[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71660-71665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28525]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Zizhuang Li, M.D.; Decision and Order

    On June 10, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Zizhuang Li, M.D. (Applicant), of Leawood, Kansas. GX 5. 
The Show Cause Order proposed the denial of Applicant's application for 
a DEA Certificate of Registration as a practitioner, on the ground that 
his ``registration would be inconsistent with the public interest.'' 
Id. at 1 (citing 21 U.S.C. 823(f)).
    As basis for the denial, the Show Cause Order alleged that ``[o]n 
September 27, 2012, the Mississippi State Board of Medical Licensure 
(Board) found that from April through August 2010, [Applicant] 
prescribed controlled substances, including oxycodone, carisoprodol, 
and alprazolam, outside the course of professional practice to four 
patients.'' Id. Next, the Show Cause Order alleged that the Board found 
that Applicant ``engaged in unprofessional conduct'' by failing ``to 
conduct an appropriate risk/benefit analysis for [his] patients,'' and 
that he also ``failed to document proper written treatment plans.'' Id. 
(citing Miss. Code Ann. Sec. Sec.  73-25-29(8)(d) & (13); 73-25-83(a)). 
The Order then alleged that based on its findings, the Board suspended 
Applicant's medical license for twelve months.\1\ Id.
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    \1\ The Show Cause Order also notified Applicant of his right to 
request a hearing on the allegations or to submit a written 
statement while waiving his right to a hearing, the procedure for 
electing either option, and the consequence of failing to elect 
either option. GX 5, at 2-3 (citing 21 CFR 1301.43).
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    On June 10, 2013, the Government attempted to serve the Show Cause 
Order by certified mail, return receipt requested, addressed to 
Applicant at the address he provided on his application for receiving 
mail from the Agency. GX 6, at 1. However, on July 6, 2013, the 
Government queried the Postal Service's Track and Confirm Web page and 
determined that the mailing had not been accepted.\2\ Accordingly, on 
July 9, 2013, the Government mailed the Show Cause Order to Applicant 
at the same address using first class mail. Id. That same day, DEA also 
emailed an electronic version of the Show Cause Order to two email 
addresses purportedly used by Applicant, including the address which he 
had provided on his application for registration.\3\ Id. Neither email 
was returned as undeliverable or resulted in an error message. Id.
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    \2\ On July 12, 2013, the mailing was returned to DEA and marked 
as ``Return to sender, unclaimed, unable to forward, returned to 
sender.'' GX 6, at 1.
    \3\ Regarding the two email addresses, the Diversion 
Investigator (DI), who investigated the application, ``discovered 
that [Applicant] gave the Board the email address of 
[email protected] . . . [and] [o]n a residential rental 
application in San Diego . . . Applicant listed his email address as 
[email protected].'' GX 4, at 2. The latter is the same email 
address Applicant provided on his DEA application.
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    Based on the above, I find that the Government has complied with 
its obligation ``to provide `notice, reasonably calculated under all 
the circumstances, to apprise [Applicant] of the pendency of the action 
and afford [him] an opportunity to present [his] objections.' '' Jones 
v. Flowers, 547 U.S. 220, 226 (2006) (quoting Mullane v. Central 
Hanover Bank & Trust Co., 339 U.S. 306, 314 (1950)); see also Emilio 
Luna, 77 FR 4829, 4830 n.2 (2012) (``[I]t seems relatively clear that 
when certified mail is returned unclaimed, in most cases, the 
Government can satisfy its constitutional obligation by simply re-
mailing the Show Cause Order by regular first class mail.'') (citing 
Jones, 547 U.S. at 234-35).
    On August 20, 2013, the Government submitted its Request for Final 
Agency Action, along with the Investigative Record. Based on the 
Government's submission, I further find that more than thirty days have 
now passed since service of the Show Cause Order was accomplished, and 
neither Applicant, nor anyone purporting to represent him, has either 
requested a hearing or submitted a written statement in lieu of a 
hearing. 21 CFR 1301.43(a) & (c). Accordingly, I find that Applicant 
has waived his right to a hearing or to submit a written statement. 21 
CFR 1301.43(d). I therefore issue this Decision and Final Order based 
on relevant material contained in the Investigative Record submitted by 
the Government. I make the following findings of fact.

[[Page 71661]]

Findings

Applicant's Registration and Licensure Status

    Applicant previously held three DEA Certificates of Registration, 
pursuant to which he was authorized to dispense controlled substances 
in schedules II through V. GX 2, at 2; GX 3, at 2. Two of the 
registrations (at least one of which was for a location in Mississippi) 
were retired on September 28, 2012, apparently after Applicant 
voluntarily surrendered them. GX 2. As for the third registration, it 
was retired on May 1, 2010. Id. However, there is no evidence 
establishing why this registration was retired.
    On November 16, 2012, Applicant applied for a new registration at 
the proposed registered address of 20265 Valley Boulevard, Suite E, 
Walnut, California. GX 1, at 1. Applicant sought authority limited to 
dispensing controlled substances in schedules IV and V. GX 2, at 1. It 
is this application which is at issue in this matter.
    Applicant also holds a current Physician's and Surgeon's 
Certificate issued by the Medical Board of California. GX 1, at 1. 
Applicant's California license is not due to expire until December 31, 
2013.\4\ Id.
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    \4\ Pursuant to 5 U.S.C. 556(e) and 21 CFR 1316.59, I take 
official notice that on December 28, 2012, the California Board 
issued an Accusation/Petition to Revoke Applicant's state license 
based on the results of the Mississippi Board's action. That matter 
is still pending.
     I have also taken official notice of the fact that Applicant 
voluntarily surrendered his Louisiana medical license (MD.204358) on 
October 8, 2012.
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    Applicant was also licensed by the Mississippi State Board of 
Medical Licensure. However, as found below, on June 8, 2012, the Board 
initiated a proceeding against Applicant, alleging twenty-four counts 
of violations of Mississippi law. GX 3, at 1. Following a hearing on 
September 27, 2012, at which Applicant was represented by counsel, the 
Board suspended his state license for a period of twelve months, which 
was effective immediately. Id. at 23-24. Moreover, ``[n]otwithstanding 
the twelve (12) month period'' of suspension, the Board ordered that 
``Licensee shall not practice medicine in any manner or form, until 
such time as he appears before this Board, [and] submits proof of 
compliance with all requirements set forth in [the] order, as well as 
Miss. Code Ann. [Sec.  ] 73-25-32.'' \5\ Id. at 23. The Board also 
required that Applicant complete courses in controlled substance 
prescribing, recordkeeping, and medical ethics, and that he pay ``all 
costs incurred in relation to the . . . matter . . . not to exceed 
$10,000.'' Id. at 23-24.
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    \5\ This statute provides that ``[a] person whose license to 
practice medicine . . . has been revoked or suspended may petition 
the [Board] to reinstate this license after a period of not less 
than one (1) year has elapsed from the date of the revocation or 
suspension.'' Miss. Code Ann. Sec.  73-25-32(1). The statute further 
requires that the petition ``be accompanied by two (2) or more 
verified recommendations from physicians . . . licensed by the Board 
. . . and by two (2) or more recommendations from citizens each 
having personal knowledge of the activities of the petitioner since 
the disciplinary penalty was imposed and such facts as may be 
required by the Board.'' Id. Sec.  73-25-32(2).
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The Board's Findings

    Based on the evidence presented at the hearing, the Board made 
extensive findings regarding Applicant's prescribing of controlled 
substances to four patients. GX 3, at 1-23. With respect to Patient 
1, a thirty-three year old male, the Board found that 
Applicant issued him twenty-one (21) prescriptions for controlled 
substances (totaling 2,415 dosage units) during the period of April 26 
through August 18, 2010. Id. at 4. The prescriptions included one 
prescription for 60 Percocet 10/650mg, six prescriptions for 945 
oxycodone 30mg, five prescriptions for 450 Xanax 2mg, 600 Soma 
(carisoprodol) 350mg, and four prescriptions for 360 Neurontin 
(gabapentin) 300mg.\6\ The Board further found that Applicant 
repeatedly prescribed multiple drugs to Patient 1 at a visit, 
including Xanax, Soma, and oxycodone. Id. at 5-6.
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    \6\ Carisoprodol did not become a federally controlled substance 
until January 11, 2012, when its placement into schedule IV of the 
Controlled Substances Act became effective. See DEA, Schedules of 
Controlled Substances: Placement of Carisoprodol into Schedule IV, 
76 FR 77330 (2011). However, several DEA final orders had previously 
discussed the abuse of carisoprodol in conjunction with other 
controlled substances, including opiates such as oxycodone and 
hydrocodone, and benzodiazepines, such as alprazolam and diazepam. 
See, e.g., Paul H. Volkman, 73 FR 30630, 30638 (2008) (noting 
expert's testimony regarding prescribing of drug cocktails of a 
narcotic, benzodiazepine, and carisoprodol, and that the cocktail, 
which ``is very popular amongst those individuals who go to doctors' 
offices to take drugs to abuse them,'' also ``increase[s] the 
likelihood of sedation, respiratory depression and death.'') (other 
citations omitted).
     Neurontin (gabapentin) is not a federally controlled substance.
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    The Board then identified multiple failures by Applicant to follow 
its regulations for the ``Use of Controlled Substances for Chronic 
(Non-Terminal) Pain'' in prescribing to Patient 1. These 
included that:
    (1) Applicant ``allowed the patient to dictate his care by 
continually prescribing controlled substances for pain notwithstanding 
[his] recommendation that the patient should have surgery'';
    (2) notwithstanding evidence in the patient's medical record that 
he ``visited multiple pharmacies and physicians in the past,'' the 
record ``contained no record of prior treatment and there [was] no 
information . . . suggesting that [Applicant] conducted an appropriate 
risk/benefit analysis by reviewing his own records . . . or records'' 
of prior treating physicians;
    (3) there was no documentation that Applicant discussed with 
Patient 1 ``taking medication as prescribed'';
    (4) there was no indication that Applicant sought ``outside 
consultation to determine the origin of the patient's pain,'' or 
recommended treatment modalities (beyond prescribing controlled 
substances) other than ``warm baths and heating pads'';
    (5) there was ``only one urine drug screen'' in Patient 
1's chart, which was done at his initial visit and there were 
``[n]o subsequent drugs screens [in] the record to document compliance 
with treatment'';
    (6) Patient 1 ``continued to come early for each visit and 
[Applicant] continued to write prescriptions on each early visit'';
    (7) Patient 1's file ``contained . . . `red flags' 
suggesting possible drug abuse by Patient 1''; and
    (8) Applicant ``issued Patient 1 prescriptions at times 
when [he] should not have finished taking the same medication from a 
previous prescription had the . . . directions been properly followed 
or the correct dosage . . . taken.''

GX 3, at 7-9.
    As for Patient 2, the Board found that from April 6 
through August 9, 2010, Applicant ``issued to [him] twenty four (24) 
prescriptions totaling approximately 2,178 dosage units of controlled 
substances,'' including six (6) prescriptions for 352 Lortab 10/500mg 
(hydrocodone/acetaminophen), six prescriptions for 704 Soma 
(carisoprodol) 350mg, six prescriptions for 704 oxycodone 30mg, and six 
prescriptions for 418 Xanax 2mg. GX 3, at 9. Here again, the Board's 
findings show that Applicant repeatedly dispensed prescriptions for all 
four of these drugs to Patient 2 on a single day.
    The Board then identified multiple failures on Applicant's part in 
complying with its regulations. These included:
    (1) Patient 2's ``chart shows very little physical exam 
conclusions and hardly any pathology . . . which would indicate the 
therapeutic nature for prescribing the particular controlled substances 
in the quantities and strengths so noted'';

[[Page 71662]]

    (2) Applicant noted in the chart that he recommended that Patient 
2 see an orthopedic specialist, yet there was ``no 
documentation or further mention of whether a referral was made or if 
Patient 2 saw an orthopedist'';
    (3) Applicant issued Patient 2 new prescriptions on June 
11, 2010, ``only 18 days after [his] visit on May 24,'' while noting in 
the chart that the visit had occurred on June 21, 2010, and there was 
no explanation in the chart for issuing the prescriptions early, nor 
``any significant change in the verbal pain scale'' to support the 
``increased consumption of the prior issued medications'';
    (4) Applicant ``continued to prescribe controlled substances for 
pain without any analysis regarding the effectiveness of the 
medications'' and there was ``no documentation of other treatment 
modalities (other than recommending warms baths and heating pads)'';
    (5) Applicant ``allowed Patient 2 to dictate his care by 
simply continuing previous prescriptions for controlled substances, 
failing to follow up on his own recommendations regarding referral to 
an orthopedist, and, at a minimum, failing to recognize non-compliance 
by the patient''; and
    (6) Patient 2's chart ``contained indicators or `red 
flags' suggesting possible drug abuse,'' including: (a) Documentation 
suggesting that Patient 2 had previously been terminated for 
noncompliance with a treatment plan by a prior pain management 
physician; (b) a printout from a pharmacy showing that Patient 
2 was obtaining controlled substances from multiple doctors; 
and (c) Applicant ``continued to write new prescriptions for controlled 
substances at a time when the previous prescriptions for the same 
medications would not have been completed had the patient followed'' 
the dosing instructions.

Id. at 11-13.
    With respect to Patient 3, the Board found that from April 
7 through August 2, 2010, Applicant issued twenty-three controlled 
prescriptions to her ``totaling approximately 2,515 dosage units.'' Id. 
These included five prescriptions for 880 Norco (hydrocodone/apap) 10/
325mg, five prescriptions for 600 Soma 350mg, one prescription for 10 
oxycodone 15mg, two prescriptions for 35 oxycodone 30mg, five 
prescriptions for 540 Xanax 2mg, and five prescriptions for 450 
Fiorinal with codeine. Id. Here again, Applicant issued the patient up 
to four controlled substance prescriptions at a single visit. Id. at 
14.
    The Board then identified multiple failures on Applicant's part in 
complying with its regulations. These included:
    (1) That the most recent MRI was five years old, and while it 
showed that Patient 3 had ``degenerative disc and hypertrophy 
issues along with prolapse of L5-S1,'' there was ``no mention of 
consultation or referral to a specialist to attempt other modalities of 
treatment'';
    (2) Applicant ``determined that the best course of treatment was to 
continue the prescriptions previously issued to [her] by prior 
physicians, along with warm baths and use of heating pads''; however, 
``[t]here [was] no . . . justification as to why the patient needed 
this particular combination of medications in these particular 
quantities and strengths'';
    (3) Patient 3's medical record ``contained no psychiatric 
analysis to determine the necessity for the use of Xanax. If the Xanax 
was prescribed for the purpose of muscle relaxation, then there [was] 
no indication to include Soma in the medication regime'';
    (4) Patient 3's file ``contained indicators or `red flags' 
suggesting possible drug abuse by'' her, including that she was driving 
from Kenner, Louisiana to Picayune, Mississippi; that she claimed to 
have gone to the emergency room (ER) for pain related reasons, but 
Applicant did not attempt to verify her claim; and that after Patient 
3 claimed to have gone to the ER, Applicant added oxycodone 
15mg to her medications, and then increased the dosage to 30mg on a 
subsequent visit, even though Patient 3 reported a 
``significant pain reduction and improvement'' during that period; and
    (5) Applicant issued Patient 3 new prescriptions ``at 
times when [she] should not have finished taking the same medication 
from a previous prescription had the prescription directions been 
properly followed.''

Id. at 15-17.
    As for Patient 4, the Board found that from May 19 through 
August 10, 2010, Applicant issued her twelve (12) controlled substance 
prescriptions for a total of approximately 1,290 dosage units. Id. at 
17. These included four (4) prescriptions for 570 Lorcet (hydrocodone/
acetaminophen) 10/650mg, four prescriptions for 480 Soma 350mg, and 
four prescriptions for 240 Xanax 2mg. Id. Here again, Applicant issued 
prescriptions for all drugs at each of her four visits. Id. at 17-18.
    The Board then identified multiple failures on Applicant's part in 
complying with its regulations. These included:
    (1) That while Patient 4 reported a very high pain level 
throughout treatment, ``there was no real analgesic response to the 
medication or improvement in general; and the continued prescribing of 
opiates and other controlled medications for pain was not supported'';
    (2) Patient 4's MRI ``show[ed] some mild degenerative 
changes,'' but was otherwise ``unremarkable'' and did not support ``the 
amount of pain the patient was reporting''; however, ``there [was] no 
outside consultation to determine the etiology of the patient's severe 
pain'';
    (3) there was ``no psychiatric evaluation'' to support the 
prescribing of Xanax, and if ``Xanax was being prescribed for muscle 
relaxation, then there [was] no justification for the additional 
prescribing of Soma'';
    (4) Applicant subjected Patient 4 to a single urine drug 
screen, which occurred at her initial visit; however, given her 
history, ``it was not appropriate to test [her] once at the beginning 
of treatment and not . . . during the treatment'';
    (5) Applicant ``continued the prescriptions previously issued to 
[her] by previous physicians and there [was] no indication or 
justification as to why [she] need[ed] this particular combination of 
medications in these particular quantities and strengths''; Applicant 
also recommended no treatment modalities ``[o]ther than controlled 
substances, warm baths and heating pads'';
    (6) Patient 4's file contained various red flags 
suggesting drug abuse, including that she had been discharged by a 
Louisiana pain clinic for testing positive on multiple occasions for 
drugs she had not been prescribed. The red flags included: (a) An 
incident, four months earlier, when she tested positive for oxycodone, 
which had not been prescribed to her and she admitted that she used her 
husband's Percocet; and (b) two incidents, which had occurred only two 
and three months before Applicant began prescribing to her, in which 
she attempted to use another person's urine during a urine drug screen. 
While Applicant obtained these records the day before he first 
prescribed controlled substances to Patient 4, he did not 
document having discussed these incidents with her; and
    (7) Applicant issued new prescriptions to Patient 4 ``at 
times when [she] should not have finished taking the same medication 
from a previous prescription had the prescription directions been 
properly followed or the correct dosage taken.''

Id. at 18-20.
    Based on these findings, the Board found Applicant guilty of four 
counts of

[[Page 71663]]

``administering, dispensing, or prescribing . . . narcotic drugs, or 
other drugs having addiction-forming or addiction-sustaining liability 
otherwise than in the course of legitimate professional practice.'' Id. 
at 21 (citing Miss. Code Ann. Sec.  73-25-29(3)). It also found 
Applicant guilty of four counts of ``prescribing controlled substances 
or other drugs having addiction-forming or addiction-sustaining 
liability for chronic pain in a non-therapeutic manner.'' Id. at 22 
(citing id. Sec.  73-25-29(13)). The Board further found Applicant 
guilty of four counts of ``prescribing controlled substances for the 
treatment of chronic pain to a patient who has consumed or disposed of 
controlled substances and other drugs having addiction forming or 
addiction sustaining liability other than in strict compliance with 
[his] directions.'' Id. (citing Miss. Code Ann. Sec.  73-25-29(13)).'' 
\7\
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    \7\ In addition, the Board found Applicant guilty of four counts 
of ``failing to conduct an appropriate risk/benefit analysis by 
review of previous medical history which was provided by another 
treating physician, which indicates there is a need for long-term 
controlled substances therapy,'' as well as ``fail[ing] to clearly 
enter into the record the analysis and a consultation/referral 
report which determines the underlying pathology or cause of the 
chronic pain.'' GX 3, at 21 (citing Miss. Code Ann. Sec.  73-25-
29(13)). Finally, the Board found Applicant guilty of four counts of 
``failing to document a written treatment plan which contains stated 
objectives as a measure of successful treatment and planned 
diagnostic evaluations, e.g., psychiatric evaluation or other 
treatments.'' Id. at 21-22 (citing Miss. Code Ann. Sec.  73-25-
29(13)).
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    The Board also found that during his testimony, Applicant 
``expressed very little understanding of the disease of addiction and 
possible drug abuse,'' and that this, when, combined ``with [the] clear 
evidence'' that he ``failed to comply with the Board's rules . . . 
increased the risk of harm to the public.'' Id. The Board further found 
that Applicant ``either failed to identify or chose to ignore clear 
evidence of drug seeking behavior by the very patients he has an 
obligation to treat, heal and protect.'' Id. Finally, the Board found 
that Applicant ``willingly participated in a medical clinic . . . 
[which] had [the] primary purpose [of] hand[ing]-out controlled 
substances.'' Id. at 22-23.

Discussion

    Section 303(f) of the Controlled Substances Act (CSA) provides that 
an application for a practitioner's registration may be denied ``if the 
Attorney General determines that the issuance of such registration . . 
. would be inconsistent with the public interest.'' 21 U.S.C. 823(f). 
In making this determination, Congress directed that the following 
factors be considered:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id. ``These factors are . . . considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or 
a combination of factors and may give each factor the weight . . . [I] 
deem[ ] appropriate in determining whether . . . an application for 
registration [should be] denied.'' Id.; see also Kevin Dennis, M.D., 78 
FR 52787, 52794 (2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 
2010).
    The Government has the burden of proving, by substantial evidence, 
that the requirements for the denial of an application, pursuant to 21 
U.S.C. 823(f), are met. 21 CFR 1301.44(e). This is so even in a non-
contested case. Gabriel Sanchez, M.D., 78 FR 59060, 59063 (2013). 
Having considered all of the factors,\8\ I conclude that the 
Government's evidence with respect to factors two and four establishes, 
prima facie, that the issuance of a new registration to Applicant 
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
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    \8\ Having considered all of the factors, I conclude that it is 
not necessary to make findings with respect to factors three (the 
applicant's conviction record) and five (such other conduct which 
may threaten public health and safety). See Jose G. Zavaleta, M.D., 
76 FR 49506, 49507 (2011).
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Factor One: The Recommendation of the Appropriate State Licensing Board

    Noting the various findings of the Mississippi Board, the 
Government argues that ``[i]n light of the Board's Order, factor one 
weighs heavily in favor of a finding that granting Applicant's . . . 
registration would be inconsistent with the public interest.'' Request 
for Final Agency Action, at 4. While the Government is undoubtedly 
correct that the Board's findings strongly support the denial of 
Applicant's application--indeed, for reasons explained later, they are 
conclusive--its contention that factor one supports the denial of the 
application is misplaced.
    Here, Applicant does not seek a new registration in Mississippi, 
where, because he has not been reinstated to practice medicine, he does 
not even meet the CSA's threshold requirement that he be ``authorized 
to dispense . . . controlled substances under the laws of the State in 
which he practices.'' 21 U.S.C. 823(f). Rather, he seeks registration 
in California, where, while he is the subject of an Accusation filed by 
the Medical Board of California (MBC) (which is based on the 
Mississippi Board's Order), he nonetheless holds a current Physician's 
and Surgeon's Certificate. Because Applicant seeks registration in 
California, the MBC, and not the Mississippi Board is the ``appropriate 
[s]tate licensing board'' for the purpose of factor one.
    Here, the MBC has not made a formal recommendation to the Agency as 
to what action should be taken in this matter. Moreover, Applicant 
currently holds an active California medical license.
    That being said, ``the Agency has long held that possession of 
state authority is not dispositive of the public interest inquiry.'' 
George Mathew, 75 FR 66138, 66145 (2010), pet. for rev. denied, Mathew 
v. DEA, No. 10-73480, slip. op. at 5 (9th Cir. Mar. 16, 2012). Instead, 
``the Controlled Substances Act requires that the Administrator . . . 
make an independent determination [from that made by state officials] 
as to whether the granting of controlled substance privileges would be 
in the public interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992). 
Thus, the fact that Applicant currently has an active California 
license neither weighs in favor of, or against a finding that issuing a 
new registration ``would be inconsistent with the public interest.'' 21 
U.S.C. 823(f).

Factors Two and Four: The Applicant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable State or Federal 
Laws

    To effectuate the dual goals of conquering drug abuse and 
controlling both the legitimate and illegitimate traffic in 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). With respect to the 
dispensing of controlled substances, the closed system is maintained by 
a longstanding Agency regulation, which provides that ``[a] 
prescription for a controlled substance [is not] effective [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). The

[[Page 71664]]

regulation further provides that ``an 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 the provisions of law relating to controlled 
substances.'' Id.
    As the Supreme Court recently explained, ``the prescription 
requirement . . . ensures 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. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 
135, 143 (1975)); see also United States v. Alerre, 430 F.3d 681, 691 
(4th Cir. 2005), cert. denied, 547 U.S. 1113 (2006) (prescription 
requirement stands as a proscription against doctors acting not ``as a 
healer[,] but as a seller of wares'').
    As found above, following a hearing before the Mississippi Board, 
at which Applicant was represented by counsel, the Board made extensive 
factual findings regarding his treatment of four patients. Most 
significantly, the Board found Applicant guilty of four counts of 
``administering, dispensing, or prescribing . . . narcotic drugs, or 
other drugs having addiction-forming or addiction-sustaining liability 
otherwise than in the course of legitimate professional practice.'' GX 
3, at 21 (citing Miss. Code Ann. Sec.  73-25-29(3)) (emphasis added). 
It also found Applicant guilty of four counts of ``prescribing 
controlled substances or other drugs having addiction-forming or 
addiction-sustaining liability for chronic pain in a non-therapeutic 
manner.'' Id. at 22 (citing id. Sec.  73-25-29(13)) (emphasis added). 
The Board further found Applicant guilty of four counts of 
``prescribing controlled substances for the treatment of chronic pain 
to a patient who has consumed or disposed of controlled substances and 
other drugs having addiction forming or addiction sustaining liability 
other than in strict compliance with [his] directions.'' Id. (citing 
Miss. Code Ann. Sec.  73-25-29(13)).
    Because Applicant had a full and fair opportunity to litigate the 
issues raised in the Mississippi Board proceeding--and in fact, was 
represented by counsel and did apparently litigate the issues--the 
Board's findings are entitled to preclusive effect in this proceeding. 
See Robert L. Dougherty, M.D., 76 FR 16823, 16830 (2011) (citing 
cases); see also Univ. of Tenn. v. Elliot, 478 U.S. 788, 797-98 (1986) 
(``When an administrative agency is acting in a judicial capacity and 
resolves disputed issues of fact properly before it which the parties 
have had an adequate opportunity to litigate, the courts have not 
hesitated to apply res judicata[.]'') (internal quotations and 
citations omitted); David A. Ruben, M.D., 78 FR 38363, 38365-67 (2013) 
(collateral estoppel precludes a party from re-litigating issues of 
fact or law that were previously decided against him in a state board 
proceeding); cf. Jose G. Zavaleta, M.D., 78 FR 27431, 27431-34 (2013) 
(``[a]llowing an applicant to relitigate issues which he/she had a full 
and fair opportunity to litigate in a prior proceeding but chose not 
to'' will likely result in unnecessary waste of agency resources).
    Moreover, the Board's findings that Applicant prescribed controlled 
substances ``otherwise than in the course of legitimate professional 
practice'' and ``in a non-therapeutic manner,'' in violation of State 
law, also establish that he acted outside of ``the usual course of 
professional practice'' and without a ``legitimate medical purpose'' in 
prescribing to the four patients identified in the Board's Order, and 
thus also violated the CSA.\9\ 21 CFR 1306.04(a); Cf. Kenneth Harold 
Bull, 78 FR 62666, 62674-75 n. 9 (2013) (rejecting ALJ's conclusion 
that state board's finding established violations of 21 CFR 1306.04(a), 
noting that state board's ``injudicious prescribing'' standard was 
``not equivalent to the standard imposed under 21 CFR 1306.04(a)''). As 
the Board further found, Applicant ``willingly participated in a 
medical clinic . . . [which] had [the] primary purpose [of] hand[ing]-
out controlled substances.'' GX 3, at 22-23. Thus, I conclude that the 
State Board's findings support a finding that Applicant knowingly and 
intentionally diverted controlled substances. See 21 U.S.C. 841(a)(1). 
I therefore hold that the Government has met its prima facie burden of 
showing why issuing a new registration to Applicant ``would be 
inconsistent with the public interest.'' Id. Sec.  823(f).\10\
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    \9\ In addition, the Board found Applicant guilty of four counts 
of ``failing to conduct an appropriate risk/benefit analysis by 
review of previous medical history which was provided by another 
treating physician, which indicates there is a need for long-term 
controlled substances therapy'' and by ``fail[ing] to clearly enter 
into the record the analysis and a consultation/referral report 
which determines the underlying pathology or cause of the chronic 
pain.'' GX 3, at 21 (citing Miss. Code Ann. Sec.  73-25-29(13)). 
Finally, the Board found Applicant guilty of four counts of 
``failing to document a written treatment plan which contains stated 
objectives as a measure of successful treatment and planned 
diagnostic evaluations, e.g., psychiatric evaluation or other 
treatments.'' Id. at 21-22 (citing Miss. Code Ann. Sec.  73-25-
29(13)). Not that it is needed given the Board's findings which are 
discussed above, these findings provide additional support for the 
conclusion that Applicant acted outside the usual course of 
professional practice and lacked a legitimate medical purpose in 
prescribing controlled substances to the four patients. 21 CFR 
1306.04(a).
    \10\ The Board also found that Applicant ignored multiple red 
flags that the four patients were abusing controlled substances. 
These included that the patients sought early refills and did not 
comply with his dosing instructions, two patients had been 
terminated by prior physicians for non-compliance (one of whom was 
obtaining controlled substances from multiple doctors), another 
patient was driving a long distance to see him, and another patient 
had not only tested positive for a controlled substance which had 
not been prescribed to her, but twice attempted to use another 
person's urine when subjected to a urine drug screen.
     These findings provide further support for the conclusion that 
issuing a new registration to Applicant ``would be inconsistent with 
the public interest.'' 21 U.S.C. 823(f). As the Administrator has 
held, ``[a] practitioner who ignores the warning signs that [his] 
patients are either personally abusing or diverting controlled 
substances commits `acts inconsistent with the public interest,' 21 
U.S.C. 824(a)(4), even if [he] is merely gullible or naive.'' Jayam 
Krishna-Iyer, M.D., 74 FR 459, 460 n.3 (2009); see also Bienvenido 
Tan, M.D., 76 FR 17673, 17689 (2011) (quoting Paul J. Caragine, Jr., 
63 FR 51592, 51601 (1998)) (``Just because misconduct is 
unintentional, innocent or devoid of improper motivation, [it] does 
not preclude revocation or denial. Careless or negligent handling of 
controlled substances creates the opportunity for diversion and 
[can] justify'' the revocation of an existing registration or the 
denial of an application for a registration.).
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    It is acknowledged that Applicant does not seek authority to 
dispense controlled substances in schedules II and III, but rather only 
those in schedule IV and V. GX 2, at 1. Be that as it may, the findings 
of the State Board conclusively establish that his misconduct is 
egregious and that he cannot be entrusted with authority to dispense 
controlled substances in any schedule, a conclusion which stands 
unrefuted given that Applicant waived his right to a hearing or to 
submit a written statement. Accordingly, because there is no evidence 
that Applicant acknowledges his misconduct and has undertaken any 
remedial measures,\11\ I conclude that denial of his application is 
necessary to protect the public interest. See, e.g., Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (``where a registrant has committed 
acts inconsistent with the public interest, the registrant must accept 
responsibility for [his] actions and demonstrate that [he] will not 
engage in future misconduct''); see also Jose G. Zavaleta, M.D., 76 FR 
49506, 49507 (2011) (denying

[[Page 71665]]

application for DEA registration in schedules IV and V where doctor 
violated federal law by, inter alia, issuing prescriptions outside the 
usual course of professional practice). Accordingly, I will order that 
his application be denied.
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    \11\ As found above, the Mississippi Board required Applicant, 
as a condition of reinstatement, to take courses in controlled 
substance prescribing, recordkeeping, and medical ethics. There is, 
however, no evidence that he has taken any of these courses.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b) and 0.104, I order that the application of Zizhuang 
Li, M.D., for a DEA Certificate of Registration as a practitioner be, 
and it hereby is, denied. This order is effective immediately.

    Dated: November 21, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-28525 Filed 11-27-13; 8:45 am]
BILLING CODE 4410-09-P