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The Medicine Shoppe; Revocation of
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FR Doc E6-12100 [Federal Register: July 28, 2006 (Volume 71, Number
145)] [Notices] [Page 42878-42879] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr28jy06-104]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
The Medicine Shoppe; Revocation of Registration
On April 8, 2005, I, the Deputy Administrator of the Drug Enforcement
Administration, issued an Order to Show Cause and further ordered the
immediate suspension of DEA Certificate of Registration, BT5626885,
issued to The Medicine Shoppe (Respondent) of Slidell, Louisiana. The
Show Cause Order proposed to revoke Respondent's pharmacy registration
and to deny any pending applications for renewal or modification of its
registration on the ground that Respondent's continued registration
would be inconsistent with the public interest. See 21
U.S.C. 823(f) & 824(a).
The Show Cause Order also immediately suspended Respondent's
registration based on my preliminary finding that Respondent's continued
registration constitutes "an imminent danger to public health and safety
because of the substantial likelihood that [Respondent would] continue
to divert controlled substances to drug abusers.'' Show Cause Order at
11; see also 21 U.S.C. 824(d). The Order further notified Respondent of
its right to a hearing. See Show Cause Order at 12.
The Show Cause Order specifically alleged that Respondent was
purchasing enormous amounts of hydrocodone products, a Schedule III
controlled substance, and that its purchases greatly exceeded the
quantities of the same drug that were bought by other retail pharmacies
in the same area. For example, the Show Cause Order alleged that from
December 31, 2003, through February 2, 2005, Respondent purchased
1,624,000 dosage units of Hydrocodone 10/650. Id. at 8. The Order
alleged that the next largest pharmacy purchaser bought 79,100 units in
the same time period. Id. The Order also alleged that during the year
2004, Respondent was the fifth largest purchaser of hydrocodone products
in the State of Louisiana. Id. at 3.
The Show Cause Order named a number of local pain management
physicians and alleged that they routinely prescribed a three drug
[[Page 42879]]
combination of hydrocodone, either alprazolam or diazepam (both
Schedule IV controlled substances), and carisoprodol, a non-controlled
substance which metabolizes into meprobamate (a Schedule IV controlled
substance), which is often used by drug abusers in conjunction with
narcotics. Id. at 7. The Order alleged that these physicians were "routinely
prescrib[ing] 90 dosage units of hydrocodone, 90 dosage units of
carisoprodol and 30 dosage unites of alprazolam at each patient visit,''
and that "[t]hese prescriptions are generally not valid'' because the
physicians wrote them without regard to the patient's medical history
and diagnosis, and without conducting an adequate physical exam. Id. The
Order further alleged that many of these prescriptions were filled by
Respondent and that these prescriptions were renewed at regular
intervals. Id.
The Show Cause Order alleged that Dr. Suzette Cullins was routinely
writing large numbers of combination prescriptions for 90 hydrocodone,
30 alprazolam, and 90 carisoprodol. See id. at 9. The Show Cause Order
further alleged that on various dates chosen at random, Respondent had
filled large amounts of new combination prescriptions that had been
written by this physician. See id. at 10. The lowest number of new
combination prescriptions written by this physician and filled by
Respondent in a day was sixty-five; Respondent frequently filled more
than 100 new combination prescriptions written by this physician in a
day. See id.
The Show Cause Order thus alleged that "[t]he sheer volume of
combination prescriptions issued by Dr. Cullins should have caused
[Respondent's] pharmacists to realize that the prescriptions were not
written in the course of professional practice and were therefore not
valid.'' Id. at 11. The Order further alleged that "[t]he majority of
the prescriptions filled by'' Respondent were combination prescriptions,
that "[p]atients receive[d] the same prescriptions regardless of their
sex, age, weight, height, or health,'' and that "[b]ased upon the sheer
volume of duplicate prescriptions from the large volume of customers
written by the same group of doctors,'' Respondent either knew or had
reason to know that these prescriptions were not valid. Id. The Order
thus alleged that Respondent and its pharmacists were "diverting massive
amounts of controlled substances'' in violation of 21
U.S.C. 841(a)(1) and 21
C.F.R. 1306.04. Id.
On May 5, 2005, Respondent requested a hearing; the case was assigned
to Administrative Law Judge (ALJ) Mary Ellen Bittner. On May 25, 2005,
the Government sought to stay the proceeding and moved for summary
disposition. The basis for the motion was that on April 28, 2005,
Respondent had entered into a consent agreement with the Louisiana Board
of Pharmacy. Pursuant to the agreement, Respondent surrendered its
Louisiana Controlled Dangerous Substances License. The Government thus
contended that because Respondent no longer had authority under state
law to engage in the distribution of controlled substances, see 21
U.S.C. 824(a)(3), it was no longer entitled to hold a federal
registration. The Government further contended that Respondent's request
for a hearing should be dismissed.
On June 9, 2005, Respondent filed a response. Respondent advised that
it did not oppose the Government's motion. Respondent further
acknowledged that it had voluntarily surrendered its state license and
was thus not eligible to hold a DEA registration.
On June 29, 2005, the ALJ granted the Government's motion for summary
disposition. The ALJ observed that, under longstanding agency precedent,
"a registrant may not hold a DEA registration if it is without
appropriate authority under the laws of the state in which it does
business.'' ALJ Dec. at 2 (citing, inter alia, Rx Network of South
Florida, LLC, 69 FR 62093-01 (2004); Wingfield Drugs, Inc., 52 FR 27070
(1987)). The ALJ further noted that Respondent had admitted that it was
no longer licensed in Louisiana and thus was not entitled to hold a DEA
registration. Id. Because there were no material facts in dispute, the
ALJ granted the Government's motion and recommended that I revoke
Respondent's registration and deny any pending applications for renewal
or modification of its registration. See id. at 2-3.
Having considered the record as a whole, I hereby issue this decision
and final order. I adopt in its entirety the ALJ's opinion and
recommended decision. Because the facts are straightforward and not in
dispute, I conclude that there is no need to elaborate on them. As the
ALJ found, Respondent is no longer authorized to distribute controlled
substances under State law. Therefore, under our precedents, Respondent
is not entitled to maintain its DEA registration. See, e.g., Rx Network
of South Florida, 69 FR at 62095.
Order
Accordingly, pursuant to the authority vested in me by 21
U.S.C. 823(f) & 824(a),
as well as 28 CFR 0.100(b) and 0.104, I hereby order that DEA
Certificate of Registration, No. BT5626885, issued to The Medicine
Shoppe, be, and it hereby is, revoked. I further order that any pending
applications for renewal or modification of such registration be, and
they hereby are, denied. This order is effective August 28, 2006.
Dated: July 20, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-12100 Filed 7-27-06; 8:45 am]
BILLING CODE 4410-09-P
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