On October 2, 2013, Administrative Law Judge (ALJ) Christopher B. McNeil issued the attached Recommended Decision (R.D.). Therein, the ALJ found that there was no dispute over the material fact that Respondent does not possess authority under the laws of California, the State in which it has applied for a DEA Certificate of Registration as a Retail Pharmacy, to dispense controlled substances. R.D. at 5–6. Accordingly, the ALJ held that Applicant does not meet the statutory definition of a practitioner,
Having reviewed the record, I have decided to adopt the ALJ's Recommended Decision in its entirety except as discussed below.
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b) and 0.104, I order that the application of House of Medicine for a DEA Certificate of Registration as a Retail Pharmacy be, and it hereby is, denied. This Order is effective immediately.
Christopher B. McNeil, Administrative Law Judge. On June 16, 2009, House of Medicine, the respondent in this case, submitted an application to the Drug Enforcement Administration seeking a new DEA retail pharmacy registration.
On August 6, 2013, the Deputy Administrator of the Drug Enforcement Administration, Office of Diversion Control, filed an Order to Show Cause proposing to deny the application pursuant to 21 U.S.C. 823(f). As grounds for revocation, the Government alleges that Respondent does not have the authority to handle controlled substances in the State of California and it alleges that Respondent's registration would be inconsistent with the public interest.
On December 26, 2012, Respondent, through its sole owner, Jahangir S. Janfaza, filed a timely request for hearing.
In my order of September 6, 2013, I directed the Government to provide evidence to support the allegation that Respondent lacks state authority to handle controlled substances. I received the Government's Motion for Summary Disposition on September 19, 2013, with proof of service upon Respondent, accompanied by supporting documentation. The factual premise relied upon by the Government in support of its motion is that Respondent does not have a pharmacy license issued by the California State Board of Pharmacy, the state in which Respondent seeks to be registered.
In my Order of September 6, 2013, I provided to Respondent the opportunity to respond to the Government's Motion for Summary Disposition. That response was due by September 25, 2013.
Although Respondent has not directly responded to the factual and legal premises raised by the Government, its initial pleading does set forth facts and arguments in support of its application for a Certificate of Registration. Drawing what I can from the premises appearing in Respondent's request for a hearing, I find as follows.
The substantial issue raised by the Government rests on an undisputed fact. The Government asserts that Respondent's application must be summarily denied because Respondent does not have a pharmacy license issued by the state in which it intends to operate. Under DEA precedent, an application for a retail-pharmacy DEA Certificate of Registration must be summarily denied if the applicant is not authorized to handle controlled substances in the state in which it seeks DEA registration.
Respondent sought a hearing on its application to explain why it currently does not have a pharmacy license in California.
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Mr. Janfaza also explained the connection between his family's financial condition and the circumstances that currently prevent him from obtaining a license to operate a pharmacy in California.
The case before me is presented under a grant of authority to recommend that the Administrator either grant or deny Respondent's application for a DEA retail-pharmacy license. Pursuant to 21 U.S.C. 823(f), the DEA may grant such an application only to a pharmacy “practitioner.” Under 21 U.S.C. 802(21), a “practitioner” must be “licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute [or] dispense . . . controlled substance[s.]” Given this statutory language, the DEA Administrator does not have the authority under the Controlled Substances Act to grant a registration to a practitioner if that practitioner is not authorized by to dispense controlled substances.
Given this body of law, the material fact here, indeed the sole fact of consequence, is whether Respondent is authorized by the State of California to dispense controlled substances. Where, as here, no material fact is in dispute, there is no need for an evidentiary hearing and summary disposition is appropriate.
In determining whether to grant the Government's motion for summary disposition, I am required to apply the principle of law that holds such a motion may be granted in an administrative proceeding if no material question of fact exists:
It is settled law that when no fact question is involved or the facts are agreed, a plenary, adversary administrative proceeding involving evidence, cross-examination of witnesses, etc., is not obligatory—even though a pertinent statute prescribes a hearing. In such situations, the rationale is that Congress does not intend administrative agencies to perform meaningless tasks (citations omitted).
In this context, I am further guided by prior decisions before the DEA involving certificate holders who lacked licenses to distribute or dispense controlled substances. On the issue of whether an evidentiary hearing is required, “it is well settled that when there is no question of material fact involved, there is no need for a plenary, administrative hearing.”
The Government argues that the sole determinative fact now before me is that Respondent lacks a California pharmacy license. I agree. In order for a pharmacy to receive a DEA registration authorizing it to dispense controlled substances under 21 U.S.C. 823(f), it must meet the definition of “practitioner” as found in the Controlled Substances Act.
As cited by the Government in its Motion for Summary Disposition, there is substantial authority both through agency precedent and through decisions of courts in review of that precedent, holding that an application for a retail pharmacy DEA registration is dependent upon the applicant having a state license to dispense controlled substances.
I am mindful of the arguments raised by Respondent in its Request for a Hearing, including the fact that Respondent's lack of a pharmacy license is based on financial obligations Respondent and Mr. Janfaza have incurred with the California Board of Pharmacy, and with the difficulties Mr. Janfaza faces in meeting those obligations. These difficulties do not, however, change the fact that without a state pharmacy license, Respondent is not a “practitioner” and cannot be granted a Certificate of Registration.
Some care should be taken to assure the parties that the actions taken in this administrative proceeding conform to constitutional requirements. I have examined the parties' contentions with an eye towards ensuring all tenets of due process have been adhered to. There is, however, no authority for me to evaluate the facts that underlie Respondent's contentions. While the details of these circumstances may explain why Mr. Janfaza has been unable to renew his pharmacy's California license, the facts or allegations in his request for a hearing are not material in the administrative proceedings now before the DEA. In the proceedings now before me, the only material question was answered by Respondent in its Request for Hearing. Further, while the Order to Show Cause sets forth a non-exhaustive summary of facts and law relevant to a determination that granting this application would be inconsistent with the public interest under 21 U.S.C. 823(f), the conclusion, order and recommendation that follow are based solely on a finding that Respondent is not a “practitioner” as that term is defined by 21 U.S.C. 802(21), and I make no finding regarding whether granting this application would or would not be inconsistent with the public interest.
I find there is no genuine dispute regarding whether Respondent is a “practitioner” as that term is defined by 21 U.S.C. 802(21), and that based on the record the Government has established that Respondent is not a practitioner and is not authorized to dispense controlled substances in the state in which it seeks to operate under a DEA Certificate of Registration. I find no other material facts at issue, for the reasons set forth in the Government's Motion for Summary Disposition. Accordingly, I GRANT the Government's Motion for Summary Disposition.
Upon this finding, I ORDER that this case be forwarded to the Administrator for final disposition and I RECOMMEND the Administrator DENY Respondent's application for a DEA Certificate of Registration.