51424 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

Dang, M.D., to renew or modify his 

registration be, and it hereby is, denied. 

This Order is effective September 19, 

2011. 

Dated: August 5, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–21062 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–4] 

Satinder Dang, M.D.; Revocation of 

Registration 

On August 31, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Satinder K. Dang, M.D. 

(Respondent), of Fountain Valley, 

California. The Order proposed the 

revocation of Respondent’s DEA 

Certificate of Registration, AD9234446, 

as a practitioner, as well as the denial 

of any pending applications to renew or 

modify her registration, ‘‘for reason that 

[Respondent’s] continued registration[] 

would be inconsistent with the public 

interest, as that term is used in 21 U.S.C. 

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

The Order specifically alleged that 

between January 2004 and July 2007, 

Respondent and her husband Surinder 

Dang, ‘‘who also possesses a DEA 

registration and shares [Respondent’s] 

registered location,’’ ordered ‘‘more than 

5,000,000 dosage units of hydrocodone’’ 

and that Respondent ‘‘failed to properly 

account for, secure, and otherwise 

handle these controlled substances.’’ Id. 

The Order alleged that on January 17, 

2006, one of Respondent’s ‘‘employees 

removed 30,000 dosage units of 

controlled substances’’ from her 

registered location and ‘‘attempted to 

take them to her residence.’’ Id. The 

Order further alleged that on the same 

day, ‘‘DEA Special Agents seized 

another 10,000 dosage units of 

controlled substances from this 

employee’s residence.’’ Id. Continuing, 

the Order alleged that on March 16, 

2006, ‘‘DEA Special Agents seized 

50,000 dosage units more from this 

employee’s residence.’’ Id. 

Next, the Order alleged that on March 

16, 2006, DEA conducted an 

accountability audit of Respondent’s 

handling of hydrocodone and that 

Respondent ‘‘could not account for 

more than 3,500,000 dosage units’’ that 

Respondent and her husband ‘‘had 

ordered’’; the Order thus also alleged 

that Respondent ‘‘failed to keep accurate 

and complete records of each controlled 

substance received, sold, delivered, or 

otherwise disposed of as required by 21 

U.S.C. 827(c) and 21 CFR 1304.01 et 

seq.’’ Id. at 2. Finally, the Order alleged 

that, when Respondent ‘‘made 

dispensing records,’’ she ‘‘frequently 

failed to indicate whether’’ she or her 

husband ‘‘actually dispensed the 

controlled substances as required by 21 

CFR 1304.03(b).’’ Id. 

By letter of October 2, 2009, 

Respondent, through her counsel, 

requested a hearing on the allegations. 

ALJ Ex. 2. The matter was then assigned 

to an Administrative Law Judge (ALJ), 

who conducted a hearing on March 2– 

3, 2010, in Santa Ana, California. 

At the hearing, the Government called 

two witnesses to testify and introduced 

documentary evidence. Respondent 

testified on her own behalf. Following 

the hearing, both parties submitted 

briefs containing their proposed 

findings of fact, conclusions of law and 

argument. 

On June 18, 2010, the ALJ issued her 

Recommended Decision (also ALJ). 

Therein, the ALJ considered the five 

public interest factors, see 21 U.S.C. 

823(f), and concluded that Respondent’s 

continued registration would be 

inconsistent with the public interest and 

recommended that her registration be 

revoked. ALJ at 29, 37–38. 

As to the first factor—the 

recommendation of the appropriate 

State licensing board or professional 

disciplinary authority—the ALJ found 

‘‘no evidence that the Medical Board of 

California has taken any action against 

the Respondent.’’ Id. at 27. However, the 

ALJ recognized that under Agency 

precedent, ‘‘the fact that the Medical 

Board of California has currently 

authorized * * * Respondent to 

practice medicine is not dispositive in 

this administrative determination as to 

whether continuation of a registration is 

consistent with the public interest.’’ Id. 

(citing Patrick W. Stodola, 74 FR 20727, 

20730 (2009); Jayam Krishna-Iyer, 74 FR 

459, 461 (2009)). The ALJ then 

concluded that ‘‘this factor does not fall 

in favor of revocation.’’ Id. Likewise, 

with respect to factor three— 

Respondent’s record of convictions for 

offenses relating to the manufacture, 

distribution, or dispensing of controlled 

substances—the ALJ found that 

Respondent has not been convicted of 

such an offense and that this factor also 

did not ‘‘fall in favor of revocation.’’ Id. 

at 27–28. 

The ALJ then considered factors two 

and four—Respondent’s experience in 

dispensing controlled substances and 

her compliance with Federal, State, and 

local laws relating to controlled 

substances—together. Id. at 28–29. The 

ALJ found that the record was ‘‘replete 

with Respondent’s lack of oversight 

concerning the use of her controlled 

substances registration.’’ Id. at 28. 

Specifically, the ALJ found that: (1) 

Respondent’s clinic was unable to 

provide a biennial inventory (or an 

inventory of any kind); (2) ‘‘Respondent 

was unable to account for any of the 

controlled substances ordered using her 

DEA registration number’’; and (3) 

Respondent had admitted that ‘‘she did 

not maintain a key to the controlled 

substance cabinet’’ at her clinic. Id. at 

28–29. Further, the ALJ found that an 

‘‘audit revealed that the approximately 

3,870,700 dosage units of hydrocodone 

were unaccounted for.’’ Id. at 29. Based 

on these findings, the ALJ concluded 

that ‘‘Respondent failed to maintain 

adequate records.’’ Id. 

The ALJ rejected Respondent’s 

argument that ‘‘the DEA’s findings did 

not distinguish between the controlled 

substances prescribed or dispensed to 

Respondent’s patients versus the 

patients of’’ her husband. Id. The ALJ 

found that ‘‘the missing controlled 

substances were ordered under both 

DEA registration numbers in a 

haphazard manner and subsequently 

mixed into an incoherent me ́lange.’’ Id. 

The ALJ reasoned that if ‘‘Respondent 

maintained some oversight of her 

controlled substances registration, then 

DEA would most likely be able to 

‘distinguish between controlled 

substances prescribed or dispensed to 

Respondent’s patients versus’ those of 

her husband.’’ Id. Based on these 

findings, the ALJ concluded that 

‘‘Respondent’s circular reasoning does 

not absolve her [of] culpability.’’ Id. The 

ALJ thus held that the Government’s 

evidence under factors two and four 

‘‘established prima facie grounds for 

revocation of * * * Respondent’s DEA 

Certificate of Registration.’’ Id. 

Turning to factor five—such other 

conduct as may threaten the public 

health and safety—the ALJ explained 

that ‘‘[e]ven if Respondent was not 

directly involved in the illegal diversion 

of controlled substances * * * she 

committed acts which constitute 

‘conduct which may threaten the public 

health and safety’ and which render her 

registration ‘inconsistent with the 

public interest.’ ’’ Id. (quoting 21 U.S.C. 

823(f)(5), 824(a)(4)). Noting that 

‘‘[u]nder DEA precedent, a registrant 

who entrusts [her] registration to 

another person is strictly liable for the 

latter’s misuse of [her] registration,’’ the 

ALJ reasoned that ‘‘even if there had 

been no conspiracy amongst 

Respondent, her husband, and [R.K., the 

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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51425 

1 Dr. Surinder Dang holds DEA Certificate of 

Registration AD6122143; he is registered at the 

same address as Respondent. ALJ Ex. 3, at 2, GX 

2 at 2. 

2 In various documents R.K.’s first name was 

spelled as both Rani and Roni. Compare GX 5, at 

7, with GX 6, at 1, 5, 9, 14–15, 18, 29; see also GX 

10 at 1. 

3Pursuant to 21 CFR 1304.33(c), manufacturers 

and distributors of various controlled substances 

including schedule III narcotics are required to 

report their distributions of controlled substances to 

DEA through the Automated Records and 

Consolidated Orders System (ARCOS). See also Tr. 

33. 

4As a combination product, hydrocodone is a 

schedule III controlled substance. 21 CFR 

1308.13(e)(1)(iv). 

5The ARCOS system reports the registration 

number used, but not necessarily the person who 

actually ordered the drugs. Tr. 114–16. 

6Moore Medical Supply reported to DEA that 

CMC ordered excessive amounts of hydrocodone. 

Tr. 32–34; GX 5. The order to Moore was placed 

under Respondent’s husband’s DEA registration and 

R.K.’s name appears on a fax sheet sent to Moore 

Medical and related to CMC’s account number. GX 

5, at 7; Tr. 131. 

office manager of the clinic where she 

practiced with her husband] to 

unlawfully distribute the drugs, 

[Respondent] would still be liable for 

the acts [R.K.] committed while being 

allowed to use [her] registration.’’ Id. 

(citations omitted). 

The ALJ further found incredible 

Respondent’s testimony that ‘‘she was 

unaware of [R.K’s] actions.’’ Id. Noting 

Respondent’s ‘‘admitted lack of 

supervision’’ over R.K.—including that 

Respondent would ‘‘tell [R.K.] which 

drug she wanted to dispense,’’ R.K. 

‘‘would retrieve the controlled 

substances from the steel cabinet and 

update the logbook,’’ and ‘‘only [R.K.] 

had a key to the controlled substances 

cabinet’’—placed R.K. in a ‘‘position 

where she could take advantage of the 

lax security’’ of Respondent’s controlled 

substances, the ALJ rejected 

Respondent’s contention that these were 

‘‘minor record-keeping violations’’ and 

held that she was ‘‘responsible for 

enabling [R.K.’s] acts of unlawful 

possession and distribution of the 

controlled substances that [R.K.] 

obtained under Respondent’s 

registration.’’ Id. (citing Harrell E. 

Robinson, M.D., 74 FR 61370, 61376–77 

(2010)). The ALJ also found that 

Respondent is ‘‘still engaged in an 

ongoing working relationship with 

[R.K.],’’ id. at 32, and held that ‘‘[a] 

practitioner’s failure to properly 

supervise patients or staff to prevent 

them from personally abusing 

controlled substances or selling them to 

others constitutes conduct ‘inconsistent 

with the public interest’ and can 

support * * * the revocation of an 

existing registration.’’ Id. at 33 (citing 

Jeri Hassman, M.D., 75 FR 8194, 8227 

(2010); Gonzales v. Oregon, 546 U.S. 

243, 274 (2006)). 

Noting that Respondent blamed her 

husband and R.K. for her misconduct, 

the ALJ further found that 

‘‘Respondent’s acceptance of 

responsibility has been minimal’’ and 

‘‘weighs heavily against her continuing 

registration.’’ Id. at 35. The ALJ further 

held that Respondent’s ‘‘lack of 

cooperation with the DEA investigation 

nominally weighs against her continued 

registration.’’ Id. at 36–37. 

The ALJ also found that ‘‘the fact that 

[Respondent] still works alongside 

[R.K.] is an aggravating factor.’’ Id. at 35. 

While noting Respondent had offered to 

file quarterly reports of her 

prescriptions with the Agency, the ALJ 

found that ‘‘Respondent’s careless use of 

her DEA Certificate of Registration 

coupled with her lack of assurances that 

she will no longer enable others such as 

[R.K.] and her husband to abuse her 

controlled substances registration 

weighs heavily against her continuing 

registration.’’ Id. at 37. The ALJ 

therefore recommended that 

‘‘Respondent’s DEA Certificate of 

Registration be revoked.’’ Id. at 38. 

On August 9, 2010, Respondent filed 

Exceptions to the ALJ’s Decision, and on 

August 18, the ALJ forwarded the record 

to me for Final Agency Action. On 

September 10, 2010, the Government 

filed a motion with my Office to accept 

its response to Respondent’s Exceptions. 

In its motion, the Government stated 

that Respondent’s counsel had 

consented to its filing. Accordingly, by 

this Order I grant the Government’s 

motion. 

Having considered the entire record, I 

adopt the ALJ findings of fact and 

conclusions of law except as expressly 

noted herein. I further adopt the ALJ’s 

ultimate conclusion that Respondent’s 

‘‘continued registration is not in the 

public interest,’’ ALJ at 38, and her 

recommendation that her registration be 

revoked. As ultimate factfinder, I make 

the following findings: 

Findings 

Respondent is the holder of DEA 

Certificate of Registration, AD9234446, 

which authorizes her to dispense 

controlled substances in schedules II 

through V, as a practitioner, at the 

registered location of 17150 Euclid 

#200, Fountain Valley, California. GX 1. 

While Respondent’s registration was to 

expire on June 30, 2007, id., on June 4, 

2007, Respondent filed an application to 

renew her registration. GX 2. 

Accordingly, her registration remains in 

effect pending the issuance of this 

Decision and Final Order. 5 U.S.C. 

558(c); see also ALJ Ex. 3, at 2 

(Prehearing Order; Stipulations). 

Respondent currently holds a medical 

license issued by the Medical Board of 

California. Moreover, the Board has not 

taken any formal action to limit her 

ability to practice medicine or to 

prescribe controlled substances. ALJ Ex. 

3, at 3. Also, Respondent has not been 

convicted of an offense related to the 

manufacture, distribution, or dispensing 

of controlled substances. Id. 

Respondent is married to Surinder 

Dang, M.D.1 He and Respondent 

practice medicine at Complete Medical 

Care, Inc. (‘‘CMC’’). Tr. 188–189; GX 6, 

at 20. Their son, Sameer Dang, also 

works in the CMC office. Tr. 58, 188. At 

all relevant times (including through the 

date of the hearing), CMC’s office 

manager was Ms. Rani K. (R.K.).2 Id. at 

190–91, 194–95, 203–04. 

In November 2005, a Diversion Group 

Supervisor (GS) in DEA’s Riverside 

Diversion Group reviewed ARCOS 3

records which showed that large 

amounts of controlled substances, 

including hydrocodone,4 were being 

ordered under the DEA registration 

numbers of both Respondent and her 

husband.5 Tr. 30–32; GXs 3 & 4. Upon 

reviewing the ARCOS data, the GS 

contacted several of the firms that were 

distributing controlled substances to 

Respondent. See, e.g., GX 6, at 7. At 

several points throughout the 

investigation, these firms provided the 

GS with copies of various documents, 

including sales records, invoices, 

statements of account, delivery 

information, applications for credit, and 

correspondence. See generally GX 5 

(records from Moore Medical, L.L.C.),6

GX 6 (record from Henry Schein, Inc.), 

GX 9 (records from ParMed 

Pharmaceuticals, Inc.). 

The majority of the controlled 

substances ordered under Respondent’s 

DEA registration were obtained from 

Anda Pharmaceuticals. GX 3; Tr. 130, 

139. The GS obtained purchase records 

from Anda showing hydrocodone and 

other controlled substances purchases 

by both Respondent and her husband 

between 2000 and 2005. GX 8; Tr. 47– 

49. However, there is no evidence that 

Respondent ever personally ordered 

these controlled substances. Tr. 140. 

CMC also ordered controlled 

substances, primarily hydrocodone, 

from another drug distributor, Henry 

Schein, Inc. GX 6; Tr. 44. The Schein 

records show that the orders were 

placed under Respondent’s husband’s 

name, but a number of the invoices note 

Respondent’s name as well as her 

husband’s. GX 6, at 8–9, 11, 14–15, 17– 

18, 29. R.K.’s name was also listed as 

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7The GS stated that he analyzed ARCOS data, 

distributors’ sales records, audit inventories, patient 

files and dispensing logs when creating GX 15. Tr. 

92–97. 

8More specifically, there were 14 bottles of 500 

count of hydrocodone/apap 7.5/500 mg; 10 bottles 

of 500 count hydrocodone/apap 10/500 mg; 36 

bottles of 500 count hydrocodone/apap 10/325 mg; 

and 10 bottles of 100 count hydrocodone/apap 10/ 

500 mg. GX 10, at 6. 

the contact person for the Henry Schein 

account. Tr. 132–34. 

In a letter dated November 7, 2005, 

Respondent’s husband explained to 

Henry Schein that CMC would begin 

ordering controlled substances so that 

CMC’s physicians could dispense 

medications directly to CMC’s patients. 

GX 7; Tr. 46. This letter listed the CMC 

physicians as Surinder Dang, M.D.; 

Satinder Dang, M.D.; Robert Belanger, 

D.O.; Huey Lin, M.D.; and Davinder 

Singh, M.D. GX 7. The letter also stated: 

‘‘We dispense medications to our 

patients only. Our practice has been 

growing.’’ Id. However, none of the 

records obtained in the investigation 

show that controlled substances were 

ordered from Schein under the 

registrations of any of the doctors 

besides those of Respondent and her 

husband. GX 6, at 7; Tr. 176–79. 

The DEA registration numbers of both 

Respondent and her husband were used 

to order controlled substances from 

Darby Medical Supply and ParMed 

Pharmaceuticals. GX 16; GX 9, 11; Tr. 

51, 61–62. The Darby records show that 

Respondent ordered hydrocodone 

fourteen times. GX 16, at 1, 5, 7, 11. The 

ParMed records show that between 

December 29, 2005 and January 4, 2006, 

88,800 dosage units of hydrocodone 

were ordered under Respondent’s 

registration. GX 9, at 2. At one point, 

D.L., ParMed’s Regulatory Affairs 

officer, reported to the GS that CMC’s 

orders were ‘‘excessive and suspicious’’; 

D.L. also identified R.K. as the point of 

contact for the clinic and that R.K. had 

opened the CMC accounts. Tr. 51–53. 

According to ARCOS records, while 

in 2004, Respondent purchased 157,100 

dosage units of hydrocodone, in 2005, 

she purchased 2,272,800 dosage units. 

GX 3, at 2–13. ARCOS data further 

showed that in 2005, Respondent and 

her husband had ordered a combined 

total of 3,626,400 tablets of 

hydrocodone. GX 3 at 13; GX 4, at 6; see 

also Tr. 93–94 (GS’s testimony that 

between January 1, 2005 and March 16, 

2006, Respondent and her husband 

purchased approximately 4 million 

tablets of hydrocodone).7

Throughout the investigations, several 

of the firms also provided the GS with 

information regarding when various 

deliveries were to be made to 

Respondent’s clinic. On December 14, 

2005, the GS, who had received 

information from two different 

distributors (Henry Schein and Moore 

Medical) that controlled substances 

deliveries were to be made that day, 

conducted surveillance at the [Dangs’] 

clinic from approximately 9:00 a.m. 

until 6:00 p.m. Tr. 43, 67–68, 75. During 

the surveillance, the GS observed both 

deliveries and noted that 

‘‘approximately no more than a dozen’’ 

people entered the clinic that day. Id. at 

75. 

On January 13, 2006, the GS 

conducted a second surveillance from 

approximately 9:00 a.m. until 3 p.m. Id. 

at 76–77. During the surveillance, the 

GS saw R.K. ‘‘tak[ing] boxes from the 

office and plac[ing] them in the trunk of 

her * * * SUV.’’ Id. at 77. 

On January 17, 2006, the GS, who had 

received notice of a controlled 

substance delivery from another 

distributor (ParMed Pharmaceuticals, 

Inc.), conducted another full-day 

surveillance. Id. at 77–78. Once again, 

Investigators observed R.K. ‘‘place 

numerous boxes in her vehicle that had 

been delivered to the clinic’’ and ‘‘put 

them in the back of her * * * SUV.’’ Id. 

at 78. The GS observed R.K. drive away 

and notified the California Highway 

Patrol (CHP). Id. at 78, 80, 147–48. After 

observing R.K., who was driving forty 

miles per hour, operate her vehicle 

within five feet of the vehicle in front 

of her, the CHP officer conducted a 

traffic stop. Id. at 78; GX 10, at 2. 

As he approached R.K., the CHP 

officer observed ‘‘cardboard boxes that 

were taped shut in the rear cargo area.’’ 

GX 10, at 2. The CHP officer advised 

R.K. of the reason for the stop and 

requested her license, registration, and 

insurance. Id. He then asked R.K. ‘‘what 

the boxes were.’’ Id. R.K. stated that the 

boxes held Vicodin, a schedule III 

controlled substance which contains 

hydrocodone. Id.; ALJ Ex. 3, at 1; 21 

CFR 1308.13(e)(iv). When the CHP 

officer asked R.K. if she was a doctor, 

she stated that ‘‘she was the president 

of a medical facility and that she was 

going to give the Vicodin to the doctor 

at her facility.’’ GX 10, at 2. The CHP 

Officer asked R.K. a second time if she 

was a doctor; R.K. again said ‘‘no’’ and 

became ‘‘extremely nervous.’’ Id. 

After the CHP Officer asked R.K. to 

step out of her car, he asked ‘‘why she 

had cases of Vicodin.’’ Id. R.K. 

answered that she ran a medical office 

and handed him a business card listing 

her name and her position as 

‘‘president.’’ Id. R.K. further stated that 

‘‘she received a delivery of Vicodin from 

a delivery company at about 1100 hours 

and that she needed to give it to’’ 

Respondent. Id. When the Officer asked 

R.K. if the Vicodin had been delivered 

‘‘to her car or to her office,’’ R.K. stated 

that it had been delivered to the office. 

Id. When the Officer asked if her office 

had a locker in which to store the 

Vicodin, R.K. answered ‘‘yes,’’ but that 

she had to personally give the drugs to 

Respondent. Id. 

The CHP Officer then asked how the 

Vicodin had ended up in her vehicle; 

R.K. stated that ‘‘she [had] carried the 

boxes to her vehicle around noon time 

and left them there,’’ and that she had 

stayed in her office until about 5 p.m., 

at which point ‘‘she left * * * to get 

something to eat.’’ Id. When the Officer 

told R.K. that he was ‘‘concerned that 

she was in possession of so much of a 

controlled substance,’’ she said she 

would return it to the office. Id. R.K. 

then stated that Respondent was ‘‘doing 

a procedure at an unknown hospital and 

he would be returning at an unknown 

time to the office’’ and that she would 

then give him the Vicodin. Id. 

The CHP Officer then ‘‘asked R.K. to 

open the boxes’’ to confirm that they 

contained Vicodin. Id. R.K. opened six 

boxes containing a total of 70 bottles of 

hydrocodone bitartrate/acetaminophen 

(hereinafter, hydrocodone/apap or 

hydrocodone). Id. at 2–3. Each of the 

bottles contained between 100 and 500 

tablets (for a total of ‘‘approximately 

31,000 tablets’’) in 7.5/500 mg, 10/500 

mg, and 10/325 mg strengths. Id. The 

Officer then seized the Vicodin and gave 

R.K. a receipt for it. Id. at 3. After giving 

R.K. a citation, the officer allowed her 

to leave. Id. 

The CHP Officer then contacted a 

DEA Task Force Officer (TFO) and 

arranged to transfer custody of the drugs 

to DEA; upon the TFO’s arrival at the 

Officer’s location, the drugs were 

transferred to the TFO. Id. The TFO 

gave the CHP Officer a receipt which 

confirms the figures in the latter’s 

report.8 Id. at 6. 

R.K. then drove to her residence in 

Anaheim Hills; Investigators followed 

her there in order to question her about 

the drugs that were found in her 

vehicle. Tr. 82. R.K. told the 

Investigators that she had taken the 

hydrocodone with her for safekeeping 

because Respondent was out of the 

office; she also maintained that she 

intended to return them to the office 

after she ate. Id. at 83. While R.K. 

initially claimed that this was the first 

time she had done this, upon being 

confronted with the fact that 

Investigators had on another occasion 

observed her placing boxes in her 

vehicle, R.K. admitted that this was the 

second time she had done so. Id. 

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9A.N. stated that Respondent, her husband, and 

R.K. handled drug deliveries when they came into 

CMC. Id. at 238–39. A.N. further stated that both 

Respondent and her husband kept records of 

dispensed drugs in the patient files and dispensing 

logs; she identified the writing in the patient log as 

R.K.’s. Id. at 239–40. 

10The transcript notes the coworker’s initials as 

C.G.; however, other documents suggest that her 

initials are K.G. See Resp. Brief at 8. C.G. stated that 

both R.K and Respondent’s husband ordered the 

drugs for CMC. Tr. 241, 249–250. R.K. usually 

accepted deliveries of drug orders; however, 

sometimes C.G. would sign for the delivery but not 

open the boxes. Id. at 241–42. C.G. further stated 

that she witnessed R.K. writing in the dispensing 

log the day before the search warrant was executed 

and heard R.K. comment that CMC’s drug 

procedures had changed. Id. at 242. 

11According to L.Y., the clinic saw twenty to 

twenty-five patients per day. Id. at 244. L.Y. also 

stated that R.K. handled the drugs once they 

arrived. Id. at 243. When shown the dispensing log, 

L.Y. identified the handwriting as belonging to R.K. 

Id. at 243–44. She further stated that Respondent 

only wrote prescriptions. Id. at 250. 

12S.B. stated that R.K. and Respondent’s husband 

handled the drugs that were dispensed directly to 

patients and that R.K. handled the drug inventory 

and payment for the drugs that were ordered. Id. at 

246. S.B. also stated that R.K. handled the 

dispensing log. Id. at 247. S.B. further stated that 

CMC had approximately twenty-five patients per 

day, of whom ten saw Respondent. Id. According 

to S.B., both Sameer Dang and R.K. paid for the 

drugs. Id. She also stated that R.K. had access to the 

controlled substances received at the CMC office. 

Id. at 248. 

13Moore Medical provided DEA with sales 

records under Respondent’s registration for 

hydrocodone from late 2005 to early 2006. Tr. 34, 

43; GX 5. ANDA provided DEA with a spreadsheet 

listing all sales under the registrations of 

Respondent and her husband from May 2000 

through mid-October 2005. Tr. 47–49; GX 8. DEA 

also acquired sales records and a sales summary 

from ParMed which show Respondent’s purchases 

of controlled substances between November 28, 

2005 and January 4, 2006. Tr. 51–52; GX 9. 

14 If any controlled substances were in fact on 

hand on the starting date of the audit period, 

assigning a zero starting inventory would reduce 

the size of any shortage. 

15 I acknowledge that this figure differs from the 

quantity of 1,400 tablets which, according to the 

GS’s testimony, was found in R.K.’s house. The 

difference, however, is inconsequential given the 

result of the audit. 

16The dispensing logs also did not contain the 

name of the dispensing physician, the initials of the 

person dispensing the drugs, and the patient’s 

address as required by 21 CFR 1304.22(c). Tr. 90; 

see also GX 14. Moreover, while there were some 

dispensing logs from 2003, the remaining logs only 

covered the period from February 28 through March 

15, 2006. See GX 14. 

17The GS credited CMC with dispensing a total 

of 87,000 hydrocodone tablets; this calculation 

counted the prescriptions issued by Respondent or 

her husband, because the prescriptions may have 

been filled in the office. Tr. 100; GX 15. 

18Neither Respondent nor her husband had 

reported to DEA any thefts, losses, or destructions 

of controlled substances. Tr. 99–101. 

19This calculation gives Respondent credit for all 

of the 167,000 tablets for which the GS could 

account. 

R.K. stated that there were about five 

physicians who worked at Respondent’s 

clinic, that they dispensed the pills in 

30- and 60-count bottles, and that the 

clinic had approximately twenty to 

twenty-five patients per day. Id. at 84. 

R.K. further said that she used her 

personal credit card to purchase drugs 

from wholesalers and that Respondent 

would reimburse her. Id. 

The Investigators then asked R.K. if 

she would consent to a search of her 

residence; she agreed. Id. According to 

the GS, the Investigators found 

approximately $69,500 in cash in an 

upstairs closet, a ‘‘quantity of 

hydrocodone and lorazepam in the 

house’’ (2000 lorazepam tablets and 

1400 hydrocodone tablets), ‘‘money 

order receipts,’’ and receipts of 

‘‘payments made to the credit card 

companies by [R.K.].’’ Id. To explain the 

cash found at her residence, R.K. 

claimed the sum was a combination of 

money received from the sale of a house 

in India and a home-based business she 

had previously run. Id. at 85–86. 

On February 24, 2006, Respondent’s 

husband wrote a letter to CHP 

requesting the return of the 

hydrocodone which had been seized 

during the traffic stop of R.K. Tr. 88–89; 

GX 12. The letter asserted that R.K. was 

the clinic’s ‘‘office manager,’’ and had 

‘‘informed CHP that the property was 

not hers, and instead belonged to her 

employer, Complete Medical Care Inc.’’ 

GX 12. 

On March 16, 2006, DEA executed 

search warrants at both Respondent’s 

clinic and R.K.’s residence. Tr. 90, 104. 

At the clinic, the Investigators took an 

inventory of the controlled substances 

on hand and found 48,000 tablets of 

hydrocodone, which they seized; the 

Investigators also seized CMC’s 

controlled substance purchasing records 

and dispensing log. Tr. at 90, 95. Later 

that day, Investigators went to 

Respondent’s residence and sought 

consent to search her house. Tr. 103. 

Respondent declined to provide consent 

and refused to talk with Investigators 

without an attorney present. Id. 

R.K. was present during the search of 

her residence and was interviewed. Id. 

at 104. R.K. stated that since January 17, 

2006, she had stopped purchasing the 

drugs on her own, and that the drugs 

were being purchased by Respondent’s 

husband, Dr. Surinder Dang. Id. at 105. 

R.K. stated that Respondent’s husband 

was the clinic’s ‘‘primary dispenser’’ of 

the drugs and that she ‘‘dispensed drugs 

to the patients under the direction of 

* * * Dr. Surinder Dang.’’ Id. 

On March 16, 2006, the Diversion 

Investigator (DI) interviewed several 

CMC employees, including A.N.,9

C.G.,10 L.Y.,11 and S.B.12 In April 2006, 

the GS interviewed Dr. B., a physician 

who had worked at CMC on a part-time 

basis since approximately 2004. Id. 109– 

110. Dr. B. also worked at a facility for 

the local county government, but he saw 

some of his patients at CMC. Id. at 110. 

Dr. B. stated that while he worked at 

CMC, he rarely, if ever, prescribed or 

dispensed controlled substances to his 

patients. Id. at 111. He also stated that 

the patient load at CMC did not justify 

the quantities of controlled substances 

that were being purchased by the clinic. 

Id. at 114. 

Using the records seized during the 

search of Respondent’s clinic and its 

patient files, ARCOS data, and 

information provided by several of the 

distributors,13 the GS conducted an 

audit of the hydrocodone ordered under 

both Respondent’s and her husband’s 

registrations between January 1, 2005 

and March 16, 2006. Tr. 93–96, 67; GX 

15. Because CMC did not maintain 

records of their inventory 

(notwithstanding Federal law requiring 

them to do so, see 21 U.S.C. 827(a) & 

(b)), the GS chose January 1, 2005 as the 

starting date and assumed that no 

controlled substances were then on 

hand; for the closing inventory, the GS 

used the inventory taken (48,000 tablets) 

when the search warrant was 

executed.14 Tr. 92–93, 95; GX 15. To 

this latter figure, the GS added the 

hydrocodone that was seized during the 

January 17, 2006 traffic stop of R.K. 

(31,000 tablets) and the 1,200 tablets15

found during the search of R.K.’s 

residence which occurred later that day. 

Tr. 95; GX 12, 15. 

Using both the ARCOS data and 

distributor invoices, the GS determined 

that 4,037,900 tablets of hydrocodone 

had been ordered during the audit 

period. Tr. 94; GX 15. The clinic’s 

dispensing logs, which did not identify 

which doctor had authorized the 

various dispensings, see GX 14, showed 

that only 12,000 tablets had been 

dispensed; 16 in addition, the GS 

reviewed the clinic’s patient files and 

credited another 75,000 tablets as 

having been dispensed.17 Tr. 95–96; GX 

15. Accordingly, CMC could only 

account for approximately 167,000 

tablets of hydrocodone.18 Tr. 96–97; GX 

15. While the DI combined the 

purchases of Respondent and her 

husband, the ARCOS data and 

distributor invoices did list whose 

registration was used to place the 

various orders. See, e.g., GXs 3 & 4. This 

evidence shows that in 2005 alone, 

2,272,800 dosage units of hydrocodone 

were ordered under Respondent’s 

registration. Accordingly, Respondent 

still could not account for more than 

two million dosage units.19 GX 3, at 13. 

Respondent testified that she had no 

knowledge that her ‘‘DEA registration 

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20 I acknowledge that Respondent holds a valid 

medical license from the State of California. 

Moreover, the State Board has not taken action 

against her, nor made any recommendation in this 

matter (factor one). ALJ at 27. 

Be that as it may, in enacting the CSA, Congress 

vested this Agency with ‘‘a separate oversight 

responsibility [apart from that which exists in state 

authorities] with respect to the handling of 

controlled substances.’’ Mortimer B. Levin, 55 FR 

8209, 8210 (1990). DEA has therefore long 

recognized that it has ‘‘a statutory obligation to 

make its independent determination as to whether 

the [continuation] of [a registration] would be in the 

public interest.’’ Id. Accordingly, ‘‘a State’s failure 

to take action against a registrant’s medical license 

is not dispositive in determining whether the 

continuation of a registration is in the public 

interest.’’ Jayam Krishna-Iyer, 74 FR 459, 461 

(2009); see also Levin, 55 FR at 8210 (holding that 

practitioner’s reinstatement by state board ‘‘is not 

dispositive’’ in public interest inquiry). Thus, that 

the Medical Board of California has taken no action 

with respect to Respondent’s medical license is not 

dispositive in determining whether her continued 

registration is consistent with the public interest. 

There is also no evidence that Respondent has 

been convicted of an offense related to the 

manufacture, distribution, or dispensing of 

controlled substances under either Federal or state 

law (factor three). ALJ at 27–28. However, while a 

history of criminal convictions for offenses 

involving the distribution or dispensing of 

controlled substances is a highly relevant 

consideration, there are any number of reasons why 

a registrant may not have been convicted of (or even 

prosecuted for) such an offense, and thus, the 

absence of such a conviction is of considerably less 

consequence in the public interest inquiry. KrishnaIyer, 74 FR at 461; Edmund Chein, 72 FR 6580, 6593 

n.22 (2007). Accordingly, that Respondent has not 

been convicted of an offense related to the 

distribution or dispensing of controlled substances 

is not dispositive of whether the continuation of her 

registration is consistent with the public interest. 

number was being used to order large 

quantities of hydrocodone that were 

being delivered to CMC.’’ Tr. 192. She 

asserted that she did not order any 

controlled substances between 2002 and 

March 16, 2006, and that she did not 

order any controlled substances after 

that period. Id. at 195–96. Specifically, 

she testified that she did not order 

Lorazepam in October 2006. Id. 

Respondent testified that while 

during this time period, she was aware 

that her husband was ordering drugs for 

his pain management practice, she did 

not know how much he was ordering. 

Id. at 201. Respondent stated that she 

had no knowledge of the controlled 

substances being delivered to CMC 

during this time period; while she 

admitted to having seen boxes being 

delivered to the clinic, she claimed to 

not know what they contained. Id. 197– 

198. Respondent further stated that R.K. 

would open the boxes after they were 

delivered. Id. at 200. 

Respondent further testified that she 

was unaware that R.K. had taken drugs 

from CMC to her residence until 

learning of it through these proceedings; 

she also stated that she was not sure if 

her husband had instructed R.K. 

regarding taking drugs to her residence. 

Id. at 204–205. However, the ALJ did 

not find credible Respondent’s 

testimony that she was unaware of 

R.K.’s activities. ALJ at 30. 

Regarding the controlled substance 

drug storage area, Respondent stated 

that she had ‘‘no idea’’ how the drugs 

were organized. Tr. 198–99. Respondent 

testified that she did not pay attention 

to what was in that storage area, but 

then stated there was a basic cabinet 

that was locked at night and that she did 

not have a key. Id. at 200–01. According 

to Respondent, the key was either kept 

by R.K. or in a place where her husband 

could find it; Respondent also did not 

know if the storage cabinet was locked 

during the day. Id. at 234. 

While Respondent testified on direct 

examination that she had not dispensed 

drugs at CMC, on cross-examination, 

she stated ‘‘I don’t recall. I might have 

dispensed but I dispensed rarely.’’ Id. at 

195. Respondent then admitted 

dispensing, stating ‘‘maybe I might have 

given [hydrocodone] once or twice to 

my patients only.’’ Id. She stated that 

other people had ordered these drugs 

that she dispensed. Id. at 229. On the 

occasions that she did dispense, 

Respondent asked R.K. for the drug. Id. 

at 230. R.K. would retrieve the 

controlled substances from the cabinet 

and give them to Respondent to hand to 

the patient. Id. In these instances, R.K. 

would record the dispensed controlled 

substances in a ‘‘separate log.’’ Id. at 

228. 

Discussion 

Section 304(a) of the Controlled 

Substances Act (CSA) provides that ‘‘[a] 

registration pursuant to section 823 of 

this title 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 

[her] 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 making 

the public interest determination in the 

case of a practitioner, Congress directed 

that the following factors be considered: 

(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). 

‘‘[T]hese factors are considered in the 

disjunctive.’’ Robert A. Leslie, 68 FR 

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

one factor, or a combination of factors, 

and may give each factor the weight I 

deem appropriate in determining 

whether to revoke an existing 

registration or to deny an application. 

Id. Moreover, I am ‘‘not required to 

make findings as to all of the factors.’’ 

Hoxie v. DEA, 419 F.3d 477, 482 (6th 

Cir. 2005) (citing Morall v. DEA, 412 

F.3d 165, 173–74 (DC Cir. 2005)). 

With respect to a practitioner’s 

registration, the Government bears the 

burden of proving by a preponderance 

of the evidence that the continuation of 

a registration would be inconsistent 

with the public interest. 21 CFR 

1301.44(d). However, where the 

Government satisfies its prima facie 

burden by showing that a registrant has 

committed acts which are inconsistent 

with the public interest, the burden then 

shifts to the applicant to demonstrate 

why he can be entrusted with a 

registration. Medicine ShoppeJonesboro, 73 FR 364, 380 (2008). 

In this matter, having considered the 

entire record and all of the factors, I 

agree with the ALJ’s conclusions that 

the Government’s evidence under 

factors two, four, and five makes out a 

prima facie that Respondent has 

committed acts which render her 

registration inconsistent with the public 

interest.20 ALJ at 29. I further agree with 

the ALJ’s conclusion that Respondent 

has not accepted responsibility for her 

misconduct and has thus not rebutted 

the Government’s prima facie case. 

Factors Two, Four, and Five— 

Respondent’s Experience in Dispensing 

Controlled Substances, Compliance 

With Applicable Laws Related to 

Controlled Substances, and Other 

Conduct Which May Threaten Public 

Health and Safety 

The Government’s case implicates 

each of these factors. As found above, 

during an approximately fifteen-month 

period, more than four million tablets of 

highly abused combination drugs 

containing hydrocodone, a schedule III 

controlled substance, were purchased 

by R.K., Respondent’s office manager, 

using her and her husband’s DEA 

registrations, approximately 2.3 million 

of which were ordered under her 

registration during 2005 alone. When 

DEA Investigators audited Respondent’s 

and her husband’s handling of the 

hydrocodone, they could account for 

only 167,000 tablets, leaving 

Respondent with over two million 

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tablets unaccounted for. In addition, law 

enforcement authorities found that R.K. 

had large quantities of hydrocodone in 

her possession during both a traffic stop 

and a search of her residence; 

Investigators also found a large quantity 

of cash in R.K.’s home. 

At a minimum, the evidence clearly 

shows that Respondent violated the 

CSA’s various recordkeeping provisions. 

Under Federal law, as soon as 

Respondent ‘‘first engage[d] in the 

* * * distribution[] or dispensing of 

controlled substances, and every second 

year thereafter,’’ she was required ‘‘to 

make a complete and accurate record of 

all stocks thereof on hand.’’ 21 U.S.C. 

827(a)(1) (emphasis added); see also 21 

CFR 1304.03(a)–(b), 1304.04(a), (g), 

1304.11. However, as found above, 

during the audit, Respondent could not 

produce an inventory record for any of 

the controlled substances that were 

purchased under her registration. 

Under Federal law, Respondent was 

also required to ‘‘maintain, on a current 

basis, a complete and accurate record of 

each such substance * * * received, 

sold, delivered, or otherwise disposed of 

by [her].’’ 21 U.S.C. 827(a)(3) (emphasis 

added). With respect to a practitioner 

who engages in dispensing, DEA 

regulations require that the record 

include ‘‘the number of units or volume 

of such finished form dispensed, * * * 

the name and address of the person to 

whom it was dispensed, the date of 

dispensing, the number of units or 

volume dispensed and the written or 

typewritten name or initials of the 

individual who dispensed * * * the 

substance on behalf of the dispenser.’’ 

21 CFR 1304.22(c); see also id.; 21 CFR 

1304.03(a)–(b), 1304.04(a), (g), 1304.21. 

However, as found above, while large 

quantities of controlled substances were 

purchased under her registration 

throughout 2004 and 2005, Respondent 

had no dispensing logs for these years 

and the 2006 logs covered only from 

February 28 through March 15. 

Moreover, the logs that were maintained 

lacked required information such as the 

name of the dispensing doctor, the 

initials/name of the person doing the 

dispensing, and the address of the 

patient. GX 14. 

Recordkeeping is one of the central 

features of the CSA’s closed system of 

distribution. See Paul H. Volkman, 73 

FR 30630, 30644 (2008), pet. for rev. 

denied 567 F.3d 215, 224 (6th Cir. 

2009). ‘‘[A] registrant’s accurate and 

diligent adherence to this obligation is 

absolutely essential to protect against 

the diversion of controlled substances.’’ 

Id. Given that millions of dosage units 

of a highly abused controlled substance 

that were ordered under Respondent’s 

registration cannot be accounted for, her 

failure to comply with the CSA’s 

recordkeeping requirements is 

egregious. This finding provides reason 

alone to conclude (with respect to 

factors two and four) that her continued 

registration ‘‘is inconsistent with the 

public interest.’’ 21 U.S.C. 823(f); see 

also Volkman, 73 FR at 30644 (holding 

that recordkeeping violations alone 

supported denial of practitioner’s 

application). 

In her Exceptions to the ALJ’s 

decision, Respondent argues that ‘‘she 

had no knowledge that her DEA 

Registration was being used by her 

husband or [R.K.] to order controlled 

substances’’ until DEA executed the 

search warrant on March 16, 2006. 

However, DEA has long held that a 

registrant is strictly liable for the misuse 

of her registration by a person to whom 

she entrusts her registration. See also 

Harrell E. Robinson, 74 FR 61370, 61377 

(2009); Paul H. Volkman, 73 FR 30630, 

30644 n.42 (2008); Rose Mary Jacinta 

Lewis, 72 FR 4035, 4041 (2007) (citing 

Anthony L. Capelli, 59 FR 42288 

(1994)); Leonard Merkow, 60 FR 22075, 

22076 (1995); Capelli, 59 FR at 49288. 

The record clearly supports the 

conclusion that Respondent entrusted 

her registration number to R.K. Thus, 

even if it were the case that Respondent 

was unaware of R.K.’s illegal activities, 

she is still strictly liable for R.K.’s 

misuse of her registration and her 

failure to properly monitor how her 

registration was being used. See Jacinta 

Lewis, 72 FR at 4041–42; Robinson, 74 

FR at 61377; Volkman, 73 FR at 30644 

n.42; Capelli, 59 FR at 49288. 

Contrary to Respondent’s 

understanding, the purpose of this 

proceeding is to protect the public 

interest, and in determining whether a 

registrant has committed acts which 

render her registration ‘‘inconsistent 

with the public interest,’’ 21 U.S.C. 

824(a)(4), the standards of mens rea for 

imposing criminal liability are not 

controlling. Accordingly, the 

Government is not required to show that 

Respondent had knowledge that her 

DEA Registration was being used by her 

husband or R.K. to order controlled 

substances. 

In any event, the ALJ did not find 

credible Respondent’s testimony that 

she was unaware of R.K.’s activities. ALJ 

at 30. I agree. Given the duration and 

scope of R.K.’s activities, Respondent’s 

denial of knowledge is implausible. 

In her Exceptions, Respondent also 

argues that the ALJ’s decision ‘‘fails to 

distinguish between the drugs ordered 

under Respondent’s DEA Registration 

and the drugs ordered under her 

husband’s.’’ Res. Exc. at 22. This is true. 

However, as ultimate factfinder, I have 

reviewed the evidence and found that 

the ARCOS data shows that in 2005 

alone, more than 2.27 million dosage 

units of hydrocodone were ordered 

under Respondent’s registration, and 

that at most, 167,000 dosage units can 

be accounted for. Thus, Respondent is 

responsible for more than two million 

dosage units that cannot be accounted 

for and were likely diverted. 

Respondent’s misconduct thus clearly 

threatened public health and safety. See 

21 U.S.C. § 823(f)(5). Moreover, the 

scope of the diversion is egregious. I 

therefore conclude that the Government 

has satisfied its prima facie burden of 

showing that Respondent has 

committed acts which render her 

registration is ‘‘inconsistent with the 

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

823(f). 

Sanction 

Under Agency precedent, where the 

Government has made out a prima facie 

case that a registrant has committed acts 

which render her ‘‘registration 

inconsistent with the public interest,’’ 

she must ‘‘‘present[] sufficient 

mitigating evidence to assure the 

Administrator that [she] can be 

entrusted with the responsibility carried 

by such a registration.’ ’’ 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), 

this Agency has repeatedly held that 

where a registrant has committed acts 

inconsistent with the public interest, the 

registrant must accept responsibility for 

[her] actions and demonstrate that [she] 

will not engage in future misconduct.’’ 

Medicine Shoppe-Jonesborough, 73 FR 

at 387. 

During her testimony, Respondent 

continued to deny that she was 

responsible for the unaccounted-for 

hydrocodone and blamed her husband 

and R.K. Furthermore, the ALJ found 

incredible Respondent’s denial that she 

had knowledge of R.K.’s illegal 

activities. DEA has repeatedly held that 

a registrant’s lack of candor is a highly 

relevant consideration in determining 

the appropriate sanction. See Hoxie v. 

DEA, 419 F.3d 477, 483 (6th Cir. 2005); 

Robert F. Hunt, 75 FR 49995, 50004 

(2010); Rosemary Jacinta Lewis, 72 FR 

4035, 4042 (2007). Respondent’s lack of 

candor further supports the revocation 

of her registration. 

Given the scope of the diversion 

which likely occurred here and what the 

ALJ characterized as Respondent’s 

minimal acceptance of responsibility 

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(which was limited to the statements of 

counsel in a post-hearing brief and 

which do not constitute evidence, see 

INS v. Phinpathya, 464 U.S. 183, 186 

n.6 (1984)), I conclude that none of the 

‘‘favorable facts’’ cited by the ALJ 

provide any reason to impose a sanction 

less than revocation. Jayam KrishnaIyer, 74 FR 459, 463 (2009). Indeed, 

none of Respondent’s proposed 

remedial measures mitigate the 

egregious harm Respondent has caused 

to public health and safety. 

I therefore conclude that it would be 

inconsistent with the public interest to 

grant her even a restricted registration. 

Accordingly, I will order that 

Respondent’s registration be revoked 

and that any pending application be 

denied. 

Order 

Pursuant to the authority vested in me 

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

as by 28 CFR 0.100(b), I hereby order 

that DEA Certificate of Registration, 

AD9234446, issued to Satinder K. Dang, 

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

further order that any pending 

application of Satinder K. Dang, M.D., to 

renew or modify her registration be, and 

it hereby is, denied. This Order is 

effective September 22, 2011. 

Dated: August 9, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–21065 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Roots Pharmaceuticals, Inc.; 

Revocation of Registration 

On September 9, 2010, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Roots Pharmaceuticals, 

Inc. (Registrant), of American Fork, 

Utah. The Show Cause Order proposed 

the revocation of Registrant’s DEA 

Certificate of Registration BR9610571, 

which authorizes it to dispense 

controlled substances as a retail 

pharmacy, on the ground that 

Registrant’s state pharmacy and 

controlled substance licenses had 

expired on September 30, 2009, and that 

it therefore lacks authority under the 

laws of the State in which it is 

registered with DEA to dispense 

controlled substances. Show Cause 

Order at 1 (citing 21 U.S.C. 823(f) and 

824(a)(3)). The Show Cause Order also 

notified Registrant of its right to request 

a hearing on the allegations or to submit 

a written statement in lieu of a hearing, 

the procedures for doing either, and the 

consequence for failing to do either. Id. 

at 2. 

The Government’s initial attempt to 

serve Registrant by certified mail was 

unsuccessful. Thereafter, as evidenced 

by the signed return receipt card, on 

January 14, 2011, the Government 

accomplished service by mailing the 

Show Cause Order to Registrant’s 

Registered Agent. On January 11, 2011, 

the Government also sent an electronic 

version of the Show Cause Order to 

Registrant’s Registered Agent at the email address he had previously 

provided to the Agency. However, since 

the date of service of the Show Cause 

Order, no person has requested a 

hearing, or submitted a written 

statement in lieu of a hearing, on behalf 

of Registrant. Because thirty days have 

now passed since service of the Show 

Cause Order, I find that Registrant has 

waived its right to request a hearing or 

to submit a written statement in lieu of 

a hearing. See 21 CFR 1301.43(a), (c), 

and (d). I therefore issue this Decision 

and Final Order without a hearing based 

on relevant evidence contained in the 

record submitted by the Government. Id. 

§ 1301.43(e). 

Findings 

Registrant is the holder of DEA 

Certificate of Registration BR9610571, 

which authorizes it to dispense 

controlled substances in schedules II 

through V as a retail pharmacy, at the 

registered location of 12 W 100N, Suite 

201B, American Fork, Utah. GX A. 

Registrant’s registration does not expire 

until April 30, 2012. Id. 

According to a Pharmacy Licensing 

Specialist with the State of Utah, 

Department of Commerce, Division of 

Occupational and Professional 

Licensing, Registrant’s Utah Pharmacy 

License and Utah Controlled Substance 

Dispensing License expired on 

September 30, 2009. GX B. Registrant 

did not renew either license. Id. 

Discussion 

Under the Controlled Substances Act 

(CSA), a practitioner must be currently 

authorized to handle controlled 

substances in the ‘‘jurisdiction in which 

[it] practices’’ in order to maintain a 

DEA registration. See 21 U.S.C. 802(21) 

(‘‘[t]he term ‘practitioner’ means a * * * 

pharmacy * * * licensed, registered, or 

otherwise permitted, by * * * the 

jurisdiction in which [it] practices 

* * * to * * * dispense * * * a 

controlled substance in the course of 

professional practice’’). See also id. 

§ 823(f) (The Attorney General shall 

register practitioners * * * to dispense 

* * * controlled substances * * * if 

the applicant is authorized to dispense 

* * * controlled substances under the 

laws of the State in which [it] 

practices.’’). As these provisions make 

plain, possessing authority under state 

law to handle controlled substances is 

an essential condition for obtaining and 

maintaining a DEA registration. 

The CSA further authorizes the 

Agency to revoke a registration ‘‘upon a 

finding that the registrant * * * has had 

[its] State license or registration 

suspended [or] revoked * * * and is no 

longer authorized by State law to engage 

in the * * * distribution [or] dispensing 

of controlled substances.’’ 21 U.S.C. 

824(a)(3). Moreover, because holding 

state authority is a statutory requirement 

for registration as a practitioner, see 21 

U.S.C. 802(21) and 823(f), DEA has held 

that revocation is warranted even when 

a registrant has merely allowed his state 

licenses to expire. James Stephen 

Ferguson, 75 FR 49994, 49995 (2010); 

Mark L. Beck, 64 FR 40899, 40900 

(1999). See also Anne Lazar Thorn, 62 

FR 12847, 12848 (1997) (‘‘the 

controlling question is not whether a 

practitioner’s license to practice 

medicine in the state is suspended or 

revoked; rather, it is whether the 

Respondent is currently authorized to 

handle controlled substances’’). 

As found above, Registrant allowed its 

state pharmacy and controlled 

substance licenses to expire, and thus, 

it no longer holds authority under Utah 

law to dispense controlled substances. 

See Utah Code Ann. §§ 58–17b–302(1); 

58–37–6(2)(a)(i). Accordingly, Registrant 

no longer satisfies the CSA’s 

requirement that it be currently 

‘‘authorized to dispense controlled 

substances’’ under Utah law. 21 U.S.C. 

823(f). Accordingly, its DEA registration 

will be revoked. Id. § 824(a)(3). 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 824(a)(3), as well as 28 CFR 

0.100(b), I order that DEA Certificate of 

Registration BR9610571, issued to Roots 

Pharmaceuticals, Inc., be, and it hereby 

is, revoked. I further order that any 

pending application of Roots 

Pharmaceuticals, Inc., to renew or 

modify its registration, be, and it hereby 

is, denied. This Order is effective 

September 19, 2011. 

Dated: August 5, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–21063 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

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