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###### Department of Justice

###### Drug Enforcement Administration

          - [Docket No. 04-9]

On October 7, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Gabriel Sagun Orzame, M.D. (Respondent) notifying him of an opportunity to show cause as to why DEA should not revoke his DEA Certificate of Registration, AO1690367, under 21 U.S.C. 824(a)(3) and (a)(4), and deny any pending applications for renewal or modification of that registration. Specifically, the Order to Show Cause alleged in relevant part, the following:

                    1. Effective November 17, 2002, the State of Michigan, Department of Consumer and Industry Services, Board of Medicine Disciplinary Subcommittee (Board), revoked the Respondent's                           ( print page 58960)                        medical licensure privileges in that state.                

2. This revocation of license was based upon the Respondent's conviction for altered records (one count of recklessly placing false information in the medical chart) in violation of MCL 750.492(a)(I)(b), a misdemeanor. Appeals of the Board's revocation order have been denied up through the Michigan Supreme Court.

3. A criminal complaint from which the above charge stems is based upon a Michigan State Police investigation for which the Respondent was charged with one count of conspiracy, three counts of delivery and thirty-two counts of delivery of a controlled substance prescription form. Four undercover officers made undercover visits to the Respondent's office and he never performed examinations on them. Nevertheless, the Respondent provided prescriptions for controlled substances for the undercover officers and for other persons who were not there.

4. As a result of the actions taken by the Board, the Respondent is currently without authority to handle controlled substances in the State of Michigan, the state in which he is registered with DEA.

By letter dated October 24, 2003, the Respondent, through his legal counsel, timely requested a hearing in this matter. As part of his hearing request, the Respondent further asserted that he “* * * still has a license to practice medicine, and is licensed by the State of New York to prescribe medication.” On October 31, 2003, the presiding Administrative Law Judge Gail A. Randall (Judge Randall) issued to counsel for DEA as well as the Respondent an Order for Prehearing Statements.

On November 19, 2003, counsel for DEA filed Government's Prehearing Statement and Motion for Summary Disposition. In its motion, the Government recited, among other things, an allegation outlined in the Order to Show Cause regarding the November 17, 2002, revocation of the Respondent's Michigan medical license. With regard to this allegation, the Government argued in relevant part that the Respondent is currently without authority to handle controlled substances in the State of Michigan. The Government further argued that the Respondent's licensure status in New York is of no consequence since he is not registered with DEA in that state. Therefore, the Government requested that the Administrative Law Judge grant its Motion for Summary Disposition and recommend that Respondent's DEA Certificate of Registration be revoked based on his lack of state authorization to handle controlled substances in Michigan.

On December 11, 2003, the Respondent filed his Response to Government's Motion for Summary Disposition. In his response, the Respondent argued that his medical license was suspended in the State of Michigan because of a mistaken guilty plea to a state misdemeanor charge related to the prohibition on health care providers placing inaccurate information in a patient file. The Respondent reiterated that he remains licensed to practice medicine in New York, and further requested that the DEA proceedings be stayed for 90 days so that he can establish professional residency in New York.

Following a Government response objecting to the Respondent's request for stay, on February 4, 2004, Judge Randall issued her Opinion and Recommended Decision of the Administrative Law Judge (Opinion and Recommended Decision). As part of her recommended ruling, Judge Randall granted the Government's Motion for Summary Disposition and found that the Respondent lacked authorization to handle controlled substances in Michigan, the jurisdiction in which he is registered with DEA. In granting the Government's motion, Judge Randall also recommended that the Respondent's DEA registration be revoked and any pending applications for modification or renewal be denied. No exceptions were filed by either party to Judge Randall's Opinion and Recommended Decision, and on March 15, 2004, the record of these proceedings was transmitted to the Office of the DEA Deputy Administer.

The Deputy Administrator has considered the record in its entirety and pursuant to 21 CFR 1316.67, hereby issues her final order based upon findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts, in full, the Opinion and Recommended Decision of the Administrative Law Judge.

The Deputy Administrator finds that the Respondent currently possesses DEA Certificate of Registration AO1690367, and is registered to handle controlled substances at a location in Benton Harbor, Michigan. The Deputy Administrator further finds that effective November 17, 2002, the Board revoked Respondent's license to practice medicine in Michigan. While the Respondent has presented evidence of his medical license in New York, there is no evidence before the Deputy Administrator that the Respondent has applied for, or has been granted resinstatement of his Michigan medical license, the state where he holds a DEA registration. Accordingly, the Deputy Administrator also finds it reasonable to infer that Respondent is also without authorization to handle controlled substances in that state.

                    DEA does not have statutory authority under the Controlled Substances Act to issue or maintain a registration if the applicant or registrant is without state authority to handle controlled substances in the state in which he conducts business.                     *See*21 U.S.C. 802(21), 823(f) and 824(a)(3). This prerequisite has been consistently upheld.                     *See Kanwaljit S. Serai, M.D.,*68 FR 48943 (2003);                     *Dominick A. Ricci, M.D.,*58 FR 51104 (1993);                     *Bobby Watts, M.D.,*53 FR 11919 (1988).                

                    Here, it is clear that the Respondent is not currently licensed to handle controlled substances in Michigan. Therefore, he is not entitled to maintain that registration. Because the Respondent is not entitled to a DEA registration in Michigan due to his lack of state authorization to handle controlled substances, the Deputy Administrator concludes that it is unnecessary to address whether his registration should be revoked based upon the other grounds asserted in the Order to Show Cause.                     *See Cordell Clark, M.D.,*68 FR 48942 (2003);                     *Nathaniel-Aikens-Afful, M.D.,*                     FR 16871 (1997);                     *Sam F. Moore, D.V.M.,*58 FR 14428 (1993).                

                    In further support of his continued registration with DEA, Respondent argues that consideration should be given to his state licensure to practice medicine in New York. The Deputy Administrator agrees with Judge Randall that the Respondent's status as a practitioner is a state other than Michigan has no bearing on this matter. The Deputy Administrator also agrees with the argument forwarded by the Government that Respondent's assertions regarding his licensure status in New York are without merit “and ultimately irrelevant” since Respondent's DEA Certificate of Registration is for a Michigan address, and he is currently not authorized to handle controlled substances in that state,                     *See, Layfe Robert Anthony, M.D.,*67 FR 35582 (2002).                

                    Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration, AO1690367, issued to Gabriel Sagun Orzame, M.D., be, and it hereby is, revoked. The Deputy Administrator further orders that any                           ( print page 58961)                        pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective November 1, 2004.                

Dated: September 8, 2004.

Michele M. Leonhart,

Deputy Administrator.

[FR Doc. 04-21964  Filed 9-30-04; 8:45 am]

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