Rezik A. Saqer, M.D.; Decision and Order, 22122-22128 [2016-08572]
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certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Stepan
Company registration as a manufacturer
of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22555, Stepan Company, Natural
Products Department, 100 W. Hunter
Avenue, Maywood, New Jersey 07607
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Stepan Company to
manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Cocaine (9041) .............................
Ecgonine (9180) ...........................
issuance of the proposed registration in
accordance with 21 CFR 1301.33(a) on
or before June 13, 2016.
DEPARTMENT OF JUSTICE
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[Docket No. 16–7]
ADDRESSES:
The
Attorney General has delegated her
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on January
13, 2016, Patheon API Manufacturing,
Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
II
II
Controlled substance
The company plans to manufacture
the listed controlled substances in bulk
for distribution to its customers.
Dated: April 4, 2016
Louis J. Milione,
Deputy Assistant Administrator.
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Noroxymorphone (9668) ..............
Schedule
I
I
II
[Docket No. DEA–392]
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredients
(API) for clinical trials.
In reference to drug codes 7360
(marihuana), and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drug codes are
authorized for this registration.
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Dated: March 29, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–08576 Filed 4–13–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
[FR Doc. 2016–08569 Filed 4–13–16; 8:45 am]
ACTION:
Notice of application.
BILLING CODE 4410–09–P
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
DATES:
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Drug Enforcement Administration
Rezik A. Saqer, M.D.; Decision and
Order
On October 1, 2015, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Rezik A. Saqer, M.D.,
(Respondent). The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificates of
Registration BS4072637 and FS1975359,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V, as a practitioner,
at the respective registered locations of
11037 FM 1960 West, Suite B1,
Houston, Texas, and 3074 College Park
Drive, Conroe, Texas. Show Cause
Order, at 1. The Show Cause Order
further proposed the denial of any
applications to renew or modify either
registration, as well as the denial of any
other application for a DEA registration.
Id.
More specifically, the Show Cause
Order alleged that ‘‘[e]ffective
September 28, 2015, the Texas Medical
Board issued an Order of Temporary
Suspension . . . which suspended
[Respondent’s] medical license,’’ and
therefore, he is currently ‘‘without
authority to handle controlled
substances in Texas, the State in which
[he is] registered with’’ DEA. Id. at 2.
The Show Cause Order thus advised
Respondent that ‘‘DEA must revoke [his]
registrations based upon [his] lack of
authority to handle controlled
substances in the State of Texas.’’ Id.
(citing 21 U.S.C. 802(21), 823(f), and
824(a)(3)).
On October 2, 2015, a Diversion
Investigator served the Show Cause
Order by travelling to Respondent’s
registered location in Houston, and
leaving it with a medical assistant, who
provided a signed receipt for the Order.
Affidavit of DI, at 1. On November 5,
2015, Respondent, through his counsel,
requested a hearing on the allegations of
the Show Cause Order.1 The matter was
then placed on the docket of the Office
of Administrative Law Judges, and
1 While Respondent’s request was untimely,
Respondent’s counsel subsequently filed a motion
which established that his secretary had attempted
to file the hearing request by UPS overnight
delivery, but had provided an incorrect address.
DEA has previously held that this type of
inadvertence may establish ‘‘good cause’’ to excuse
an untimely hearing request, at least when the party
promptly moves to rectify the omission. Tony Bui,
75 FR 49979, 49980 (2010).
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assigned to the Chief Administrative
Law Judge (hereinafter, CALJ).
In the same filing which contained his
hearing request, Respondent also sought
a ‘‘brief stay’’ of the proceeding, stating
that a hearing on the Texas Medical
Board’s (TMB) emergency suspension
order was to commence on November
19, 2015. Respondent further expressed
his expectation that ‘‘[o]n or shortly
after that date . . . the [TMB] will issue
an order regarding his challenge to the
temporary suspension.’’ Respondent’s
Req. for Hrng. and Mot. for Brief Stay of
Admin. Proceedings, at 1.
The next day, the CALJ denied
Respondent’s request for a stay and
ordered the Government to provide
evidence in support of the allegation
that Respondent lacks state authority
and any accompanying motion, no later
than 2 p.m. on November 23, 2015.
CALJ Order, at 2 (Nov. 6, 2015). The
CALJ also ordered that if the
Government filed such a motion,
Respondent’s Reply would be due no
later than 2 p.m. on December 3, 2015.
Id.
On November 18, 2015, the
Government filed its Motion for
Summary Disposition. Therein, the
Government argued that it was
undisputed that Respondent’s medical
license has been suspended by the State,
and while Respondent argued that the
TMB was to hold a hearing on the
suspension, whether and when the TMB
would lift its order was ‘‘a matter of
speculation.’’ Mot. at 3. The
Government thus argued that even
where a registrant’s state authority has
been temporarily suspended, revocation
of his registration is still warranted
because the registrant must possess
authority to handle controlled
substances under state law in order for
the Agency to maintain his registration.
Id. at 3–4. As support for its Motion, the
Government attached the Order of
Temporary Suspension (Without Notice
of Hearing), which was issued to
Respondent by the TMB’s Disciplinary
Panel on September 28, 2015.
On December 3, 2015, Respondent
filed its Opposition to the Government’s
Motion. Therein, he argued that both the
Controlled Substances Act (CSA) and
DEA’s regulations require that if a
registrant ‘‘requests a hearing, the
agency is required to provide such a
hearing.’’ Resp. Opp., at 1 (citing 21
U.S.C. 824(c); 21 CFR 1301.36(d) and
1301.37(d)). He also argued that ‘‘[t]here
are no provisions in DEA’s regulations
or the CSA that allow for summary
disposition whereby Respondent’s right
to a hearing is denied.’’ Id. And he
argued that Title 5 (the Administrative
Procedure Act) ‘‘requires an ‘agency
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hearing’ in every case in which a statute
requires adjudication to be determined
on the record,’’ and that 5 U.S.C. 554
does not contain ‘‘an exception for
‘summary disposition.’ ’’ Id. at 2.
Respondent also argued that the
Agency’s position that the possession of
state authority is a condition for
maintaining a DEA registration is based
on a misreading of the term
‘‘practitioner,’’ id. at 3–4, which the
CSA defines as meaning ‘‘a physician
. . . or other person licensed, registered,
or otherwise permitted, by the United
States or the jurisdiction in which he
practices to . . . dispense . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). More specifically, Respondent
argued that because the definition uses
the disjunctive ‘‘or,’’ rather than the
conjunctive of ‘‘and,’’ this ‘‘clearly
signals Congress’ intent that a
practitioner is one who either has state
authority or federal authority to
prescribe or dispense controlled
substances.’’ Id. at 4. And finally,
Respondent argued that under 21 U.S.C.
843(a), the Agency ‘‘may revoke a
registration based on the suspension or
revocation of state authority to dispense
controlled substances, not that it must
revoke based on those allegations.’’ Id.
at 5. Respondent then contended that
granting summary disposition was
‘‘inappropriate’’ because he ‘‘intend[ed]
to present evidence that his registration
is consistent with the public interest
notwithstanding the status of [sic] state
license,’’ and he ‘‘is challenging the loss
of his state authority and until his rights
are exhausted, there exists a real
prospect that his state authority will be
reinstated.’’ Id.
Finding that ‘‘no genuine dispute
exists over the fact that the Respondent
lacks state authority to handle
controlled substances,’’ the CALJ
concluded that because Respondent
lacks such authority, ‘‘Agency precedent
dictates that he is not entitled to
maintain his DEA registration.’’ Order
Granting Govt. Mot. for Summ. Disp., at
9. Noting that ‘‘there is no contested
factual matter adducible at a hearing
that would, in the Agency’s view,
provide authority to allow the
Respondent to continue to hold his’’
registration, the CALJ granted the
Government’s motion for summary
disposition and recommended that his
‘‘registration be revoked’’ and that ‘‘any
pending applications for renewal be
denied.’’ Id. at 9–10 (bold and
capitalization deleted).
Respondent filed Exceptions to the
CALJ’s Order and the Government filed
a Response to Respondent’s Exceptions.
Thereafter, the record was forwarded to
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me for Final Agency Action. Having
considered the record including
Respondent’s Exceptions, I adopt the
CALJ’s finding that Respondent lacks
authority under Texas law to handle
controlled substances, and his
conclusion of law that Respondent is
not entitled to maintain his registration.
For reasons explained below, I will also
adopt the ALJ’s recommendation but
only with respect to Respondent’s
Certificate of Registration BS4072637. I
make the following findings.
Findings of Fact
Respondent is the holder of DEA
Certificate of Registration BS4072637,
pursuant to which he is authorized to
dispense controlled substances in
schedules II through V, as a practitioner,
at the address of 11037 FM 1960 West,
Suite B1, Houston, Texas. Mot. for
Summ. Disp., at Attachment 2. Under
this registration, Respondent is also
authorized to treat up to 100 patients as
a DATA-waived physician. Id. This
registration does not expire until
February 28, 2018. Id.
Respondent also previously held DEA
Certificate of Registration FS1975359,
pursuant to which he was authorized to
dispense controlled substances in
schedules II through V, as a practitioner,
at the address of 3074 College Park
Drive, Conroe, Texas. Mot. for. Summ.
Disp., at Attachment 3. This registration
was due to expire on February 29, 2016,
id., and according to the registration
records of this Agency of which I take
official notice, Respondent has not filed
a timely renewal application (let alone
any application to renew this
registration).2 Accordingly, I find that
this registration has expired. See 21 CFR
1301.36(i).
Respondent is also the holder of
Texas Medical License No. K–2282. In
re Saqer, Order of Temporary
Suspension (Without Notice of Hearing),
at 1 (Tex. Med. Bd. Sept. 28, 2015).
However, on September 28, 2015, the
Disciplinary Panel of the Texas Medical
Board entered an Order of Temporary
Suspension against Respondent’s
medical license following an ex-parte
hearing on the Board’s Application for
2 Under the Administrative Procedure Act (APA),
an agency ‘‘may take official notice of facts at any
stage in a proceeding—even in the final decision.’’
U.S. Dept. of Justice, Attorney General’s Manual on
the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance
with the APA and DEA’s regulations, Respondent
is ‘‘entitled on timely request to an opportunity to
show to the contrary.’’ 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the
opportunity to refute the facts of which I take
official notice, Respondent may file a motion for
reconsideration within ten calendar days of service
of this order which shall commence on the date this
order is mailed.
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Temporary Suspension (Without Notice
of Hearing). Id. at 4.
As the basis for the Order, the Panel
found that on September 22, 2015, a
search warrant was executed at a pain
management clinic owned by
Respondent, during which DEA agents
‘‘obtained evidence establishing that
Respondent pre-signed treatment notes,
pre-signed prescriptions and illegally
maintained schedule II controlled
substances in his personal office.’’ Id. at
2. The Panel also found ‘‘that patients
of [the clinic] were sometimes seen by
unlicensed individuals that would fill
in the records and prescriptions to make
it appear that Respondent had seen the
patient and written the prescription.’’
Id. The Panel thus found that
‘‘Respondent engaged in illegal
activities related to his operation of [the
clinic], and engaged in the
inappropriate prescribing, dispensing,
or administering of controlled
substances, and therefore Respondent
has committed violations of state and
federal law, including the Medical
Practice Act and Board Rules.’’ Id.
The Panel concluded that
‘‘Respondent’s continued practice of
medicine, including improper and
illegal activities related to his operation
of a pain management clinic, and
including the method and manner in
which controlled substances were
prescribed and maintained, poses a
continuing threat to public welfare.’’ Id.
Based on these findings, the Panel
found ‘‘a continuing threat to the public
health, safety, or welfare that requires
immediate effect of this Order of
Temporary Suspension on the date
rendered.’’ Id. And after setting forth its
legal conclusions that Respondent
violated multiple provisions of the
Medical Practice Act, the Panel ordered
that Respondent’s medical license be
suspended. Id. at 3–4.
On November 19, 2015, the
Disciplinary Panel conducted a hearing
at which Respondent appeared and was
represented by counsel. In re Saqer,
Order of Temporary Suspension (With
Notice of Hearing), at 1 (Tex. Med. Bd.
Nov. 19, 2015). However, following the
hearing, the Board made the same
factual findings and legal conclusions as
it had at the ex parte proceeding, see id.
at 1–4, and it again ordered the
temporary suspension of Respondent’s
medical license. Id. According to the
online records of the Texas Medical
Board, the suspension remains in effect.
I therefore find that Respondent is
currently without authority to dispense
controlled substances in Texas, the State
in which he is engages in professional
practice and holds his DEA registration.
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Discussion
Respondent’s Contention That DEA
Cannot Use Summary Disposition to
Adjudicate This Matter
As explained above, in his Opposition
to the Government’s Motion,
Respondent contends that because he
requested a hearing, under the Agency’s
regulation, the Agency was required to
provide him with a hearing. Opp. at 1–
3. He further contends that there are no
provisions in either the CSA or the
Agency’s regulations that allow for
summary disposition, thereby denying
him his right to a hearing. Id. at 2–3.
However, numerous courts, including
the Supreme Court, have held that even
where a statute directs an agency to
provide a party with a hearing, the
agency can nonetheless resolve the
matter on summary disposition when
there are no material facts in dispute.
See, e.g., Veg-Mix, Inc. v. Department of
Agriculture, 832 F.2d 601, 607 (D.C. Cir.
1987). As the DC Circuit explained in
Veg-Mix, ‘‘[c]ommon sense suggests the
futility of hearings where there is no
factual dispute of substance.’’ Id. 3 See
also NLRB v. International Ass’n of
Bridge, Structural and Ornamental
Ironworkers, 549 F.2d 634, 639 (9th Cir.
1977) (‘‘ ‘It is settled law that when no
fact question is involved or the facts are
agreed, a plenary, adversary
administrative proceeding involving
evidence, cross-examination of
witnesses, etc., is not obligatory, even
though a pertinent statute prescribes a
hearing. In such situations, the rationale
is that Congress does not intend
administrative agencies to perform
meaningless tasks.’ ’’) (quoting United
States v. Consolidated Mines & Smelting
Co., Ltd., 455 F.2d 432, 453 (9th Cir.
1971)).4 Cf. Weinberger v. Hynson,
Westcott and Dunning, Inc., 412 U.S.
609, 620–22 (1973) (upholding agency’s
authority to dispense with a formal
hearing where applicant has not
3 While Respondent noted that the Agency’s rules
regarding the conduct of hearings do not include a
provision which expressly authorizes the use of
summary disposition, this Agency has used
summary disposition to resolve proceedings based
on a registrant’s loss of his/her state authority for
nearly 40 years. See, e.g., Alfred Tennyson
Smurthwaite, N.D., 43 FR 11873 (1978). There are
hundreds of such cases reported in the Federal
Register. Contrary to Respondent’s contention that
the Agency cannot rely on summary disposition in
the absence of a regulation which expressly allows
for it, ‘‘[i]t is well established that agencies are free
to announce and develop rules in an adjudicatory
setting.’’ Puerto Rico Aqueduct and Sewer Auth. v.
EPA, 35 F.3d 600 607 (1st Cir. 1994) (citing NLRB
v. Bell Aerospace Co., 416 U.S. 267, 294 (1974)).
4 See also Travers v. Shalala, 20 F.3d 993, 998
(9th Cir. 1994) (quoting Consolidated Mines, 455
F.2d at 453).
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provided any evidence that it meets
statutory standards).
Notably, while Respondent was given
the opportunity to demonstrate the
existence of a factual dispute as to
whether he retains state authority, he
could not do so, as even after he was
allowed to appear before the Board and
challenge the temporary suspension of
his license, the Board re-imposed the
suspension. However, even in the
absence of a disputed material fact,
Respondent contends that ‘‘summary
disposition [was] inappropriate,’’
because he ‘‘intend[ed] to present
evidence that his registration is
consistent with the public interest
notwithstanding the status of [his] state
license.’’ Opp. at 5. The short answer to
this argument is that even if Respondent
could show that his registration is
consistent with the public interest, his
lack of state authority precludes his
continued registration under the CSA,
and it is the Government and not
Respondent who decides what ground
or grounds to pursue when seeking the
revocation of his registration.
Respondent’s Challenge to the Agency’s
Authority To Revoke His Registration
Respondent nonetheless maintains
that the Agency’s rule that a
practitioner’s loss of his ‘‘state authority
is an automatic bar to maintaining a
DEA registration’’ is based ‘‘on a
misreading of the CSA.’’ Resp.
Exceptions, at 1–2. In his Exceptions,
Respondent contends that ‘‘[f]or
proceedings seeking the revocation of a
DEA registration, the [A]gency derives
its authority from 21 U.S.C. 824, not 21
U.S.C. 823, and 21 U.S.C. 824 does not
support the [A]gency’s position that it
must revoke a DEA registration in all
instances where a registrant lacks state
authority.’’ Id. at 2.
To be sure, section 824(a) states, in
relevant part, that ‘‘[a] registration
pursuant to section 823 of this title to
manufacture, distribute, or dispense a
controlled substance or list I chemical
may be suspended or revoked . . . upon
a finding that the registrant . . . has had
his State license or registration
suspended, revoked, or denied by
competent State authority and is no
longer authorized by State law to engage
in the manufacturing, distribution or
dispensing of controlled substances or
list I chemicals.’’ 21 U.S.C. 824(a)(3).
Thus, Respondent is correct that section
824 grants the Attorney General
discretion and does not mandate the
revocation of a ‘‘registration in all
instances where a registrant lacks state
authority.’’ Resp. Exceptions, at 2.
Indeed, in Bio-Diagnostic
International, 78 FR 39327 (2013), a
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case involving a list I chemical
distributor which did not possess state
authority, the Agency held that granting
summary disposition to the Government
on this basis was improper because
neither the provision setting forth the
standards for the registration of list I
distributors, nor the definition of a
distributor, requires that a distributor
possess state authority in order to be
registered.5 While Bio-Diagnostic
involved an application, in a footnote,
the decision explained that while
‘‘section 824(a)(3) authorizes revocation
where a registrant ‘has had [its] State
license suspended, revoked, or denied
by competent state authority and is no
longer authorized by State law to engage
in the manufacturing [or] distribution of
. . . list I chemicals[,]’ [this] does not
mean that revocation is warranted in all
instances.’’ Id. at 39330 n.6. Continuing,
the decision explained that ‘‘[t]his
provision grants the Agency
discretionary authority to impose an
appropriate sanction; the failure to
consider factors such as the
egregiousness of the misconduct and
mitigating factors in imposing the
sanction would render the sanction
arbitrary and capricious.’’ Id.
Respondent is not, however, a List I
chemical distributor. Rather, he is a
practitioner, and by contrast to the
CSA’s provisions applicable to list I
distributors, both the CSA’s definition
of the term ‘‘practitioner’’ and the
registration provision applicable to
practitioners make clear that a
practitioner must be currently
authorized to dispense controlled
substances by the State in which he
practices in order to obtain and
maintain a registration.
As for the registration provision
applicable to practitioners, it provides,
in relevant part, that: ‘‘[t]he Attorney
General shall register practitioners . . .
to dispense . . . controlled substances
. . . if the applicant is authorized to
dispense . . . controlled substances
under the laws of the State in which he
practices.’’ 21 U.S.C. 823(f). As the
Supreme Court explained in United
States v. Moore, 423 U.S. 122, 140–41
(1975), ‘‘[r]egistration of physicians and
other practitioners is mandatory if the
applicant is authorized to dispense
drugs . . . under the law of the State in
which he practices. [21 U.S.C.] § 823(f).
In the case of a physician, this scheme
contemplates that he is authorized by
5 The decision did note, however, that where a
list I distributor was required to obtain state
authority and had not done so, this could be
considered under the public interest factor which
examines ‘‘compliance by the applicant with
applicable Federal, State and local law.’’ 78 FR at
39330–31 (quoting 21 U.S.C. 823(h)(2)).
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the State to practice medicine and to
dispense drugs in connection with his
professional practice.’’ 6
Thus, the CSA defines ‘‘[t]he term
‘practitioner’ [to] mean[] a physician
. . . or other person licensed, registered,
or otherwise permitted, by the United
States or the jurisdiction in which he
practices to . . . dispense . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). As noted above, in his
Opposition, Respondent argued that
‘‘[t]he use of the disjunctive ‘or’ clearly
signals Congress’ intent that a
practitioner is one who either has state
authority or federal authority to
prescribe or dispense controlled
substances[,]’’ and that ‘‘[h]ad Congress
required that a practitioner maintain
both state and federal authority to
handle controlled substances, it would
have used the word ‘and.’’’ Resp. Opp.
at 4. Continuing, Respondent argued
that ‘‘[w]hile it is not entirely clear why
Congress took this approach . . . the
clear statutory language’’ refutes the
Government’s argument that ‘‘a lack of
state licensure [is] an automatic bar to
maintaining a DEA registration.’’ Id.
Respondent is mistaken. As for why
Congress used the disjunctive rather
than the conjunctive in defining the
term practitioner, notwithstanding the
absence of any relevant discussion in
the CSA’s legislative history, there is an
explanation. While the overwhelming
majority of practitioners who practice
medicine (or dentistry and veterinary
medicine) are subject to regulation by
the State in which they practice their
professions, multiple federal
Departments and Agencies (e.g., the
Department of Defense, Veterans
Administration, Bureau of Prisons,
United States Public Health Service, and
Indian Health Service) employ
practitioners. However, by virtue of the
Supremacy Clause, these health-care
professionals are not subject to
regulation by the State in which the
federal facility is located as long they
confine their practice to the facility. See
Taylor v. United States, 821 F.2d 1428,
1431 (9th Cir. 1987) (noting that under
the Supremacy Clause, a State ‘‘lacks
power to require licensing of federal
health care providers and physicians’’
and that ‘‘[t]he United States has
essentially deemed [an] Army [h]ospital
and its staff fit to provide health care
services’’); United States v. Composite
State Bd. of Med. Exmn’rs, 656 F.2d
6 While in 1984 Congress granted the Attorney
General authority to deny a registration on public
interest grounds, the provision did not alter the
CSA’s requirement that a practitioner must be
‘‘authorized by the State to practice medicine’’ and
dispense drugs in order to be registered.
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131, 135 n.4 (5th Cir. 1981) (citing
Sperry v. Florida ex rel. Florida Bar, 373
U.S. 379 (1963) (‘‘A State may not
enforce licensing requirements that,
though valid in the absence of federal
regulation, give the state’s licensing
board a virtual power of review over the
federal determination that a person is
qualified to perform certain
functions.’’).
Thus, Congress used the word ‘‘or’’
only to distinguish between those
practitioners who practice at federal
facilities and are subject to the licensing
requirements of the United States,7 and
the vast majority of practitioners who
are subject to the licensing requirements
of the State in which they practice their
profession. And while the Agency has
exempted from ‘‘[t]he requirement of
registration . . . any official of’’ the
military, the Public Health Service, or
Bureau of Prisons who is authorized to
prescribe, dispense, or administer, but
not to procure or purchase, controlled
substances in the course of his/her
official duties,’’ 21 CFR 1301.23(a),
these practitioners otherwise remain
subject to the Act. See, e.g., 21 U.S.C.
829(a) (‘‘Except when dispensed
directly by a practitioner, other than a
pharmacist, to an ultimate user, no
controlled substance in schedule II,
which is a prescription drug as
determined under the [FDCA], may be
dispensed without the written
prescription of a practitioner, except
[for] in emergency situations, as
prescribed by . . . regulation . . . .’’);
21 CFR 1306.04(a) (‘‘A prescription for
a controlled substance to be effective
must be issued for a legitimate medical
purpose by an individual practitioner
acting in the usual course of his
professional practice.’’).
Respondent further asserts that ‘‘[h]ad
Congress required that a practitioner
maintain both state and federal
authority to handle controlled
substances, it would have used the word
‘and.’’’ Resp. Opp. at 4. Were this the
case, any practitioner who is no longer
7 As a general matter, federal entities that employ
physicians require only that the physician hold a
medical license in one of the 50 States. See U.S.
Public Health Service, Job Requirements (available
at www.usphs.gov/profession/physician/
requirements.aspx) (requiring that a physician have
a‘‘[c]urrent, unrestricted, and valid medical license
to practice in one of the 50 states; Washington, DC;
Commonwealth of Puerto Rico; U.S. Virgin Islands;
or Guam’’; Indian Health Service, Indian Health
Manual, Part 3–1.4(C)(5) (‘‘Members of the medical
staff and others who must apply for clinical
privileges must hold an active and unrestricted
State license, certification, or registration, as
applicable, to practice in their professional field.’’);
VA Careers (available at www.vacareers.va.gov/
careers/physicians/credentially.asp) (‘‘At VA, only
one active, unrestricted state license is required to
practice in every VA facility across all 50 States, the
District of Columbia, and U.S. Territories.’’).
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authorized to practice medicine by his
State (even those who engaged in drug
dealing) would nonetheless still be
allowed to dispense controlled
substances under their federal
registration. The argument is, however,
refuted by the CSA’s definition of the
term ‘‘dispense’’ to ‘‘mean[ ] to deliver a
controlled substance to an ultimate user
or research subject by, or pursuant to
the lawful order of, a practitioner,
including the prescribing and
administering of a controlled
substance.’’ 21 U.S.C. 802(10) (emphasis
added). Because Respondent is required
to possess state authority to dispense
controlled substances in Texas, and by
virtue of the Board’s Order, no longer
holds such authority, he cannot issue a
‘‘lawful order’’ to deliver a controlled
substance. And he therefore no longer
meets the requirement for being a
registered practitioner under the Act.
Respondent further argues that ‘‘had
Congress wanted the lack of a state
license to be an automatic bar to
maintaining a DEA registration, it would
have used the word ‘shall’ ’’ rather than
‘‘may’’ in section 824. He argues that ‘‘if
DEA understood that to be what
Congress intended the agency could
have added lack of state licensure to one
of the grounds for immediate
termination of a DEA registration found
in 21 CFR 1301.52(a). It chose not too
[sic], presumably because DEA knew it
had no such authority.’’ Resp. Opp. at
4–5.
It is not clear, however, why using the
word ‘‘shall’’ rather than ‘‘may’’ would
make any difference, as section 824(a)
grants the Agency authority to either
revoke or suspend. Moreover, were it
the case that section 824(a) used the
word ‘‘shall,’’ the Agency would be
mandated to either suspend or revoke a
registration upon making one of the
enumerated findings, regardless of how
persuasive a registrant’s showing was on
issues of remediation where, as in a
proceeding brought under the public
interest authority, such a showing is
authorized.
As this Agency has previously
explained, Section 824(a)’s grant of
authority to suspend or revoke a
registration applies across all categories
of registration, including manufacturers,
distributors, importers, exporters,
narcotic treatment programs, list I
distributors, and practitioners. And it
applies to five different grounds for
sanctioning a registrant. As the Agency
has previously explained, ‘‘this general
grant of authority in imposing a
sanction must be reconciled with the
CSA’s specific provisions which
mandate that a practitioner hold
authority under state law in order to
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obtain and maintain a DEA
registration.’’ James L. Hooper, 76 FR
71371, 71372 (2011), pet. for rev.
denied, Hooper v. Holder, 481 Fed.
App’x 826 (4th Cir. 2012). See also
Gozlon-Peretz v. United States, 498 U.S.
395, 407 (1991) (‘‘A specific provision
controls over one of more general
application.’’); Bloate v. United States,
559 U.S. 196, 207 (2010) (‘‘language of
a statutory provision, although broad
enough to include it, will not be held to
apply to a matter specifically dealt with
in another part of the same
enactment.’ ’’).
Thus, in Hooper v. Holder, a
physician whose state authority was
suspended for a period of one year,
challenged the revocation of his
registration, arguing that the Agency
‘‘failed to recognize the discretion under
§ 824(a) to revoke or suspend a
registration and that it was
impermissible for the [Agency] to
conclude that the CSA requires
revocation of a practitioner’s DEA
registration when the practitioner’s
State license is suspended.’’ 481 Fed.
App’x, at 826. The Fourth Circuit
rejected the physician’s challenge,
explaining:
We find Hooper’s contention
unconvincing. Section 824(a) does state that
the [Agency] may ‘‘suspend or revoke’’ a
registration, but the statute provides for this
sanction in five different circumstances, only
one of which is loss of a State license.
Because § 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
[Agency’s] decision to construe § 824(a)(3) as
mandating revocation upon suspension of a
state license is not an unreasonable
interpretation of the CSA. The [Agency’s]
decision does not ‘‘read[ ] the suspension
option’’ out of the statute, because that
option may still be available for the other
circumstances enumerated in § 824(a).
Id. 8 See also Maynard v. DEA, 117 Fed.
Appx. 941, 945 (5th Cir. 2004)
(upholding revocation of DEA
registration after Texas DPS summarily
suspended practitioner’s controlled
substance registration, noting that the
Agency ‘‘has construed the CSA to
require revocation when a registrant no
longer possesses valid state authority to
handle controlled substances’’; ‘‘We
agree with [the] argument that it may
have been arbitrary and capricious had
8 As for Respondent’s contention that if Congress
intended that lack of a state license should be an
automatic bar, the Agency could have made this a
ground for immediate termination without a
hearing, the argument ignores that by requiring the
Agency to serve a Show Cause Order on the
registrant, and affording the registrant an
opportunity to respond, the procedures reduce the
risk of an erroneous deprivation. See Mathews v.
Eldridge, 424 U.S. 319 (1976).
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
the DEA failed to revoke [the
physician’s] registration under the
circumstances.’’).
Indeed, DEA has interpreted the CSA
in this manner for nearly 40 years. See
Frederick Marsh Blanton, M.D., 43 FR
27616 (1978). In Blanton, a physician’s
state license was suspended for a period
of one year. Id. at 27616. The Agency
nonetheless revoked the physician’s
registration, explaining that ‘‘it is the
Administrator’s finding and conclusion
that there is a lawful or statutory basis
for the revocation of the Respondent’s
DEA registration. State authorization to
dispense or otherwise handle controlled
substances is a prerequisite to the
issuance and maintenance of a Federal
controlled substances registration. The
Respondent’s registration must,
therefore, be revoked.’’ Id. at 27617
(emphasis added). See also Alfred
Tennyson Smurthwaite, 43 FR at 11873
(same). Moreover, on various occasions,
Congress has amended the CSA,
including in 1984, when it granted the
Agency the authority to revoke a
practitioner’s registration on the ground
that he had committed acts inconsistent
with the public interest. See Drug
Enforcement Amendments to the
Comprehensive Crime Control Act of
1984. See P.L. 98–473, § 512, 98 Stat.
1838, 2073 (1984). Yet it has left the
Agency’s interpretation intact. See
NLRB v. Bell Aerospace Co., 416 U.S.
267, 275 (1974).
The Agency has also long held that
revocation is warranted even where a
practitioner has lost his state authority
by virtue of the State’s use of summary
process and the State has yet to provide
a hearing to challenge the suspension.
Bourne Pharmacy, 72 FR 18273, 18274
(2007); Wingfield Drugs, 52 FR 27070,
27071 (1987). Indeed, as this case
demonstrates, state proceedings can go
on for an extended period, and thus, it
is not DEA’s policy to hold revocation
proceedings in abeyance while
practitioners challenge Board decisions
which suspend or revoke their state
authority.
Respondent argues, however, that
‘‘the agency’s decision [in Odette
Campbell, 80 FR 41062 2015)] to
remand the matter and allow
administrative proceedings to be
conducted by the ALJ (and ultimately
hold proceedings in abeyance), pending
the outcome of state board
proceedings[,] undermines . . . the
agency’s notion that it must revoke a
DEA registration in all instances where
a registrant lacks state authority,
rendering an administrative hearing
unnecessary.’’ Exceptions at 2.
Respondent then asserts that ‘‘[w]hile
the agency conjured up a Due Process
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argument to support its decision in
[Campbell], in doing so it implicitly
held that lack of state authority is not an
automatic bar to holding a DEA
registration.’’ Id. Respondent further
asserts that ‘‘[w]hile declaring that Due
Process was the basis for this decision,
the only outcome that could have been
reached in that case, if the [A]gency
followed its own case law, was the
revocation of Dr. Campbell’s DEA
registration as the DEA proceedings
would not have changed the fact that
she did not have state authority to
handle state authority to handle
controlled substances.’’ Id. at 2–3.
Respondent’s reliance on Campbell is
unavailing because he ignores critical
aspects of the case’s procedural history.
For one, the case began when DEA
issued an Order to Show Cause and
Immediate Suspension of Registration
(ISO) to the physician, which was based
on allegations that she violated various
provisions of the Controlled Substances
Act. 80 FR at 41063 n.3. Thereafter, the
Texas Medical Board suspended her
medical license and the Texas
Department of Public Safety suspended
her state controlled substance
registration based on the Agency’s
issuance of the ISO. Id. The Government
then moved for summary disposition on
the ground that the physician lacked
authority to dispense controlled
substances under Texas law and the ALJ
granted the motion. Id.
While the matter was under review,
the physician submitted a letter to the
ALJ (which was forwarded to the
Administrator), in which she asserted
that the Medical Board had reinstated
her license. Id. After the Government
responded by letter to the ALJ that the
physician was still without state
authority because her DPS registration
had been revoked, Respondent
submitted a letter to the ALJ asserting
that her DPS registration could not be
reinstated unless her DEA registration
was reinstated. Id.
Noting that parties had directed their
letters to each other and the ALJ, and
that neither party had sought relief from
her, the former Administrator directed
the Government to file a properly
supported motion seeking a final order
based on the physician’s lack of state
authority. Id. The Government filed its
request, which Respondent opposed,
arguing that because the DPS’s action
was based on the unsubstantiated
allegations of the ISO, it was
fundamentally unfair and a denial of
due process to revoke her DEA
registration based on the DPS’s action.
Id.
On further review, the former
Administrator observed that ‘‘it
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appeared that under Texas law and
regulations, Respondent was not
entitled to a hearing before the DPS to
challenge either the DPS’s suspension or
the denial of her application for a new
registration.’’ Id. (citing Tex. Health &
Safety Code § 481.063(e)(3) & (h); id.
§ 481.066(g); 37 Tex. Admin. Code
§ 13.272(h)). The Administrator then
explained that ‘‘if this was so, revoking
her [DEA] registration based on her lack
of state authority would preclude her
from ever being able to challenge the
basis of the Immediate Suspension
Order.’’ Id. The Administrator thus
remanded the case, instructing the ALJ
‘‘to first determine whether the DPS
would provide [the respondent] with a
hearing on the allegations.’’ Id. The
Administrator further instructed that if
the DPS had provided or would provide
respondent with a hearing, the
Government could renew its motion for
summary disposition. Id. However, if
DPS would not provide her with a
hearing, the ALJ was to conduct a
hearing on the allegations of the Show
Cause Order and ISO. Id.
In short, there was nothing ‘‘conjured
up’’ in the Agency’s due process
rationale, which recognized only that
due to the vagaries of Texas law,9 the
Agency’s litigation strategy might well
result in the respondent having no
meaningful opportunity to challenge the
allegations which both the Agency and
the DPS had relied on in suspending
their respective registrations. As for
Respondent’s contention that revocation
was ‘‘the only outcome that could have
been reached . . . as the DEA
proceedings would not have changed
the fact that she did not have state
authority to handle controlled
substances,’’ Respondent ignores that
DPS imposed its suspension based
solely on the Agency’s ISO and that if
the physician succeeded in challenging
the ISO, the basis for the DPS’
suspension would no longer exist. And
Respondent further ignores that in her
remand order, the Administrator
provided that the Government could
move for summary disposition if it
could show that DPS would provide the
physician with a hearing.10
9 See Tex. Health & Safety Code § 481.066(g)
(State Administrative Procedure Act ‘‘does not
apply to a . . . suspension of a registration for a
cause described by Section 481.063 . . . (e)(3),’’
which includes the suspension of a registration
under the CSA); 37 Tex. Admin. Code § 13.272(h)
(‘‘Under the Act, § 481.0639(h), the [State
Administrative Procedure Act] does not apply to a
denial, suspension, or revocation of an application
for registration if the denial is based on a denial or
other disciplinary action taken by DEA under the
Federal Controlled Substances Act.’’).
10 As for Respondent’s assertion that the
Administrator’s decision to hold the Campbell case
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22127
Accordingly, I reject Respondent’s
contentions.11 Because Respondent
lacks state authority to dispense
controlled substances, he is not entitled
to maintain his DEA registration. I will
therefore order that his remaining
registration be revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a)(3) and 823(f), as
well as 28 CFR 0.100(b), I order that
DEA Certificate of Registration
BS4072637 issued to Rezik A. Saqer,
M.D., be, and it hereby is, revoked. I
further order that any application by
Rezik A. Saqer, M.D., for registration in
the State of Texas, be, and it hereby is,
denied. This Order is effective
immediately.12
in abeyance, pending the outcome of state board
proceedings, ‘‘undermines . . . the [A]gency’s
notion that it must revoke a DEA registration in all
instances where a registration lacks state authority,’’
Exceptions at 2, Respondent ignores that at the time
the proceeding was held in abeyance, the physician
(who had been indicted on multiple counts of
health care fraud) had allowed her registration to
expire and had only an application pending before
the Agency. Moreover, the physician then held both
a state license and state controlled substance
registration. See 80 FR at 41063. The case thus does
not support Respondent’s contention.
11 Respondent also points to a provision of the
DEA Pharmacist’s Manual, which allows an entity
to obtain a registration for a pharmacy it is
acquiring prior to the State’s issuance of a
pharmacy license for that location. Opp. at 5.
Respondent asserts that ‘‘[w]hile the Agency is
permitted to interpret its regulations, it is not free
to contradict its long-standing policy that a state
license is not a prerequisite to obtaining a DEA
registration when doing so is simply a convenient
litigation position designed to prevent a registrant
from proving that the underlying state action was
erroneous.’’ Id. at 5–6.
However, the Pharmacist’s Manual makes clear
that provision applies only ‘‘[i]f the registrant
acquiring the pharmacy owns at least one other
pharmacy licensed in the same state as the
pharmacy being transferred,’’ and that while the
registrant may take possession of the controlled
substances, ‘‘the registrant may not dispense
controlled substances until the pharmacy haw been
issued a valid state pharmacy license.’’ DEA,
Pharmacists Manual, at 10 (2010) (emphasis added).
This policy exists because some States will not
grant a pharmacy license to the acquiring pharmacy
until DEA issues it a registration. However, the
period in which the registrant is without the state
license for the acquired pharmacy is typically of
short duration.
As for Respondent’s assertion that the Agency’s
position ‘‘is simply a convenient litigation position
designed to prevent a registrant from proving that
the underlying state action was erroneous,’’ not
only is this refuted by nearly 40 years of precedent
(and hundreds of cases), the Agency has also made
clear in multiple cases that a challenge to a state
board proceeding must be litigated in the forums
provided by the State. See Kamal Tiwari, 76 FR
71604, 71606 (2011) (collecting cases); see also
George S. Heath, 51 FR 26610 (1986).
12 For the same reasons which led the Texas
Board to order the emergency suspension of
Respondent’s medical license, I conclude that the
public interest necessitates that this Order be
effective immediately. 21 CFR 1316.67.
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Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices
Dated: April 5, 2016.
Chuck Rosenberg,
Acting Administrator.
Office/ZP30, Marshall Space Flight
Center, Huntsville, AL 35812, (256)
544–5226. Information about other
NASA inventions available for licensing
can be found online at https://
technology.nasa.gov.
[FR Doc. 2016–08572 Filed 4–13–16; 8:45 am]
BILLING CODE 4410–09–P
Mark P. Dvorscak,
Agency Counsel for Intellectual Property.
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[FR Doc. 2016–08546 Filed 4–13–16; 8:45 am]
[Notice (16–027)]
BILLING CODE 7510–13–P
Notice of Intent To Grant a Partially
Exclusive License
NATIONAL AERONAUTUICS AND
SPACE ADMINISTRATION
National Aeronautics and
Space Administration.
ACTION: Notice of intent to grant a
partially exclusive license.
AGENCY:
Notice of Intent To Grant a Partially
Exclusive License
This notice is issued in
accordance with 35 U.S.C. 209(e) and 37
CFR 404.7(a)(1)(i). NASA hereby gives
notice of its intent to grant a partially
exclusive license in the United States to
practice the invention described and
claimed in U.S. Patent Application
Serial No. 14/196,203 entitled Vibration
Damping Circuit Card Assembly to
TopLine Corporation, having its
principal place of business in Irvine,
CA. The patent rights in these invention
have been assigned to the United States
of America as represented by the
Administrator of the National
Aeronautics and Space Administration.
The prospective partially exclusive
license will comply with the terms and
conditions of 35 U.S.C. 209 and 37 CFR
404.7.
DATES: The prospective partially
exclusive license may be granted unless,
within fifteen (15) days from the date of
this published notice, NASA receives
written objections including evidence
and argument that establish that the
grant of the license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR 404.7.
Competing applications completed and
received by NASA within fifteen (15)
days of the date of this published notice
will also be treated as objections to the
grant of the contemplated exclusive
license.
Objections submitted in response to
this notice will not be made available to
the public for inspection and, to the
extent permitted by law, will not be
released under the Freedom of
Information Act, 5 U.S.C. 552.
ADDRESSES: Objections relating to the
prospective license may be submitted to
Mr. James J. Mcgroary, Chief Patent
Counsel/LS01, Marshall Space Flight
Center, Huntsville, AL 35812, (256)
544–0013.
FOR FURTHER INFORMATION CONTACT: Mr.
Sammy A. Nabors, Technology Transfer
SUMMARY:
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[Notice (16–028)]
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National Aeronautics and
Space Administration.
ACTION: Notice of intent to grant a
partially-exclusive license.
AGENCY:
This notice is issued in
accordance with 35 U.S.C. 209(e) and 37
CFR 404.7(a)(l)(i). NASA hereby gives
notice of its intent to grant a partially
exclusive license in the United States to
practice the invention described and
claimed in U.S. Non-Provisional Patent
Application, Application No. 14/
714,756, titled ‘‘Auto-Tracking Antenna
Platform,’’ NASA Case No. DRC–013–
031, and any issued patents or
continuations-in-part resulting
therefrom, to Mobile Antenna Platform
Systems, Inc. having its principal place
of business in Navarre, Florida. Certain
patent rights in this invention have been
assigned to the United States of America
as represented by the Administrator of
the National Aeronautics and Space
Administration. The prospective
partially exclusive license will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR 404.7.
DATES: The prospective partially
exclusive license may be granted unless,
within fifteen (15) days from the date of
this published notice, NASA receives
written objections including evidence
and argument that establish that the
grant of the license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR. 404.7.
Competing applications completed and
received by NASA within fifteen (15)
days of the date of this published notice
will also be treated as objections to the
grant of the contemplated partially
exclusive license.
Objections submitted in response to
this notice will not be made available to
the public for inspection and, to the
extent permitted by law, will not be
released under the Freedom of
Information Act, 5 U.S.C. 552.
SUMMARY:
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Objections relating to the
prospective license may be submitted to
Patent Counsel, NASA Management
Office, Jet Propulsion Laboratory, 4800
Oak Grove Drive, M/S 180–800C,
Pasadena, CA 91109, (818) 854–7770
(phone), 818–393–2607 (fax).
FOR FURTHER INFORMATION CONTACT:
Mark Homer, Patent Counsel, NASA
Management Office, Jet Propulsion
Laboratory, 4800 Oak Grove Drive, M/S
180–800C, Pasadena, CA 91109, (818)
854–7770 (phone), 818–393–2607 (fax).
Information about other NASA
inventions available for licensing can be
found online at https://
technology.nasa.gov
ADDRESSES:
Mark P. Dvorscak,
Agency Counsel for Intellectual Property.
[FR Doc. 2016–08547 Filed 4–13–16; 8:45 am]
BILLING CODE 7510–13–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 50–382; NRC–2016–0078]
Entergy Operations, Inc.; Waterford
Steam Electric Station, Unit 3
Nuclear Regulatory
Commission.
ACTION: License renewal application;
receipt.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) has received an
application for the renewal of operating
license NPF–38, which authorizes
Entergy Operations, Inc. (the applicant)
to operate the Waterford Steam Electric
Station, Unit 3 (Waterford 3). The
renewed license would authorize the
applicant to operate Waterford 3 for an
additional 20-year period beyond the
period specified in the current license.
The current operating license for
Waterford 3 expires at midnight on
December 18, 2024.
DATES: The license renewal application
referenced in this document is available
on April 14, 2016.
ADDRESSES: Please refer to Docket ID
NRC–2016–0078 when contacting the
NRC about the availability of
information regarding this document.
You may obtain publicly-available
information related to this document
using any of the following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2016–0078. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
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SUMMARY:
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Agencies
[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22122-22128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08572]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 16-7]
Rezik A. Saqer, M.D.; Decision and Order
On October 1, 2015, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Rezik A. Saqer, M.D., (Respondent). The Show Cause Order
proposed the revocation of Respondent's DEA Certificates of
Registration BS4072637 and FS1975359, pursuant to which he is
authorized to dispense controlled substances in schedules II through V,
as a practitioner, at the respective registered locations of 11037 FM
1960 West, Suite B1, Houston, Texas, and 3074 College Park Drive,
Conroe, Texas. Show Cause Order, at 1. The Show Cause Order further
proposed the denial of any applications to renew or modify either
registration, as well as the denial of any other application for a DEA
registration. Id.
More specifically, the Show Cause Order alleged that ``[e]ffective
September 28, 2015, the Texas Medical Board issued an Order of
Temporary Suspension . . . which suspended [Respondent's] medical
license,'' and therefore, he is currently ``without authority to handle
controlled substances in Texas, the State in which [he is] registered
with'' DEA. Id. at 2. The Show Cause Order thus advised Respondent that
``DEA must revoke [his] registrations based upon [his] lack of
authority to handle controlled substances in the State of Texas.'' Id.
(citing 21 U.S.C. 802(21), 823(f), and 824(a)(3)).
On October 2, 2015, a Diversion Investigator served the Show Cause
Order by travelling to Respondent's registered location in Houston, and
leaving it with a medical assistant, who provided a signed receipt for
the Order. Affidavit of DI, at 1. On November 5, 2015, Respondent,
through his counsel, requested a hearing on the allegations of the Show
Cause Order.\1\ The matter was then placed on the docket of the Office
of Administrative Law Judges, and
[[Page 22123]]
assigned to the Chief Administrative Law Judge (hereinafter, CALJ).
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\1\ While Respondent's request was untimely, Respondent's
counsel subsequently filed a motion which established that his
secretary had attempted to file the hearing request by UPS overnight
delivery, but had provided an incorrect address. DEA has previously
held that this type of inadvertence may establish ``good cause'' to
excuse an untimely hearing request, at least when the party promptly
moves to rectify the omission. Tony Bui, 75 FR 49979, 49980 (2010).
---------------------------------------------------------------------------
In the same filing which contained his hearing request, Respondent
also sought a ``brief stay'' of the proceeding, stating that a hearing
on the Texas Medical Board's (TMB) emergency suspension order was to
commence on November 19, 2015. Respondent further expressed his
expectation that ``[o]n or shortly after that date . . . the [TMB] will
issue an order regarding his challenge to the temporary suspension.''
Respondent's Req. for Hrng. and Mot. for Brief Stay of Admin.
Proceedings, at 1.
The next day, the CALJ denied Respondent's request for a stay and
ordered the Government to provide evidence in support of the allegation
that Respondent lacks state authority and any accompanying motion, no
later than 2 p.m. on November 23, 2015. CALJ Order, at 2 (Nov. 6,
2015). The CALJ also ordered that if the Government filed such a
motion, Respondent's Reply would be due no later than 2 p.m. on
December 3, 2015. Id.
On November 18, 2015, the Government filed its Motion for Summary
Disposition. Therein, the Government argued that it was undisputed that
Respondent's medical license has been suspended by the State, and while
Respondent argued that the TMB was to hold a hearing on the suspension,
whether and when the TMB would lift its order was ``a matter of
speculation.'' Mot. at 3. The Government thus argued that even where a
registrant's state authority has been temporarily suspended, revocation
of his registration is still warranted because the registrant must
possess authority to handle controlled substances under state law in
order for the Agency to maintain his registration. Id. at 3-4. As
support for its Motion, the Government attached the Order of Temporary
Suspension (Without Notice of Hearing), which was issued to Respondent
by the TMB's Disciplinary Panel on September 28, 2015.
On December 3, 2015, Respondent filed its Opposition to the
Government's Motion. Therein, he argued that both the Controlled
Substances Act (CSA) and DEA's regulations require that if a registrant
``requests a hearing, the agency is required to provide such a
hearing.'' Resp. Opp., at 1 (citing 21 U.S.C. 824(c); 21 CFR 1301.36(d)
and 1301.37(d)). He also argued that ``[t]here are no provisions in
DEA's regulations or the CSA that allow for summary disposition whereby
Respondent's right to a hearing is denied.'' Id. And he argued that
Title 5 (the Administrative Procedure Act) ``requires an `agency
hearing' in every case in which a statute requires adjudication to be
determined on the record,'' and that 5 U.S.C. 554 does not contain ``an
exception for `summary disposition.' '' Id. at 2.
Respondent also argued that the Agency's position that the
possession of state authority is a condition for maintaining a DEA
registration is based on a misreading of the term ``practitioner,'' id.
at 3-4, which the CSA defines as meaning ``a physician . . . or other
person licensed, registered, or otherwise permitted, by the United
States or the jurisdiction in which he practices to . . . dispense . .
. a controlled substance in the course of professional practice.'' 21
U.S.C. 802(21). More specifically, Respondent argued that because the
definition uses the disjunctive ``or,'' rather than the conjunctive of
``and,'' this ``clearly signals Congress' intent that a practitioner is
one who either has state authority or federal authority to prescribe or
dispense controlled substances.'' Id. at 4. And finally, Respondent
argued that under 21 U.S.C. 843(a), the Agency ``may revoke a
registration based on the suspension or revocation of state authority
to dispense controlled substances, not that it must revoke based on
those allegations.'' Id. at 5. Respondent then contended that granting
summary disposition was ``inappropriate'' because he ``intend[ed] to
present evidence that his registration is consistent with the public
interest notwithstanding the status of [sic] state license,'' and he
``is challenging the loss of his state authority and until his rights
are exhausted, there exists a real prospect that his state authority
will be reinstated.'' Id.
Finding that ``no genuine dispute exists over the fact that the
Respondent lacks state authority to handle controlled substances,'' the
CALJ concluded that because Respondent lacks such authority, ``Agency
precedent dictates that he is not entitled to maintain his DEA
registration.'' Order Granting Govt. Mot. for Summ. Disp., at 9. Noting
that ``there is no contested factual matter adducible at a hearing that
would, in the Agency's view, provide authority to allow the Respondent
to continue to hold his'' registration, the CALJ granted the
Government's motion for summary disposition and recommended that his
``registration be revoked'' and that ``any pending applications for
renewal be denied.'' Id. at 9-10 (bold and capitalization deleted).
Respondent filed Exceptions to the CALJ's Order and the Government
filed a Response to Respondent's Exceptions. Thereafter, the record was
forwarded to me for Final Agency Action. Having considered the record
including Respondent's Exceptions, I adopt the CALJ's finding that
Respondent lacks authority under Texas law to handle controlled
substances, and his conclusion of law that Respondent is not entitled
to maintain his registration. For reasons explained below, I will also
adopt the ALJ's recommendation but only with respect to Respondent's
Certificate of Registration BS4072637. I make the following findings.
Findings of Fact
Respondent is the holder of DEA Certificate of Registration
BS4072637, pursuant to which he is authorized to dispense controlled
substances in schedules II through V, as a practitioner, at the address
of 11037 FM 1960 West, Suite B1, Houston, Texas. Mot. for Summ. Disp.,
at Attachment 2. Under this registration, Respondent is also authorized
to treat up to 100 patients as a DATA-waived physician. Id. This
registration does not expire until February 28, 2018. Id.
Respondent also previously held DEA Certificate of Registration
FS1975359, pursuant to which he was authorized to dispense controlled
substances in schedules II through V, as a practitioner, at the address
of 3074 College Park Drive, Conroe, Texas. Mot. for. Summ. Disp., at
Attachment 3. This registration was due to expire on February 29, 2016,
id., and according to the registration records of this Agency of which
I take official notice, Respondent has not filed a timely renewal
application (let alone any application to renew this registration).\2\
Accordingly, I find that this registration has expired. See 21 CFR
1301.36(i).
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\2\ Under the Administrative Procedure Act (APA), an agency
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is ``entitled on timely request to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to refute the
facts of which I take official notice, Respondent may file a motion
for reconsideration within ten calendar days of service of this
order which shall commence on the date this order is mailed.
---------------------------------------------------------------------------
Respondent is also the holder of Texas Medical License No. K-2282.
In re Saqer, Order of Temporary Suspension (Without Notice of Hearing),
at 1 (Tex. Med. Bd. Sept. 28, 2015). However, on September 28, 2015,
the Disciplinary Panel of the Texas Medical Board entered an Order of
Temporary Suspension against Respondent's medical license following an
ex-parte hearing on the Board's Application for
[[Page 22124]]
Temporary Suspension (Without Notice of Hearing). Id. at 4.
As the basis for the Order, the Panel found that on September 22,
2015, a search warrant was executed at a pain management clinic owned
by Respondent, during which DEA agents ``obtained evidence establishing
that Respondent pre-signed treatment notes, pre-signed prescriptions
and illegally maintained schedule II controlled substances in his
personal office.'' Id. at 2. The Panel also found ``that patients of
[the clinic] were sometimes seen by unlicensed individuals that would
fill in the records and prescriptions to make it appear that Respondent
had seen the patient and written the prescription.'' Id. The Panel thus
found that ``Respondent engaged in illegal activities related to his
operation of [the clinic], and engaged in the inappropriate
prescribing, dispensing, or administering of controlled substances, and
therefore Respondent has committed violations of state and federal law,
including the Medical Practice Act and Board Rules.'' Id.
The Panel concluded that ``Respondent's continued practice of
medicine, including improper and illegal activities related to his
operation of a pain management clinic, and including the method and
manner in which controlled substances were prescribed and maintained,
poses a continuing threat to public welfare.'' Id. Based on these
findings, the Panel found ``a continuing threat to the public health,
safety, or welfare that requires immediate effect of this Order of
Temporary Suspension on the date rendered.'' Id. And after setting
forth its legal conclusions that Respondent violated multiple
provisions of the Medical Practice Act, the Panel ordered that
Respondent's medical license be suspended. Id. at 3-4.
On November 19, 2015, the Disciplinary Panel conducted a hearing at
which Respondent appeared and was represented by counsel. In re Saqer,
Order of Temporary Suspension (With Notice of Hearing), at 1 (Tex. Med.
Bd. Nov. 19, 2015). However, following the hearing, the Board made the
same factual findings and legal conclusions as it had at the ex parte
proceeding, see id. at 1-4, and it again ordered the temporary
suspension of Respondent's medical license. Id. According to the online
records of the Texas Medical Board, the suspension remains in effect. I
therefore find that Respondent is currently without authority to
dispense controlled substances in Texas, the State in which he is
engages in professional practice and holds his DEA registration.
Discussion
Respondent's Contention That DEA Cannot Use Summary Disposition to
Adjudicate This Matter
As explained above, in his Opposition to the Government's Motion,
Respondent contends that because he requested a hearing, under the
Agency's regulation, the Agency was required to provide him with a
hearing. Opp. at 1-3. He further contends that there are no provisions
in either the CSA or the Agency's regulations that allow for summary
disposition, thereby denying him his right to a hearing. Id. at 2-3.
However, numerous courts, including the Supreme Court, have held
that even where a statute directs an agency to provide a party with a
hearing, the agency can nonetheless resolve the matter on summary
disposition when there are no material facts in dispute. See, e.g.,
Veg-Mix, Inc. v. Department of Agriculture, 832 F.2d 601, 607 (D.C.
Cir. 1987). As the DC Circuit explained in Veg-Mix, ``[c]ommon sense
suggests the futility of hearings where there is no factual dispute of
substance.'' Id. \3\ See also NLRB v. International Ass'n of Bridge,
Structural and Ornamental Ironworkers, 549 F.2d 634, 639 (9th Cir.
1977) (`` `It is settled law that when no fact question is involved or
the facts are agreed, a plenary, adversary administrative proceeding
involving evidence, cross-examination of witnesses, etc., is not
obligatory, even though a pertinent statute prescribes a hearing. In
such situations, the rationale is that Congress does not intend
administrative agencies to perform meaningless tasks.' '') (quoting
United States v. Consolidated Mines & Smelting Co., Ltd., 455 F.2d 432,
453 (9th Cir. 1971)).\4\ Cf. Weinberger v. Hynson, Westcott and
Dunning, Inc., 412 U.S. 609, 620-22 (1973) (upholding agency's
authority to dispense with a formal hearing where applicant has not
provided any evidence that it meets statutory standards).
---------------------------------------------------------------------------
\3\ While Respondent noted that the Agency's rules regarding the
conduct of hearings do not include a provision which expressly
authorizes the use of summary disposition, this Agency has used
summary disposition to resolve proceedings based on a registrant's
loss of his/her state authority for nearly 40 years. See, e.g.,
Alfred Tennyson Smurthwaite, N.D., 43 FR 11873 (1978). There are
hundreds of such cases reported in the Federal Register. Contrary to
Respondent's contention that the Agency cannot rely on summary
disposition in the absence of a regulation which expressly allows
for it, ``[i]t is well established that agencies are free to
announce and develop rules in an adjudicatory setting.'' Puerto Rico
Aqueduct and Sewer Auth. v. EPA, 35 F.3d 600 607 (1st Cir. 1994)
(citing NLRB v. Bell Aerospace Co., 416 U.S. 267, 294 (1974)).
\4\ See also Travers v. Shalala, 20 F.3d 993, 998 (9th Cir.
1994) (quoting Consolidated Mines, 455 F.2d at 453).
---------------------------------------------------------------------------
Notably, while Respondent was given the opportunity to demonstrate
the existence of a factual dispute as to whether he retains state
authority, he could not do so, as even after he was allowed to appear
before the Board and challenge the temporary suspension of his license,
the Board re-imposed the suspension. However, even in the absence of a
disputed material fact, Respondent contends that ``summary disposition
[was] inappropriate,'' because he ``intend[ed] to present evidence that
his registration is consistent with the public interest notwithstanding
the status of [his] state license.'' Opp. at 5. The short answer to
this argument is that even if Respondent could show that his
registration is consistent with the public interest, his lack of state
authority precludes his continued registration under the CSA, and it is
the Government and not Respondent who decides what ground or grounds to
pursue when seeking the revocation of his registration.
Respondent's Challenge to the Agency's Authority To Revoke His
Registration
Respondent nonetheless maintains that the Agency's rule that a
practitioner's loss of his ``state authority is an automatic bar to
maintaining a DEA registration'' is based ``on a misreading of the
CSA.'' Resp. Exceptions, at 1-2. In his Exceptions, Respondent contends
that ``[f]or proceedings seeking the revocation of a DEA registration,
the [A]gency derives its authority from 21 U.S.C. 824, not 21 U.S.C.
823, and 21 U.S.C. 824 does not support the [A]gency's position that it
must revoke a DEA registration in all instances where a registrant
lacks state authority.'' Id. at 2.
To be sure, section 824(a) states, in relevant part, that ``[a]
registration pursuant to section 823 of this title to manufacture,
distribute, or dispense a controlled substance or list I chemical may
be suspended or revoked . . . upon a finding that the registrant . . .
has had his State license or registration suspended, revoked, or denied
by competent State authority and is no longer authorized by State law
to engage in the manufacturing, distribution or dispensing of
controlled substances or list I chemicals.'' 21 U.S.C. 824(a)(3). Thus,
Respondent is correct that section 824 grants the Attorney General
discretion and does not mandate the revocation of a ``registration in
all instances where a registrant lacks state authority.'' Resp.
Exceptions, at 2.
Indeed, in Bio-Diagnostic International, 78 FR 39327 (2013), a
[[Page 22125]]
case involving a list I chemical distributor which did not possess
state authority, the Agency held that granting summary disposition to
the Government on this basis was improper because neither the provision
setting forth the standards for the registration of list I
distributors, nor the definition of a distributor, requires that a
distributor possess state authority in order to be registered.\5\ While
Bio-Diagnostic involved an application, in a footnote, the decision
explained that while ``section 824(a)(3) authorizes revocation where a
registrant `has had [its] State license suspended, revoked, or denied
by competent state authority and is no longer authorized by State law
to engage in the manufacturing [or] distribution of . . . list I
chemicals[,]' [this] does not mean that revocation is warranted in all
instances.'' Id. at 39330 n.6. Continuing, the decision explained that
``[t]his provision grants the Agency discretionary authority to impose
an appropriate sanction; the failure to consider factors such as the
egregiousness of the misconduct and mitigating factors in imposing the
sanction would render the sanction arbitrary and capricious.'' Id.
---------------------------------------------------------------------------
\5\ The decision did note, however, that where a list I
distributor was required to obtain state authority and had not done
so, this could be considered under the public interest factor which
examines ``compliance by the applicant with applicable Federal,
State and local law.'' 78 FR at 39330-31 (quoting 21 U.S.C.
823(h)(2)).
---------------------------------------------------------------------------
Respondent is not, however, a List I chemical distributor. Rather,
he is a practitioner, and by contrast to the CSA's provisions
applicable to list I distributors, both the CSA's definition of the
term ``practitioner'' and the registration provision applicable to
practitioners make clear that a practitioner must be currently
authorized to dispense controlled substances by the State in which he
practices in order to obtain and maintain a registration.
As for the registration provision applicable to practitioners, it
provides, in relevant part, that: ``[t]he Attorney General shall
register practitioners . . . to dispense . . . controlled substances .
. . if the applicant is authorized to dispense . . . controlled
substances under the laws of the State in which he practices.'' 21
U.S.C. 823(f). As the Supreme Court explained in United States v.
Moore, 423 U.S. 122, 140-41 (1975), ``[r]egistration of physicians and
other practitioners is mandatory if the applicant is authorized to
dispense drugs . . . under the law of the State in which he practices.
[21 U.S.C.] Sec. 823(f). In the case of a physician, this scheme
contemplates that he is authorized by the State to practice medicine
and to dispense drugs in connection with his professional practice.''
\6\
---------------------------------------------------------------------------
\6\ While in 1984 Congress granted the Attorney General
authority to deny a registration on public interest grounds, the
provision did not alter the CSA's requirement that a practitioner
must be ``authorized by the State to practice medicine'' and
dispense drugs in order to be registered.
---------------------------------------------------------------------------
Thus, the CSA defines ``[t]he term `practitioner' [to] mean[] a
physician . . . or other person licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he
practices to . . . dispense . . . a controlled substance in the course
of professional practice.'' 21 U.S.C. 802(21). As noted above, in his
Opposition, Respondent argued that ``[t]he use of the disjunctive `or'
clearly signals Congress' intent that a practitioner is one who either
has state authority or federal authority to prescribe or dispense
controlled substances[,]'' and that ``[h]ad Congress required that a
practitioner maintain both state and federal authority to handle
controlled substances, it would have used the word `and.''' Resp. Opp.
at 4. Continuing, Respondent argued that ``[w]hile it is not entirely
clear why Congress took this approach . . . the clear statutory
language'' refutes the Government's argument that ``a lack of state
licensure [is] an automatic bar to maintaining a DEA registration.''
Id.
Respondent is mistaken. As for why Congress used the disjunctive
rather than the conjunctive in defining the term practitioner,
notwithstanding the absence of any relevant discussion in the CSA's
legislative history, there is an explanation. While the overwhelming
majority of practitioners who practice medicine (or dentistry and
veterinary medicine) are subject to regulation by the State in which
they practice their professions, multiple federal Departments and
Agencies (e.g., the Department of Defense, Veterans Administration,
Bureau of Prisons, United States Public Health Service, and Indian
Health Service) employ practitioners. However, by virtue of the
Supremacy Clause, these health-care professionals are not subject to
regulation by the State in which the federal facility is located as
long they confine their practice to the facility. See Taylor v. United
States, 821 F.2d 1428, 1431 (9th Cir. 1987) (noting that under the
Supremacy Clause, a State ``lacks power to require licensing of federal
health care providers and physicians'' and that ``[t]he United States
has essentially deemed [an] Army [h]ospital and its staff fit to
provide health care services''); United States v. Composite State Bd.
of Med. Exmn'rs, 656 F.2d 131, 135 n.4 (5th Cir. 1981) (citing Sperry
v. Florida ex rel. Florida Bar, 373 U.S. 379 (1963) (``A State may not
enforce licensing requirements that, though valid in the absence of
federal regulation, give the state's licensing board a virtual power of
review over the federal determination that a person is qualified to
perform certain functions.'').
Thus, Congress used the word ``or'' only to distinguish between
those practitioners who practice at federal facilities and are subject
to the licensing requirements of the United States,\7\ and the vast
majority of practitioners who are subject to the licensing requirements
of the State in which they practice their profession. And while the
Agency has exempted from ``[t]he requirement of registration . . . any
official of'' the military, the Public Health Service, or Bureau of
Prisons who is authorized to prescribe, dispense, or administer, but
not to procure or purchase, controlled substances in the course of his/
her official duties,'' 21 CFR 1301.23(a), these practitioners otherwise
remain subject to the Act. See, e.g., 21 U.S.C. 829(a) (``Except when
dispensed directly by a practitioner, other than a pharmacist, to an
ultimate user, no controlled substance in schedule II, which is a
prescription drug as determined under the [FDCA], may be dispensed
without the written prescription of a practitioner, except [for] in
emergency situations, as prescribed by . . . regulation . . . .''); 21
CFR 1306.04(a) (``A prescription for a controlled substance to be
effective must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice.'').
---------------------------------------------------------------------------
\7\ As a general matter, federal entities that employ physicians
require only that the physician hold a medical license in one of the
50 States. See U.S. Public Health Service, Job Requirements
(available at www.usphs.gov/profession/physician/requirements.aspx)
(requiring that a physician have a``[c]urrent, unrestricted, and
valid medical license to practice in one of the 50 states;
Washington, DC; Commonwealth of Puerto Rico; U.S. Virgin Islands; or
Guam''; Indian Health Service, Indian Health Manual, Part 3-
1.4(C)(5) (``Members of the medical staff and others who must apply
for clinical privileges must hold an active and unrestricted State
license, certification, or registration, as applicable, to practice
in their professional field.''); VA Careers (available at
www.vacareers.va.gov/careers/physicians/credentially.asp) (``At VA,
only one active, unrestricted state license is required to practice
in every VA facility across all 50 States, the District of Columbia,
and U.S. Territories.'').
---------------------------------------------------------------------------
Respondent further asserts that ``[h]ad Congress required that a
practitioner maintain both state and federal authority to handle
controlled substances, it would have used the word `and.''' Resp. Opp.
at 4. Were this the case, any practitioner who is no longer
[[Page 22126]]
authorized to practice medicine by his State (even those who engaged in
drug dealing) would nonetheless still be allowed to dispense controlled
substances under their federal registration. The argument is, however,
refuted by the CSA's definition of the term ``dispense'' to ``mean[ ]
to deliver a controlled substance to an ultimate user or research
subject by, or pursuant to the lawful order of, a practitioner,
including the prescribing and administering of a controlled
substance.'' 21 U.S.C. 802(10) (emphasis added). Because Respondent is
required to possess state authority to dispense controlled substances
in Texas, and by virtue of the Board's Order, no longer holds such
authority, he cannot issue a ``lawful order'' to deliver a controlled
substance. And he therefore no longer meets the requirement for being a
registered practitioner under the Act.
Respondent further argues that ``had Congress wanted the lack of a
state license to be an automatic bar to maintaining a DEA registration,
it would have used the word `shall' '' rather than ``may'' in section
824. He argues that ``if DEA understood that to be what Congress
intended the agency could have added lack of state licensure to one of
the grounds for immediate termination of a DEA registration found in 21
CFR 1301.52(a). It chose not too [sic], presumably because DEA knew it
had no such authority.'' Resp. Opp. at 4-5.
It is not clear, however, why using the word ``shall'' rather than
``may'' would make any difference, as section 824(a) grants the Agency
authority to either revoke or suspend. Moreover, were it the case that
section 824(a) used the word ``shall,'' the Agency would be mandated to
either suspend or revoke a registration upon making one of the
enumerated findings, regardless of how persuasive a registrant's
showing was on issues of remediation where, as in a proceeding brought
under the public interest authority, such a showing is authorized.
As this Agency has previously explained, Section 824(a)'s grant of
authority to suspend or revoke a registration applies across all
categories of registration, including manufacturers, distributors,
importers, exporters, narcotic treatment programs, list I distributors,
and practitioners. And it applies to five different grounds for
sanctioning a registrant. As the Agency has previously explained,
``this general grant of authority in imposing a sanction must be
reconciled with the CSA's specific provisions which mandate that a
practitioner hold authority under state law in order to obtain and
maintain a DEA registration.'' James L. Hooper, 76 FR 71371, 71372
(2011), pet. for rev. denied, Hooper v. Holder, 481 Fed. App'x 826 (4th
Cir. 2012). See also Gozlon-Peretz v. United States, 498 U.S. 395, 407
(1991) (``A specific provision controls over one of more general
application.''); Bloate v. United States, 559 U.S. 196, 207 (2010)
(``language of a statutory provision, although broad enough to include
it, will not be held to apply to a matter specifically dealt with in
another part of the same enactment.' '').
Thus, in Hooper v. Holder, a physician whose state authority was
suspended for a period of one year, challenged the revocation of his
registration, arguing that the Agency ``failed to recognize the
discretion under Sec. 824(a) to revoke or suspend a registration and
that it was impermissible for the [Agency] to conclude that the CSA
requires revocation of a practitioner's DEA registration when the
practitioner's State license is suspended.'' 481 Fed. App'x, at 826.
The Fourth Circuit rejected the physician's challenge, explaining:
We find Hooper's contention unconvincing. Section 824(a) does
state that the [Agency] may ``suspend or revoke'' a registration,
but the statute provides for this sanction in five different
circumstances, only one of which is loss of a State license. Because
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 [Agency'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.
The [Agency's] decision does not ``read[ ] the suspension option''
out of the statute, because that option may still be available for
the other circumstances enumerated in Sec. 824(a).
Id. \8\ See also Maynard v. DEA, 117 Fed. Appx. 941, 945 (5th Cir.
2004) (upholding revocation of DEA registration after Texas DPS
summarily suspended practitioner's controlled substance registration,
noting that the Agency ``has construed the CSA to require revocation
when a registrant no longer possesses valid state authority to handle
controlled substances''; ``We agree with [the] argument that it may
have been arbitrary and capricious had the DEA failed to revoke [the
physician's] registration under the circumstances.'').
---------------------------------------------------------------------------
\8\ As for Respondent's contention that if Congress intended
that lack of a state license should be an automatic bar, the Agency
could have made this a ground for immediate termination without a
hearing, the argument ignores that by requiring the Agency to serve
a Show Cause Order on the registrant, and affording the registrant
an opportunity to respond, the procedures reduce the risk of an
erroneous deprivation. See Mathews v. Eldridge, 424 U.S. 319 (1976).
---------------------------------------------------------------------------
Indeed, DEA has interpreted the CSA in this manner for nearly 40
years. See Frederick Marsh Blanton, M.D., 43 FR 27616 (1978). In
Blanton, a physician's state license was suspended for a period of one
year. Id. at 27616. The Agency nonetheless revoked the physician's
registration, explaining that ``it is the Administrator's finding and
conclusion that there is a lawful or statutory basis for the revocation
of the Respondent's DEA registration. State authorization to dispense
or otherwise handle controlled substances is a prerequisite to the
issuance and maintenance of a Federal controlled substances
registration. The Respondent's registration must, therefore, be
revoked.'' Id. at 27617 (emphasis added). See also Alfred Tennyson
Smurthwaite, 43 FR at 11873 (same). Moreover, on various occasions,
Congress has amended the CSA, including in 1984, when it granted the
Agency the authority to revoke a practitioner's registration on the
ground that he had committed acts inconsistent with the public
interest. See Drug Enforcement Amendments to the Comprehensive Crime
Control Act of 1984. See P.L. 98-473, Sec. 512, 98 Stat. 1838, 2073
(1984). Yet it has left the Agency's interpretation intact. See NLRB v.
Bell Aerospace Co., 416 U.S. 267, 275 (1974).
The Agency has also long held that revocation is warranted even
where a practitioner has lost his state authority by virtue of the
State's use of summary process and the State has yet to provide a
hearing to challenge the suspension. Bourne Pharmacy, 72 FR 18273,
18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Indeed, as
this case demonstrates, state proceedings can go on for an extended
period, and thus, it is not DEA's policy to hold revocation proceedings
in abeyance while practitioners challenge Board decisions which suspend
or revoke their state authority.
Respondent argues, however, that ``the agency's decision [in Odette
Campbell, 80 FR 41062 2015)] to remand the matter and allow
administrative proceedings to be conducted by the ALJ (and ultimately
hold proceedings in abeyance), pending the outcome of state board
proceedings[,] undermines . . . the agency's notion that it must revoke
a DEA registration in all instances where a registrant lacks state
authority, rendering an administrative hearing unnecessary.''
Exceptions at 2. Respondent then asserts that ``[w]hile the agency
conjured up a Due Process
[[Page 22127]]
argument to support its decision in [Campbell], in doing so it
implicitly held that lack of state authority is not an automatic bar to
holding a DEA registration.'' Id. Respondent further asserts that
``[w]hile declaring that Due Process was the basis for this decision,
the only outcome that could have been reached in that case, if the
[A]gency followed its own case law, was the revocation of Dr.
Campbell's DEA registration as the DEA proceedings would not have
changed the fact that she did not have state authority to handle state
authority to handle controlled substances.'' Id. at 2-3.
Respondent's reliance on Campbell is unavailing because he ignores
critical aspects of the case's procedural history. For one, the case
began when DEA issued an Order to Show Cause and Immediate Suspension
of Registration (ISO) to the physician, which was based on allegations
that she violated various provisions of the Controlled Substances Act.
80 FR at 41063 n.3. Thereafter, the Texas Medical Board suspended her
medical license and the Texas Department of Public Safety suspended her
state controlled substance registration based on the Agency's issuance
of the ISO. Id. The Government then moved for summary disposition on
the ground that the physician lacked authority to dispense controlled
substances under Texas law and the ALJ granted the motion. Id.
While the matter was under review, the physician submitted a letter
to the ALJ (which was forwarded to the Administrator), in which she
asserted that the Medical Board had reinstated her license. Id. After
the Government responded by letter to the ALJ that the physician was
still without state authority because her DPS registration had been
revoked, Respondent submitted a letter to the ALJ asserting that her
DPS registration could not be reinstated unless her DEA registration
was reinstated. Id.
Noting that parties had directed their letters to each other and
the ALJ, and that neither party had sought relief from her, the former
Administrator directed the Government to file a properly supported
motion seeking a final order based on the physician's lack of state
authority. Id. The Government filed its request, which Respondent
opposed, arguing that because the DPS's action was based on the
unsubstantiated allegations of the ISO, it was fundamentally unfair and
a denial of due process to revoke her DEA registration based on the
DPS's action. Id.
On further review, the former Administrator observed that ``it
appeared that under Texas law and regulations, Respondent was not
entitled to a hearing before the DPS to challenge either the DPS's
suspension or the denial of her application for a new registration.''
Id. (citing Tex. Health & Safety Code Sec. 481.063(e)(3) & (h); id.
Sec. 481.066(g); 37 Tex. Admin. Code Sec. 13.272(h)). The
Administrator then explained that ``if this was so, revoking her [DEA]
registration based on her lack of state authority would preclude her
from ever being able to challenge the basis of the Immediate Suspension
Order.'' Id. The Administrator thus remanded the case, instructing the
ALJ ``to first determine whether the DPS would provide [the respondent]
with a hearing on the allegations.'' Id. The Administrator further
instructed that if the DPS had provided or would provide respondent
with a hearing, the Government could renew its motion for summary
disposition. Id. However, if DPS would not provide her with a hearing,
the ALJ was to conduct a hearing on the allegations of the Show Cause
Order and ISO. Id.
In short, there was nothing ``conjured up'' in the Agency's due
process rationale, which recognized only that due to the vagaries of
Texas law,\9\ the Agency's litigation strategy might well result in the
respondent having no meaningful opportunity to challenge the
allegations which both the Agency and the DPS had relied on in
suspending their respective registrations. As for Respondent's
contention that revocation was ``the only outcome that could have been
reached . . . as the DEA proceedings would not have changed the fact
that she did not have state authority to handle controlled
substances,'' Respondent ignores that DPS imposed its suspension based
solely on the Agency's ISO and that if the physician succeeded in
challenging the ISO, the basis for the DPS' suspension would no longer
exist. And Respondent further ignores that in her remand order, the
Administrator provided that the Government could move for summary
disposition if it could show that DPS would provide the physician with
a hearing.\10\
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\9\ See Tex. Health & Safety Code Sec. 481.066(g) (State
Administrative Procedure Act ``does not apply to a . . . suspension
of a registration for a cause described by Section 481.063 . . .
(e)(3),'' which includes the suspension of a registration under the
CSA); 37 Tex. Admin. Code Sec. 13.272(h) (``Under the Act, Sec.
481.0639(h), the [State Administrative Procedure Act] does not apply
to a denial, suspension, or revocation of an application for
registration if the denial is based on a denial or other
disciplinary action taken by DEA under the Federal Controlled
Substances Act.'').
\10\ As for Respondent's assertion that the Administrator's
decision to hold the Campbell case in abeyance, pending the outcome
of state board proceedings, ``undermines . . . the [A]gency's notion
that it must revoke a DEA registration in all instances where a
registration lacks state authority,'' Exceptions at 2, Respondent
ignores that at the time the proceeding was held in abeyance, the
physician (who had been indicted on multiple counts of health care
fraud) had allowed her registration to expire and had only an
application pending before the Agency. Moreover, the physician then
held both a state license and state controlled substance
registration. See 80 FR at 41063. The case thus does not support
Respondent's contention.
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Accordingly, I reject Respondent's contentions.\11\ Because
Respondent lacks state authority to dispense controlled substances, he
is not entitled to maintain his DEA registration. I will therefore
order that his remaining registration be revoked.
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\11\ Respondent also points to a provision of the DEA
Pharmacist's Manual, which allows an entity to obtain a registration
for a pharmacy it is acquiring prior to the State's issuance of a
pharmacy license for that location. Opp. at 5. Respondent asserts
that ``[w]hile the Agency is permitted to interpret its regulations,
it is not free to contradict its long-standing policy that a state
license is not a prerequisite to obtaining a DEA registration when
doing so is simply a convenient litigation position designed to
prevent a registrant from proving that the underlying state action
was erroneous.'' Id. at 5-6.
However, the Pharmacist's Manual makes clear that provision
applies only ``[i]f the registrant acquiring the pharmacy owns at
least one other pharmacy licensed in the same state as the pharmacy
being transferred,'' and that while the registrant may take
possession of the controlled substances, ``the registrant may not
dispense controlled substances until the pharmacy haw been issued a
valid state pharmacy license.'' DEA, Pharmacists Manual, at 10
(2010) (emphasis added). This policy exists because some States will
not grant a pharmacy license to the acquiring pharmacy until DEA
issues it a registration. However, the period in which the
registrant is without the state license for the acquired pharmacy is
typically of short duration.
As for Respondent's assertion that the Agency's position ``is
simply a convenient litigation position designed to prevent a
registrant from proving that the underlying state action was
erroneous,'' not only is this refuted by nearly 40 years of
precedent (and hundreds of cases), the Agency has also made clear in
multiple cases that a challenge to a state board proceeding must be
litigated in the forums provided by the State. See Kamal Tiwari, 76
FR 71604, 71606 (2011) (collecting cases); see also George S. Heath,
51 FR 26610 (1986).
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Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a)(3) and
823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration BS4072637 issued to Rezik A. Saqer, M.D., be, and it
hereby is, revoked. I further order that any application by Rezik A.
Saqer, M.D., for registration in the State of Texas, be, and it hereby
is, denied. This Order is effective immediately.\12\
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\12\ For the same reasons which led the Texas Board to order the
emergency suspension of Respondent's medical license, I conclude
that the public interest necessitates that this Order be effective
immediately. 21 CFR 1316.67.
[[Page 22128]]
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Dated: April 5, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-08572 Filed 4-13-16; 8:45 am]
BILLING CODE 4410-09-P