On September 3, 2004, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Katarzyna Rygiel, M.D. (Dr. Rygiel) of San Diego, California, notifying her of an opportunity to show cause as to why DEA should not revoke her DEA Certificate of Registration BK4222179, as a practitioner, pursuant to 21 U.S.C. 824(a)(3) and deny any pending applications for renewal of that registration pursuant to 21 U.S.C. 823(f). As the basis for revocation, the Order to Show Cause alleged that Dr. Rygiel's license to practice medicine in California had been revoked and accordingly, she was not authorized to handle controlled substances in California, the state in which she is registered.
In a letter dated October 6, 2004, through her counsel, Dr. Rygiel timely requested a hearing in this matter. In that letter she admitted the California Medical Board had revoked her license but argued that decision was being reviewed by the Superior Court of California, County of San Diego.
On October 13, 2004, the government filed a Motion for Summary Disposition, requesting that Administrative Law Judge Gail A. Randall (Judge Randall) summarily dismiss the action, arguing that Dr. Rygiel lacked state authority to handle controlled substances in California. On October 14, 2004, Judge Randall issued an Order staying proceedings and affording Dr. Rygiel an opportunity to respond to the Government's motion. Dr. Rygiel then filed a Motion for Further Stay of Proceedings and Opposition to Government's Motion for Summary Adjudication and Alternatively, Motion for Stay of Judgment (Response). In that Response Dr. Rygiel acknowledged she was currently without state authority to practice medicine in California but argued the DEA hearing should be stayed until the San Diego Superior Court had issued an anticipated decision in her favor.
On November 22, 2004, Judge Randall issued her Order, 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, finding Dr. Rygiel lacked authorization to handle controlled substances in California, the jurisdiction in which she is registered. Judge Randall recommended that Dr. Rygiel's DEA registration be revoked. No exceptions were filed by either party to the Opinion and Recommended Decision and on January 11, 2005, the record of these proceedings was 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 Dr. Rygiel holds DEA Certificate of Registration, BK4222179. The Deputy Administrator further finds that on March 16, 2004, the Division of Medical Quality, Medical Board of California, Department of Consumer Affairs, State of California (Board) issued a Decision revoking Dr. Rygiel's Physician and Surgeon's Certificate. In that Decision, the Board adopted a February 13, 2004, Proposed Decision of a California Administrative Law Judge which recommended revocation of Dr. Rygiel's medical license on certain enumerated grounds.
There is no evidence in the record indicating the Board's Decision has been stayed or set aside by judicial action, rescinded by the Board or that Dr. Rygiel's license has been reinstated. Therefore, the Deputy Administrator finds that Dr. Rygiel is currently not licensed to practice medicine in California and, as a result, it is reasonable to infer that she 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 she conducts business. See 21 U.S.C. 802(21), 823(f) and 824(a)(3). This prerequisite has been consistently upheld. See Gabriel Sagun Orzame, M.D., 69 FR 58959 (2004); Dominick A. Ricci, M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 11919 (1988).
Here, it is clear that Dr. Rygiel is not currently authorized to handle controlled substances in California, where she is registered with DEA. Therefore, she is not entitled to maintain that registration. 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, BK4222179, issued to Katarzyna Rygiel, M.D., 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 June 17, 2005.Start Signature
Dated: May 9, 2005.
Michele M. Leonhart,
[FR Doc. 05-9837 Filed 5-17-05; 8:45 am]
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