[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51424-51430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21065]


-----------------------------------------------------------------------

 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 m[eacute]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

[[Page 51425]]

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 <greek-i>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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.).
---------------------------------------------------------------------------

    \3\ Pursuant 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.
    \4\ As a combination product, hydrocodone is a schedule III 
controlled substance. 21 CFR 1308.13(e)(1)(iv).
    \5\ The ARCOS system reports the registration number used, but 
not necessarily the person who actually ordered the drugs. Tr. 114-
16.
    \6\ Moore 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.
---------------------------------------------------------------------------

    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

[[Page 51426]]

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\
---------------------------------------------------------------------------

    \7\ The GS stated that he analyzed ARCOS data, distributors' 
sales records, audit inventories, patient files and dispensing logs 
when creating GX 15. Tr. 92-97.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \8\ More 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.
---------------------------------------------------------------------------

    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.

[[Page 51427]]

    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.
---------------------------------------------------------------------------

    \9\ A.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.
    \10\ The 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.
    \11\ According 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.
    \12\ S.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.
---------------------------------------------------------------------------

    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 tablets\15\ found during 
the search of R.K.'s residence which occurred later that day. Tr. 95; 
GX 12, 15.
---------------------------------------------------------------------------

    \13\ Moore 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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \16\ The 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.
    \17\ The 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.
    \18\ Neither Respondent nor her husband had reported to DEA any 
thefts, losses, or destructions of controlled substances. Tr. 99-
101.
    \19\ This calculation gives Respondent credit for all of the 
167,000 tablets for which the GS could account.
---------------------------------------------------------------------------

    Respondent testified that she had no knowledge that her ``DEA 
registration

[[Page 51428]]

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 Shoppe-Jonesboro, 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.
---------------------------------------------------------------------------

    \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. Krishna-Iyer, 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.
---------------------------------------------------------------------------

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

[[Page 51429]]

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. Sec.  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

[[Page 51430]]

(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 Krishna-Iyer, 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