80_FR_57575 80 FR 57391 - James Alvin Chaney, M.D.: Decision and Order

80 FR 57391 - James Alvin Chaney, M.D.: Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 184 (September 23, 2015)

Page Range57391-57393
FR Document2015-24128

Federal Register, Volume 80 Issue 184 (Wednesday, September 23, 2015)
[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Pages 57391-57393]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24128]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-25]


James Alvin Chaney, M.D.: Decision and Order

    On July 23, 2015, Chief Administrative Law Judge (CALJ) John J. 
Mulrooney, II, issued the attached Recommended Decision (cited as 
R.D.). Respondent filed Exceptions to the Recommended Decision.
    In his Recommended Decision, the CALJ found that on October 21, 
2014, the Commonwealth of Kentucky, Board of Medical Licensure, had 
issued Respondent an Emergency Order of Suspension against his medical 
license. R.D. at 2. The CALJ further found that on November 17, 2014, 
the Board issued a final order that affirmed the emergency order of 
suspension ``and that the suspension order remains in effect.'' Id. 
Noting that the Controlled Substances Act defines ``term `practitioner' 
[to] mean[ ] a physician . . . licensed, registered, or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to . . 
. dispense [or] administer . . . a controlled substance in the course 
of professional practice,'' id. at 3 (quoting 21 U.S.C. 802(21), as 
well as that the registration provision applicable to practitioners 
directs the Attorney General to ``register [a] practitioner[] . . . if 
the applicant is authorized to dispense . . . controlled substances 
under the laws of the State in which he practices,'' id. (quoting 21 
U.S.C. 823(f)), the CALJ then noted that the Agency ``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.'' Id. (collecting cases). Because there is no dispute 
that ``Respondent lacks state authority to handle controlled substances 
in'' Kentucky, the CALJ granted the Government's motion for summary 
disposition and recommended that Respondent's registration be 
revoked.\1\ Id. at 5.
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    \1\ While the Government alleged in the Order to Show Cause that 
Respondent's registration does not expire until August 31, 2016, 
Show Cause Order, at 1; and in his hearing request, Respondent 
states that he ``holds a medical license . . . and a DEA 
registration,'' Hearing Request, at 1; the Agency is still required 
to establish that it has jurisdiction to act. See Sharad C. Patel, 
80 FR 28693, 28694 n.3 (2015) (``Even in summary disposition 
proceedings which are based on a lack of state authority, the ALJ is 
obligated to make a finding establishing that the Agency has 
jurisdiction.''); see also 5 U.S.C. 706(2)(C) (directing reviewing 
courts ``to hold unlawful and set aside agency action, findings and 
conclusions found to be . . . in excess of statutory 
jurisdiction''). This generally requires the ALJ to make a finding 
either that a respondent retains an active registration or has 
submitted an application for registration.
     In the interest of conducting an expeditious review of this 
matter, I have taken official notice of Respondent's registration 
record with the Agency and find that his registration does not 
expire until August 31, 2016. See 5 U.S.C. 556(e); 21 CFR 
1316.59(e). However, in the future, where a recommended decision 
lacks the requisite finding, I will remand the matter for this 
purpose.
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    In his Exceptions, Respondent argues that Board's Emergency Order 
suspending his license ``is not a final order as it has been appealed 
and is currently being reviewed by the Kentucky Court of Appeals.'' 
Exceptions at 1. He argues that the CALJ's Recommended Decision is 
therefore ``based upon an order that is not final and consequently will 
constitute arbitrary and capricious action.'' Id. at 2. Finally, 
Respondent contends that ``[s]ummary judgment is improper because 
issues of fact exist concerning the enforceability of the temporary 
suspension of [his] medical license given its unconstitutionality.'' 
Id.
    I reject Respondent's contentions. Putting aside whether--in light 
of the state Hearing Officer's issuance of the ``Final Order Affirming 
The Emergency Order of Suspension''--Respondent has accurately 
described the procedural posture of the state licensing matter, based 
on the plain language of sections 802(21) and 823(f), this Agency has 
held repeatedly that ``the controlling question'' in a proceeding 
brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA 
registration ```is currently authorized to handle controlled substances 
in the [S]tate.''' James L. Hooper, 76 FR 71371, 71371 (2011) (quoting 
Anne Lazar Thorn, 62 FR 12847, 12848 (1997)), pet. for rev.

[[Page 57392]]

denied, Hooper v. Holder, 481 Fed.Appx. 826 (4th Cir. 2012). Thus, it 
is of no consequence that the State has employed summary process in 
suspending Respondent's state license and that the Board's ``order 
remains subject to challenge in either [further] administrative or 
judicial proceedings.'' Patel, 80 FR at 28694; see also Gary Alfred 
Shearer, 78 FR 19009, 19012 (2013); Michael G. Dolin, 65 FR at 5661, 
5662 (2000).
    As for Respondent's contention that summary disposition is 
inappropriate ``because issues of fact exist concerning the 
enforceability of the temporary suspension'' order, the only fact that 
is material in this proceeding is whether Respondent ``is currently 
authorized to handle controlled substances'' by the State. Hooper, 76 
FR at 71371; cf. Sunil Bhasin, 72 FR 5082, 5083 (2007) (holding that a 
registrant cannot collaterally attack the results of a state 
administrative or criminal proceeding in a proceeding brought under 
section 304 (21 U.S.C. 824(a)). Accordingly, because the suspension 
order remains in effect, I adopt the Recommended Decision \2\ and will 
order that Respondent's registration be revoked.
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    \2\ 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, see 
R.D. at 4 n.1, 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 
sections 823(f) and 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 section 824(a)(3) as mandating revocation upon 
suspension of a state license is not an unreasonable interpretation 
of the CSA.'' Hooper, 481 Fed.Appx. at 828.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 
CFR 0.100(b), I order that DEA Certificate of Registration BC3278492 
issued to James Alvin Chaney, M.D., be, and it hereby is, revoked. I 
further order that any application of James Alvin Chaney, M.D., to 
renew or modify his registration be, and it hereby is, denied. This 
Order is effective immediately.\3\
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    \3\ For the same reasons that lead the Board to order the 
emergency suspension of Respondent's medical license (i.e., his 
indictment on various counts of the unlawful distribution of 
controlled substances), I find that the public interest necessitates 
that this Order be effective immediately. 21 CFR 1316.67.

    Dated: September 15, 2015.
Chuck Rosenberg,
Acting Administrator.
Brian Bayly, Esq., for the Government.
Lisa English Hinkle, 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 May 21, 2015, 
seeking to revoke the DEA Certificate of Registration (COR), Number 
BC3278492, of James Alvin Chaney, 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 Commonwealth of Kentucky'' as grounds for revocation of the 
Respondent's DEA registration. On July 2, 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 
review of [the Kentucky Board of Medical Licensure's] illegal 
suspension by emergency order of [the Respondent's] medical license is 
currently on appeal before the Kentucky Court of Appeals . . .'' and 
because ``any action concerning [the Respondent's DEA COR] . . . is 
premature . . . .'' Req. for Hrg. at 7.
    Consistent with my direction, the parties have briefed the issues. 
On July 9, 2015, the Government filed a Motion for Summary Disposition 
Based on Respondent's Lack of State Authorization to Handle Controlled 
Substances and Submission of Evidence in Support of Such Motion (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 Commonwealth of Kentucky, Board of Medical 
Licensure (BML) suspended the Respondent's license to practice medicine 
effective October 21, 2014, and that suspension order remains in 
effect. Id. Attached to the Government's Motion is the BML Emergency 
Order of Suspension dated October 21, 2014 suspending the Respondent's 
state license No. 28914 on the grounds that there was probable cause to 
believe that the Respondent's practice constituted a danger to the 
health, welfare, and safety of his patients or the general public, as 
evidenced by the Respondent's indictments for crimes related to 
controlled substances. Id. at 1-2; Attachment 1 at 1-4. Also attached 
to the Government's Motion is the BML Final Order Affirming the 
Emergency Order of Suspension, dated November 17, 2014. Attachment 2 at 
17.
    On July 23, the Respondent, through counsel, filed a reply styled 
``Response to Government's Motion for Summary Judgment'' (Respondent's 
Reply). In his Reply, the Respondent alleges that his situation is 
distinguishable from Agency precedent mandating revocation for lack of 
state authority, Resp't Reply at 4-5, because the BML's suspension of 
his license was ``based on the [BML's] application of an incorrect rule 
of law and an unconstitutional regulation.'' Id. at 5. In opposing the 
Government's requested relief, the Respondent also avers that inasmuch 
as he is not currently practicing medicine or prescribing controlled 
substances, maintenance of his DEA COR constitutes no danger to the 
public, and that he ``should not be penalized'' by the DEA because his 
underlying federal criminal charges have not yet been resolved. Id. at 
8.
    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 the 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

[[Page 57393]]

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, M.D., 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, M.D., 74 FR 61370, 61375 (2009).\1\ ``[R]evocation is 
warranted even where a practitioner's state authority has been 
summarily suspended and the State has yet to provide the practitioner 
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, M.D., 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).
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    \1\ 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). Thus, 
notwithstanding the Agency's extensive body of internal precedent to 
the contrary, the plain language of section 824(a)(3) provides that 
loss of state authority constitutes a discretionary--not mandatory--
basis for revocation. However, inasmuch as the Agency precedent is 
clear on the matter, I am without authority or inclination to render 
a contrary interpretation.
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    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 
BML Order establishes, and the Respondent does not contest, that the 
Respondent is currently without authorization to handle controlled 
substances in Kentucky, 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'').\2\ While not 
unsympathetic to the procedural issues raised by the Respondent in his 
state administrative proceedings, under current Agency precedent, the 
disposition of the Government's motion is wholly dependent upon a 
single issue: whether he continues to possess authority under state law 
to handle controlled substances--which he does not.
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    \2\ Even assuming, arguendo, the possibility that the 
Respondent's state controlled substances privileges could be 
reinstated, summary disposition would still be warranted because 
under Agency precedent ``revocation is also appropriate when a state 
license has been suspended, but with the possibility of future 
reinstatement,'' Rodriguez, 70 FR 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).
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    At this juncture, no genuine dispute exists over the fact that the 
Respondent lacks state authority to handle controlled substances in the 
state of Kentucky. Because the Respondent lacks such state authority, 
both the plain language of applicable federal statutory provisions and 
Agency interpretive precedent dictate that he 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.
    Accordingly, I hereby

    GRANT the Government's Motion for Summary Disposition; and further

    RECOMMEND that the Respondent's DEA registration be REVOKED 
forthwith \3\ and any pending applications for renewal be DENIED.

    \3\ While Agency precedent has held that a stay of DEA 
administrative proceedings is unlikely ever to be justified by the 
existence of ancillary proceedings (Grider Drug #1 & Grider Drug, 
#2, 77 FR 44069, 44104 n.97 (2012)), the Agency recently held 
revocation proceedings in abeyance at the post-hearing adjudication 
level for a lengthy period pending the resolution of criminal fraud 
charges and ``pending resolution of [a state] Board proceeding.'' 
Odette L. Campbell, M.D., 80 FR 41062, 41064 (2015). However, 
inasmuch as no stay was sought by the Respondent here, and good 
cause does not appear to exist in any event, the Government's motion 
will be granted and the case forwarded for a final order.
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Dated: July 23, 2015.
John J. Mulrooney II,
Chief Administrative Law Judge.

[FR Doc. 2015-24128 Filed 9-22-15; 8:45 am]
 BILLING CODE 4410-09-P



                                                                           Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices                                                         57391

                                                    Dated: September 16, 2015.                                   Controlled Substance                   Schedule    to dispense controlled substances is an
                                                  Joseph T. Rannazzisi,                                                                                             essential condition for obtaining and
                                                  Deputy Assistant Administrator.                         Phenylacetone (8501) ................        II           maintaining a DEA registration.’’ Id.
                                                                                                          Methadone (9250) ......................      II           (collecting cases). Because there is no
                                                  [FR Doc. 2015–24120 Filed 9–22–15; 8:45 am]
                                                                                                          Methadone intermediate (9254)                II           dispute that ‘‘Respondent lacks state
                                                  BILLING CODE 4410–09–P                                  Oripavine (9330) .........................   II           authority to handle controlled
                                                                                                          Tapentadol (9780) ......................     II
                                                                                                                                                                    substances in’’ Kentucky, the CALJ
                                                  DEPARTMENT OF JUSTICE                                     The company plans to manufacture                        granted the Government’s motion for
                                                                                                          the listed controlled substances in bulk                  summary disposition and recommended
                                                  Drug Enforcement Administration                         for distribution and sale to its                          that Respondent’s registration be
                                                                                                          customers.                                                revoked.1 Id. at 5.
                                                  [Docket No. DEA–392]
                                                                                                            In reference to oripavine (9330), the                      In his Exceptions, Respondent argues
                                                  Bulk Manufacturer of Controlled                         company plans to acquire the listed                       that Board’s Emergency Order
                                                  Substances Application: Euticals, Inc.                  controlled substance in bulk from a                       suspending his license ‘‘is not a final
                                                                                                          domestic source in order to manufacture                   order as it has been appealed and is
                                                  ACTION:   Notice of application.                                                                                  currently being reviewed by the
                                                                                                          other controlled substances in bulk for
                                                                                                                                                                    Kentucky Court of Appeals.’’ Exceptions
                                                                                                          distribution to its customers.
                                                  DATES:  Registered bulk manufacturers of                                                                          at 1. He argues that the CALJ’s
                                                  the affected basic classes, and                           Dated: September 16, 2015.                              Recommended Decision is therefore
                                                  applicants therefore, may file written                  Joseph T. Rannazzisi,                                     ‘‘based upon an order that is not final
                                                  comments on or objections to the                        Deputy Assistant Administrator.                           and consequently will constitute
                                                  issuance of the proposed registration in                [FR Doc. 2015–24124 Filed 9–22–15; 8:45 am]               arbitrary and capricious action.’’ Id. at 2.
                                                  accordance with 21 CFR 1301.33(a) on                    BILLING CODE 4410–09–P                                    Finally, Respondent contends that
                                                  or before November 23, 2015.                                                                                      ‘‘[s]ummary judgment is improper
                                                  ADDRESSES: Written comments should                                                                                because issues of fact exist concerning
                                                  be sent to: Drug Enforcement                            DEPARTMENT OF JUSTICE                                     the enforceability of the temporary
                                                  Administration, Attention: DEA Federal                                                                            suspension of [his] medical license
                                                  Register Representative/ODXL, 8701                      Drug Enforcement Administration                           given its unconstitutionality.’’ Id.
                                                  Morrissette Drive, Springfield, Virginia                [Docket No. 15–25]                                           I reject Respondent’s contentions.
                                                  22152. Request for hearings should be                                                                             Putting aside whether—in light of the
                                                  sent to: Drug Enforcement                               James Alvin Chaney, M.D.: Decision                        state Hearing Officer’s issuance of the
                                                  Administration, Attention: Hearing                      and Order                                                 ‘‘Final Order Affirming The Emergency
                                                  Clerk/LJ, 8701 Morrissette Drive,                                                                                 Order of Suspension’’—Respondent has
                                                                                                             On July 23, 2015, Chief                                accurately described the procedural
                                                  Springfield, Virginia 22152.                            Administrative Law Judge (CALJ) John J.                   posture of the state licensing matter,
                                                  SUPPLEMENTARY INFORMATION: The                          Mulrooney, II, issued the attached                        based on the plain language of sections
                                                  Attorney General has delegated her                      Recommended Decision (cited as R.D.).                     802(21) and 823(f), this Agency has held
                                                  authority under the Controlled                          Respondent filed Exceptions to the                        repeatedly that ‘‘the controlling
                                                  Substances Act to the Administrator of                  Recommended Decision.                                     question’’ in a proceeding brought
                                                  the Drug Enforcement Administration                        In his Recommended Decision, the                       under 21 U.S.C. 824(a)(3) is whether the
                                                  (DEA), 28 CFR 0.100(b). Authority to                    CALJ found that on October 21, 2014,                      holder of a DEA registration ‘‘‘is
                                                  exercise all necessary functions with                   the Commonwealth of Kentucky, Board                       currently authorized to handle
                                                  respect to the promulgation and                         of Medical Licensure, had issued                          controlled substances in the [S]tate.’’’
                                                  implementation of 21 CFR part 1301,                     Respondent an Emergency Order of                          James L. Hooper, 76 FR 71371, 71371
                                                  incident to the registration of                         Suspension against his medical license.                   (2011) (quoting Anne Lazar Thorn, 62
                                                  manufacturers, distributors, dispensers,                R.D. at 2. The CALJ further found that                    FR 12847, 12848 (1997)), pet. for rev.
                                                  importers, and exporters of controlled                  on November 17, 2014, the Board issued
                                                  substances (other than final orders in                  a final order that affirmed the                              1 While the Government alleged in the Order to
                                                  connection with suspension, denial, or                  emergency order of suspension ‘‘and                       Show Cause that Respondent’s registration does not
                                                  revocation of registration) has been                    that the suspension order remains in                      expire until August 31, 2016, Show Cause Order,
                                                  redelegated to the Deputy Assistant                                                                               at 1; and in his hearing request, Respondent states
                                                                                                          effect.’’ Id. Noting that the Controlled                  that he ‘‘holds a medical license . . . and a DEA
                                                  Administrator of the DEA Office of                      Substances Act defines ‘‘term                             registration,’’ Hearing Request, at 1; the Agency is
                                                  Diversion Control (‘‘Deputy Assistant                   ‘practitioner’ [to] mean[ ] a physician                   still required to establish that it has jurisdiction to
                                                  Administrator’’) pursuant to section 7 of               . . . licensed, registered, or otherwise                  act. See Sharad C. Patel, 80 FR 28693, 28694 n.3
                                                  28 CFR part 0, appendix to subpart R.                                                                             (2015) (‘‘Even in summary disposition proceedings
                                                                                                          permitted, by . . . the jurisdiction in                   which are based on a lack of state authority, the ALJ
                                                     In accordance with 21 CFR                            which he practices . . . to . . . dispense                is obligated to make a finding establishing that the
                                                  1301.33(a), this is notice that on July 23,             [or] administer . . . a controlled                        Agency has jurisdiction.’’); see also 5 U.S.C.
                                                  2015, Euticals, Inc., 2460 W. Bennett                   substance in the course of professional                   706(2)(C) (directing reviewing courts ‘‘to hold
                                                  Street, Springfield, Missouri 65807–                                                                              unlawful and set aside agency action, findings and
                                                                                                          practice,’’ id. at 3 (quoting 21 U.S.C.                   conclusions found to be . . . in excess of statutory
                                                  1229 applied to be registered as a bulk                 802(21), as well as that the registration                 jurisdiction’’). This generally requires the ALJ to
                                                  manufacturer of the following basic                     provision applicable to practitioners                     make a finding either that a respondent retains an
                                                  classes of controlled substances:                                                                                 active registration or has submitted an application
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          directs the Attorney General to ‘‘register
                                                                                                                                                                    for registration.
                                                                                                          [a] practitioner[] . . . if the applicant is                 In the interest of conducting an expeditious
                                                        Controlled Substance                  Schedule    authorized to dispense . . . controlled                   review of this matter, I have taken official notice of
                                                  Gamma Hydroxybutyric Acid               I
                                                                                                          substances under the laws of the State                    Respondent’s registration record with the Agency
                                                                                                          in which he practices,’’ id. (quoting 21                  and find that his registration does not expire until
                                                    (2010).                                                                                                         August 31, 2016. See 5 U.S.C. 556(e); 21 CFR
                                                  Amphetamine (1100) ..................   II              U.S.C. 823(f)), the CALJ then noted that                  1316.59(e). However, in the future, where a
                                                  Lisdexamfetamine (1205) ...........     II              the Agency ‘‘has long held that                           recommended decision lacks the requisite finding,
                                                  Methylphenidate (1724) ..............   II              possession of authority under state law                   I will remand the matter for this purpose.



                                             VerDate Sep<11>2014   18:00 Sep 22, 2015   Jkt 235001   PO 00000   Frm 00060    Fmt 4703    Sfmt 4703     E:\FR\FM\23SEN1.SGM   23SEN1


                                                  57392                   Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices

                                                  denied, Hooper v. Holder, 481                           ORDER GRANTING THE                                    danger to the health, welfare, and safety
                                                  Fed.Appx. 826 (4th Cir. 2012). Thus, it                 GOVERNMENT’S MOTION FOR                               of his patients or the general public, as
                                                  is of no consequence that the State has                 SUMMARY DISPOSITION AND                               evidenced by the Respondent’s
                                                  employed summary process in                             RECOMMENDED RULINGS, FINDINGS                         indictments for crimes related to
                                                  suspending Respondent’s state license                   OF FACT, CONCLUSIONS OF LAW,                          controlled substances. Id. at 1–2;
                                                  and that the Board’s ‘‘order remains                    AND DECISION OF THE                                   Attachment 1 at 1–4. Also attached to
                                                  subject to challenge in either [further]                ADMINISTRATIVE LAW JUDGE                              the Government’s Motion is the BML
                                                  administrative or judicial proceedings.’’                  Chief Administrative Law Judge John                Final Order Affirming the Emergency
                                                  Patel, 80 FR at 28694; see also Gary                    J. Mulrooney, II. The Deputy Assistant                Order of Suspension, dated November
                                                  Alfred Shearer, 78 FR 19009, 19012                      Administrator, Drug Enforcement                       17, 2014. Attachment 2 at 17.
                                                  (2013); Michael G. Dolin, 65 FR at 5661,                                                                         On July 23, the Respondent, through
                                                                                                          Administration (DEA or Government),
                                                  5662 (2000).                                                                                                  counsel, filed a reply styled ‘‘Response
                                                                                                          issued an Order to Show Cause (OSC)
                                                     As for Respondent’s contention that                                                                        to Government’s Motion for Summary
                                                                                                          dated May 21, 2015, seeking to revoke
                                                  summary disposition is inappropriate                                                                          Judgment’’ (Respondent’s Reply). In his
                                                                                                          the DEA Certificate of Registration
                                                  ‘‘because issues of fact exist concerning                                                                     Reply, the Respondent alleges that his
                                                                                                          (COR), Number BC3278492, of James
                                                  the enforceability of the temporary                                                                           situation is distinguishable from Agency
                                                                                                          Alvin Chaney, M.D. (Respondent),
                                                  suspension’’ order, the only fact that is                                                                     precedent mandating revocation for lack
                                                                                                          pursuant to 21 U.S.C. 824(a)(3) and 21
                                                  material in this proceeding is whether                                                                        of state authority, Resp’t Reply at 4–5,
                                                                                                          U.S.C. 823(f), and deny any pending
                                                  Respondent ‘‘is currently authorized to                                                                       because the BML’s suspension of his
                                                                                                          applications for renewal or modification
                                                  handle controlled substances’’ by the                                                                         license was ‘‘based on the [BML’s]
                                                                                                          of the COR, pursuant to 21 U.S.C. 823(f).             application of an incorrect rule of law
                                                  State. Hooper, 76 FR at 71371; cf. Sunil
                                                  Bhasin, 72 FR 5082, 5083 (2007)                         In the OSC, the Government alleges that               and an unconstitutional regulation.’’ Id.
                                                  (holding that a registrant cannot                       the Respondent is, inter alia, without                at 5. In opposing the Government’s
                                                  collaterally attack the results of a state              ‘‘authority to handle controlled                      requested relief, the Respondent also
                                                  administrative or criminal proceeding in                substances in the Commonwealth of                     avers that inasmuch as he is not
                                                  a proceeding brought under section 304                  Kentucky’’ as grounds for revocation of               currently practicing medicine or
                                                  (21 U.S.C. 824(a)). Accordingly, because                the Respondent’s DEA registration. On                 prescribing controlled substances,
                                                  the suspension order remains in effect,                 July 2, 2015, the Respondent, by                      maintenance of his DEA COR
                                                  I adopt the Recommended Decision 2                      counsel, filed a Request for Hearing in               constitutes no danger to the public, and
                                                  and will order that Respondent’s                        the above-captioned matter. The                       that he ‘‘should not be penalized’’ by
                                                  registration be revoked.                                Request for Hearing stated that a hearing             the DEA because his underlying federal
                                                                                                          is appropriate because ‘‘the review of                criminal charges have not yet been
                                                  Order                                                   [the Kentucky Board of Medical                        resolved. Id. at 8.
                                                     Pursuant to the authority vested in me               Licensure’s] illegal suspension by                       In order to revoke a registrant’s DEA
                                                  by 21 U.S.C. 824(a) and 28 CFR 0.100(b),                emergency order of [the Respondent’s]                 registration, the DEA has the burden of
                                                  I order that DEA Certificate of                         medical license is currently on appeal                proving that the requirements for
                                                  Registration BC3278492 issued to James                  before the Kentucky Court of Appeals                  revocation are satisfied. 21 CFR
                                                  Alvin Chaney, M.D., be, and it hereby is,               . . .’’ and because ‘‘any action                      1301.44(e) (2015). Once the DEA has
                                                  revoked. I further order that any                       concerning [the Respondent’s DEA                      made its prima facie case for revocation
                                                  application of James Alvin Chaney,                      COR] . . . is premature . . . .’’ Req. for            of the registrant’s DEA COR, the burden
                                                  M.D., to renew or modify his                            Hrg. at 7.                                            of production then shifts to the
                                                  registration be, and it hereby is, denied.                 Consistent with my direction, the                  Respondent to show that, given the
                                                  This Order is effective immediately.3                   parties have briefed the issues. On July              totality of the facts and circumstances in
                                                    Dated: September 15, 2015.
                                                                                                          9, 2015, the Government filed a Motion                the record, revoking the registrant’s
                                                                                                          for Summary Disposition Based on                      registration would not be appropriate.
                                                  Chuck Rosenberg,
                                                                                                          Respondent’s Lack of State                            Morall v. DEA, 412 F.3d 165, 174 (D.C.
                                                  Acting Administrator.
                                                                                                          Authorization to Handle Controlled                    Cir. 2005); Humphreys v. DEA, 96 F.3d
                                                  Brian Bayly, Esq., for the Government.                  Substances and Submission of Evidence
                                                  Lisa English Hinkle, Esq., for the                                                                            658, 661 (3d Cir. 1996); Shatz v. U.S.
                                                                                                          in Support of Such Motion (Motion for                 Dept. of Justice, 873 F.2d 1089, 1091
                                                  Respondent.
                                                                                                          Summary Disposition), seeking that this               (8th Cir. 1989); Thomas E. Johnston, 45
                                                    2 Notwithstanding that the language of section
                                                                                                          tribunal issue a Recommended Decision                 FR 72311 (1980).
                                                  824(a) authorizes either the suspension or              granting the Government’s Motion on                      The Controlled Substances Act (CSA)
                                                  revocation of a registration upon the making of one     the ground that the Respondent is                     requires that, in order to maintain a
                                                  of the five findings enumerated therein, see R.D. at    currently without state authority to                  DEA registration, a practitioner must be
                                                  4 n.1, the Agency has consistently interpreted the
                                                  CSA as mandating revocation where a practitioner’s
                                                                                                          handle controlled substances. Mot. for                authorized to handle controlled
                                                  state authority has been suspended or revoked. As       Summary Disp. at 1. According to the                  substances in ‘‘the jurisdiction in which
                                                  the Fourth Circuit has held, ‘‘[b]ecause sections       Government’s Motion, the                              he practices.’’ See 21 U.S.C. 802(21)
                                                  823(f) and 802(21) make clear that a practitioner’s     Commonwealth of Kentucky, Board of                    (2012) (‘‘[t]he term ‘practitioner’ means
                                                  registration is dependent upon the practitioner
                                                  having state authority to dispense controlled
                                                                                                          Medical Licensure (BML) suspended the                 a physician . . . licensed, registered, or
                                                  substances, the [Administrator’s] decision to           Respondent’s license to practice                      otherwise permitted, by . . . the
                                                  construe section 824(a)(3) as mandating revocation      medicine effective October 21, 2014,                  jurisdiction in which he practices . . .
                                                  upon suspension of a state license is not an
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                                                                                                          and that suspension order remains in                  to distribute, dispense, [or] administer
                                                  unreasonable interpretation of the CSA.’’ Hooper,
                                                  481 Fed.Appx. at 828.                                   effect. Id. Attached to the Government’s              . . . a controlled substance in the
                                                    3 For the same reasons that lead the Board to         Motion is the BML Emergency Order of                  course of professional practice’’); see
                                                  order the emergency suspension of Respondent’s          Suspension dated October 21, 2014                     also 21 U.S.C. 823(f) (2012) (‘‘The
                                                  medical license (i.e., his indictment on various        suspending the Respondent’s state                     Attorney General shall register
                                                  counts of the unlawful distribution of controlled
                                                  substances), I find that the public interest
                                                                                                          license No. 28914 on the grounds that                 practitioners . . . if the applicant is
                                                  necessitates that this Order be effective               there was probable cause to believe that              authorized to dispense . . . controlled
                                                  immediately. 21 CFR 1316.67.                            the Respondent’s practice constituted a               substances under the laws of the State


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                                                                           Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices                                                   57393

                                                  in which he practices.’’). DEA has long                 Int’l Assoc. of Bridge, Structural &                   forthwith 3 and any pending
                                                  held that possession of authority under                 Ornamental Ironworkers, AFL–CIO, 549                   applications for renewal be DENIED.
                                                  state law to dispense controlled                        F.2d 634 (9th Cir. 1977); United States                Dated: July 23, 2015.
                                                  substances is an essential condition for                v. Consol. Mines & Smelting Co., 455                   John J. Mulrooney II,
                                                  obtaining and maintaining a DEA                         F.2d 432, 453 (9th Cir. 1971). Thus, it                Chief Administrative Law Judge.
                                                  registration. Serenity Café, 77 FR 35027,              is well-settled that, where no genuine                 [FR Doc. 2015–24128 Filed 9–22–15; 8:45 am]
                                                  35028 (2012); David W. Wang, 72 FR                      question of fact is involved or when the               BILLING CODE 4410–09–P
                                                  54297, 54298 (2007); Sheran Arden                       material facts are agreed upon, a
                                                  Yeates, 71 FR 39130, 39131 (2006);                      plenary, adversarial administrative
                                                  Dominick A. Ricci, M.D., 58 FR 51104                    proceeding is not required. See Jesus R.               DEPARTMENT OF JUSTICE
                                                  (1993); Bobby Watts, M.D., 53 FR 11919                  Juarez, M.D., 62 FR 14945 (1997);
                                                  (1988). Because ‘‘possessing authority                  Dominick A. Ricci, M.D., 58 FR 51104                   Drug Enforcement Administration
                                                  under state law to handle controlled                    (1993). Here, the supplied BML Order                   [Docket No. 15–23]
                                                  substances is an essential condition for                establishes, and the Respondent does
                                                  holding a DEA registration,’’ this                      not contest, that the Respondent is                    Brown’s Discount Apothecary, BC,
                                                  Agency has consistently held that ‘‘the                 currently without authorization to                     Inc., and Bolling Apothecary, Inc.
                                                  CSA requires the revocation of a                        handle controlled substances in                           On May 18, 2015, the Deputy
                                                  registration issued to a practitioner who               Kentucky, the jurisdiction where the                   Assistant Administrator, Office of
                                                  lacks [such authority].’’ Roy Chi Lung,                 Respondent holds the DEA COR that is                   Diversion Control, Drug Enforcement
                                                  M.D., 74 FR 20346, 20347 (2009); see                    the subject of this litigation.                        Administration, issued an Order to
                                                  also Scott Sandarg, D.M.D., 74 FR                          Summary disposition of an                           Show Cause to Brown’s Discount
                                                  17528, 174529 (2009); John B. Freitas,                  administrative case is warranted where,                Apothecary, BC, Inc. (holder of DEA
                                                  D.O., 74 FR 17524, 17525 (2009); Roger                  as here, ‘‘there is no factual dispute of              Certificate of Registration FB3717153),
                                                  A. Rodriguez, M.D., 70 FR 33206, 33207                  substance.’’ See Veg-Mix, Inc., 832 F.2d               of Jasper, Alabama and Bolling
                                                  (2005); Stephen J. Graham, M.D., 69 FR                  601, 607 (D.C. Cir. 1987) (‘‘an agency                 Apothecary, Inc., (holder of DEA
                                                  11661 (2004); Abraham A. Chaplan,                       may ordinarily dispense with a hearing                 Certificate of Registration AB9375456),
                                                  M.D., 57 FR 55280 (1992); see also                      when no genuine dispute exists’’).2                    of Fayette, Alabama. Show Cause Order,
                                                  Harrell E. Robinson, M.D., 74 FR 61370,                 While not unsympathetic to the                         at 1. The Show Cause Order proposed
                                                  61375 (2009).1 ‘‘[R]evocation is                        procedural issues raised by the                        the revocation of each pharmacy’s DEA
                                                  warranted even where a practitioner’s                   Respondent in his state administrative                 Certificate of Registration, on the ground
                                                  state authority has been summarily                      proceedings, under current Agency                      that on April 7, 2015, the Alabama State
                                                  suspended and the State has yet to                      precedent, the disposition of the                      Board of Pharmacy issued an Emergency
                                                  provide the practitioner with a hearing
                                                                                                          Government’s motion is wholly                          Suspension Order suspending each
                                                  to challenge the State’s action at which
                                                                                                          dependent upon a single issue: whether                 pharmacy’s Alabama Controlled
                                                  he may ultimately prevail.’’ Kamal
                                                                                                          he continues to possess authority under                Substances Permit, and that therefore,
                                                  Tiwari, M.D., 76 FR 71604, 71606,
                                                                                                          state law to handle controlled                         each pharmacy is ‘‘without authority to
                                                  (2011); see also Bourne Pharmacy, Inc.,
                                                                                                          substances—which he does not.                          handle controlled substances in
                                                  72 FR 18273, 18274 (2007); Anne Lazar
                                                  Thorn, M.D., 62 FR 12847 (1997).                           At this juncture, no genuine dispute                Alabama, the [S]tate in which each is
                                                  Additionally, Agency precedent has                      exists over the fact that the Respondent               registered with the DEA.’’ Id. at 1–2.
                                                                                                          lacks state authority to handle                           On May 20, 2015, a Diversion
                                                  established that the existence of other
                                                                                                          controlled substances in the state of                  Investigator from the Birmingham
                                                  proceedings in which the Respondent is
                                                                                                          Kentucky. Because the Respondent                       District Office personally served the
                                                  involved is not a basis upon which to
                                                  justify a stay of DEA administrative                    lacks such state authority, both the plain             Order to Show Cause on Bolling
                                                  enforcement proceedings. Grider Drug                    language of applicable federal statutory               Apothecary, Inc. Notice of Service of
                                                  #1 & Grider Drug #2, 77 FR 44069,                       provisions and Agency interpretive                     Order to Show Cause, at 1. According to
                                                  44104 n.97 (2012).                                      precedent dictate that he is not entitled              the Government, on June 2, 2015, an
                                                    Congress does not intend for                          to maintain his DEA registration.                      attorney ‘‘accepted service by email of
                                                  administrative agencies to perform                      Simply put, there is no contested factual              the Order to Show Cause on behalf of
                                                  meaningless tasks. See Philip E. Kirk,                  matter adducible at a hearing that would               Brown’s Discount Apothecary and its
                                                  M.D., 48 FR 32887 (1983), aff’d sub                     provide DEA with the authority to allow                owner George Bolling, Jr. Id.
                                                  nom. Kirk v. Mullen, 749 F.2d 297 (6th                  the Respondent to continue to hold his                    On June 1, 2015, George R. Bolling,
                                                  Cir. 1984); see also Puerto Rico                        COR.                                                   Sr., owner of Respondent Bolling
                                                  Aqueduct & Sewer Auth. v. EPA, 35                          Accordingly, I hereby                               Apothecary, Inc., filed a request for a
                                                  F.3d 600, 605 (1st Cir. 1994); NLRB v.                                                                         hearing on behalf of the pharmacy with
                                                                                                             GRANT the Government’s Motion for                   the Office of Administrative Law Judges
                                                     1 But see 21 U.S.C. 824(a)(3) (2012) (‘‘A
                                                                                                          Summary Disposition; and further
                                                  registration pursuant to section 823 of this title to      RECOMMEND that the Respondent’s                       3 While Agency precedent has held that a stay of

                                                  manufacture, distribute, or dispense a controlled       DEA registration be REVOKED                            DEA administrative proceedings is unlikely ever to
                                                  substance may be suspended or revoked by the                                                                   be justified by the existence of ancillary
                                                  Attorney General upon a finding that the registrant                                                            proceedings (Grider Drug #1 & Grider Drug, #2, 77
                                                                                                             2 Even assuming, arguendo, the possibility that     FR 44069, 44104 n.97 (2012)), the Agency recently
                                                  . . . has had his State license or registration
                                                                                                          the Respondent’s state controlled substances           held revocation proceedings in abeyance at the
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                                                  suspended, revoked, or denied by competent State
                                                  authority . . . .’’) (emphasis added). Thus,            privileges could be reinstated, summary disposition    post-hearing adjudication level for a lengthy period
                                                  notwithstanding the Agency’s extensive body of          would still be warranted because under Agency          pending the resolution of criminal fraud charges
                                                  internal precedent to the contrary, the plain           precedent ‘‘revocation is also appropriate when a      and ‘‘pending resolution of [a state] Board
                                                  language of section 824(a)(3) provides that loss of     state license has been suspended, but with the         proceeding.’’ Odette L. Campbell, M.D., 80 FR
                                                  state authority constitutes a discretionary—not         possibility of future reinstatement,’’ Rodriguez, 70   41062, 41064 (2015). However, inasmuch as no stay
                                                  mandatory—basis for revocation. However,                FR 33207 (citations omitted), and even where there     was sought by the Respondent here, and good cause
                                                  inasmuch as the Agency precedent is clear on the        is a judicial challenge to the state medical board     does not appear to exist in any event, the
                                                  matter, I am without authority or inclination to        action actively pending in the state courts. Michael   Government’s motion will be granted and the case
                                                  render a contrary interpretation.                       G. Dolin, M.D., 65 FR 5661, 5662 (2000).               forwarded for a final order.



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Document Created: 2015-12-15 09:45:34
Document Modified: 2015-12-15 09:45:34
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 57391 

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