[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]
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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