On December 8, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Rodolfo D. Bernal, M.D. (Dr. Bernal), proposing to revoke Start Printed Page 58538his DEA Certificate of Registration, AB5067916, as a practitioner pursuant to 21 U.S.C. 824(a)(3) based on lack of state authorization to handle controlled substances in Illinois. The Order to Show Cause also alleged that Dr. Bernal's continued registration would be inconsistent with the public interest under 21 U.S.C. 824(a)(4), and sought to deny any pending applications for renewal or modification of registration under 21 U.S.C. 823(f). The Order to Show Cause alleged in relevant part, the following:
1. Effective April 17, 2003, the Illinois Department of Professional Regulation (IDPR) signed an order and placed Dr. Bernal's license as a physician and surgeon, as well as his controlled substance license, in a summary suspension Status. On October 21, 2003, the summary suspension became a suspension.
2. The suspension was based upon the following set of circumstanced:
(i) Dr. Bernal ordered large quantities of controlled substances and failed to keep a proper log and inventory of the controlled substances;
(ii) Dr. Bernal purchased controlled substances for his personal use; and,
(iii) Dr. Bernal ingested the controlled substances during office hours while practicing medicine at his office.
The above actions were also grounds for suspension of Dr. Bernal's Certificate of Registration pursuant to 225 Illinois Compiled Statutes (2000) 60/22(a)(7), (17) and (33).
3. During the years of 2000 through March of 2003, Dr. Bernal ordered Lortab, a schedule III controlled substance, Xanax, a schedule IV controlled substance, as well as Ambien, also a schedule IV controlled substance. Dr. Bernal failed to keep a proper log and inventory of these controlled substances in violation of 21 U.S.C. 827(a)(3) and 21 CFR 304.04. He also admitted to purchasing the above controlled substances at his residence, a non-registered location. The maintenance of controlled substances for his personal use and self-administered these controlled substances for other than medically accepted therapeutic purposes.
4. On April 10, 2003, DEA diversion investigators interviewed Dr. Bernal at his registered location in Chicago, Illinois. Dr. bernal was found to have been unusually slow in responding to questions asked of him and he appeared impaired. Dr. Bernal admitted to taking two Lortab tablets that same morning, during office hours while practicing medicine at his office. He also admitted to keeping controlled substances at his residence, a non-registered location. The maintenance of controlled substances in this fashion is a violation of 21 CFR 1301.12.
5. During the above interview, Dr. Bernal agreed to the immediate destruction of all controlled substances at his registered location, which was later carried out by the DEA investigators. The investigators provided Dr. Bernal with documentation of the destruction. Dr. Bernal also agreed to immediately make arrangements to enter a drug treatment program, however he failed to do so.
6. As a result of the action taken by IDPR, Dr. Bernal is currently without authority to handle controlled substances in Illinois, the state in which he is registered with DEA.
According to the investigative file, the Order to Show Cause was sent by certified mail to Dr. Bernal's registered location on December 12, 2003, but the notice was later returned to DEA unclaimed. No other address was located for Dr. Bernal, however, there was an office telephone number located for him. On February 24, 2004, DEA personnel placed a call to Dr. Bernal's office number and obtained a facsimile number for him. On that same date, the Order to Show Cause was faxed to his office. Included in the investigative file is a facsimile confirmation document which shows that the Order to Show Cause was received at the number provided by Dr. Bernal's office. Despite attempts to reach him, DEA has not received a request for hearing or any other reply from Dr. Bernal or anyone purporting to represent him in his matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty days having passed since delivery of the Order to Show Cause to Dr. Bernal's address of record and his receipt of the same, and (2) no request for hearing having been received, concludes that Dr. Bernal is deemed to have waived his hearing right. See David W. Linder, 67 FR 12579 (2002). After considering material from the investigative file in this matter, the Deputy Administrator now enters her final order without a hearing pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
Dr. Bernal is registered with DEA under certificate of Registration number AB5067916. That registration remains valid until July 31, 2004. According to the investigative file, on October 21, 2003, the Medical Disciplinary Board of IDPR issued an Order which suspended indefinitely Dr. Bernal's state certificate to practice as a physician and surgeon, as well as his certificate to issue controlled substances. The IDPR Order was based on findings that during the years 2000 through March of 2003, Dr. Bernal ordered 12,100 dosage units of Lortab, a Schedule III controlled substance, as well as 2,700 dosage units of Xanax and 2,400 dosage units of Ambien, both Schedule IV controlled substances. IDPR found that Dr. Bernal failed to keep a proper log and inventory of these controlled substances. IDPR also found that Dr. Bernal ingested controlled substances during office hours while practicing medicine in his office; self administered controlled substances for other than medically accepted therapeutic purposes; and, that his habitual and excessive use or abuse of controlled substances resulted in his inability to practice medicine with reasonable judgment, skill or safety.
The investigative file contains no evidence that the suspensions of Dr. Bernal's Illinois medical and controlled substance licenses have been lifted. Therefore, the Deputy Administrator finds that Dr. Bernal is currently not authorized 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 Rory Patrick Doyle, M.D., 69 FR 11655 (2004); Dominick A. Ricci, M.D., 58 FR 51104 (1993); Bobby Watts, M.D., 53 FR 11919 (1988).
Here, it is clear that Dr. Bernal's controlled substance authority in the state of Illinois has been suspended. As a result, he is currently not licensed under Illinois law to handle controlled substances and therefore, he is not entitled to a DEA registration in that state. As a result of a finding that Dr. Bernal lacks state authorization to handle controlled substances, the Deputy Administrator concludes that it is unnecessary to address further whether his DEA registration should be revoked based upon the public interest grounds asserted in the Order to Show Cause. See Fereida Walker-Graham, M.D., 68 FR 24761 (2003); 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, AB5067916, issued to Rodolfo D. Bernal, M.D., be, and it Start Printed Page 58539hereby 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 November 1, 2004.Start Signature
Dated: September 8, 2004.
Michele M. Leonhart,
[FR Doc. 04-21959 Filed 9-29-04; 8:45 am]
BILLING CODE 4410-09-M