On October 1, 1999, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Gregory D. Owens, D.D.S. (Respondent), seeking to revoke his DEA Certificate of Registration as a practitioner and deny any pending applications for renewal of such registration pursuant to 21 U.S.C. 823(f) for reason that his continued registration is inconsistent with the public interest, as defined by 21 U.S.C. 823(f) and 824(a)(4). The Respondent timely filed a request for a hearing on the allegations raised by the Order to Show Cause, and the requested hearing was held before Judge Gail A. Randall in Abingdon, Virginia, on October 4, 2000. At the hearing, each party called one witness to testify and the Government introduced documentary evidence. The Respondent offered no documentary evidence at the hearing. After the hearing, both parties submitted Proposed Findings of Fact, Conclusions of Law and Argument. On May 4, 2001, Judge Randall issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge, recommending that Respondent's registration be continued subject to certain restrictions.
On May 24, 2001, the Government filed Exceptions to Judge Randall's decision, and thereafter Judge Randall transmitted the record of these proceedings to the Deputy Administrator for final decision on June 4, 2001.
The Deputy Administrator has considered the record in its entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order based upon findings of fact and conclusions of law as hereinafter set forth. The Deputy Administrator adopts in full the recommended rulings, findings of fact, conclusions of law, and decision of the Administrative Law Judge. His adoption is in no way diminished by any recitation of facts, issues, or conclusions herein, or of any failure to mention a matter of fact or law.
On October 20, 1981, the Respondent received a DEA Certificate of Registration, number AO1188881, with a registration location of Knoxville, Tennessee. The registration was renewed annually until it expired on December 31, 1985. The last renewal of that registration number was given for a location in Kingsport, Tennessee.
In 1981, the Respondent received a license to practice dentistry in the state of Virginia. Sometime in 1986, the Respondent moved from Tennessee to Virginia. The Respondent has maintained his license to practice dentistry in the Commonwealth of Virginia since the time he first received it, through the time of this hearing.
Before July 1, 1996, licensed health care professionals in Virginia needed a separate Controlled Substance Registration from the Virginia Board of Start Printed Page 50462Pharmacy. After July 1, 1996, a valid Virginia license to practice dentistry also conferred upon the license state authorization to handle controlled substances without a separate certificate from the Board of Pharmacy.
On August 29, 1987, the Respondent received a Controlled Substances Registration Certificate, number 0204-030208, from the Virginia Board of Pharmacy. The Respondent maintained the registration until its expiration on December 31, 1992.
On November 5, 1996, the Virginia Board of Dentistry, Department of Health Professions, conducted an unannounced inspection of the Respondent's practice. The Board of Dentistry found that the Respondent had hired an unlicensed hygienist, that the Respondent failed to keep records for two patients, and that he did not keep records for any prescriptions written on the weekends for any patient.
The Government alleged in the Order to Show Cause, and the Respondent agreed, that the Respondent issued prescriptions without a valid state license to handle controlled substances and with an expired DEA Certificate of Registration.
The Respondent testified that he did not realize that his DEA Certificate of Registration had expired until the Board of Dentistry inspected his office. The Respondent testified that he now understands that he must maintain a DEA registration if he wants to prescribe controlled substances.
On or about December 16, 1996, the DEA received an application from the Respondent for a controlled substances registration. The Respondent testified that he sent in the application after discussing his expired registration with the DEA on the telephone. The Respondent testified that he did not remember who told him that the DEA registration had expired. That application was granted, for on February 4, 1997, the DEA issued to the Respondent the DEA Certificate of Registration number BO5201366, and renewed it on October 25, 1999. An additional pending application for renewal is at issued in this proceeding.
Between the time that the DEA received the Respondent's 1996 application and the time that the DEA issued the certificate of registration at issue, the Respondent continued to prescribe controlled substances. A DEA Diversion Investigator (DI) testified that, on March 3, 1997, he received a tip from a Special Agent (SA) of the Virginia State Police that the Respondent may have prescribed controlled substances without authorization from either the DEA or the Commonwealth of Virginia. Consequently, the DI and SA began an investigation of area pharmacies.
The DI discovered that the Respondent used his expired DEA number, AO1188881, to prescribe controlled substances from January 1990 to January 1997. In addition, from December 31, 1992 to July 1, 1996, the Respondent lacked state authorization when he wrote prescriptions for controlled substances. The DI also testified that he found no evidence of diversion to the illicit market by the Respondent of any controlled substances. Furthermore, he testified that there was no indication by the regulatory agencies of Virginia, or by the DEA, that the Respondent had intentionally refused to renew a license or registration.
The DI testified that the Respondent called in a prescription to East Gate Drugstore for Darvocet on or about January 3, 1997, and again on or about January 15, 1997.
The Respondent credibly testified that he did not know, prior to this hearing, that Darvocet was a controlled substance, and further, at the hearing he stated that he did not understand what ‘Schedule IV’ meant.
While the Respondent awaited action on his December 16, 1996 application, he pleaded guilty to a misdemeanor in the U.S. District Court for the Western District of Virginia for failure to file income tax returns from 1990-94. Upon the Respondent's plea entered on January 30, 1997, the District Court sentenced him with a fine of $10,000 plus cost of $125 and five months in the Virginia Community Correctional Center, where the Respondent was allowed daily work release.
The Respondent testified that he was wrong not to file his taxes. He explained that he believed that he was not legally obligated to pay federal income taxes, and that he had so written to the IRS. The IRS chose not to pursue the matter at the time. The Respondent testified that he now understands that he is obligated to pay taxes, having learned “the hard way.”
On June 30, 1997, the Respondent pleaded guilty to a second misdemeanor in the Western District of Virginia, this time for failure to report his change of address to the DEA. The District Court sentenced the Respondent to two years of probation, a $5,000 fine and $25 in costs.
On November 24, 1997, the Board of Dentistry for the Commonwealth of Virginia (Board) issued an Order, placing the Respondent on indefinite probation and imposing various terms and conditions on his continued dental license. For example, the Respondent was ordered to attend fifteen hours of continuing education for the renewal of his license, with a specific course on OSHA. The Respondent must provide the Board with certificates of his attendance within six months of the date that the Order became final. The Order also required the Respondent to provide a copy of his “current DEA registration/certificate” within two weeks of that same date of finality. The Respondent credibly testified that he had completed these requirements, and the Government presented no evidence to the contrary. Significantly, the Board's Order did not limit the Respondent's authority to handle controlled substances, despite a finding that the Respondent prescribed controlled substances at a time when he did not have authority from either Virginia or the DEA to do so. The Respondent consented to one annual unannounced inspection of his patent records by the Board, and he further consented to the Board's observing the on-site treatment of his patients. Also, the Board required that the Respondent's conduct be commensurate with Virginia's statutes that regulate dentistry, specifically Virginia Code sections 54.1-2700-2729, and Virginia's Drug Control Act, Virginia Code sections 54.1-3400-3472.
The DEA last renewed the Respondent's registration, number BO5201366, on October 1, 1999. That registration expired on December 31, 1999. On November 17, 1999, the DEA received the Respondent's renewal application, which was dated November 8, 1999. The address on the Certificate of Registration is current.
On March 30, 2000, the DI approved the Respondent's renewal application and sent it to DEA Headquarters.
Pursuant to 21 U.S.C. 823(f), and subdelegations of authority thereunder found at 28 CFR 0.100(b) and 0.104, the Deputy Administrator may deny an application for registration as a practitioner, if he determines that the issuance of such a registration would be inconsistent with the public interest. Section 823(f) requires that the following factors be considered in evaluating the public interest:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority;
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances;
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances; Start Printed Page 50463
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances;
(5) Such other conduct which may threaten the public health or safety.
These factors are to be considered in the disjunctive. The Deputy Administrator may properly rely on any one or any combination of these factors, and may give each factor the weight he deems appropriate in determining whether an application for registration should be denied. See Henry J. Schwarz, M.D., 54 FR 16,422 (1989). As an initial matter, the Government bears the burden of proving that registration of the Respondent is not in the public interest. See Shatz v. United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989).
Regarding factor one, the recommendation of the State licensing board, Judge Randall found the Virginia Board of Dentistry has not made any official recommendation regarding this proceeding's outcome. The record shows that Respondent's dental license is currently on indefinite probation, under the conditions imposed by the Board's Order.
Judge Randall found it significant that the Board's Order did not limit Respondent's authority to handle controlled substances, despite a finding that Respondent prescribed controlled substances during a period when he was not authorized to do so by either the State of Virginia nor by DEA. The parties did not dispute that Respondent currently has state authority to handle controlled substances.
The Deputy Administrator concurs with Judge Randall's noting that a review of the Respondent's terms of probation serves to shed light on what the Board believed was necessary to protect the public interest. The following terms are relevant: the Respondent must attend fifteen hours of continuing education for the renewal of his license, with a specific course on OSHA, and must provide the Board with certificates of his attendance; the Respondent must submit to the Board quarterly reports of his current address and current employment, if any; the Respondent must consent to one annual unannounced inspection of his patient records by the Board; the Respondent must also consent to the Board's observation of the on-site treatment of his patients, if requested; and finally, the Board required Respondent to comply with Virginia's statues that regulate dentistry, specifically Virginia Code Sections 54.1-2700-2729, and Virginia's Drug Control Act, Virginia Code Sections 54.1-3400-3472.
The Deputy Administrator concurs with Judge Randall's conclusion that the Board's placement of Respondent's license on probation reflects favorably upon Respondent's retaining his DEA Certificate of Registration, and upon DEA's granting Respondent's pending renewal application. Instead of suspending or limiting Respondent's authority to handle controlled substances, the Board simply chose to heighten monitoring of Respondent's practice. The Deputy Administrator concurs with Judge Randall's conclusion that such action by the Board demonstrates that the Board does not believe Respondent poses a danger to the public health or safety, to the extent that he cannot be trusted with the serious responsibilities of practicing dentistry and handling controlled substances.
Regarding factors two and four, experience in dispensing controlled substances, and compliance with laws related to controlled substances, the Deputy Administrator concurs with Judge Randall's finding that the record shows Respondent clearly has demonstrated a lack of attention to maintaining the necessary state licenses and federal registration to handle controlled substances. While maintaining his license to practice dentistry in Virginia since 1981, Respondent allowed his state license to handle controlled substances lapse in December 1992. The record further shows Respondent continued to prescribe controlled substances without a valid DEA registration number from January 1990 to January 1997, and without state authority from January 1993 to July 1996. The Government correctly asserts that the Respondent's conduct was proscribed by 21 U.S.C. 822(b), 841(a)(1), and 843(a)(2), as well as 21 CFR 1306.03.
The Deputy Administrator concurs with Judge Randall's finding that Respondent's admitted ignorance of his responsibilities as a practitioner are extremely troubling. Not only did Respondent forget to renew his state license and DEA registration over the years, but he also continued to prescribe controlled substances without the authority granted by these licenses. Judge Randall noted that Respondent prescribed Darvocet for a patient in January 1997, while his initial application for the DEA registration at issue was pending. Respondent testified at the hearing that he did not know Darvocet was a controlled substance or in what schedule it was. In fact, Respondent testified he did not know what the term “Schedule IV” meant.
The Deputy Administrator concurs with Judge Randall's conclusion that Respondent's past failures to pay attention to his state license to handle controlled substances and his DEA registration provide ample evidence for the revocation of his DEA Certificate of Registration and the denial of any pending applications for renewal.
The Deputy Administrator also concurs, however, with Judge Randall's findings that Respondent credibly testified that he has been made acutely aware of his licensing obligations since the Board's involvement in his practice since 1997, and also the significance of the Board's decision to continue Respondent's state authorization to handle controlled substances, with conditions, as discussed pursuant to factor one, above.
Regarding factor three, convictions under Federal or State laws relating to controlled substances, the Deputy Administrator finds the record contains no evidence that Respondent has been convicted of a crime related to his handling of controlled substances. Respondent does have a federal misdemeanor conviction for his failure to report his change of address to the DEA.
Regarding factor five, other conduct which may threaten the public health or safety, Judge Randall found the Government's reliance on Respondent's conduct prior to the 1999 DEA renewal of Respondent's registration as a basis for denial was inappropriate. The Deputy Administrator concurs with Judge Randall's conclusion that since the Government knew about this conduct before it renewed Respondent's registration in 1999, it would be inconsistent to now allow the Government to use this information as a basis to revoke Respondent's registration and deny his application for renewal, especially since there is no information in the record of any additional or subsequent misconduct that would warrant a change in DEA's position. The Deputy Administrator has considered and rejected the Government's Exceptions to this finding.
The Deputy Administrator further concurs with Judge Randall's findings that the record demonstrates that Respondent has learned from his past mistakes and has demonstrated sufficient willingness to accept responsibility, as shown by his 1997 guilty pleas to the charges of federal income tax evasion and failure to notify DEA of his change of address. The Deputy Administrator has considered and rejected the Government's Start Printed Page 50464exceptions to Judge Randall's findings in this regard.
Further evidence relevant to this factor was received by the Deputy Administrator subsequent to the transmittal of the record for his final decision. Judge Randall's Recommended Decision included a requirement that, within one year of the final order, Respondent attend a course in the handling and identification of controlled substances, and provide proof to DEA of his completion of the course. Apparently acting upon his own initiative following receipt of Judge Randall's Recommended Decision, Respondent wrote a letter to the attention of Judge Randall wherein he stated that he was unable to find a course concerning controlled substances, but instead had attended “three minor and two major dental meetings” and in a four page attachment had apparently taken the Virginia Board of Dentistry Statutes and Regulations and had apparently handwritten in outline format “all pertinent laws” relating to controlled substances. By letter dated January 25, 2002, Judge Randall transmitted this submission to the Office of the Deputy Administrator, noting also that she “informed both parties that I am forwarding this letter to you for consideration with the record.” While this submission's primary relevance lies in tending to show Respondent's apparent desire to rehabilitate himself, more concrete evidence was soon forthcoming.
By letter dated March 27, 2002, Respondent submitted documentation to the Office of the Deputy Administrator evidencing his attendance of the 70th Annual Nation's Capitol Dental Meeting, held February 28 through March 2, 2002, and sponsored by the District of Columbia Dental Society. Respondent's submission included a Continuing Education Verification Form indicating his attendance at inter alia two Registered Clinics entitled Pharmacology and Therapeutics I and II. The course outline, also submitted, indicated the clinics focused on the proper handling of controlled substances in a dental setting. The Verification Form states that, at the end of each clinical program listed thereon, a verification code will be announced. Respondent's Verification Form listed such a code beside each of the above-mentioned clinics. The Form further stated the verification codes could be checked by contacting the District of Columbia Dental Society. This was done, and Respondent's codes were verified as being correct, indicating his attendance at the clinics.
By letter dated June 18, 2002, the Office of the Deputy Administrator transmitted copies of the two above-referenced submissions to the attention of counsel for the Government in this matter, and granted until close of business June 21, 2002, to provide any response deemed necessary. By letter dated June 21, 2002, the Government objected to the consideration of the submissions as an unauthorized attempt to re-open the record, and further objected on the purported grounds that the Government would be prejudiced by lack of an opportunity to cross-examine the Respondent and introduce rebuttal evidence. The Deputy Administrator hereby rejects the Government's objections for the following reasons. First, the Deputy Administrator finds that this evidence is cumulative, in that it merely reinforces the same conclusion he would have reached in the absence of this evidence. Second, of the two submissions, the March 27, 2002, submission of Respondent's attendance at the Registered Clinics at the 70th Annual Nation's Capitol Dental Meeting carries far more probative weight, for the very reason the Government seeks to object to its consideration—Respondent's attendance at the clinics is objectively verifiable by checking the verification codes. The codes were verified as correct, indicating Respondent's attendance at the clinics. It is hard to conceive what cross examination and rebuttal evidence could accomplish to change that fact.
Therefore, the Deputy Administrator has considered these two submissions, and finds they constitute evidence that Respondent is sincere in his desire to comply with the obligations of a DEA registrant, and that they contribute to the Deputy Administrator's finding that Respondent would not pose a threat to the public health or safety if allowed to maintain a DEA Registration.
The Deputy Administrator concurs with Judge Randall's finding that the Government has met its burden of proof for revocation of the Respondent's Certificate of Registration and denial of the pending renewal application. The Deputy Administrator notes, however, that he must consider all of the facts and circumstances of a particular case when deciding the appropriate remedy. See Martha Hernandez, M.D., 62 FR 61,145, 61,147 (1997). The Deputy Administrator must also consider the Respondent's acceptance of responsibility for past offenses and rehabilitation efforts when deciding the likelihood that the Respondent's future conduct with respect to his DEA registration will be consistent with the public interest as defined by 21 U.S.C. 823(f). See e.g., Michael Alan Patterson, M.D., 65 FR 5,682 (2000).
In the instant case, the Deputy Administrator concurs with Judge Randall's conclusion that the Respondent should be allowed the opportunity to demonstrate that he can now handle the responsibilities of a DEA registrant. The Deputy Administrator further concurs with Judge Randall's determination that the public interest would best be served by monitoring the Respondent's handling of controlled substances during this registration period. Therefore, like Judge Randall, the Deputy Administrator concludes that granting the Respondent a registration, with restrictions, “will allow the Respondent to demonstrate that he can responsibly handle controlled substances in his [dental] practice, yet simultaneously protect the public by providing a mechanism for rapid detection of any improper activity related to controlled substances.” Michael J. Septer, D.O., 61 FR 53,762, 53,765 (1996) (citing Steven M. Gardner, M.D., 51 FR 12,576 (1986)).
Therefore, the Respondent's application shall be granted, pursuant to the following restrictions and conditions:
(1) During the duration of the newly renewed registration, the Respondent must provide the local DEA office with a log of activities on a quarterly basis that shall state: (1) The date that a controlled substance prescription was written, or such substance was administered; (2) the name of the patient for whom the prescription was written, or to whom the substance was administered; (3) the patient's complaint; (4) the name, dosage, and quantity of the substance prescribed, dispensed, or administered; and (5) the date that the medication was last prescribed, dispensed, or administered to that patient, as well as the amount last provided to that patient. If no controlled substances are prescribed, administered, or dispensed during a given quarter, the Respondent shall indicate that fact in writing, in lieu of submission of the log.
(2) Within 30 days of the event, the Respondent must inform the local DEA office of any action taken by any state upon his medical license or upon his authorization to handle controlled substances within that state.
(3) Should the Respondent change employment during this registration period, he shall immediately notify the local DEA office that is monitoring his log of activities.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the Start Printed Page 50465authority vested in him by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the application for renewal of his registration submitted by Gregory D. Owens, D.D.S., be, and it hereby is, granted subject to the above described restrictions. This order is effective upon the issuance of the DEA Certificate of Registration, but no later than September 3, 2002.Start Signature
Dated: July 24, 2002.
John B. Brown, III,
[FR Doc. 02-19530 Filed 8-01-02; 8:45 am]
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