[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24348-24350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11268]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 18-11]


Health Fit Pharmacy; Decision and Order

    On November 15, 2017, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Health Fit Pharmacy (Respondent), of Houston, 
Texas. The Show Cause Order proposed the revocation of Respondent's DEA 
Certificate of Registration No. FH1729942 on the ground that he has 
``no state authority to handle controlled substances.'' Order to Show 
Cause, at 1 (citing 21 U.S.C. 824(a)(3)). For the same reason, the 
Order also proposed the denial of any of Respondent's ``applications 
for renewal or modification of such registration and any applications 
for any other DEA registrations.'' Id.
    With respect to the Agency's jurisdiction, the Show Cause Order 
alleged that Respondent is the holder of Certificate of Registration 
No. FH1729942, pursuant to which it is authorized to dispense 
controlled substances as a retail pharmacy in schedules II through V, 
at the registered address of 1307 Yale Street, Suite H, Houston, Texas. 
Id. The Order also alleged that this registration does not expire until 
October 31, 2018. Id.
    Regarding the substantive grounds for the proceeding, the Show 
Cause Order alleged that on September 15, 2017, the Texas State Board 
of Pharmacy (TSBP) ``suspended'' Respondent's Texas pharmacy license, 
and Respondent is therefore ``without authority to practice pharmacy or 
handle controlled substances in the State of Texas, the [S]tate in 
which [it is] registered with the DEA.'' Id. at 2. Based on its ``lack 
of authority to [dispense] controlled substances in . . . Texas,'' the 
Order asserted that ``DEA must revoke'' Respondent's registration. Id. 
(citing 21 U.S.C. 824(a)(3); 21 CFR 1301.37(b)).
    The Show Cause Order notified Respondent of (1) its right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, (2) the procedure for electing either option, and 
(3) the consequence for failing to elect either option. Id. (citing 21 
CFR 1301.43). The Order also notified Respondent of its right to submit 
a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 824(c)(2)(C)).
    On December 4, 2017, Respondent, through counsel, filed a letter 
requesting a hearing on the allegations. Letter from Respondent's 
Counsel to Hearing Clerk (dated Nov. 30, 2017) (hereinafter, Hearing 
Request). In this letter, Respondent ``objects to the cancellation of 
Health Fit Pharmacy['s DEA] controlled substance registration'' for two 
reasons. First, Respondent states that, ``although temporar[il]y 
suspended,'' it ``maintains an active license.'' Id. at 1. Second, 
Respondent ``expects to prevail'' in a ``final contested hearing 
regarding the temporary suspension of this license on the merits . . . 
scheduled for February, 2018.'' Id.
    The matter was placed on the docket of the Office of Administrative 
Law Judges and assigned to Chief Administrative Law Judge John J. 
Mulrooney, II (hereinafter, CALJ). On December 4, 2017, the CALJ 
ordered the Government to file ``evidence to support the allegation 
that the Respondent lacks state authority to handle controlled 
substances'' and file ``any Government motion for summary disposition'' 
no later than December 15, 2017. Order Directing the Filing of 
Government Evidence of Lack of State Authority Allegation and Briefing 
Schedule, at 1-2. The CALJ also directed Respondent to file its 
response to any summary disposition motion no later than December 29, 
2017. Id. at 2.
    On December 15, 2017, the Government filed its Motion for Summary 
Disposition. In its Motion, the Government argued that it is undisputed 
that Respondent lacks authority to handle controlled substances in 
Texas because the TSBP suspended Respondent's Texas medical license on 
September 15, 2017. Government's Motion for Summary Disposition 
(hereinafter Government's Motion or Govt. Mot.) at 2-3; TSBP Temporary 
Suspension Order #A-16-008-BS1 (Government Exhibit (GX) 2 to Govt. Mot. 
or ``Sept. 15, 2017 TSBP Order''). The Government also noted that, in 
its Hearing Request, Respondent did not dispute that the TSBP had 
suspended Respondent's pharmacy license. Govt. Mot. at 3 n.1. The 
Government further argued that, ``[a]bsent authority by the State of 
Texas to dispense controlled substances, Respondent is not authorized 
to possess a DEA registration in that state.'' Id. at 3. Lastly, the 
Government argued that under Agency precedent, revocation is warranted 
even where a State has temporarily suspended a practitioner's state 
authority with the possibility of future reinstatement. Id. at 3-4 
(citations omitted). As support for its summary disposition request, 
the Government attached, inter alia, a copy of the TSBP's September 15, 
2017 Order directing that Respondent's license ``is hereby temporarily 
suspended . . . effective immediately and shall continue in effect, 
pending a contested hearing on disciplinary action against the 
suspended license.'' GX 2 to Govt. Mot., at 14.
    In its responsive pleading, Respondent did not dispute that it 
``maintains a[n] active suspended license'' in the State of Texas. 
Respondent's Dec. 29, 2017 Response to Government's Motion for Summary 
Disposition (hereinafter, Resp. Br.), at 2. Instead, Respondent argued 
that ``the

[[Page 24349]]

merits of the temporary suspension is being disputed by'' Respondent 
and that the Government filed its Motion ``prematurely in li[ght] of 
the fact that a final order . . . has not been entered.'' Id. at 2-3. 
Finally, Respondent argued that ``[t]he effect of'' the Government's 
motion for summary disposition ``is to circumvent contested litigation 
procedure.'' Id. at 3.
    After considering these pleadings, the CALJ issued an order 
recommending that I find that there was no dispute over the fact that 
``Respondent lacks state authority to handle controlled substances in 
Texas.'' Order Granting the Government's Motion for Summary 
Disposition, and Recommended Rulings, Findings of Fact, Conclusions of 
Law, and Decision of the Administrative Law Judge (R.D.), at 6. As a 
result, the CALJ granted the Government's motion for summary 
disposition and recommended that I revoke Respondent's DEA registration 
and deny any pending renewal applications. Id.
    Neither party filed exceptions to the CALJ's Recommended Decision. 
Thereafter, the record was forwarded to my Office for Final Agency 
Action. Having reviewed the record, I find that Respondent is currently 
without authority to handle controlled substances in Texas, the State 
in which it holds its registration with the Agency, and is thus not 
entitled to maintain its DEA registration. I adopt the CALJ's 
recommendation that I revoke Respondent's registration and deny any 
pending renewal application. I make the following factual findings.

Findings of Fact

    Respondent is the holder of DEA Certificate of Registration No. 
FH1729942, pursuant to which it is authorized to dispense controlled 
substances in schedules II through V as a retail pharmacy. GX 1 to 
Govt. Mot. On September 15, 2017, the TSBP issued an Order temporarily 
suspending Respondent's Texas Pharmacy License #26701 ``pending a 
contested case hearing on disciplinary action against the suspended 
license to be held . . . not later than . . . [90] days after the date 
of this Order.'' GX 2 to Govt. Mot., at 4-5.\1\ In its Order, the TSBP 
specifically directed that Respondent ``not operate as a pharmacy in 
this state in any manner that would allow receipt, distribution, or 
dispensing prescription drugs during the period said license is 
suspended.'' Id. at 5. The TSBP also ordered Respondent to 
``immediately transfer all prescription drugs to a secured licensed 
pharmacy or other entity with the authority to legally possess 
prescription drugs, not later than September 22, 2017.'' Id. There is 
no evidence in the record establishing that the TSBP ever lifted this 
suspension.
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    \1\ The principal basis for the TSBP's Order was the TSBP's 
finding that Respondent's pharmacist-in-charge filled prescriptions 
for controlled substances such as alprazolam 2mg and carisoprodol 
350mg when he ``should have known the prescriptions . . . were 
invalid, i.e., not issued for a legitimate therapeutic purpose or 
valid medical need and/or prescription forgeries, due to 
prescription red flags factors indicating recurrent and readily-
identifiable nontherapeutic prescribing and dispensing activity to a 
reasonable pharmacist.'' Id. at 2-3.
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    In its Order, the TSBP also stated that Respondent's pharmacy 
license was ``current through November 30, 2017.'' Id. at 2. Neither 
the CALJ nor the parties addressed the fact that the Order stated that 
Respondent's Texas pharmacy license would expire on November 30, 2017. 
As a result, I have reviewed the TSBP's official website, and it 
confirms that Respondent's current ``License status'' is ``Expired.'' 
\2\ Accordingly, I find that Respondent currently does not possess a 
pharmacy license in the State of Texas, and thus does not possess 
authority to dispense controlled substances in the State in which it is 
registered with the DEA. See id. at 5.
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    \2\ See www.pharmacy.texas.gov/dbsearch/phy_zoom.asp?id=26701&type=1. On November 9, 2017, the TSBP issued 
another suspension order stating that Respondent ``agreed to the 
entry of this Order continuing the suspension of pharmacy number 
26701 held by Respondent for an additional period of . . . [120] 
days from the date of entry of this Order pending a contested case 
hearing . . . against the suspended license'' before ``the State 
Office of Administrative Hearings.'' TSBP Temporary Suspension Order 
#A-16-008-BS2 (see www.pharmacy.texas.gov/abo/detail/282232%20%20P26701%20%20Health%20Fit%20Pharmacy%20%20EDTSO%20%20A160008BS2%20%202017-11.pdf), at 1. The TSBP also repeated its directive 
that ``Respondent shall not operate as a pharmacy in this state in 
any manner that would allow receipt, distribution, or dispensing 
prescription drugs during the period said license is suspended.'' 
Id. The TSBP website does not show that the TSBP ever held a 
subsequent hearing regarding Respondent's suspended pharmacy license 
or took any other action to lift the suspension.
    I take official notice of the TSBP's November 2017 enforcement 
action and the fact that the TSBP website currently shows that 
Respondent's Texas pharmacy license is expired. 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 15 calendar days of service of this order which shall 
commence on the date this order is mailed.
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Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
Controlled Substances Act (CSA), ``upon a finding that the registrant . 
. . has had his State license . . . suspended [or] revoked . . . by 
competent State authority and is no longer authorized by State law to 
engage in the . . . dispensing of controlled substances.'' Also, DEA 
has long held that the possession of authority to dispense controlled 
substances under the laws of the State in which a practitioner engages 
in professional practice is a fundamental condition for obtaining and 
maintaining a practitioner's registration. See, e.g., James L. Hooper, 
76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 
2012); see also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State 
authorization to dispense or otherwise handle controlled substances is 
a prerequisite to the issuance and maintenance of a Federal controlled 
substances registration.'').
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean[] a . . . 
physician . . . or other person licensed, registered or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to 
distribute, dispense, [or] administer . . . a controlled substance in 
the course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f).
    Moreover, because ``the controlling question'' in a proceeding 
brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA 
registration ``is currently authorized to handle controlled substances 
in the [S]tate,'' Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 
FR 12847, 12848 (1997)), 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). Thus, 
even assuming that Respondent's pharmacy license is not expired but is 
still active and suspended, it is of no consequence that the TSBP has 
suspended Respondent's

[[Page 24350]]

pharmacy license and that Respondent may prevail in a future state 
hearing. What is consequential is the fact that Respondent is not 
currently authorized to dispense controlled substances in Texas, the 
State in which it is registered.\3\ See GX2 to Govt. Mot. (Sept. 15, 
2017 TSBP Order), at 4-5. Accordingly, Respondent is not entitled to 
maintain its DEA registration.
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    \3\ In its brief opposing summary disposition, Respondent argued 
that the TSBP ``abused it's [sic] discretion in granting the 
temporary suspension . . . because the evidence shows that an agent 
of the DEA entrapped the Pharmacy in[to] committing a violation of 
the Controlled Substance[s] Act by intentionally failing to inform 
the Registrant that'' it was filling prescriptions for a 
practitioner who ``was not authorized to issue these 
prescriptions.'' Resp. Br. at 2. Respondent's claim relates to its 
challenge to the merits of the TSBP's decision to suspend 
Respondent's Texas pharmacy license, and I agree with the CALJ that 
Respondent has failed to show why or how this claim relates to 
whether Respondent is currently authorized to dispense controlled 
substances in the State of Texas. See R.D. at 3 n.1.
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    I will therefore adopt the CALJ's recommendation that I revoke 
Respondent's registration and deny any pending applications to renew 
its registration. R.D. at 6. I will also deny any pending application 
to modify its registration, or any pending application for any other 
DEA registration in Texas, as requested in the Show Cause Order. Order 
to Show Cause, at 1.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration No. FH1729942, issued to Health Fit Pharmacy, be, and it 
hereby is, revoked. I further order that any pending application of 
Health Fit Pharmacy to renew or modify the above registration, or any 
pending application of Health Fit Pharmacy for any other DEA 
registration in the State of Texas, be, and it hereby is, denied. This 
Order is effective immediately.\4\
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    \4\ For the same reasons which led the TSBP to suspend 
Respondent's Texas pharmacy license, I conclude that the public 
interest necessitates that this Order be effective immediately. 21 
CFR 1316.67.

    Dated: May 17, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-11268 Filed 5-24-18; 8:45 am]
 BILLING CODE 4410-09-P