[Federal Register: August 24, 2006 (Volume 71, Number 164)]
[Notices]
[Page 50099-50100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au06-78]
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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