84 FR 18320 - Palafox Pharmacy; Decision and Order

[Federal Register Volume 84, Number 83 (Tuesday, April 30, 2019)]
[Notices]
[Pages 18320-18321]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-08703]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Palafox Pharmacy; Decision and Order

    On August 14, 2018, the Assistant Administrator, Diversion Control 
Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Palafox Pharmacy 
(hereinafter, Registrant), of Anthony, Texas. Order to Show Cause 
(hereinafter, OSC), at 1. The Show Cause Order proposes the revocation 
of Registrant's Certificate of Registration on the ground that it has 
``no state authority to handle controlled substances.'' Id. (citing 21 
U.S.C. 824(a)(3)).
    Regarding jurisdiction, the Show Cause Order alleges that 
Registrant holds DEA Certificate of Registration No. FP1305564 at the 
registered address of 929 S Main St., Anthony, Texas 79821. OSC, at 1. 
The Show Cause Order alleges that this registration expires on March 
31, 2021. Id.
    The substantive ground for the proceeding, as alleged in the Show 
Cause Order, is that Registrant is ``currently without authority to 
handle controlled substances in the State of Texas, the state in which 
. . . [it] is registered with the DEA.'' Id. at 1-2. Specifically, the 
Show Cause Order alleges that the Texas State Board of Pharmacy 
suspended Registrant's pharmacy license on June 18, 2018. Id. at 1.
    The Show Cause Order notifies Registrant of its right to request a 
hearing on the allegation or to submit a written statement while 
waiving its right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. Id. at 
2 (citing 21 CFR 1301.43). The Show Cause Order also notifies 
Registrant of the opportunity to submit a corrective action plan. OSC, 
at 2-3 (citing 21 U.S.C. 824(c)(2)(C)).

Adequacy of Service

    In a Declaration dated November 2, 2018, a Diversion Investigator 
(hereinafter, DI), who describes herself as being assigned to the El 
Paso Field Division, states that she had the OSC delivered to the 
residential address of Registrant's owner. Government Exhibit 
(hereinafter, GX) 6 (DI Declaration), at 1-2.\1\ See also GX 6, at 8-10 
(proof of delivery).
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    \1\ According to the DI, delivery attempts to Registrant's 
registered address were not successful. GX 6, at 1.
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    In its Request for Final Agency Action dated November 7, 2018, the 
Government represents that ``[a]t least 30 days have passed since the 
time the . . . [OSC] was served on Registrant . . . [and] Registrant 
has not requested a hearing.'' Request for Final Agency Action 
(hereinafter, RFAA), at 1.\2\ The Government seeks the issuance of ``a 
Final Order revoking Registrant's DEA registration.'' RFAA, at 4.
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    \2\ In its Supplement to Request for Final Agency Action dated 
March 19, 2019, the Government represents that ``Registrant has not 
otherwise corresponded or communicated with DEA regarding the Order 
to Show Cause served on it, including the filing of any written 
statement in lieu of a hearing.'' Supplement, at 1.
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    Based on the DI's Declaration, the Government's written 
representations, and my review of the record, I find that the 
Government accomplished service on August 30, 2018.\3\ GX 6, at 1-2, 8-
10. I also find that more than 30 days have passed since the date the 
Government served the OSC. Further, based on the Government's written 
representations, I find that neither Registrant, nor anyone purporting 
to represent him, requested a hearing, submitted a written statement 
while waiving Registrant's right to a hearing, or submitted a 
corrective action plan. Accordingly, I find that Registrant has waived 
his right to a hearing and his right to submit a written statement and 
corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). 
I, therefore, issue this Decision and Order based on the record 
submitted by the Government, which constitutes the entire record before 
me. 21 CFR 1301.43(e).
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    \3\ Nasim F. Khan, M.D., 73 FR 4630, 4630 (2008); Patrick K. 
Riggs, M.D., 72 FR 71,959, 71,959 (2007).
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Findings of Fact

Registrant's DEA Registration

    Registrant is the holder of DEA Certificate of Registration No. 
FP1305564 at the registered address of 929 S Main St., Anthony, Texas 
79821 under the electronic signature of Samuel Ambrosio Gurrola. GX 1 
(Certification of Registration History), at 1. Pursuant to this 
registration, Registrant is authorized to dispense controlled 
substances in schedules IV and V as a retail pharmacy. Id. Registrant's 
registration expires on March 31, 2021 and is in an active pending 
status. Id.

The Status of Registrant's State License

    Registrant's Texas pharmacy license (number 26185) was revoked by 
Order of the Texas State Board of Pharmacy. GX 5 (Texas State Board of 
Pharmacy certified ``Agreed Board Order #J-18-022-B'' dated August 7, 
2018), at 3. The revocation was effective on the date of entry of the 
Order. Id. The record evidence shows that Registrant's Texas pharmacy 
license number 26185 is revoked. GX 7 (Texas State Board of Pharmacy 
website screen print showing Registrant's pharmacy license status as 
``Revocation''), at 1. Further, according to the online records of the 
Texas State Board of Pharmacy, of which I take official notice, 
Registrant's pharmacy license is still revoked.\4\ Texas State Board of 
Pharmacy website, https://

[[Page 18321]]

www.pharmacy.texas.gov/ (last visited April 5, 2019).
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    \4\ Under the Administrative Procedure Act, an agency ``may take 
official notice of facts at any stage in a proceeding--even in the 
final decision.'' United States Department of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), 
``[w]hen an agency decision rests on official notice of a material 
fact not appearing in the evidence in the record, a party is 
entitled, on timely request, to an opportunity to show the 
contrary.'' Accordingly, Registrant may dispute my finding by filing 
a properly supported motion for reconsideration within 15 calendar 
days of the date of this Order. Any such motion shall be filed with 
the Office of the Administrator and a copy shall be served on the 
Government. In the event Registrant files a motion, the Government 
shall have 15 calendar days to file a response.
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    Accordingly, I find that Registrant currently does not have a 
license to operate a pharmacy in Texas, the State in which he is 
registered with the DEA.

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 (hereinafter, CSA), ``upon a finding that the 
registrant . . . has had his State license or registration suspended . 
. . [or] revoked . . . by competent State authority and is no longer 
authorized by State law to engage in the . . . dispensing of controlled 
substances.'' A pharmacy is a ``practitioner'' under the CSA. 21 U.S.C. 
802(21). With respect to a practitioner, the DEA has also 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, 
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 
(4th Cir. 2012); Roots Pharmaceuticals, Inc., 76 FR 51,430 (2011); 
Ideal Pharmacy Care, Inc., d/b/a Esplanade Pharmacy, 76 FR 51,415 
(2011); Bourne Pharmacy, Inc., 72 FR 18,273 (2007); Frederick Marsh 
Blanton, M.D., 43 FR 27,616 (1978).
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined the term ``practitioner'' to mean ``a 
physician, . . . pharmacy, . . . 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). Because Congress 
has clearly mandated that a practitioner possess State authority in 
order to be deemed a practitioner under the CSA, the DEA has held 
repeatedly that revocation of a practitioner's registration is the 
appropriate sanction whenever he is no longer authorized to dispense 
controlled substances under the laws of the State in which he 
practices. See, e.g., James L. Hooper, supra, 76 FR at 71,371-72; Roots 
Pharmaceuticals, Inc., supra, 76 FR at 51,430; Ideal Pharmacy Care, 
Inc., d/b/a Esplanade Pharmacy, supra, 76 FR at 51,416 n.1; Bourne 
Pharmacy, Inc., supra, 72 FR at 18,274; Sheran Arden Yeates, M.D., 71 
FR 39,130, 39,131 (2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 
(1993); Bobby Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh 
Blanton, supra, 43 FR at 27,617.
    According to Texas statute, ``A person may not operate a pharmacy 
in this state unless the pharmacy is licensed by the board.'' Tex. 
Occupations Code Ann. Sec.  560.001(a) (West, Westlaw current through 
the end of the 2017 Regular and First Called Sessions of the 85th 
Legislature). Further, ``a person who is not registered with or exempt 
from registration with the Federal Drug Enforcement Administration may 
not manufacture, distribute, prescribe, possess, analyze, or dispense a 
controlled substance in this state.'' \5\ Tex. Health and Safety Code 
Ann. Sec.  481.061(a) (West, Westlaw current through the end of the 
2017 Regular and First Called Sessions of the 85th Legislature).
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    \5\ A ``dispenser'' includes a pharmacy that dispenses a 
controlled substance. Tex. Health and Safety Code Ann. Sec.  
481.002(13) (West, Westlaw current through the end of the 2017 
Regular and First Called Sessions of the 85th Legislature).
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    The undisputed evidence in the record before me is that Registrant 
currently lacks authority to operate a pharmacy in Texas. As such, 
Registrant is not qualified to dispense controlled substances as a 
``practitioner.'' I will, therefore, order that Registrant's DEA 
registration be revoked.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 824(a), I order that DEA Certificate of Registration No. 
FP1305564 issued to Palafox Pharmacy be, and it hereby is, revoked. 
This Order is effective May 30, 2019.

    Dated: April 5, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-08703 Filed 4-29-19; 8:45 am]
 BILLING CODE 4410-09-P