Registrant Actions - 2010
[Federal Register: June 2, 2010 (Volume 75, Number 105)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-14]
Shepard Ginandes, M.D.; Revocation of Registration
On September 28, 2009, I, the Deputy Administrator of the Drug Enforcement Administration, issued an Order to Show Cause and Immediate Suspension of Registration to Shepard Ginandes, M.D. (Respondent), of Honolulu, Hawaii. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration, BG0241024, and the denial of any pending applications to renew or modify his registration, on the ground that his "continued registrations is inconsistent with the public interest." Show Cause Order at 1 (citing 21 U.S.C. 824(a)(4) & 823(f)).
The Show Cause Order specifically alleged that on twenty-four different occasions between March 2007 and January 2009, Respondent had given prescriptions to law enforcement personnel for schedule II controlled substances including methadone, morphine, oxycodone, and hydromorphone, the schedule III controlled substance hydrocodone, and the schedule IV controlled substances alprazolam and diazepam. Id. at 1-2. The Order further alleged that Respondent's office did not have any exam rooms and medical equipment; that he did not take a medical history or require the officers to fill out any paperwork; did not conduct a physical examination; and that the officers would simply write their name, address and the drug they were seeking on a piece of paper which Respondent would take and then use to prepare a prescription. Id. at 2. The Order thus alleged that these prescriptions lacked a legitimate medical purpose and were issued in violation of 21 CFR 1306.04. Id. The Order further alleged that Respondent was continuing to prescribe controlled substances without a legitimate medical purpose. Id.
Based on the above, I further found that there was a substantial likelihood that Respondent "will continue to write controlled substance prescriptions for other than a legitimate medical purpose." Id. I therefore concluded that Respondent's continued registration during the pendency of the proceeding "would constitute an imminent danger to the public health and safety" and ordered that his registration be immediately suspended. Id.\1\
\1\ The Order also informed Respondent of his right to request a hearing on the allegations and the procedure for doing so, including that he must file a written request for a hearing "[w]ithin 30 days after the date of receipt of" the Order, Show Cause Order at 2, that "[m]atters are deemed filed upon receipt by the Hearing Clerk," id. at 3 (citing 21 CFR 1316.45), and that should he "decline to file a request for a hearing" he "shall be deemed to have waived the right to a hearing." Id. (citing 21 CFR 1301.43(d) & (e)).
On September 30, 2009, the Order was served on Respondent. On November 3, 2009, Respondent, through his counsel, filed a letter requesting a hearing. ALJ Dec. at 2. Therein, Respondent also sought "a reversal of the proposed suspension." Id. The matter was then placed on the docket of the Agency's Administrative Law Judges.
The next day, the Government moved for summary disposition on the ground that on September 30, 2009, the State of Hawaii had "suspended/ revoked" Respondent's state controlled substances registration and that "Respondent is no longer authorized to administer, prescribe, dispense or possess controlled substances." Gov. Mot. for Summ. Disp. at 1. Based on long-standing precedent which holds that "possessing authority under state law to handle controlled substance is an essential condition for holding a DEA registration," the Government requested that the ALJ grant its motion, cancel the pending proceeding and forward the matter to me with the recommendation that I revoke Respondent's registration and deny any pending applications. Id. at 2- 3. Noting that Respondent's hearing request was not received until November 3, 2009, and was therefore untimely, the Government also argued that Respondent had waived his right to a hearing. Id. n.1. Thereafter, the ALJ ordered that Respondent file a Response to the Government's Motion no later than November 12, 2009. ALJ Dec. at 3. The ALJ also stayed the proceeding. Id.
Respondent did not, however, file a Response. Id. Thereafter, the ALJ found that "Respondent's lacks authority to handle controlled substance in the State of Hawaii," the State in which he is licensed to practice medicine. Id. Because holding authority under state law to handle controlled substances is an essential condition for holding a DEA registration, the ALJ granted the Government's Motion for Summary Disposition and recommended that his registration be revoked and his pending application be denied. Id. at 4-6.
The ALJ then forwarded the matter to me for final agency action. Having considered the record as a whole, I find that under the Agency's regulation, Respondent's request for a hearing was untimely and that he has not offered good cause for his failure to file a timely request. 21 CFR 1301.43(d). I therefore find that Respondent waived his right to contest the proceeding. Id. (1301.43(e)).
I further find that on September 4, 2009, Respondent applied to renew his registration, which was to expire on September 30, 2009. I therefore find that Respondent's registration has remained in effect, albeit in suspended status, pending the issuance of this Decision and Final Order. See 5 U.S.C. 557(c).
I further find that on September 30, 2009, the Administrator of the Narcotics Enforcement Division, Department of Public Safety, State of Hawaii, "suspended/revoked" Respondent's State of Hawaii Controlled Substance
Registration. Gov. Mot. for Summ. Disp., Ex. A (letter from Keith Kamita, Administrator, Narcotics Enforcement Division, Hawaii Dept. of Public Safety to Shepard Ginandes, M.D.) Based on Administrator Kamita's letter, I further find that Respondent is "no longer authorized to administer, prescribe, dispense or posses any controlled substance" in Hawaii. Id.
Under the Controlled Substances Act (CSA), a practitioner must be currently authorized to handle controlled substances in "the jurisdiction in which he practices" in order to maintain a DEA registration. See 21 U.S.C. 802(21) ("[t]he term 'practitioner' means a physician * * * licensed, registered, or otherwise permitted, by * * * the jurisdiction in which he practices * * * to distribute, dispense, [or] administer * * * a controlled substance in the course of professional practice"). See also id. Sec. 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 he practices."). As these provisions make plain, possessing authority under state law to handle controlled substances is an essential condition for holding a DEA registration.
Accordingly, DEA has held repeatedly that the CSA requires the revocation of a registration issued to a practitioner whose state license has been suspended or revoked. David Wang, 72 FR 54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988). See also 21 U.S.C. 824(a)(3)(authorizing the revocation of a registration "upon a finding that the registrant * * * has had his State license or registration suspended [or] revoked * * * and is no longer authorized by State law to engage in the * * * distribution [or] dispensing of controlled substances").
The record here establishes that the Respondent's State of Hawaii Controlled Substances Registration has been suspended/revoked by the Administrator of the Narcotics Enforcement Division, Department of Public Safety, State of Hawaii. As the Administrator's letter makes clear, Respondent is "no longer authorized to administer, prescribe, dispense or posses any controlled substance" under Hawaii law and thus, he no longer meets the requirement for obtaining and maintaining a registration under Federal law. Because Respondent is not entitled to maintain his DEA registration, his registration will be revoked and his pending application to renew his registration will be denied.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA Certificate of Registration, BG0241024, issued to Shepard Ginandes, M.D., be, and it hereby is, revoked. I further order that the pending application to renew this registration be, and it hereby is, denied. This order is effective immediately.
Dated: February 25, 2010.
Michele M. Leonhart,
[FR Doc. 2010-13144 Filed 6-1-10; 8:45 am]
BILLING CODE 4410-09-P
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