On June 13, 2003, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Simon J. Trueblood, M.D. (Dr. Trueblood), proposing to revoke his DEA Certificate of Registration, BT5741081, as a practitioner pursuant to 21 U.S.C. 824(a)(3), and deny any pending applications for registration as a practitioner under 21 U.S.C. 823(f), for reason that Dr. Trueblood does not have a controlled substance license for the State of Illinois, the state in which he intends to move his practice. The Order to Show Cause further alleged that renewal or modification of Dr. Trueblood's DEA registration would be inconsistent with the public interest, based in relevant part, upon the following:
1. On March 10, 1998, the Medical Licensing Board of Indiana (the Board) placed Dr. Trueblood's medical license on indefinite probation. As grounds for this action, the Board found that Dr. Trueblood had prescribed legend drugs and controlled substances to a number of members of his family. Dr. Trueblood admitted that all the prescriptions had been for his mother. Dr. Trueblood also admitted that he had written the prescriptions in different names in order Start Printed Page 40657to deceive pharmacists and not draw attention to his practices.
2. On February 22, 1999, Dr. Trueblood entered into a Memorandum of Understanding (MOU) with DEA in lieu of the agency taking action to revoke his DEA controlled substance registration. Under the MOU, Dr. Trueblood agreed, among other things, that he would:
a. Not purchase, manufacture, possess, dispense, administer or in any way acquire, handle or engage in any other controlled substance activities whatever, except to prescribe in Schedules II through V;
b. Not prescribe, dispense or administer controlled substances to himself or to any member of his immediate family;
c. Maintain and submit to DEA a complete and accurate record of all controlled substances that he prescribed, every three months, for three years.
3. In November 2000, Dr. Trueblood applied for renewal of his Illinois DEA Registration, BT57 41081, as well as his Indiana DEA registration, AT23001241. On his applications, Dr. Trueblood answered “no” to a question which asked: “has the applicant ever surrendered or had a federal controlled substance registration revoked, suspended, restricted or denied.” This answer was false, since the MOU restricted Dr. Trueblood's DEA registrations.
4. On January 10, 2001, Dr. Trueblood admitted to DEA investigators that the violated the MOU by purchasing, administering, handling and possessing controlled substances. On January 17, 2001, DEA investigators conducted an inspection of the office of Dr. Trueblood and found that he had violated the MOU and numerous laws and regulations concerning controlled substances. Among the violations noted were failure to keep an inventory of controlled substances, in violation of 21 U.S.C. 827 and 21 CFR 1304.11(e)(3); failure to keep records of controlled substances that he received and dispensed, in violation of 21 CFR 1304.22(c) and 21 CFR 1304.03(b); the ordering of controlled substances on 55 occasions, in violation of the MOU; maintaining controlled substances at an unregistered location, in violation of 21 CFR 1301.13(a); violation of terms of the MOU by failing to send to DEA complete and accurate records of all controlled substances prescribed, every three months; failure to maintain records of administering controlled substances to patients, in violation of 21 CFR 1304.03(d); and, failure to maintain prescribing records in separate files or ledgers for three years, in violation of the MOU.
5. DEA investigators inspecting Dr. Trueblood's Merrillville, Indiana office on January 17, 2001, seized controlled substances found in the office. Pursuant to the investigators' request that the surrender all controlled substances in his office, Dr. Trueblood provided the investigators with a box containing controlled substances. Dr. Trueblood told investigators that he had provided all controlled substances that were in his office, but further informed them that they were free to conduct a further search of the office for these products. A further search uncovered additional controlled substances, which Dr. Trueblood claimed he was unaware of. Dr. Trueblood again told inspectors that there were no more controlled substances in his office.
6. On January 19, 2001, DEA investigators returned to the Merrillville office where they met with Dr. Trueblood and his counsel. The investigators found additional controlled substances in Dr. Trueblood's office. On the same day, DEA investigators met Dr. Trueblood and his attorney at the doctor's second office location in Valparaiso, Indiana. The investigators searched and seized controlled substances in that office. The investigators advised Dr. Trueblood that he had not obtained a registration for the Valparaiso office and therefore no controlled substances could be stored, dispensed, or administered at that location.
7. On January 19, 2001, Dr. Trueblood surrendered his DEA registration, AT2301341, which was assigned to his Indiana registered location. The surrender of Dr. Trueblood's Indiana DEA registration rendered his renewal application for that registration null and void.
8. Following the surrender of his registration, Dr. Trueblood continued writing prescriptions using his Indiana DEA registration. Between January 19 and March 2, 2001, Dr. Trueblood wrote prescriptions for OxyContin, Percodan, Dilaudid and methadone, all Schedule II controlled substances; two prescriptions for Vicodin, a Schedule III controlled substance; and Xanax and Ambien, both Schedule IV controlled substances.
9. On February 28, 2001, the Board suspended Dr. Trueblood's Indiana medical license for 90 days, on the grounds that he represented a clear and immediate danger to the public health and safety. Dr. Trueblood admitted to the Board that he violated the restrictions in the MOU from the time it was signed by continuing to purchase, possess, dispense and administer Schedules II through V controlled substances. The Board found that Dr. Trueblood effectively ignored and failed to comply with the terms of the MOU. Dr. Trueblood appealed the Board's decision and a stay was issued.
10. On May 30, 2001, the Board revoked Dr. Trueblood's Indiana medical license and forbade him from reapplying for that license for seven years. Despite the revocation, Dr. Trueblood continued to write prescriptions for non-controlled substances.
11. On September 27, 2001, Dr. Trueblood appeared before the Board concerning his request for renewal of his Indiana medical license.
12. On October 23, 2001, the Board denied Dr. Trueblood's renewal application.
13. On January 24, 2003, a hearing was held concerning Dr. Trueblood's appeal of the denial of his renewal application. The Board voted in favor of denying Dr. Trueblood's appeal.
14. On February 23, 2003, the Board revoked Dr. Trueblood's Indiana medical license.
The Order to Show Cause was sent by certified mail to Dr. Trueblood at his address in Buffalo Springs, Illinois, and was received by Dr. Trueblood on June 23, 2003. Nevertheless, DEA has not received a request for hearing or any other reply from Dr. Trueblood or anyone purporting to represent him in this matter.
Therefore, the Deputy Administrator of DEA, finding that (1) thirty days having passed since the delivery of the Order to Show Cause to Dr. Trueblood's address of record and his receipt of the same, and (2) no request for hearing having been received, concludes that Dr. Trueblood 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.
According to the investigative file, DEA Certificate of Registration, AT2301341, was assigned to Dr. Trueblood in or around 1986, at an address in Merrillville, Indiana. On January 23, 2001, Dr. Trueblood surrendered that registration. The investigative file also reveals that on March 3, 1998, DEA Certificate of Registration, BT5741081, was assigned to Dr. Trueblood for an address in Calumet, Illinois. The latter DEA registration of Dr. Trueblood is the subject of the instant proceeding.
Subsequent to the issuance of the Order to Show Cause, and in light of Dr. Start Printed Page 40658Trueblood's waiver of a hearing, the Deputy Administrator accepted into the record a copy of a Certification of Licensure (certification) from the Illinois Department of Professional Regulation (IDPR). The certification was dated April 7, 2004, and was signed by the Deputy Director, Licensing and Testing for IDPR. According to the certification, Dr. Trueblood's Illinois controlled substance license expired on July 31, 1999, and is currently in a “NON-RENEWED” status.
The investigative file contains no evidence that Dr. Trueblood's Illinois controlled substance license has been renewed. Therefore, the Deputy Administrator finds that Dr. Trueblood 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. Trueblood's Illinois controlled substance license has expired and has not been renewed. 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. Trueblood 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, BT5741081, issued to Simon J. Trueblood, 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 August 5, 2004.Start Signature
Dated: June 21, 2004.
Michele M. Leonhart,
[FR Doc. 04-15150 Filed 7-2-04; 8:45 am]
BILLING CODE 4410-09-M