[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Page 51430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21063]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Roots Pharmaceuticals, Inc.; Revocation of Registration

    On September 9, 2010, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Roots Pharmaceuticals, Inc. (Registrant), of American 
Fork, Utah. The Show Cause Order proposed the revocation of 
Registrant's DEA Certificate of Registration BR9610571, which 
authorizes it to dispense controlled substances as a retail pharmacy, 
on the ground that Registrant's state pharmacy and controlled substance 
licenses had expired on September 30, 2009, and that it therefore lacks 
authority under the laws of the State in which it is registered with 
DEA to dispense controlled substances. Show Cause Order at 1 (citing 21 
U.S.C. 823(f) and 824(a)(3)). The Show Cause Order also notified 
Registrant of its right to request a hearing on the allegations or to 
submit a written statement in lieu of a hearing, the procedures for 
doing either, and the consequence for failing to do either. Id. at 2.
    The Government's initial attempt to serve Registrant by certified 
mail was unsuccessful. Thereafter, as evidenced by the signed return 
receipt card, on January 14, 2011, the Government accomplished service 
by mailing the Show Cause Order to Registrant's Registered Agent. On 
January 11, 2011, the Government also sent an electronic version of the 
Show Cause Order to Registrant's Registered Agent at the e-mail address 
he had previously provided to the Agency. However, since the date of 
service of the Show Cause Order, no person has requested a hearing, or 
submitted a written statement in lieu of a hearing, on behalf of 
Registrant. Because thirty days have now passed since service of the 
Show Cause Order, I find that Registrant has waived its right to 
request a hearing or to submit a written statement in lieu of a 
hearing. See 21 CFR 1301.43(a), (c), and (d). I therefore issue this 
Decision and Final Order without a hearing based on relevant evidence 
contained in the record submitted by the Government. Id. Sec.  
1301.43(e).

Findings

    Registrant is the holder of DEA Certificate of Registration 
BR9610571, which authorizes it to dispense controlled substances in 
schedules II through V as a retail pharmacy, at the registered location 
of 12 W 100N, Suite 201B, American Fork, Utah. GX A. Registrant's 
registration does not expire until April 30, 2012. Id.
    According to a Pharmacy Licensing Specialist with the State of 
Utah, Department of Commerce, Division of Occupational and Professional 
Licensing, Registrant's Utah Pharmacy License and Utah Controlled 
Substance Dispensing License expired on September 30, 2009. GX B. 
Registrant did not renew either license. Id.

Discussion

    Under the Controlled Substances Act (CSA), a practitioner must be 
currently authorized to handle controlled substances in the 
``jurisdiction in which [it] practices'' in order to maintain a DEA 
registration. See 21 U.S.C. 802(21) (``[t]he term `practitioner' means 
a * * * pharmacy * * * licensed, registered, or otherwise permitted, by 
* * * the jurisdiction in which [it] practices * * * to * * * dispense 
* * * a controlled substance in the course of professional practice''). 
See also id. Sec.  823(f) (The 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 [it] practices.''). As these 
provisions make plain, possessing authority under state law to handle 
controlled substances is an essential condition for obtaining and 
maintaining a DEA registration.
    The CSA further authorizes the Agency to revoke a registration 
``upon a finding that the registrant * * * has had [its] State license 
or registration suspended [or] revoked * * * and is no longer 
authorized by State law to engage in the * * * distribution [or] 
dispensing of controlled substances.'' 21 U.S.C. 824(a)(3). Moreover, 
because holding state authority is a statutory requirement for 
registration as a practitioner, see 21 U.S.C. 802(21) and 823(f), DEA 
has held that revocation is warranted even when a registrant has merely 
allowed his state licenses to expire. James Stephen Ferguson, 75 FR 
49994, 49995 (2010); Mark L. Beck, 64 FR 40899, 40900 (1999). See also 
Anne Lazar Thorn, 62 FR 12847, 12848 (1997) (``the controlling question 
is not whether a practitioner's license to practice medicine in the 
state is suspended or revoked; rather, it is whether the Respondent is 
currently authorized to handle controlled substances'').
    As found above, Registrant allowed its state pharmacy and 
controlled substance licenses to expire, and thus, it no longer holds 
authority under Utah law to dispense controlled substances. See Utah 
Code Ann. Sec. Sec.  58-17b-302(1); 58-37-6(2)(a)(i). Accordingly, 
Registrant no longer satisfies the CSA's requirement that it be 
currently ``authorized to dispense controlled substances'' under Utah 
law. 21 U.S.C. 823(f). Accordingly, its DEA registration will be 
revoked. Id. Sec.  824(a)(3).

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a)(3), as 
well as 28 CFR 0.100(b), I order that DEA Certificate of Registration 
BR9610571, issued to Roots Pharmaceuticals, Inc., be, and it hereby is, 
revoked. I further order that any pending application of Roots 
Pharmaceuticals, Inc., to renew or modify its registration, be, and it 
hereby is, denied. This Order is effective September 19, 2011.

    Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-21063 Filed 8-17-11; 8:45 am]
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