81 FR 22122 - Rezik A. Saqer, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 72 (April 14, 2016)

Page Range		22122-22128
FR Document		2016-08572
Federal Register, Volume 81 Issue 72 (Thursday, April 14, 2016)
[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22122-22128]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08572]


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 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).
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    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.
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    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).
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    \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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    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.
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    \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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    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\
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    \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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    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.'').
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    \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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    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.'').
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    \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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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]]


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

    Dated: April 5, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-08572 Filed 4-13-16; 8:45 am]
BILLING CODE 4410-09-P
22122 Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices

certain basic classes of controlled issuance of the proposed registration in DEPARTMENT OF JUSTICE
substances. The Drug Enforcement accordance with 21 CFR 1301.33(a) on
Administration (DEA) grants Stepan or before June 13, 2016. Drug Enforcement Administration
Company registration as a manufacturer
ADDRESSES: Written comments should [Docket No. 16–7]
of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
be sent to: Drug Enforcement
Administration, Attention: DEA Federal Rezik A. Saqer, M.D.; Decision and
dated April 14, 2015, and published in Order
the Federal Register on April 22, 2015, Register Representative/ODW, 8701
80 FR 22555, Stepan Company, Natural Morrissette Drive, Springfield, Virginia On October 1, 2015, the Deputy
Products Department, 100 W. Hunter 22152. Assistant Administrator, Office of
Avenue, Maywood, New Jersey 07607 Diversion Control, Drug Enforcement
SUPPLEMENTARY INFORMATION: The Administration, issued an Order to
applied to be registered as a
Attorney General has delegated her Show Cause to Rezik A. Saqer, M.D.,
manufacturer of certain basic classes of
controlled substances. No comments or authority under the Controlled (Respondent). The Show Cause Order
objections were submitted for this Substances Act to the Administrator of proposed the revocation of
notice. the Drug Enforcement Administration Respondent’s DEA Certificates of
The DEA has considered the factors in (DEA), 28 CFR 0.100(b). Authority to Registration BS4072637 and FS1975359,
21 U.S.C. 823(a) and determined that exercise all necessary functions with pursuant to which he is authorized to
the registration of Stepan Company to respect to the promulgation and dispense controlled substances in
manufacture the basic classes of implementation of 21 CFR part 1301, schedules II through V, as a practitioner,
controlled substances is consistent with incident to the registration of at the respective registered locations of
the public interest and with United manufacturers, distributors, dispensers, 11037 FM 1960 West, Suite B1,
States obligations under international importers, and exporters of controlled Houston, Texas, and 3074 College Park
treaties, conventions, or protocols in substances (other than final orders in Drive, Conroe, Texas. Show Cause
effect on May 1, 1971. The DEA connection with suspension, denial, or Order, at 1. The Show Cause Order
investigated the company’s maintenance revocation of registration) has been further proposed the denial of any
of effective controls against diversion by redelegated to the Deputy Assistant applications to renew or modify either
inspecting and testing the company’s Administrator of the DEA Office of registration, as well as the denial of any
physical security systems, verifying the Diversion Control (‘‘Deputy Assistant other application for a DEA registration.
company’s compliance with state and Administrator’’) pursuant to section 7 of Id.
local laws, and reviewing the company’s 28 CFR part 0, appendix to subpart R. More specifically, the Show Cause
background and history. Order alleged that ‘‘[e]ffective
Therefore, pursuant to 21 U.S.C. In accordance with 21 CFR September 28, 2015, the Texas Medical
823(a), and in accordance with 21 CFR 1301.33(a), this is notice that on January Board issued an Order of Temporary
1301.33, the above-named company is 13, 2016, Patheon API Manufacturing, Suspension . . . which suspended
granted registration as a bulk Inc., 309 Delaware Street, Building [Respondent’s] medical license,’’ and
manufacturer of the following basic 1106, Greenville, South Carolina 29605 therefore, he is currently ‘‘without
classes of controlled substances: applied to be registered as a bulk authority to handle controlled
manufacturer of the following basic substances in Texas, the State in which
Controlled substance Schedule classes of controlled substances: [he is] registered with’’ DEA. Id. at 2.
The Show Cause Order thus advised
Cocaine (9041) ............................. II
Ecgonine (9180) ........................... II
Controlled substance Schedule Respondent that ‘‘DEA must revoke [his]
registrations based upon [his] lack of
Marihuana (7360) ......................... I authority to handle controlled
The company plans to manufacture
Tetrahydrocannabinols (7370) ..... I substances in the State of Texas.’’ Id.
the listed controlled substances in bulk Noroxymorphone (9668) .............. II
for distribution to its customers. (citing 21 U.S.C. 802(21), 823(f), and
824(a)(3)).
Dated: April 4, 2016
The company plans to manufacture On October 2, 2015, a Diversion
Louis J. Milione, Investigator served the Show Cause
the above-listed controlled substances
Deputy Assistant Administrator. as Active Pharmaceutical Ingredients Order by travelling to Respondent’s
[FR Doc. 2016–08576 Filed 4–13–16; 8:45 am] (API) for clinical trials. registered location in Houston, and
BILLING CODE 4410–09–P
In reference to drug codes 7360 leaving it with a medical assistant, who
provided a signed receipt for the Order.
(marihuana), and 7370 (THC), the
Affidavit of DI, at 1. On November 5,
DEPARTMENT OF JUSTICE company plans to bulk manufacture
2015, Respondent, through his counsel,
these drugs as synthetics. No other requested a hearing on the allegations of
Drug Enforcement Administration activities for these drug codes are the Show Cause Order.1 The matter was
[Docket No. DEA–392] authorized for this registration. then placed on the docket of the Office
Dated: March 29, 2016. of Administrative Law Judges, and
Bulk Manufacturer of Controlled
Louis J. Milione,
Substances Application: Patheon API 1 While Respondent’s request was untimely,
mstockstill on DSK4VPTVN1PROD with NOTICES

Manufacturing, Inc. Deputy Assistant Administrator.
Respondent’s counsel subsequently filed a motion
[FR Doc. 2016–08569 Filed 4–13–16; 8:45 am] which established that his secretary had attempted
ACTION: Notice of application. BILLING CODE 4410–09–P to file the hearing request by UPS overnight
delivery, but had provided an incorrect address.
DATES: Registered bulk manufacturers of DEA has previously held that this type of
inadvertence may establish ‘‘good cause’’ to excuse
the affected basic classes, and an untimely hearing request, at least when the party
applicants therefore, may file written promptly moves to rectify the omission. Tony Bui,
comments on or objections to the 75 FR 49979, 49980 (2010).

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case involving a list I chemical the State to practice medicine and to 131, 135 n.4 (5th Cir. 1981) (citing
distributor which did not possess state dispense drugs in connection with his Sperry v. Florida ex rel. Florida Bar, 373
authority, the Agency held that granting professional practice.’’ 6 U.S. 379 (1963) (‘‘A State may not
summary disposition to the Government Thus, the CSA defines ‘‘[t]he term enforce licensing requirements that,
on this basis was improper because ‘practitioner’ [to] mean[] a physician though valid in the absence of federal
neither the provision setting forth the . . . or other person licensed, registered, regulation, give the state’s licensing
standards for the registration of list I or otherwise permitted, by the United board a virtual power of review over the
distributors, nor the definition of a States or the jurisdiction in which he federal determination that a person is
distributor, requires that a distributor practices to . . . dispense . . . a qualified to perform certain
possess state authority in order to be controlled substance in the course of functions.’’).
registered.5 While Bio-Diagnostic professional practice.’’ 21 U.S.C. Thus, Congress used the word ‘‘or’’
involved an application, in a footnote, 802(21). As noted above, in his only to distinguish between those
the decision explained that while Opposition, Respondent argued that practitioners who practice at federal
‘‘section 824(a)(3) authorizes revocation ‘‘[t]he use of the disjunctive ‘or’ clearly facilities and are subject to the licensing
where a registrant ‘has had [its] State signals Congress’ intent that a requirements of the United States,7 and
license suspended, revoked, or denied practitioner is one who either has state the vast majority of practitioners who
by competent state authority and is no authority or federal authority to are subject to the licensing requirements
longer authorized by State law to engage prescribe or dispense controlled of the State in which they practice their
in the manufacturing [or] distribution of substances[,]’’ and that ‘‘[h]ad Congress profession. And while the Agency has
. . . list I chemicals[,]’ [this] does not required that a practitioner maintain exempted from ‘‘[t]he requirement of
mean that revocation is warranted in all both state and federal authority to registration . . . any official of’’ the
instances.’’ Id. at 39330 n.6. Continuing, handle controlled substances, it would military, the Public Health Service, or
the decision explained that ‘‘[t]his have used the word ‘and.’’’ Resp. Opp. Bureau of Prisons who is authorized to
provision grants the Agency at 4. Continuing, Respondent argued prescribe, dispense, or administer, but
discretionary authority to impose an that ‘‘[w]hile it is not entirely clear why not to procure or purchase, controlled
appropriate sanction; the failure to Congress took this approach . . . the substances in the course of his/her
consider factors such as the clear statutory language’’ refutes the official duties,’’ 21 CFR 1301.23(a),
egregiousness of the misconduct and Government’s argument that ‘‘a lack of these practitioners otherwise remain
mitigating factors in imposing the state licensure [is] an automatic bar to subject to the Act. See, e.g., 21 U.S.C.
sanction would render the sanction maintaining a DEA registration.’’ Id. 829(a) (‘‘Except when dispensed
arbitrary and capricious.’’ Id. Respondent is mistaken. As for why directly by a practitioner, other than a
Respondent is not, however, a List I Congress used the disjunctive rather pharmacist, to an ultimate user, no
chemical distributor. Rather, he is a than the conjunctive in defining the controlled substance in schedule II,
practitioner, and by contrast to the term practitioner, notwithstanding the which is a prescription drug as
CSA’s provisions applicable to list I absence of any relevant discussion in determined under the [FDCA], may be
distributors, both the CSA’s definition the CSA’s legislative history, there is an dispensed without the written
of the term ‘‘practitioner’’ and the explanation. While the overwhelming prescription of a practitioner, except
registration provision applicable to majority of practitioners who practice [for] in emergency situations, as
practitioners make clear that a medicine (or dentistry and veterinary prescribed by . . . regulation . . . .’’);
practitioner must be currently medicine) are subject to regulation by 21 CFR 1306.04(a) (‘‘A prescription for
authorized to dispense controlled the State in which they practice their a controlled substance to be effective
substances by the State in which he professions, multiple federal must be issued for a legitimate medical
practices in order to obtain and Departments and Agencies (e.g., the purpose by an individual practitioner
maintain a registration. Department of Defense, Veterans acting in the usual course of his
As for the registration provision Administration, Bureau of Prisons, professional practice.’’).
applicable to practitioners, it provides, United States Public Health Service, and Respondent further asserts that ‘‘[h]ad
in relevant part, that: ‘‘[t]he Attorney Indian Health Service) employ Congress required that a practitioner
General shall register practitioners . . . practitioners. However, by virtue of the maintain both state and federal
to dispense . . . controlled substances Supremacy Clause, these health-care authority to handle controlled
. . . if the applicant is authorized to professionals are not subject to substances, it would have used the word
dispense . . . controlled substances regulation by the State in which the ‘and.’’’ Resp. Opp. at 4. Were this the
under the laws of the State in which he federal facility is located as long they case, any practitioner who is no longer
practices.’’ 21 U.S.C. 823(f). As the confine their practice to the facility. See
Supreme Court explained in United Taylor v. United States, 821 F.2d 1428, 7 As a general matter, federal entities that employ

1431 (9th Cir. 1987) (noting that under physicians require only that the physician hold a
States v. Moore, 423 U.S. 122, 140–41 medical license in one of the 50 States. See U.S.
(1975), ‘‘[r]egistration of physicians and the Supremacy Clause, a State ‘‘lacks Public Health Service, Job Requirements (available
other practitioners is mandatory if the power to require licensing of federal at www.usphs.gov/profession/physician/
applicant is authorized to dispense health care providers and physicians’’ requirements.aspx) (requiring that a physician have
and that ‘‘[t]he United States has a‘‘[c]urrent, unrestricted, and valid medical license
drugs . . . under the law of the State in to practice in one of the 50 states; Washington, DC;
which he practices. [21 U.S.C.] § 823(f). essentially deemed [an] Army [h]ospital Commonwealth of Puerto Rico; U.S. Virgin Islands;
In the case of a physician, this scheme and its staff fit to provide health care or Guam’’; Indian Health Service, Indian Health
mstockstill on DSK4VPTVN1PROD with NOTICES

services’’); United States v. Composite Manual, Part 3–1.4(C)(5) (‘‘Members of the medical
contemplates that he is authorized by staff and others who must apply for clinical
State Bd. of Med. Exmn’rs, 656 F.2d privileges must hold an active and unrestricted
5 The decision did note, however, that where a
State license, certification, or registration, as
list I distributor was required to obtain state 6 While in 1984 Congress granted the Attorney
applicable, to practice in their professional field.’’);
authority and had not done so, this could be General authority to deny a registration on public VA Careers (available at www.vacareers.va.gov/
considered under the public interest factor which interest grounds, the provision did not alter the careers/physicians/credentially.asp) (‘‘At VA, only
examines ‘‘compliance by the applicant with CSA’s requirement that a practitioner must be one active, unrestricted state license is required to
applicable Federal, State and local law.’’ 78 FR at ‘‘authorized by the State to practice medicine’’ and practice in every VA facility across all 50 States, the
39330–31 (quoting 21 U.S.C. 823(h)(2)). dispense drugs in order to be registered. District of Columbia, and U.S. Territories.’’).

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authorized to practice medicine by his obtain and maintain a DEA the DEA failed to revoke [the
State (even those who engaged in drug registration.’’ James L. Hooper, 76 FR physician’s] registration under the
dealing) would nonetheless still be 71371, 71372 (2011), pet. for rev. circumstances.’’).
allowed to dispense controlled denied, Hooper v. Holder, 481 Fed. Indeed, DEA has interpreted the CSA
substances under their federal App’x 826 (4th Cir. 2012). See also in this manner for nearly 40 years. See
registration. The argument is, however, Gozlon-Peretz v. United States, 498 U.S. Frederick Marsh Blanton, M.D., 43 FR
refuted by the CSA’s definition of the 395, 407 (1991) (‘‘A specific provision 27616 (1978). In Blanton, a physician’s
term ‘‘dispense’’ to ‘‘mean[ ] to deliver a controls over one of more general state license was suspended for a period
controlled substance to an ultimate user application.’’); Bloate v. United States, of one year. Id. at 27616. The Agency
or research subject by, or pursuant to 559 U.S. 196, 207 (2010) (‘‘language of nonetheless revoked the physician’s
the lawful order of, a practitioner, a statutory provision, although broad registration, explaining that ‘‘it is the
including the prescribing and enough to include it, will not be held to Administrator’s finding and conclusion
administering of a controlled apply to a matter specifically dealt with that there is a lawful or statutory basis
substance.’’ 21 U.S.C. 802(10) (emphasis in another part of the same for the revocation of the Respondent’s
added). Because Respondent is required enactment.’ ’’). DEA registration. State authorization to
to possess state authority to dispense Thus, in Hooper v. Holder, a dispense or otherwise handle controlled
controlled substances in Texas, and by physician whose state authority was substances is a prerequisite to the
virtue of the Board’s Order, no longer suspended for a period of one year, issuance and maintenance of a Federal
holds such authority, he cannot issue a challenged the revocation of his controlled substances registration. The
‘‘lawful order’’ to deliver a controlled registration, arguing that the Agency Respondent’s registration must,
substance. And he therefore no longer ‘‘failed to recognize the discretion under therefore, be revoked.’’ Id. at 27617
meets the requirement for being a § 824(a) to revoke or suspend a (emphasis added). See also Alfred
registered practitioner under the Act. registration and that it was Tennyson Smurthwaite, 43 FR at 11873
Respondent further argues that ‘‘had impermissible for the [Agency] to (same). Moreover, on various occasions,
Congress wanted the lack of a state conclude that the CSA requires Congress has amended the CSA,
license to be an automatic bar to revocation of a practitioner’s DEA including in 1984, when it granted the
maintaining a DEA registration, it would registration when the practitioner’s Agency the authority to revoke a
have used the word ‘shall’ ’’ rather than State license is suspended.’’ 481 Fed. practitioner’s registration on the ground
‘‘may’’ in section 824. He argues that ‘‘if App’x, at 826. The Fourth Circuit that he had committed acts inconsistent
DEA understood that to be what rejected the physician’s challenge, with the public interest. See Drug
Congress intended the agency could explaining: Enforcement Amendments to the
have added lack of state licensure to one We find Hooper’s contention Comprehensive Crime Control Act of
of the grounds for immediate unconvincing. Section 824(a) does state that 1984. See P.L. 98–473, § 512, 98 Stat.
termination of a DEA registration found the [Agency] may ‘‘suspend or revoke’’ a 1838, 2073 (1984). Yet it has left the
in 21 CFR 1301.52(a). It chose not too registration, but the statute provides for this Agency’s interpretation intact. See
[sic], presumably because DEA knew it sanction in five different circumstances, only NLRB v. Bell Aerospace Co., 416 U.S.
had no such authority.’’ Resp. Opp. at one of which is loss of a State license. 267, 275 (1974).
4–5. Because § 823(f) and § 802(21) make clear The Agency has also long held that
that a practitioner’s registration is dependent
It is not clear, however, why using the revocation is warranted even where a
upon the practitioner having state authority
word ‘‘shall’’ rather than ‘‘may’’ would to dispense controlled substances, the practitioner has lost his state authority
make any difference, as section 824(a) [Agency’s] decision to construe § 824(a)(3) as by virtue of the State’s use of summary
grants the Agency authority to either mandating revocation upon suspension of a process and the State has yet to provide
revoke or suspend. Moreover, were it state license is not an unreasonable a hearing to challenge the suspension.
the case that section 824(a) used the interpretation of the CSA. The [Agency’s] Bourne Pharmacy, 72 FR 18273, 18274
word ‘‘shall,’’ the Agency would be decision does not ‘‘read[ ] the suspension (2007); Wingfield Drugs, 52 FR 27070,
mandated to either suspend or revoke a option’’ out of the statute, because that 27071 (1987). Indeed, as this case
option may still be available for the other
registration upon making one of the demonstrates, state proceedings can go
circumstances enumerated in § 824(a).
enumerated findings, regardless of how on for an extended period, and thus, it
persuasive a registrant’s showing was on Id. 8 See also Maynard v. DEA, 117 Fed. is not DEA’s policy to hold revocation
issues of remediation where, as in a Appx. 941, 945 (5th Cir. 2004) proceedings in abeyance while
proceeding brought under the public (upholding revocation of DEA practitioners challenge Board decisions
interest authority, such a showing is registration after Texas DPS summarily which suspend or revoke their state
authorized. suspended practitioner’s controlled authority.
As this Agency has previously substance registration, noting that the Respondent argues, however, that
explained, Section 824(a)’s grant of Agency ‘‘has construed the CSA to ‘‘the agency’s decision [in Odette
authority to suspend or revoke a require revocation when a registrant no Campbell, 80 FR 41062 2015)] to
registration applies across all categories longer possesses valid state authority to remand the matter and allow
of registration, including manufacturers, handle controlled substances’’; ‘‘We administrative proceedings to be
distributors, importers, exporters, agree with [the] argument that it may conducted by the ALJ (and ultimately
narcotic treatment programs, list I have been arbitrary and capricious had hold proceedings in abeyance), pending
distributors, and practitioners. And it the outcome of state board
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8 As for Respondent’s contention that if Congress
applies to five different grounds for proceedings[,] undermines . . . the
intended that lack of a state license should be an
sanctioning a registrant. As the Agency automatic bar, the Agency could have made this a
agency’s notion that it must revoke a
has previously explained, ‘‘this general ground for immediate termination without a DEA registration in all instances where
grant of authority in imposing a hearing, the argument ignores that by requiring the a registrant lacks state authority,
sanction must be reconciled with the Agency to serve a Show Cause Order on the rendering an administrative hearing
registrant, and affording the registrant an
CSA’s specific provisions which opportunity to respond, the procedures reduce the
unnecessary.’’ Exceptions at 2.
mandate that a practitioner hold risk of an erroneous deprivation. See Mathews v. Respondent then asserts that ‘‘[w]hile
authority under state law in order to Eldridge, 424 U.S. 319 (1976). the agency conjured up a Due Process

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Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices 22127

argument to support its decision in appeared that under Texas law and Accordingly, I reject Respondent’s
[Campbell], in doing so it implicitly regulations, Respondent was not contentions.11 Because Respondent
held that lack of state authority is not an entitled to a hearing before the DPS to lacks state authority to dispense
automatic bar to holding a DEA challenge either the DPS’s suspension or controlled substances, he is not entitled
registration.’’ Id. Respondent further the denial of her application for a new to maintain his DEA registration. I will
asserts that ‘‘[w]hile declaring that Due registration.’’ Id. (citing Tex. Health & therefore order that his remaining
Process was the basis for this decision, Safety Code § 481.063(e)(3) & (h); id. registration be revoked.
the only outcome that could have been § 481.066(g); 37 Tex. Admin. Code
reached in that case, if the [A]gency § 13.272(h)). The Administrator then Order
followed its own case law, was the explained that ‘‘if this was so, revoking Pursuant to the authority vested in me
revocation of Dr. Campbell’s DEA her [DEA] registration based on her lack by 21 U.S.C. 824(a)(3) and 823(f), as
registration as the DEA proceedings of state authority would preclude her well as 28 CFR 0.100(b), I order that
would not have changed the fact that from ever being able to challenge the DEA Certificate of Registration
she did not have state authority to basis of the Immediate Suspension BS4072637 issued to Rezik A. Saqer,
handle state authority to handle Order.’’ Id. The Administrator thus M.D., be, and it hereby is, revoked. I
controlled substances.’’ Id. at 2–3. remanded the case, instructing the ALJ further order that any application by
Respondent’s reliance on Campbell is ‘‘to first determine whether the DPS Rezik A. Saqer, M.D., for registration in
unavailing because he ignores critical would provide [the respondent] with a the State of Texas, be, and it hereby is,
aspects of the case’s procedural history. hearing on the allegations.’’ Id. The denied. This Order is effective
For one, the case began when DEA Administrator further instructed that if immediately.12
issued an Order to Show Cause and the DPS had provided or would provide
Immediate Suspension of Registration respondent with a hearing, the in abeyance, pending the outcome of state board
(ISO) to the physician, which was based Government could renew its motion for proceedings, ‘‘undermines . . . the [A]gency’s
on allegations that she violated various summary disposition. Id. However, if notion that it must revoke a DEA registration in all
provisions of the Controlled Substances DPS would not provide her with a instances where a registration lacks state authority,’’
Act. 80 FR at 41063 n.3. Thereafter, the Exceptions at 2, Respondent ignores that at the time
hearing, the ALJ was to conduct a the proceeding was held in abeyance, the physician
Texas Medical Board suspended her hearing on the allegations of the Show (who had been indicted on multiple counts of
medical license and the Texas Cause Order and ISO. Id. health care fraud) had allowed her registration to
Department of Public Safety suspended In short, there was nothing ‘‘conjured expire and had only an application pending before
her state controlled substance the Agency. Moreover, the physician then held both
up’’ in the Agency’s due process a state license and state controlled substance
registration based on the Agency’s rationale, which recognized only that registration. See 80 FR at 41063. The case thus does
issuance of the ISO. Id. The Government due to the vagaries of Texas law,9 the not support Respondent’s contention.
then moved for summary disposition on Agency’s litigation strategy might well 11 Respondent also points to a provision of the

the ground that the physician lacked result in the respondent having no DEA Pharmacist’s Manual, which allows an entity
authority to dispense controlled to obtain a registration for a pharmacy it is
meaningful opportunity to challenge the acquiring prior to the State’s issuance of a
substances under Texas law and the ALJ allegations which both the Agency and pharmacy license for that location. Opp. at 5.
granted the motion. Id. the DPS had relied on in suspending Respondent asserts that ‘‘[w]hile the Agency is
While the matter was under review, their respective registrations. As for permitted to interpret its regulations, it is not free
the physician submitted a letter to the to contradict its long-standing policy that a state
Respondent’s contention that revocation license is not a prerequisite to obtaining a DEA
ALJ (which was forwarded to the was ‘‘the only outcome that could have registration when doing so is simply a convenient
Administrator), in which she asserted been reached . . . as the DEA litigation position designed to prevent a registrant
that the Medical Board had reinstated proceedings would not have changed from proving that the underlying state action was
her license. Id. After the Government the fact that she did not have state
erroneous.’’ Id. at 5–6.
responded by letter to the ALJ that the However, the Pharmacist’s Manual makes clear
authority to handle controlled that provision applies only ‘‘[i]f the registrant
physician was still without state substances,’’ Respondent ignores that acquiring the pharmacy owns at least one other
authority because her DPS registration DPS imposed its suspension based pharmacy licensed in the same state as the
had been revoked, Respondent solely on the Agency’s ISO and that if pharmacy being transferred,’’ and that while the
submitted a letter to the ALJ asserting registrant may take possession of the controlled
the physician succeeded in challenging substances, ‘‘the registrant may not dispense
that her DPS registration could not be the ISO, the basis for the DPS’ controlled substances until the pharmacy haw been
reinstated unless her DEA registration suspension would no longer exist. And issued a valid state pharmacy license.’’ DEA,
was reinstated. Id. Respondent further ignores that in her Pharmacists Manual, at 10 (2010) (emphasis added).
Noting that parties had directed their This policy exists because some States will not
remand order, the Administrator grant a pharmacy license to the acquiring pharmacy
letters to each other and the ALJ, and
provided that the Government could until DEA issues it a registration. However, the
that neither party had sought relief from period in which the registrant is without the state
move for summary disposition if it
her, the former Administrator directed license for the acquired pharmacy is typically of
could show that DPS would provide the
the Government to file a properly short duration.
physician with a hearing.10 As for Respondent’s assertion that the Agency’s
supported motion seeking a final order
position ‘‘is simply a convenient litigation position
based on the physician’s lack of state 9 See Tex. Health & Safety Code § 481.066(g) designed to prevent a registrant from proving that
authority. Id. The Government filed its (State Administrative Procedure Act ‘‘does not the underlying state action was erroneous,’’ not
request, which Respondent opposed, apply to a . . . suspension of a registration for a only is this refuted by nearly 40 years of precedent
arguing that because the DPS’s action cause described by Section 481.063 . . . (e)(3),’’ (and hundreds of cases), the Agency has also made
which includes the suspension of a registration clear in multiple cases that a challenge to a state
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was based on the unsubstantiated under the CSA); 37 Tex. Admin. Code § 13.272(h) board proceeding must be litigated in the forums
allegations of the ISO, it was (‘‘Under the Act, § 481.0639(h), the [State provided by the State. See Kamal Tiwari, 76 FR
fundamentally unfair and a denial of Administrative Procedure Act] does not apply to a 71604, 71606 (2011) (collecting cases); see also
due process to revoke her DEA denial, suspension, or revocation of an application George S. Heath, 51 FR 26610 (1986).
for registration if the denial is based on a denial or 12 For the same reasons which led the Texas
registration based on the DPS’s action. other disciplinary action taken by DEA under the Board to order the emergency suspension of
Id. Federal Controlled Substances Act.’’). Respondent’s medical license, I conclude that the
On further review, the former 10 As for Respondent’s assertion that the public interest necessitates that this Order be
Administrator observed that ‘‘it Administrator’s decision to hold the Campbell case effective immediately. 21 CFR 1316.67.

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Document Created: 2018-02-07 13:48:14
Document Modified: 2018-02-07 13:48:14
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		81 FR 22122
81 FR 22122 - Rezik A. Saqer, M.D.; Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 72 (April 14, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
