Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices 36751 

Wholesale Distributors be, and it hereby 

is, dismissed. This Order is effective 

immediately. 

Dated: July 16, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–17688 Filed 7–23–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 06–77] 

Gregory D. Owens, D.D.S.; Suspension 

of Registration; Grant of Restricted 

Registration 

On August 7, 2007, the Deputy 

Assistant Administrator, Office of 

Diversion Control, issued an Order to 

Show Cause to Gregory D. Owens, 

D.D.S. (Respondent), of Abingdon, 

Virginia. The Show Cause Order 

proposed the revocation of 

Respondent’s DEA Certificate of 

Registration as a practitioner on the 

ground that his continued ‘‘registration 

would be inconsistent with the public 

interest, as that term is defined under 21 

U.S.C. 823(f).’’ Show Cause Order at 1. 

More specifically, the Show Cause 

Order alleged that in 1986, when 

Respondent moved his dental practice 

from Tennessee to Virginia, he had 

failed to obtain a new registration as 

required by 21 U.S.C. 822. Id. The Order 

further alleged that in 1992, Respondent 

did not renew his State ‘‘controlled 

dangerous substances license’’ and that 

he only acquired the proper State and 

Federal registrations in 1996 after a 

Virginia Board of Dentistry (‘‘the 

Board’’) inspection. Id. Relatedly, the 

Order alleged that in 1996 and 1997, 

Respondent had ‘‘continued to prescribe 

controlled substances in violation of 

law,’’ using his ‘‘long-expired DEA 

Tennessee registration to facilitate this 

illegal activity.’’ Id. 

Next, the Show Cause Order alleged 

that in both November 1997 and May 

2000, the Board had placed 

Respondent’s dental license on 

probation and subjected him to certain 

conditions. Id. at 1–2. The Order also 

alleged that in August 2005, the State 

Board had ‘‘issued an Order which 

concluded that [Respondent] had 

continuously demonstrated disregard 

for the Board’s orders,’’ reprimanded 

him, and continued him on probation. 

Id. at 2. 

Finally, the Show Cause Order alleged 

that in October 1999, DEA had issued an 

Order to Show Cause to revoke 

Respondent’s registration, and that on 

August 2, 2002, my predecessor had 

issued a Decision and Final Order 

which granted Respondent a registration 

which was ‘‘subject to restrictions and 

conditions’’ including ‘‘recordkeeping 

requirements.’’ Id. at 1. The Show Cause 

Order further alleged that in November 

2005, Respondent applied for a renewal 

of his registration and that a compliance 

review found ‘‘that in 2004 and 2005, 

[Respondent had] failed to submit the 

required controlled substance 

recordkeeping information to DEA in 

violation of the conditions of [the] 

previously granted registration.’’ Id. at 2. 

Respondent, through his counsel, 

timely requested a hearing. The case 

was assigned to a DEA Administrative 

Law Judge (ALJ), who conducted a 

hearing in Abingdon, Virginia, on June 

27, 2007. At the hearing, both parties 

called witnesses to testify and 

introduced documentary evidence. 

Following the hearing, both parties 

submitted briefs containing proposed 

findings of fact, conclusions of law, and 

argument. 

On March 6, 2009, the ALJ issued her 

recommended decision (also ALJ). 

Therein, the ALJ found that Respondent 

had violated the terms of my 

predecessor’s Final Order by failing to 

file quarterly reports of the controlled 

substances he dispensed between the 

effective date of the Order (Sept. 3, 

2002) and December 31, 2002, the date 

stated as the expiration date on a 

registration which was subsequently 

issued to him several months after the 

expiration date and which was the 

result of a clerical error. ALJ at 37–39. 

However, the ALJ further found that 

Respondent’s failure to file the reports 

after that date should be excused 

because the Government did not clearly 

communicate to him that this 

registration was issued in error and that 

a registration issued to him on 

September 8, 2003 (which expired on 

December 31, 2005) was the ‘‘newly 

renewed registration’’ to which the 

reporting requirement imposed by the 

2002 Order applied. Id. at 39. However, 

she also found that because Respondent 

did not present evidence that he had 

submitted the required drug activity 

logs from August 2002 through 

December 2002, Respondent’s ‘‘lack of 

evidence proving good faith compliance 

weigh[ed] against the Respondent’s 

continued registration.’’ Id. at 40. 

The ALJ also found that Respondent 

had not complied with a second 

requirement of the 2002 Order—that he 

notify DEA within thirty days of any 

action taken against his State ‘‘medical 

license.’’ Id. at 40–41. According to the 

ALJ, Respondent violated this provision 

because he failed to report the 2005 

Board action which continued his 

probation upon finding that he had 

committed additional violations. Id. at 

41. In so holding, the ALJ specifically 

rejected Respondent’s contention that 

because the 2002 Order had used the 

term ‘‘medical license’’ rather than 

‘‘dental license’’ in imposing the 

condition, he had no obligation to report 

the proceeding to DEA. Id. 

While the ALJ found that the 

Government had made out a prima facie 

case to revoke Respondent’s registration, 

she concluded that other factors 

counseled against a revocation. Id. at 47. 

More specifically, she noted that 

Respondent treated ‘‘many patients from 

underserved counties, and a substantial 

portion of his patients have limited 

incomes,’’ that there was no evidence of 

diversion or irresponsible prescribing 

practices on Respondent’s part, that 

Respondent had instituted procedures 

to ensure the accuracy of his dental 

records, and that he had begun filing 

drug activity reports with this Agency 

following a 2006 inspection. Id. at 48. 

The ALJ thus recommended the 

revocation of Respondent’s registration 

but that the revocation be stayed for 

twelve months, and that ‘‘[d]uring 

pendency of the stay, the Respondent 

should be allowed to handle controlled 

substances,’’ subject to certain 

restrictions. Id. 

Neither party filed exceptions to the 

ALJ’s decision. Thereafter, the record 

was forwarded to me for final agency 

action. 

Having considered the record as a 

whole, I hereby issue this Decision and 

Final Order. I adopt the ALJ’s findings 

of fact and conclusions of law except as 

noted below. While I accept 

Respondent’s contention that the March 

13, 2003 registration was the ‘‘newly 

renewed registration’’ for purposes of 

the 2002 Order, I note that Respondent 

did not comply with the Order’s 

requirement pertaining to the 

submission of quarterly reports even 

during period in which there is no 

dispute that he was required to do so. 

I also hold that Respondent violated the 

2002 Order because he failed to report 

the 2005 Board action to DEA. While I 

agree that the record does not support 

an outright revocation of his 

registration, I conclude that 

Respondent’s lengthy history of 

regulatory troubles supports the 

suspension of his registration as well as 

the imposition of conditions on his new 

registration. I make the following 

findings. 

Findings 

Respondent graduated from the 

Medical College of Virginia Dental 


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1Respondent previously held a DEA registration 

which was issued on February 4, 1997, and which 

expired on December 31, 1999. ALJ at 5. On October 

1, 1999, the first DEA proceeding was initiated. RX 

42, at 2. On November 8, 1999, Respondent filed 

a renewal application, id. at 9, the effect of which 

was to extend the expiration date of his registration 

until the Agency issued its Decision and Final 

Order resolving the first proceeding, which it did 

on July 24, 2002. See Gregory D. Owens, 67 FR 

50461, 50465 (2002) (RX 1, at 5). 

On March 13, 2003, Respondent was issued a 

new Certificate of Registration. RX 2. However, the 

Certificate stated that it had expired on ‘‘12–31– 

2002.’’ Id. According to the registration history, this 

Certificate was issued in error. Tr. 85. However, the 

fact that it was issued in error was not 

communicated to Respondent. Id. at 85–86. It is not 

clear whether Respondent filed a further 

application to obtain the Certificate which was 

issued on September 8, 2003. 

It is also noted that registration certificate which 

expired on December 31, 2005, did not contain any 

indication that it was subject to restrictions. Tr. 53. 

DEA does not, however, indicate on the face of a 

certificate whether a registration is subject to 

restrictions. Id. at 53–54. 

2On or about January 30, 1997, in the United 

States District Court, Abingdon, Virginia, 

Respondent pled guilty to five (5) misdemeanor 

counts of Failure to File Federal Tax Returns, and 

was sentenced to five months of home detention 

and fined $10,000. GX 13, at 1, 2 & 5. 

3The November 24, 1997 order was part of the 

grounds of the prior DEA action. See RX 1, at 2; see 

also Owens, 67 FR 50461, 50462. 

4The proceeding was also based on the results of 

a September 8, 1999 inspection, which revealed 

various deficiencies related to Respondent’s alleged 

violation of the laws and regulations governing the 

practice of dentistry. GX 6, at 1–2. 

5Respondent was required to submit quarterly 

reports of his address and current employment as 

part of this Order as well as the 1997 Order. See 

GX 7, at 4. 

6More specifically, the Board alleged that 

Respondent had ‘‘failed to consistently provide the 

signature of the dentist completing laboratory work 

order and the address of the dental practice,’’ and 

that he had kept expired drugs (none of which are 

controlled under Federal law) in his working stock. 

GX 8, at 1–2. 

7Respondent was again required to submit 

quarterly report noting his address and current 

employment. GX 9, at 4. 

School, now the Virginia 

Commonwealth University Dental 

School, in 1981. Tr. 151. Respondent is 

licensed to practice dentistry in the 

State of Virginia and practices in 

Abingdon (Washington County), 

Virginia. Id. at 150–52, 163. Respondent 

performs root canals and tooth 

extractions and often issues a 

prescription for a controlled substance 

to treat a patient’s post-operative pain. 

Id. at 160. 

Respondent’s last DEA Certificate of 

Registration was issued on September 8, 

2003, and had an expiration date of 

December 31, 2005.1 RX 3; GX 1, at 1. 

On or about November 21, 2005, 

however, Respondent submitted a 

renewal application. GX 2, at 1–2. 

Accordingly, Respondent’s registration 

has remained in effect throughout the 

course of this proceeding. 

While Respondent currently holds 

both a DEA registration and a State 

license, he is not a stranger to either 

DEA or Board proceedings (nor to 

Federal criminal proceedings either). 

Indeed, Respondent has been 

disciplined by the Virginia Board on 

three occasions and has been the subject 

of DEA proceedings on two occasions. 

The State Proceedings 

The first of these proceedings began 

in October 1997, when the Board’s 

Executive Director gave notice and 

ordered Respondent to appear at an 

informal conference based in part on 

allegations that an inspection of four of 

his patient records had found that in 

two of them, he had ‘‘failed to list drugs 

prescribed, dispensed, administered and 

the quantity.’’ GX 4, at 2. In the notice, 

the Board also alleged that ‘‘on divers 

occasions since March 31, 1986, 

[Respondent] ha[s] prescribed various 

controlled substances for patients, 

including but not limited to Demerol, 

Percocet, Percodan, Endocet (all 

Schedule II), and hydrocodone 

(Schedule III), without a current DEA 

number.’’ Id. The Board further alleged 

that ‘‘from December 31, 1992 to July 

1996, [Respondent had] issued said 

prescriptions without having a current 

Controlled Substance Registration 

Certification.’’ Id. Finally, the Board 

alleged that ‘‘[o]n or about June 30, 

1997, in the United States District Court, 

Abingdon, Virginia, [Respondent] w[as] 

found guilty of one count of Failure to 

report change of address to DEA, a 

misdemeanor.’’ 2 GX 4, at 2. See also GX 

14 (judgment finding that defendant had 

pled guilty to violations of 21 U.S.C. 

842(a)(5) & (c)(2), fining him $5000, and 

sentencing him to two years of 

supervised release). 

On November 5, 1997, the Board 

found the above allegations (as well as 

others) proved. GX 5, at 2–3. The Board 

imposed various sanctions including a 

reprimand, subjected him to one 

unannounced inspection annually, and 

placed him on probation 

indefinitely.3 Id. at 3. 

On March 21, 2000, the State Board 

commenced a second proceeding. This 

proceeding was based, in part, on a 

September 9, 1998 review of 

Respondent’s drug inventory and 

records which found that Respondent 

had on hand two boxes, which had 

originally contained twelve bottles each 

of dihydrocodeine tablets but, at the 

time of the inspection, held only eight 

bottles each. GX 6, at 2. The Board 

further alleged that Respondent had 

‘‘failed to take a complete and accurate 

biennial inventory of the schedule III 

and V drugs maintained,’’ that he 

‘‘failed to maintain a record of drugs 

received to include the date of receipt, 

the name and address from whom 

received and the kind and quantity of 

drugs received,’’ and that he had ‘‘failed 

to maintain a record of drugs received 

to include the date of receipt, the name 

and address for which the drugs were 

dispensed, and the kind and quantity of 

drugs.’’ GX 6, at 2–3.4

On May 8, 2000, the Board found that 

Respondent had violated certain terms 

of its 1997 Order as well as various 

provisions of the Virginia Code and the 

Board of Dentistry Regulations. GX 7, at 

1–2, 4. Pertinent to the Controlled 

Substances Act, the Board specifically 

found proved the allegations pertaining 

to Respondent’s handling of the 

dihydrocodeine tablets, including his 

failure to take biennial inventories of 

schedule III and V drugs, and to 

maintain proper records of both the 

drugs received and dispensed. Id. at 3. 

The Order reprimanded Respondent and 

continued his probation 

‘‘INDEFINITELY,’’ subjected him to two 

unannounced inspections annually and 

a reporting requirement,5 and imposed 

a monetary penalty of $ 5000. Id. at 4– 

5 (emphasis in original). 

On July 26, 2005, the Board 

commenced a third proceeding. This 

proceeding was initiated ‘‘to receive and 

act upon [Respondent’s] petition for 

termination of [his] probation, to review 

[his] compliance with the terms and 

conditions imposed on [his] license by 

[the Board’s 2000 Order], and to receive 

and act upon evidence that [he] may 

have violated certain laws and 

regulations governing the practice of 

dentistry.’’ GX 8. More specifically, the 

Board alleged that Respondent had been 

delinquent in submitting multiple 

reports, and that an unannounced 

inspection on February 9, 2005 had 

found that he ‘‘may have violated’’ State 

law and regulations pertaining to the 

practice of dentistry.6 Id. at 1–2. 

On September 6, 2005, the Board 

entered an Order which found each of 

the allegations proved. GX 9, at 2–3. The 

Order further found that Respondent 

‘‘has continuously demonstrated 

disregard for the Board’s Orders.’’ Id. at 

3. The Board thus reprimanded 

Respondent, levied an $11,000 penalty, 

and denied Respondent’s request to 

terminate his probation, which was 

continued indefinitely.7 Id. at 3–4. The 

Order provided that Respondent’s 

probation ‘‘shall continue from the date 

this Order is entered and shall continue 

indefinitely.’’ Id. at 4. 


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8My predecessor adopted the ALJ’s 

recommended conditions nearly verbatim with the 

exception of the first recommended condition 

which was that Respondent take a course in the 

identification and handling of controlled 

substances. RX 42, at 19. 

9Respondent objected to the Government’s 

questioning the DI regarding Respondent’s failure to 

submit the drug logs in the years prior to 2004 and 

2005 on the ground that neither the Show Cause 

Order nor the Government’s pre-hearing statement 

had disclosed that this would be at issue. Tr. 44– 

46. Respondent, however, did not object when the 

Government had previously asked the DI: ‘‘What log 

of activities were received by DEA from 

[Respondent] after the date of the issuance of this 

order on August 2, 2002?’’ and the DI answered: 

‘‘There were no activity logs or drug logs submitted 

after August of 2002 until after we visited Dr. 

Owens’ office in 2006.’’ Id. at 42–43. Notably, when 

the DI continued with his answer and the 

Government’s counsel interrupted him, 

Respondent’s counsel did not object to the line of 

questioning but only that ‘‘the witness be allowed 

to complete his answer.’’ Id. at 43. The DI then 

explained that in 2007, Respondent’s attorney had 

‘‘submitted all the drug logs that were kept.’’ Id. 

Respondent’s objection was untimely and was 

properly overruled for this reason as well. 

In October 2006, the Board conducted 

an inspection of Respondent’s dental 

practice and found no deficiencies. RX 

13, at 5. Subsequently, in April 2007, 

the Board notified Respondent that he 

was in compliance with the Board’s 

Order of September 6, 2005, and that no 

action would be taken against his dental 

license. RX 23. 

The First DEA Proceeding 

On October 1, 1999, the Deputy 

Assistant Administrator of the Office of 

Diversion Control issued an Order to 

Show Cause which sought the 

revocation of Respondent’s registration 

on the ground that Respondent had 

committed various acts which rendered 

his registration inconsistent with the 

public interest. RX 1, at 1 (Gregory D. 

Owens, 67 FR 50461 (2002)). More 

specifically, the Show Cause Order 

alleged that: (1) Between January 1990 

and January 1997, Respondent had 

prescribed approximately 8,600 dosages 

units of controlled substances using his 

DEA Registration number, which had 

expired on August 5, 1986; (2) 

Respondent had issued controlledsubstance prescriptions between May 1 

and November 14, 1996, without 

holding a valid State controlledsubstance registration; and (3) 

Respondent had pled guilty to failing to 

report his change of address to DEA. RX 

42, at 2–3. 

Following a hearing, on May 4, 2001, 

the ALJ issued her recommended 

decision. Id. at 1. Therein, the ALJ 

found that between January 1990 and 

January 1997, Respondent had issued 

controlled-substance prescriptions 

without a valid DEA registration; she 

also found that from January 1993 until 

July 1996, he had issued controlledsubstance prescriptions without a valid 

State registration. Id. at 14–15. While in 

the first proceeding Respondent testified 

that he did not intend to violate Federal 

law, the ALJ also found significant that 

Respondent had prescribed Darvocet 

(also a controlled substance) at the time 

when his 1996 application was pending 

but had yet to be renewed. Id. at 15. The 

ALJ, however, recommended that my 

predecessor consider ‘‘Respondent’s 

acceptance of responsibility for past 

offenses and rehabilitation when 

deciding the likelihood that [his] future 

conduct * * * will be consistent with 

the public interest,’’ and that 

Respondent be allowed ‘‘to demonstrate 

that he can now handle the 

responsibilities a DEA registrant.’’ Id. at 

18. The ALJ thus recommended that my 

predecessor grant Respondent a new 

registration subject to various 

conditions.8 Id. at 19–20. 

On July 24, 2002, the Deputy 

Administrator issued his final decision 

in the matter, which was effective no 

later than September 3, 2002. See 

Gregory D. Owens, 67 FR 50461, 50465 

(2002). The Order granted Respondent’s 

application for renewal of his 

registration subject to the following 

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 of 

any action taken by any State upon his 

medical license or upon his authorization to 

handle controlled substances in 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. 

Id. at 50464. 

Respondent’s Compliance With the 

2002 DEA Order 

After receiving the ALJ’s 

recommended decision (and before the 

2002 Decision and Final Order was 

issued), Respondent began filing 

quarterly drug activity logs with the 

Agency. Tr. 43 & 169; see also id. at 70– 

71 (Respondent’s counsel asking DI 

whether Respondent had started 

sending in the drug logs following his 

receipt of the ALJ’s decision). While not 

part of the ALJ’s recommended sanction 

(or subsequently required by the 

Agency’s Final Order), Respondent 

started using a carbon-copy prescription 

pad and faxing prescriptions to 

pharmacies so that the original 

prescription could go in the patient file 

and the carbon copy could be 

maintained as a record to double-check 

the drug activity log. Id. at 135 & 169. 

However, following the issuance of 

the Final Order, Respondent stopped 

sending in the quarterly activity logs. Id. 

at 42–43; 51. When asked by the 

Government on cross-examination how 

many quarterly reports he had sent to 

DEA following the issuance of the Final 

Order and the date he thought his 

obligation to file the reports had ended, 

Respondent testified that he did not 

know and did not have that information 

with him because he was ‘‘just prepared 

to talk about 2004 and 2005.’’ Id. at 186. 

On redirect examination, Respondent 

further maintained that he was not 

prepared to testify about what happened 

in 2001 and 2002 because the 

Government had not given him notice 

that this would be at issue in the Show 

Cause Order and other documents. Id. at 

191. 

Yet on direct examination, 

Respondent had testified that when he 

received the ALJ’s May 2001 decision, 

he ‘‘began sending in our quarterly 

reports.’’ Id. at 169.9 He also testified 

that he believed—and had told the DI— 

‘‘that the newly renewed registration 

referred to in the DEA’s decision had 

expired.’’ Id. at 162. 

Regarding the 2002 Order’s 

requirement that he notify the Agency 

‘‘within 30 days’’ of ‘‘any action taken 

by any State upon his medical license,’’ 

67 FR at 50464, Respondent testified 

that he has never had a medical license 

and that he has a dental license. Tr. 163 

& 178. With respect to the 2005 State 

Board proceeding, in which the Board 

had reprimanded him, fined him, 

rejected his petition to terminate and 

continued him on probation, 

Respondent maintained that the Board 

had not taken action against his license 

because there was no change in the 

status of his license. Id. at 165. 

Amplifying this testimony, Respondent 

stated: ‘‘My license was under probation 

and it did not change. Nothing changed 


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10The letter is not in the record. 

11Most of the logs pertaining to this period 

(including those pertaining to the period between 

the issuance of the 2002 Order and December 31, 

2002) are not in evidence. 

The ALJ found that these drug activity logs did 

not meet the requirements of the 2002 Decision and 

Order as they ‘‘failed to record when and the 

amount of controlled substances that had last been 

provided to the patient.’’ ALJ at 18 (citing Tr. 185; 

RX 42, at 19; RX 1, at 4). It is noted that the Drug 

Log for the period September 18, 2005, through 

January 18, 2006, was frequently missing 

information such as ‘‘the patient’s complaint,’’ as 

well as the date the medicine was last prescribed 

to the specific patient and the quantity. Compare 

GX 10 with GX 3, at 6–7. Neither party, however, 

submitted the drug logs for the period between the 

issuance of the 2002 Order and December 31, 2002. 

12Respondent offered into evidence affidavits of 

three other dentists, who variously declared that he 

is ‘‘an asset to the dental community in the 

Abingdon, Virginia area,’’ ‘‘an excellent asset to the 

dental and general community,’’ and an ‘‘excellent 

dentist who uses good dental techniques.’’ RXs 15– 

17. 

Respondent also put on extensive evidence 

regarding the socioeconomic status of his patients 

and the shortage of dentists in the area where he 

practices. However, for reasons discussed below, I 

conclude that it is not necessary to engage in factfinding on these issues. 

13 DEA has the burden of proving that the 

requirements for revocation are met. 21 CFR 

1301.44(e). However, if the Government makes out 

a prima facie case, the burden shifts to the 

Respondent to demonstrate that the continuation of 

his registration is consistent with the public 

interest. 

on my license itself. I guess you could 

split hairs.’’ Id. at 181. He also 

maintained that his obligation to report 

any Board actions against his license 

had expired on December 31, 2002, 

based on the expiration date of the 

registration certificate, although he 

acknowledge that ‘‘I don’t think it’s 

quite as clear as on the other one.’’ Id. 

at 188. 

The 2006 DEA Investigation 

On November 21, 2005, Respondent 

submitted an application to renew his 

registration. GX 2, at 2. On January 19, 

2006, two DEA DIs, who were 

accompanied by a member of the 

Virginia State Police, inspected 

Respondent’s office and inquired as to 

why Respondent had not submitted the 

drug activity logs in 2004 and 2005. Tr. 

23, 33–34. Respondent told the 

investigators that ‘‘he wasn’t aware of 

that’’ and showed them a copy of the 

ALJ’s ruling. Id. at 65–66. The 

investigators also determined that 

Respondent did not have any Federally 

controlled substances on the premises 

and reviewed a drug log that he had 

kept since September 18, 2005. Id. at 

34–35; see also GX 10. 

The DIs then looked at Respondent’s 

appointment book and selected sixtyeight patient records to review to 

determine whether the controlled 

substances Respondent had prescribed 

had been recorded in the drug log. Id. 

at 38–39. According to the DI, there 

were seven instances in which a 

prescription which was recorded in a 

patient file was not listed in the drug 

log. Id. at 39, 60–61. The DI further 

acknowledged that Respondent 

consented to the inspection and was 

cooperative, id. at 54–55, and that he 

had no evidence that Respondent 

engaged in the diversion of controlled 

substances. Id. at 58. 

The next day, Respondent had a 

telephone conversation with one of the 

DIs and asked him ‘‘exactly what was 

the term of a newly renewed 

registration.’’ Id. at 63. The DI did not 

directly answer the question and instead 

told Respondent that ‘‘we would take a 

look at’’ the information that had been 

obtained. Id. According to the DI, during 

the conversation, Respondent told him 

that he had found a letter which 

explained what the requirements 

were.10 Id. at 67. Respondent testified 

that he ‘‘didn’t believe’’ that he was 

required to submit records in 2004 and 

2005 because he thought the ‘‘newly 

renewed registration referred to in the 

DEA’s decision had expired.’’ Id. at 

161–62. 

In his testimony, the DI further 

testified that the Certificate of 

Registration which was issued on March 

13, 2003, and which had expired on 

December 31, 2002, was not his new 

registration, but rather ‘‘a continuation 

of his previous registration.’’ Id. at 84. 

He further maintained that this 

registration certificate was issued in 

error and pointed to an administrative 

code, which indicated as much, on 

Respondent’s registration history. Id. at 

85; see also GX 15. However, the DI was 

aware of no evidence that this 

information had been communicated to 

Respondent. Id. at 86. 

On March 16, 2006, Respondent’s 

counsel submitted the drug activity logs 

from July 2002 through December 2005 

to the DI. RX 22. In his letter forwarding 

the logs, Respondent’s counsel 

maintained that, based on the 2002 

Order, Respondent ‘‘is under no duty to 

provide these to the DEA.’’ 11 Id. 

Relatedly, Respondent testified that he 

submitted the drug activity logs out of 

‘‘an abundance of caution’’ because it 

was ‘‘difficult to know exactly what [he 

was] supposed to do.’’ Tr. 183. 

Respondent’s Evidence Regarding 

Remedial Measures 

On September 2, 2006, Respondent 

entered into a consulting agreement 

with a registered nurse, who was to 

review his compliance with DEA 

regulations on a monthly basis. RX 5, at 

1, 5. Moreover, at the end of each 

month, the consultant audits all the 

patient charts that are listed in the drug 

activity log. Tr. 106. The consultant also 

goes through the appointment book and 

randomly selects twenty-five patient 

charts which she reviews to see if any 

prescriptions were not entered into the 

drug activity log. Id. The entries in the 

drug activity log are also checked 

against the patient charts for accuracy. 

RX 6. The consultant then provides a 

monthly report of both the drug activity 

log audit and the random patient chart 

audit. Tr. 106; RXs 7–13. According to 

the consultant, Respondent’s 

recordkeeping is now ‘‘well organized’’ 

and ‘‘efficient’’ and Respondent is 

capable of providing ‘‘accurate’’ records 

to this Agency.12 Tr. 113–14. 

Discussion 

Section 304(a) of the Controlled 

Substances Act (CSA) provides that a 

registration to ‘‘dispense a controlled 

substance * * * may be suspended or 

revoked by the Attorney General upon 

a finding that the registrant * * * has 

committed such acts as would render 

his registration under section 823 of this 

title inconsistent with the public 

interest as determined under such 

section.’’ 21 U.S.C. 824(a)(4). With 

respect to a practitioner, the CSA 

requires that the following factors be 

considered in making the public interest 

determination: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing * * * controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

21 U.S.C. 823(f). 

These factors are considered in the 

disjunctive; I ‘‘may rely on any one or 

a combination of factors and may give 

each factor the weight [I] deem[] 

appropriate’’ in determining whether a 

registration should be revoked and/or an 

application should be denied. Robert A. 

Leslie, 68 FR 15227, 15230 (2003). 

Moreover, case law establishes that I am 

‘‘not required to make findings as to all 

the factors.’’ Hoxie v. DEA, 419 F.3d 

477, 482 (6th Cir. 2005); see also Morall 

v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 

2005).13


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14As my predecessor noted in the 2002 Decision 

and Order, the various orders issued in the State 

board proceedings are not in any sense an ‘‘official 

recommendation regarding this proceeding’s 

outcome.’’ 67 FR at 50463. Moreover, a State board 

may apply a different standard than the public 

interest standard applicable under the CSA and 

thus consider factors which DEA does not consider 

relevant. Thus, I give this factor only nominal 

weight. 

15 I further note Respondent’s misdemeanor 

conviction for failing to notify DEA of his address 

change. See 21 U.S.C. 823(f)(3). 

16Under DEA regulations, ‘‘[a] registered 

individual practitioner is required to keep records 

* * * of controlled substances in Schedules II, III, 

IV, and V which are dispensed, other than by 

prescribing or administering in the lawful course of 

professional practice.’’ 21 CFR 1304.03(b). 

17 It is unclear, however, how many tablets were 

in each bottle. 

18Moreover, on cross-examination Respondent’s 

Counsel asked the DI whether Respondent had 

started sending in the drug logs following his 

receipt of the ALJ’s Decision. Tr. 70–71. 

19Furthermore, while the ALJ denied 

Respondent’s request for a continuance to gather 

the evidence that would show that the logs were 

sent in during the period between the issuance of 

the 2002 Order and December 2002, the ALJ made 

clear that Respondent could renew his request at 

‘‘the conclusion of the presentation of [the] 

evidence’’ and noted that the record could be left 

open for this purpose. Tr. 48–49. Respondent did 

not, however, request that the record be left open 

or submit any such reports. 

Factor One: The Recommendation of 

the State Licensing Board 

As found above, Respondent had been 

the subject of three separate State board 

proceedings and been disciplined on 

each occasion. Moreover, the first two 

proceedings involved violations which 

did not simply involve violations of 

State rules pertaining to the practice of 

dentistry but also violations of the CSA 

and DEA’s regulations. 

The ALJ noted that in the 2002 

Decision and Order, the Agency had 

concurred with her conclusion that 

because the Board had not restricted 

Respondent’s ability to handle 

controlled substances, this 

‘‘demonstrate[d] that the Board does not 

believe Respondent poses a danger to 

the public health and safety, to the 

extent that he cannot be trusted with the 

serious responsibilities of practicing 

dentistry and handling controlled 

substances.’’ ALJ at 34–35 (quoting 

Owens, 67 FR at 50463). Remarking on 

the 2005 Board proceeding and the 

April 2007 Board letter which closed 

the case, the ALJ found it ‘‘significant 

that in all orders, the Board chose not 

to restrict Respondent’s handling of 

controlled substances,’’ and that this 

factor ‘‘weighs in favor of continuing the 

Respondent’s DEA Certificate of 

Registration.’’ Id. at 35–36. 

While DEA has frequently considered 

State board proceedings which do not 

result in a revocation or suspension 

under this factor, the Agency 

‘‘maintains a separate oversight 

responsibility with respect to the 

handling of controlled substances and 

has a statutory obligation to make its 

independent determination’’ as to 

whether the continuation of an existing 

registration is in the public interest. 

Mortimer B. Levin, 55 FR 8209, 8210 

(1990); see also Jayam Krishna-Iyer, 74 

FR 459, 462 (2009).14 Accordingly, 

while I concur in the ALJ’s conclusion 

regarding this factor, I give it only 

nominal weight in the public interest 

inquiry. See Martha Hernandez, 62 FR 

61145, 61147 (1997) (finding that State 

board decisions are relevant, although 

not dispositive, on the issue of granting 

or denying a DEA application). 

Factors Two and Four: Applicant’s 

Experience in Dispensing Controlled 

Substances and Compliance With 

Applicable State, Federal or Local Law 

The record in this matter establishes 

a pattern of Respondent’s noncompliance with the requirements of 

both State and Federal Law relating to 

controlled substances. More 

specifically, for at least seven years, 

Respondent violated Federal law by 

issuing prescriptions for both schedule 

II and III controlled substance based on 

an expired registration.15 See 21 U.S.C. 

822(a)(2); see also 21 U.S.C. 843(a)(2). 

He also violated Virginia law, which at 

the time required that he also hold a 

State registration, for more than three 

years. 

Subsequently, the Virginia Board 

found that Respondent was in violation 

of various State rules because he had on 

hand a stock of schedule III controlled 

substances and was not taking 

inventories and maintaining both 

receiving and dispensing records.16

Moreover, the findings of the Board 

establish that Respondent could not 

account for eight bottles of 

dihydrocodeine, a schedule III 

controlled substance.17 GX 7, at 3. 

The central issue in this case was, 

however, Respondent’s compliance with 

the terms of this Agency’s 2002 Order. 

More specifically, the Government 

contended that Respondent had failed to 

comply with the requirements that he 

submit drug activity logs each quarter 

and notify DEA of any action taken 

against his ‘‘medical license.’’ 

With respect to the first issue, 

Respondent raises several contentions. 

First, he argues that his rights under the 

Due Process Clause and the 

Administrative Procedure Act were 

violated because the Government was 

allowed to introduce evidence regarding 

his compliance with the 2002 Order 

pertaining to years which were not 

alleged in the Show Cause Order (which 

alleged that he had not complied during 

the years 2004 and 2005) or in the 

Government’s Pre-Hearing Statement. 

Resp. Br. at 21. Respondent also argues 

that ‘‘he had no notice to prepare for or 

to rebut the testimony as to the years 

before 2004.’’ Id. Relatedly, Respondent 

contends that ‘‘[o]ver [his] objection, the 

ALJ allowed the Government to inquire 

into [his] reporting before 2004.’’ Id. at 

25. 

Respondent did not, however, timely 

object to the Government’s questioning 

the DI as to what logs have been 

received after the issuance of the Order 

on August 2, 2002. Tr. 42–43. Indeed, 

Respondent’s counsel objected that the 

Government had not allowed the DI to 

complete his answer. Id. at 43. Nor did 

Respondent object to the Government’s 

subsequent question as to what logs he 

had submitted prior to the issuance of 

the 2002 Order. Id. Rather, Respondent 

did not object until after the 

Government had asked several 

additional questions. Id. at 43–44. I thus 

conclude that Respondent waived his 

objection to the admission of this 

evidence.18

Finally, even if it was error for the 

ALJ to allow the Government to pursue 

this line of questioning, the error was 

not prejudicial. See 5 U.S.C. 706. 

Notably, on direct examination, 

Respondent testified that after receiving 

the ALJ’s recommended decision, which 

was issued in May 2001, ‘‘[W]e began 

sending in our quarterly reports.’’ Tr. 

168–69. Thus, Respondent went into 

areas that pre-dated the time-frame 

referenced in the Show Cause Order and 

Government’s Pre-Hearing Statement. 

Moreover, on direct examination, 

Respondent maintained that he was not 

required to file the reports because he 

believed ‘‘that the newly renewed 

registration referred to in the [2002] 

decision had expired.’’ Id. at 162. Given 

his testimony that he had started 

sending in the reports after receiving the 

ALJ’s May 2001 decision and that he 

believed his obligation ended based on 

the expiration of the erroneously issued 

registration, the contention that his 

compliance during the four-month 

period in which it is undisputed that he 

was required to submit the reports is not 

properly at issue, amounts to trying to 

have his cake and eat it too.19

I am also unpersuaded by 

Respondent’s contention that he was 

‘‘not prepared to testify about what 

happened in 2001 and 2002’’ because 


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20Under the APA, Respondent’s November 1999 

renewal application provided authority only ‘‘until 

the application ha[d] finally been finally 

determined by the agency.’’ 5 U.S.C. 558(c). The 

final determination on this application was the 

2002 Decision and Final Order which granted the 

application. 

21See also RX 42, at 19 (ALJ’ s recommended 

sanction that ‘‘Respondent must inform the DEA of 

any action taken by any State upon his medical 

license’’). 

the Government failed to give notice. Tr. 

191. Respondent’s testimony that he 

started sending in the reports after 

receiving the ALJ’s May 2001 decision 

demonstrates that he was obviously 

prepared to discuss what happened in 

2001 and 2002. I therefore reject 

Respondent’s contention that his rights 

under the Due Process Clause and APA 

were violated because the Government 

introduced evidence regarding his noncompliance with the Order. 

As found above, the record establishes 

that Respondent did not submit any 

drug activity logs as required by the 

2002 Decision and Final Order. I 

conclude, however, that Respondent 

cannot be deemed to have violated the 

terms of the Order subsequent to 

December 31, 2002. 

The Order expressly stated that it was 

granting Respondent’s renewal 

application and that it was effective ‘‘no 

later than September 3, 2002.’’ GX 3, at 

7. Thus, while the certificate issued on 

March 13, 2003, indicated that it had 

expired on December 31, 2002, and the 

evidence indicates that it was issued in 

error, the registration could be 

reasonably interpreted as having granted 

authority to Respondent for the period 

between September 3 and December 31, 

2002.20

Throughout this proceeding, the 

Government has contended that 

Respondent’s obligation to submit the 

quarterly drug activity logs did not end 

with the expiration date indicated on 

this registration. The Government 

further contends that the actual 

registration the 2002 Order referred to 

was that which issued on September 8, 

2003, and which expired on December 

31, 2005. 

It is acknowledged that my 

predecessor likely used the phrase— 

‘‘[d]uring the duration of the newly 

renewed registration’’—intending that 

the first condition would last for the 

period of a full registration. Under 

DEA’s regulations, a practitioner’s 

registration is typically valid for thirtysix months, see 21 CFR 1301.13(d)), and 

not for only four months. 

The Government ignores, however, 

that Due Process requires that when the 

Agency imposes conditions on a 

registration, those conditions must be 

‘‘sufficiently clear to inform’’ a 

registrant as to ‘‘what conduct will 

result in’’ a violation. United States v. 

Ashland, Inc., 356 F.3d 871, 874 (8th 

Cir. 2004) (citing United States v. 

Guagliardo, 278 F.3d 868, 872 (9th Cir. 

2002)). Relatedly, the Government 

ignores that it never informed 

Respondent that the March 13, 2003 

registration was issued by mistake. It 

also ignores that it was not until more 

than three years later that it informed 

Respondent of its view that the 

September 8, 2003 registration was ‘‘the 

newly renewed registration’’ which 

governed the duration of his obligation 

to file the drug activity logs. 

Respondent therefore cannot be held 

to have violated the 2002 Order because 

he failed to file the drug activity logs 

after December 31, 2002. Respondent 

did, however, violate the Order because 

he did not file the logs even during the 

period when it was clear that he was 

required to do so. 

As found above, the record also 

establishes that Respondent did not 

report the 2005 Board proceeding to the 

Agency. Respondent offers three 

arguments in response. First, relying on 

the 2002 Order’s mistaken reference to 

‘‘any action taken * * * upon his 

medical license,’’ 21 he contends that he 

‘‘has never held a medical license,’’ and 

that ‘‘[t]he [S]tate of Virginia has never 

taken any action against [his] nonexistent medical license.’’ Resp. Br. at 

21. 

The argument is too clever by half. 

Precisely because Respondent has never 

held a medical license, and the prior 

DEA proceeding discussed an action by 

the State Board of Dentistry which 

imposed conditions on his dental 

license, see RX 42, at 13–14, 

Respondent had ample reason to know 

that the 2002 Order had mistakenly 

referred to his ‘‘medical license’’ and 

that the purpose of the condition was to 

require him to report any action taken 

upon his dental license. 

Next, Respondent contends that the 

2005 Board action ‘‘occurred long after 

[his] duty to report to the DEA lapsed.’’ 

Resp. Br. at 21. However, in contrast to 

the other two conditions it imposed, the 

2002 Order did not limit the duration 

that this condition would be in effect. 

See GX 3, at 6–7. This is hardly 

surprising given that at the time the 

Order was issued, the State Board had 

placed him on probation 

‘‘INDEFINITELY’’ and had imposed 

various conditions. See GX 7, at 4–5. 

Nor is it surprising given Respondent 

history of non-compliance with the 

Board’s orders. Most significantly, the 

2002 DEA Order was ‘‘sufficiently clear 

to inform’’ Respondent as to his 

obligation to report the 2005 Board 

action. Ashland, 356 F.3d at 874. 

Finally, Respondent maintains that he 

had no obligation to report the 2005 

Board action because the Board ‘‘took 

no action against [his] dental license’’ 

and ‘‘[h]e remained on probation 

throughout the relevant period.’’ Resp. 

Br. at 21. In the 2005 proceeding, 

however, the Board (in addition to 

reprimanding and fining him), rejected 

Respondent’s petition to terminate his 

probation, and again, continued his 

probation ‘‘indefinitely.’’ GX 9, at 3. 

Moreover, the Board stated that 

‘‘[v]iolation of this Order may constitute 

grounds for suspension or revocation of 

[Respondent’s] license.’’ Id. at 4. The 

Board’s Order thus clearly constituted 

‘‘action taken by any State upon his 

* * * license.’’ GX 3, at 7. 

I therefore conclude that Respondent 

violated the terms of the Agency’s 2002 

Order by failing to report the 2005 

Board action as well as by his failure to 

file the quarterly drug activity logs 

during the period between the issuance 

of the Order and December 31, 2002. 

These failures alone establish that 

Respondent has committed acts which 

‘‘render his registration * * * 

inconsistent with the public interest’’ 

and which support the suspension or 

revocation of his registration. 21 U.S.C. 

824(a). Moreover, even though 

Respondent’s misconduct, which was 

the subject of the 2002 Order, occurred 

some time ago, it buttresses this 

conclusion. See 21 U.S.C. 823(f)(2) 

(directing the Attorney General to 

consider the registrant’s experience in 

dispensing controlled substances). 

Factor Five—Such Other Conduct 

Which May Threaten Public Health and 

Safety 

Under this factor, the ALJ made 

extensive findings regarding the 

shortage of dentists in the region where 

Respondent practices and the 

percentage of his patients who come 

from underserved areas. The ALJ further 

noted that in Pettigrew Rexall Drugs, 64 

FR 8855 (1999), a case involving a 

pharmacy, the Agency had considered 

that the ‘‘pharmacy was located in an 

underserved community’’ and that this 

was a factor that ‘‘impacted the public 

interest.’’ ALJ at 46 (citing 64 FR at 

8860). The ALJ then reasoned that even 

though Respondent is not ‘‘physically 

located in an underserved community 

* * * the focus should be on who is 

actually being served by the practice.’’ 

Id. Because Respondent has 561 patients 

from underserved counties, and many of 

these patients have limited incomes, the 

ALJ concluded that this factor weighs 


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22 It is acknowledged that there is no evidence 

that Respondent has diverted controlled substances. 

However, in assessing what sanction to impose, the 

Agency already considers the extent and 

egregiousness of a practitioner’s misconduct. 

Accordingly, it is not clear what principle exists for 

determining when evidence that a practitioner 

treats underserved patients should be considered 

and when it should not be. 

Beyond this, the ALJ’s reasoning suggests how 

unworkable applying this standard would be. As 

she explained: ‘‘the focus should not simply be on 

whether a dental practice is physically located in 

an underserved community; this is simply too 

narrow a view. Rather, the focus should be on who 

is actually being served by the practice.’’ ALJ at 46. 

The ALJ then noted that 561 of his patients 

(notably, only about ten percent of his patients) 

were from underserved areas, and that a majority 

of his patients have limited finances. 

The ALJ’s reasoning begs the question of how 

many patients from underserved areas would a 

practitioner have to treat to claim the benefit of the 

rule. As for her reliance on the fact that a majority 

of Respondent’s patients have limited incomes, 

determining what constitutes a patient with a 

limited income or finances and how many patients 

(or what percentage of patients) a practitioner must 

have to claim entitlement to this rule, would inject 

a new level of complexity into already complex 

proceedings and take the Agency far afield of the 

purpose of the CSA’s registration provisions, which 

is to prevent diversion. Finally, while I decline to 

extend the Pettigrew rule to prescribing 

practitioners, I further note that Respondent offered 

no evidence that he charges his patients who have 

‘‘limited finances’’ lower fees for his services. 

23 In setting this sanction, I place no weight on 

the DI’s testimony that during the 2006 inspection, 

he found seven discrepancies between the drug 

activity logs and Respondent’s patient records 

because the discrepancies did not involve the 

period in which it is clear that Respondent had an 

obligation to maintain the logs. I also place no 

weight on Respondent’s evidence regarding the 

drug logs he eventually submitted for the period in 

which the requirement clearly applied. Even were 

I to ignore that the logs were submitted years late, 

because Respondent did not submit copies of these 

documents for the record, it is unclear whether they 

contained all of the information required by the 

2002 Order. 

against the imposition of either a 

suspension or revocation of his 

registration. Id. at 48. 

DEA has never applied this rule in a 

subsequent case, and I conclude that it 

would be ill-advised to extend it to the 

case of a prescribing practitioner. The 

public interest standard of 21 U.S.C. 

823(f) is not a freewheeling inquiry but 

is guided by the five specific factors 

which Congress directed the Attorney 

General to consider; consideration of the 

socioeconomic status of a practitioner’s 

patient population is not mandated by 

the text of either 21 U.S.C. 823(f) or 

824(a)(4), which focus primarily on the 

acts committed by a practitioner. 

Moreover, where, as here, the 

Government has made out a prima facie 

case that a practitioner has committed 

acts which render his registration 

inconsistent with the public interest, the 

relevant inquiry is (and the Agency’s 

longstanding rule has been to examine) 

whether the practitioner has put 

forward ‘‘sufficient mitigating evidence 

to assure the Administrator that he can 

be entrusted with the responsibility 

carried by such a registration.’’ Medicine 

Shoppe-Jonesborough, 73 FR 364, 387 

(2008) (citing cases). As noted in 

numerous cases, this inquiry looks to 

whether the registrant has accepted 

responsibility for his misconduct and 

undertaken corrective measures to 

prevent the re-occurrence of similar 

acts. Whether a practitioner treats 

patients who come from a medically 

underserved community or who have 

limited incomes has no bearing on 

whether he has accepted responsibility 

and undertaken adequate corrective 

measures. 

Finally, contrary to the ALJ’s 

understanding, extending the holding of 

Rexall Pettigrew would likely cause 

greater harm to the public interest. The 

diversion of prescription drugs has 

become an increasingly serious societal 

problem, which is particularly 

significant in poorer communities 

whether they are located in rural or 

urban areas. See, e.g., George C. Aycock, 

74 FR 17529, 17544 n.33 (2009); 

Laurence T. McKinney, 73 FR 43260 

(2008); Paul H. Volkman, 73 FR 30630 

(2008); Medicine Shoppe-Jonesborough, 

73 FR at 363. See also U.S. General 

Accounting Office, PRESCRIPTION 

DRUGS: OxyContin Abuse and 

Diversion and Efforts to Address the 

Problem 31–32 (Dec. 2003) (noting that 

‘‘the Appalachian region, which 

encompasses parts of Kentucky, 

Tennessee, Virginia, and West Virginia, 

has been severely affected by 

prescription drug abuse, particularly 

pain relievers * * * for many years’’). 

The residents of this Nation’s poorer 

areas are as deserving of protection from 

diverters as are the citizens of its 

wealthier communities, and there is no 

legitimate reason why practitioners 

should be treated any differently 

because of where they practice or the 

socioeconomic status of their patients.22

I thus conclude that this factor does not 

support the continuation of 

Respondent’s registration. 

Sanction 

Where, as here, the Government has 

made out a prima facie case that a 

practitioner has committed acts which 

render his registration inconsistent with 

the public interest, the practitioner must 

put forward ‘‘sufficient mitigating 

evidence to assure the Administrator 

that he can be entrusted with the 

responsibility carried by such a 

registration.’’ Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(citing cases). As noted in numerous 

cases, this inquiry looks to whether the 

registrant has accepted responsibility for 

his misconduct and undertaken 

corrective measures to prevent reoccurrence of similar acts. 

As found above, Respondent violated 

the terms of the restricted registration 

which the Agency granted him by 

failing to submit a quarterly drug 

activity log during the four- month 

period over which there is no dispute 

that he was required to submit the log. 

Moreover, Respondent failed to report 

the 2005 Board Action. When coupled 

with the acts which gave rise to the 

2002 Order, Respondent has 

demonstrated a disturbing record of 

non-compliance with both State and 

Agency requirements. 

Respondent’s evidence regarding his 

acceptance of responsibility is 

equivocal. While it appears that 

Respondent started sending in drug logs 

upon receipt of the ALJ’s 2001 decision, 

he offered no explanation as to why he 

stopped upon receiving the 2002 Order. 

Moreover, while I acknowledge that a 

registrant can in good faith dispute 

whether a regulatory provision requires 

certain action, Respondent’s arguments 

with respect to his failure to report the 

2005 Board action (e.g., that the Order 

did not apply to him because he has a 

dental license and that the State took no 

action against him when it rejected his 

petition to terminate and continued his 

probation) were generally disingenuous. 

I acknowledge that Respondent also 

instituted corrective measures to 

improve his documentation of his 

prescribing practices, including bringing 

in a consultant to audit his records.23 I 

also note that there is no evidence that 

Respondent has prescribed controlled 

substances without ‘‘a legitimate 

medical purpose.’’ 21 CFR 1306.04(a). I 

therefore conclude that the record as a 

whole does not support the revocation 

of Respondent’s registration. 

However, Respondent has a lengthy 

history of non-compliance with both 

DEA and State requirements and did not 

appreciate the forbearance which this 

Agency exercised in the 2002 Order. 

Moreover, in light of the wording of the 

2002 Order and the circumstances 

surrounding the issuance of the 

registration certificate in March 2003, 

Respondent has not been required to 

comply with the intended requirements 

of that Order. I therefore conclude that 

Respondent should be granted a new 

registration subject to the following 

conditions. 

(A) Respondent shall submit to the local 

DEA office, a drug activity log on a quarterly 

basis, no later than twenty (20) days from the 

last day of the quarter which shall be March 

31, June 30, September 30, and December 31 

of each calendar year. Each log must contain 


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1Respondent also invoked the ‘‘mend the hold 

doctrine,’’ an obscure common law rule which 

prohibits a party to a contract from changing its 

position on the contract’s meaning during the 

course of litigation over it. Id. at 3 (citing Utica Mut. 

Ins. Co. v. Vigo Coal Co., Inc., 393 F.3d 707, 716 

(7th Cir. 2004)). Specifically, Respondent 

contended that the Government’s reliance on the 

expiration of Respondent’s lack of a state controlled 

substance license was ‘‘analogous to an attempt to 

mend the hold,’’ presumably because the Show 

Cause Order had cited the consent agreement rather 

than the expiration. Id. at 3 (citation omitted). 

Respondent did not renew this argument in his 

exceptions, and in any event, the analogy is 

misplaced. 

the following: (1) The date that a controlled 

substance was administered, or dispensed 

(whether by prescription or actual delivery of 

the drug); (2) the name of the patient to 

whom a controlled substance was 

administered or dispensed (whether by 

prescription or actual delivery); (3) the 

patient’s dental complaint; (4) the name, 

dosage, and quantity of the substance 

prescribed, dispensed or administered; and 

(5) the date that the medication was 

previously prescribed, dispensed or 

administered to that patient if the medication 

was prescribed, dispensed or administered in 

the last year, as well as the amount last 

provided to that patient. If no controlled 

substances are prescribed, administered, or 

dispensed during a given quarter, 

Respondent shall submit a letter to the DEA 

office indicating that there was no activity to 

report during the quarter. 

(B) Within 15 days of the event, 

Respondent shall inform the local DEA office 

of any proceeding initiated against him by a 

State licensing board, whether the board 

regulates his professional practice or his 

authority to prescribe controlled substances. 

In addition, within 15 days of the event, 

Respondent shall inform the local DEA office 

of any interim or final order of a State 

licensing board which imposes a sanction, 

whether the sanction be a reprimand, a fine, 

a civil penalty, a probationary period, a 

rejection of a petition for termination of 

probation, an imposition of a condition, a 

suspension, or a revocation of any State 

professional license or authority to prescribe 

a controlled substance. 

(C) In the event that Respondent changes 

employment during this three-year period, he 

shall immediately notify the local DEA office 

that is monitoring his drug activity logs. 

To ensure that there is no confusion 

as to the duration of these conditions, 

all three conditions shall remain in 

effect for a period of three years from 

the date of this Order’s publication in 

the Federal Register. 

Moreover, because Respondent has 

not previously appreciated the 

seriousness of these proceedings and his 

obligation to comply with the CSA, the 

Agency’s rules, and the conditions 

imposed pursuant to the 2002 Order, I 

further conclude that a period of 

outright suspension of his registration is 

warranted. Accordingly, while I grant 

Respondent a new registration, said 

registration will be suspended outright 

for a period of three months. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823 and 824, as well as 28 

CFR 0.100(b) and 0.104, I hereby order 

that the application of Gregory D. 

Owens, D.D.S., to renew his DEA 

Certificate of Registration, be, and it 

hereby is, granted subject to the 

conditions set forth above. I further 

order that the DEA Certificate of 

Registration issued to Gregory D. 

Owens, be, and it hereby is, suspended 

for a period of three months from the 

effective date of this Order. This Order 

is effective August 24, 2009. 

Dated: July 16, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–17681 Filed 7–23–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 08–59] 

Roy E. Berkowitz, M.D.; Revocation of 

Registration 

On August 26, 2008, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Roy E. Berkowitz, M.D. 

(Respondent), of Slidell, Louisiana. The 

Show Cause Order proposed the 

revocation of Respondent’s DEA 

Certificate of Registration, BB0492912, 

as a practitioner, and the denial of any 

pending applications to renew or 

modify his registration, on the grounds 

that Respondent does ‘‘not have 

authority to prescribe controlled 

substances in the State of Louisiana,’’ 

and that his ‘‘continued registration is 

inconsistent with the public interest.’’ 

Show Cause Order at 1. 

More specifically, the Show Cause 

Order alleged that as a result of 

prescriptions for controlled substances 

which Respondent issued in 2006 and 

2007 that were inconsistent with State 

rules and regulations, Respondent 

entered into a Consent Order with the 

Louisiana State Board of Medical 

Examiners, which ‘‘strips [Respondent] 

of authority to handle controlled 

substances in the State of Louisiana, the 

state in which [he is] registered with 

DEA.’’ Id. 

Respondent requested a hearing on 

the allegations, and the matter was 

assigned to an Administrative Law 

Judge (ALJ), who commenced prehearing procedures. Thereafter, the 

Government moved for summary 

disposition on the ground that 

Respondent ‘‘currently lacks authority 

to handle controlled substances in the 

State of Louisiana—his state of 

registration.’’ Gov. Mot. at 1. 

In support of its motion, the 

Government attached a declaration of a 

DEA Diversion Investigator (DI). 

Therein, the DI stated that on October 

15, 2008, she had queried the Louisiana 

State Board of Pharmacy’s Web site to 

determine Respondent’s license status, 

and found that ‘‘the Controlled 

Dangerous Substance license #33853 of 

Roy E. Berkowitz, M.D. was delinquent, 

having expired on September 25, 2008.’’ 

Id. at Appendix I. 

The ALJ allowed the Respondent to 

file a response to the motion through 

October 30, 2008. Moreover, on October 

29, 2008, the ALJ granted Respondent 

an extension of the due date until 

November 6, 2008, on which date 

Respondent filed his response. 

Therein, Respondent noted that while 

the Show Cause Order had relied on the 

State Board’s Consent Order, the motion 

for summary disposition relied on a 

‘‘declaration * * * asserting that a 

license issued by the Louisiana Board of 

Pharmacy to [Respondent] expired on 

September 25, 2008.’’ Resp. at 1. 

Respondent maintained that the 

Government was improperly changing 

its theory of the case, and argued that 

‘‘[t]he DEA without leave to amend the 

Order to Show Cause has sought to 

change the underlying basis of the 

case.’’ 1 Id. at 2–3. 

Next, Respondent argued that the 

Agency lacks authority to revoke his 

registration because in his view, 21 

U.S.C. 824(a)(3) requires both a 

suspension, denial or revocation of the 

state license or registration, and that the 

practitioner no longer be authorized by 

state law to handle controlled 

substances. Id. at 3–4. In support of his 

contention, Respondent attached his 

declaration in which he stated that he 

submitted his application for renewal of 

his Louisiana Controlled Dangerous 

Substance License in July 2008, and that 

he was ‘‘advised by the Louisiana Board 

of Pharmacy that this agency was unable 

to process’’ his application. Id., Ex. A at 

1. The declaration further asserted that 

the Louisiana Board of Pharmacy ‘‘did 

not enter an order’’ denying, suspending 

or revoking Respondent’s application. 

Id. at 1–2. Thus, Respondent argued that 

the Government’s motion should be 

denied ‘‘[b]ased upon a failure to 

establish the elements required under 

21 U.S.C. 824(a)(3) and 21 U.S.C. 

824(a)(4).’’ Resp. at 5. 

On January 27, 2009, the ALJ issued 

her Opinion and Recommended 


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