Four Seasons Distributors, Inc.; Order Accepting Settlement Agreement and Terminating Proceeding, 20042 [2011-8537]
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20042
Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices
that the prescriptions were unlawful. I
thus hold that Respondent violated its
corresponding responsibility under
Federal law and DEA’s regulation by
filling prescriptions which it had reason
to know were not legitimate. 21 CFR
1306.04(a); Bertolino, 55 FR at 4730. It
is also clear that Respondent has
breached the Settlement Agreement by
failing to comply with Federal law and
DEA regulations and by failing to
institute a policy to prevent the filling
of unlawful prescriptions.
The evidence also supports the
conclusion that Respondent violated
Federal law when it dispensed
numerous prescriptions for Lyrica to
T.M. which were purportedly
authorized by Dr. M. by telephone. The
evidence shows that the prescriptions
were fraudulent because Dr. M. had
previously discharged T.M. from his
practice and ceased writing
prescriptions for her. The evidence also
shows that Mr. Weeks falsely
represented to a State inspector that
Respondent had not dispensed Lyrica
after November 28, 2008, when, in fact,
it had dispensed the drug multiple
times to her. At a minimum, Mr. Weeks’
willingness to lie about this issue
(coupled with his failure to submit any
evidence rebutting the allegation)
supports the inference that he and
Respondent had reason to know that the
prescriptions were fraudulent and yet
dispensed them anyway. See 21 U.S.C.
841(a)(1) and 843(a)(3); 21 CFR
1306.04(a).
In addition, the evidence shows that
Respondent repeatedly dispensed
narcotic drugs such as hydromorphone
(also purportedly authorized by Dr. M)
to T.M. for more than six months after
she had been discharged by him, and
that during this time period, it also
repeatedly dispensed hydrocodone
based on prescriptions which were
issued by J.B. (a nurse practitioner). Dr.
M. and J.B. did not, however, practice
together. Yet Respondent repeatedly
dispensed both drugs to T.M. and even
dispensed both drugs to her on the same
day (May 1, 2009). Once again, it is clear
that Respondent violated its
corresponding responsibility under 21
CFR 1306.04(a) and the Settlement
Agreement on numerous occasions.
The record further establishes that
Respondent violated South Carolina law
when, on August 7, 2009, it dispensed
180 tablets of Roxicodone (oxycodone)
30 mg. and 60 tablets of MS Contin
(morphine sulfate) 100 mg. to J.W. based
on prescriptions which were dated
March 6, 2009. Both drugs are schedule
II controlled substances under South
Carolina law (as they are under the
CSA). See S.C. Code § 44–53–210(a).
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Under South Carolina law,
‘‘[p]rescriptions for Schedule II
substances must be dispensed within
ninety days of the date of issue, after
which time they are void.’’ Id. § 44–53–
360(e). However, on the date
Respondent dispensed these two
prescriptions, they were more than five
months old and were void. I thus
conclude that Respondent violated
South Carolina law by dispensing these
prescriptions.
Finally, the Settlement Agreement
clearly required that Respondent submit
‘‘quarterly reports of all schedule II
controlled substances [it] dispensed.’’ As
found above, the DI’s affidavit
establishes that Respondent has never
submitted such a report. Respondent is
therefore in violation of the Settlement
Agreement for this reason as well.
I therefore find that Respondent has
committed acts which render its
registration ‘‘inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4).
Accordingly, Respondent’s registration
will be revoked and its pending
application to renew its registration will
be denied. For the same reasons which
led me to order the immediate
suspension of Respondent’s registration,
I conclude that this Order shall be
effective immediately.
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) and 0.104, I hereby
order that DEA Certificate of
Registration, BT2981214, issued to The
Medicine Dropper, be, and it hereby is,
revoked. I further order that any
pending application of The Medicine
Dropper for renewal or modification of
its registration be, and it hereby is,
denied. This Order is effective
immediately.
Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–8542 Filed 4–8–11; 8:45 am]
BILLING CODE 4410–09–P
Distributors, Inc. (Respondent), of
Belleville, Illinois. The Show Cause
Order proposed the revocation of
Respondent’s Certificate of Registration,
which authorizes it to distribute listed
chemicals, and the denial of any
pending applications to renew or
modify the registration, on the ground
that Respondent’s registration is
‘‘inconsistent with the public interest.’’
ALJ Ex. 1 (citing 21 U.S.C. 823(h) &
824(d)).
Respondent, through its counsel,
requested a hearing on the allegations
and the matter was assigned to an
agency Administrative Law Judge (ALJ),
who conducted a hearing on April 21,
2008. Thereafter, on October 30, 2009,
the ALJ issued her recommended
decision. Therein, the ALJ found that
the Government ‘‘ha[d] not met its
burden of proof in showing that the
Respondent’s continued registration
would be against the public interest’’
and recommended that its registration
be continued. ALJ at 37. The
Government apparently agreed as it did
not file exceptions to the ALJ’s decision.
The ALJ then forwarded the record to
me for final agency action.
Thereafter, the parties ‘‘reached a
settlement of all administrative matters
pending before’’ me and filed a joint
motion which requests that I terminate
the proceedings. Motion to Terminate
Administrative Proceedings. The parties
also included a copy of the
Memorandum of Agreement, setting
forth the terms of their settlement.
Having reviewed the ALJ’s decision
and the terms of the settlement
agreement, I find that the settlement is
appropriate and consistent with the
public interest. Accordingly, the parties’
motion to terminate the proceeding is
hereby granted and the Order to Show
Cause is dismissed.
It is so ordered.
Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–8537 Filed 4–8–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Federal Bureau of Investigation
[Docket No. 08–16]
[OMB Number 1110–0002]
Four Seasons Distributors, Inc.; Order
Accepting Settlement Agreement and
Terminating Proceeding
Agency Information Collection
Activities: Proposed Collection,
Comments Requested
On October 31, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Four Seasons
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
30-day Notice of Information
Collection Under Review: Revision of a
currently approved collection;
Supplementary Homicide Report.
ACTION:
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Agencies
[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Page 20042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8537]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-16]
Four Seasons Distributors, Inc.; Order Accepting Settlement
Agreement and Terminating Proceeding
On October 31, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Four Seasons Distributors, Inc. (Respondent), of
Belleville, Illinois. The Show Cause Order proposed the revocation of
Respondent's Certificate of Registration, which authorizes it to
distribute listed chemicals, and the denial of any pending applications
to renew or modify the registration, on the ground that Respondent's
registration is ``inconsistent with the public interest.'' ALJ Ex. 1
(citing 21 U.S.C. 823(h) & 824(d)).
Respondent, through its counsel, requested a hearing on the
allegations and the matter was assigned to an agency Administrative Law
Judge (ALJ), who conducted a hearing on April 21, 2008. Thereafter, on
October 30, 2009, the ALJ issued her recommended decision. Therein, the
ALJ found that the Government ``ha[d] not met its burden of proof in
showing that the Respondent's continued registration would be against
the public interest'' and recommended that its registration be
continued. ALJ at 37. The Government apparently agreed as it did not
file exceptions to the ALJ's decision. The ALJ then forwarded the
record to me for final agency action.
Thereafter, the parties ``reached a settlement of all
administrative matters pending before'' me and filed a joint motion
which requests that I terminate the proceedings. Motion to Terminate
Administrative Proceedings. The parties also included a copy of the
Memorandum of Agreement, setting forth the terms of their settlement.
Having reviewed the ALJ's decision and the terms of the settlement
agreement, I find that the settlement is appropriate and consistent
with the public interest. Accordingly, the parties' motion to terminate
the proceeding is hereby granted and the Order to Show Cause is
dismissed.
It is so ordered.
Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-8537 Filed 4-8-11; 8:45 am]
BILLING CODE 4410-09-P