Registrant Actions - 2012
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 35027-35028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14291]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Serenity Café; Decision and Order
On December 2, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Serenity Café (Applicant), of Chicago, Illinois.
The Show Cause Order proposed the denial of Serenity Café's
application for a DEA Certificate of Registration as a Maintenance
Narcotic Treatment Program, on the grounds that the Applicant does
"not have authority to handle controlled substances in the state of
Illinois," and because its registration would be inconsistent with the
public interest. Show Cause Order, at 1 (citing 21 U.S.C. 824(a)(3) and
21 U.S.C. 823(f)).
Specifically, the Show Cause Order alleged that on January 26,
2011, Applicant, while doing business as Recovery Café, had
voluntarily surrendered its DEA Certificate of Registration for cause.
Id. at 1. The Order alleged that an investigation of Recovery
Café found that it "failed to maintain the mandatory records
required to be kept for controlled substances, had an unexplained
shortage of approximately 199,476 mg of methadone, and left controlled
substances in an open safe unattended." Id.
The Show Cause Order further alleged that Applicant had failed to
disclose on its application that Recovery Café had voluntarily
surrendered for cause its DEA registration. Id. at 2 (citing 21 U.S.C.
824(a)(1)). Next, the Order alleged that Applicant does not have a
valid Illinois Department of Human Services Alcoholism and Substance
Abuse Treatment and Intervention License as required by state law. Id.
(citing 20 Ill. Comp. Stat. 301/15-5; Ill. Admin. Code tit. 77,
2060.201). Finally, the Order also notified Applicant of its right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing, the procedure for doing either, and the
consequence for failing to do either. Id. (citing 21 CFR 1301.43).
On December 8, 2011, Diversion Investigators (DIs) personally
served the Show Cause Order on Mr. Derrick Arna, who, according to the
affidavit of a DI, is the Chief Executive Officer and owner of Serenity
Café. GX 1, at 3; GX 6. Since the date of service of the Order,
thirty days have now passed and neither Applicant, nor anyone
purporting to represent it, has requested a hearing or submitted a
written statement in lieu of a hearing. I therefore find that Applicant
has waived its right to a hearing or to submit a written statement in
lieu of a hearing, and issue this Decision and Final Order based on
relevant evidence contained in the record submitted by the Government.
21 CFR 1301.43(d) & (e). I make the following findings of fact.
Findings
Serenity Café is owned by Mr. Derrick Arna. GX 1, at 3. Mr.
Arna is also the authorized agent of Recovery Café, a former
Opioid Treatment Program in Chicago, Illinois, which, on January 26,
2011, voluntarily surrendered its DEA Registration for cause following
a January 6, 2001 on-site inspection which found numerous violations.
Id. at 1; GX 3. More specifically, during the on-site inspection, DEA
DIs found that Recovery Café had multiple record-keeping
violations. Id. at 2. These included, inter alia, that it: (1) Failed
to record on DEA Form 222s, the date of receipt and quantity of
schedule II controlled substances it received; (2) failed to maintain
accurate and complete controlled substance records; and (3) failed to
maintain dispensing records for the methadone it dispensed, including
the date of the dispensing and the name of the patient receiving the
drug. Id.
In addition, the DIs performed an audit of its handling of
methadone hcl (5mg & 40mg) for the period from October 19, 2009 to
January 6, 2011. Id. The audit found that the clinic was short
approximately 199,476 mg of methadone. Id. Finally, on January 25,
2011, the DIs found that controlled substances were left unattended in
an open safe. Id. The next day, Mr. Arna executed a voluntary surrender
of Recovery Café's DEA registration.
On February 14, 2011, Mr. Arna filed an application under the name
of Serenity Café for registration as a Narcotic Treatment
Program--Maintenance, at the proposed address of 110 E. 78th Street,
Chicago, Illinois. GX 2, at 1. Mr. Arna sought authorization to handle
methadone, a schedule II narcotic controlled substance, and
buprenorphine, a schedule III narcotic controlled substance. Id.
In Section 4 of the application, Mr. Arna was required to list
Applicant's state of licensure, license number and its expiration date.
GX 2, at 2. Mr. Arna completed only the state of licensure block,
writing "Illinois" and the word "pending." Id. at 2.
In Section 5 of the application, Mr. Arna was required to answer
four liability questions. Among them was question 2, which asked: "Has
the
[[Page 35028]]
applicant ever surrendered (for cause) or had a federal controlled
substance registration revoked, suspended, restricted, or denied, or is
any such action pending?" Mr. Arna marked "NO," and in the area
provided for explaining any "YES" answer, wrote "None." Id.
On February 17, 2012, following a hearing before a state
Administrative Law Judge (ALJ), the Secretary of the Illinois
Department of Human Services issued a Final Order on Applicant's
application for state licensure. See In the Matter of Serenity
Café at 1, 11 DASA 001 (Ill. Dep't Hum. Servs., Feb. 17, 2012).
Adopting the ALJ's findings and report, the Final Order denied
Applicant's application for a state license to provide both Level I
Adult and Adolescent Outpatient Treatment and Level II Adult and
Adolescent Intensive Outpatient Treatment, DUI Evaluation, DUI Risk
Education, and Methadone as Adjunct Services. Id.
Accordingly, because Applicant does not possess a valid Illinois
license to provide substance abuse treatment, I find that Applicant is
not currently authorized to dispense controlled substances in the State
of Illinois, the State in which it seeks registration. See 20 Ill.
Comp. Stat. 301/15-5 (it is "unlawful for any person to provide
treatment for alcoholism and other drug abuse or dependency . . .
unless the person is licensed to do so by the Department"); Ill.
Admin. Code tit. 77, 2060.201 ("Substance abuse treatment and
intervention services * * * shall be licensed by the Department.").
Discussion
Under section 303(g) of the Controlled Substances Act (CSA),
"practitioners who dispense narcotic drugs [in schedule II] to
individuals for maintenance treatment * * * shall obtain annually a
separate registration for that purpose." 21 U.S.C. 823(g)(1) (emphasis
added). Moreover, this provision imposes as a requirement of
registration, that the applicant meet three conditions, including that
"the applicant is a practitioner who is determined by the Secretary to
be qualified * * * to engage in the treatment with respect to which
registration is sought." Id. 823(g)(1)(A) (emphasis added). Thus, it
is clear that in order to obtain a registration authorizing the
dispensing of schedule II narcotics such as methadone for maintenance
treatment, the applicant must be (among other things), a practitioner
within the meaning of the CSA.\1\
---------------------------------------------------------------------------
\1\ Likewise, the requirements of section 303(g)(1) "are waived
in the case of the dispensing (including the prescribing), by a
practitioner, of narcotic drugs in schedule III, IV, or V or
combinations of such drugs if the practitioner meets the conditions
specified in subparagraph (B). 21 U.S.C. 823(g)(2)(A) (emphasis
added). This provision requires that the "the practitioner submit
to the Secretary [of HHS] a notification of the intent of the
practitioner to begin dispensing the drugs or combinations for"
maintenance or detoxification treatment, "as well as to certify
that "[t]he practitioner is a qualifying physician," that "the
practitioner has the capacity to refer the patients for appropriate
counseling and other appropriate ancillary services," and that
"[t]he total number of such patients of the practitioner at any one
time will not exceed the applicable number." Id. 823(g)(2)(B)
(emphasis added). Moreover, a practitioner's notification to the
Secretary must "identif[y] the registration issued for the
practitioner pursuant to subsection (f) of this section." Id.
823(g)(2)(D)(i)(II). See also 21 CFR 1301.28.
---------------------------------------------------------------------------
The CSA defines the term "practitioner' to mean "a physician * *
* pharmacy, hospital 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). Likewise, in
the case of practitioners, the CSA imposes, as a condition of
registration, that it be currently authorized to dispense controlled
substances under the laws of the State in which it engages in
professional practice. See id. 823(f) ("The Attorney General shall
register practitioners * * * if the applicant is authorized to dispense
* * * controlled substances under the laws of the State in which he
practices."). Thus, DEA has long held that the possession of authority
under state law to dispense controlled substances is an essential
condition for obtaining and maintaining a DEA registration. See David
W. Wang, 72 FR 54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988).
As found above, the Illinois Department of Human Services has
issued a final order denying Applicant's application for the state
licenses required to dispense controlled substances for the purpose of
providing maintenance treatment. Therefore, Applicant is not a
"practitioner" within the meaning of the CSA, and thus, it is not
entitled to be registered. See 21 U.S.C. 802(21); 823(f); 823(g).
Accordingly, its application will be denied.\2\
---------------------------------------------------------------------------
\2\ Because it is clear that Applicant is not entitled to be
registered, it is not necessary to decide whether denial of its
application is warranted under the public interest standard of 21
U.S.C. 823(f).
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
823(g)(1) & (2), as well as 28 CFR 0.100(b), I order that the
application of Serenity Café for a DEA Certificate of
Registration as a Narcotic Treatment Program, be, and it hereby is,
denied. This Order is effective July 12, 2012.
Dated: June 4, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14291 Filed 6-11-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
|
