On August 1, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Deborah Y. Strauss, D.V.M. (Respondent) notifying her of an opportunity to show cause as to why DEA should not revoke her Certificate of Registration, BS6351821, and deny any pending applications for renewal or modification of such registration pursuant to 21 U.S.C. 824(a)(3) and (a)(4). Specifically, the Order to Show alleged that the Respondent's State controlled substances registration has been suspended and her continued registration would be inconsistent with the public interest based on matters concerning her purported issuance of prescriptions for Demerol, a Schedule II controlled substance, for no legitimate medical purpose. The Order to Show Cause further alleged that as a result of an accountability audit, the Respondent was unable to account for over 10,000 mg. of injectible Demerol, and her records involving the Schedule IV controlled substance diazepam, were not complete or accurate in violation of DEA regulations.Start Printed Page 33667
By letter dated September 3, 2003, the Respondent, through her legal counsel, timely requested a hearing in response to the show cause order. On September 29, 2003, the presiding Administrative Law Judge Mary Ellen Bittner (Judge Bittner) issued to the Government as well as the Respondent an Order for Prehearing Statements.
In lieu of filing a pre-hearing statement, counsel for DEA filed Government's Motion for Summary Disposition. In its motion, the Government asserted that the Respondent is without authorization to handle controlled substances in the State of Iowa, and as a result, further proceedings in the matter were not required. Attached to the Government's motion was an Order of Immediate Suspension of Controlled Substance Registration issued by the Board of Pharmacy Examiners of the State of Iowa (Pharmacy Board), dated May 9, 2003.
On October 17, 2003, the Respondent filed a reply brief with the caption, “Resistance to Government's Motion for Summary Disposition.” In its brief, the Respondent argued, inter alia, that she is entitled to due process of law; she has been wrongfully accused of having a controlled substance abuse problem; a requested hearing before the Pharmacy Board will clarify the issue and should result in the reinstatement of Respondent's State controlled substance registration; the Pharmacy Board arrived at an “incorrect decision” in suspending Respondent's State controlled substance registration; and, there is no compelling need for DEA to proceed with summary disposition in this proceeding when matters involving Respondent's State controlled substance registration are under review. The Respondent however, concedes that she is currently without authorization to handle controlled substances in Iowa.
On December 8, 2003, Judge Bittner issued her Opinion and Recommended Decision of the Administrative Law Judge (Opinion and Recommended Decision). As part of her recommended ruling, Judge Bittner granted the Government's Motion for Summary Disposition and found that Respondent lacked authorization to handle controlled substances in Iowa, the jurisdiction where Respondent holds a DEA registration. In granting the Government's motion, Judge Bittner 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 Bittner's Opinion and Recommended Decision, and on January 16, 2004, the record of these proceedings were transmitted to the Office of the DEA Deputy Administrator.
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 BS6351821, and is registered to handle controlled substances in Iowa. The record before the Deputy Administrator reveals that on May 9, 2003, the Iowa Pharmacy Board issued an order suspending the Respondent's State controlled substance registration, effective immediately.
In reaching its decision, the Pharmacy Board found that during a thirteen-month period, Respondent wrote 176 prescriptions for Demerol, purportedly for animal patients. Several of the animal patients were owned by the Respondent. The Pharmacy Board found however, that the Respondent did not administer Demerol to her patients, but instead, obtained the drug for her personal use. The Pharmacy Board also found that the Respondent did not maintain required records for the dispensing of controlled substances. There is no evidence before the Deputy Administrator that the Pharmacy Board's order has been stayed or rescinded, or that Respondent's State controlled substance privileges have otherwise been reinstated.
Pursuant to 21 U.S.C. 824(a), the Deputy Administrator may revoke a DEA Certificate of Registration if she finds that the registrant has had his State license revoked and is no longer authorized to dispense controlled substances or has committed such acts as would render his registration contrary to the public interest as determined by factors listed in 21 U.S.C. 823(f). Thomas B. Pelkowski, D.D.S., 57 FR 28538 (1992). Nevertheless, despite the Pharmacy Board's findings regarding the Respondent's inappropriate handling of controlled substances, and notwithstanding the other public interest factors for the revocation of her DEA registration asserted herein, the more relevant consideration here is the present status of the Respondent's State authorization to handle controlled substances.
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 Stephen J. Graham, M.D., 69 FR 11661 (2004); Dominick A. Ricci, M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 11919 (1988).
Here, it is clear that Respondent's Iowa controlled substance license has been suspended, and as a result, she is not licensed under Iowa law to handle these products. Therefore, she is not entitled to a DEA registration in that state. As a result of a finding that Respondent lacks State authorization to handle controlled substances, the Deputy Administrator concludes that it is unnecessary to address further whether Respondent's DEA registration should be revoked based upon the public interest grounds asserted in the Order to Show Cause. See Samuel Silas Jackson, D.D.S., 67 FR 65145 (2002); Nathaniel-Aikens-Afful, M.D., 62 FR 16871 (1997); Sam F. Moore, D.V.M, 58 FR 14428 (1993).
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, BS6351821, issued to Deborah Y. Strauss, D.V.M., be, and it hereby is, revoked. The Deputy Administrator further orders that any pending applications for renewal or modification of such registration be, and they hereby are, denied. This order is effective July 16, 2004.Start Signature
Dated: May 17, 2004.
Michele M. Leonhart,
[FR Doc. 04-13534 Filed 6-15-04; 8:45 am]
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