80_FR_46473 80 FR 46324 - Pedro E. Lopez, M.D.; Decision and Order

80 FR 46324 - Pedro E. Lopez, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 149 (August 4, 2015)

Page Range46324-46326
FR Document2015-19119

Federal Register, Volume 80 Issue 149 (Tuesday, August 4, 2015)
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46324-46326]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19119]


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

 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-16]


Pedro E. Lopez, M.D.; Decision and Order

    On March 20, 2015, Chief Administrative Law Judge (CALJ) John J. 
Mulrooney, II, issued the attached Recommended Decision. Neither party 
filed exceptions to the Recommended Decision.
    Having reviewed the record in its entirety, I adopt the CALJ's 
findings of fact,\1\ conclusions of law, and

[[Page 46325]]

recommended order. Accordingly, I will order that Respondent's DEA 
Certificate of Registration be revoked and that any pending 
applications to renew or modify his registration be denied.
---------------------------------------------------------------------------

    \1\ I take official notice of the fact that, according to the 
registration records of the Agency, Respondent retains an active 
registration as of this date. Pursuant to 21 CFR 1316.59(e), 
Respondent may controvert this finding by filing a properly 
supported motion, no later than 10 days from the date of this Order.
     Notwithstanding that the language of section 824(a) authorizes 
either the suspension or revocation of a registration upon the 
making of one of the five findings enumerated therein, the Agency 
has consistently interpreted the CSA as mandating revocation where a 
practitioner's state authority has been suspended or revoked. As the 
Fourth Circuit has held, ``[b]ecause Sec.  823(f) and Sec.  802(21) 
make clear that a practitioner's registration is dependent upon the 
practitioner having state authority to dispense controlled 
substances, the [Administrator's] decision to construe Sec.  
824(a)(3) as mandating revocation upon suspension of a state license 
is not an unreasonable interpretation of the CSA.'' Hooper v. 
Holder, 2012 WL 2020079, *2 (4th Cir. 2012) (unpublished).
---------------------------------------------------------------------------

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a)(3), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration BL2132049, issued to Pedro E. Lopez, M.D., be, and it 
hereby is, revoked. I further order that any pending application of 
Pedro E. Lopez, M.D., to renew or modify his registration, be, and it 
hereby is, denied. This Order is effective September 3, 2015.

    Dated: July 27, 2015.
Chuck Rosenberg,
Acting Administrator.

Brian Bayly, Esq., for the Government.
Alan Rhine, Esq., for the Respondent.

ORDER GRANTING THE GOVERNMENT'S MOTION FOR SUMMARY DISPOSITION AND 
RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION 
OF THE ADMINISTRATIVE LAW JUDGE

    Chief Administrative Law Judge John J. Mulrooney, II. The Deputy 
Assistant Administrator, Drug Enforcement Administration (DEA or 
Government), issued an Order to Show Cause (OSC), dated February 6, 
2015, proposing to revoke the DEA Certificate of Registration (COR), 
Number BL2132049, of Pedro E. Lopez, M.D. (Respondent), pursuant to 21 
U.S.C. 824(a)(3) and 21 U.S.C. 823(f), and deny any pending 
applications for renewal or modification of the COR, pursuant to 21 
U.S.C. 823(f).
    In the OSC, the Government alleges that the Respondent is, inter 
alia, without ``authority to handle controlled substances in the State 
of Illinois'' as grounds for revocation of the Respondent's DEA 
registration. On March 6, 2015, the Respondent, by counsel, filed a 
Request for Hearing in the above-captioned matter. The Request for 
Hearing stated that a hearing is appropriate because ``the Respondent 
has instituted proceedings to restore his authority to handle 
controlled substances in Illinois.'' Req. for Hrg. at 1.
    Consistent with my direction, the parties have briefed the issues. 
On March 11, 2015, the Government filed a Motion for Summary 
Disposition and Evidence in Support of its Motion for Summary 
Disposition (Motion for Summary Disposition), seeking that this 
tribunal issue a Recommended Decision granting the Government's Motion 
on the ground that the Respondent is currently without state authority 
to handle controlled substances. Mot. for Summary Disp. at 1. According 
to the Government's Motion, the State of Illinois, Department of 
Financial and Professional Regulation (IDFPR) suspended the 
Respondent's license to practice medicine, effective March 12, 2014, 
and that suspension order remains in effect. Id. Attached to the 
Government's Motion is the IDFPR Order dated March 12, 2014 suspending 
the Respondent's state Physician and Surgeon License No. 036.074815 on 
the grounds that the Respondent failed to comply with the provisions an 
Agreement of Care, Counseling and Treatment that he had entered into 
with IDFPR.\2\ Id., Attachment 1 at 1-2. Under the IDPFR Order, the 
Respondent's state license was indefinitely suspended for a minimum 
period of six months. Id., Attachment 1 at 2.
---------------------------------------------------------------------------

    \2\ No objection to consideration of the Government's exhibit, 
or factual challenge to the matters asserted therein was asserted by 
the Respondent.
---------------------------------------------------------------------------

    On March 20, 2015, the Respondent, through counsel, filed a reply 
styled ``Response to the Government's Motion for Summary Disposition 
and Evidence in Support of its Motion for Summary Disposition'' 
(Respondent's Reply). In his Reply, the Respondent alleges that he is 
in the process of seeking reinstatement of his medical license from the 
state of Illinois. Resp't Reply at 2. In opposing the Government's 
requested relief, the Respondent avers that inasmuch as he is currently 
not prescribing controlled substances, granting a hearing, or at least 
deferring adjudication until his state privileges are restored presents 
no cognizable danger to the public. Id. at 2-3.
    In order to revoke a registrant's DEA registration, the DEA has the 
burden of proving that the requirements for revocation are satisfied. 
21 CFR 1301.44(e) (2015). Once DEA has made its prima facie case for 
revocation of the registrant's DEA COR, the burden of production then 
shifts to the Respondent to show that, given the totality of the facts 
and circumstances in the record, revoking the registrant's registration 
would not be appropriate. Morall v. DEA, 412 F.3d 165, 174 (D.C. Cir. 
2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. U.S. 
Dept. of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E. 
Johnston, 45 FR 72311 (1980).
    The Controlled Substances Act (CSA) requires that, in order to 
maintain a DEA registration, a practitioner must be authorized to 
handle controlled substances in ``the jurisdiction in which he 
practices.'' See 21 U.S.C. 802(21) (2012) (``[t]he term `practitioner' 
means a physician . . . 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''); see also 21 U.S.C. 823(f) (2012) (``The 
Attorney General shall register practitioners . . . if the applicant is 
authorized to dispense . . . controlled substances under the laws of 
the State in which he practices.''). DEA has long held that possession 
of authority under state law to dispense controlled substances is an 
essential condition for obtaining and maintaining a DEA registration. 
Serenity Caf[eacute], 77 FR 35027, 35028 (2012); David W. Wang, 72 FR 
54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130, 39131 (2006); 
Dominick A. Ricci, M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 
11919 (1988). Because ``possessing authority under state law to handle 
controlled substances is an essential condition for holding a DEA 
registration,'' this Agency has consistently held that ``the CSA 
requires the revocation of a registration issued to a practitioner who 
lacks [such authority].'' Roy Chi Lung, 74 FR 20346, 20347 (2009); see 
also Scott Sandarg, D.M.D., 74 FR 17528, 174529 (2009); John B. 
Freitas, D.O., 74 FR 17524, 17525 (2009); Roger A. Rodriguez, M.D., 70 
FR 33206, 33207 (2005); Stephen J. Graham, M.D., 69 FR 11661 (2004); 
Abraham A. Chaplan, M.D., 57 FR 55280 (1992); see also Harrell E. 
Robinson, 74 FR 61370, 61375 (2009).\3\ ``[R]evocation is warranted 
even where a practitioner's state authority has been summarily 
suspended and the State has yet to provide the practitioner

[[Page 46326]]

with a hearing to challenge the State's action at which he may 
ultimately prevail.'' Kamal Tiwari, M.D., 76 FR 71604, 71606, (2011); 
see also Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007); Anne Lazar 
Thorn, 62 FR 12847 (1997). Additionally, Agency precedent has 
established that the existence of other proceedings in which the 
Respondent is involved is not a basis upon which to justify a stay of 
DEA administrative enforcement proceedings. Grider Drug #1 & Grider 
Drug #2, 77 FR 44069, 44104 n.97 (2012).
---------------------------------------------------------------------------

    \3\ But see 21 U.S.C. 824(a)(3) (2012) (``A registration 
pursuant to section 823 of this title to manufacture, distribute, or 
dispense a controlled substance may be suspended or revoked by the 
Attorney General upon a finding that the registrant . . . has had 
his State license or registration suspended, revoked, or denied by 
competent State authority . . . .'') (emphasis added).
---------------------------------------------------------------------------

    Congress does not intend for administrative agencies to perform 
meaningless tasks. See Philip E. Kirk, M.D., 48 FR 32887 (1983), aff'd 
sub nom. Kirk v. Mullen, 749 F.2d 297 (6th Cir. 1984); see also Puerto 
Rico Aqueduct & Sewer Auth. v. EPA, 35 F.3d 600, 605 (1st Cir. 1994); 
NLRB v. Int'l Assoc. of Bridge, Structural & Ornamental Ironworkers, 
AFL-CIO, 549 F.2d 634 (9th Cir. 1977); United States v. Consol. Mines & 
Smelting Co., 455 F.2d 432, 453 (9th Cir. 1971). Thus, it is well-
settled that, where no genuine question of fact is involved, or when 
the material facts are agreed upon, a plenary, adversarial 
administrative proceeding is not required. See Jesus R. Juarez, M.D., 
62 FR 14945 (1997); Dominick A. Ricci, M.D., 58 FR 51104 (1993). Here, 
the supplied IDFPR Order establishes, and the Respondent does not 
contest, that the Respondent is currently without authorization to 
handle controlled substances in Illinois, the jurisdiction where the 
Respondent holds the DEA COR that is the subject of this litigation.
    Summary disposition of an administrative case is warranted where, 
as here, ``there is no factual dispute of substance.'' See Veg-Mix, 
Inc., 832 F.2d 601, 607 (D.C. Cir. 1987) (``an agency may ordinarily 
dispense with a hearing when no genuine dispute exists'').\4\ At this 
juncture, no genuine dispute exists over the fact that the Respondent 
lacks state authority to handle controlled substances in the state of 
Illinois. Because the Respondent lacks such state authority, both the 
plain language of applicable federal statutory provisions and Agency 
interpretive precedent dictate that the Respondent is not entitled to 
maintain his DEA registration. Simply put, there is no contested 
factual matter adducible at a hearing that would provide DEA with the 
authority to allow the Respondent to continue to hold his COR.
---------------------------------------------------------------------------

    \4\ Even assuming, arguendo, the possibility that the 
Respondent's state controlled substances privileges could be 
reinstated, summary disposition would still be warranted because 
``revocation is also appropriate when a state license has been 
suspended, but with the possibility of future reinstatement,'' 
Rodriguez, 70 FR at 33207 (citations omitted), and even where there 
is a judicial challenge to the state medical board action actively 
pending in the state courts. Michael G. Dolin, M.D., 65 FR 5661, 
5662 (2000).
---------------------------------------------------------------------------

    Accordingly, I hereby
    GRANT the Government's Motion for Summary Disposition; and further
    DENY the Respondent's Request for Stay; and further
    RECOMMEND that the Respondent's DEA registration be REVOKED 
forthwith and any pending applications for renewal be DENIED.

    Dated: March 20, 2015.

JOHN J. MULROONEY, II,
Chief Administrative Law Judge.

[FR Doc. 2015-19119 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P



                                              46324                                    Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices

                                              80 FR 22557, Sigma Aldrich Research                                        Research Biochemicals, Inc. to                                               company’s compliance with state and
                                              Biochemicals, Inc., 1–3 Strathmore                                         manufacture the basic classes of                                             local laws, and reviewing the company’s
                                              Road, Natick, Massachusetts 01760–                                         controlled substances is consistent with                                     background and history.
                                              2447 applied to be registered as a                                         the public interest and with United                                            Therefore, pursuant to 21 U.S.C.
                                              manufacturer of certain basic classes of                                   States obligations under international
                                                                                                                                                                                                      823(a), and in accordance with 21 CFR
                                              controlled substances. No comments or                                      treaties, conventions, or protocols in
                                                                                                                                                                                                      1301.33, the above-named company is
                                              objections were submitted for this                                         effect on May 1, 1971. The DEA
                                                                                                                         investigated the company’s maintenance                                       granted registration as a bulk
                                              notice.
                                                The DEA has considered the factors in                                    of effective controls against diversion by                                   manufacturer of the basic classes of
                                              21 U.S.C. 823(a) and determined that                                       inspecting and testing the company’s                                         controlled substances listed:
                                              the registration of Sigma Aldrich                                          physical security systems, verifying the

                                                                                                                                    Controlled substance                                                                                                      Schedule

                                              Cathinone (1235) .........................................................................................................................................................................................      I
                                              Methcathinone (1237) ..................................................................................................................................................................................         I
                                              Mephedrone (4-Methyl-N-methylcathinone) (1248) ....................................................................................................................................                             I
                                              Aminorex (1585) ..........................................................................................................................................................................................      I
                                              Alpha-ethyltryptamine (7249) ......................................................................................................................................................................             I
                                              Lysergic acid diethylamide (7315) ...............................................................................................................................................................               I
                                              Tetrahydrocannabinols (7370) .....................................................................................................................................................................              I
                                              4-Bromo-2,5-dimethoxyamphetamine (7391) ..............................................................................................................................................                          I
                                              4-Bromo-2,5-dimethoxyphenethylamine (7392) ..........................................................................................................................................                           I
                                              4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................                         I
                                              2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................                    I
                                              3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................                       I
                                              N-Hydroxy-3,4-methylenedioxyamphetamine (7402) ..................................................................................................................................                               I
                                              3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................                           I
                                              3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................                           I
                                              Dimethyltryptamine (7435) ..........................................................................................................................................................................            I
                                              Psilocybin (7437) .........................................................................................................................................................................................     I
                                              5-Methoxy-N,N-diisopropyltryptamine (7439) ..............................................................................................................................................                       I
                                              1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ...............................................................................................................................................                    I
                                              N-Benzylpiperazine (7493) ..........................................................................................................................................................................            I
                                              MDPV (3,4-Methylenedioxypyrovalerone) (7535) .......................................................................................................................................                            I
                                              Methylone (3,4-Methylenedioxy-N-methylcathinone) (7540) .......................................................................................................................                                 I
                                              Heroin (9200) ...............................................................................................................................................................................................   I
                                              Normorphine (9313) ....................................................................................................................................................................................         I
                                              Amphetamine (1100) ...................................................................................................................................................................................          II
                                              Methamphetamine (1105) ...........................................................................................................................................................................              II
                                              Nabilone (7379) ...........................................................................................................................................................................................     II
                                              1-Phenylcyclohexylamine (7460) .................................................................................................................................................................                II
                                              Phencyclidine (7471) ...................................................................................................................................................................................        II
                                              Cocaine (9041) ............................................................................................................................................................................................     II
                                              Codeine (9050) ............................................................................................................................................................................................     II
                                              Ecgonine (9180) ..........................................................................................................................................................................................      II
                                              Levomethorphan (9210) ..............................................................................................................................................................................            II
                                              Levorphanol (9220) .....................................................................................................................................................................................        II
                                              Meperidine (9230) .......................................................................................................................................................................................       II
                                              Metazocine (9240) .......................................................................................................................................................................................       II
                                              Methadone (9250) .......................................................................................................................................................................................        II
                                              Morphine (9300) ..........................................................................................................................................................................................      II
                                              Thebaine (9333) ..........................................................................................................................................................................................      II
                                              Levo-alphacetylmethadol (9648) .................................................................................................................................................................                II
                                              Remifentanil (9739) .....................................................................................................................................................................................       II
                                              Sufentanil (9740) .........................................................................................................................................................................................     II
                                              Carfentanil (9743) ........................................................................................................................................................................................     II
                                              Fentanyl (9801) ...........................................................................................................................................................................................     II



                                                The company plans to manufacture                                         DEPARTMENT OF JUSTICE                                                        filed exceptions to the Recommended
                                              reference standards.                                                                                                                                    Decision.
                                                                                                                         Drug Enforcement Administration
                                                Dated: July 29, 2015.                                                                                                                                    Having reviewed the record in its
                                              Joseph T. Rannazzisi,                                                                                                                                   entirety, I adopt the CALJ’s findings of
                                                                                                                         [Docket No. 15–16]                                                           fact,1 conclusions of law, and
                                              Deputy Assistant Administrator.
tkelley on DSK3SPTVN1PROD with NOTICES




                                              [FR Doc. 2015–19166 Filed 8–3–15; 8:45 am]                                 Pedro E. Lopez, M.D.; Decision and                                             1 I take official notice of the fact that, according
                                              BILLING CODE P                                                             Order
                                                                                                                                                                                                      to the registration records of the Agency,
                                                                                                                                                                                                      Respondent retains an active registration as of this
                                                                                                                           On March 20, 2015, Chief                                                   date. Pursuant to 21 CFR 1316.59(e), Respondent
                                                                                                                         Administrative Law Judge (CALJ) John J.                                      may controvert this finding by filing a properly
                                                                                                                         Mulrooney, II, issued the attached                                           supported motion, no later than 10 days from the
                                                                                                                         Recommended Decision. Neither party                                          date of this Order.



                                         VerDate Sep<11>2014         18:45 Aug 03, 2015          Jkt 235001      PO 00000        Frm 00091       Fmt 4703       Sfmt 4703       E:\FR\FM\04AUN1.SGM              04AUN1


                                                                            Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices                                                     46325

                                              recommended order. Accordingly, I will                  is appropriate because ‘‘the Respondent               production then shifts to the
                                              order that Respondent’s DEA Certificate                 has instituted proceedings to restore his             Respondent to show that, given the
                                              of Registration be revoked and that any                 authority to handle controlled                        totality of the facts and circumstances in
                                              pending applications to renew or                        substances in Illinois.’’ Req. for Hrg. at            the record, revoking the registrant’s
                                              modify his registration be denied.                      1.                                                    registration would not be appropriate.
                                                                                                         Consistent with my direction, the                  Morall v. DEA, 412 F.3d 165, 174 (D.C.
                                              Order                                                                                                         Cir. 2005); Humphreys v. DEA, 96 F.3d
                                                                                                      parties have briefed the issues. On
                                                 Pursuant to the authority vested in me               March 11, 2015, the Government filed a                658, 661 (3d Cir. 1996); Shatz v. U.S.
                                              by 21 U.S.C. 823(f) and 824(a)(3), as                   Motion for Summary Disposition and                    Dept. of Justice, 873 F.2d 1089, 1091
                                              well as 28 CFR 0.100(b), I order that                   Evidence in Support of its Motion for                 (8th Cir. 1989); Thomas E. Johnston, 45
                                              DEA Certificate of Registration                         Summary Disposition (Motion for                       FR 72311 (1980).
                                              BL2132049, issued to Pedro E. Lopez,                    Summary Disposition), seeking that this                  The Controlled Substances Act (CSA)
                                              M.D., be, and it hereby is, revoked. I                  tribunal issue a Recommended Decision                 requires that, in order to maintain a
                                              further order that any pending                          granting the Government’s Motion on                   DEA registration, a practitioner must be
                                              application of Pedro E. Lopez, M.D., to                 the ground that the Respondent is                     authorized to handle controlled
                                              renew or modify his registration, be, and               currently without state authority to                  substances in ‘‘the jurisdiction in which
                                              it hereby is, denied. This Order is                     handle controlled substances. Mot. for                he practices.’’ See 21 U.S.C. 802(21)
                                              effective September 3, 2015.                            Summary Disp. at 1. According to the                  (2012) (‘‘[t]he term ‘practitioner’ means
                                                Dated: July 27, 2015.                                 Government’s Motion, the State of                     a physician . . . licensed, registered, or
                                                                                                      Illinois, Department of Financial and                 otherwise permitted, by . . . the
                                              Chuck Rosenberg,
                                                                                                      Professional Regulation (IDFPR)                       jurisdiction in which he practices . . .
                                              Acting Administrator.
                                                                                                      suspended the Respondent’s license to                 to distribute, dispense, [or] administer
                                              Brian Bayly, Esq., for the Government.                  practice medicine, effective March 12,                . . . a controlled substance in the
                                              Alan Rhine, Esq., for the Respondent.                   2014, and that suspension order remains               course of professional practice’’); see
                                              ORDER GRANTING THE                                      in effect. Id. Attached to the                        also 21 U.S.C. 823(f) (2012) (‘‘The
                                              GOVERNMENT’S MOTION FOR                                 Government’s Motion is the IDFPR                      Attorney General shall register
                                              SUMMARY DISPOSITION AND                                 Order dated March 12, 2014 suspending                 practitioners . . . if the applicant is
                                              RECOMMENDED RULINGS, FINDINGS                           the Respondent’s state Physician and                  authorized to dispense . . . controlled
                                              OF FACT, CONCLUSIONS OF LAW,                            Surgeon License No. 036.074815 on the                 substances under the laws of the State
                                              AND DECISION OF THE                                     grounds that the Respondent failed to                 in which he practices.’’). DEA has long
                                              ADMINISTRATIVE LAW JUDGE                                comply with the provisions an                         held that possession of authority under
                                                                                                      Agreement of Care, Counseling and                     state law to dispense controlled
                                                 Chief Administrative Law Judge John                                                                        substances is an essential condition for
                                              J. Mulrooney, II. The Deputy Assistant                  Treatment that he had entered into with
                                                                                                      IDFPR.2 Id., Attachment 1 at                          obtaining and maintaining a DEA
                                              Administrator, Drug Enforcement                                                                               registration. Serenity Café, 77 FR 35027,
                                              Administration (DEA or Government),                     1–2. Under the IDPFR Order, the
                                                                                                      Respondent’s state license was                        35028 (2012); David W. Wang, 72 FR
                                              issued an Order to Show Cause (OSC),                                                                          54297, 54298 (2007); Sheran Arden
                                              dated February 6, 2015, proposing to                    indefinitely suspended for a minimum
                                                                                                      period of six months. Id., Attachment 1               Yeates, 71 FR 39130, 39131 (2006);
                                              revoke the DEA Certificate of                                                                                 Dominick A. Ricci, M.D., 58 FR 51104
                                              Registration (COR), Number BL2132049,                   at 2.
                                                                                                         On March 20, 2015, the Respondent,                 (1993); Bobby Watts, M.D., 53 FR 11919
                                              of Pedro E. Lopez, M.D. (Respondent),                                                                         (1988). Because ‘‘possessing authority
                                              pursuant to 21 U.S.C. 824(a)(3) and 21                  through counsel, filed a reply styled
                                                                                                      ‘‘Response to the Government’s Motion                 under state law to handle controlled
                                              U.S.C. 823(f), and deny any pending                                                                           substances is an essential condition for
                                              applications for renewal or modification                for Summary Disposition and Evidence
                                                                                                      in Support of its Motion for Summary                  holding a DEA registration,’’ this
                                              of the COR, pursuant to 21 U.S.C. 823(f).                                                                     Agency has consistently held that ‘‘the
                                                 In the OSC, the Government alleges                   Disposition’’ (Respondent’s Reply). In
                                                                                                      his Reply, the Respondent alleges that                CSA requires the revocation of a
                                              that the Respondent is, inter alia,                                                                           registration issued to a practitioner who
                                              without ‘‘authority to handle controlled                he is in the process of seeking
                                                                                                      reinstatement of his medical license                  lacks [such authority].’’ Roy Chi Lung,
                                              substances in the State of Illinois’’ as                                                                      74 FR 20346, 20347 (2009); see also
                                              grounds for revocation of the                           from the state of Illinois. Resp’t Reply at
                                                                                                      2. In opposing the Government’s                       Scott Sandarg, D.M.D., 74 FR 17528,
                                              Respondent’s DEA registration. On                                                                             174529 (2009); John B. Freitas, D.O., 74
                                              March 6, 2015, the Respondent, by                       requested relief, the Respondent avers
                                                                                                      that inasmuch as he is currently not                  FR 17524, 17525 (2009); Roger A.
                                              counsel, filed a Request for Hearing in                                                                       Rodriguez, M.D., 70 FR 33206, 33207
                                              the above-captioned matter. The                         prescribing controlled substances,
                                                                                                      granting a hearing, or at least deferring             (2005); Stephen J. Graham, M.D., 69 FR
                                              Request for Hearing stated that a hearing                                                                     11661 (2004); Abraham A. Chaplan,
                                                                                                      adjudication until his state privileges
                                                                                                      are restored presents no cognizable                   M.D., 57 FR 55280 (1992); see also
                                                 Notwithstanding that the language of section
                                              824(a) authorizes either the suspension or              danger to the public. Id. at 2–3.                     Harrell E. Robinson, 74 FR 61370, 61375
                                              revocation of a registration upon the making of one        In order to revoke a registrant’s DEA              (2009).3 ‘‘[R]evocation is warranted even
                                              of the five findings enumerated therein, the Agency     registration, the DEA has the burden of               where a practitioner’s state authority
                                              has consistently interpreted the CSA as mandating                                                             has been summarily suspended and the
                                              revocation where a practitioner’s state authority has   proving that the requirements for
                                              been suspended or revoked. As the Fourth Circuit        revocation are satisfied. 21 CFR                      State has yet to provide the practitioner
                                              has held, ‘‘[b]ecause § 823(f) and § 802(21) make       1301.44(e) (2015). Once DEA has made
tkelley on DSK3SPTVN1PROD with NOTICES




                                              clear that a practitioner’s registration is dependent   its prima facie case for revocation of the               3 But see 21 U.S.C. 824(a)(3) (2012) (‘‘A

                                              upon the practitioner having state authority to                                                               registration pursuant to section 823 of this title to
                                              dispense controlled substances, the                     registrant’s DEA COR, the burden of                   manufacture, distribute, or dispense a controlled
                                              [Administrator’s] decision to construe § 824(a)(3) as                                                         substance may be suspended or revoked by the
                                              mandating revocation upon suspension of a state           2 No objection to consideration of the              Attorney General upon a finding that the registrant
                                              license is not an unreasonable interpretation of the    Government’s exhibit, or factual challenge to the     . . . has had his State license or registration
                                              CSA.’’ Hooper v. Holder, 2012 WL 2020079, *2 (4th       matters asserted therein was asserted by the          suspended, revoked, or denied by competent State
                                              Cir. 2012) (unpublished).                               Respondent.                                           authority . . . .’’) (emphasis added).



                                         VerDate Sep<11>2014   18:45 Aug 03, 2015   Jkt 235001   PO 00000   Frm 00092   Fmt 4703   Sfmt 4703   E:\FR\FM\04AUN1.SGM   04AUN1


                                              46326                         Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices

                                              with a hearing to challenge the State’s                 registration. Simply put, there is no                  DEPARTMENT OF JUSTICE
                                              action at which he may ultimately                       contested factual matter adducible at a
                                              prevail.’’ Kamal Tiwari, M.D., 76 FR                    hearing that would provide DEA with                    Drug Enforcement Administration
                                              71604, 71606, (2011); see also Bourne                   the authority to allow the Respondent to
                                              Pharmacy, Inc., 72 FR 18273, 18274                      continue to hold his COR.                              [Docket No. DEA–392]
                                              (2007); Anne Lazar Thorn, 62 FR 12847                     Accordingly, I hereby
                                              (1997). Additionally, Agency precedent                    GRANT the Government’s Motion for                    Manufacturer of Controlled
                                              has established that the existence of                   Summary Disposition; and further                       Substances Registration: National
                                              other proceedings in which the                            DENY the Respondent’s Request for                    Center for Natural Products Research
                                              Respondent is involved is not a basis                   Stay; and further                                      (NIDA MPROJECT), Inc.
                                              upon which to justify a stay of DEA                       RECOMMEND that the Respondent’s
                                              administrative enforcement                              DEA registration be REVOKED forthwith                  ACTION:   Notice of registration.
                                              proceedings. Grider Drug #1 & Grider                    and any pending applications for
                                              Drug #2, 77 FR 44069, 44104 n.97                        renewal be DENIED.                                     SUMMARY:    National Center for Natural
                                              (2012).                                                   Dated: March 20, 2015.                               Products Research (NIDA MPROJECT),
                                                 Congress does not intend for                         JOHN J. MULROONEY, II,
                                                                                                                                                             Inc. applied to be registered as a
                                              administrative agencies to perform                      Chief Administrative Law Judge.                        manufacturer of certain basic classes of
                                              meaningless tasks. See Philip E. Kirk,                                                                         controlled substances. The Drug
                                                                                                      [FR Doc. 2015–19119 Filed 8–3–15; 8:45 am]
                                              M.D., 48 FR 32887 (1983), aff’d sub                                                                            Enforcement Administration (DEA)
                                                                                                      BILLING CODE 4410–09–P
                                              nom. Kirk v. Mullen, 749 F.2d 297 (6th                                                                         grants National Center for Natural
                                              Cir. 1984); see also Puerto Rico                                                                               Products Research (NIDA MPROJECT),
                                              Aqueduct & Sewer Auth. v. EPA, 35                       DEPARTMENT OF JUSTICE                                  Inc. registration as a manufacturer of
                                              F.3d 600, 605 (1st Cir. 1994); NLRB v.                                                                         those controlled substances.
                                              Int’l Assoc. of Bridge, Structural &                    Drug Enforcement Administration                        SUPPLEMENTARY INFORMATION: By notice
                                              Ornamental Ironworkers, AFL–CIO, 549                    [Docket No. 12–49]                                     dated April 14, 2015, and published in
                                              F.2d 634 (9th Cir. 1977); United States                                                                        the Federal Register on April 22, 2015,
                                              v. Consol. Mines & Smelting Co., 455                    AIM Pharmacy & Surgical S. Corp.                       80 FR 22559, National Center for
                                              F.2d 432, 453 (9th Cir. 1971). Thus, it                 Order                                                  Natural Products Research (NIDA
                                              is well-settled that, where no genuine                                                                         MPROJECT), Inc., University of
                                              question of fact is involved, or when the                 On May 8, 2015, the Administrator of                 Mississippi, 135 Coy Waller Complex,
                                              material facts are agreed upon, a                       the Drug Enforcement Administration,                   University, Mississippi 38677–1848
                                              plenary, adversarial administrative                     noting that the expiration date of                     applied to be registered as a
                                              proceeding is not required. See Jesus R.                Respondent’s registration was June 30,                 manufacturer of certain basic classes of
                                              Juarez, M.D., 62 FR 14945 (1997);                       2014, ordered the parties to address                   controlled substances. No comments or
                                              Dominick A. Ricci, M.D., 58 FR 51104                    whether the case is now moot. The                      objections were submitted for this
                                              (1993). Here, the supplied IDFPR Order                  Administrator’s Order was served on                    notice.
                                              establishes, and the Respondent does                    Respondent’s counsel at his address of                   The DEA has considered the factors in
                                              not contest, that the Respondent is                     record.                                                21 U.S.C. 823(a) and determined that
                                                                                                        The Government filed a timely                        the registration of National Center for
                                              currently without authorization to
                                                                                                      response and served a copy of its                      Natural Products Research (NIDA
                                              handle controlled substances in Illinois,
                                                                                                      response on Respondent’s counsel at his                MPROJECT), Inc. to manufacture the
                                              the jurisdiction where the Respondent
                                                                                                      address of record. Govt. Response to                   basic classes of controlled substances is
                                              holds the DEA COR that is the subject
                                                                                                      Administrator’s May 8, 2015 Order, at 1.               consistent with the public interest and
                                              of this litigation.
                                                                                                      Respondent has not filed a response.1                  with United States obligations under
                                                 Summary disposition of an                              In its Response, the Government
                                              administrative case is warranted where,                                                                        international treaties, conventions, or
                                                                                                      advises that Respondent neither
                                              as here, ‘‘there is no factual dispute of                                                                      protocols in effect on May 1, 1971. The
                                                                                                      submitted a renewal application prior to
                                              substance.’’ See Veg-Mix, Inc., 832 F.2d                                                                       DEA investigated the company’s
                                                                                                      the expiration of its registration nor an
                                              601, 607 (D.C. Cir. 1987) (‘‘an agency                                                                         maintenance of effective controls
                                                                                                      application for a new registration. Id.
                                              may ordinarily dispense with a hearing                                                                         against diversion by inspecting and
                                                                                                      The Government therefore
                                              when no genuine dispute exists’’).4 At                                                                         testing the company’s physical security
                                                                                                      acknowledges that this case is now
                                              this juncture, no genuine dispute exists                                                                       systems, verifying the company’s
                                                                                                      moot. Id.; see Ronald J. Riegel, 63 FR
                                              over the fact that the Respondent lacks                                                                        compliance with state and local laws,
                                                                                                      67132, 67133 (1998). Accordingly, I
                                              state authority to handle controlled                                                                           and reviewing the company’s
                                                                                                      dismiss the Order to Show Cause.
                                              substances in the state of Illinois.                      It is so ordered.                                    background and history.
                                              Because the Respondent lacks such state                                                                          Therefore, pursuant to 21 U.S.C.
                                              authority, both the plain language of                     Date: July 27, 2015.                                 823(a), and in accordance with 21 CFR
                                              applicable federal statutory provisions                 Chuck Rosenberg,                                       1301.33, the above-named company is
                                              and Agency interpretive precedent                       Acting Administrator.                                  granted registration as a bulk
                                              dictate that the Respondent is not                      [FR Doc. 2015–19116 Filed 8–3–15; 8:45 am]             manufacturer of the basic classes of
                                              entitled to maintain his DEA                            BILLING CODE 4410–09–P                                 controlled substances:
tkelley on DSK3SPTVN1PROD with NOTICES




                                                4 Even assuming, arguendo, the possibility that       pending in the state courts. Michael G. Dolin, M.D.,   different address than that listed in the record.
                                              the Respondent’s state controlled substances            65 FR 5661, 5662 (2000).                               Notice of Recent Order and Government’s Response
                                              privileges could be reinstated, summary disposition       1 After both the Administrator’s Order and the       II, at 1–2. The Government represents that on June
                                              would still be warranted because ‘‘revocation is also                                                          30, 2015, it served both the Administrator’s Order
                                                                                                      Government’s Response were returned to the
                                              appropriate when a state license has been
                                                                                                      Agency as undelivered following efforts to serve       and its Response on each of Respondent’s attorneys
                                              suspended, but with the possibility of future
                                              reinstatement,’’ Rodriguez, 70 FR at 33207 (citations   both of Respondent’s counsels, the Government          by mailing them to the addresses of Respondent’s
                                              omitted), and even where there is a judicial            determined through the New York State Unified          attorneys as listed in the New York Unified Court
                                              challenge to the state medical board action actively    Court System’s database that each attorney had a       System’s database. Id. at 2.



                                         VerDate Sep<11>2014   18:45 Aug 03, 2015   Jkt 235001   PO 00000   Frm 00093   Fmt 4703   Sfmt 4703   E:\FR\FM\04AUN1.SGM   04AUN1



Document Created: 2015-12-18 14:50:57
Document Modified: 2015-12-18 14:50:57
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 Citation80 FR 46324 

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR