E6-12100. 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 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.