[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
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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
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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]
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