81_FR_6068 81 FR 6045 - David W. Bailey, M.D.; Decision and Order

81 FR 6045 - David W. Bailey, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 23 (February 4, 2016)

Page Range6045-6047
FR Document2016-02127

Federal Register, Volume 81 Issue 23 (Thursday, February 4, 2016)
[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6045-6047]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02127]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


David W. Bailey, M.D.; Decision and Order

    On September 9, 2015, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to David W. Bailey, M.D. (Registrant), of Hesperia, 
California. The Show Cause order proposed the revocation of 
Registrant's Certificate of Registration FB4421474, and the denial of 
any applications to renew or modify this registration or for any other 
registration on two grounds. GX 1, at 1.
    First, the Show Cause Order alleged on April 3, 2015, the Medical 
Board of California (MBC or Board) revoked his state medical license, 
and that therefore, Registrant is ``without authority to handle 
controlled substances in California, the [S]tate in which [he is] 
registered with the DEA. Id. (citing 21 U.S.C. 802(21), 823(f), and 
824(a)(3)). Second, the Order alleged that Registrant's registration 
``is inconsistent with the public interest'' because he failed to 
``comply with applicable state and Federal law[s]'' related to 
controlled substances. Id. at 2.
    With respect to the latter contention, the Show Cause Order alleged 
that in the MBC proceeding, the MBC Administrative Law Judge (ALJ) 
found that Registrant admitted to eighteen occasions on which he issued 
clonazepam prescriptions to his wife but had the drugs dispensed to 
himself for his ``own abuse.'' Id. at 2. The Show Cause Order also 
alleged that the MBC's ALJ found that Registrant ``started a treatment 
program for alcohol and clonazepam abuse but completed only five days 
of the thirty-day program,'' and that ``[a]n expert physician testified 
that [his] diagnosis included benzodiazepine dependence and that [he 
was] not currently undergoing any recovery. Id. The Order alleged these 
findings establish that Registrant violated 21 U.S.C. 844(a) and 
843(a)(3), as well as various provisions of the California Business and 
Professions Code. Id. The Order thus alleged that the MBC ALJ's 
findings prove that Registrant's registration ``is inconsistent with 
the public interest under 21 U.S.C. 824(a)(4) and 823(f)(4).'' Id.
    Finally, the Show Cause Order notified Registrant of his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, the procedure for electing either option, and the 
consequence for failing to elect either option. Id. at 2 (citing 21 CFR 
1301.43). On September 16, 2015, DEA Diversion Investigators (DIs) 
travelled to Registrant's address and after verifying his identity, 
personally served him with the Show Cause Order. GX 5, at 2 
(Declaration of DI).
    On December 1, the Government filed its Request for Final Agency 
Action along with with various exhibits. In its Request, the Government 
states that since the date of service of the Show Cause Order, neither 
Registrant, ``nor anyone representing him[,] has requested a hearing or 
sent any other correspondence to'' the Agency. Request for Final Agency 
Action, at 9.
    Based on the Government's submission, I find that 30 days have now 
passed since the date of service of the Show Cause Order, and neither 
Registrant, nor anyone purporting to represent him, has either 
requested a hearing on the allegations or submitted a written statement 
in lieu of a hearing. See 21 CFR 1301.43(a) and (c). Accordingly, I 
find that Registrant has waived his right to a hearing or to submit a 
written statement in lieu of hearing. Id. Sec.  1301.43(c) and (d). I 
therefore issue this Decision and Final Order based on the 
Investigative Record submitted by the Government. Id. Sec.  1301.43(e). 
I make the following findings of fact.

Findings

    Registrant is a physician authorized to dispense controlled 
substances in schedules II through V as a practitioner, at the 
registered address of LaSalle Medical Associates, 16455 Main St., Suite 
1, Hesperia, California. GX 2. His registration is not due to expire 
until July 31, 2016. Id.
    On March 6, 2015, the MBC issued an order revoking Registrant's 
Physician's and Surgeon's License to practice medicine in the State of 
California, effective April 3, 2015. GX 4. The MBC's revocation was 
based on the decision of a state ALJ who found, based on clear and 
convincing evidence, that Registrant: (1) Is alcohol and benzodiazepine 
dependent, (2) used alcohol and controlled substances in a manner 
dangerous to himself and others, (3) prescribed a controlled substance 
to another with the intention of using that substance himself, (4) 
self-administered a controlled substance that he had prescribed in the 
name of another, (5) violated the California Medical Practice Act, and 
6) engaged in unprofessional conduct.\1\ GX 3, at 1.
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    \1\ Notwithstanding that Registrant failed to appear at the MBC 
hearing, the MBC's findings of fact and conclusions of law are 
entitled preclusive effect in this proceeding. The MBC found that 
Registrant was properly served with the Accusation and, in fact, 
several days before the hearing telephoned the MBC's counsel ``and 
advised her that he was not going to appear.'' GX 3, at 2. Thus, 
notwithstanding that he defaulted, Registrant had a full and fair 
opportunity to challenge the MBC's allegations. See Jose G. 
Zavaleta, 78 FR 27431, 27434 (2013) (collecting cases holding that 
findings made in a proceeding against a party in default are 
entitled to preclusive effect if the party could have appeared and 
defended if he had wanted to); see also id. (quoting Gottlieb v. 
Kest, 141 Cal. App. 4th 110, 149 (Cal. Ct. App. 2006) (``A default 
judgment conclusively establishes, between the parties so far as 
subsequent proceedings on a different cause of action are concerned, 
the truth of all material allegations contained in the complaint in 
the first action, and every fact necessary to uphold the default 
judgment.'') (int. quotations and citations omitted).
---------------------------------------------------------------------------

    More specifically, the state ALJ found, by clear and convincing 
evidence, that Registrant:

engaged in unprofessional conduct by violating state laws related to 
the prescription and use of Klonopin as follows: [he] repeatedly 
issued prescriptions for Klonopin in [his wife's] name with the 
intent of self-administering the Klonopin obtained from the 
prescriptions; he engaged in fraud and deceit in order to obtain 
Klonopin; he provided a false name to obtain Klonopin; he repeatedly 
used Klonopin in violation of the

[[Page 6046]]

law; and he repeatedly used and possessed Klonopin that was not 
obtained with a legitimate prescription.

Id. at 19 (citing Cal. Bus. & Prof. Code sec. 2238(a)).

    The state ALJ also found that Registrant ``intentionally created 
medical records--prescriptions to [his wife] for Klonopin--that were 
false because he intended to use the Klonopin obtained from the 
prescription for himself.'' Id. (citing Cal. Bus. & Prof. Code Sec.  
2262). The state ALJ further found that Registrant violated the 
California Medical Practice Act when he ``used dangerous drugs in a 
manner that was dangerous to himself, violated state laws related to 
dangerous drugs and controlled substances, knowingly made false 
representation of fact, and created false medical records with a 
fraudulent intent.'' Id. (citing Bus. & Prof. Code sec. 2234).

    The ALJ then concluded that Registrant:

suffers from alcohol dependence and benzodiazepine dependence, and 
his substance abuse presents a substantial risk of harm to himself, 
patients and the public. [H]e does not appear to be able or willing 
to become abstinent of alcohol despite his treatment with 
psychiatrists and psychologists and despite his brief participation 
in substance abuse programs.

Id. at 20. The state ALJ thus concluded that ``[u]nder all the 
circumstances, the outright revocation of respondent's certificate is 
the only disciplinary option available at this time that will protect 
the public.'' Id.
    On March 6, 2015, the MBC adopted the proposed decision, and on 
April 3, 2015, Registrant's Physician's and Surgeon's Certificate was 
revoked. GX 4. According to the online records of the MBC, Registrant's 
license remains revoked. See also www.breeze.ca.gov.

Discussion

The Loss of State Authority Ground

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823, ``upon a 
finding that the Registrant . . . has had his State license . . . 
suspended [or] revoked . . . by competent State authority and is no 
longer authorized by State law to engage in the . . . dispensing of 
controlled substances.'' Moreover, DEA has held repeatedly that the 
possession of authority to dispense controlled substances under the 
laws of the State in which a practitioner engages in professional 
practice is a fundamental condition for obtaining and maintaining a 
practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 
(2011), pet. for rev. denied, 481 Fed Appx. 826 (4th Cir. 2012).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean[] a . . . 
physician . . . or other person licensed, registered or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to 
distribute, dispense, [or] administer . . . a controlled substance in 
the course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated 
that a practitioner possess state authority in order to be deemed a 
practitioner under the Act, DEA has held repeatedly that revocation of 
a practitioner's registration is the appropriate sanction whenever he 
is no longer authorized to dispense controlled substances under the 
laws of the State in which he practices medicine. See, e.g., Calvin 
Ramsey, 76 FR 20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 
39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); 
Bobby Watts, 53 FR 11919, 11920 (1988). See also Hooper v. Holder, 481 
Fed. Appx. at 828.
    Based on the MBC's revocation of his medical license, I find that 
Registrant lacks authority to dispense controlled substances in 
California, the State in which he holds his DEA registration. 
According, I will order that Registrant's registration be revoked and 
that any pending applications be denied. 21 U.S.C. 824(a)(3).

The Public Interest Ground

    Section 304(a) of the Controlled Substances Act (CSA) also provides 
that a registration to ``dispense a controlled substance . . . may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant . . . has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). With respect to a practitioner, the Act requires the 
consideration of the following factors in making the public interest 
determination:

    (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. Sec.  823(f).

    ``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 a registration should be revoked.'' 
Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009). And 
while I must consider each factor, I ``need not make explicit findings 
as to each one and can `give each factor the weight [I] determine[] is 
appropriate.' '' MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011) 
(quoting Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009)); see also 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005)); see also Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005) (same). In this matter, I 
concluded that the evidence with respect to Factors Two and Four 
establishes that Registrant has committed acts which render his 
registration inconsistent with the public interest.
    The Government contends that the MBC ALJ's findings of fact and 
conclusions of law establish that Registrant violated state and federal 
laws related to controlled substances.\2\ I agree that the State's 
findings establish that Registrant committed several violations of 
state laws that are actionable under Factor Four. Specifically, 
Respondent violated Cal. Bus. & Prof. Code sec. 2239(a), which provides 
that ``[t]he use or prescribing for or administering to himself. . . of 
any controlled substance; or the use of any of the dangerous drugs. . . 
to the extent, or in such a manner as to be dangerous or injurious to 
the licensee, or to any other persons or to the public, or to the 
extent that such use impairs the ability of the licensee to practice

[[Page 6047]]

medicine safely. . . constitutes unprofessional conduct.'' See also 
Cal. Bus. & Prof. Code sec. 2238 (``A violation of any federal statute 
or regulation, or any of the statutes or regulations of this state 
regulating dangerous drugs or controlled substances constitutes 
unprofessional conduct.'').
---------------------------------------------------------------------------

    \2\ As for Factor One, while the State has not made a 
recommendation to the Agency, the State has revoked Respondent's 
medical license and thus, he no longer meets the CSA's requirement 
that he is authorized to dispense controlled substances in the State 
where he is registered.
    As for Factor Three, the record contains no evidence that 
Registrant has been convicted of an offense related to the 
manufacture, distribution or dispensing of controlled substances.
    As for Factor Five, even though the evidence shows that 
Respondent engaged in the self-abuse of controlled substances, the 
Government did not set forth any argument that Respondent's conduct 
is also actionable under this Factor. Thus, I make no findings under 
this Factor.
---------------------------------------------------------------------------

    I further conclude that the MBC's findings establish that 
Registrant violated the CSA when he issued fraudulent prescriptions in 
his wife's name for Klonopin (clonazepam), a schedule IV controlled 
substance, which he then used and abused. See 21 U.S.C. 843(a)(3) (``It 
shall be unlawful for any person knowingly or intentionally. . . to 
acquire or obtain possession of a controlled substance by 
misrepresentation, fraud, forgery, deception or subterfuge.''); see 
also id. sec. 844(a) (``It shall be unlawful for any person knowingly 
or intentionally to possess a controlled substance unless such 
substance was obtained directly, or pursuant to a valid prescription or 
order, from a practitioner, while acting in the course of his 
professional practice.''); 21 CFR 1306.04(a) (``A prescription for a 
controlled substance. . . must be issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of his 
professional practice.''). Not only is this conduct actionable under 
Factor Four, it is also relevant in assessing Registrant's experience 
in dispensing controlled substances (Factor Two).
    Accordingly, I find that the evidence establishes Registrant ``has 
committed such acts as would render his registration. . . inconsistent 
with the public interest.'' See 21 U.S.C. 824(a)(4). Because Registrant 
failed to respond in any manner to the Show Cause Order, I will order 
that his registration be revoked and that any pending application be 
denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration FB4421474, issued to David W. Bailey, M.D., be, and it 
hereby is, revoked. I further order that any pending application of 
David W. Bailey, M.D., to renew or modify his registration, be, and it 
hereby is, denied. This Order is effective March 7, 2016.

    Dated: January 18, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-02127 Filed 2-3-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices                                                      6045

                                                    the Drug Enforcement Administration                     Second, the Order alleged that                        hearing. Id. § 1301.43(c) and (d). I
                                                    (DEA), 28 CFR 0.100(b). Authority to                    Registrant’s registration ‘‘is inconsistent           therefore issue this Decision and Final
                                                    exercise all necessary functions with                   with the public interest’’ because he                 Order based on the Investigative Record
                                                    respect to the promulgation and                         failed to ‘‘comply with applicable state              submitted by the Government. Id.
                                                    implementation of 21 CFR part 1301,                     and Federal law[s]’’ related to controlled            § 1301.43(e). I make the following
                                                    incident to the registration of                         substances. Id. at 2.                                 findings of fact.
                                                    manufacturers, distributors, dispensers,                   With respect to the latter contention,
                                                                                                            the Show Cause Order alleged that in                  Findings
                                                    importers, and exporters of controlled
                                                    substances (other than final orders in                  the MBC proceeding, the MBC                              Registrant is a physician authorized to
                                                    connection with suspension, denial, or                  Administrative Law Judge (ALJ) found                  dispense controlled substances in
                                                    revocation of registration) has been                    that Registrant admitted to eighteen                  schedules II through V as a practitioner,
                                                    redelegated to the Deputy Assistant                     occasions on which he issued                          at the registered address of LaSalle
                                                    Administrator of the DEA Office of                      clonazepam prescriptions to his wife                  Medical Associates, 16455 Main St.,
                                                    Diversion Control (‘‘Deputy Assistant                   but had the drugs dispensed to himself                Suite 1, Hesperia, California. GX 2. His
                                                    Administrator’’) pursuant to section 7 of               for his ‘‘own abuse.’’ Id. at 2. The Show             registration is not due to expire until
                                                    28 CFR part 0, appendix to subpart R.                   Cause Order also alleged that the MBC’s               July 31, 2016. Id.
                                                      In accordance with 21 CFR                             ALJ found that Registrant ‘‘started a                    On March 6, 2015, the MBC issued an
                                                    1301.33(a), this is notice that on                      treatment program for alcohol and                     order revoking Registrant’s Physician’s
                                                    December 3, 2015, Pharmacore, Inc.,                     clonazepam abuse but completed only                   and Surgeon’s License to practice
                                                    4180 Mendenhall Oaks Parkway, High                      five days of the thirty-day program,’’                medicine in the State of California,
                                                    Point, North Carolina 27265 applied to                  and that ‘‘[a]n expert physician testified            effective April 3, 2015. GX 4. The MBC’s
                                                    be registered as a bulk manufacturer of                 that [his] diagnosis included                         revocation was based on the decision of
                                                    the following basic classes of controlled               benzodiazepine dependence and that                    a state ALJ who found, based on clear
                                                    substances:                                             [he was] not currently undergoing any                 and convincing evidence, that
                                                                                                            recovery. Id. The Order alleged these                 Registrant: (1) Is alcohol and
                                                           Controlled substance               Schedule      findings establish that Registrant                    benzodiazepine dependent, (2) used
                                                                                                            violated 21 U.S.C. 844(a) and 843(a)(3),              alcohol and controlled substances in a
                                                    Oxymorphone (9652) ...................    II            as well as various provisions of the                  manner dangerous to himself and
                                                    Noroxymorphone (9668) ..............      II            California Business and Professions                   others, (3) prescribed a controlled
                                                                                                            Code. Id. The Order thus alleged that                 substance to another with the intention
                                                      The company plans to manufacture                      the MBC ALJ’s findings prove that                     of using that substance himself, (4) self-
                                                    the listed controlled substances as                     Registrant’s registration ‘‘is inconsistent           administered a controlled substance that
                                                    active pharmaceutical ingredients (APIs)                with the public interest under 21 U.S.C.              he had prescribed in the name of
                                                    for clinical trials.                                    824(a)(4) and 823(f)(4).’’ Id.                        another, (5) violated the California
                                                      Dated: January 27, 2016.                                 Finally, the Show Cause Order                      Medical Practice Act, and 6) engaged in
                                                    Louis J. Milione,                                       notified Registrant of his right to request           unprofessional conduct.1 GX 3, at 1.
                                                                                                            a hearing on the allegations or to submit                More specifically, the state ALJ found,
                                                    Deputy Assistant Administrator.
                                                                                                            a written statement in lieu of a hearing,             by clear and convincing evidence, that
                                                    [FR Doc. 2016–02128 Filed 2–3–16; 8:45 am]
                                                                                                            the procedure for electing either option,             Registrant:
                                                    BILLING CODE 4410–09–P
                                                                                                            and the consequence for failing to elect
                                                                                                                                                                  engaged in unprofessional conduct by
                                                                                                            either option. Id. at 2 (citing 21 CFR                violating state laws related to the
                                                                                                            1301.43). On September 16, 2015, DEA                  prescription and use of Klonopin as follows:
                                                    DEPARTMENT OF JUSTICE
                                                                                                            Diversion Investigators (DIs) travelled to            [he] repeatedly issued prescriptions for
                                                    Drug Enforcement Administration                         Registrant’s address and after verifying              Klonopin in [his wife’s] name with the intent
                                                                                                            his identity, personally served him with              of self-administering the Klonopin obtained
                                                    David W. Bailey, M.D.; Decision and                     the Show Cause Order. GX 5, at 2                      from the prescriptions; he engaged in fraud
                                                                                                            (Declaration of DI).                                  and deceit in order to obtain Klonopin; he
                                                    Order                                                                                                         provided a false name to obtain Klonopin; he
                                                                                                               On December 1, the Government filed
                                                      On September 9, 2015, the Deputy                                                                            repeatedly used Klonopin in violation of the
                                                                                                            its Request for Final Agency Action
                                                    Assistant Administrator, Office of                      along with with various exhibits. In its                 1 Notwithstanding that Registrant failed to appear
                                                    Diversion Control, Drug Enforcement                     Request, the Government states that                   at the MBC hearing, the MBC’s findings of fact and
                                                    Administration (DEA), issued an Order                   since the date of service of the Show                 conclusions of law are entitled preclusive effect in
                                                    to Show Cause to David W. Bailey, M.D.                  Cause Order, neither Registrant, ‘‘nor                this proceeding. The MBC found that Registrant was
                                                    (Registrant), of Hesperia, California. The              anyone representing him[,] has                        properly served with the Accusation and, in fact,
                                                                                                                                                                  several days before the hearing telephoned the
                                                    Show Cause order proposed the                           requested a hearing or sent any other                 MBC’s counsel ‘‘and advised her that he was not
                                                    revocation of Registrant’s Certificate of               correspondence to’’ the Agency. Request               going to appear.’’ GX 3, at 2. Thus, notwithstanding
                                                    Registration FB4421474, and the denial                  for Final Agency Action, at 9.                        that he defaulted, Registrant had a full and fair
                                                    of any applications to renew or modify                     Based on the Government’s                          opportunity to challenge the MBC’s allegations. See
                                                                                                                                                                  Jose G. Zavaleta, 78 FR 27431, 27434 (2013)
                                                    this registration or for any other                      submission, I find that 30 days have                  (collecting cases holding that findings made in a
                                                    registration on two grounds. GX 1, at 1.                now passed since the date of service of               proceeding against a party in default are entitled to
                                                      First, the Show Cause Order alleged                   the Show Cause Order, and neither
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                                                                  preclusive effect if the party could have appeared
                                                    on April 3, 2015, the Medical Board of                  Registrant, nor anyone purporting to                  and defended if he had wanted to); see also id.
                                                                                                                                                                  (quoting Gottlieb v. Kest, 141 Cal. App. 4th 110, 149
                                                    California (MBC or Board) revoked his                   represent him, has either requested a                 (Cal. Ct. App. 2006) (‘‘A default judgment
                                                    state medical license, and that therefore,              hearing on the allegations or submitted               conclusively establishes, between the parties so far
                                                    Registrant is ‘‘without authority to                    a written statement in lieu of a hearing.             as subsequent proceedings on a different cause of
                                                    handle controlled substances in                         See 21 CFR 1301.43(a) and (c).                        action are concerned, the truth of all material
                                                                                                                                                                  allegations contained in the complaint in the first
                                                    California, the [S]tate in which [he is]                Accordingly, I find that Registrant has               action, and every fact necessary to uphold the
                                                    registered with the DEA. Id. (citing 21                 waived his right to a hearing or to                   default judgment.’’) (int. quotations and citations
                                                    U.S.C. 802(21), 823(f), and 824(a)(3)).                 submit a written statement in lieu of                 omitted).



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                                                    6046                        Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices

                                                    law; and he repeatedly used and possessed               pet. for rev. denied, 481 Fed Appx. 826                 (3) The applicant’s conviction record under
                                                    Klonopin that was not obtained with a                   (4th Cir. 2012).                                      Federal or State laws relating to the
                                                    legitimate prescription.                                                                                      manufacture, distribution, or dispensing of
                                                                                                               This rule derives from the text of two             controlled substances.
                                                    Id. at 19 (citing Cal. Bus. & Prof. Code sec.           provisions of the CSA. First, Congress
                                                    2238(a)).                                                                                                       (4) Compliance with applicable State,
                                                                                                            defined ‘‘the term ‘practitioner’ [to]                Federal, or local laws relating to controlled
                                                       The state ALJ also found that                        mean[] a . . . physician . . . or other               substances.
                                                    Registrant ‘‘intentionally created                      person licensed, registered or otherwise                (5) Such other conduct which may threaten
                                                    medical records—prescriptions to [his                   permitted, by . . . the jurisdiction in               the public health and safety.
                                                    wife] for Klonopin—that were false                      which he practices . . . to distribute,               Id. § 823(f).
                                                    because he intended to use the                          dispense, [or] administer . . . a                        ‘‘These factors are. . . considered in
                                                    Klonopin obtained from the prescription                 controlled substance in the course of                 the disjunctive.’’ Robert A. Leslie, M.D.,
                                                    for himself.’’ Id. (citing Cal. Bus. & Prof.            professional practice.’’ 21 U.S.C.                    68 FR 15227, 15230 (2003). I ‘‘may rely
                                                    Code § 2262). The state ALJ further                     802(21). Second, in setting the                       on any one or a combination of factors,
                                                    found that Registrant violated the                      requirements for obtaining a                          and may give each factor the weight [I]
                                                    California Medical Practice Act when he                 practitioner’s registration, Congress                 deem[] appropriate in determining
                                                    ‘‘used dangerous drugs in a manner that                 directed that ‘‘[t]he Attorney General                whether a registration should be
                                                    was dangerous to himself, violated state                shall register practitioners . . . if the             revoked.’’ Id.; see also Volkman v. DEA,
                                                    laws related to dangerous drugs and                     applicant is authorized to dispense . .               567 F.3d 215, 222 (6th Cir. 2009). And
                                                    controlled substances, knowingly made                   . controlled substances under the laws                while I must consider each factor, I
                                                    false representation of fact, and created               of the State in which he practices.’’ 21              ‘‘need not make explicit findings as to
                                                    false medical records with a fraudulent                 U.S.C. 823(f). Because Congress has                   each one and can ‘give each factor the
                                                    intent.’’ Id. (citing Bus. & Prof. Code sec.            clearly mandated that a practitioner                  weight [I] determine[] is appropriate.’ ’’
                                                    2234).                                                  possess state authority in order to be                MacKay v. DEA, 664 F.3d 808, 816 (10th
                                                                                                            deemed a practitioner under the Act,                  Cir. 2011) (quoting Volkman v. DEA,
                                                       The ALJ then concluded that Registrant:
                                                                                                            DEA has held repeatedly that revocation               567 F.3d 215, 222 (6th Cir. 2009)); see
                                                    suffers from alcohol dependence and
                                                                                                            of a practitioner’s registration is the               also Hoxie v. DEA, 419 F.3d 477, 482
                                                    benzodiazepine dependence, and his
                                                    substance abuse presents a substantial risk of          appropriate sanction whenever he is no                (6th Cir. 2005)); see also Morall v. DEA,
                                                    harm to himself, patients and the public. [H]e          longer authorized to dispense controlled              412 F.3d 165, 173–74 (D.C. Cir. 2005)
                                                    does not appear to be able or willing to                substances under the laws of the State                (same). In this matter, I concluded that
                                                    become abstinent of alcohol despite his                 in which he practices medicine. See,                  the evidence with respect to Factors
                                                    treatment with psychiatrists and                        e.g., Calvin Ramsey, 76 FR 20034, 20036               Two and Four establishes that
                                                    psychologists and despite his brief                     (2011); Sheran Arden Yeates, M.D., 71                 Registrant has committed acts which
                                                    participation in substance abuse programs.              FR 39130, 39131 (2006); Dominick A.                   render his registration inconsistent with
                                                    Id. at 20. The state ALJ thus concluded                 Ricci, 58 FR 51104, 51105 (1993); Bobby               the public interest.
                                                                                                            Watts, 53 FR 11919, 11920 (1988). See                    The Government contends that the
                                                    that ‘‘[u]nder all the circumstances, the
                                                                                                            also Hooper v. Holder, 481 Fed. Appx.                 MBC ALJ’s findings of fact and
                                                    outright revocation of respondent’s
                                                                                                            at 828.                                               conclusions of law establish that
                                                    certificate is the only disciplinary
                                                                                                               Based on the MBC’s revocation of his               Registrant violated state and federal
                                                    option available at this time that will
                                                                                                            medical license, I find that Registrant               laws related to controlled substances.2 I
                                                    protect the public.’’ Id.
                                                                                                            lacks authority to dispense controlled                agree that the State’s findings establish
                                                      On March 6, 2015, the MBC adopted                                                                           that Registrant committed several
                                                    the proposed decision, and on April 3,                  substances in California, the State in
                                                                                                            which he holds his DEA registration.                  violations of state laws that are
                                                    2015, Registrant’s Physician’s and                                                                            actionable under Factor Four.
                                                    Surgeon’s Certificate was revoked. GX 4.                According, I will order that Registrant’s
                                                                                                            registration be revoked and that any                  Specifically, Respondent violated Cal.
                                                    According to the online records of the                                                                        Bus. & Prof. Code sec. 2239(a), which
                                                    MBC, Registrant’s license remains                       pending applications be denied. 21
                                                                                                            U.S.C. 824(a)(3).                                     provides that ‘‘[t]he use or prescribing
                                                    revoked. See also www.breeze.ca.gov.                                                                          for or administering to himself. . . of
                                                    Discussion                                              The Public Interest Ground                            any controlled substance; or the use of
                                                                                                               Section 304(a) of the Controlled                   any of the dangerous drugs. . . to the
                                                    The Loss of State Authority Ground                                                                            extent, or in such a manner as to be
                                                                                                            Substances Act (CSA) also provides that
                                                       Pursuant to 21 U.S.C. 824(a)(3), the                 a registration to ‘‘dispense a controlled             dangerous or injurious to the licensee,
                                                    Attorney General is authorized to                       substance . . . may be suspended or                   or to any other persons or to the public,
                                                    suspend or revoke a registration issued                 revoked by the Attorney General upon                  or to the extent that such use impairs
                                                    under section 823, ‘‘upon a finding that                a finding that the registrant . . . has               the ability of the licensee to practice
                                                    the Registrant . . . has had his State                  committed such acts as would render
                                                                                                                                                                     2 As for Factor One, while the State has not made
                                                    license . . . suspended [or] revoked .                  his registration under section 823 of this
                                                                                                                                                                  a recommendation to the Agency, the State has
                                                    . . by competent State authority and is                 title inconsistent with the public                    revoked Respondent’s medical license and thus, he
                                                    no longer authorized by State law to                    interest as determined under such                     no longer meets the CSA’s requirement that he is
                                                    engage in the . . . dispensing of                       section.’’ 21 U.S.C. 824(a)(4). With                  authorized to dispense controlled substances in the
                                                    controlled substances.’’ Moreover, DEA                                                                        State where he is registered.
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                                                                                                            respect to a practitioner, the Act
                                                    has held repeatedly that the possession                                                                          As for Factor Three, the record contains no
                                                                                                            requires the consideration of the                     evidence that Registrant has been convicted of an
                                                    of authority to dispense controlled                     following factors in making the public                offense related to the manufacture, distribution or
                                                    substances under the laws of the State                  interest determination:                               dispensing of controlled substances.
                                                    in which a practitioner engages in                        (1) The recommendation of the appropriate
                                                                                                                                                                     As for Factor Five, even though the evidence
                                                    professional practice is a fundamental                                                                        shows that Respondent engaged in the self-abuse of
                                                                                                            State licensing board or professional                 controlled substances, the Government did not set
                                                    condition for obtaining and maintaining                 disciplinary authority.                               forth any argument that Respondent’s conduct is
                                                    a practitioner’s registration. See, e.g.,                 (2) The applicant’s experience in                   also actionable under this Factor. Thus, I make no
                                                    James L. Hooper, 76 FR 71371 (2011),                    dispensing . . . controlled substances.               findings under this Factor.



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                                                                                Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices                                                       6047

                                                    medicine safely. . . constitutes                        DEPARTMENT OF JUSTICE                                 during a November 2009 administrative
                                                    unprofessional conduct.’’ See also Cal.                                                                       inspection.1 Id.
                                                    Bus. & Prof. Code sec. 2238 (‘‘A                        Drug Enforcement Administration                          The Show Cause Order was served on
                                                    violation of any federal statute or                                                                           Respondent by registered mail sent to
                                                    regulation, or any of the statutes or                   Kenneth H. Bull, M.D.; Decision and                   his registered location; according to the
                                                    regulations of this state regulating                    Order                                                 Government, the return receipt card
                                                    dangerous drugs or controlled                                                                                 showed that the mailing was received
                                                                                                               On August 21, 2015, the Deputy
                                                    substances constitutes unprofessional                                                                         on September 16, 2015. Request for
                                                                                                            Assistant Administrator, Office of
                                                    conduct.’’).                                                                                                  Final Agency Action (RFAA), at 2; GX
                                                                                                            Diversion Control, Drug Enforcement
                                                       I further conclude that the MBC’s                    Administration (DEA), issued an Order                 7. Thereafter, on September 22, 2015,
                                                    findings establish that Registrant                      to Show Cause to Kenneth H. Bull, M.D.                Respondent, through his attorney, filed
                                                    violated the CSA when he issued                         (Respondent), of Albuquerque, New                     a written response to the Show Cause
                                                    fraudulent prescriptions in his wife’s                  Mexico. GX 1, at 1. The Show Cause                    Order. GX 8.
                                                    name for Klonopin (clonazepam), a                       Order proposed the revocation of                         Therein, Respondent expressly
                                                    schedule IV controlled substance, which                 Respondent’s DEA Certificate of                       waived his right to a hearing but
                                                    he then used and abused. See 21 U.S.C.                  Registration AB5662552, and the denial                submitted a written statement for my
                                                    843(a)(3) (‘‘It shall be unlawful for any               of any applications for renewal or                    consideration. GX 8, at 1 (citing 21 CFR
                                                    person knowingly or intentionally. . .                  modification of the registration, as well             1301.43(c)). Thereafter, the Government
                                                    to acquire or obtain possession of a                    as for any other registration, on two                 submitted a Request for Final Agency
                                                    controlled substance by                                 grounds: (1) That he lacks authority to               Action with supporting documents; in
                                                    misrepresentation, fraud, forgery,                      handle controlled substances in New                   its submission, the Government also
                                                    deception or subterfuge.’’); see also id.               Mexico, the State in which he is                      included Respondent’s written
                                                    sec. 844(a) (‘‘It shall be unlawful for any             registered with DEA, and (2) his                      statement.
                                                    person knowingly or intentionally to                    ‘‘registration would be inconsistent with                Based on Respondent’s submission, I
                                                    possess a controlled substance unless                   the public interest.’’ Id. (citing 21 U.S.C.          find that he has waived his right to a
                                                    such substance was obtained directly, or                823(f), 824(a)(3) and (4)).                           hearing on the allegations of the Show
                                                    pursuant to a valid prescription or                                                                           Cause Order. 21 CFR 1301.43(c).
                                                                                                               The Show Cause Order alleged that
                                                    order, from a practitioner, while acting                                                                      However, I will consider Respondent’s
                                                                                                            Respondent is registered as a
                                                    in the course of his professional                                                                             statement along with the evidence
                                                                                                            practitioner in schedules IIN, IIIN, IV
                                                    practice.’’); 21 CFR 1306.04(a) (‘‘A                                                                          submitted by the Government in this
                                                                                                            and V, at the registered address of 3500
                                                    prescription for a controlled                                                                                 matter. I make the following findings of
                                                                                                            Comanche Blvd., Building Suite 6,
                                                    substance. . . must be issued for a                                                                           fact.
                                                                                                            Albuquerque, New Mexico. Id. The
                                                    legitimate medical purpose by an
                                                                                                            Order also alleged that his registration              Findings
                                                    individual practitioner acting in the
                                                                                                            does not expire until July 31, 2017. Id.
                                                    usual course of his professional                                                                                 Respondent, who is a psychiatrist in
                                                    practice.’’). Not only is this conduct                     As grounds for the proposed action,                the State of New Mexico, is the holder
                                                    actionable under Factor Four, it is also                the Show Cause Order alleged that                     of DEA Certificate of Registration
                                                    relevant in assessing Registrant’s                      effective June 30, 2014, the New Mexico               AB5662552, pursuant to which he is
                                                    experience in dispensing controlled                     Medical Board (Board) issued a Decision               currently authorized to dispense
                                                    substances (Factor Two).                                and Order which revoked Respondent’s                  controlled substances in Schedules IIN,
                                                                                                            medical license, thus rendering him                   IIIN, IV and V; his registration does not
                                                       Accordingly, I find that the evidence                without authority ‘‘to order, dispense,
                                                    establishes Registrant ‘‘has committed                                                                        expire until July 31, 2017. GX 2, at 1.
                                                                                                            prescribe or administer any controlled                Respondent was previously authorized
                                                    such acts as would render his                           substances’’ in New Mexico, the State in
                                                    registration. . . inconsistent with the                                                                       to dispense controlled substances in
                                                                                                            which he holds his registration. Id.                  Schedules II through V, as well to
                                                    public interest.’’ See 21 U.S.C. 824(a)(4).             Continuing, the Order asserted that ‘‘the
                                                    Because Registrant failed to respond in                                                                       dispense buprenorphine as a DATA-
                                                                                                            DEA must revoke [Respondent’s]                        Waiver physician. See Bull, 78 FR at
                                                    any manner to the Show Cause Order,                     registration based upon [his] lack of
                                                    I will order that his registration be                                                                         62669. However, on September 22,
                                                                                                            authority to handle controlled                        2013, the then-Administrator issued a
                                                    revoked and that any pending                            substances in’’ New Mexico. Id. (citing
                                                    application be denied.                                                                                        Decision and Order which suspended
                                                                                                            21 U.S.C. 802(21), 823(f), and 824(a)(3)).            Respondent’s registration for six
                                                    Order                                                      As further ground, the Government                  months; the Order also revoked
                                                                                                            alleged that Respondent’s ‘‘registration              Respondent’s DATA-Waiver
                                                       Pursuant to the authority vested in me
                                                                                                            is inconsistent with the public interest              Identification Number and restricted his
                                                    by 21 U.S.C. 823(f) and 824(a), as well
                                                                                                            because [he] did not comply with                      dispensing authority to non-narcotic
                                                    as 28 CFR 0.100(b), I order that DEA
                                                                                                            applicable Federal law related to                     controlled substances only.2 Id. at 62676;
                                                    Certificate of Registration FB4421474,
                                                                                                            controlled substances, in violation of 21             GX 2.
                                                    issued to David W. Bailey, M.D., be, and
                                                                                                            U.S.C. 824(a)(4) and 823(f)(4).’’ Id. The
                                                    it hereby is, revoked. I further order that
                                                                                                            Government based this allegation on the                  1 The Show Cause Order also notified Respondent
                                                    any pending application of David W.
                                                                                                            factual findings and legal conclusions of             of his right to request a hearing on the allegations
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                                                    Bailey, M.D., to renew or modify his
                                                                                                            a prior agency proceeding, which                      or to submit a written statement in lieu of a hearing,
                                                    registration, be, and it hereby is, denied.                                                                   the procedure for electing either option, and the
                                                                                                            suspended his DEA registration for six
                                                    This Order is effective March 7, 2016.                                                                        consequence of failing to elect either option. GX 1,
                                                                                                            months and restricted his registration to             at 2 (citing 21 CFR 1301.43).
                                                      Dated: January 18, 2016.                              non-narcotic controlled substances. Id.                  2 Pursuant to an earlier Board Order, Respondent
                                                    Chuck Rosenberg,                                        at 2 (citing Kenneth Harold Bull, M.D.,               did not, at the time of the prior Agency proceeding,
                                                    Acting Administrator.                                   78 FR 62666 (2013)). The Show Cause                   possess state authority ‘‘to prescribe narcotics,
                                                                                                                                                                  including but not limited to, all opioid analgesics,
                                                    [FR Doc. 2016–02127 Filed 2–3–16; 8:45 am]              Order then set forth several of the 2013              including buprenorphine and all synthetic opioid
                                                    BILLING CODE 4410–09–P                                  Order’s findings of the violations found              analgesics.’’ Id. at 62676.



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Document Created: 2016-02-04 00:31:10
Document Modified: 2016-02-04 00:31:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 6045 

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