83_FR_24450 83 FR 24348 - Health Fit Pharmacy; Decision and Order

83 FR 24348 - Health Fit Pharmacy; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 102 (May 25, 2018)

Page Range24348-24350
FR Document2018-11268

Federal Register, Volume 83 Issue 102 (Friday, May 25, 2018) 
[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24348-24350]
From the Federal Register Online  [www.thefederalregister.org]
[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

24348 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices DEPARTMENT OF JUSTICE revocation of Respondent’s DEA The matter was placed on the docket Certificate of Registration No. of the Office of Administrative Law Antitrust Division FH1729942 on the ground that he has Judges and assigned to Chief ‘‘no state authority to handle controlled Administrative Law Judge John J. Notice Pursuant to the National substances.’’ Order to Show Cause, at 1 Mulrooney, II (hereinafter, CALJ). On Cooperative Research and Production (citing 21 U.S.C. 824(a)(3)). For the same December 4, 2017, the CALJ ordered the Act of 1993—National Fire Protection reason, the Order also proposed the Government to file ‘‘evidence to support Association denial of any of Respondent’s the allegation that the Respondent lacks Notice is hereby given that, on May 8, ‘‘applications for renewal or state authority to handle controlled 2018, pursuant to Section 6(a) of the modification of such registration and substances’’ and file ‘‘any Government National Cooperative Research and any applications for any other DEA motion for summary disposition’’ no Production Act of 1993, 15 U.S.C. 4301 registrations.’’ Id. later than December 15, 2017. Order et seq. (‘‘the Act’’), National Fire With respect to the Agency’s Directing the Filing of Government Protection Association (‘‘NFPA’’) has jurisdiction, the Show Cause Order Evidence of Lack of State Authority filed written notifications alleged that Respondent is the holder of Allegation and Briefing Schedule, at 1– simultaneously with the Attorney Certificate of Registration No. 2. The CALJ also directed Respondent to FH1729942, pursuant to which it is file its response to any summary General and the Federal Trade authorized to dispense controlled disposition motion no later than Commission disclosing additions or substances as a retail pharmacy in December 29, 2017. Id. at 2. changes to its standards development schedules II through V, at the registered On December 15, 2017, the activities. The notifications were filed address of 1307 Yale Street, Suite H, Government filed its Motion for for the purpose of extending the Act’s Houston, Texas. Id. The Order also Summary Disposition. In its Motion, the provisions limiting the recovery of alleged that this registration does not Government argued that it is undisputed antitrust plaintiffs to actual damages expire until October 31, 2018. Id. that Respondent lacks authority to under specified circumstances. Regarding the substantive grounds for handle controlled substances in Texas Specifically, NFPA has provided an the proceeding, the Show Cause Order because the TSBP suspended updated and current list of its standards alleged that on September 15, 2017, the Respondent’s Texas medical license on development activities, related technical Texas State Board of Pharmacy (TSBP) September 15, 2017. Government’s committee and conformity assessment ‘‘suspended’’ Respondent’s Texas Motion for Summary Disposition activities. Information concerning NFPA pharmacy license, and Respondent is (hereinafter Government’s Motion or regulations, technical committees, therefore ‘‘without authority to practice Govt. Mot.) at 2–3; TSBP Temporary current standards, standards pharmacy or handle controlled Suspension Order #A–16–008–BS1 development and conformity substances in the State of Texas, the (Government Exhibit (GX) 2 to Govt. assessment activities are publically [S]tate in which [it is] registered with Mot. or ‘‘Sept. 15, 2017 TSBP Order’’). available at nfpa.org. the DEA.’’ Id. at 2. Based on its ‘‘lack of The Government also noted that, in its On September 20, 2004, NFPA filed authority to [dispense] controlled Hearing Request, Respondent did not its original notification pursuant to substances in . . . Texas,’’ the Order dispute that the TSBP had suspended Section 6(a) of the Act. The Department asserted that ‘‘DEA must revoke’’ Respondent’s pharmacy license. Govt. of Justice published a notice in the Respondent’s registration. Id. (citing 21 Mot. at 3 n.1. The Government further Federal Register pursuant to Section U.S.C. 824(a)(3); 21 CFR 1301.37(b)). argued that, ‘‘[a]bsent authority by the 6(b) of the Act on October 21, 2004 (69 The Show Cause Order notified State of Texas to dispense controlled FR 61869). Respondent of (1) its right to request a substances, Respondent is not The last notification was filed with hearing on the allegations or to submit authorized to possess a DEA registration the Department on March 6, 2018. A a written statement in lieu of a hearing, in that state.’’ Id. at 3. Lastly, the notice was published in the Federal (2) the procedure for electing either Government argued that under Agency Register pursuant to Section 6(b) of the option, and (3) the consequence for precedent, revocation is warranted even Act on April 24, 2018 (83 FR 17852). failing to elect either option. Id. (citing where a State has temporarily Patricia A. Brink, 21 CFR 1301.43). The Order also suspended a practitioner’s state Director of Civil Enforcement, Antitrust notified Respondent of its right to authority with the possibility of future Division. submit a corrective action plan. Id. at 2– reinstatement. Id. at 3–4 (citations [FR Doc. 2018–11242 Filed 5–24–18; 8:45 am] 3 (citing 21 U.S.C. 824(c)(2)(C)). omitted). As support for its summary On December 4, 2017, Respondent, disposition request, the Government BILLING CODE 4410–11–P through counsel, filed a letter requesting attached, inter alia, a copy of the TSBP’s a hearing on the allegations. Letter from September 15, 2017 Order directing that DEPARTMENT OF JUSTICE Respondent’s Counsel to Hearing Clerk Respondent’s license ‘‘is hereby (dated Nov. 30, 2017) (hereinafter, temporarily suspended . . . effective Drug Enforcement Administration Hearing Request). In this letter, immediately and shall continue in Respondent ‘‘objects to the cancellation effect, pending a contested hearing on [Docket No. 18–11] of Health Fit Pharmacy[’s DEA] disciplinary action against the controlled substance registration’’ for suspended license.’’ GX 2 to Govt. Mot., Health Fit Pharmacy; Decision and two reasons. First, Respondent states at 14. Order that, ‘‘although temporar[il]y In its responsive pleading, amozie on DSK3GDR082PROD with NOTICES1 On November 15, 2017, the Acting suspended,’’ it ‘‘maintains an active Respondent did not dispute that it Assistant Administrator, Diversion license.’’ Id. at 1. Second, Respondent ‘‘maintains a[n] active suspended Control Division, Drug Enforcement ‘‘expects to prevail’’ in a ‘‘final license’’ in the State of Texas. Administration (DEA), issued an Order contested hearing regarding the Respondent’s Dec. 29, 2017 Response to to Show Cause to Health Fit Pharmacy temporary suspension of this license on Government’s Motion for Summary (Respondent), of Houston, Texas. The the merits . . . scheduled for February, Disposition (hereinafter, Resp. Br.), at 2. Show Cause Order proposed the 2018.’’ Id. Instead, Respondent argued that ‘‘the VerDate Sep<11>2014 18:28 May 24, 2018 Jkt 241001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1

Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24349 merits of the temporary suspension is specifically directed that Respondent Discussion being disputed by’’ Respondent and that ‘‘not operate as a pharmacy in this state Pursuant to 21 U.S.C. 824(a)(3), the the Government filed its Motion in any manner that would allow receipt, Attorney General is authorized to ‘‘prematurely in li[ght] of the fact that a distribution, or dispensing prescription suspend or revoke a registration issued final order . . . has not been entered.’’ drugs during the period said license is under section 823 of the Controlled Id. at 2–3. Finally, Respondent argued suspended.’’ Id. at 5. The TSBP also Substances Act (CSA), ‘‘upon a finding that ‘‘[t]he effect of’’ the Government’s ordered Respondent to ‘‘immediately that the registrant . . . has had his State motion for summary disposition ‘‘is to transfer all prescription drugs to a license . . . suspended [or] revoked circumvent contested litigation secured licensed pharmacy or other . . . by competent State authority and is procedure.’’ Id. at 3. entity with the authority to legally no longer authorized by State law to After considering these pleadings, the possess prescription drugs, not later engage in the . . . dispensing of CALJ issued an order recommending than September 22, 2017.’’ Id. There is controlled substances.’’ Also, DEA has that I find that there was no dispute no evidence in the record establishing long held that the possession of over the fact that ‘‘Respondent lacks that the TSBP ever lifted this authority to dispense controlled state authority to handle controlled suspension. substances under the laws of the State substances in Texas.’’ Order Granting the Government’s Motion for Summary In its Order, the TSBP also stated that in which a practitioner engages in Disposition, and Recommended Respondent’s pharmacy license was professional practice is a fundamental Rulings, Findings of Fact, Conclusions ‘‘current through November 30, 2017.’’ condition for obtaining and maintaining of Law, and Decision of the Id. at 2. Neither the CALJ nor the parties a practitioner’s registration. See, e.g., Administrative Law Judge (R.D.), at 6. addressed the fact that the Order stated James L. Hooper, 76 FR 71371 (2011), As a result, the CALJ granted the that Respondent’s Texas pharmacy pet. for rev. denied, 481 Fed. Appx. 826 Government’s motion for summary license would expire on November 30, (4th Cir. 2012); see also Frederick Marsh disposition and recommended that I 2017. As a result, I have reviewed the Blanton, 43 FR 27616 (1978) (‘‘State revoke Respondent’s DEA registration TSBP’s official website, and it confirms authorization to dispense or otherwise and deny any pending renewal that Respondent’s current ‘‘License handle controlled substances is a applications. Id. status’’ is ‘‘Expired.’’ 2 Accordingly, I prerequisite to the issuance and Neither party filed exceptions to the find that Respondent currently does not maintenance of a Federal controlled CALJ’s Recommended Decision. possess a pharmacy license in the State substances registration.’’). Thereafter, the record was forwarded to of Texas, and thus does not possess This rule derives from the text of two my Office for Final Agency Action. authority to dispense controlled provisions of the CSA. First, Congress Having reviewed the record, I find that substances in the State in which it is defined ‘‘the term ‘practitioner’ [to] Respondent is currently without registered with the DEA. See id. at 5. mean[] a . . . physician . . . or other authority to handle controlled person licensed, registered or otherwise substances in Texas, the State in which 2 See www.pharmacy.texas.gov/dbsearch/phy_ permitted, by . . . the jurisdiction in it holds its registration with the Agency, zoom.asp?id=26701&type=1. On November 9, 2017, which he practices . . . to distribute, the TSBP issued another suspension order stating dispense, [or] administer . . . a and is thus not entitled to maintain its that Respondent ‘‘agreed to the entry of this Order DEA registration. I adopt the CALJ’s continuing the suspension of pharmacy number controlled substance in the course of recommendation that I revoke 26701 held by Respondent for an additional period professional practice.’’ 21 U.S.C. Respondent’s registration and deny any of . . . [120] days from the date of entry of this 802(21). Second, in setting the Order pending a contested case hearing . . . against requirements for obtaining a pending renewal application. I make the the suspended license’’ before ‘‘the State Office of following factual findings. Administrative Hearings.’’ TSBP Temporary practitioner’s registration, Congress Suspension Order #A–16–008–BS2 (see directed that ‘‘[t]he Attorney General Findings of Fact www.pharmacy.texas.gov/abo/detail/282232%20% shall register practitioners . . . if the Respondent is the holder of DEA 20P26701%20%20Health%20Fit%20 applicant is authorized to dispense . . . Pharmacy%20%20EDTSO%20%20A160008BS2% Certificate of Registration No. 20%202017-11.pdf), at 1. The TSBP also repeated controlled substances under the laws of FH1729942, pursuant to which it is its directive that ‘‘Respondent shall not operate as the State in which he practices.’’ 21 authorized to dispense controlled a pharmacy in this state in any manner that would U.S.C. 823(f). substances in schedules II through V as allow receipt, distribution, or dispensing Moreover, because ‘‘the controlling prescription drugs during the period said license is question’’ in a proceeding brought a retail pharmacy. GX 1 to Govt. Mot. suspended.’’ Id. The TSBP website does not show On September 15, 2017, the TSBP that the TSBP ever held a subsequent hearing under 21 U.S.C. 824(a)(3) is whether the issued an Order temporarily suspending regarding Respondent’s suspended pharmacy holder of a DEA registration ‘‘is Respondent’s Texas Pharmacy License license or took any other action to lift the currently authorized to handle suspension. controlled substances in the [S]tate,’’ #26701 ‘‘pending a contested case I take official notice of the TSBP’s November hearing on disciplinary action against 2017 enforcement action and the fact that the TSBP Hooper, 76 FR at 71371 (quoting Anne the suspended license to be held . . . website currently shows that Respondent’s Texas Lazar Thorn, 62 FR 12847, 12848 not later than . . . [90] days after the pharmacy license is expired. Under the (1997)), the Agency has also long held date of this Order.’’ GX 2 to Govt. Mot., Administrative Procedure Act (APA), an agency that revocation is warranted even where ‘‘may take official notice of facts at any stage in a at 4–5.1 In its Order, the TSBP proceeding—even in the final decision.’’ U.S. Dept. a practitioner has lost his state authority of Justice, Attorney General’s Manual on the by virtue of the State’s use of summary 1 The principal basis for the TSBP’s Order was the Administrative Procedure Act 80 (1947) (Wm. W. process and the State has yet to provide TSBP’s finding that Respondent’s pharmacist-in- Gaunt & Sons, Inc., Reprint 1979). In accordance a hearing to challenge the suspension. amozie on DSK3GDR082PROD with NOTICES1 charge filled prescriptions for controlled substances with the APA and DEA’s regulations, Respondent such as alprazolam 2mg and carisoprodol 350mg is ‘‘entitled on timely request to an opportunity to Bourne Pharmacy, 72 FR 18273, 18274 when he ‘‘should have known the prescriptions show to the contrary.’’ 5 U.S.C. 556(e); see also 21 (2007); Wingfield Drugs, 52 FR 27070, . . . were invalid, i.e., not issued for a legitimate CFR 1316.59(e). To allow Respondent the 27071 (1987). Thus, even assuming that therapeutic purpose or valid medical need and/or opportunity to refute the facts of which I take Respondent’s pharmacy license is not prescription forgeries, due to prescription red flags official notice, Respondent may file a motion for factors indicating recurrent and readily-identifiable reconsideration within 15 calendar days of service expired but is still active and nontherapeutic prescribing and dispensing activity of this order which shall commence on the date this suspended, it is of no consequence that to a reasonable pharmacist.’’ Id. at 2–3. order is mailed. the TSBP has suspended Respondent’s VerDate Sep<11>2014 18:28 May 24, 2018 Jkt 241001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1

24350 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices pharmacy license and that Respondent DEPARTMENT OF LABOR ADDRESSES: Submit written comments may prevail in a future state hearing. to the Employment and Training What is consequential is the fact that Employment and Training Administration (ETA), Office of Respondent is not currently authorized Administration Financial Administration, 200 to dispense controlled substances in Constitution Avenue NW, Room Program Year (PY) 2018 Workforce N–4702, Washington, DC 20210, Texas, the State in which it is Innovation and Opportunity Act (WIOA) Attention: Ms. Anita Harvey, email: registered.3 See GX2 to Govt. Mot. (Sept. Allotments; PY 2018 Wagner-Peyser harvey.anita@dol.gov. 15, 2017 TSBP Order), at 4–5. Act Final Allotments and PY 2018 Accordingly, Respondent is not entitled Commenters are advised that mail Workforce Information Grants delivery in the Washington area may be to maintain its DEA registration. AGENCY: Employment and Training delayed due to security concerns. The I will therefore adopt the CALJ’s Department will receive hand-delivered Administration, Labor. recommendation that I revoke comments at the above address. All Respondent’s registration and deny any ACTION: Notice. overnight mail will be considered hand- pending applications to renew its SUMMARY: This notice announces delivered and must be received at the registration. R.D. at 6. I will also deny allotments for PY 2018 for WIOA Title designated place by the date specified any pending application to modify its I Youth, Adult and Dislocated Worker above. registration, or any pending application Activities programs; final allotments for Please submit your comments by only for any other DEA registration in Texas, Employment Service (ES) activities one method. The Department will not as requested in the Show Cause Order. under the Wagner-Peyser Act for PY review comments received by means Order to Show Cause, at 1. 2018 and the allotments of Workforce other than those listed above or that it Information Grants to States for PY receives after the comment period has Order closed. 2018. Pursuant to the authority vested in me WIOA allotments for states and the Comments: The Department will by 21 U.S.C. 823(f) and 824(a), as well state final allotments for the Wagner- retain all comments on this notice and as 28 CFR 0.100(b), I order that DEA Peyser Act are based on formulas will release them upon request via email defined in their respective statutes. to any member of the public. The Certificate of Registration No. WIOA requires allotments for the Department also will make all the FH1729942, issued to Health Fit Outlying Areas to be competitively comments it receives available for Pharmacy, be, and it hereby is, revoked. awarded rather than based on a formula public inspection by appointment I further order that any pending during normal business hours at the determined by the Secretary of Labor application of Health Fit Pharmacy to (Secretary) as occurred under the above address. If you need assistance to renew or modify the above registration, Workforce Investment Act (WIA). review the comments, the Department or any pending application of Health Fit However, for PY 2018, the Consolidated will provide you with appropriate aids Pharmacy for any other DEA registration Appropriations Act, 2018 waives the such as readers or print magnifiers. The in the State of Texas, be, and it hereby competition requirement, and the Department will make copies of this is, denied. This Order is effective Secretary is using the discretionary notice available, upon request, in large immediately.4 formula rationale and methodology for print, Braille, and electronic file. The Dated: May 17, 2018. allocating PY 2018 funds for the Department also will consider providing Robert W. Patterson, Outlying Areas (American Samoa, the notice in other formats upon Guam, the Commonwealth of the request. To schedule an appointment to Acting Administrator. review the comments and/or obtain the Northern Mariana Islands, the Republic [FR Doc. 2018–11268 Filed 5–24–18; 8:45 am] of Palau, and the United States Virgin notice in an alternative format, contact BILLING CODE 4410–09–P Islands) that was published in the Ms. Harvey using the information Federal Register at 65 FR 8236 (Feb. 17, provided above. The Department will 2000). WIOA specifically included the retain all comments received without Republic of Palau as an Outlying Area, making any changes to the comments, except during any period for which the including any personal information 3 In its brief opposing summary disposition, Secretary of Labor and the Secretary of provided. The Department therefore Education determine that a Compact of cautions commenters not to include Respondent argued that the TSBP ‘‘abused it’s [sic] discretion in granting the temporary suspension Free Association is in effect and their personal information such as . . . because the evidence shows that an agent of contains provisions for training and Social Security Numbers, personal the DEA entrapped the Pharmacy in[to] committing education assistance prohibiting the addresses, telephone numbers, and a violation of the Controlled Substance[s] Act by assistance provided under WIOA; no email addresses in their comments; this intentionally failing to inform the Registrant that’’ such determinations prohibiting information would be released with the it was filling prescriptions for a practitioner who assistance have been made. The formula comment if the comments are requested. ‘‘was not authorized to issue these prescriptions.’’ It is the commenter’s responsibility to that the Department of Labor Resp. Br. at 2. Respondent’s claim relates to its challenge to the merits of the TSBP’s decision to (Department) used for PY 2018 is the safeguard his or her information. suspend Respondent’s Texas pharmacy license, and same formula used in PY 2017 and is FOR FURTHER INFORMATION CONTACT: I agree with the CALJ that Respondent has failed to described in the section on Youth WIOA Youth Activities allotments— show why or how this claim relates to whether Activities program allotments. The Evan Rosenberg at (202) 693–3593 or amozie on DSK3GDR082PROD with NOTICES1 Respondent is currently authorized to dispense Department invites comments only on LaSharn Youngblood at (202) 693–3606; controlled substances in the State of Texas. See R.D. the formula used to allot funds to the WIOA Adult and Dislocated Worker at 3 n.1. 4 For the same reasons which led the TSBP to Outlying Areas. Activities and ES final allotments— suspend Respondent’s Texas pharmacy license, I DATES: The Department must receive Robert Kight at (202) 693–3937; conclude that the public interest necessitates that comments on the formula used to allot Workforce Information Grant this Order be effective immediately. 21 CFR funds to the Outlying Areas by June 25, allotments—Donald Haughton at (202) 1316.67. 2018. 693–2784. Individuals with hearing or VerDate Sep<11>2014 18:28 May 24, 2018 Jkt 241001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\25MYN1.SGM 25MYN1


Document Created: 2018-05-25 02:13:06
Document Modified: 2018-05-25 02:13:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation83 FR 24348 
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