, 28 (3 prescriptions), 
30. These seven prescriptions were issued outside the California 
standard of care because there is no listed patient, nor is there any 
stated reason for any of the prescriptions. Tr. 224-25.
    65. Twenty-four *I prescriptions that Respondent wrote 
for controlled substances contain no patient name but they were written 
for office use. Tr. 228-37; GE-7, at 146, 150, 152 (3 prescriptions), 
156 (1 prescription), 160 (3 prescriptions), 162 (2 prescriptions), 166 
(2 prescriptions), 171 (2 prescriptions), 173, 175, 177 (2 
prescriptions), 178 (5 prescriptions). These 24 prescriptions were 
issued outside the California standard of care because Respondent did 
not follow the proper procedures for ordering controlled substances for 
office use. Tr. 229.
---------------------------------------------------------------------------

    \*I\ [There was one additional prescription between GE-7, at 156 
and 160 that appeared to be neglected in the final count in the RD.]
---------------------------------------------------------------------------

    66. Seventy prescriptions that Respondent wrote to herself for 
controlled substances contain a notation that the prescription was for 
office use. Id. at 237-66; GE-7, at 4, 6-15, 17-21, 27, 32, 35, 36 (3 
prescriptions), 38, 39, 46, 50, 53, 55, 56, 58, 62, 65, 71, 75, 80 (4 
prescriptions), 84, 85, 90, 91, 93, 96 (2 prescriptions), 97, 102, 103, 
105, 108, 115 (3 prescriptions), 117 (2 prescriptions), 119, 120 (3 
prescriptions), 123, 126, 128, 131, 137, 142, 144, 148 (4 
prescriptions). These 70 prescriptions were issued outside the 
California standard of care because Respondent did not follow the 
proper procedures for ordering controlled substances for office use. 
Tr. 250.
    67. Respondent wrote two prescriptions for controlled substances 
where she listed the patient's name as ``office use.'' Id. at 266-67; 
GE-7, at 48, 164. These two prescriptions were issued outside the 
California standard of care because Respondent did not follow the 
proper procedures for ordering controlled substances for office use. 
Tr. 200-01, 250.

Analysis

    To revoke a respondent's registration, the Government must prove, 
by a preponderance of the evidence, that the regulatory requirements 
for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02 
(1981); 21 CFR 1301.44(e). Under 21 U.S.C. 824(a)(4), the DEA may 
revoke a registrant's COR if the registrant acted in a way that renders 
continued registration ``inconsistent with the public interest.'' The 
DEA considers the following five factors to determine whether continued 
registration is in the public interest:

    (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).
    These public interest factors are considered separately. See Robert 
A. Leslie, M.D., 68 FR 15,227, 15,230 (2003). Each factor is weighed on 
a case-by-case basis. Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 
2005). Any one factor, or combination of factors, may be decisive. 
David H. Gillis, M.D., 58 FR 37,507, 37,508 (1993). Thus, there is no 
need to enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 
477, 482 (6th Cir. 2005). Further, there is no requirement to consider 
a factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76-
77 (4th Cir. 1988). When deciding whether registration is in the public 
interest, the totality of the circumstances must be considered. See 
generally Joseph Gaudio, M.D., 74 FR 10,083 (2009).
    The Government bears the initial burden of proof and must justify 
revocation by a preponderance of the evidence. Steadman, 450 U.S. at 
100-03. If the Government presents a prima facie case for revocation, 
the burden of proof shifts to the registrant to show that revocation 
would be inappropriate. Med. Shoppe--Jonesborough, 73 FR 364, 387 
(2008). A registrant may prevail by successfully attacking the veracity 
of the Government's allegations or evidence. Alternatively, a 
registrant may rebut the Government's prima facie case for revocation 
by accepting responsibility for wrongful behavior and by taking 
remedial measures to ``prevent the re-occurrence of similar acts.'' 
Jeri Hassman, M.D., 75 FR 8194, 8236 (2010). In addition, when 
assessing the appropriateness and extent of sanctioning, the DEA 
considers the egregiousness of the offenses and the DEA's interest in 
specific and general deterrence. David A. Ruben, M.D., 78 FR 38,363, 
38,385 (2013).

I. The Government's Position

    The Government filed its Post-Hearing Brief on March 19, 2018.\7\ 
In its introduction, the Government highlighted the allegations against 
Respondent. ALJ-50, at 2. The Government asserts that between January 
2010 and June 2014 Respondent: Prescribed controlled substances to her 
husband, S.P., ``without maintaining a patient file'' for him; 
prescribed controlled substances to herself for `` `office use' in 
order to dispense controlled substances'' to patients; violated 
security and recordkeeping requirements; and displayed a lack of candor 
to DEA investigators during their investigation. Id. The Government 
requests that Respondent's COR be revoked. Id.
---------------------------------------------------------------------------

    \7\ The Government's Post-Hearing Brief has been marked as ALJ-
50.
---------------------------------------------------------------------------

    The Government argues that its evidence is ``largely uncontested 
and entirely unrebutted.'' ALJ-50, at 12. Specifically, the Government 
claims that it offered unrebutted evidence under Factors Two, Four, and 
Five. Id. at 14.
    Under Factors Two and Four, the Government argues that the evidence 
shows that Respondent ``routinely prescribed controlled substances 
without a patient chart,'' issued prescriptions for controlled 
substances to herself, and violated storage and recordkeeping 
requirements under state and federal law. ALJ-50, at 15. After citing 
the DEA's prescription requirement, the Government notes that 
California has adopted the same requirement as set forth in 21 CFR 
1306.04(a), that a prescription must be issued for a `` `legitimate 
medical purpose' '' and in the `` `usual course of . . . professional 
practice.' '' Id. (citing Cal. Health & Safety Code Sec.  11153(a)). 
The Government then highlights the testimony of its expert witness, Dr. 
Munzing, who explained that the standard of practice in California 
requires a physician to ``maintain a complete and accurate patient 
file, which documents examinations performed and treatments provided.'' 
ALJ-50, at 15. The State of California has codified the requirement 
that a physician maintain complete patient files. Id. at 15-16 (citing 
Cal. Bus. & Prof. Code Sec.  2266 and Cal. Health & Safety Code Sec.  
11190).
    Looking at the prescriptions in Government's Exhibit 8, the 
Government argues that it is undisputed that Respondent wrote at least 
50

[[Page 16769]]

prescriptions \8\ for controlled substances to her husband, S.P. ALJ-
50, at 16. DEA investigators requested S.P.'s patient file during 
execution of the AIW in March 2014, and state investigators requested 
S.P.'s file during service of the search warrant in June 2014. Id. The 
Government then notes that during the inspection in March, Respondent 
told investigators that some of the requested patient records were 
located at a storage facility in Lake Forest, California. ALJ-50, at 4, 
16. Respondent, however, claimed that she did not know the address of 
the facility and ``did not know where it was.'' ALJ-50, at 4. When 
interviewed by a state investigator in April 2014, however, Respondent 
stated that all her patient files were kept at her registered address. 
ALJ-50, at 16. The Government notes that Respondent ``never provided a 
patient file for Patient S.P.,'' investigators never found a patient 
file for S.P. in March or June 2014, and Respondent never produced a 
patient file for S.P. ``in connection with this proceeding.'' Id. The 
Government reasons that ``[t]he only logical conclusion is that 
[Respondent] did not keep a patient file for Patient S.P.'' Id. The 
Government further reasons that based on Dr. Munzing's testimony that 
physicians must keep complete and accurate patient records, the 50 
prescriptions Respondent issued to S.P. fell below the standard of care 
in California and violated state law. Id.
---------------------------------------------------------------------------

    \8\ See supra n.6.
---------------------------------------------------------------------------

    Next, looking at Government Exhibit 7, the Government argues that 
Respondent issued at least 179 prescriptions for controlled substances 
to herself between January and December 2012. ALJ-50, at 17. The 
Government notes that many of the prescriptions in Government Exhibit 7 
were issued ``for office use'' while others listed Respondent's name as 
the patient. Id. State and federal law prohibits a physician from 
prescribing controlled substances to herself. Id. (citing Cal. Health & 
Safety Code Sec.  11170 and 21 CFR 1306.04(b)). The Government notes 
that the state prohibition is ``categorical'' and that self-prescribing 
controlled substances violates state law ``irrespective of purpose.'' 
Id. n.2. Further, the Government notes that Dr. Munzing testified that 
writing a prescription for a controlled substance in order to obtain it 
``for office use'' is considered unprofessional practice in California. 
Id. at 17. Thus, Dr. Munzing opined that the prescriptions in 
Government Exhibit 7 ``were issued outside of the usual course of 
professional practice and beneath the standard of care.'' Id. The 
Government notes that Dr. Munzing's expert opinion is unrebutted. Id. 
at 18.
    The Government then discusses the recordkeeping and storage 
violations discovered during service of the AIW and search warrant. 
ALJ-50, at 18-19. The Government contends that Respondent ``was not 
able to produce either an initial or biennial inventory of the 
controlled substances stored at her registered address.'' ALJ-50, at 
18. Additionally, Respondent never provided investigators with a 
dispensing log.\9\ Id. The Government argues that Respondent's failure 
to maintain a proper inventory and a dispensing log violates state and 
federal recordkeeping requirements. Id. at 19.
---------------------------------------------------------------------------

    \9\ State investigators, however, seized a document entitled 
``Class III Meds Dispensing Log,'' marked as Respondent's Exhibit 1, 
during execution of the search warrant. Tr. 304-06; GE-14, at 9. The 
Government argues that neither Government counsel nor DEA 
investigators were provided with a copy of Respondent's Exhibit 1 
before the hearing. ALJ-50, at 18-19 n.4. The Government claims that 
``the California Medical Board declined to provide the evidence that 
was seized from'' Respondent's home during the search, and that the 
DEA failed in its attempts to obtain the release of the evidence by 
subpoena in state court. Id. I give no weight to this explanation, 
however, because there is no evidence in the record supporting the 
Government's claim that the California Medical Board refused to 
disclose evidence to DEA. Statements made in post-hearing briefs are 
not evidence. See Samuel Mintlow, M.D., 80 FR 3630, 3653 n.33 (2015) 
(concluding promises made by respondent in exceptions to the 
recommended decision were not in evidence and were never attested to 
under oath during the hearing); Surinder Dang, M.D., 76 FR 51,417, 
51,423 n.25 (2011) (``[S]tatements of counsel in a brief are not 
evidence.'' (citing INS v. Phinpathya, 464 U.S. 183, 186 n.6 
(1984))). *[Respondent implies that the Government's failure to 
produce this dispensing log indicates bad faith on the part of the 
investigators. Resp Exceptions, at 3,19-20. The investigators 
testified that they had not previously seen this document and that 
they had asked Respondent repeatedly for her dispensing logs and she 
had not produced them. I do not see any indication on the record nor 
from the ALJ's characterization of the investigators' testimony that 
their actions were anything but honest. Ultimately, the document was 
admitted into evidence and the ALJ used the document to lessen the 
number of found discrepancies in controlled substances.]
---------------------------------------------------------------------------

    With respect to the storage violation, the Government argues that 
Respondent ignored the attempts made by DEA and state investigators 
``to bring her into compliance with'' DEA's storage requirements. ALJ-
50, at 19. During the inspection in March 2014, Respondent assured DEA 
investigators that she would promptly secure the controlled substances 
in her office. Id. At the interview in April, however, Respondent 
admitted that she had not done so. Id. When state investigators 
conducted the search in June, the controlled substances in her office 
were still unsecured. Id. The Government urges that Respondent's 
``noncompliance is aggravated by her obduracy.'' Id.
    Based on the prescriptions in Government Exhibits 7 and 8, and the 
evidence that Respondent failed to keep complete records and properly 
secure controlled substances, the Government argues that ``Factors Two 
and Four weigh heavily in favor of revoking'' Respondent's COR. ALJ-50, 
at 20.
    Citing DEA precedent, the Government next asserts that Respondent's 
lack of candor supports an ``adverse finding'' under Factor Five. ALJ-
50, at 20. The Government claims that Respondent ``attempted to mislead 
federal and state investigators'' during their investigation by making 
a ``series of misleading statements.'' ALJ-50, at 13. For instance, the 
Government points to the inconsistent statements Respondent made to 
investigators regarding her patient file for S.P. ALJ-50, at 20. During 
the March inspection, Respondent stated that all patient files were 
located at an off-site facility. Id. A month later, however, she told a 
state investigator that all patient files were stored at her registered 
address. Id. The Government interprets these inconsistent statements as 
evidence of Respondent's ``deliberate effort to impede the 
investigation.'' ALJ-50, at 21.
    The Government then examines the marijuana, cash, and firearms 
discovered in Respondent's home. ALJ-50, at 21. The Government notes 
that Respondent lacked the authority to possess marijuana, a Schedule I 
controlled substance, ``in the course of her professional practice.'' 
ALJ-50, at 21. Additionally, when investigators found a suitcase of 
marijuana in her garage, Respondent denied having any knowledge of its 
presence at her home. Id. The Government argues that this represents 
either a lack of candor or ``a troubling situation in which 
[Respondent] was actually unaware of the presence of Schedule I 
controlled substances at her registered address.'' Id. The Government 
then argues that the presence of $26,000 in cash, firearms, and 
marijuana at Respondent's registered location is ``highly suspicious 
and raises serious concerns about [Respondent's] ability to maintain a 
[COR].'' Id.
    Because Respondent failed to offer ``substantive testimony'' at the 
hearing, the Government argues that she ``cannot be viewed as having 
accepted responsibility.'' ALJ-50, at 22. By failing to accept 
responsibility, the Government contends that Respondent ``has not met 
her burden'' to rebut the Government's prima facie case. ALJ-50, at 14. 
Specifically, the Government argues that

[[Page 16770]]

Respondent's refusal to testify demonstrates that she ``knowingly 
violated the Controlled Substances Act.'' ALJ-50, at 2. The Government 
requests that I draw an adverse inference from Respondent's decision to 
not testify at the hearing. ALJ-50, at 2, 22. The Government reasons 
that ``because [Respondent] failed to introduce any evidence that would 
rebut the Government's evidence showing that [Respondent] violated 
state and federal law relating to controlled substances, such evidence 
does not exist.'' ALJ-50, at 22 (citing T.J. McNichol, M.D., 77 FR 
57133, 57150 (2012)).
    With respect to the DEA's interest in specific and general 
deterrence, the Government contends that ``[a] refusal to sanction 
[Respondent's] prolonged and egregious violations here would send the 
wrong message to other practitioners.'' ALJ-50, at 23. The Government 
concludes that the DEA's interest in deterrence weighs in favor of 
revoking Respondent's COR. ALJ-50, at 24.

II. The Respondent's Position

    Respondent submitted her Post-Hearing Brief on March 19, 2018.\10\ 
Much of Respondent's position lacks evidentiary support in the 
Administrative Record.\11\ Respondent opens her brief by describing 
events beginning in May 2013, when she ``abruptly close[d] [her] office 
due to extreme hardship caused by a very contentious divorce that still 
continues . . . to this day.'' ALJ-51, at 2. Respondent explains that 
closing her medical office triggered a ``stressful chain of events,'' 
culminating in eviction from her office and incurring ``unforeseen 
[moving] expenses.'' Id. After closing her practice, Respondent moved 
medical equipment, office furniture, and cabinets to her mother-in-
law's garage. Id. Respondent also moved ``approximately 700 patient 
charts'' to her home in Mission Viejo which doubled as her registered 
address beginning in September 2013. Id. at 2-3. Respondent then began 
seeing patients at her home. Id.
---------------------------------------------------------------------------

    \10\ Respondent's Post-Hearing Brief has been marked as ALJ-51. 
The Office of Administrative Law Judges received a hard copy of 
Respondent's brief by mail on March 22, 2018. There are minor, non-
substantive differences between the hard copy received by mail on 
March 22 and the copy received by fax on March 19. For example, the 
formatting is different between the two copies and Respondent 
corrected a few misspellings in the hard copy. I will use the faxed 
copy of Respondent's Post-Hearing Brief because it was the first 
copy received and the only variations are typographical in nature.
    \11\ Because statements contained in post-hearing briefs are not 
evidence, I give no weight to comments made by Respondent in her 
post-hearing brief that are not supported by evidence in the 
Administrative Record. See Surinder Dang, M.D., 76 FR at 51,423 
n.25.
---------------------------------------------------------------------------

    With respect to the controlled substances that were observed 
unsecured in her home office, Respondent explains that many of them 
were ``expired and waiting to be safely disposed.'' ALJ-51, at 5, 14. 
Additionally, she states that ``[n]o patients ever went inside the 
office,'' patients were never left unattended, only one patient was 
allowed in her home at a time, and she and her husband, S.P., were the 
only individuals living in the home. Id. at 8. Respondent further 
describes the security in place at her home, explaining that her 
registered address is located ``in a very safe gated community with 24/
7 security patrols.'' Id. at 9. She further argues that her home has a 
``sophisticated security system'' that sounds a ``highly audible 
notification'' when doors are opened. Id. She also receives email 
notifications when doors are opened. Id. Additionally, Respondent 
asserts that there is a security camera in her office and in the 
hallway outside the office. Id. Respondent argues that she explained 
the features of her security system to SA 1 during the April interview. 
Id. at 9, 11. Respondent contends that the security in place at her 
home was adequate, especially in light of the fact that she intended to 
relocate her practice to a new office. Id. Respondent also claims that 
she consulted a ``pharmaceutical supplier[ ],'' who visited her 
residence and deemed the security at her home sufficient. Id. at 11. 
Respondent explains that she never obtained a safe because she planned 
on practicing out of her home temporarily and was ``actively 
negotiating for a new office space.'' Id.
    In regard to the allegation that Respondent failed to maintain 
adequate inventories, Respondent asserts that she ``kept all the 
medication purchase orders as an inventory guide.'' ALJ-51, at 6. 
Respondent acknowledges that these purchase orders are not in evidence 
and contends that she assumed, as a pro se litigant, the Government 
would introduce the documents into evidence. Id. at 7.
    Respondent also addresses the alleged inconsistencies in her 
statements to investigators regarding the location of her patient 
files. She believed some of the missing patient files could have been 
left in the cabinets or office furniture that were moved into storage 
after the abrupt closing of her practice. ALJ-51, at 8. She also 
contends that investigators never requested that she take them to the 
storage location and further notes that the search warrant authorized 
investigators to search the storage facility, but they never did. Id.
    Respondent also discusses the CURES reports that DEA and state 
investigators ran of her prescribing history. ALJ-51, at 11. Respondent 
acknowledges that ``[Agent] SA 1's concerns were legitimate''; however, 
the CURES reports ``clearly showed'' that Respondent's patients ``did 
not fit the category for high potential for abuse, addiction or 
diversion.'' Id. Respondent does not explain why her patients do not 
fit this category. Id. She also recognizes that urine screening and 
patient contracts are useful, but argues that such precautions only 
``need to be implemented'' on an individual basis ``as determined by 
medical judgment.'' Id. at 12. Respondent asserts that reporting to 
CURES ``was not mandatory at first for dispensing physicians.'' Id. 
Respondent states that she understands the importance of reporting 
prescriptions to CURES, and that doing so ``helps to provide the best 
care for our patients and avoid harm.'' Id.
    Respondent provides an explanation regarding the prescription 
bottles with labels that bore patients' names that were found in her 
office during service of the search warrant. She argues that it is not 
uncommon for ``patients [to] leave prescriptions with their doctors'' 
for a variety of reasons. ALJ-51, at 14. Without pointing to a specific 
example, Respondent claims that a patient may leave a prescription 
bottle with her for it to be administered in the office, to pick it up 
at a later date, or for ``issues of privacy.'' Id.
    Regarding the discrepancies between the controlled substances 
inventoried by investigators in March and June, Respondent argues that 
the missing controlled substances were dispensed and documented in a 
dispensing log, patient chart, or both. ALJ-51, at 14. Presumably, the 
dispensing log she refers to is Respondent's Exhibit 1.
    Respondent argues that the large amount of cash discovered at her 
home during the search warrant represented ``some savings [she] had put 
away through the years.'' ALJ-51, at 15. Respondent also states, as she 
did to investigators, that she was unaware of the marijuana in the 
suitcase in her garage.\12\ Id. The firearms found during the search 
were obtained lawfully for purposes of self-defense ``after violence 
and threats of violence committed by [her] ex-husband.'' Id. Respondent 
responds that the idea that the firearms

[[Page 16771]]

played a role in her medical practice is ``absurd and slanderous.'' Id.
---------------------------------------------------------------------------

    \12\ Respondent does not explain any of the other marijuana 
found in other locations of her home.
---------------------------------------------------------------------------

    Addressing the allegation of self-prescribing, Respondent explains 
that the prescriptions in Government Exhibit 7 were phoned in by either 
herself or a staff member calling under her supervision. ALJ-51, at 15. 
According to Respondent, the dispensing pharmacy, E-Compounding, used 
``generic prescription forms,'' instead of the proper order form, and 
incorrectly wrote Respondent's ``name on the prescriptions as if [she] 
were the patient.'' Id. at 15-16. Respondent contends that the pharmacy 
``failed to adhere to the standard practice of transferring from a 
pharmacy to any licensing entity, [such] as a medical doctor, when 
ordering medications for office stocking, thus mischaracterizing the 
transactions.'' Id. at 16. Further, Respondent explains the pharmacy 
``should have used an invoice form and not a prescription when [she] 
was ordering for office stock.'' Id. In her defense, Respondent argues 
that ``[i]f [the pharmacy] recorded my orders as office use using 
prescriptions under my name I had no way to know.'' Id. Respondent 
faults the pharmacy for its ``poor record keeping'' and notes that the 
pharmacist was ``disciplined for that violation among others.'' Id. 
Respondent states that she never used E-Compounding Pharmacy after 
December 2012. Id.
    In response to the issue of prescribing to S.P., Respondent argues 
that ``[t]here are no specific regulations or laws prohibiting 
physicians from treating family members.'' ALJ-51, at 17. She then 
cites the American Medical Association's Code of Medical Ethics to 
support the proposition that physicians may provide medical care to 
family members in emergencies or `` `isolated settings where there are 
no other qualified physicians available.' '' Id. Respondent contends 
that she has always maintained records for her patients and that she 
obtained S.P.'s previous medical records before treating him as a 
patient. Id. at 18. She also claims, without citing any evidence of 
record, that some of S.P.'s records were located during the search 
warrant. Id. She then argues that Dr. Munzing gave an expert opinion 
based solely on CURES reports. Id. at 18-19. In essence, Dr. Munzing 
``gave an opinion on evidence he was not provided with.'' Id. at 19. 
Respondent's argument seems to rest on the assumption that medical 
files for S.P. were in fact created and never given to Dr. Munzing for 
review; however, Respondent fails to explain where those records are 
located and why she has not produced them either during the 
investigation or these proceedings. Id.
    Throughout her brief, Respondent cites to ongoing issues in her 
personal life. Respondent opines that ``circumstances of extreme duress 
in [her] personal life should have been taken into consideration.'' 
ALJ-51, at 12. She also highlights ``harassment and stalking'' and 
threats of violence made by her ex-husband. Id. at 3, 10, 15. 
Respondent assures that even during challenging times, she was ``trying 
hard to get back to normal.'' Id. Additionally, Respondent asserts that 
she has never been the subject of a medical malpractice lawsuit or a 
patient complaint. Id. at 4. In conclusion, Respondent argues that the 
Administrative Record does not establish by a preponderance of the 
evidence that allowing her to retain her COR is ``[in]consistent with 
the public interest.'' Id. at 19.

Factors One & Three: The Recommendation of the Appropriate State 
Licensing Board or Professional Disciplinary Authority, and Conviction 
Record Under Federal or State Laws Relating to the Manufacture, 
Distribution, or Dispensing of Controlled Substances

    In this case, it is undisputed that Respondent holds a valid and 
current state license to practice medicine in California. Stip. 3. The 
record contains no evidence of a recommendation regarding Respondent's 
medical privileges by a relevant state licensing board or professional 
disciplinary authority. However, possession of a state license does not 
entitle a holder of that license to a DEA registration. Mark De La 
Lama, P.A., 76 FR 20,011, 20,018 (2011). Rather, a state medical 
board's decision to allow a doctor to practice medicine is not 
dispositive as to whether the doctor's DEA registration is consistent 
with the public interest. Patrick W. Stodola, M.D., 74 FR 20,727, 
20,730 n.16 (2009).
    At the hearing, the Government presented evidence that Respondent 
is not currently licensed to practice medicine in Florida. Tr. 133. 
Respondent presented Respondent's Exhibit 2, her expired Florida 
medical license. *[The Government Prehearing Statement alleged, 
``Respondent is presently not licensed to practice medicine in 
Florida.'' ALJ-9, at 3.*J I address the lack of Respondent's 
state authority further below; however, as it relates to Factor One it 
is noted that there is nothing on the record to indicate that the 
Florida Medical Board has taken any action on Respondent's medical 
license.]
---------------------------------------------------------------------------

    \*J\ The RD found that the issue of Respondent's loss of state 
authority in Florida was not sufficiently noticed, but the 
Government had noticed it prior to the hearing in its Prehearing 
Statement, and the Respondent presented arguments regarding her 
state authority at the hearing; therefore, I find that based on her 
own submissions during the proceeding, Respondent had adequate 
notice that her lack of state authority in Florida was at issue. See 
Hatem M. Ataya, M.D., 81 FR 8221, 8244 (2016).
---------------------------------------------------------------------------

    DEA precedent establishes that where the record contains no 
evidence of a recommendation by a state licensing board that absence 
does not weigh for or against revocation. See Roni Dreszer, M.D., 76 FR 
19,434, 19,444 (2011) (``The fact that the record contains no evidence 
of a recommendation by a state licensing board does not weigh for or 
against a determination as to whether continuation of the Respondent's 
DEA certification is consistent with the public interest.''). 
Accordingly, Factor One does not weigh for or against revocation of 
Respondent's California registration in this matter.
    As to Factor Three, there is no evidence that Respondent has been 
convicted of an offense under either federal or California law 
``relating to the manufacture, distribution, or dispensing of 
controlled substances.'' 21 U.S.C. 823(f)(3). However, there are a 
number of reasons why even a person who has engaged in criminal 
misconduct may never have been convicted of an offense or even 
prosecuted for one. Dewey C. MacKay, M.D., 75 FR 49,956, 49,973 (2010), 
pet. for rev. denied, MacKay v. DEA, 664 F.3d 808, 822 (10th Cir. 
2011). The DEA has, therefore, held that ``the absence of such a 
conviction is of considerably less consequence in the public interest 
inquiry'' and is therefore not dispositive. Id. Accordingly, Factor 
Three neither weighs for nor against revocation in this case.

Factors Two & Four: The Respondent's Experience in Dispensing 
Controlled Substances and Compliance With Applicable State, Federal, or 
Local Laws Relating to Controlled Substances

    Factors Two and Four are often analyzed together. See, e.g., Fred 
Samimi, M.D., 79 FR 18,698, 18,709 (2014); John V. Scalera, M.D., 78 FR 
12,092, 12,098 (2013). Under Factor Two, the DEA analyzes a 
registrant's ``experience in dispensing . . . controlled substances.'' 
21 U.S.C. 823(f)(2). Factor Two analysis focuses on an applicant's acts 
that are inconsistent with the public interest, rather than on an 
applicant's neutral or positive acts and experience. Randall L. Wolff, 
M.D., 77 FR 5106, 5121 n.25

[[Page 16772]]

(2012) (explaining that ``every registrant can undoubtedly point to an 
extensive body of legitimate prescribing over the course of [the 
registrant's] professional career'') (quoting Jayam Krishna-Iyer, M.D., 
74 FR 459, 463 (2009)). Similarly, under Factor Four, the DEA analyzes 
an applicant's compliance with federal and state controlled substance 
laws. 21 U.S.C. 823(f)(4). Factor Four analysis focuses on violations 
of state and federal laws and regulations. Volkman v. DEA, 567 F.3d 
215, 223-24 (6th Cir. 2009) (citing Gonzales v. Oregon, 546 U.S. 243, 
272, 274 (2006)); see Joseph Gaudio, M.D., 74 FR 10,083, 10,090-91 
(2009).
    Here, the Government alleges that revocation of Respondent's COR 
and denial of her pending application is appropriate under Factors Two 
and Four (as well as Factor Five) for the following reasons: (1) 
Improper storage; (2) failing to maintain proper inventories and 
dispensing logs; (3) possession of controlled substances with the names 
of other individuals on the bottle; (4) improperly prescribing 
controlled substances ``for office use''; (5) prescribing to S.P. 
without maintaining a medical record for S.P.; and (6) displaying a 
lack of candor during the investigation. ALJ-1, at 2-4.

The Allegations

Improper Storage

    Concerning improper storage of controlled substances, the 
Government asserts that Respondent was found to be improperly storing 
controlled substances on March 13, 2014, and again on June 13, 2014, in 
violation of 21 CFR 1301.75(a) and (b). ALJ-1, at 2, paras. 3, 5. 
Specifically, the Government claims that on both dates, investigators 
found a variety of controlled substances located on open shelves, on 
top of the office copier or desk, and in unlocked glass cabinets in 
Respondent's office. Id. The Government alleges that ``[n]one of the 
controlled substances found at Respondent's registered address were 
secured in a locked cabinet,'' as required by 21 CFR 1301.75(b). ALJ-1, 
at 2, para. 3. In addition, the Government claims that on June 13, 
2014, the investigators also found marijuana in Respondent's home. ALJ-
1, at 2, para. 5. The Government further asserts that the door to 
Respondent's office where the controlled substances were observed could 
not be locked. ALJ-1, at 2, para. 3.
    DEA regulations provide that controlled substances ``shall be 
stored in a securely locked, substantially constructed cabinet.'' 21 
CFR 1301.75(a), (b). The regulations do not define the term 
``substantially constructed cabinet.'' Peter F. Kelly, D.P.M., 82 FR 
28,676, 28,689 (2017). DEA decisions, however, provide some indication 
that a locked room with adequate security features is sufficient to 
satisfy the storage requirement of Section 1301.75. See id. (finding 
that the Government failed to meet its burden where controlled 
substances were left in a locked room *[dedicated to the storage of 
controlled substances] with an alarm system). Additionally, as noted in 
Kelly, at least one dictionary supports the interpretation of 
``cabinet'' as a small room. Id.
    Controlled substances were observed in Respondent's office on two 
occasions: During service of the AIW in March 2014 and during execution 
of the search warrant in June 2014. Between those dates, Respondent's 
COR authorized her to possess and prescribe controlled substances in 
Schedules II-V. GE-1, at 1.
    During the inspection in March, investigators found multiple 
bottles of controlled substances on the desk, on the shelf, and on the 
printer in Respondent's office. FF 4. In fact, the investigators found 
``a great deal of controlled substances'' in Schedules III-V. Tr. 22; 
GE-3, at 1-2. Furthermore, the controlled substances found in 
Respondent's office were not secured in any way, and there did not 
appear to be any place to secure them in her office. FF 5. During the 
inspection, DEA investigators requested that Respondent purchase some 
type of safe in which to store the controlled substances and Respondent 
indicated that one would be purchased that day. FF 8. Following the 
inspection, SA 1 informed Respondent that controlled substances needed 
to be locked-up. FF 21.
    On June 13, 2014, when DEA investigators returned to Respondent's 
office the condition of her office looked the same as it did on March 
13, 2014, with controlled substances being found all over the office 
area. FF 35, 36. There was no safe in Respondent's office on June 13, 
2014. Id. A bottle of controlled substances was also found in 
Respondent's kitchen. Id. During the June 13, 2014 search of 
Respondent's home, marijuana was discovered in a suitcase in 
Respondent's garage. FF 39. Marijuana was also found in Respondent's 
kitchen and bedroom. Id. [Omitted language from RD.] *K
---------------------------------------------------------------------------

    \*K\ [See infra n.16]
---------------------------------------------------------------------------

    Although the record is clear that controlled substances were not 
``stored in a securely locked, substantially constructed cabinet,'' 21 
CFR 1301.75(a) and (b), at the time of the inspection and search, the 
evidence is less than clear concerning whether the door to Respondent's 
office could be locked. In response to Government counsel's question 
about whether she noticed a lock on the office door, FF 8, DI 1 
responded, ``No.'' Tr. 39. SA 1 was unsure whether there was a lock on 
the door, stating ``I do not believe there was.'' Tr. 67. DI 2 
testified, however, that ``[t]here may have been'' a lock on the door, 
but it was open when investigators entered the home to serve the AIW. 
Tr. 124. The fact that the door was already open when investigators 
entered the home, however, could be easily explained by the fact that a 
separate team of officers made the initial entry into the home to clear 
the way for investigators. Tr. 20, 110, 122; see Jack A. Danton, D.O., 
76 FR 60,900, 60,908 (2011) (noting DI ``was not the first to see the 
[unlocked] closet'' alleged to be in violation of storage requirement).
    It is also troubling that investigators had two opportunities to 
photograph the door to the office and did not do so. Investigators took 
extensive photographic evidence of the office during service of the 
search warrant and could have easily turned the camera on the door. 
Furthermore, the fact that three investigators who inspected 
Respondent's office on two occasions were unable to testify with 
confidence that the office door could not be locked undermines the 
Government's allegation that the ``investigators could not lock . . . 
[the] office door.'' ALJ-1, at 2, para. 3. If there was a lock on the 
office door, as DI 2 believes there may have been, Tr. 124, the office 
could have been locked. The question then becomes, if Respondent could 
lock her office door, would the manner in which she stored her 
controlled substances in her office be in compliance with 21 CFR 
1301.75(b). Compare Jeffery J. Baker, D.D.S., 77 FR 72,387, 72,394, 
72405 (2012) (finding violation where controlled substances were 
routinely left unattended on a counter in an unlocked room) \13\ with 
Peter F. Kelly, D.P.M., 82 FR 28,676, 28,689 (2017) (finding no 
violation where controlled substances were left outside safe but in a 
locked room *[dedicated to the storage of controlled substances]); see 
also United States v. Poulin, 926 F. Supp. 246, 253 (D. Mass. 1996) 
(reasoning that controlled substances kept ``in an

[[Page 16773]]

unlocked area'' violated Section 1301.75). I find that it would not.
---------------------------------------------------------------------------

    \13\ The storage violation in Becker ``played little or no role 
in the disciplinary decision'' because the respondent introduced 
evidence that the deficiencies had been corrected. Becker v. DEA, 
541 Fed. App'x 587, 589 (6th Cir. 2013). That is not the case here.
---------------------------------------------------------------------------

    In a fairly recent case, the Administrator concluded that a 
registrant was in substantial compliance with 21 CFR 1301.75(b) when he 
left a small amount of controlled substances outside a safe overnight 
so they could be administered in the morning, but where the controlled 
substances were also in a small locked room and the office was 
protected by a security alarm system. Kelly, 82 FR at 28,689. In Kelly, 
however, the controlled substances at issue involved medications that 
the registrant occasionally left ``out overnight for his office manager 
to administer to patients who were undergoing procedures the following 
morning.'' Id. at 28,678. In addition, the decision ``noted that the 
room in which the medications were kept was locked, that only the 
Respondent and his office manager had a key, that the room had a steel 
reinforced door and steel doorframe with a deadbolt, that Respondent's 
office was protected by a security system, and that there was no 
evidence that the room `was used for any purpose other than to store 
controlled substances . . . .' '' Id.
    Unlike Dr. Kelly, who occasionally set out medications in a room 
that was only used to store controlled substances so that his office 
manager could administer the medication to early arriving patients, 
Respondent had controlled substances continually strewn all about her 
office. FF 3; see GE-5; GE-11, at 7-9. Even though Respondent stated in 
a sworn interview that *[. . .] *L her office is protected 
by an alarm system,\14\ the area where she was storing her controlled 
substances was her actual office, it was not an area set aside for the 
storage of controlled substances.\15\ *[I am omitting a section of the 
RD and footnote 20 based on relevance and omitting the RD's analysis 
related to marijuana under Factors 2 and 4.\16\
---------------------------------------------------------------------------

    \*L\ [The ALJ found that Respondent had stated during her 
interview that she always kept her office locked, but I do not find 
that the record supports this statement. She stated that when she 
was in her previous office (before she moved her office to her 
home), the door where she ``stored medication, was all the time 
locked . . . . See right now it's my house, so I'm-I'm only there, 
uh-uh, with my husband, and I have an alarm system . . . . But I had 
in mind to change the lock.'' GE-12, at 78. When SA 1 pointed out 
that there could be patients that walk by the office unsupervised, 
Respondent stated, ``[y]eah, the door is . . . . locked all--I mean 
closed at all times.'' Id. at 81. The exhibit supports that if there 
was a lock on the office door, Respondent was only keeping it closed 
at all times, not locked, and whatever lock might have been on the 
door for some reason needed to be changed. Further, although 
Respondent claimed that for her office, ``[e]very time you open the 
door, there's a sensor, so it makes a noise and it communicates to 
my phone,'' GE-12, at 79, there was also a large window depicted in 
the pictures of her office, for which she did not describe any 
security. GE-5, at 1. Even if I could take the security measures 
that she described as true, her office does not appear to be similar 
to a locked room dedicated to the storage of controlled substances, 
and most importantly, she was specifically told that her security 
was inadequate and did nothing to remedy it. The record does not 
support a finding that Respondent's office could constitute a locked 
cabinet in order to comply with DEA regulations.]
    \14\ Because the DEA was not a party to the proceeding in which 
Respondent gave this sworn statement concerning the security of her 
office, the weight that can be given to the statement is 
``substantially diminished.'' Lon F. Alexander, M.D., 82 FR 49,704, 
49,730 n.54. (2017).
    \15\ *[omitted. It is noted that there was also evidence that 
contradicted her off-the-record claims about the level of security 
of her home in that there was a suitcase of marijuana about which 
she allegedly had no knowledge in her garage, and she felt the need 
to have three firearms for protection from her ex-husband.]
    \16\ In its Post-Hearing Brief, the Government has made no 
distinction between how Respondent should have been storing the 
Schedule III-V controlled substances found in her office and the 
marijuana, none of which was found in her office. ALJ-50, at 18-19. 
While the OSC specifically addresses Respondent's failure to 
properly store controlled substances, ``including marijuana,'' ALJ-
1, at 2, para. 5, with respect to storage the Government's Post-
Hearing Brief focused only upon ``the controlled substances that 
were located in her office.'' ALJ-50, at 19. Rather than addressing 
marijuana as a storage concern, in its Post-Hearing Brief the 
Government argues, for the first time, that Respondent's possession 
of marijuana should be considered under Factor 5. ALJ-50, at 21. 
*[The RD stated that ``[t]he Government also seemingly alleged that 
[Respondent] violated 21 CFR 1301.75(a) by failing to keep 
marijuana, a Schedule I controlled substance, `in a securely locked, 
substantially constructed cabinet.' '' RD, at 32 (citing ALJ-1, at 
2, para. 5). I find that the OSC was unclear as to the legal basis 
of the allegation related to marijuana; therefore, I am omitting the 
RD's analysis under Factors 2 and 4 about whether the storage 
requirement would apply to the marijuana in Respondent's home as 
irrelevant.]
---------------------------------------------------------------------------

    Furthermore, the evidence on the record demonstrates that 
Respondent was fully on notice that her office did not constitute 
adequate secure storage under DEA regulations, because she was informed 
of that fact by both SA 1 and DI 1 on March 13, 2014, and she made no 
effort to correct this violation by June 13, 2014. FF 20 & 21.]
    Accordingly, the allegation contained in Paragraphs 3 and 5 of the 
OSC that Respondent violated 21 CFR 1301.75(b) on both March 13, 2014, 
and June 13, 2014, when investigators found a variety of controlled 
substances located on open shelves, on top of the office copier or 
desk, and in unlocked glass cabinets in Respondent's office is 
sustained. These sustained allegations weigh in favor of revoking 
Respondent's registration, and denying her pending application. 
*[Omitted, see infra n.16].17 18
---------------------------------------------------------------------------

    \17\ *[Omitted]
    \18\ *[Omitted]
---------------------------------------------------------------------------

Recordkeeping

    The Government next alleges that Respondent failed to ``maintain 
complete and accurate records,'' in violation of Cal. Bus. & Prof. Code 
Sec.  2266; Cal. Health & Safety Code Sec.  11190; 21 U.S.C. 827(a)(1), 
and (a)(3); 21 U.S.C. 842(a)(5); 21 CFR 1304.03(b), 1304.04(a), 
1306.04, 1304.11(c), 1304.21(a), and 1304.22(c). ALJ-1, at 2, paras. 4-
5. Specifically, the Government contends that during the March 
inspection and June search, investigators were unable to find an 
initial inventory; biennial inventory; 222 Forms; or dispensing log, 
for Respondent's controlled substances. Id. The Government claims that 
the only records Respondent provided to investigators ``were a series 
of invoices from on or about May 23, 2013 through March 13, 2014.'' Id. 
The Government also alleges that the controlled substances inventoried 
in Respondent's office in June varied from what was counted in March, 
and that Respondent failed to account for the discrepancies through the 
production of dispensing records, in violation of 21 CFR 1304.22(c) and 
1306.04, and Cal. Health & Safety Code Sec.  11190. ALJ-1, at 3, para. 
6.
Inventories
    Registrants are required to keep inventories for two years from the 
date of their creation. Margy Temponeras, M.D., 77 FR 45,675, 45,678 
(2012) (citing 21 U.S.C. 827(b)); 21 CFR 1304.04(a). Respondent changed 
her registered address on September 26, 2013, to 22391 Sunbrook, 
Mission Viejo, California, the location that investigators searched in 
March and June of 2014. Stip. 4; GE-1, at 4. At the time of executing 
both the AIW and search warrant, two years had not lapsed from the date 
that Respondent changed her registered location to her residence in 
Mission Viejo. Thus, Respondent should have had an initial inventory 
available for inspection if it existed. 21 U.S.C. 827(b); 21 CFR 
1304.04(a); see also Zvi H. Perper, M.D., 77 FR 64,131, 64,141 (2012) 
(finding that ``Respondent failed to conduct the required initial 
inventory after moving to a new practice location'').\19\
---------------------------------------------------------------------------

    \19\ 21 CFR 1304.11(a) requires that ``[a] separate inventory 
shall be made for each registered location . . . .''
---------------------------------------------------------------------------

    During the March inspection, DI 1 asked Respondent to provide the 
initial and biennial inventories of controlled substances used at her 
registered address. FF 14. Respondent did not

[[Page 16774]]

provide them.\20\ Id. Although DI 1 could not recall if she requested 
the initial inventory again in June, she testified that Respondent did 
not provide one at that time. Tr. 39; GE-14. If Respondent had created 
an initial inventory, it is not in the Administrative Record. In fact, 
there is no evidence in the record indicating that Respondent ever 
provided DEA with copies of her initial inventory.
---------------------------------------------------------------------------

    \20\ *[Omitted footnote. The ALJ did not sustain the allegation 
related to the biennial inventory and I agree.]
---------------------------------------------------------------------------

    Although there is no direct evidence that Respondent failed to 
create an initial inventory of the controlled substances she maintained 
at her Mission Viejo address,\21\ the fact that Respondent did not 
provide an inventory to the investigators and has not produced one 
during the course of these proceedings strongly suggests that 
Respondent never took an initial inventory at that location. See Odette 
L. Campbell, M.D., 80 FR 41,062, 41,078 (2015) (reasoning that 
investigator's inability to find 222 Forms and registrant's failure to 
provide them demonstrates non-compliance). Further, inventories must be 
made ``available . . . for inspection and copying'' upon request by DEA 
investigators, which Respondent failed to do when requested by DI 1. 21 
U.S.C. 827(b); Tr. 24, 39.
---------------------------------------------------------------------------

    \21\ The DI testified that she asked Respondent for her initial 
and biennial inventories, and not whether she ever made an initial 
inventory in the first place. See Tr. 24-25; Margy Temponeras, M.D., 
77 FR 45,675, 45,678 (2012) (noting respondent admitted to state 
inspector that an initial inventory had never been made).
---------------------------------------------------------------------------

    Accordingly, the allegation that Respondent failed to maintain an 
initial inventory, in violation of 21 U.S.C. 827(b) and 21 CFR 
1304.04(a), as alleged in paragraph 4 of the OSC, is sustained. This 
sustained allegation weighs in favor of revoking Respondent's 
registration, and denying her pending application. *[Omitted].
Dispensing Logs
    One of a registrant's recordkeeping responsibilities under Federal 
law includes the requirement to document each instance in which the 
registrant dispenses a controlled substance to a patient.\22\ 21 CFR 
1304.22(c). Stated differently, registrants must document dispensing 
activity \23\ by maintaining ``complete and accurate'' dispensing logs. 
21 U.S.C. 827(a)(3); 21 CFR 1304.22(c). To be compliant, a dispensing 
log must include, among other things: ``the name of the substance;'' 
``the name and address of the person to whom [the substance] was 
dispensed;'' ``the date of dispensing;'' and ``the number of units or 
volume dispensed.'' Id. at Sec.  1304.22(a)(2)(i), (c). California law 
imposes similar requirements on practitioners to document information 
such as the patient's name, address, and telephone number, as well as 
certain details about the substance, when the practitioner dispenses 
controlled substances in Schedules II, III, or IV. Cal. Health & Safety 
Code Sec.  11190(c)(1).
---------------------------------------------------------------------------

    \22\ The Government's Post-Hearing Brief provides little in the 
way of argument or analysis on this issue. The Government addresses 
this allegation in one sentence and without any citations to DEA 
decisions. ALJ-50, at 18-19.
    \23\ For purposes of Section 1304.22(c), ``dispensing'' refers 
to a situation where the registrant transfers the controlled 
medication from the registrant's possession directly to the patient. 
Margy Temponeras, M.D., 77 FR 45,675, 45,676, 456,86 (2012) 
(describing how registrant purchased controlled substances for her 
practice location and then dispensed the medication from that 
location to patients, and discussing the requirements of Section 
1304.22).
---------------------------------------------------------------------------

    The record shows that DI 1 asked Respondent for her dispensing logs 
on March 13, 2014, and Respondent did not provide any. FF 12, 14. 
Respondent said the dispensing logs were at her mother-in-law's home in 
Lake Forest, California. FF 14. DI 1 again requested dispensing records 
at the time of conducting the June search, and again DI 1 testified 
that Respondent failed to provide investigators with her dispensing 
logs or tell them where such records were kept.\24\ FF 38. Likewise, DI 
2 testified that investigators asked Respondent in both March and June 
for her dispensing records and that she never provided any. Tr. 128, 
132, 322.
---------------------------------------------------------------------------

    \24\ Although being handcuffed during the search may have 
prevented Respondent from retrieving her dispensing log and handing 
it over to investigators, Respondent could have told them where to 
find it. Tr. 110, 312.
---------------------------------------------------------------------------

    Although DI 1 and DI 2 testified they never received a dispensing 
log from Respondent, Tr. 24, 35-36, 39, 49-50, 128, 132, the property 
receipt from the June 2014 search indicates that a ``Class III Med 
log'' was seized from Respondent's office. GE-14, at 9. The Government 
did not introduce the ``Class III Med log'' into evidence. At the 
hearing, however, Respondent produced a 10-page photocopied document 
that she testified was seized during the search. Tr. 302-03; RE-1. 
``Class III Meds Dispensing Log'' is written on the cover of the 
exhibit. RE-1, at 1. Respondent testified that she received copies of 
the document in 2016 from the district attorney prosecuting her 
criminal case.\25\ Tr. 302-03. DI 1 and DI 2 testified that they had 
never seen the document before. Tr. 318, 322.
---------------------------------------------------------------------------

    \25\ I admitted the document into evidence over Government's 
objection even though Respondent failed to disclose in her 
prehearing statements that she intended to introduce the document 
into evidence. Tr. 303-04. While Respondent offered her inexperience 
for her failure to disclose the document, the Government knew of the 
document's existence. Tr. 305; GE-14, at 9. In fact, the log is 
identified in the Government's own exhibit. See GE-14, at 9, and 
supra note 9.
---------------------------------------------------------------------------

    Assuming Respondent's Exhibit 1 is Respondent's dispensing log, it 
fails to satisfy her recordkeeping responsibility under Section 
1304.22(c) for a number of reasons. First, it fails to explain the 
variances discovered in Respondent's office stock between March and 
June 2014 when investigators counted the controlled substances on-hand 
in her home office. The DI testified that ``[t]here were missing 
controlled substances'' in June compared to the inventory taken in 
March. Tr. 40-41, 57-58. DI 1 characterized the discrepancy as 
significant. Tr. 40. DEA precedent establishes that the inability to 
account for controlled substances missing from a registrant's inventory 
by production of dispensing records constitutes a violation of Section 
1304.22(c). Paul Weir Battershell, N.P., 76 FR 44,359, 44,366-67 
(2011). In other words, a practitioner violates DEA regulations where 
she is unable to produce dispensing records explaining overages or 
shortages in the practitioner's supply of controlled substances. Id. at 
44,366 n.23. For example, in Daniel Koller, D.V.M., the Administrator 
found a violation of 21 CFR 1304.22(c) where respondent failed to 
provide dispensing records notwithstanding the fact that respondent 
possessed controlled substances at his home and was dispensing 
controlled substances from that location. 71 FR 66,975, 66,982 (2006). 
Such is the case here.
    Comparing Respondent's Exhibit 1 to the inventories taken during 
the March and June searches reveals that Respondent's dispensing log 
fails to account for several controlled substances. RE-1; GE-3; GE-14, 
at 11-12; see Paul Weir Battershell, N.P., 76 FR at 44,366 n.23 
(finding violation where missing controlled substances could not be 
accounted for by dispensing records); Satinder Dang, M.D., 76 FR 
51,424, 51,429 (2011) (deeming it inconsistent with the public interest 
where dispensing logs failed to include all instances of dispensing). 
Here, Respondent's Exhibit 1 fails to explain the discrepancies found 
in Respondent's stock of the following substances: 360 tablets of 
alprazolam; 22 tablets of diethylproprion; *[57.5] tablets of 
hydrocodone 10/325 mg; 60 tablets of hydrocodone 7.5/200 mg; 90

[[Page 16775]]

tablets of temazepam; and 90 tablets of zolpidem tartrate.\26\
---------------------------------------------------------------------------

    \26\ Investigators counted 750 tablets of alprazolam in March 
and 0 tablets in June, and Respondent's Exhibit 1 indicates 390 
tablets were dispensed between those dates, meaning 360 tablets of 
alprazolam are not accounted for in Respondent's Exhibit 1. GE-3, at 
1; GE-14, at 11-12. Investigators counted 106 tablets of 
diethylproprion in March and 0 tablets in June, and Respondent's 
Exhibit 1 indicates 84 tablets had been dispensed between those 
dates, meaning 22 tablets of diethylproprion are not accounted for 
in Respondent's Exhibit 1. GE-3, at 2; GE-14, at 11-12. 
Investigators counted *[462] tablets of hydrocodone 10/325 mg in 
March and 344.5 tablets in June, and Respondent's Exhibit 1 
indicates 60 tablets had been dispensed between those dates, meaning 
*[57.5] tablets of hydrocodone 10/325 mg are not accounted for in 
Respondent's Exhibit 1. GE-3, at 1; GE-14, at 11. Investigators 
counted 60 tablets of hydrocodone 7.5/200 mg in March and 0 tablets 
in June, and Respondent's Exhibit 1 indicates 0 tablets had been 
dispensed between those dates, meaning 60 tablets of hydrocodone 
7.5/200 mg are not accounted for in Respondent's Exhibit 1. GE-3, at 
1; GE-14, at 11-12. Investigators counted 263 tablets of temazepam 
in March and 173 tablets in June, and Respondent's Exhibit 1 
indicates 0 tablets had been dispensed between those dates, meaning 
90 tablets of temazepam are not accounted for in Respondent's 
Exhibit 1. GE-3, at 1; GE-14, at 11. Investigators counted 360 
tablets of zolpidem tartrate in March and 0 tablets in June, and 
Respondent's Exhibit 1 indicates 270 tablets had been dispensed 
between those dates, meaning 90 tablets of zolpidem are not 
accounted for in Respondent's Exhibit 1. GE-3, at 1; GE-14, at 11-
12. See infra pp. 41-44.
---------------------------------------------------------------------------

    To the extent that there are unresolved discrepancies between the 
controlled substances counted during the March inspection and the June 
search, the logical conclusion based on the lack of additional 
dispensing records in evidence is that Respondent failed to maintain 
the required records. Notwithstanding Respondent's Exhibit 1, the fact 
that investigators never found other dispensing records that could 
reconcile the variances between March and June, despite asking multiple 
times for her dispensing logs, is ``persuasive proof of non-
compliance.'' Odette L. Campbell, M.D., 80 FR at 41,078. Where 
investigators are unable to find dispensing records for certain 
medications, it is reasonable to infer that such records were never 
created. Id. Further, whether the discrepancies ``are attributable to 
outright diversion'' or simply ``the failure to maintain accurate 
records,'' is not relevant. Ideal Pharmacy Care, Inc., d/b/a Esplanade 
Pharmacy, 76 FR 51,415, 51,416 (2011). What matters to the public 
interest inquiry is the fact that Respondent could not account for a 
significant number of controlled substances by adequate documentation. 
Id.
    Second, Respondent's Exhibit 1 does not contain patient addresses 
or phone numbers, as required by 21 CFR 1304.22(c) and California law. 
RE-1, at 2-10; Cal. Health & Safety Code Sec.  11190(c)(1); Satinder 
Dang, M.D., 76 FR at 51,429 (dispensing records lacked patient 
addresses). Finally, Respondent's Exhibit 1 does not contain dispensing 
information going back to the date that Respondent relocated her office 
to her home, as required by DEA's inventory regulations. Paul H. 
Volkman, 73 FR 30,630, 30,643-44 (2008) (DEA unable to locate 
dispensing records for one year); Edmund Chein, M.D., 72 FR 6580, 6593 
(2007) (dispensing log covered only seven months); 21 CFR 1304.04(a). 
In fact, Respondent's Exhibit 1 documents about 70 instances of 
dispensing over a period of 6 months. RE-1, at 2-10. While Respondent 
indicates in her post-hearing brief that she documented instances of 
dispensing in patient charts and not a separate dispensing log, ALJ-51, 
at 14, even if true, that statement cannot be treated as evidence. See 
supra note 11. Additionally, Respondent never provided testimony on 
this point while under oath \27\ at the hearing and did not introduce 
any patient charts demonstrating that she did in fact record the 
dispensing of controlled substances in patient charts.*M 
Without any evidence in the record supporting Respondent's post-hearing 
contention, the Government's evidence on this allegation stands 
unrebutted.
---------------------------------------------------------------------------

    \27\ Although Respondent did not offer this argument in her 
sworn testimony at the hearing, she did explain to SA 1 in the April 
interview, which was under oath, that she documented dispensing of 
controlled substances in patient charts. GE-12, at 69. I cannot 
consider Respondent's statement as evidence, however, because it was 
not made at the DEA's hearing. See Lon F. Alexander, M.D., 82 FR 
49,704, 49,730 n.56 (2017) (``[A] respondent is required to present 
his evidence in the Agency's proceeding.'').
    \*M\ [I agree with the ALJ and find that his analysis here 
addresses the same argument that Respondent made in her Exceptions. 
Resp Exceptions, at 19.]
---------------------------------------------------------------------------

    Failure to provide DEA with accurate records which correctly 
reflect the controlled substances dispensed by a registrant constitutes 
a recordkeeping violation and is *[evidence that Respondent's 
registration is] inconsistent with the public interest. The Medicine 
Shoppe, 79 FR 59,504, 59,516 (2014) (citing Jack A. Danton, D.O., 76 FR 
60,900, 60,919 (2011)). In light of the foregoing, the allegation that 
Respondent failed to maintain ``complete and accurate'' dispensing 
records, as set forth in paragraph 4 of the OSC, in violation of 21 
U.S.C. 827(a)(3), 21 CFR 1304.22(c), and Cal. Health & Safety Code 
Sec.  11190, is sustained. This sustained allegation weighs in favor of 
revoking Respondent's registration and denying her pending application.
Receiving Records
    The Government's next recordkeeping allegation concerns receiving 
records. ALJ-1, at 2, para. 4. Specifically, the Government contends 
that Respondent was unable to provide any receiving records, such as 
DEA 222 Forms, to investigators in March and June 2014, other than a 
series of invoices, in violation of 21 U.S.C. 827 and 842(a)(5), and 21 
CFR 1304.21(a). ALJ-1, at 2, para. 4.
    During the inspection in March 2014, DI 1 requested recordkeeping 
documents from Respondent, specifically invoices. FF 17. The invoices 
that Respondent provided are contained in Government Exhibit 2. Id. 
Those invoices show that between May 23, 2013, and March 7, 2014, 
Respondent received the following controlled substances:

------------------------------------------------------------------------
                                    Total quantity
      Controlled substance             received            Reference
------------------------------------------------------------------------
Hydrocodone 10/325 mg...........  300 tablets.......  GE-2, at 1-3.
Phentermine 37.5 mg.............  2,520 tablets.....  GE-2, at 1-3; 4, 6-
                                                       7; 5.
Furosemide 20 mg................  2,000 tablets.....  GE-2, at 8-9.
Testosterone 100 mg/ml 10 ml....  3 vials...........  GE-2, at 11.
Testosterone Propionate 100 mg/   4 vials...........  GE-2, at 11.
 ml 10 ml.
Stanozolol 50 mg/ml 10 ml.......  3 vials...........  GE-2, at 11.
Tri-Testosterone 200/50/200 mg/   6 vials...........  GE-2, at 11.
 ml 10 ml.
Anastrozole 1 mg................  1,350 tablets.....  GE-2, at 12-18.
Fluoxetine 20 mg................  300 tablets.......  GE-2, at 12-14.
Clonidine .1 mg.................  600 tablets.......  GE-2, at 15, 17-
                                                       18.
------------------------------------------------------------------------


[[Page 16776]]

    On March 13, 2014, however, Respondent possessed quantities of 11 
different controlled substances for which she had no invoices, and she 
also possessed 462 tablets of hydrocodone. Compare GE-3, at 1-2, with 
the above table. Based on the controlled substances that were counted 
in the office during the inspection, Respondent should have had more 
invoices than the 9 invoices she provided.\28\ FF 18.
---------------------------------------------------------------------------

    \28\ Government Exhibit 2 consists of 18 invoices, but several 
of the invoices are duplicates.
---------------------------------------------------------------------------

    While the Government also alleged that Respondent did not produce 
any DEA 222 Forms, none of the investigators provided any testimony 
regarding 222 Forms. Based on the testimony of all four investigators, 
it is not possible to discern whether they were looking for 222 Forms, 
whether Respondent should have kept 222 Forms, or whether they asked 
for receiving records other than invoices. Furthermore, Respondent did 
not possess any Schedule I or II controlled substances on March 13, 
2014. See GE-3, at 1-2. Since DEA 222 Forms are only used to order 
Schedule I and II controlled substances, there is no evidence before me 
suggesting that Respondent was missing any DEA 222 Forms. See 21 CFR 
1305.03.
    Accordingly, the allegation that Respondent failed to maintain 
receiving records, as alleged in paragraph 4 of the OSC, in violation 
of 21 CFR 1304.21(a), is sustained. This sustained allegation weighs in 
favor of revoking Respondent's registration, and denying her pending 
application. The allegation that Respondent failed to maintain DEA 222 
Forms, however, as alleged in paragraph 4 of the OSC, is not sustained, 
because Respondent did not possess any Schedule I or II controlled 
substances on March 13, 2014.
Variance
    The Government also alleged that when Respondent's controlled 
substances were inventoried on June 13, 2014, she was unable to account 
for some of the controlled substances that she possessed on March 13, 
2014. ALJ-1, at 3, para. 6. Specifically, the Government alleges that 
Respondent was not able to account for:

25 bottles of Alprazolam 1 mg, containing 30 tablets (750 tablets)
10 bottles of Clonazepam 1 mg, containing 30 tablets (300 tablets)
3 bottles of Diethylpropion HCI 25 mg, containing 28 tablets (84 
tablets)
3 bottles of Hydrocodone 10/325 mg, containing 30 tablets (90 
tablets)
2 bottles of Hydrocodone/IBU 7.5/200 mg, containing 30 tablets (60 
tablets)
64 bottles of Phentermine 37.5 mg, containing 30 tablets (1,920 
tablets)
3 bottles of Temazepam 30 mg, containing 30 tablets (90 tablets)
12 bottles of Zolpidem 10 mg, containing 30 tablets (360 tablets)
10 vials of various anabolic steroid and testosterone-related 
products

Id. The Government did not allege that Respondent's inability to 
account for these controlled substances was an independent violation of 
law or regulations, but asserted that she was unable to account for the 
controlled substances because she did not have any dispensing logs. Id. 
In support of this allegation the Government cited to 21 CFR 
1304.22(c), 21 CFR 1306.04, and Cal. Health and Safety Code Sec.  
11190. Id.
    It is the Government's responsibility to `` `sift through the 
records and highlight that information which is probative of the issues 
in the proceeding.' '' Top RX Pharmacy, 78 FR 26,069, 26,069-70 n.7 
(2013) (quoting Gregg & Son Distribs., 74 FR 17517, 17517-18 n.1 
(2009)); see also James William Eisenberg, M.D., 77 FR 45,663, 45,674 
n.47 (2012). To prove the variance, the Government introduced 
Government Exhibits 3 and 14. In addition, the Government presented 
testimony that in comparing the quantity of controlled substances that 
Respondent had in her office on March 13, 2014, to those found in her 
office on June 13, 2014, that there was ``[a] fair amount'' fewer 
controlled substances in Respondent's office in June. Tr. 131-32; see 
also ALJ-50, at 7, para. 26. The Government, however, has made 
absolutely no effort to explain how it determined the variances it 
alleged in paragraph 6 of the OSC.
    The following table lists the specific controlled substances the 
Government alleged that Respondent could not account for on June 13, 
2014. The table compares the inventory of those controlled substances 
taken by the DEA on March 13, 2014, with the inventory taken on June 
13, 2014 from Respondent's office. In addition, the table includes the 
number of these controlled substances that Respondent dispensed between 
those two dates, as indicated by her dispensing log that was seized 
during the search on June 13, 2014.
---------------------------------------------------------------------------

    \29\ This column reflects controlled substances reportedly 
dispensed by Respondent between March 13, 2014, and June 13, 2014, 
as reported in Respondent's Exhibit 1. There is no evidence that the 
Respondent received any new controlled substances between March 13, 
2014 and June 13, 2014.
    *N The ALJ noted 810 tablets, but upon review, I 
counted 15 bottles of 30 count and 12 tablets as 462 tablets.

----------------------------------------------------------------------------------------------------------------
                                   AIW on March 13,    Search warrant on
      Controlled substance               2014            June 13, 2014       Dispensed 29          Reference
----------------------------------------------------------------------------------------------------------------
Alprazolam 1 mg.................  750 tablets.......  0 tablets.........  390 tablets.......  GE-3, at 1; GE-14,
                                                                                               at 11-12; RE-1,
                                                                                               at 5-9.
Clonazepam 1 mg.................  300 tablets.......  300 tablets.......  0 tablets.........  GE-3, at 1; GE-14,
                                                                                               at 11.
Diethylpropion 25 mg............  106 tablets.......  0 tablets.........  84 tablets........  GE-3, at 2; GE-14,
                                                                                               at 11-12; RE-1,
                                                                                               at 5.
Hydrocodone 10/325 mg...........  462 tablets *N....  344.5 tablets.....  60 tablets........  GE-3, at 1; GE-14,
                                                                                               at 11; RE-1, at
                                                                                               6.
Hydrocodone 7.5/200 mg..........  60 tablets........  0 tablets.........  0 tablets.........  GE-3, at 1; GE-14,
                                                                                               at 11-12.
Phentermine 37.5 mg.............  616 tablets.......  187 tablets.......  660 tablets.......  GE-3, at 2; GE-14,
                                                                                               at 11; RE-1, at 5-
                                                                                               9.
Temazepam 30 mg.................  263 tablets.......  173 tablets.......  0 tablets.........  GE-3, at 2; GE-14,
                                                                                               at 11-12.
Zolpidem 10 mg..................  360 tablets.......  0 tablets.........  270 tablets.......  GE-3, at 2; GE-14,
                                                                                               at 11-12; RE-1,
                                                                                               at 6-9.
----------------------------------------------------------------------------------------------------------------

    While this table reveals that Respondent could not account for some 
of the controlled substances she was missing on June 13, 2014, the 
numbers are not as large as those alleged by the Government. For 
example, Respondent was not missing any clonazepam, and she actually 
accounted for more phentermine on June 13, 2014, than she started with 
on March 13, 2014.\30\ In addition, while the Government alleged that 
Respondent could not account for

[[Page 16777]]

``10 vials of various anabolic steroid and testosterone-related 
products,'' ALJ-1, at 3, para. 6, the March 13, 2014 inventory lists no 
such products. GE-3, at 1-2. Nevertheless, despite the Government's 
failure to explain where it came up with some of the quantities of 
controlled substances in paragraph 6 of the OSC that it alleged 
Respondent could not account for, the direct comparison detailed in the 
above table demonstrates that on June 13, 2014, Respondent was not able 
to account for ``[a] fair amount'' of the controlled substances she 
possessed on March 13, 2014. Tr. 131.
---------------------------------------------------------------------------

    \30\ Although the Government alleged that Respondent possessed 
1,920 tablets of phentermine on March 13, 2014, ALJ-1, at 3, para. 
6, the inventory that was conducted that day only shows she had 616 
tablets that day. GE-3, at 1. The Government offered no evidence to 
support the allegation that on March 13, 2014, Respondent possessed 
64 bottles of phentermine, each containing 30 tablets. Further, as 
the below table illustrates, Respondent had other controlled 
substances where she had more of those substances on June 13, 2014, 
than she did on March 13, 2014. These overages also cannot be 
explained by evidence in the Administrative Record.

----------------------------------------------------------------------------------------------------------------
                                                                 Search warrant on June
         Controlled substance            AIW on March 3, 2014           13, 2014                Reference
----------------------------------------------------------------------------------------------------------------
Hydrocodone 7.5/500 mg...............  120 tablets............  150 tablets............  GE-3, at 1; GE-14, at
                                                                                          11.
Temazepam 15 mg......................  0 tablets..............  115 tablets............  GE-3, at 1-2; GE-14, at
                                                                                          11.
APAP Codeine 300/30 mg...............  266 tablets............  295 tablets............  GE-3, at 1; GE-14, at
                                                                                          11.
----------------------------------------------------------------------------------------------------------------

    None of the regulations cited by the Government in the OSC, 21 CFR 
1304.22(c), 21 CFR 1306.04, and Cal. Health and Safety Code Sec.  
11190, require that Respondent be able to account for her controlled 
substances. Both 21 CFR 1304.22(c) and Cal. Health and Safety Code 
Sec.  11190 address the requirement to maintain dispensing logs. The 
other cited regulation, 21 CFR 1306.04, addresses the requirements for 
issuing prescriptions and has no relevance to Respondent's inability to 
account for her controlled substances. The inability to account for a 
significant number of dosage units, however, creates a grave risk of 
diversion. The Medicine Shoppe, 79 FR 59,504, 59,516 (2014) (citing 
Medicine Shoppe-Jonesborough, 73 FR 364, 367 (2008) (finding 50 dosage 
units a significant amount)). In this case, because Respondent was 
unable to account for more than 50 dosage units of several controlled 
substances, I find that she was unable to account for a significant 
amount of controlled substances.
    [*Omitted. The violations of law have been considered with regard 
to her lack of complete dispensing logs.] *O
---------------------------------------------------------------------------

    \*O\ [The RD also noted that the OSC had alleged violations of 
21 CFR 1306.04 and Cal. Health & Safety Code Sec.  11350 based on 
Respondent's possession of prescription pill bottles belonging to at 
least five other individuals, L.F., B.S., D.V., J.W., and D.D. RD, 
at 44-45 (citing ALJ-1, at 3, para. 7). I am omitting this section, 
but I agree with the RD that there is not substantial evidence on 
the record to support these allegations. Id.]
---------------------------------------------------------------------------

Illegal Prescribing to Self and to S.P.

    The Government next alleged that Respondent unlawfully issued over 
75 prescriptions between February 16, 2010, and July 13, 2015.\31\ ALJ-
1, at 3, para. 8. The Government alleges that the prescriptions for 
controlled substances that Respondent issued to herself and to her 
husband, S.P., during this period were issued for ``other than a 
legitimate medical purpose or outside the usual course of professional 
practice.'' Id.
---------------------------------------------------------------------------

    \31\ The Government did not address any prescription written on 
July 13, 2015. The most recent prescription the Government 
identified during the hearing was written by Respondent to her 
husband, S.P., on September 16, 2014. GE-8, at 27.
---------------------------------------------------------------------------

    Under the Controlled Substances Act (``CSA''), it is unlawful for a 
person to distribute controlled substances, except as authorized under 
the CSA. 21 U.S.C. 841(a)(1). To combat abuse and diversion of 
controlled substances, ``Congress devised a closed regulatory system 
making it unlawful to manufacture, distribute, dispense, or possess any 
controlled substance except in a manner authorized by the CSA.'' 
Gonzales v. Raich, 545 U.S. 1, 13 (2005). To maintain this closed 
regulatory system, controlled substances may only be prescribed if a 
DEA registrant writes a valid prescription. Carlos Gonzalez, M.D., 76 
FR 63,118, 63,141 (2011). As the Supreme Court explained, ``the 
prescription requirement . . . ensures that patients use controlled 
substances under the supervision of a doctor so as to prevent addiction 
and recreational abuse. As a corollary, [it] also bars doctors from 
peddling to patients who crave the drugs for those prohibited uses.'' 
Gonzales v. Oregon, 546 U.S. at 274 (2006) (citing United States v. 
Moore, 423 U.S. 122, 135, 143 (1975)).
    A controlled substance prescription is not valid unless it is 
``issued for a legitimate medical purpose by an individual practitioner 
acting in the usual course of his professional practice.'' 21 CFR 
1306.04(a). Federal regulations further provide that ``[a]n order 
purporting to be a prescription issued not in the usual course of 
professional treatment . . . is not a prescription within the meaning 
and intent of [21 U.S.C. 829] and . . . the person issuing it[ ] shall 
be subject to the penalties provided for violations of [controlled 
substance laws].'' Id.; see 21 U.S.C. 842(a)(1) (establishing that, 
under the CSA, it is illegal for a person to distribute or dispense 
controlled substances without a prescription, as is required under 21 
U.S.C. 829).
    There are four ways to prove that a practitioner violated the 
prescription requirements of 21 CFR 1306.04(a): (1) By providing expert 
testimony that the prescription was not issued for a legitimate medical 
purpose or in the usual course of professional practice; (2) by showing 
that a practitioner violated ``a state medical practice standard which 
is sufficiently tied to a state law finding of illegitimacy to support 
a similar finding under Federal law''; (3) by demonstrating that the 
respondent ``knowingly diverted drugs''; and/or (4) by showing that the 
respondent violated a state medical practice standard ``which has a 
substantial relationship to the CSA's purpose of preventing substance 
abuse and diversion.'' Jack A. Danton, D.O., 76 FR 60,900, 60,901 
(2011); see also Joe W. Morgan, D.O., 78 FR 61,961, 61,978 (2013).
    In this case, the Government has presented evidence that touches on 
two of the four methods of proving a violation of 21 CFR 1306.04(a). 
First, the Government presented the expert testimony of Dr. Munzing 
that the prescriptions that Respondent issued to both herself and S.P. 
were not issued for a legitimate medical purpose and that they were 
also issued outside the usual course of professional practice. FF 55-
62, 64-67. Second, the Government's evidence suggests that by failing 
to properly keep records of the controlled substances Respondent stored 
in her office and the manner in which she prescribed controlled 
substances, she violated state standards which have a substantial 
relationship to the CSA's goal of preventing diversion. See Cal. Health 
& Safety Code Sec. Sec.  11153(a), 11170, and 11190.
California Law
    California law echoes federal standards and provides that ``[a] 
prescription for a controlled substance shall only be issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his or her professional practice.'' Cal. Health & 
Safety Code Sec.  11153(a). State law further adds that prescribing a 
controlled substance without first conducting a proper medical 
examination ``constitutes unprofessional conduct.'' Cal. Bus. & Prof. 
Code Sec.  2242(a). California law prohibits a

[[Page 16778]]

practitioner from prescribing ``a controlled substance for himself.'' 
Cal. Health & Safety Code Sec.  11170.
    California's controlled substance laws set forth several 
requirements related to the documentation and reporting of 
prescriptions. Specifically, California practitioners must document 
certain information when they prescribe or administer a controlled 
substance, depending on the schedule of the drug. Cal. Health & Safety 
Code Sec.  11190. Additionally, failing ``to maintain adequate and 
accurate records relating to the provision of services to [] patients 
constitutes unprofessional conduct.'' Id. at Sec.  2266. *[Omitted.]
Self-Prescribing
    The Government alleged that between February 16, 2010, and November 
29, 2012, Respondent issued at least 40 prescriptions to herself for 
controlled substances ``for office use,'' in violation of 21 CFR 
1306.04(a) and (b), and Cal. Health & Safety Code Sec.  11170. ALJ-1, 
at 3, para. 8(a). It is further alleged that the prescriptions 
Respondent wrote ``for office use'' were without a legitimate medical 
purpose and were written outside the course of professional practice. 
Id.
    DEA regulations prohibit a practitioner from obtaining controlled 
substances ``for the purpose of general dispensing to patients.'' 21 
CFR 1306.04(b). This makes sense in light of the requirement that for a 
prescription to be valid, it must be written for a ``medical purpose'' 
in the ordinary course of professional practice. Id. at Sec.  
1306.04(a). [*Omitted]. Relatedly, under California law, ``[n]o person 
shall prescribe, administer, or furnish a controlled substance for 
himself.'' Cal. Health & Safety Code Sec.  11170; Tr. 134, 200. As for 
the standard of care, Dr. Munzing explained that if a practitioner 
intends to obtain controlled substances for office use, simply writing 
``for office use'' on the prescription is not the proper procedure in 
California.\32\ Tr. 200-01. Dr. Munzing also testified that the 
American Medical Association's Code of Ethics forbids a practitioner 
from prescribing controlled substances to herself. Id. at 200.
---------------------------------------------------------------------------

    \32\ The Administrative Record contains no evidence explaining 
the proper procedure a practitioner must use to obtain controlled 
substances for office use.
---------------------------------------------------------------------------

    Government Exhibit 7 contains 168 prescriptions \33\ authorized by 
Respondent between February 16, 2010, and November 29, 2012, that were 
either written for herself or for office use instead of a particular 
patient. FF 61-62, 65-67; GE-7, at 4, 177. The Government further 
alleged that the prescriptions Respondent issued to herself violated 
DEA's prescription requirement because they lacked a legitimate medical 
purpose and were issued outside the course of professional practice. 
ALJ-1, at 3, para. 8(a) (citing 21 CFR 1306.04(a)). A prescription 
violates Section 1306.04(a) if it lacks a legitimate medical purpose or 
was issued outside the course of professional practice in the 
practitioner's state. United States v. Nelson, 383 F.3d 1227, 1233 
(10th Cir. 2004). At the very least, testimony and documentary evidence 
demonstrate that the prescriptions in Government Exhibit 7 were not 
issued in the course of professional practice. For example, in 
addressing these prescriptions Dr. Munzing testified that it is outside 
the standard of care and the course of professional practice in 
California for a prescription to list ``office use'' instead of the 
patient's name. Tr. 201.
---------------------------------------------------------------------------

    \33\ In its Post-Hearing Brief, the Government asserts that 
Respondent wrote 179 prescriptions to herself, but makes no effort 
to explain how it came up with that number, except citing to 
Government Exhibit 7. ALJ-50, at 8, 17. During the hearing, the 
Government only addressed 168 such prescriptions. I have identified 
each of those prescriptions in my Findings of Fact. See FF 61-62, 
65-67; GE-7, at 4, 177.
---------------------------------------------------------------------------

    At the hearing, the Government directed Dr. Munzing's attention to 
several prescriptions in Government Exhibit 7 that appear to be 
examples of prohibited self-prescribing. Dr. Munzing opined that these 
prescriptions were issued outside the California standard of care. FF 
62. As Dr. Munzing noted at the hearing, these prescriptions do not 
contain any indication they were intended for office use, and instead 
represent instances of Respondent prescribing a controlled drug to 
herself, in violation of California law and the California standard of 
care. FF 57; Tr. 206-10; Cal. Health & Safety Code Sec.  11170. 
[*Omitted.]
    Several of the prescriptions were also issued outside the standard 
of care in California to the extent that they prescribed an extremely 
high number of pills. FF 59-60. Three prescriptions authorized by 
Respondent for herself were written for 300, 450, and 600 tablets of 
phentermine, respectively. FF 59. Phentermine is a Schedule IV 
controlled substance. Stip. 11. Dr. Munzing testified that 600 tablets 
of phentermine is ``an incredibly high number.'' Tr. 213. Further, he 
added that 450 pills of phentermine are excessive, and a prescription 
for 450 phentermine tablets would be outside the standard of care in 
California. Tr. 247-48.
    It is also significant that, according to Dr. Munzing, four of the 
prescriptions Respondent issued to herself contained dosing 
instructions. FF 63. Because dosing instructions are typically tailored 
to the patient's needs at the time of seeing the patient, as opposed to 
when the substance is obtained, the fact that these four prescriptions 
are accompanied with specific dosing directions strongly suggests that 
the prescribed substances were intended to be used by the named patient 
(i.e., Respondent) and not used as office stock from which to supply 
other patients. Tr. 226-27.
    Thus, Dr. Munzing's assessment of the prescriptions in Government 
Exhibit 7 demonstrate that Respondent issued numerous prescriptions 
outside the course of professional practice in California by 
prescribing controlled substances to herself, and in a few instances, 
by prescribing an ``incredibly high number'' of tablets to herself. Id. 
at 213. In evaluating these prescriptions, Dr. Munzing referred 
repeatedly to the standard of care in California and based his expert 
opinion on the assessment that these prescriptions were not issued in 
the course of professional practice. Essentially, Dr. Munzing's 
testimony regarding Government Exhibit 7 overlooked the second aspect 
of the prescription requirement, namely that a prescription must be 
issued for legitimate medical treatment to be valid. The fact that Dr. 
Munzing's testimony focused almost exclusively on only one end of the 
equation, however, is inconsequential. See Wesley Pope, M.D., 82 FR 
14,944, 14,967 n.38 (2017) (explaining ``there is no material 
difference between'' the dual criteria of Section 1306.04(a)). 
Prescribing a controlled substance outside the course of professional 
practice is enough to violate DEA's prescription requirement. Id.
    Further, Respondent's post-hearing attempt to blame the pharmacy 
for incorrectly filling the ``office use'' prescriptions cannot be 
considered as evidence. See supra note 9; ALJ-51, at 15-
16.*P
---------------------------------------------------------------------------

    \* P\ [Respondent argues that the prescriptions to herself were 
the fault of E-Compounding Pharmacy's record systems and that the 
pharmacy ``should have used an invoice and not a prescription number 
when billing [her] orders.'' Resp Exceptions, at 25. Regardless of 
whether the pharmacy also erred in filling these prescriptions in 
this manner, Respondent cannot pass all of the blame on the pharmacy 
and expect that she absolves herself of responsibility. I do not 
find her argument credible that she would have no way of knowing 
that the pharmacy was recording her prescriptions this way. ALJ-51, 
at 15. The evidence contains several fax cover sheets from her 
office, ``Beauty Mark Wellness Center,'' listing prescription orders 
and indicating ``Office Use.'' See e.g., GE-7, at 146, 150, 152, 
160, 166, 171, 173, 175, 177, 178. Further, the evidence also 
includes a prescription signed by Respondent from her prescription 
pad indicating, ``Office Use.'' GE-7, at 164. Therefore, the 
evidence on the record does not support Respondent's contention that 
the blame for the manner in which these prescriptions were recorded 
and filled lies with the pharmacy and not on her, and I agree with 
the ALJ's findings regarding these prescriptions.]

---------------------------------------------------------------------------

[[Page 16779]]

    Accordingly, the allegation that Respondent issued at least 40 
prescriptions to herself for controlled substances between February 16, 
2010, and November 29, 2012, outside the course of professional 
practice and without a legitimate medical purpose, as alleged in 
paragraph 8(a) of the OSC, and in violation of 21 CFR 1306.04(a) and 
(b), and Cal. Health & Safety Code Sec.  11170, is sustained. This 
sustained allegation weighs in favor of revoking Respondent's 
registration and denying her pending application.
Prescribing to S.P.
    The Government also alleged that between April 21, 2012, through 
June 12, 2014,\34\ Respondent issued at least 35 prescriptions \35\ to 
S.P. outside the course of professional practice or for other than a 
legitimate medical purpose, in violation of 21 CFR 1306.04(a), Cal. 
Bus. & Prof. Code Sec.  2242(a), and Cal. Health & Safety Code Sec.  
11153(a). ALJ-1, at 3-4, para. 8(b). Specifically, the Government 
alleged that Respondent issued the prescriptions to S.P. without 
conducting a medical examination or documenting a medical examination 
in S.P.'s patient record.\36\ ALJ-1, at 4, para. 8(b).
---------------------------------------------------------------------------

    \34\ The Government has not identified which prescriptions match 
these dates. Of the prescriptions identified by the Government at 
the hearing, the earliest prescription was written on March 30, 
2012, and the most recent was written on September 16, 2014. GE-8, 
at 27, 67.
    \35\ In its Post-Hearing Brief, the Government asserts that 
Respondent wrote ``approximately 50 prescriptions for controlled 
substances'' to S.P., ALJ-50, at 9, 16, but makes no effort to 
explain how it came up with that number, except citing to Government 
Exhibit 8. See supra note 6.
    \36\ The OSC also alleged that California regulations 
``explicitly provide that the failure to . . . document . . . an 
evaluation in a patient's record, means that the physician is not 
prescribing in the usual course of professional practice.'' ALJ-1, 
at 4, para. 8. Neither the OSC nor the Government's Post-Hearing 
Brief identify any California regulation that supports this 
allegation. ALJ-1, at 4; ALJ-50, at 16. Rather, the Government's 
Post-Hearing Brief focuses on Respondent's failure to produce the 
medical record for S.P. ALJ-50, at 16.
---------------------------------------------------------------------------

    Title 21 CFR 1306.04(a) details the requirements for issuing a 
valid prescription. That section states that for a prescription to be 
effective it ``must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of [her] 
professional practice.'' 21 CFR 1306.04(a). That section further 
provides that ``[a]n order purporting to be a prescription issued not 
in the usual course of professional treatment . . . is not a 
prescription within the meaning and intent of [the Controlled 
Substances Act].'' Id. The Cal. Health & Safety Code Sec.  11153(a) 
closely parallels the language contained in 21 CFR 1306.04(a). 
Furthermore, the Cal. Health & Safety Code Sec.  2242(a) provides that 
``[p]rescribing, dispensing, or furnishing dangerous drugs . . . 
without an appropriate prior examination and a medical indication, 
constitutes unprofessional conduct.''
    Dr. Munzing testified that under the standard of care in 
California, a practitioner must maintain a medical record for a patient 
to whom controlled substances are prescribed. FF 51-53; Tr. 180. 
Specifically, to meet the California standard of care, the patient's 
medical record must contain: Details of the medical exam, such as 
medical history, informed consent, diagnosis, and management plan; 
results of laboratory testing or imaging; PMP reports; and results of 
drug tests. FF 54. Notes pertaining to the medical examination itself 
would likely comprise the bulk of the patient's file, and would narrate 
details of the patient-physician encounter, including: Current 
complaint; review of symptoms; cause of the complaint; patient's 
history of drug and alcohol use; physical examination; and risk and 
benefits of treatment options. Tr. 176-80.
    In this case, the DEA investigators asked Respondent for patient 
charts when they first went to her home on March 13, 2014. FF 10. While 
Respondent did have some patient charts in her home, she did not have 
all of the charts that DEA wanted. FF 11-13. Then again on June 13, 
2014, investigators were in Respondent's home looking for specific 
patient charts, to include a chart for Respondent's husband, S.P. FF 
44; Tr. 107. The chart for S.P. was not located during either the AIW 
or the execution of the search warrant. FF 13, 44. Further, S.P.'s 
patient file is not part of the Administrative Record. As with the 
initial inventory, the fact that Respondent did not provide S.P.'s 
medical file when requested to do so by the investigators and has not 
produced it during the course of these proceedings strongly suggests 
that Respondent never created a medical file for her husband. See 
Odette L. Campbell, M.D., 80 FR 41,062, 41,078 (2015) (reasoning that 
investigator's inability to find 222 Forms and registrant's failure to 
provide them demonstrates non-compliance).
    Here, the Administrative Record demonstrates that between April 21, 
2012, and June 12, 2014, Respondent wrote at least 27 prescriptions for 
controlled substances for S.P. FF 55; GE-8, at 27. Unfortunately, there 
is no medical record documenting that Respondent performed ``an 
appropriate prior examination'' and formulated ``a medical indication'' 
concerning S.P. before issuing him prescriptions for controlled 
substances. See Cal. Health & Safety Code Sec.  2242(a). By issuing 
those 27 prescriptions to S.P., without documenting the required 
medical examination, Respondent engaged in ``unprofessional conduct.'' 
Id. Further, because there is no medical record for S.P., the 27 
prescriptions that Respondent issued to S.P. for controlled substances 
were issued outside the standard of care in California. FF 55.
    Accordingly, that portion of the Government's allegation that 
Respondent wrote 27 prescriptions for controlled substances to S.P. 
outside the course of professional practice and for other than a 
legitimate medical purpose, as alleged in paragraph 8(b) of the OSC, in 
violation of 21 CFR 1306.04(a), Cal. Bus. & Prof. Code Sec.  2242(a), 
and Cal. Health & Safety Code Sec.  11153(a) is sustained. This 
sustained allegation weighs in favor of revoking Respondent's 
registration and denying her pending application. [*Omitted.]

*[Lack of Candor
    The Government alleged that the Respondent's lack of candor during 
the investigation should be considered under Factor Five to provide 
further weight that Respondent's continued registration is not in the 
public interest. ALJ-1, at 4, para. 9. The ALJ considered this evidence 
accordingly under Factor Five, and although I agree with both the ALJ 
and the Government that in prior DEA decisions,*Q I have 
often weighed lack of candor under Factor Five, I find it appropriate 
in this case, given the nature of Respondent's lack of candor, to 
consider this under my sanctions analysis. I am retaining the ALJ's 
analysis of the allegation regarding lack

[[Page 16780]]

of candor and will consider it more thoroughly in the Sanctions below.]
---------------------------------------------------------------------------

    \*Q\ [The RD stated that ``[t]he DEA has consistently held that 
``[c]andor during DEA investigations, regardless of the severity of 
the violations alleged, is considered by the DEA to be an important 
factor when assessing whether a physician's registration is 
consistent with the public interest.'' Hassman, 75 FR at 8236 
(internal citations and quotations omitted); see also Hoxie, 419 
F.3d at 483. For example, the DEA held that a respondent's lack of 
candor weighed against his registration under Factor Five when he 
lied to DEA investigators ``when first confronted'' about his 
wrongful conduct. Scalera, 78 FR at 12,100. The DEA ``places great 
weight on a registrant's candor, both during an investigation and in 
any subsequent proceeding.'' Robert F. Hunt, D.O., 75 FR 49,995, 
50,004 (2010) (citing The Lawsons, Inc., 72 FR 74334, 74338 (2007)). 
Thus, the DEA may consider a respondent's lack of candor to be a 
threat to public health and safety. Annicol Marrocco, M.D., 80 FR 
28,695, 28,705 (2015).'' RD, at 52.]
---------------------------------------------------------------------------

    Here, the Government alleged that Respondent displayed a lack of 
candor during DEA's investigation. ALJ-1, at 4, para. 9. Specifically, 
the Government alleged that in March 2014 Respondent told DEA 
investigators that patient files they requested ``were not there,'' and 
that at least some of the missing files were at a location in Lake 
Forest, California, for which she did not know the address. Id. The 
Government also alleged that during subsequent questioning, Respondent 
again stated that the charts requested by the DEA were at another 
location, and that the dispensing log that DEA requested were with the 
missing charts, but she did not know the location. Id. Finally, the 
Government alleged that in June 2014, Respondent told a Medical Board 
investigator that she did not know who owned the marijuana that was 
found in a suitcase in the garage of her registered location, despite 
the fact that additional stashes of marijuana and large amounts of cash 
were discovered throughout her registered location and she and her 
husband were the only individuals who lived there. Id. \37\
---------------------------------------------------------------------------

    \37\ * [Omitted. I find it unnecessary to consider the 
marijuana, firearms and cash under Factor Five in this case.].
---------------------------------------------------------------------------

    As with any allegation, the Government bears the burden of proof 
regarding its claim that Respondent ``displayed a lack of candor during 
DEA's investigation.'' ALJ-1, at 4, para. 9. Concerning this 
allegation, the Government primarily focuses on statements that 
Respondent made to investigators while they were at her home on both 
March 13, 2014, and June 13, 2014. FF 10, 12, 14, 27, 38, 43, 45.
    When DEA investigators were at Respondent's home on March 13, 2014, 
they asked her for some patient charts. FF 10. While Respondent 
apparently provided some patient charts, which were in her garage, FF 
11, she also told the DEA investigators that other requested patient 
records were at a storage facility in Lake Forest, California, but she 
did not know the address of the facility or where it was located. FF 
12. Respondent had similar conversations with the DEA investigators 
concerning her dispensing logs. FF 14. She informed the investigators 
that her dispensing logs were with the patient records in a storage 
facility. Id. Apparently, these statements were not true.
    In a subsequent interview conducted by Special Agent SA 1, 
Respondent told her that all of the patient charts were located in 
Respondent's garage. FF 27. Subsequently, on June 13, 2014, 
Respondent's dispensing log, what there was of it, was found and seized 
from Respondent's office. GE-14, at 9; RE-1.* R During that 
search, Respondent also told the investigators that her husband's 
medical chart was located in pieces around her house, but the file was 
never found. FF 45. In addition, during the search on June 13, 2014, a 
significant amount of marijuana was found in Respondent's home, though 
none was found in her office. FF 40-41; GE-14, at 4, 14. Despite the 
quantity of marijuana that was seized and the fact that marijuana was 
found in the kitchen and bedroom of Respondent's home, as well as in 
the garage, she claimed she had no knowledge of how it came to be in 
her home. FF 43. All of this evidence is unrebutted.
---------------------------------------------------------------------------

    \*R\ [Respondent notes that ``all three agents testified that 
they never seized the dispensing log of Ex. 1, when in fact they 
did.'' Resp Exceptions, at 20. She implies that the facts 
demonstrate lack of candor on the Government's behalf, rather than 
her own. I disagree. It is clear that the reason that the Government 
did not possess the dispensing log was not adequately explained in 
the record; however, I agree with the ALJ that the testimony that 
the Government witnesses presented was credible that they had not 
seen the log prior to the hearing. I have fully considered the 
dispensing log in Respondent's favor. Regarding Respondent's candor, 
there is unrebutted testimony that Respondent made a variety of 
inconsistent statements about the whereabouts of her records, and 
when Respondent was testifying on cross examination, she avoided 
questions regarding the dispensing log before ultimately saying that 
she did not recall whether or not she provided the dispensing log to 
the investigators. Tr. 309-12. Also, there is no dispute that no 
dispensing log was provided to or located by the investigators in 
March, when the dates on the dispensing log suggest that it existed 
during the AIW. Ultimately, I am not considering Respondent's lack 
of candor under the public interest analysis, but I am considering 
her lack of cooperation with the investigation and inconsistent 
statements in my decision regarding whether she can be entrusted 
with a DEA registration below.]
---------------------------------------------------------------------------

    The Administrative Record established by a preponderance of the 
evidence that Respondent was not truthful in her dealings with DEA 
investigators when they were at her home on March 13, 2014, and again 
on June 13, 2014. When questioned about missing patient charts and 
dispensing records, Respondent initially stated that the charts and 
records were not at her registered location, but rather were at another 
location. She also professed no knowledge of where that location was. 
Later, it was determined that the location was the home of her mother-
in-law, a location she surely knew. Eventually, her dispensing log was 
found in her office, rather than at the home of her mother-in-law. When 
questioned about the marijuana found in her home, Respondent claimed 
she had no idea where it came from. As stated earlier, given the 
quantity and the locations of where the marijuana was found in 
Respondent's home, her claimed lack of knowledge strains credulity.
    Accordingly, the Government's allegation, contained in paragraph 9 
of the OSC, that Respondent displayed a lack of candor during the DEA 
investigation is sustained. *[Omitted. As previously stated, I am 
considering Respondent's lack of candor under the Sanction section 
below.]
*[Lack of State Authority in Florida
    According to Florida's online records, of which I take official 
notice, Respondent's license is ``delinquent.'' * S Florida 
Department of Health License Verification, https://mqa-internet.doh.state.fl.us/MQASearchServices/HealthCareProviders (last 
visited date of signature of this Order). Respondent confirmed that her 
license to practice medicine in Florida had expired. Tr. 307; RE-2. 
Accordingly, I find that Respondent currently is not licensed to engage 
in the practice of medicine in Florida, the state in which Respondent 
has applied to transfer her DEA registration.
---------------------------------------------------------------------------

    \*S\ [Under the Administrative Procedure Act, an agency ``may 
take official notice of facts at any stage in a proceeding--even in 
the final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Registrant may dispute my finding by filing 
a properly supported motion for reconsideration of finding of fact 
within fifteen calendar days of the date of this Order. Any such 
motion shall be filed with the Office of the Administrator and a 
copy shall be served on the Government. In the event Registrant 
files a motion, the Government shall have fifteen calendar days to 
file a response. Any such motion and response may be filed and 
served by email ([email protected]).]
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    According to Florida statute, ``A practitioner, in good faith and 
in the course of his or her professional practice only, may prescribe, 
administer, [or] dispense . . . a controlled substance.'' Fla. Stat. 
Ann. Sec.  893.05(1)(a). Further, ``practitioner,'' as defined by 
Florida statute, includes ``a physician licensed under chapter 458.'' 
Fla. Stat. Ann. Sec.  893.02(23).* T
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    \*T\ [Chapter 458 regulates medical practice.]
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    Here, the undisputed evidence in the record is that Respondent's 
license to practice medicine in Florida is currently delinquent. As 
such, she is not a ``practitioner'' as that term is defined by Florida 
statute. As already discussed, however, a physician must be a 
practitioner to dispense a controlled substance in Florida. Thus, 
because

[[Page 16781]]

Respondent lacks authority to practice medicine in Florida, she is not 
currently authorized to handle controlled substances in Florida. 
Accordingly, I am ordering that Respondent's application for a DEA 
registration in Florida be denied both because granting the application 
would be inconsistent with the public interest and because she lacks 
the requisite state authority.]

Discussion and Conclusions of Law

    With minor modification I have sustained all of the Government's 
allegations against Respondent concerning her: (1) Improper storage of 
controlled substances; (2) failing to maintain proper inventories and 
dispensing logs; (3) improperly prescribing controlled substances to 
herself and ``for office use''; (4) improperly prescribing to S.P. 
without maintaining a medical record for S.P.; and (5) displaying a 
lack of candor during the investigation. In sustaining each of these 
allegations, I have also found that Respondent violated one or more DEA 
regulations, and one or more regulations of the State of California 
relating to the practice of medicine and/or controlled substances. I 
also sustained an allegation that Respondent was unable to account for 
a significant amount of the controlled substances that she had in her 
office in March of 2014 when investigators inventoried the controlled 
substances found in her office on June 13, 2014. Respondent's inability 
to account for those controlled substances is not a separate violation 
of DEA regulations, but rather is a result of failure to maintain 
adequate records as required by both the DEA and the State of 
California. Finally, although the OSC alleged that Respondent had 
violated 21 CFR 1306.04 and the Cal. Health and Safety Code Sec.  11350 
by possessing controlled substances belonging to other individuals, I 
did not sustain that allegation.
    Specifically, I have found that Respondent failed to properly store 
a significant amount of controlled substances that she kept in her 
office in violation of 21 CFR 1301.75(b). Her failure to do so is 
aggravated by the fact that after being advised on March 13, 2014, and 
again on April 4, 2014, that her storage was non-compliant, the 
controlled substances were still improperly stored on June 13, 2014. I 
have also found that Respondent was deficient in that she: Failed to 
maintain an initial inventory of the controlled substances she kept at 
her registered location in violation of 21 U.S.C. 827(b) and 21 CFR 
1304.04(a); failed to maintain complete and accurate dispensing records 
in violation of 21 U.S.C. 827(a)(3), 21 CFR 1304.22(c), and Cal. Health 
& Safety Code Sec.  11190; and that she failed to maintain receiving 
records as is required by 21 U.S.C. 827 and 842(a)(5), and 21 CFR 
1304.21(a). As a result of Respondent's recordkeeping failures, the DEA 
was not able to conduct a reliable audit of the controlled substances 
Respondent stored in her office and she was not able to account for a 
significant amount of her controlled substances, which creates a grave 
risk of diversion. See The Medicine Shoppe, 79 FR at 59,516. 
Respondent's inability to account for a significant amount of 
controlled substances further supports the conclusion that she violated 
federal law by failing to maintain complete and accurate records of 
those controlled substances. Fred Samimi, M.D., 79 FR 18,698, 18,712-13 
(2014).
    In addition, I also found that Respondent had issued numerous 
prescriptions for no legitimate medical purpose and outside the usual 
course of professional practice in violation of 21 CFR 1306.04(a) and 
(b), and Cal. Health & Safety Code Sec.  11170. Specifically, 
Respondent improperly issued 168 prescriptions between February 16, 
2010 and November 29, 2012, that were either written for herself or for 
office use instead of for a particular patient, and between March 30, 
2012 and September 16, 2014, she wrote at least 32 prescriptions for 
controlled substances for S.P. without having a medical record for him. 
Finally, I have found that Respondent was less than candid in her 
dealing with DEA investigators, misleading them concerning the 
existence and/or the location of records and her knowledge about 
marijuana that was found in her home.

Prima Facie Showing and Balancing

    In this case Factors One and Three weigh neither for nor against 
revocation. However, Factors Two and Four strongly weigh in favor of 
revoking Respondent's COR and denying her pending application because 
of her improper storage, improper recordkeeping, and improper 
prescribing to herself and her husband. *[Omitted sentence.] 
Considering the public interest factors in their totality, I find that 
the Government has made a prima facie case showing that Respondent's 
registration is inconsistent with the public interest.
    After the Government presents a prima facie case for revocation, a 
respondent has the burden of production to present ``sufficient 
mitigating evidence'' to show why she can be entrusted with a DEA 
registration. See Medicine Shoppe--Jonesborough, 73 FR 364, 387 (2008) 
(quoting Samuel S. Jackson, D.D.S., 72 FR 23848, 23853 (2007)). To 
rebut the Government's prima facie case and escape sanction, a 
respondent must both accept responsibility for her actions and 
demonstrate that she will not engage in future misconduct. Patrick W. 
Stodola, M.D., 74 FR 20,727, 20,734-35 (2009). Additionally, a 
respondent must introduce evidence of remedial measures. Jeri Hassman, 
M.D., 75 FR 8194, 8235-36 (2010).
    A respondent may accept responsibility by providing evidence of her 
remorse, her efforts at rehabilitation, and her recognition of the 
severity of her misconduct. See Robert A. Leslie, M.D., 68 FR 15,227, 
15,228 (2003). To accept responsibility, a respondent must show ``true 
remorse'' for wrongful conduct. Michael S. Moore, M.D., 76 FR 45,867, 
45,877 (2011). An expression of remorse includes acknowledgment of 
wrongdoing. See Wesley G. Harline, M.D., 65 FR 5665, 5671 (2000). A 
respondent must express remorse for all acts of documented misconduct. 
Jeffrey Patrick Gunderson, M.D., 61 FR 26,208, 26,211 (1996). 
Acceptance of responsibility and remedial measures are assessed in the 
context of the ``egregiousness of the violations and the [DEA's] 
interest in deterring similar misconduct by [the] Respondent in the 
future as well as on the part of others.'' David A. Ruben, M.D., 78 FR 
38,363, 38,364 (2013).
    Here, the Government accurately argued in its Post-Hearing Brief 
that the ``Respondent has not accepted responsibility for her 
actions.'' ALJ-50, at 21. While Respondent presented limited testimony 
to identify Respondent's Exhibits 1 and 2, she presented no testimony 
concerning the allegations contained in the OSC or concerning whether 
she accepted responsibility for her conduct that was proven by a 
preponderance of the evidence. I find, therefore, that Respondent has 
not accepted any responsibility for the allegations that I have 
sustained.\38\
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    \38\ The Government has also urged that I draw an adverse 
inference concerning acceptance of responsibility as well as 
violating Federal and State laws and regulations. ALJ-50, at 22. I 
decline to do so. I decline simply because it is unnecessary to do 
so in this case. Even without the adverse inference the 
preponderance of the evidence establishes each of the allegations I 
have sustained, and the Administrative Record is already devoid of 
any acceptance of responsibility. * [Respondent repeatedly notes in 
her Exceptions that she believes an adverse inference was drawn 
against her for not presenting testimony at the hearing. See Resp 
Exceptions, at 3, 21, 27. It is noted that although the Government 
did request such an inference, the ALJ did not draw one.]

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[[Page 16782]]

    Notwithstanding the fact that the Government has made a prima facie 
case for sanction, imposing a sanction is a matter of discretion. See 
21 U.S.C. 824(a) (``A registration . . . may be suspended or revoked by 
the Attorney General . . . .'') (emphasis added); Martha Hernandez, 
M.D., 62 FR 61,145, 61,147 (1997) (referring to Administrator's 
authority to exercise discretion in issuing the appropriate sanction). 
Even where a respondent does not accept responsibility, the DEA is 
still tasked with determining the appropriate sanction, and will 
examine: (1) ``The egregiousness and extent of a registrant's 
misconduct,'' and (2) the DEA's interest in specific and general 
deterrence. Fred Samimi, M.D., 79 FR 18,698, 18,713-14 (2014); see 
Daniel A. Glick, D.D.S., 80 FR 74,800, 74,810 (2015) (analyzing 
egregiousness and deterrence even though the registrant failed to 
tender an unequivocal acceptance of responsibility); Jacobo Dreszer, 
M.D., 76 FR 19,386, 19,387-88 (2011) (explaining that ``even though the 
Government has made out a prima facie case'' for sanction, the 
registrant remains free to argue that ``his conduct was not so 
egregious as to warrant revocation'').
    When considering whether Respondent's continued registration is 
consistent with the public interest, I must consider both the 
egregiousness of her violations and the DEA's interest in deterring 
future misconduct by both Respondent as well as other registrants. 
David A. Ruben, M.D., 78 FR 38,363, 38,364 (2013). ``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.'' Richard J. Settles, D.O., 
81 FR 64,940, 64,945 n.17 (2016) (quoting Jayam Krishna-Iyer, M.D., 74 
FR 459, 462 (2009)).
    I find that Respondent's multiple and repeated recordkeeping, 
security, and prescribing violations, coupled with her lack of candor, 
are sufficiently egregious to warrant revocation. To begin, 
``[r]ecordkeeping is one of the CSA's central features; a registrant's 
accurate and diligent adherence to this obligation is absolutely 
essential to protect against diversion of controlled substances.'' 
Superior Pharmacy I & Superior Pharmacy II, 81 FR 31,310, 31,321 n.14 
(2016) (quoting Paul H. Volkman, M.D., 73 FR 30,630, 30,644 (2008)). 
Respondent's recordkeeping shortcomings prevented the DEA from being 
able to conduct a reliable audit. Tr. 25. Due to the shortcomings, 
Respondent was unable to account for a significant number of controlled 
substances in June 2014, which creates the risk of diversion. See The 
Medicine Shoppe, 79 FR at 59,516. Respondent's storage violations also 
raise diversion concerns. The physical security of controlled 
substances is required to prevent unlawful diversion. Jerry Neil Rand, 
M.D., 61 FR 28,895, 28,897 (1996).
    In addition, while Respondent wrote 200 illegal prescriptions, only 
a few instances of illegal prescribing can be sufficient to support 
revocation of a registration. For instance, in Alan H. Olefsky, M.D., 
the DEA imposed revocation based on evidence of only two fraudulent 
prescriptions.\39\ 57 FR 928, 928-29 (1992). In James Clopton, M.D., 
the DEA denied the respondent's application on evidence that he wrote 
only four unlawful prescriptions. 79 FR 2475, 2475-77 (2014). Although 
the record contained additional evidence of recordkeeping violations, 
the Administrator viewed the unlawful prescriptions as ``reason alone 
to deny [respondent's] application.'' Id. at 2478. [* Omitted.]
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    \39\ Additionally, in the Olefsky case, the registrant argued in 
his exceptions to the ALJ's recommended ruling that suspension of 
his license was disproportionate to the proven misconduct, which was 
limited to two fraudulent prescriptions presented on one occasion. 
57 FR at 929. The Administrator rejected the registrant's exception 
and ruled that ``[r]evocation [was] an acceptable remedy.'' Id.
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    Further, when determining whether revocation is appropriate, the 
DEA ``places great weight on an [applicant's] candor, both during an 
investigation and in [a] subsequent proceeding.'' Robert F. Hunt, D.O., 
75 FR 49,995, 50,004 (2010). *[Omitted.] [Respondent's found lack of 
candor and inconsistent statements during the investigation 
demonstrates an unwillingness to cooperate with this agency in future 
compliance inspections. Truthful cooperation with agency requests for 
information ensures that agency officials can easily monitor and ensure 
compliance with the CSA and help to correct violations. See Jeffrey 
Stein, M.D., 84 FR 46,968, 46,973 (2019) (finding that a registrant's 
honesty during law enforcement regulations is ``crucial to the Agency's 
ability to complete its mission of preventing diversion within such a 
large regulated population''). In order to entrust Respondent with a 
registration, I need to know that she will not repeat her dishonest 
behavior, and in this case, she has given me no reason to believe that 
I can trust her.
    Furthermore, although Registrant contends that DEA and state 
investigators should have ``point[ed] out any of the mistakes [she] 
made, help[ed] [her] fix her mistakes,'' Resp Exceptions, at 18, the 
evidence on the record demonstrated that even after being explicitly 
told on at least two occasions that her controlled substances required 
additional security, she failed to adequately secure them. As such, I 
cannot be assured that Registrant would amend her behavior in the 
future to avoid repeating the violations found herein.]
    Finally, as well as considering the egregiousness of Respondent's 
violations, I must also consider the DEA's interest in deterring future 
misconduct by both the respondent as well as other registrants. David 
A. Ruben, M.D., 78 FR 38,363, 38,364 (2013). ``Consideration of the 
deterrent effect of a potential sanction is supported by the CSA's 
purpose of protecting the public interest.'' Joseph Gaudio, M.D., 74 FR 
at 10,094. Further, given all of the above facts, I find that 
considerations of both specific and general deterrence weigh in favor 
of revocation in this case.

Recommendation

    The Government established that Respondent's continued registration 
is inconsistent with the public interest because of her improper: 
Storage; recordkeeping; and prescribing; and her lack of candor. Once 
the Government made a prima facie case for sanction, the burden shifted 
to Respondent to demonstrate that she could be entrusted with a DEA 
COR. For her part, Respondent was required to accept responsibility and 
demonstrate remedial measures; however, she failed to accept any 
responsibility for her misconduct. Respondent's failure to acknowledge 
any wrongdoing whatsoever exacerbates the egregiously sub-standard 
manner in which she prescribed controlled substances in this case and 
her total failure to properly store controlled substances after being 
told how to do so. A practitioner who refuses to acknowledge the severe 
deficiencies in her security, recordkeeping, prescribing, and candor 
cannot be entrusted with the ability to continue prescribing controlled 
substances. Accordingly, I RECOMMEND that Respondent's DEA COR, Number 
BM5370123, be REVOKED, and that her pending application, control number 
W15069021C, for renewal or modification of her registration, be DENIED.


[[Page 16783]]


Dated: April 5, 2018.

Charles Wm. Dorman,
U.S. Administrative Law Judge.

[FR Doc. 2021-06583 Filed 3-30-21; 8:45 am]
BILLING CODE 4410-09-P