Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51415 

the Darvocet?’’ The Agent answered 

‘‘yes,’’ but Registrant did not even ask 

her if she had pain, let alone ask her any 

questions regarding the nature and 

intensity of the pain, whether the 

Darvocet was helping to alleviate her 

pain, or how the pain was affecting her 

physical and psychological function. 

Accordingly, with respect to the Agent’s 

second visit, I again conclude that 

Registrant failed to establish a doctorpatient relationship with her. I also 

conclude that Registrant lacked a 

legitimate medical purpose and acted 

outside of the usual course of 

professional practice in prescribing 

Xanax and Darvocet-N to her and 

violated Federal law. See 21 CFR 

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

As the forgoing demonstrates, 

Registrant has committed acts which 

‘‘render his registration * * * 

inconsistent with the public interest.’’ 

21 U.S.C. 824(a)(4). I will therefore 

order that his registration be revoked 

and that any pending applications 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, 

BF7430781, issued to Joe C. Fermo, 

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

further order that any pending 

application of Joe C. Fermo, 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. 2011–21061 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Ideal Pharmacy Care, Inc., D/B/A 

Esplanade Pharmacy; Revocation of 

Registration 

On November 12, 2010, I, the then 

Deputy Administrator of the Drug 

Enforcement Administration, issued an 

Order to Show Cause and Immediate 

Suspension of Registration to Ideal 

Pharmacy Care, Inc., d/b/a Esplanade 

Pharmacy (Registrant), of New Orleans, 

Louisiana. The Show Cause Order 

proposed the revocation of Registrant’s 

DEA Certificate of Registration 

FF1125651, which authorizes it to 

dispense controlled substances in 

schedules II through V as a retail 

pharmacy, on the ground that it has 

committed acts which render its 

registration ‘‘inconsistent with the 

public interest.’’ Show Cause Order at 1 

(citing 21 U.S.C. 824(a)(4)). The Show 

Cause Order also proposed the denial of 

any pending applications to renew or 

modify Registrant’s registration. Id. 

The Show Cause Order specifically 

alleged that on October 14, 2010, 

investigators conducted an 

accountability audit of Registrant and 

found that it had ‘‘significant shortages’’ 

of various controlled substances. Id. The 

Order alleged that these included 

shortages of: (1) 3,891 dosage units of 

hydrocodone 7.5/650 mg, 78 percent of 

the accountable total; (2) 27,179 dosage 

units of hydrocodone 7.5/750 mg, 59 

percent of the accountable total; (3) 

5,514 dosage units of hydrocodone 10/ 

500 mg, 48 percent of the accountable 

total; (4) 114,826 dosage units of 

hydrocodone 10/650 mg, 96 percent of 

the accountable total; (5) 83,254 dosage 

units of alprazolam 2 mg, 96 percent of 

the accountable total; and (6) 1,616,420 

ml of promethazine with codeine, 99 

percent of the accountable total. Id. at 

1–2. Based on the audit results, the 

Order alleged that the Registrant had 

violated 21 U.S.C. 827(a)(3) and 

842(a)(5), as well as 21 CFR 1304.03, 

1304.04, and 1304.21. Id. at 2. 

Next, the Show Cause Order alleged 

that various distributors make deliveries 

of controlled substances to Registrant 

when it ‘‘is closed,’’ and that the 

‘‘deliveries are received and signed for 

by’’ non-employees who work ‘‘at the 

grocery store in which [it] is located,’’ 

and that the deliveries are then 

‘‘diverted in violation of 21 U.S.C. 

843(a)(3).’’ Id. The Order thus alleged 

that Registrant ‘‘has failed to provide 

effective controls’’ against theft and 

diversion of controlled substances. Id. 

(citing 21 CFR 1301.71). 

The Show Cause Order also alleged 

that Registrant had violated a 

Memorandum of Agreement (MOA) it 

entered into with DEA. Id. The Order 

alleged that in the MOA, Registrant 

agreed that it would not employ its 

former owners ‘‘in any capacity relating 

to [its] business,’’ and that it would not 

permit its former owners to have 

‘‘access to any area of [it] where 

controlled substances are kept, stored, 

or maintained.’’ Id. The Order alleged 

that Registrant ‘‘has permitted [its 

former owners] to enter the pharmacy 

where controlled substances are present 

in violation of’’ the MOA and 21 CFR 

1301.72(d). Id. 

Based on the matters set forth above, 

I concluded that Registrant’s continued 

registration during the pendency of the 

proceeding would constitute ‘‘an 

imminent danger to public health and 

safety.’’ Id. (citing 21 U.S.C. 824(d)). I, 

therefore, ordered the immediate 

suspension of Registrant’s registration. 

Id. 

On November 17, 2010, the Order to 

Show Cause and Immediate Suspension 

of Registration, which 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 

consequences for failing to do either, id. 

at 3 (citing 21 CFR 1301.43(a) & (c)), was 

personally served on Registrant’s 

Pharmacist-in-Charge. GX 2. Since the 

date of service of the Order, more than 

thirty days have now passed, and 

neither Registrant, nor anyone 

purporting to represent it, has requested 

a hearing or submitted a written 

statement. Accordingly, I find that 

Registrant has waived its right to a 

hearing or to submit a written statement 

in lieu of a hearing. 21 CFR 1301.43(a), 

(c) & (d). I, therefore, issue this Decision 

and Final Order based on relevant 

material contained in the record 

submitted by the Government. 21 CFR 

1301.43(e). 

Findings 

Registrant is the holder of DEA 

Certificate of Registration FI1125651, 

which authorizes it to dispense 

controlled substances in schedules II 

through V as a retail pharmacy, at the 

registered address of 1400 Esplanade 

Ave., New Orleans, Louisiana. 

Registrant’s registration does not expire 

until November 30, 2011. Registrant is 

apparently located in a building which 

also contains a grocery store. Affidavit 

of DI, at 8 (GX 22). 

On October 14, 2010, DEA 

Investigators conducted an audit of 

Registrant’s handling of controlled 

substances. Id. at 9. The audit covered 

the period of October 22, 2008, on 

which date Registrant had no controlled 

substances on hand, through the 

beginning of business on October 14, 

2010, at which time the closing 

inventory for the audit was taken. Id. 

According to the DI, she obtained 

invoices provided by Registrant’s 

suppliers to determine the total amount 

of the controlled substances it had 

purchased during the audit period and 

was accountable for; the DI also 

obtained Registrant’s records (including 

the prescriptions on file), as well as data 

from the state’s prescription monitoring 

program showing the pharmacy’s 

dispensings, and added the amount of 

its dispensings to the closing inventory 

to determine the total amount of each 

drug which it could account for. Id. 

Upon comparing the two amounts, the 

DI found that Registrant had large 

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51416 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

1On November 17, 2010, the Louisiana Board of 

Pharmacy issued an Active Suspension Notice to 

Registrant, which placed its Louisiana Pharmacy 

Permit in active suspension pending further 

proceedings. Thus, Registrant also no longer meets 

the CSA’s requirement for holding a registration 

that it be ‘‘authorized to dispense * * * controlled 

substances under the laws of the State in which [it] 

practices.’’ 21 U.S.C. 823(f); see also id. § 824(a)(3) 

(authorizing revocation where registrant’s ‘‘[s]tate 

license or registration [has been] suspended * * * 

by competent State authority and [registrant] is no 

longer authorized by State law to engage in the 

* * * dispensing of controlled substances’’); id. § 

802(21) (defining ‘‘[t]he term ‘practitioner’ [to] 

mean[] a * * * pharmacy * * * licensed, 

registered, or otherwise permitted, by the United 

States or the jurisdiction in which [it] practices 

* * * to dispense * * * a controlled substance in 

the course of professional practice’’). 

Registrant’s loss of state authority thus provides 

an additional ground to revoke its registration. See 

Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007). 

However, the State’s suspension was not cited as a 

basis for Agency action in the Order to Show Cause 

(as it occurred five days after the latter was issued) 

and there are no pleadings establishing that the 

Agency subsequently gave notice of its intent to rely 

shortages of six different drugs. These 

included: 

1. A shortage of 3,891 dosage units of 

hydrocodone/apap 7.5/650 mg, which 

was 78 percent of the total amount for 

which it was accountable; 

2. A shortage of 27,179 dosage units 

of hydrocodone/apap 7.5/750 mg, which 

was 59 percent of the total amount for 

which it was accountable; 

3. A shortage of 5,514 dosage units of 

hydrocodone/apap 10/500 mg, which 

was 48 percent of the total amount for 

which it was accountable; 

4. A shortage of 114,826 dosage units 

of hydrocodone/apap 10/650 mg. which 

was 96 percent of the total amount for 

which it was accountable; 

5. A shortage of 83,254 dosage units 

of alprazolam 2 mg., which was also 96 

percent of the total amount for which it 

was accountable; and 

6. A shortage of 1,616,420 ml of 

promethazine with codeine, a shortage 

of 99 percent of the total amount for 

which it was accountable. 

Id. at 9. 

While pharmacy employees told the 

DI that they were the only persons who 

accepted controlled substance 

deliveries, based on the records 

obtained from one of Registrant’s 

distributors, the DI determined that 

many of the shipments had been 

delivered on Saturdays, a day when the 

pharmacy was closed, and that a 

number of the shipments were signed 

for by non-pharmacy employees who 

worked in the grocery store. Id. at 7–8, 

10. Moreover, while Registrant’s 

employees had told the DI that 

McKesson was the only distributor it 

purchased controlled substances from, 

Registrant was also purchasing from 

ANDA and Smith Drug Company. Id. at 

7–8. 

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 

[its] 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, the 

CSA requires 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). 

These factors are considered in the 

disjunctive. Robert A. Leslie, M.D., 68 

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

any one or a combination of factors, and 

I may give each factor the weight I deem 

appropriate in determining whether to 

revoke an existing registration. Id. 

Moreover, I am ‘‘not required to make 

findings as to all the factors.’’ Hoxie v. 

DEA, 419 F.3d 477, 482 (6th Cir. 2005); 

see also Morall v. DEA, 412 F.3d 165, 

173–74 (D.C. Cir. 2005). The 

Government bears the burden of proof. 

21 CFR 1316.56. 

Having considered all of the factors, I 

conclude that the evidence pertinent to 

Registrant’s compliance with applicable 

laws related to controlled substances 

(factor four) is dispositive and supports 

a finding that it has committed acts 

which render its registration 

‘‘inconsistent with the public interest.’’ 

21 U.S.C. 824(a)(4). 

As found above, DIs conducted an 

audit of Registrant’s handling of various 

controlled substances and found that it 

could not account for extraordinary 

quantities of four different formulations 

of hydrocodone, a schedule III 

controlled substance, and alprazolam 2 

mg (generic for Xanax), a schedule IV 

controlled substance; both of these 

drugs are highly popular with drug 

abusers. See 21 CFR 1308.13(e); 

13018.14(c). More specifically, 

approximately 150,000 dosage units of 

various hydrocodone drugs and 83,000 

dosage units of alprazolam (96% of the 

amount purchased) were purchased by 

Registrant and could not be accounted 

for. In addition, 1.6 million mls of 

promethazine with codeine (99% of the 

amount purchased), another highlyabused controlled substance, was 

purchased by Registrant and could not 

be accounted for. 

Pursuant to DEA regulations, all 

‘‘registrants shall provide effective 

controls and procedures to guard against 

theft and diversion of controlled 

substances.’’ 21 CFR 1301.71(a). Among 

the factors DEA considers in assessing 

whether a registrant maintains effective 

controls against theft and diversion, is 

‘‘[t]he adequacy of the registrant’s * * * 

system for monitoring the receipt * * * 

distribution, and disposition of 

controlled substances in its operations.’’ 

Id. 1301.71(b)(14). 

Moreover, under Federal law and 

DEA regulations, ‘‘every registrant 

under this subchapter * * * 

distributing, or dispensing a controlled 

substance or substances shall maintain, 

on a current basis, a complete and 

accurate record of each such substance 

* * * received, sold, delivered, or 

otherwise disposed of by [it].’’ 21 U.S.C. 

827(a)(3). See also 21 CFR 1304.03; 

1304.04, 1304.21, 1304.22(c). A 

registrant is required to maintain these 

records for at least two years. Id. 

§ 827(b) (‘‘every inventory or other 

record required under this section 

* * * shall be kept and be available, for 

at least two years, for inspection and 

copying’’). See also 21 CFR 1304.03 

(‘‘Each registrant shall maintain the 

records and inventories and shall file 

the reports required by this part, except 

as exempted by this section.’’); id. 

§ 1304.04 (mandating that records be 

maintained for at least two years and be 

available for inspection and copying). 

See also Paul H. Volkman, 73 FR 30630, 

30644 (2008) (‘‘Recordkeeping is one of 

the CSA’s central features; a registrant’s 

accurate and diligent adherence to this 

obligation is absolutely essential to 

protect against the diversion of 

controlled substances.’’). 

Whether the shortages are attributable 

to outright diversion by either pharmacy 

or store employees, theft, or the failure 

to maintain accurate records, does not 

matter. What is clear is that Registrant 

purchased several hundred thousand 

dosage units of highly abused controlled 

substances which cannot be accounted 

for and that it has committed acts which 

render its registration ‘‘inconsistent 

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

824(a)(4). Accordingly, I will order that 

Registrant’s registration be revoked and 

that any pending application be 

denied.1

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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51417 

on the State’s suspension. See 5 U.S.C. 554(b). I 

therefore do not rely on it. 

Order 

Pursuant to the authority vested in me 

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

28 CFR 0.100(b), I order that DEA 

Certificate of Registration FI1125651, 

issued to Ideal Pharmacy Care, Inc., 

d/b/a/Esplanade Pharmacy, be, and it 

hereby is, revoked. 

I further order that any pending 

application to renew or modify this 

registration, be, and it hereby is, denied. 

Dated: August 5, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–21060 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 10–2] 

Surinder 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 Surinder Singh Dang, 

M.D. (‘‘Respondent’’), of Fountain 

Valley, California. The Order proposed 

the revocation of Respondent’s DEA 

Certificate of Registration, AD6122143, 

as a practitioner, as well as the denial 

of any pending applications to renew or 

modify his 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 his wife, Dr. Satinder 

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 his 

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. at 1–2. 

Continuing, the Order alleged that on 

March 16, 2006, ‘‘DEA Special Agents 

seized 50,000 dosage units more from 

this employee’s residence.’’ Id. at 2. 

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 his wife ‘‘had ordered,’’ 

and 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. Finally, the Order 

alleged that when Respondent ‘‘made 

dispensing records,’’ he ‘‘frequently 

failed to indicate whether’’ he or his 

wife ‘‘actually dispensed the controlled 

substances as required by 21 CFR 

1304.03(b).’’ 1 Id. 

By letter of October 2, 2009, 

Respondent, through his 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 3, 

2010, in Santa Ana, California. 

At the hearing, the Government called 

one witness to testify and introduced 

documentary evidence. Respondent did 

not call any witnesses and introduced a 

single exhibit, this being a letter from 

the counsel for Respondent’s employee 

R.K. stating that she intended to assert 

her Fifth Amendment privilege if called 

to testify. See RX 1. Following the 

hearing, both parties submitted briefs 

containing their proposed findings of 

fact, conclusions of law and argument. 

On May 19, 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 his registration be 

revoked. ALJ at 26, 30–31. 

As to the first factor—the 

recommendation of the appropriate 

State licensing board or professional 

disciplinary authority—the ALJ found 

that the California Medical Board ‘‘has 

not taken any formal action to limit 

Respondent’s right to practice medicine 

nor has it recommended limiting his 

ability to prescribe controlled 

substances.’’ Id. at 23. 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.’’ ALJ 

at 22–23 (citing Patrick W. Stodola, 74 

FR 20727, 20730 (2009); Jayam KrishnaIyer, 74 FR 459, 461 (2009)). The ALJ 

thus concluded that ‘‘this factor does 

not fall in favor of revocation.’’ Id. at 23. 

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. 

The ALJ then considered factors two 

and four—Respondent’s experience in 

dispensing controlled substances and 

his compliance with Federal, State, and 

local laws relating to controlled 

substances—together. Id. at 23–26. The 

ALJ specifically found that: (1) 

‘‘Respondent authorized’’ his employee 

R.K. ‘‘to purchase large amounts of 

hydrocodone using his DEA registration 

and that of his wife’’; (2) another 

physician who practiced at 

Respondent’s clinic had ‘‘stated that the 

patient load’’ at the clinic ‘‘would not 

justify such large purchases of 

controlled substances’’; (3) R.K. 

remained in Respondent’s employ even 

after ‘‘drugs were discovered in [her] 

personal vehicle by the California 

Highway Patrol’’; (4) ‘‘[l]arge bundles of 

cash, controlled substances, and other 

* * * evidence, such as receipts and 

money order stubs were discovered at 

[her] home’’; and (5) ‘‘[a]fter being 

questioned, [R.K.] stated that she was 

ordering and transporting controlled 

substances all at the direction of the 

Respondent.’’ Id. at 24. Based on these 

findings, the ALJ concluded that ‘‘either 

[Respondent] is personally involved in 

hydrocodone diversion or he is 

facilitating such diversion on the part of 

his employee.’’ Id. 

The ALJ further found that 

Respondent ‘‘prescribed Vicodin,’’ a 

schedule III controlled substance, to 

patient B.R. ‘‘on many occasions 

without a thorough examination.’’ Id. 

Based on Cal. Bus. & Prof. Code 

§ 2242(a), which provides that it is 

‘‘unprofessional conduct’’ to 

‘‘[p]rescrib[e], dispens[e] or furnish[ ] 

dangerous drugs as defined in Section 

4022 without an appropriate prior 

examination and a medical indication,’’ 

the ALJ concluded that Respondent 

prescribed Vicodin to B.R. without an 

‘‘appropriate prior examination.’’ Id. at 

25. The ALJ thus concluded that 

Respondent ‘‘prescribed controlled 

substances without establishing a bonafide patient relationship’’ and violated 

both Federal and state law. Id. at 24–25. 

Next, the ALJ found that Respondent 

did not have any inventories for the 

controlled substances his clinic 

dispensed, that he ‘‘failed to maintain 

accurate records of the controlled 

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