The Medicine Shoppe; Revocation of Registration, 42878-42879 [E6-12100]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 71, Number 145 (Friday, July 28, 2006)]
[Notices]
[Pages 42878-42879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12100]


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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