[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50099-50100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14049]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 05-27]


Michael's Discount Pharmacy; 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 Certification of Registration, 
BM8291572, issued to Michael's Discount Pharmacy (Respondent) of 
Kenner, Louisiana. The Show Cause Order proposed to revoke Respondent's 
registration and to deny any pending applications for renewal or 
modification of its registration on the ground that Respondent's 
continued registration as a retail pharmacy would be inconsistent with 
the public interest. See 21 U.S.C. 823(f) and 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.'' See Show Cause Order at 17; 
see also 21 U.S.C. 824(d). The Order further notified Respondent of its 
right to a hearing. See Show Cause Order at 17-18.
    The Show Cause Order specifically alleged that Respondent was 
purchasing enormous amounts of hydrocodone products, a Schedule III 
controlled substance, and that its purchases dwarfed the quantities of 
the same drugs that were bought by other retail pharmacies in the same 
area. For example, the Show Cause Order alleged that from January 2, 
2004, through February 3, 2005, Respondent purchased 2,486,600 dosage 
units of Hydrocodone 10/650. Id. at 3. The Order further alleged that 
the next largest pharmacy purchaser had bought only 13,500 dosage units 
in the same time period. Id. The Order also alleged that during the 
year 2004, Respondent was the second largest purchaser of hydrocodone 
products in the State of Louisiana. Id.
    The Show Cause Order alleged that Respondent was filling large 
amounts of combination prescriptions consisting of hydrocodone, either 
alprazolam or diazepam (both Schedule IV depressants), and 
carisoprodol, a non-controlled analgesic that metabolizes into 
meprobamate, a Schedule IV depressant, and which is often used by drug 
abusers in conjunction with narcotics. See id. at 4. The Show Cause 
Order alleged that these ``combination prescriptions are issued to 
persons of all types, regardless of their age, weight, height, gender 
and complaint.'' Id. The Order also alleged that an accountability 
audit had found multiple discrepancies which included large underages 
of hydrocodone, diazepam, and alprazolam products. See id. at 5.
    Most significantly, the Show Cause Order alleged that the Kenner 
Police Department (KPD) had received numerous complaints of persons 
illegally selling prescription drugs in Respondent's parking lot. Id. 
at 8. The Show Cause Order described the arrests of more than twenty 
individuals (who were first observed either leaving Respondent's store 
or in its parking lot) for either the illegal possession of controlled 
substances or the illegal distribution of controlled substances which 
had been obtained from Respondent. See id. at 9-17. The Show Cause 
Order further alleged that many of the arrestees had continued to 
obtain large quantities of combination prescriptions from Respondent 
even after their arrests. See id. The Order also alleged that a number 
of the arrestees possessed other controlled substances such as 
marijuana and

[[Page 50100]]

methamphetamine. See id. at 9, 11-13. The Order also alleged that 
Respondent's employees knew that the KPD was arresting Respondent's 
customers, that customers would often complain about the police, and 
that the police would sometimes enter the pharmacy to look for a 
suspect. See id. at 16. In addition, many of Respondent's customers 
were from out of town. See id.
    The Show Cause Order also recounted the facts surrounding a 
complaint that had been filed with the Louisiana Board of Pharmacy 
against Respondent. The complainant alleged that on both January 17 and 
February 3, 2004, her 19 year old son had obtained from Respondent a 
combination prescription of 90 hydrocodone 10 mg., 90 carisoprodol 350 
mg., and 30 alprazolam 2mg. See id. at 16. On February 5, 2004, the 
complainant's son died of respiratory failure due to acute and chronic 
drug use. Id. The autopsy's toxicology tests found elevated levels of 
hydrocodone and alprazolam. See id.
    Finally, the Show Cause Order alleged that the majority of 
prescriptions filled by Respondent were for the aforementioned drug 
combination and were issued by a small group of doctors. See id. at 17. 
The Order alleged that ``[b]ased upon the sheer volume of duplicate 
prescriptions from the large volume of customers written by the same 
group of doctors, and the knowledge that [Respondent's] customers were 
routinely being arrested * * * after leaving'' the pharmacy, Respondent 
``knows or should know that the combination prescriptions it fills are 
not valid prescriptions.'' 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 CFR 1306.04. 
Id. at 17.
    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 July 1, 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 62,093-01 (2004); Wingfield Drugs, Inc., 52 FR 
27,070 (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) and 824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order 
that DEA Certificate of Registration, No. BM8291572, issued to 
Michael's Discount Pharmacy, 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 
September 25, 2006.

    Dated: August 15, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-14049 Filed 8-23-06; 8:45 am]
BILLING CODE 4410-09-P