Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 78745 

45 It is acknowledged that Respondent undertook 

to ensure that its customers obtained the necessary 

certifications required by the CMEA. Tr. 399. Yet 

this is only one of many factors that are properly 

considered in assessing whether Respondent’s 

registration is consistent with the public interest. 

do not ask their customers whether they 

are purchasing from other distributors; 

and (4) Mr. Mitchell acknowledged that 

he continued to sell to stores even when 

he knew they were obtaining ‘‘large 

quantities’’ from other distributors. 

Regarding these four deficiencies, Mr. 

Mitchell addressed only one of them— 

the storage of products on its trucks— 

and did so only with respect to when 

the trucks were at his facility.45

The evidence also showed that 

Respondent failed on six occasions to 

report suspicious monthly sales to a 

store as required by Federal law even 

though Mr. Mitchell acknowledged that 

the transactions were suspicious. Here 

again, Respondent did not offer any 

evidence that it has instituted a program 

to identify and report suspicious orders. 

Relatedly, when asked whether he 

had ‘‘ever pause[d] to think’’ that the 

ephedrine products his firm distributes 

could be resold to traffickers, Mr. 

Mitchell explained: ‘‘I’ve guess I’ve 

taken the attitude that I have no control 

on what the retail public does with the 

product.’’ Tr. 404. As noted above, 

consistent with this attitude, Mr. 

Mitchell admitted that his firm had 

continued to sell to stores even when he 

knew the stores were buying large 

quantities from other distributors. And 

as if further evidence of Mr. Mitchell’s 

and his firm’s indifference to their 

obligations to comply with the law is 

needed, the record further showed that 

Respondent violated the CSA by selling 

a product whose likely use is as drug 

paraphernalia, and did so even after the 

DI told Mr. Mitchell that the product 

was used for this purpose. 

Mr. Mitchell’s and his firm’s clear 

disregard of their responsibility to 

protect against diversion and comply 

with the law ‘‘is fundamentally 

inconsistent with the obligations of a 

DEA registrant.’’ Holloway, 72 FR at 

42124; see also D & S Sales, 71 FR 71 

FR at 37610 (noting that a registrant is 

‘‘required to exercise a high degree of 

care in monitoring its customers’ 

purchases’’) (int. quotations and 

citations omitted). Because it is clear 

that Mr. Mitchell does not understand 

the nature of his firm’s obligations, I 

conclude that Respondent’s continued 

registration ‘‘would be inconsistent with 

the public interest.’’ 21 U.S.C. 823(h). 

Accordingly, Respondent’s registration 

will be revoked and any pending 

application will be denied. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(h) and 824(a), as well 

as by 28 CFR 0.100(b) and 0.104, I order 

that DEA Certificate of Registration, 

004413RAY, issued to R & M Sales 

Company, Inc., be, and it hereby is, 

revoked. I further order that any 

pending application of R & M Sales 

Company, Inc., for renewal or 

modification of its registration, be, and 

it hereby is, denied. This order is 

effective January 18, 2011. 

Dated: December 3, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–31640 Filed 12–15–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 08–43] 

Ronald Lynch, M.D.; Revocation of 

Registration 

On April 4, 2008, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration (DEA), issued an Order 

to Show Cause to Ronald Lynch, M.D. 

(Respondent), of Sanford, Florida. The 

Show Cause Order proposed the 

revocation of Respondent’s DEA 

Certificate of Registration, BL6686541, 

and the denial of any pending 

applications to renew or modify his 

registration, on the ground that 

Respondent’s ‘‘continued registration is 

inconsistent with the public interest, as 

that term is defined in 21 U.S.C. 

§§ 823(f), 824(a)(4).’’ ALJ Ex. 1, at 1. 

The Show Cause Order alleged that 

Respondent ‘‘authorized controlled 

substance prescriptions for Internet 

customers throughout the United States 

from approximately June 2002, through 

September 2004, on the basis of online 

questionnaires and/or telephone 

consultations.’’ Id. The Order alleged 

that Respondent ‘‘issued these 

prescriptions without a legitimate 

medical purpose and outside the usual 

course of professional practice, in 

violation of 21 CFR 1306.04(a) and 21 

U.S.C. 841(a)(1).’’ Id. The Order further 

alleged that, while Respondent 

authorized controlled substance ‘‘drug 

orders’’ for ‘‘online customers 

throughout the United States,’’ he is 

only licensed to practice medicine in 

the State of Florida and that he ‘‘violated 

state laws that prohibit the 

unauthorized practice of medicine, 

including unlicensed, out-of-state 

physicians issuing controlled substance 

prescriptions to state residents.’’ Id. at 2 

(citations omitted). Finally, the Order 

alleged that Respondent ‘‘violated 

Florida law and regulation prohibiting 

licensed physicians from issuing 

controlled substance prescriptions in 

excessive or inappropriate quantities, 

and from issuing prescriptions via the 

Internet without a documented patient 

evaluation and discussion between the 

physician and patient regarding 

treatment options.’’ Id. (citing Fla. Stat. 

§ 458.331(q) and Fla. Admin. Code Ann. 

r. 64B8–9.014). 

On May 7, 2008, Respondent’s 

counsel requested a hearing on 

allegations, ALJ Ex. 2, and the matter 

was placed on the docket of the 

Agency’s Administrative Law Judges 

(ALJs). On March 24–25, 2009, a hearing 

was held in Arlington, Virginia. 

At the hearing, the Government called 

several witnesses (including the 

Respondent) to testify and introduced 

documentary evidence. Respondent also 

testified on his own behalf. Following 

the hearing, both parties filed briefs 

containing their proposed findings of 

fact, conclusions of law, and argument. 

On September 18, 2009, the ALJ 

issued her recommended decision (also 

ALJ). Therein, the ALJ, after considering 

the five public interest factors, see 21 

U.S.C. 823(f), concluded that 

‘‘Respondent has misused his DEA 

registration [in] the past and has not 

shown any indication that he will not 

do so in the future.’’ ALJ at 46. The ALJ 

thus recommended that Respondent’s 

‘‘registration be revoked and that any 

pending applications be denied.’’ Id. 

As to the first factor—the 

recommendation of the appropriate state 

licensing board—the ALJ found that 

Respondent’s continued licensure by 

the State of Florida ‘‘throughout the 

relevant time period’’ weighed ‘‘in favor 

of a finding that his continued 

registration would not be inconsistent 

with the public interest.’’ Id. at 34. 

However, the ALJ also noted that ‘‘state 

licensure is a necessary but not 

sufficient condition for [holding a] DEA 

registration’’ so that ‘‘this factor is not 

dispositive.’’ Id. 

Examining factors two and four 

together—Respondent’s experience in 

handling controlled substances and his 

compliance with applicable Federal, 

State or local laws—the ALJ determined 

that ‘‘both the Controlled Substances Act 

and the Florida telemedicine standards 

require that the prescribing physician or 

a provider under his supervision 

personally conduct a physical 

examination.’’ Id. at 38–39. The ALJ 

found that because Respondent failed to 

perform such examinations, ‘‘he did not 

establish a proper doctor-patient 


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1This appears to be a typographical error given 

that there is no evidence that Respondent was 

unlawfully distributing or dispensing ‘‘a counterfeit 

substance.’’ 21 U.S.C. 841(a)(2). The correct 

provision is section 841(a)(1). 

2Respondent testified that he is a member of the 

American Academy of Environmental Physicians. 

Tr. 282. 

3Throughout this proceeding, the clinic was 

referred to simply as the ‘‘Kennedy Clinic.’’ 

4At some point while he was working for the 

Kennedy Clinic, Respondent also started his own 

practice, Integrative Natural Solutions. Id. at 68, 73, 

194. Integrative Natural Solutions occupied one 

floor of an office building at the same address as 

the Kennedy Clinic in Kissimmee, Florida when, on 

September 21, 2004, a search warrant was executed 

at both offices, as well as at other locations. Id. at 

16, 68. 

5This entity was previously named Kenadee 

Group, Inc., and was also known as the Kenaday 

Group. GX 2, at 8. 

relationship’’ and, as a result, ‘‘was not 

a practitioner ‘acting in the usual course 

of his professional practice’ ’’ and thus 

‘‘violated 21 U.S.C. 841(a)(2).’’ 1 Id. at 39. 

The ALJ also concluded that 

Respondent’s ‘‘failure to review medical 

records prior to prescribing controlled 

substances was a violation of Florida 

standards for telemedicine’’ and that he 

therefore ‘‘failed to satisfy the 

requirements for a doctor-patient 

relationship; did not act in the usual 

course of his professional practice; and 

thereby violated the Controlled 

Substances Act.’’ Id. at 40. 

The ALJ further found that 

Respondent had permitted ‘‘Ken Drugs 

to use a rubber stamp bearing his 

signature to issue prescriptions for 

controlled substances’’ and that this 

constituted a violation of 21 CFR 

1306.05(a), which generally requires 

that prescriptions ‘‘be manually signed 

by the practitioner.’’ Id. at 40–41; 21 

CFR 1306.05(a). Next, the ALJ found 

that ‘‘Respondent authorized refills for 

controlled substance prescriptions 

without a legitimate purpose’’ such that 

‘‘the decision whether or not to dispense 

these refills was made by Ken Drugs 

personnel, and not by Respondent,’’ 

thereby violating Florida Administrative 

Code r. 64B8–9.014. ALJ at 41. The ALJ 

therefore concluded that ‘‘factors two 

and four weigh in favor of a finding that 

Respondent’s continued registration 

would be inconsistent with the public 

interest.’’ Id. at 43. 

With respect to the third factor— 

Respondent’s conviction record under 

Federal or state laws relating to 

controlled substances—the ALJ found 

that ‘‘Respondent has never been 

convicted’’ of an offense related to the 

manufacture, distribution or dispensing 

of controlled substances. Id. However, 

the ALJ also noted that this factor was 

not dispositive. Id. 

As for factor five—other conduct 

which may threaten public health and 

safety—the ALJ found that ‘‘Respondent 

maintained throughout the hearing . . . 

that any shortcomings involving Ken 

Drugs’ Internet patients were due largely 

to the system set up by the Kennedee 

Group, and not to any irresponsibility 

on his part.’’ Id. Noting that ‘‘[a]s a DEA 

registrant, Respondent bears full 

responsibility for understanding his 

obligations under the Controlled 

Substances Act and related Federal 

regulations,’’ the ALJ found that 

Respondent’s ‘‘claims merely 

demonstrate [his] unwillingness to 

accept his responsibilities as a DEA 

registrant’’ and that his ‘‘refusal or 

inability to acknowledge outright that 

he acted improperly in basing 

prescriptions on these telephone 

conversations suggests an unwillingness 

to recognize that he abrogated his 

responsibilities as a DEA registrant.’’ Id. 

at 43 & 44. 

The ALJ thus found that Respondent 

had failed ‘‘to accept responsibility for 

his actions’’ and that his continued 

registration ‘‘poses a threat to the public 

health and safety.’’ Id. at 45. She thus 

concluded that factor five also 

supported ‘‘a finding that Respondent’s 

continued registration would be 

inconsistent with the public interest.’’ 

Id. 

Neither party filed exceptions to the 

ALJ’s recommended decision. 

Thereafter, the ALJ forwarded the record 

to me for final agency action. 

Having considered the entire record 

in this matter, I adopt the ALJ’s findings 

of fact including those related to the 

credibility of the witnesses. I also adopt 

her conclusions of law except for her 

conclusion that under the Florida 

telemedicine rule, Respondent, as the 

prescribing physician, was required to 

conduct the physical examination or to 

direct another health care provider in 

the performance of the examination. See 

ALJ at 38. However, I agree with the 

ALJ’s conclusion that Respondent 

violated the Florida telemedicine rule in 

those instances when he prescribed 

without having obtained a documented 

patient evaluation, id., and that 

Respondent has failed to accept 

responsibility for his misconduct. I 

further conclude that Respondent 

violated various state laws and the 

Controlled Substances Act by 

prescribing controlled substances to 

residents of States where he was not 

authorized to practice medicine, as well 

as by prescribing controlled substances 

without having performed a physical 

exam on the residents of various States, 

whose laws require a prescribing 

physician to have personally performed 

a physical exam of his patient. I 

therefore adopt the ALJ’s 

recommendation to revoke 

Respondent’s registration and to deny 

any pending applications. I make the 

following factual findings. 

Findings 

Respondent is a physician who is 

board-certified in family practice and 

holds a medical license issued by the 

State of Florida.2 Tr. 191 & 279. In 1999, 

Respondent also obtained a license to 

practice medicine in the State of New 

York; however, he believes that this 

authority has now expired. Id. at 191– 

92. He is not, and never has been, 

licensed in any other State. Id. at 193. 

Respondent currently holds DEA 

Certificate of Registration BL6686541, 

which was last renewed on March 8, 

2006 and was due to expire on March 

31, 2009. GX 1. However, on February 

9, 2009, Respondent submitted an 

application to renew his registration. 

Accordingly, because Respondent’s 

application was timely submitted in 

accordance with the Agency’s rule, his 

registration has remained in effect 

pending the issuance of this Decision 

and Final Order. See 5 U.S.C. 558(c); 21 

CFR 1301.36(i). 

In 2002, Respondent began working 

for the Kennedy Medical Clinic, Inc.,3 as 

a family physician.4 Id. at 194. On April 

8, 2002, Kenneth Shobola, a Floridaregistered pharmacist, incorporated 

Kennedy Medical Clinic, Inc., under the 

laws of the State of Florida; Shobola is 

the president and registered agent of the 

corporation, which operated two 

medical clinics in Tampa, Florida. GX 2, 

at 8. 

On the same date, Shobola also 

incorporated Ken Drugs, Inc. Id. at 7. 

Shobola also served as president of this 

entity and was its sole shareholder. Id. 

This entity owned four pharmacies, 

three of which were located in Tampa, 

the other in Kissimmee, Florida. Id. at 

7–8. 

Shobola also incorporated and was 

the president of the Kennedee Group, 

Inc.5 Id. at 8. Two websites, 

medsviaweb.com and medsviaweb.net, 

were registered to the Kennedee Group 

at the address of 1612 W. Waters Ave., 

Tampa, Florida; this was also the 

address of one of the Ken Drugs 

pharmacies. Id. at 7. 

In September 2002, the DEA Tampa 

Diversion Group received information 

that prescriptions for hydrocodone, a 

schedule III controlled substance, were 

being sent to another pharmacy through 

the medsviaweb.com website and that 

refills of these prescriptions were being 

filled by the Ken Drugs pharmacy 


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6According to an affidavit prepared by an IRS 

Special Agent who participated in the investigation, 

‘‘[a] review of the prescriptions filled by the KEN 

DRUGS pharmacy on Waters Avenue in Tampa, 

Florida, from June of 2002 through of 2003, reveals 

that 50,237 Schedule II, III, and IV prescriptions 

were filled. Further, that 48,793 prescriptions were 

written by Hameed, Lynch, Oluwole, Osuji, and 

Shyngle, and the vast majority were for 

hydrocodone.’’ GX 2, at 23. 

7Respondent testified that the voice on this 

recording sounded like his own. Tr. 223. As 

indicated infra, the prescription label on the vial 

identified the prescribing physician as Dr. Ronald 

Lynch. I therefore find that the individual 

identifying himself as Dr. Lynch in the telephone 

conversation recorded in Government Exhibit 7 is 

Respondent. 

located on W. Waters Ave. in Tampa. Id. 

at 9–10. Moreover, ‘‘the vast majority of 

clients seeking hydrocodone were from 

states other than Florida.’’ Id. at 10. 

Based on this information, DEA 

opened an investigation. During the 

investigation, DEA, along with 

personnel from the Florida Department 

of Law Enforcement, the Florida 

Department of Health, the Kentucky 

State Police, and the Tampa Police 

Department made seventeen undercover 

purchases through either the 

medsviaweb.com website or through 

Ken Drugs of such drugs as 

hydrocodone and Xanax (a schedule IV 

controlled substance). Id. at 11. 

The Investigators obtained the drugs 

by filling out an online questionnaire, 

giving names, addresses, credit card 

information, dates of birth and 

purported medical conditions. Tr. 15; 

GX 2, at 10; see also GXs 6 & 10. After 

providing this information, a clerk from 

Ken Drugs’ Tampa, Florida headquarters 

would call the Investigator and shortly 

thereafter, connect him/her with one of 

five different physicians employed by 

the Kennedee Group. Tr. 15; GX 2, at 11. 

A brief telephone consultation would 

occur with a physician who then issued 

a prescription for a controlled 

substance. Tr. 15; see also GX 2, at 11 

(‘‘After the receipt of consultation 

payment * * *. the undercover 

purchaser would talk by telephone to an 

employee of Kennedee Group * * * 

who advised that the purchaser would 

have to telefax a medical record 

accompanied by a photocopy of his or 

her driver’s license. Regardless of these 

requirements, the employee of 

Kennedee Group * * * customarily 

resumed telephonic contact with the 

aspirant purchaser immediately after 

payment of the $120 or $125 fee to 

advise that a doctor was available for an 

expeditious medical consultation soon 

after which, according to the employee, 

the controlled substances prescribed 

would be delivered to the purchaser by 

UPS or FedEx.’’). 

According to a DEA Diversion 

Investigator (DI), 97 percent of the 

prescriptions were for hydrocodone, 

with the other 3 percent being for the 

schedule IV controlled substances 

alprazolam (generic for Xanax), and 

occasionally, diazepam (generic for 

Valium). See 21 CFR 1308.14(c); Tr. 15; 

see also GX 2, at 23 (‘‘Between June 17 

and September 9, 2004, a review of the 

Ken Drugs pharmacy records revealed 

that 4,842 prescriptions were written for 

Schedule[] II, III, and IV controlled 

substances.6 The vast majority of the 

prescriptions were for hydrocodone and 

only a small number were for other 

controlled substances such as diazepam 

(Valium) and alprazolam (Xanax)’’). The 

prescriptions were filled at one of 

Shobola’s Ken Drug pharmacies in 

either Tampa or Kissimmee and then 

shipped to the customer. Tr. 16. 

In February 2004, the DI, using the 

undercover name ‘‘Michael Patrick,’’ 

made an undercover purchase from Ken 

Drugs. Id. at 39 & 44. Upon accessing 

http://www.medsviaweb.com, the DI 

registered as a patient and provided 

‘‘biographical data, credit card data, 

address data, information about 

allergies, [and] medical conditions.’’ Id. 

at 49–50; see GX 6 (screens printed out 

from medsviaweb.com). Next, because 

he lacked an undercover credit card, the 

DI called Ken Drugs in Tampa to ask 

whether he could purchase the 

controlled substance he was seeking 

with a postal money order; an employee 

of Ken Drugs approved this 

arrangement. Tr. 50. 

On February 6, the DI purchased the 

money order for $125 and sent it to Ken 

Drugs; several days later, the DI received 

a telephone call from Ken Drugs during 

which he was told that a medical 

consultation would follow if he would 

send a copy of his driver’s license and 

medical records. Id.; see GX 8, at 1. 

While the DI could not remember 

whether he sent in a copy of his 

undercover driver’s license, he did not 

send in any medical records. Tr. 50. 

The Government then played into the 

record Government Exhibit 7, an audio 

recording of the DI’s telephone 

consultation with a Kennedee Group 

physician. A speaker, who identified 

herself as Jennifer, arranged for the 

consultation once she had confirmed 

that the DI’s money order had been 

received. Tr. 31–32. Jennifer then asked 

the DI whether he had faxed his driver’s 

license and medical records; the DI 

answered, ‘‘Yes.’’ Id. at 34. Jennifer then 

put the DI through to an individual who 

identified himself as Respondent. Id. 

The DI stated that he suffered ‘‘back 

pain from an automobile crash’’ and 

requested ‘‘Vicodin extra strength.’’ Id. 

He further explained that several years 

earlier another physician had 

‘‘recommended’’ Vicodin and that it had 

‘‘helped.’’ Id. at 35. He also stated that 

he had not used Vicodin in several 

months. Id. 

Respondent recommended Lortab 

because it was something with less 

‘‘Tylenol.’’ 7 Id. He then inquired as to the 

extent of the DI’s back pain. Id. at 35– 

36. The DI stated that the back pain 

‘‘interfere[d] with [his] sleeping, can last 

for hours some days and for minutes in 

[sic] other days,’’ and amounted to ‘‘a 

little bit of interference.’’ Id. at 36. The 

DI further offered that prior x-rays 

indicated that there was no structural 

damage. Id. Respondent then asked the 

DI how many pills he thought he would 

need per day; the DI responded two to 

three per day. Id. at 37. Respondent then 

stated: ‘‘Let’s say two, two would be 

fine,’’ and indicated that the DI would 

be sent ‘‘something that’s actually a little 

safer for you and better than what you 

were asking for.’’ Id. at 37–38. 

On February 12, 2004, the DI picked 

up the Lortab in person at Ken Drugs #3, 

which was located at 4730 North 

Havana Avenue in Tampa. Id. at 44. He 

received sixty tablets of hydrocodone/ 

apap (10/500), a drug which combines 

10 mgs. of hydrocodone with 500 mgs. 

of acetaminophen in each tablet. Id. at 

46; GX 8, at 2, 4. Laboratory testing 

confirmed that the tablets contained 

hydrocodone. Tr. 47. The label 

identified the prescribing physician as 

Respondent. GX 8 at 2, 4. 

The DI further testified that no 

physical examination was performed, 

that he did not know whether 

Respondent had a copy of the online 

questionnaire in front of him when he 

prescribed the Lortab, and that 

Respondent did not take a medical 

‘‘history’’ or give him a ‘‘treatment plan.’’ 

Tr. 41, 77–78. 

At DEA’s request, on July 20, 2004, a 

Medical Quality Assurance Investigator 

with the Florida Department of Health 

(DOH) made an undercover purchase of 

hydrocodone through the website 

modernlifestylemeds.com; this 

prescription was also authorized by 

Respondent. Tr. 148; GX 9. According to 

the DOH Investigator, he registered as a 

customer, giving his undercover name 

of ‘‘Donald Huntley,’’ date of birth, home 

address, telephone number, and a 

medical complaint; he then requested 

Percodan. Tr. 149, 152–53; GX 9, at 1. 

On July 29, the DOH Investigator filled 

out a medical history form and received 

an e-mail confirming his name, date of 

birth, phone number, and his medical 

complaint. Tr. 150–152; GX 9, at 1. The 


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8At this point in the hearing, counsel for 

Respondent objected to the witness referring to this 

individual as Dr. Lynch, the Respondent. Tr. 155. 

The ALJ overruled this objection. Id. In his 

testimony, Respondent did not dispute that he had 

prescribed to either the DEA or DOH Investigators. 

Moreover, the prescription label for the medication 

that was dispensed to the Investigator indicated that 

the prescribing physician was Dr. Ronald Lynch. 

GX 10, at 2–3. I therefore find that Respondent was 

the individual who identified himself as Dr. Lynch. 

9According to Dr. Osuji, although he was to be 

the medical director from the initial plans with Ken 

Shobola, there turned out to be ‘‘many medical 

directors’’ so that Dr. Osuji ultimately was not in 

charge of ‘‘oversee[ing]’’ the operation. GX 4, at 7. 

Apparently, there were a total of six medical 

directors. Id. at 42. 

10According to Dr. Osuji, the customers were 

supposedly seen by ‘‘doctors, nurses, and 

[physicians assistants]’’ before he spoke with them. 

GX 4, at 8. 

following day he received a telephone 

call from ‘‘Jasmine at Modern 

Lifestyles,’’ who asked ‘‘what type of 

medication [he] was trying to obtain.’’ 

Tr. 152; GX 9, at 1. After the DOH 

Investigator told her that he wanted 

Percodan, Jasmine replied that he could 

not get this drug (which is a schedule 

II controlled substance), but that he 

would be able to get Lortab at a cost of 

$177 for a thirty-day supply; she also 

instructed him to send in a copy of his 

driver’s license and his medical records. 

Tr. 152; GX 9, at 1. 

On August 1, the DOH Investigator 

faxed a copy of his undercover driver’s 

license but not his medical records, and 

on August 2, Jasmine called again to 

confirm that he wanted Lortab. Tr. 153; 

GX 9, at 1. Jasmine told the Investigator 

that he could not personally pick up the 

medication and that he would need to 

pay by credit card; he then gave her his 

undercover credit card information. GX 

9, at 1. Jasmine did not ask about the 

medical records which the Investigator 

had failed to provide; she then put the 

Investigator through to an individual 

who identified himself as Respondent. 

GX 9, at 1; Tr. 154, 157. 

Respondent 8 asked the Investigator 

his age and the cause of his pain. Tr. 

154; GX 9, at 1. The Investigator 

responded that he was sixty years old 

and that he had injured his back some 

four to five years earlier while helping 

his son move furniture. Tr. 155; GX 9, 

at 1. Respondent further asked about 

other medications that the Investigator 

was taking and about whether he had 

any liver damage; the latter responded 

that he was taking Vicodin and Lortab 

and did not have liver damage. Tr. 155; 

GX 9, at 1. Respondent then asked the 

Investigator to provide the name of the 

physician he was currently seeing; the 

Investigator named a Dr. Cichon. Tr. 

155; GX 9, at 1. After some three to five 

minutes, the conversation ended with 

Respondent stating that he would 

prescribe Lortab with three refills. Tr. 

156; GX 9, at 1. 

In his testimony, the Investigator 

stressed that he never sent the required 

medical records, never met Respondent 

in person, and never underwent a 

physical examination by Respondent or 

anyone associated with the website he 

had accessed to obtain the medication. 

Tr. 157–158; see also GX 9, at 1–2. 

On August 4, the Investigator received 

a vial which contained hydrocodone/ 

apap 10/500. Tr. 156; GX 9, at 2. The 

prescription was dispensed by Ken 

Drugs, Inc.’s pharmacy #3, which was 

located at 4730 North Habana Avenue in 

Tampa, Florida. Tr. 158; GX 9, at 2. The 

label on the vial indicated that it 

contained ninety pills and that 

Respondent was the prescribing 

physician. Tr. 159–60; GX 9, at 2; GX 

10, at 2, 3. 

On September 21, 2004, DEA 

executed a search warrant at seven 

locations associated with Ken Shobola 

and his Ken Drugs enterprise, two in 

Kissimmee and five in Tampa, 

including Respondent’s Integrative 

Natural Solutions business, which was 

located at the same address as one of the 

Kennedy Clinic’s offices. Tr. 16, 68, 73. 

As part of the search, the Investigators 

‘‘imaged [and] downloaded’’ the files on 

thirty-three computers; they also seized 

another computer and sent it to the DEA 

forensics laboratory for analysis. Id. at 

17. 

Among the items seized were records 

of ten controlled substance 

prescriptions which Respondent issued 

to residents of California, Ohio and 

Tennessee. Id. at 67; GX 18. Only one 

prescription bore Respondent’s actual 

signature; this prescription was clearly 

faxed to the Kennedee Group. Tr. 226, 

GX 18, at 6. The other prescriptions bore 

a stamped signature and were 

electronically transmitted by 

Respondent. Tr. 226; GX 18, at 5–6. 

Three of the prescriptions were 

dispensed to residents of California; all 

of these prescriptions were for 90 tablets 

of hydrocodone/apap, containing either 

7.5 or 10 mgs. of hydrocodone per 

tablet. GX 18, at 1–6. Six prescriptions 

were dispensed to residents of 

Tennessee; four of these were for 90 

tablets of hydrocodone/apap containing 

10 mgs. of hydrocodone, one was for 90 

tablets of alprazolam, and one was for 

60 tablets of diazepam. Id. at 7–10, 13– 

18. The remaining prescription, which 

was dispensed to a customer in Ohio, 

was for 90 hydrocodone/apap (10/500). 

Id. at 11–12. 

At least three physicians who worked 

for Shobola’s scheme were interviewed 

by DEA Investigators. The lead DI 

testified that on October 20, 2004, he 

interviewed a Dr. Ladapo Shyngle at his 

Tampa residence. Tr. 23; GX 2, at 9. 

During the interview, Dr. Shyngle stated 

that he did not have face-to-face 

meetings with the Ken Drugs customers 

he prescribed hydrocodone to; he also 

admitted that he did not review the 

customers’ medical records in every 

case before prescribing controlled 

substances to them. Tr. 24; GX 5, at 15– 

16, 20; GX 17, at 2. 

Dr. Shyngle further admitted that as 

the number of Ken Drugs’ customers 

increased, he saw their medical records 

before prescribing only approximately 

thirty percent of the time. GX 5, at 20– 

21; GX 17, at 1–2. According to Shyngle, 

Ken Drugs ‘‘hired an institution’’ that 

performed physical examinations for 

them. GX 5, at 25. Shyngle admitted, 

however, that the physicians were ‘‘not 

always’’ ‘‘actually able to look at the 

information’’ documenting those 

physical exams before they prescribed. 

Id. 

The DI also testified that on 

November 17, 2004, he interviewed a 

Dr. Chuma Osuji, Director of Medicine 

for Ken Drugs.9 Tr. 19–20, 82; GX 2, at 

8; GX 4, at 5. The Government entered 

into evidence a transcript of the taped 

2-hour interview of Dr. Osuji; the DI 

also testified as to the substance of the 

interview. Tr. 20–22; GX 4. 

In the interview, Dr. Osuji admitted 

that he did not see the patients to whom 

he prescribed controlled substances; 10

that most of the prescriptions he wrote 

were for hydrocodone; that, while he 

sometimes saw the medical records 

prior to, or at the time of prescribing, he 

‘‘frequently’’ did not; and that all of the 

prescriptions authorized by the 

physicians retained by the Kennedee 

Group were filled at pharmacies owned 

by Ken Shobola. Tr. 20–21; GX 4, at 9– 

10, 30. 

Dr. Osuji also stated that he issued 

prescriptions by completing a form 

authorizing the prescription and faxing 

it to one of the Ken Drugs pharmacies 

for filling; the authorization was not 

‘‘manually’’ signed. Tr. 88–89; GX 4, at 

29–30. Dr. Osuji stated that Ken Drugs 

contracted with another company which 

was supposed to provide physical 

examinations of patients so Dr. Osuji 

assumed that the customers had 

undergone physical examinations prior 

to his prescribing to them. GX 4, at 25, 

38. Also according to Dr. Osuji, one or 

two months earlier, he had learned that 

patients were not getting physical 

examinations (apparently after someone 

complained that he had paid for a 

physical and not received one). Tr. 21; 

GX 4, at 38–40, 47. 


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Another DI testified that she 

participated in an interview of 

Respondent on the day the search 

warrant was executed. Tr. 168–69. She 

testified that Respondent conducted two 

different kinds of medical practice, the 

first an ‘‘individual practice, which 

involved holistic medicine’’ and was 

named Integrative Natural Solutions; the 

other was an ‘‘internet pharmacy 

business, which was connected to the 

Ken Drugs business.’’ Id. at 169. 

Respondent was hired by Shobola to 

write prescriptions for the Kennedee 

Group and was paid $30 per telephone 

consultation. Id. at 173. However, 

Respondent admitted that he was not 

paid if he did not authorize a 

prescription. Id. at 198. Respondent 

stated that he conducted approximately 

fifty consultations per week, ‘‘usually no 

more than about 10 a [sic] day.’’ Id. 

Respondent primarily prescribed 

hydrocodone. Id. at 171. The 

prescriptions were always filled by Ken 

Drugs. Id. 

Respondent contacted the customers 

by accessing the website ‘‘through the 

Kenned[ee] Group Corporation’’ and 

then did telephone consultations with 

them. Id. at 170, 172–73. Respondent 

stated that he ‘‘talk[ed] with the patient 

[sic] regarding their medical concern, 

their medical need, if they had any 

problems, liver damage, if they had been 

taking medication, [and] what drugs or 

medication in particular they were 

seeking.’’ Id. 

Respondent maintained that the 

customers’ medical records were filed at 

the corporate offices of the Kennedee 

Group and that he would ‘‘periodically’’ 

look at the records to determine 

patients’ medical needs. Id. Respondent 

admitted, however, that his examination 

of the records did not ‘‘necessarily’’ 

occur ‘‘before he dispensed the 

medication.’’ Id. Respondent allowed 

the corporate office to ‘‘use a rubber 

stamp with his signature, a custom 

stamp,’’ to complete prescription 

authorizations. Id. at 172. He also told 

the Investigators that he was 

electronically transmitting the 

prescriptions to the pharmacy. Id. at 

181. 

During the interview, Respondent 

stated that he ‘‘believed that what he 

was doing was in line, because he 

thought that the Kenned[ee] Group were 

[sic] known. They [sic] had a big 

business and he felt he was doing what 

he thought was appropriate.’’ Id. at 177. 

Respondent also stated that he believed 

that Shobola ‘‘had looked into the 

legalities of the business[;] and he felt 

that with the size of the business, 

surely, what they were doing could not 

be wrong. He trusted the insight of Ken 

Shobola.’’ Id. at 185. 

The Government also called 

Respondent to testify. The ALJ found, 

however, that Respondent’s ‘‘testimony 

was frequently at odds with that of the 

[other] Government witnesses’’ and that 

he ‘‘displayed a lack of candor and 

appeared to shade his testimony to 

support his position on the issues.’’ ALJ 

at 32. She accordingly found ‘‘the [other] 

Government witnesses more credible.’’ 

Id. 

According to Respondent, the Ken 

Drugs corporate center was designed for 

telemedicine and not for the physical 

receiving and treating of patients. Id. at 

202. He described the business as ‘‘a 

nation-wide endeavor’’ in which 

patients were serviced by regional staff 

which conducted home visits to 

ascertain such matters as whether the 

customers were minors. Id. at 203–04. 

In his testimony, Respondent 

admitted that the Ken Drugs scheme 

‘‘[o]bviously[] did not lend itself to 

do[ing] any physical examination.’’ Id. at 

212–13. He further maintained that 

‘‘[v]ery often, the majority of the time 

* * * [a]t least 75 to 85 percent of the 

time’’ he conducted his telephone 

consultations with the customers’ 

medical records in front of him. Id. at 

206. The ALJ did not find this testimony 

credible in light of his admission during 

the September 21, 2004 interview that 

he did not necessarily review the 

records before he prescribed. ALJ at 39. 

Moreover, both the DEA and DOH 

Investigators testified that they did not 

send in their medical records prior to 

Respondent’s prescribing hydrocodone 

to them. For the same reason, the ALJ 

did not credit Respondent’s testimony 

that he would have to turn away 

Internet patients who did not provide 

medical records.11

As to the potential for fraud in 

prescribing to persons he never met, 

Respondent admitted that ‘‘the real 

doctor/patient relationship is based 

upon honesty,’’ and that if the patients 

‘‘were liars’’ ‘‘they could break through.’’ 

Id. at 206–07. Respondent then testified 

that the Shobola scheme used ‘‘the team 

approach’’ and that other employees 

were responsible for confirming the 

customers’ identities and screening the 

required medical records and physical 

examination before he did his telephone 

consultations with them. Id. at 206–07, 

220. According to Respondent, prior to 

his contacting the customers, the other 

employees obtained the required 

medical records, imaging studies, and 

sometimes, documentation of an actual 

in-person consultation with what he 

called a ‘‘mid-level provider.’’ Id. at 199– 

200. This was so Respondent would not 

have ‘‘to waste [his] time with being a 

police agent or * * * a lawyer.’’ Id. at 

208. 

He also maintained that customers 

‘‘wouldn’t get me on the phone until 

they had gone through some of these 

hurdles.’’ Id. at 208. Here again, 

Respondent’s testimony is contradicted 

by the purchases made by the DEA and 

DOH Investigators, both of whom 

obtained hydrocodone without sending 

in their medical records. 

Later in his testimony, Respondent 

claimed that he could make a 

‘‘judgment’’ that persons were either 

drug abusers or drug seekers based on 

their ‘‘voice,’’ ‘‘diction,’’ and ‘‘answers to 

some of the questions that I might have 

posed to them.’’ Id. at 230. However, he 

then admitted that this ‘‘is, by no means, 

any criteria to determine who is being 

evasive and who is being under-handed 

or who is legitimately seeking a 

substance. It is very, very less than 

perfect.’’ Id. at 231. 

Respondent further maintained that 

‘‘[t]here was not one letter, not one 

comment from any medical quality 

boards or anyone, regarding safety, 

regarding guidance in any way’’ as to 

‘‘the practice of telemedicine.’’ Id. at 

209. However, as explained below, at 

the time Respondent issued the 

prescriptions, substantial guidance was 

available as to the legality of this 

practice. Respondent further claimed 

that he was ‘‘very glad that since that 

faithful [sic] day in September 2004’’ 

(apparently the date on which the 

search warrant was executed) he had 

‘‘not returned to internet medicine 

because [he] do[es] think it does have 

some holes in it.’’ Id. 

Respondent also asserted that he 

visited the Ken Drugs corporate 

headquarters to meet the clerks and the 

personnel handling the telephone 

consultation transfers because he 

‘‘need[ed] to talk to them and find out 

that everything [was] happening 

legitimately and appropriately.’’ Id. at 

202. The record, however, contains no 

evidence that Respondent sought to 

independently determine whether the 

practices he was engaging in were legal. 

Moreover, the ALJ found Respondent’s 

‘‘asserted reliance on Ken Drugs’ 

administrative personnel disingenuous 

at best.’’ ALJ at 44. 

Respondent further maintained that 

he kept medical records ‘‘of every 

conversation or most of the 

conversations’’ in one of his notebooks. 

Tr. 210. However, when asked whether 

he wrote the prescriptions contained in 

Government Exhibit 18, Respondent 

stated that he did not bring his records 

with him to the hearing. Id. at 225–26. 


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12His testimony as to what subjects were covered 

was vague. 

Respondent further asserted that he 

discussed the patients’ diagnoses with 

the patients and that he ‘‘absolutely’’ 

discussed alternative treatments such as 

physical therapy, magnetic therapy, 

acupuncture and eating ‘‘certain antiinflammatory foods.’’ Id. at 210, 214–15. 

He also maintained that he discussed 

the risks and benefits of treatment with 

controlled substances, i.e., the risk of 

‘‘habituation and the risk of 

acetaminophen damage,’’ the latter 

concern compelling him to inquire 

always about blood tests, liver damage 

and kidney function. Id. at 216–17. 

While the evidence pertaining to the 

undercover purchases indicates that 

Respondent did discuss the risks to liver 

function caused by taking too much 

acetaminophen, there is no evidence 

that he discussed the risk of addiction 

caused by taking narcotics with either 

Investigator. Nor did Respondent even 

discuss, let alone recommend, to the 

DEA and DOH Investigators that they try 

alternative treatments. 

For Florida residents, Respondent 

claimed that he provided outside 

referrals and that it was ‘‘fairly 

infrequent’’ that customers did not have 

‘‘background’’ MRIs, blood work, or xrays. Id. at 213–14. However, he claimed 

that he could not do this for his out-ofstate patients. Id. at 213. 

According to Respondent, the audio 

recording of his telephone consultation 

with the DEA DI was ‘‘[n]ot necessarily’’ 

representative of his typical 

consultation, as it was the ‘‘minority of 

the time’’ that he participated in a 

consultation without the medical 

records in front of him; he also claimed 

that he would later review the medical 

record if it was not available at the time 

of the consultation. Id. at 224–25. He 

also maintained that he was 

‘‘[s]ometimes’’ available to customers to 

review the ‘‘course and efficacy of the 

treatment.’’ Id. at 218. 

As for the prescriptions identified in 

Government Exhibit 18, Respondent 

maintained that he had actually signed 

only one of them. Tr. 226 (discussing 

GX 18, at 6). As for the others, 

Respondent stated that they looked like 

they had been stamped. Id. at 228. 

However, he admitted that the stamp 

was a facsimile of his signature and that 

he ‘‘may have’’ provided the Kennedy 

clinic with a stamp containing his 

signature. Id. He then stated that while 

‘‘it was [his] practice to sign’’ the 

prescriptions ‘‘when he could,’’ he had 

granted ‘‘the pharmacist’’ at Ken Drugs 

‘‘some permission to use the stamp, if 

[he] was not able to do that’’ himself. Id. 

at 229. With respect to those 

prescriptions which were stamped, 

Respondent could not even address 

whether he did ‘‘indeed, * * * have a 

consultation with these * * * 

individuals.’’ Id. at 228. 

Respondent also testified on his own 

behalf. Respondent primarily testified 

about his professional background and 

that in 2006, he had attended a course 

offered by the American Academy of 

Pain Management which included 

classes about DEA, controlled 

substances, and the use or misuse of 

opioids.12 Id. at 281–84. Respondent also 

further asserted that he has identified 

drug seeking patients in his ‘‘current 

practice’’ and that he handles them by 

discharging them. Id. He further 

testified that from 2005 on, he sees 100 

percent of his patients in ‘‘a face to face 

setting,’’ and that he will diagnose a 

person he does not know over the 

telephone only in an emergency. Id. at 

290. 

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). In the case 

of a practitioner, Congress directed 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 [registrant’s] experience in 

dispensing * * * controlled substances. 

(3) The [registrant’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). 

‘‘[T]hese factors are considered in the 

disjunctive.’’ Robert A. Leslie, 68 FR 

15227, 15230 (2003). I may rely on any 

one or a combination of factors and give 

each factor the weight I deem 

appropriate in determining whether to 

revoke or renew an existing registration. 

Id. Moreover, I am ‘‘not required to make 

findings as to all of the factors.’’ Morall 

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

2005); see also Volkman v. DEA, 567 

F.3d 215, 222 (6th Cir. 2009). 

In this matter, I acknowledge that the 

State of Florida has taken no action 

against Respondent’s medical license 

(factor one) and that Respondent has not 

been convicted of an offense related to 

controlled substances (factor three). 

However, under settled Agency 

precedent, ‘‘neither of these factors is 

dispositive.’’ Joseph Gaudio, 74 FR 

10083, 10090 n.25 (2009) (citing 

Edmund Chein, 72 FR 6580, 6590 n.22 

(2007) and Mortimer B. Levin, 55 FR 

8209, 8210 (1990)). 

Rather, the gravamen of the 

Government’s case is that Respondent 

violated the CSA and numerous state 

laws by: (1) Prescribing controlled 

substances to persons whom he never 

met and physically examined, and (2) 

by engaging in the unauthorized 

practice of medicine because he lacked 

the state licenses required to prescribe 

to the residents of various States. Gov. 

Br. at 5–9 (discussing factors two and 

four). The Government further argues 

that Respondent’s conduct in 

prescribing over the Internet creates an 

extraordinary threat to public health 

and safety. Id. at 9–10. While 

Respondent offered some testimony as 

to changes he has made in his medical 

practice, as explained below, I agree 

with the ALJ’s finding that his 

testimony was evasive and that he 

repeatedly failed to accept 

responsibility for his misconduct. 

Factors Two and Four—Respondent’s 

Experience in Dispensing Controlled 

Substances and His Record of 

Compliance With Applicable Controlled 

Substance Laws 

Under a longstanding DEA regulation, 

a prescription for a controlled substance 

is not ‘‘effective’’ unless it is ‘‘issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 CFR 1306.04(a). This 

regulation further provides that ‘‘an 

order purporting to be a prescription 

issued not in the usual course of 

professional treatment * * * is not a 

prescription within the meaning and 

intent of [21 U.S.C. 829] and * * * the 

person issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law relating to controlled 

substances.’’ Id. 

As the Supreme Court recently 

explained, ‘‘the prescription 

requirement * * * ensures patients use 

controlled substances under the 

supervision of a doctor so as to prevent 

addiction and recreational abuse. As a 

corollary, [it] also bars doctors from 

peddling to patients who crave the 

drugs for those prohibited uses.’’ 

Gonzalez v. Oregon, 546 U.S. 243, 274 


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(2006) (citing United States v. Moore, 

423 U.S. 122, 135 (1975)). 

Under the CSA, it is ‘‘fundamental’’ 

that a practitioner must establish a 

bonafide doctor-patient relationship to 

act ‘‘in the usual course of * * * 

professional practice’’ and to issue a 

prescription for a ‘‘legitimate medical 

purpose.’’ Gaudio, 74 FR at 10090 (citing 

Moore, 423 U.S. at 141–43). Moreover, 

at the time of the events at issue here, 

whether a doctor and patient have 

established a bona fide doctor-patient 

relationship under the CSA was 

generally a question of state law. Id.; see 

also Kamir Garces-Mejias, 72 FR 54931, 

54935 (2007); United Prescription 

Services, Inc., 72 FR 50397, 50407 

(2007); Dispensing and Purchasing 

Controlled Substances Over the Internet 

(DEA Guidance Document), 66 FR 

21181, 21182–83 (2001). 

Moreover, ‘‘[a] physician who engages 

in the unauthorized practice of 

medicine’’ under state law ‘‘is not ‘a 

practitioner acting in the usual course of 

* * * professional practice’ ’’ under the 

CSA. Gaudio, 74 FR at 10090 (quoting 

United Prescription Services, 72 FR at 

50407). As the Supreme Court explained 

shortly after the CSA’s enactment, ‘‘in 

the case of a physician,’’ the CSA 

‘‘contemplates that he is authorized by 

the State to practice medicine and to 

dispense drugs in connection with his 

professional practice.’’ Moore, 423 U.S. 

at 140–41. This rule derives from the 

plain text of the statute which defines 

the term ‘‘practitioner’’ to mean ‘‘a 

physician * * * licensed, registered, or 

otherwise permitted, by the United 

States or the jurisdiction in which he 

practices * * * to * * * dispense a 

controlled substance,’’ 21 U.S.C. 

802(21), and the term ‘‘dispense’’ to 

mean ‘‘to deliver a controlled substance 

to an ultimate user * * * by, or 

pursuant to the lawful order of a 

practitioner.’’ 21 U.S.C. 802(10). Thus, a 

controlled-substance prescription issued 

by a physician who lacks the license or 

other authority necessary to practice 

medicine within a State is unlawful 

under the CSA. See 21 CFR 1306.04(a); 

Cf. 21 CFR 1306.03(a)(1) (‘‘A 

prescription for a controlled substance 

may be issued only by an individual 

practitioner who is * * * [a]uthorized 

to prescribe controlled substances by 

the jurisdiction in which he is licensed 

to practice his profession.’’). 

The record establishes that 

Respondent repeatedly violated the CSA 

when he prescribed controlled 

substances for the customers of the 

Kennedee Group. He did so for two 

reasons: (1) He failed to establish a bona 

fide doctor-patient relationship as 

required by the laws of the States where 

the patients resided, and (2) because he 

was licensed only in Florida (and 

possibly New York at the time), he 

engaged in the unauthorized practice of 

medicine in those States (other than 

Florida and possibly New York) where 

the customers lived. Nor can 

Respondent credibly claim that ‘‘[t]here 

was not one letter, not one comment 

from any medical quality boards or 

anyone, regarding safety, regarding 

guidance in any way’’ as to the practice 

of telemedicine.’’ Id. at 209. 

As found above, Respondent issued 

three prescriptions for schedule III 

controlled substances containing 

hydrocodone to residents of California. 

However, in 2000, California enacted a 

provision which prohibits the 

prescribing or dispensing of a dangerous 

drug ‘‘on the Internet for delivery to any 

person in this state, without an 

appropriate prior examination and 

medical indication therefore.’’ Cal. Bus. 

& Prof. Code § 2242.1. Moreover, in 

2003 (and prior to the three 

prescriptions identified in GX 18), the 

Medical Board of California (MBC) 

revoked a physician’s medical license 

when he engaged in practices similar to 

those of Respondent. See In re Steven 

Opsahl, M.D., Decision and Order, at 3 

(Med. Bd. Cal. 2003) (available by query 

at http://publicdocs.medbd.ca.gov/pdl/ 

mbc.aspx). 

In Opsahl, the MBC explained that 

‘‘[b]efore prescribing a dangerous drug, a 

physical examination must be 

performed.’’ Id. The MBC held that a 

physician ‘‘cannot do a good faith prior 

examination based on a history, a 

review of medical records, responses to 

a questionnaire, and a telephone 

consultation with the patient, without a 

physical examination of the patient.’’ Id. 

The MBC also held that a ‘‘medical 

indication’’ is determined only after the 

taking of a history, the conducting of a 

physical examination, and an 

assessment of ‘‘the patient’s condition.’’ 

Id. The MBC further explained that ‘‘[a] 

physician cannot determine whether 

there is a medical indication for 

prescription of a dangerous drug 

without performing a physical 

examination.’’ Id. 

In approximately the same timeframe, MBC also issued numerous 

Citation Orders to out-of-state 

physicians for prescribing over the 

Internet to California residents. These 

Orders cited both the physicians’ failure 

to conduct ‘‘a good faith prior 

examination’’ and their lack of ‘‘a valid 

California Physician and Surgeon’s 

License to practice medicine in 

California.’’ Citation Order, Martin P. 

Feldman (Aug. 15, 2003); see also 

Citation Order, Harry Hoff (June 17, 

2003); Citation Order, Carlos Gustav 

Levy (Jan. 28, 2003); Citation Order, 

Carlos Gustav Levy (Nov. 30, 2001). 

As the evidence shows, Respondent 

has never held a California Physician 

and Surgeon’s license. Moreover, given 

Respondent’s admission that the scheme 

‘‘[o]bviously, did not lend itself to do 

any physical examinations,’’ Tr. 212–13, 

I conclude that Respondent did not 

conduct a physical examination of any 

of the three California residents he 

prescribed to (and who were identified 

in GX 18). Accordingly, I conclude that 

in prescribing to these three persons, 

Respondent violated California law by 

engaging in the unauthorized practice of 

medicine and by prescribing ‘‘without 

an appropriate prior examination and 

medical indication therefore.’’ Cal. Bus. 

& Prof. Code § 2242.1. I further hold that 

these prescriptions lacked a ‘‘legitimate 

medical purpose’’ and were issued 

‘‘outside of the usual course of [his] 

professional practice’’ and therefore 

violated the CSA as well. 21 CFR 

1306.04(a); 21 U.S.C. 841(a)(1). 

Respondent issued a prescription for 

hydrocodone to an Ohio resident. As 

does every State, Ohio prohibits the 

practice of medicine without a state 

license. Ohio Rev. Code Ann. § 4731.41 

(1998). Moreover, Ohio has enacted a 

statute which defines ‘‘telemedicine’’ as 

‘‘the practice of medicine in this state 

through the use of any communication, 

including oral, written, or electronic 

communication, by a physician outside 

th[e] state’’ and requires that a physician 

obtain a ‘‘telemedicine certificate’’ to 

lawfully prescribe within the State, id. 

§ 4731.296 (effective 4–10–01), and a 

‘‘special activity certificate.’’ Id. 

§ 4731.294 (effective 4–10–01). 

Moreover, in 2002, Ohio adopted a 

regulation which, except for in 

circumstances not at issue here, 

prohibits the dispensing of controlled 

substances ‘‘to a person who the 

physician has never personally 

examined and diagnosed.’’ Ohio Admin. 

Code § 4731–11–09(A). 

Respondent did not possess either an 

Ohio medical license or Ohio 

‘‘telemedicine certificate’’ and thus, he 

was not authorized to prescribe to an 

Ohio resident. Moreover, because 

Respondent did not perform a physical 

examination of the Ohio resident as 

required by the State’s rule, he did not 

establish a legitimate doctor-patient 

relationship with this person. In 

prescribing hydrocodone to this person, 

not only did Respondent violate Ohio 

law and regulation, he also acted 

outside of the usual course of 

professional practice and lacked a 

legitimate medical purpose and 


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13 In addition to these statute and rules, which 

had been promulgated prior to his conduct, in April 

2001, DEA published a guidance document entitled 

Dispensing and Purchasing Controlled Substances 

over the Internet, 66 FR 21181. The Agency’s 2001 

Guidance expressly stated that ‘‘[u]nder Federal and 

state law, for a doctor to be acting in the usual 

course of professional practice, there must be a 

bona fide doctor/patient relationship.’’ 66 FR at 

21182. Continuing, the Guidance observed that 

‘‘[f]or purposes of state law, many state authorities, 

with the endorsement of medical societies, consider 

the existence of the following four elements as an 

indication that a legitimate doctor/patient 

relationship has been established: 

A patient has a medical complaint; 

A medical history has been taken; 

A physical examination has been performed; and 

Some logical connection exists between the 

medical complaint; the medical history, the 

physical examination, and the drug prescribed. 

Id. at 21182–83. The Guidance further stated that 

‘‘[c]ompleting a questionnaire that is then reviewed 

by a doctor hired by the internet pharmacy could 

not be considered the basis for a doctor/patient 

relationship.’’ Id. at 21183. 

Of further relevance, the Guidance explained that 

‘‘[o]nly practitioners acting in the usual course of 

their professional practice may prescribe controlled 

substances. These practitioners must be registered 

with DEA and licensed to prescribe controlled 

substances by the State(s) in which they operate.’’ 

Id. at 21181 (emphasis added). 

14The ALJ also found that ‘‘the record establishes 

that Respondent failed to review medical records 

for most, if not all, of his patients.’’ ALJ at 38. While 

there is evidence that Respondent failed to review 

the medical records of the DEA and DOH 

Investigators, and there is evidence that other 

doctors admitted that in many instances they did 

not review medical records before prescribing, it is 

not necessary to decide whether the ALJ’s finding 

is supported by substantial evidence. Given that: (1) 

the Investigators obtained prescriptions without 

providing medical records, and (2) even putting 

aside the ALJ’s finding that Respondent’s testimony 

that he had the medical records in front him ‘‘[a]t 

least 75 to 85 percent of the time,’’ Tr. 206, was not 

credible, ALJ at 39; it is still clear that Respondent 

frequently prescribed without reviewing a person’s 

medical record. Beyond this, given the clear 

requirements of California, Ohio, and Tennessee 

that the prescribing physician must perform the 

physical examination, whether he reviewed 

medical records of these persons is immaterial. 

15 In his brief, Respondent argues that ‘‘there is no 

requirement that the prescribing physician 

personally conduct a physical examination of a 

patient for a valid doctor-patient relationship to 

exist.’’ Resp. Br. at 10 (citing Forlaw, M.D. v. Fitzer, 

246 So.2d 432, 435 (Fla. 1984)). However, as 

explained above, in California, Ohio and Tennessee 

there is such a requirement. Moreover, with respect 

therefore violated the CSA as well. 21 

CFR 1306.04(a); 21 U.S.C. 841(a)(1). 

Respondent issued six prescriptions 

for controlled substances (which 

included hydrocodone, as well as 

alprazolam and diazepam), to residents 

of Tennessee. Tennessee law prohibits 

the practice of medicine within the 

State without a license issued by the 

State. Tenn. Code Ann. § 63–6–201(a) 

(2002); see also id. § 63–6–204 (2002) 

(defining ‘‘a person [who is] regarded as 

practicing medicine’’ as one ‘‘who treats, 

or professes to diagnose, treat, operate[] 

on or prescribes for any physical 

ailment or any physical injury to or 

deformity of another’’). Like Ohio, 

Tennessee also provides for ‘‘restricted 

licenses and special licenses based upon 

licensure to another state for the limited 

purpose of authorizing the practice of 

telemedicine.’’ Id. § 63–6–209(b) (1996). 

Prior to the prescribings at issue here, 

Tennessee had also promulgated a 

regulation which provided clear notice 

that, prior to issuing a prescription for 

a controlled substance ‘‘by electronic 

means or over the Internet or over 

telephone lines,’’ a physician must 

‘‘[p]erform[] an appropriate history and 

medical examination,’’ ‘‘[m]a[k]e a 

diagnosis based upon the examinations 

and all diagnostic and laboratory tests 

consistent with good medical care,’’ 

‘‘[f]ormulate[] a therapeutic plan,’’ and 

‘‘[i]nsure[] availability of the physician 

or coverage for the patient for 

appropriate follow-up care.’’ Tenn. 

Comp. R. & Regs. 0880–2–14.(7)(a) 

(2002). Here again, Respondent did not 

possess a Tennessee license and 

violated state law when he issued the 

six prescriptions to Tennessee residents. 

He also violated Tennessee’s regulation 

because he did not perform a medical 

examination of the persons he 

prescribed to. Because Respondent did 

not establish a legitimate doctor-patient 

relationship and lacked the necessary 

State license, in issuing these 

prescriptions, he acted outside of the 

usual course of professional practice 

and lacked a legitimate medical purpose 

and therefore violated the CSA as 

well.13

Respondent also violated both 

Florida’s telemedicine regulation 

(which was promulgated in September 

2003) and the CSA when he prescribed 

hydrocodone to the DEA and DOH 

Investigators. The Florida rule defines 

‘‘the term ‘telemedicine’ ’’ to include the 

‘‘prescribing [of] legend drugs’’ made to 

patients via the internet, telephone, or 

facsimile. Fla. Admin. Code Ann. r. 

64B8–9.014(5). The rule provides that 

prescribing medications solely on the 

basis of an electronic questionnaire 

‘‘constitutes the failure to practice 

medicine with that level of care, skill, 

and treatment which is recognized by 

reasonably prudent physicians as being 

acceptable under similar conditions and 

circumstances, as well as prescribing 

legend drugs other than in the course of 

a physician’s professional practice.’’ Fla. 

Admin. Code Ann. r. 64B8–9.014 

(emphasis added). The rule further 

provides that physician shall not issue 

a prescription, through electronic or 

other means, unless following are done: 

(a) A documented patient evaluation, 

including history and physical examination 

to establish the diagnosis for which any 

legend drug is prescribed. 

(b) Discussion between the physician 

* * * and the patient regarding treatment 

options and the risks and benefits of 

treatment. 

(c) Maintenance of contemporaneous 

medical records meeting the requirements of 

[Fla. Admin. Code] Rule 64B8–9.003. 

Id. r. 64B8–9.014(2). 

In her recommended decision, the 

ALJ noted that ‘‘the Florida regulation 

governing telemedicine standards does 

not specify who must conduct the 

physical examination.’’ ALJ at 38. Rather 

than research whether the Florida 

Medical Board had resolved this 

apparent ambiguity, the ALJ found ‘‘it 

reasonable to infer that the examination 

must be conducted by the prescribing 

physician or a health care provider 

under his direction (such as a nurse or 

physician assistant).’’ Id. 

The ALJ did not, however, cite any 

authority such as an administrative or 

judicial opinion of the Florida Board of 

Medicine, the Florida Attorney General, 

or the Florida courts definitively 

construing the regulation as imposing 

this requirement. Moreover, as the 

Supreme Court has made clear, while 

DEA has authority under the public 

interest standard to determine whether 

a physician has complied with state 

law, it does not have the power to 

‘‘authoritatively interpret’’ ambiguous 

provisions of State law. Gonzales v. 

Oregon, 546 U.S. 243, 264 (2006) (noting 

‘‘the obvious constitutional problems’’ 

were the Attorney General to ‘‘do[] so’’). 

Thus, while it may be reasonable to 

construe the regulation as the ALJ did, 

absent either an administrative or 

judicial decision interpreting the 

regulation in this manner, I am 

compelled to reject the ALJ’s conclusion 

that Florida’s telemedicine rule 

‘‘require[s] that the prescribing 

physician or a provider under his 

supervision personally conduct a 

physical examination.’’ ALJ at 38–39. 

In any event, whatever the rule 

requires as far as who can perform the 

physical exam, it does not matter 

because the rule clearly requires that a 

physician cannot prescribe a drug 

unless there is ‘‘[a] documented patient 

evaluation’’ and neither the DEA nor 

DOH investigator provided any medical 

records to Ken Drugs.14 Thus, it is clear 

that Respondent violated the Florida 

rule when he prescribed hydrocodone to 

the DEA and DOH investigators. 

Moreover, it is clear that Respondent 

acted outside of the usual course of 

professional practice and lacked a 

legitimate medical purpose and thus 

violated the CSA.15 21 CFR 1306.04(a); 

21 U.S.C. 841(a)(1). 


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Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 78753 

to the undercover purchases, the argument provides 

no comfort to Respondent because he prescribed 

without obtaining a ‘‘documented patient 

evaluation, including [a] physical examination’’ and 

the Florida rule expressly provides that such 

prescribing is not ‘‘in the course of a physician’s 

professional practice.’’ Fla. Admin. Code Ann. R. 

64B8–9.014.(1) & (2). 

Respondent also testified that Ken Drugs had 

‘‘other locations that were designed for seeing 

patients’’ and that the patients ‘‘would be directed 

to an office where they could get a physical 

examination, where they could go through getting 

their vital signs and so forth.’’ Tr. 203. Respondent 

did not, however, produce any evidence showing 

that any of the patients identified in Government 

Exhibit 18 were physically examined at these ‘‘other 

locations.’’ Nor did he offer any evidence showing 

that the so-called regional staffers were qualified to 

perform physical exams and diagnose patients. 

Finally, Respondent does not cite to any law or 

regulation of the States of California, Ohio or 

Tennessee authorizing this practice. 

16Even if he did not authorize the prescriptions, 

the evidence supports a finding that Respondent 

authorized the pharmacist to issue prescriptions 

under the authority of his registration. Under DEA 

case law, a registrant who authorizes others to use 

his registration is responsible for any misuse of his 

registration by these individuals. See Paul H. 

Volkman, 73 FR 30630, 30644 n.42 (2008); Rose 

Mary Jacinta Lewis, 72 FR 4035, 4040 (2007); Robert 

G. Hallermeier, 62 FR 26818, 26820 (1997); Summer 

Grove Pharmacy, 54 FR 28522, 28523 (1989). 

17An oral prescription must be ‘‘reduced to 

writing by the pharmacist’’ and ‘‘contain[ ] all 

information required by 21 CFR 1306.05, except for 

the signature of the practitioner.’’ 21 CFR 

1306.21(a). 

18Notably, at an earlier point in his testimony, 

Respondent stated: ‘‘We were all constantly 

reviewing legalities and making certain that we 

were responding to the best practice possible.’’ Tr. 

202. See also Tr. 222 (‘‘there were very, very few 

guidelines’’). 

In his testimony, Respondent 

appeared to deny having personally 

issued all but one of the prescriptions 

contained in Government Exhibit 18. Tr. 

228–29. However, as found above, in an 

interview, Respondent admitted that he 

was electronically transmitting 

prescriptions to Ken Drugs, and in his 

testimony, Respondent admitted that he 

had provided a stamp with his signature 

to at least one of the Ken Drugs 

pharmacies. Thus, it is clear from his 

testimony that Respondent’s intent in 

doing so was to authorize Ken Drugs to 

dispense prescriptions under his 

registration number. Id. at 229 (‘‘It was 

my practice to sign them when I could 

and when everything was variable and 

proper and there would be some 

permission to use the stamp, if I was not 

able to do that myself.’’). I thus reject 

Respondent’s contention that he did not 

authorize the nine stamped 

prescriptions.16

Moreover, Respondent did not claim 

that these were oral prescriptions. Thus, 

Respondent also violated DEA 

regulations because he did not manually 

sign the prescriptions. See 21 CFR 

1306.05(a) (‘‘Where an oral order is not 

permitted, prescriptions shall be written 

with ink or indelible pencil or 

typewriter and shall be manually signed 

by the practitioner.’’) 17

As the foregoing demonstrates, 

Respondent’s experience in dispensing 

controlled substances and his record of 

compliance with laws related to 

controlled substances is characterized 

by his repeated prescribing in violation 

of state laws prohibiting the 

unauthorized practice of medicine as 

well as those requiring that a physician 

personally perform a physical 

examination of a patient he prescribes 

to. These prescriptions also violated 

Federal law because in issuing them, 

Respondent lacked ‘‘a legitimate medical 

purpose’’ and acted outside of ‘‘the usual 

course of [his] professional practice.’’ 21 

CFR 1306.04(a). I thus hold that the 

Government has satisfied its prima facie 

burden of showing that Respondent has 

committed acts which ‘‘render his 

registration * * * inconsistent with the 

public interest.’’ 21 U.S.C. 824(a)(4). 

Sanction 

Under Agency precedent, where, as 

here, ‘‘the Government has proved that 

a registrant has committed acts 

inconsistent with the public interest, a 

registrant must ‘present 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) 

(quoting Samuel S. Jackson, 72 FR 

23848, 23853 (2007) (quoting Leo R. 

Miller, 53 FR 21931, 21932 (1988))). 

‘‘Moreover, because ‘past performance is 

the best predictor of future 

performance,’ ALRA Labs, Inc. v. DEA, 

54 F.3d 450, 452 (7th Cir.1995), [DEA] 

has repeatedly held that where a 

registrant has committed acts 

inconsistent with the public interest, 

[he] must accept responsibility for [his] 

actions and demonstrate that [he] will 

not engage in future misconduct.’’ 

Medicine Shoppe, 73 FR at 387; see also 

Jackson, 72 FR at 23853; John H. 

Kennedy, 71 FR 35705, 35709 (2006); 

Prince George Daniels, 60 FR 62884, 

62887 (1995). See also Hoxie v. DEA, 

419 F.3d at 483 (‘‘admitting fault’’ is 

‘‘properly consider[ed]’’ by DEA to be an 

‘‘important factor[ ]’’ in the public 

interest determination). 

It is acknowledged that Respondent 

ceased his internet prescribing activities 

shortly after the execution of the search 

warrant. It is also acknowledged that 

Respondent took a course of the 

American Academy of Pain 

Management, which included subjects 

pertaining to the prescribing of 

controlled substances. 

The ALJ found, however, that 

Respondent has not accepted 

responsibility for his misconduct. ALJ at 

43–45. As support for this finding, the 

ALJ cited: (1) Respondent’s statement to 

the investigators that he believed the 

Ken Drugs’ scheme was lawful because 

the Kennedee Group was well known, 

had a large business, and that Shobola 

had researched its legality, (2) his 

testimony that he relied on Ken Drugs’ 

employees to screen for drug abusers, 

which she characterized as 

‘‘disingenuous at best,’’ and (3) his 

‘‘evasive and unresponsive’’ testimony 

in ‘‘describing his interactions with Ken 

Drugs patients.’’ ALJ at 43–44. 

The ALJ’s finding is well supported 

by the record. With respect to 

Respondent’s contention that he 

believed that what he was doing was 

lawful, I have previously held that ‘‘a 

licensed physician * * * is * * * 

properly charged with the obligation to 

determine what the law require[s] with 

respect to his prescribing activities.’’ 

Patrick W. Stodola, M.D., 74 FR 20727, 

20735 (2009). In short, Respondent’s 

various contentions as to why he 

believed Shobola’s internet prescribing 

scheme was lawful are absurd on their 

faces. 

Indeed, further evidence of 

Respondent’s failure to accept 

responsibility is his testimony that 

‘‘[t]here was not one letter, not one 

comment from any medical quality 

boards or anyone, regarding safety, 

regarding guidance in any way’’ as to 

‘‘the practice of telemedicine.’’ Tr. 209.18

As noted above, this is utter nonsense, 

as prior to his prescribing, each of the 

three States whose residents he 

prescribed to (California, Ohio, and 

Tennessee) had enacted statutes and/or 

promulgated regulations which clearly 

prohibited his prescribing without 

obtaining a state license and without 

physically examining his patients. 

As the California Court of Appeal has 

noted, ‘‘the proscription of the 

unlicensed practice of medicine is 

neither an obscure nor an unusual state 

prohibition of which ignorance can 

reasonably be claimed, and certainly not 

by persons * * * who are licensed 

health care providers. Nor can such 

persons reasonably claim ignorance of 

the fact that authorization of a 

prescription pharmaceutical constitutes 

the practice of medicine.’’ Hageseth v. 

Superior Court, 59 Cal. Rptr. 3d 385, 

403 (Ct. App. 2007). The same is true of 

the state law standards for establishing 

a valid doctor-patient relationship. 

Respondent’s testimony regarding 

how Ken Drugs screened for drug 

abusers likewise manifests a degree of 

irresponsibility that is incompatible 


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78754 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

19The National Center on Addiction and 

Substance Abuse (CASA) has reported that ‘‘[t]he 

number of people who admit abusing controlled 

prescription drugs increased from 7.8 million in 

1992 to 15.1 million in 2003.’’ National Center on 

Addiction and Substance Abuse, Under the 

Counter: The Diversion and Abuse of Controlled 

Prescription Drugs in the U.S. 3 (2005) (cited in 

Stodola, 74 FR at 10089 n.24). Moreover, 

‘‘[a]pproximately six percent of the U.S. population 

(15.1 million people) admitted abusing controlled 

prescription drugs in 2003, 23 percent more than 

the combined number abusing cocaine (5.9 million), 

hallucinogens (4.0 million), inhalants (2.1 million) 

and heroin (328,000).’’ Id. Relatedly, ‘‘[b]etween 

1992 and 2003, there has been a * * * 140.5 

percent increase in the self-reported abuse of 

prescription opioids’’; in the same period, the 

‘‘abuse of controlled prescription drugs has been 

growing at a rate twice that of marijuana abuse, five 

times greater than cocaine abuse and 60 times 

greater than heroin abuse.’’ Id. 

CASA has further reported that teenagers 

‘‘represent an especially vulnerable group,’’ because 

‘‘[t]eens may view prescription drugs as relatively 

safe either when abused alone or in combination 

with alcohol or other drugs.’’ Id. According to 

CASA, ‘‘[i]n 2003, 2.3 million teens ages 12 to 17 

(9.3 percent) reported abusing a controlled 

prescription drug in the past year; 83 percent of 

them reported abusing opioids.’’ Id. Moreover, 

‘‘[b]etween 1992 and 2002, the number of [first time] 

teenage prescription opioid abusers increased by 

542 percent.’’ Id. 

Finally, CASA noted that ‘‘[i]nternet sites not 

adhering to state licensing requirements, medical 

board standards or Federal law have enabled 

consumers to obtain controlled prescription drugs 

without a valid prescription or physician 

supervision and without regard to age.’’ Id. at 63. 

CASA also noted that ‘‘illegal [i]nternet pharmacies 

have introduced a new avenue through which 

unscrupulous buyers and users can purchase 

controlled substances for unlawful purposes.’’ Id. 

Moreover, ‘‘[t]he age of the customers appears not 

to be an issue for Internet pharmacies,’’ and that 

there are ‘‘no mechanisms in place to block children 

from purchasing controlled drugs over the Internet.’’ 

Id. at 66. 

20See also Stodola, 74 FR at 20730–31 

(practitioner’s continued registration deemed 

inconsistent with the public interest where, inter 

alia, ‘‘he has not accepted responsibility for his 

misconduct but blames others’’); Leslie, 68 FR at 

15231 (revoking registration where, inter alia, 

‘‘Respondent refuse[d] to take responsibility for his 

past misconduct’’ and ‘‘remain[ed] steadfast in his 

insistence upon denying any previous 

wrongdoing’’); Prince George Daniels, 60 FR 62881, 

62887 (1995) (registrant’s ‘‘lack of candor * * * as 

to the full extent of his involvement in the cocaine 

incident creates concern about his future conduct’’); 

John Stanford Noell, 59 FR 47359, 47361 (1994) 

(denying Respondent’s application for registration 

where, as to factor five, ‘‘Respondent has exhibited 

no remorse for his illegal activities’’). 

with what DEA expects of a registrant. 

While Respondent testified that other 

employees were responsible for 

screening the patients, he acknowledged 

that if the patients ‘‘were liars * * * 

they could break through’’ and that ‘‘a lot 

of fraud can happen.’’ He then justified 

his prescribing notwithstanding the 

obvious diversion risk, claiming that he 

is not a lawyer or police agent and that 

as ‘‘a physician * * * I take people at 

their word’’ and ‘‘as a family physician, 

I have patients that come to me face-toface and can be dishonest with me.’’ Id. 

at 206–09. 

Later, Respondent claimed that he 

could identify drug abusers and drug 

seekers by their voice or diction, but 

then acknowledged that this was ‘‘by no 

means, any criteria to determine who is 

being evasive’’ and that it was ‘‘very, 

very less than perfect.’’ Id. at 230–31. 

Putting aside the obvious risk of 

diversion by prescribing to people one 

never meets, if Respondent, as a trained 

physician, could not identify drug 

abusers and drug seeking patients, it 

should have been apparent that Ken 

Drugs’ employees could not either. Yet 

he proceeded to prescribe controlled 

substances to numerous persons even 

though he had no idea as to whether 

they were legitimate patients or drug 

seekers and abusers.19

The ALJ was also unimpressed by 

Respondent’s testimony regarding his 

interactions with Ken Drugs’ patients. 

For example, Respondent testified that 

Ken Drugs’ customers would not be able 

to get him ‘‘on the phone until they had 

gone through some of these hurdles’’ 

such as sending in their medical 

records. Id. at 206. He also claimed that 

there were times when the customers 

got through to him without having 

provided their medical records, and that 

he ‘‘would have to say, ‘No, we can’t 

help you.’ ’’ Id. at 214. Yet he prescribed 

to both the DEA and DOH Investigators 

who had not sent in any records. He 

also testified that he discussed ‘‘the risk 

of habituation’’ with the persons he 

prescribed to. Id. at 217. Once again, he 

did not do so when he prescribed to 

either the DEA or DOH Investigators. 

As the ALJ found, much of 

Respondent’s testimony was self-serving 

and disingenuous. Moreover, 

Respondent repeatedly attempted to 

minimize his misconduct, which is 

egregious. In short, Respondent has 

failed to acknowledge any wrongdoing 

on his part. Accordingly, I agree with 

the ALJ’s finding that Respondent has 

failed to accept responsibility for his 

misconduct and that this ‘‘warrants the 

finding * * * that his continued 

registration poses a threat to the public 

health and safety.’’ ALJ at 46.20 Having 

concluded that Respondent has failed to 

rebut the Government’s prima facie 

case, his registration will be revoked 

and any pending application will be 

denied. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f) & 824(a)(4), as well 

as by 28 CFR 0.100(b) & 0.104, I order 

that DEA Certificate of Registration, 

BL6686541, issued to Ronald Lynch, 

M.D., be, and it hereby is, revoked. I 

further order that any application for 

renewal or modification of such 

registration be, and it hereby is, denied. 

This Order is effective January 18, 2011. 

Dated: December 3, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–31650 Filed 12–15–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Office of the Secretary 

Bureau of International Labor Affairs; 

Notice of Publication of 2010 Update to 

the Department of Labor’s List of 

Goods From Countries Produced by 

Child Labor or Forced Labor 

AGENCY: Bureau of International Labor 

Affairs, Department of Labor. 

ACTION: Announcement of Public 

Availability of updated list of goods. 

SUMMARY: This notice announces the 

publication of an updated list of 

goods—along with countries of origin— 

that the Bureau of International Labor 

Affairs (‘‘ILAB’’) has reason to believe 

are produced by child labor or forced 

labor in violation of international 

standards (‘‘List’’). ILAB is required to 

develop and make available to the 

public the List pursuant to the 

Trafficking Victims Protection 

Reauthorization Act of 2005 (‘‘TVPRA’’). 

FOR FURTHER INFORMATION CONTACT: 

Director, Office of Child Labor, Forced 

Labor, and Human Trafficking, Bureau 

of International Labor Affairs, U.S. 

Department of Labor at (202) 693–4843 

(this is not a toll-free number). 

SUPPLEMENTARY INFORMATION: ILAB’s 

Office of Child Labor, Forced Labor, and 

Human Trafficking (OCFT) carries out 

the mandates of section 105(b)(1) of the 

TVPRA, Public Law 109–164. For 

complete information on OCFT’s 

TVPRA activities, please visit the Web 

site listed below. Previous Federal 

Register notices issued on this subject 

include: Notice of Proposed Procedural 

Guidelines for the Development and 

Maintenance of the List of Goods From 

Countries Pursuant to the Trafficking 

Victims Protection Reauthorization Act 

of 2005 (72 FR 55808, Oct. 1, 2007); 

Notice of Procedural Guidelines for the 

Development and Maintenance of the 

List of Goods from Countries Produced 

by Child Labor or Forced Labor; Request 

for Information (72 FR 73374, Dec. 27, 

2007); Notice of Public Hearing to 

Collect Information to Assist in the 

Development of the List of Goods From 

Countries Produced by Child Labor or 


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