On February 21, 2007, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Newcare Home Health Services (Respondent), of Baltimore, Maryland. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration, BN3795892, as a retail pharmacy, on the ground that the Maryland State Board of Pharmacy had suspended Respondent's state pharmacy license. See id.
The Show Cause Order also alleged that Respondent had committed acts which rendered its registration “inconsistent with the public interest.” Show Cause Order at 1 (citing 21 U.S.C. 823(f) & 824(a)(4)). More specifically, the Show Cause Order alleged that Respondent “illegally distributed vast quantities of hydrocodone and other controlled substances” by filling prescriptions that were issued over the internet and which were issued by physicians who did not establish “a doctor-patient relationship with the customers.” Id. In light of the disposition of this case, a more detailed recitation of the allegations of the Show Cause Order is not necessary.
On or about February 23, 2007, the Show Cause Order was served on Respondent. On March 9, 2007, Respondent, through its counsel, requested a hearing. The matter was assigned to Administrative Law Judge (ALJ) Gail Randall, who, on March 15, 2007, ordered the parties to file pre-hearing statements.
On March 19, 2007, the Government moved for summary disposition and to stay the filing of pre-hearing statements. The basis for the Government's motion was that on January 5, 2007, the Maryland Board of Pharmacy had summarily suspended Respondent's state pharmacy and distributor permits. Mot. for Summ. Disp. at 2. In support of its motion, the Government attached a copy of the Maryland Board's Order for Summary Suspension. Upon receipt of the motion, the ALJ granted the Government's motion to stay the proceeding and ordered Respondent to reply to the motion for summary disposition. See Order Staying Proceedings at 1-2.
On March 29, 2007, Respondent submitted its reply. Respondent acknowledged that summary disposition would be appropriate but asked the ALJ “to stay all proceedings * * * while the criminal prosecution of [its] owners proceeds through the U.S. District Court.” Resp.'s Reply at 1. Respondent further argued that “[i]f the outcome of the criminal case is favorable to [its] owners, then the posture and merits of this matter * * * will be substantially different than if one or more convictions are obtained.” Id. at 2. Respondent further stated that it had appealed the State Board's suspension of its pharmacy license and had “asked the Board to defer any hearing on the appeal until the criminal case concludes.” Id. Respondent further stated that it would agree to the suspension of its registration in the interim. Id.
On April 3, 2007, the ALJ issued her recommended decision. Noting that state authority is “a prerequisite to DEA registration,” the ALJ held that Respondent was not entitled to maintain its registration because there was no dispute that Respondent currently lacks “authority to handle controlled substances in the jurisdiction where it seeks to maintain its DEA registration.” ALJ at 4. The ALJ also denied Respondent's request for a stay. The ALJ thus granted the Government's motion for summary disposition, lifted her stay order, and denied Respondent's request for a continued stay of the proceeding. The ALJ also recommended that Respondent's registration be revoked and forwarded the record to me for final agency action.
Having considered the record as a whole, I adopt the ALJ's decision and recommended order in its entirety. As the ALJ found, Respondent does not currently possess authority under the laws of Maryland to handle controlled substances.
Under the Controlled Substances Act (CSA), “a practitioner must be currently authorized to handle controlled substances in ‘the jurisdiction in which [it] practices' in order to maintain its DEA registration.” Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007) (quoting 21 U.S.C. 802(21)). See also 21 U.S.C. 802(21) (“[t]he term ‘practitioner' means a * * * pharmacy * * * licensed, registered, or otherwise permitted, by * * * the jurisdiction in which [it] practices * * * to * * * dispense * * * a controlled substance in the course of professional practice”). See also id. 823(f) (“The Attorney General shall register practitioners * * * if the applicant is authorized to dispense * * * controlled substances under the laws of the State in which [it] practices.”).
State authority is thus an essential prerequisite to maintaining a DEA registration. Moreover, this Agency has repeatedly revoked the DEA registrations of those registrants who no longer hold state authority to handle controlled substances, regardless of whether that authority has been revoked or suspended pending further proceedings. See Bourne Pharmacy, 72 FR at 18274; The Medicine Shoppe, 71 FR 42878, 42879 (2006); Rx Network of South Florida, LLC, 69 FR 62093 (2004); Wingfield Drugs, Inc., 52 FR 27070 (1987). Because Respondent is not currently authorized to handle controlled substances in the State in which it engages in the practice of pharmacy, it is not entitled to maintain its DEA registration. Therefore, its registration will be revoked and any pending applications for renewal or modification of its registration will be denied.
The ALJ properly rejected Respondent's request for a stay. It is not DEA's policy to stay proceedings under section 304 while registrants litigate in other forums. See Bourne Pharmacy, Inc., 72 FR 18273 (2007); Oakland Medical Pharmacy, 71 FR 50100 (2006); Kennard Kobrin, M.D., 70 FR 33199 (2005). As the ALJ explained, Respondent can always apply for a new registration if it prevails in the pending state administrative proceeding.
Based on this Agency's records, I find that Respondent is the holder of DEA Certificate of Registration, BN3795892, which does not expire until October 31, 2008.
Order
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, BN3795892, issued to Newcare Home Health Services, 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 31, 2007.
Dated: July 20, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-14819 Filed 7-31-07; 8:45 am]
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