[Federal Register Volume 72, Number 18 (Monday, January 29, 2007)]
[Notices]
[Pages 4035-4042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1318]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 04-36]


Rose Mary Jacinta Lewis, M.D.; Affirmance of Immediate Suspension

    On March 22, 2004, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Notice of 
Immediate Suspension of the practitioner's Certificate of Registration, 
AL8962993, held by Rose Mary Jacinta Lewis, M.D. (Respondent), of 
Richmond, CA. The Notice of Immediate Suspension was based on my 
preliminary finding that substantial amounts of Schedule III controlled 
substances that had been ordered using Respondent's DEA registration 
could not be accounted for. Show Cause Order at 7. Based on the 
significant risk that these drugs had been diverted as well as evidence 
showing that Respondent had allowed unregistered entities and 
individuals to use her registration to obtain controlled substances, I 
concluded that Respondent's continued registration ``would constitute 
an imminent danger to the public health and safety.'' Id.
    More specifically, the Show Cause Order alleged that in September 
2003, R & S Sales, a registered distributor, had reported to DEA ``that 
excessive amounts of controlled substances were being ordered under'' 
Respondent's name and registration number. Id. at 2. The Show Cause 
Order further alleged that shortly thereafter, DEA investigators went 
to Respondent's registered location and determined that Respondent was 
no longer practicing medicine at the location and had retired from 
practice and vacated the premises six months earlier. See id. During 
the attempted visit, DEA investigators found several United Parcel 
Service (UPS) delivery notices including one from R & S. See id. 
According to the Show Cause Order, DEA investigators subsequently 
determined that on September 10, 2003, an order for 300 bottles, each 
containing 500 count hydrocodone/apap \1\ (7.5/75), a Schedule III 
controlled substance, had been placed with R & S under Respondent's 
registration and that UPS had been unable to deliver the order to 
Respondent's former office. See id. The Show Cause Order further 
alleged that the order was subsequently delivered to an entity known as 
International Surplus Medical Products, Inc. (ISMP), at its Richmond, 
California office. See id. The address was not, however, a registered 
location. See id.
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    \1\ Apap is an abbreviation for acetaminophen.
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    The Show Cause Order next alleged that on November 24, 2003, 
Respondent left a voicemail message with a DEA investigator in which 
she stated that she was ISMP's medical director and was using her 
medical license to order supplies. See id. According to the Show Cause 
Order, a DEA investigator then called Respondent and advised her that R 
& S could not ship supplies to ISMP's office because it was not a 
registered location. Id. at 3. The Show Cause Order alleged that during 
the conversation, Respondent stated that she was working for a non-
profit project that provided medical supplies for AIDS patients in 
Nigeria, that the project ordered only AIDS-related drugs such as AZT, 
and that it was not ordering controlled substances. See id.
    The Show Cause Order further alleged that following the 
conversation, Respondent submitted a written request to change the 
address of her registered location to ISMP's Richmond office. Id. The 
Show Cause Order alleged that in her letter requesting the change, 
Respondent stated that she worked with ISMP, a non-profit entity that 
``sends AIDS drugs to Nigeria.'' Id. On December 1, 2003, DEA personnel 
changed the address of Respondent's registered location to ISMP's 
office. Id.
    The Show Cause Order next alleged that during the week of December 
3, 2003, R & S notified DEA that on November 26, 2003, an order for 504 
bottles, each containing 500 tablets of hydrocodone/apap, had been 
placed using Respondent's registration. See id. The Show Cause Order 
alleged that R & S was told to ship the order to Respondent's former 
office, and that on December 1, 2003, 19 packages were received at that 
address and an additional package was sent to ISMP's office. Id.
    The Show Cause Order alleged that on December 10, 2003, DEA 
investigators attempted to serve an Administrative Inspection Warrant 
at ISMP's office but no one was present. See id. The Show Cause Order 
next alleged that on January 15, 2004, DEA investigators interviewed 
Respondent at her home. Id. During the interview Respondent allegedly 
told investigators that she had retired from medical practice and was 
working as ISMP's medical director. Id.
    The Show Cause Order further alleged that Respondent told the 
investigators that she had provided her DEA number to Mr. Chuka Ogele, 
ISMP's Chief Executive Officer, so that he could order medical supplies 
and controlled substances which were to be exported to Nigeria, and 
that she denied personally

[[Page 4036]]

placing any orders for controlled substances. Id. at 4. The Show Cause 
Order alleged that during the interview, Respondent stated that she did 
not know how what drugs and quantities Ogele had ordered from R & S and 
also had none of the records that she was required to maintain under 
federal law. Id. According to the Show Cause Order, Respondent also 
told the investigators that she did not have a key to the ISMP office, 
notwithstanding that it was her new registered location. Id.
    The Show Cause Order alleged that DEA investigators then contacted 
Ogele, who stated that he did not keep the records at ISMP's office but 
rather at his home. Id. According to the allegations, the investigators 
subsequently interviewed Ogele, who told them that controlled 
substances were ordered based on requests he received from Nigeria, and 
that he either personally carried the drugs to Nigeria or arranged for 
unidentified Nigerian ``diplomats'' to pick up the drugs in San 
Francisco and take them to Nigeria. Id.
    The Show Cause Order further alleged that the investigators 
inventoried the controlled substances at the ISMP office. Id. The Show 
Cause Order alleged that the office had neither a substantially 
constructed cabinet nor an alarm system. Id. at 4-5.
    The Show Cause Order next alleged that on January 22, 2004, an 
employee of the physician who had purchased Respondent's former office 
informed the investigators that several months earlier, a shipment of 
controlled substances had been received by a workman who was renovating 
the office and had been stored there. See id. at 5. The shipment was 
turned over to the investigators, who determined based on a packing 
slip, that five boxes were shipped by R & S on August 14, 2003, that 
each box held 36 bottles (each containing 500 tables of hydrocodone/
apap), and that the order had been placed by Ogele. See id. The Show 
Cause Order further alleged that the other four boxes have not been 
accounted for. See id.
    The Show Court Order also alleged that on January 26, 2004, DEA 
investigators went to ISMP's office to serve an administrative 
inspection warrant. Id. According to the Order, the investigators 
seized thirty thousand dosage units of hydrocodone/apap (in sixty 500-
count bottles) and 211,000 dosage units of codeine/apap (in 500 and 
1,000 count bottles). Id. at 6.
    Finally, the Show Cause Order alleged that Respondent did not 
maintain any of the records documenting the receipt and disposition of 
the controlled substances that were ordered under her registration. Id. 
at 6-7. The Order further alleged that the disposition of ``the bulk of 
the controlled substances ordered under [Respondent's] name and 
registration from March 2003'' through the issuance of the Order of 
Immediate Suspension were unknown. Id. at 7.
    On April 5, 2004, DEA Investigators personally served Respondent 
with the Order to Show Cause and Immediate Suspension. ALJ Ex. 2, at 1. 
Thereafter, on May 3, 2004, Respondent through her counsel, timely 
requested a hearing. See id. Respondent also responded to the Show 
Cause Order's allegations.
    The matter was assigned to Administrative Law Judge (ALJ) Gail 
Randall, who conducted a hearing in San Francisco, CA, on August 2 and 
3, 2005. At the hearing, both parties called witnesses and introduced 
documentary evidence. Following the hearing, both parties submitted 
proposed findings of fact and conclusions of law.
    On September 26, 2006, the ALJ issued her decision. ALJ at 1. The 
ALJ concluded that the Government had proved by a preponderance of the 
evidence that the continuation of Respondent's registration would be 
inconsistent with the public interest. The ALJ also concluded that 
``Respondent's lack of responsible handling of the authority granted to 
her through her DEA registration poses a threat to the public health 
and safety,'' and recommended that I revoke her Certificate of 
Registration. Id. at 38. Neither party filed exceptions.
    Having carefully reviewed the record as a whole, I hereby issue 
this decision and final order. I adopt the ALJ's findings of fact and 
conclusions of law except as expressly noted herein. I further affirm 
the immediate suspension of Respondent's registration and make the 
following findings.

Findings Of Fact

    Respondent has held a California Physician and Surgeon's license 
since July 1, 1975, which remains in active status. Respondent 
practiced medicine as a plastic surgeon from 1980 until March 2003. 
During March 2003, Respondent closed her practice and sold her office 
condominium to Dr. Randy Weil. Her state license has never been 
subjected to disciplinary action. ALJ at 3-4.
    Respondent held DEA Certificate of Registration, AL8962993, which 
was issued on December 1, 2003, and expired on March 31, 2006. Gov. Ex. 
1. According to DEA records, Respondent has not submitted a renewal 
application.\2\ I thus find that Respondent is not currently 
registered. Respondent testified, however, that ``[j]ust because [she] 
closed [her] practice didn't mean [she] was never going to work 
again.'' Tr. 353.
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    \2\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding-
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA regulations, Respondent is ``entitled on timely request, to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). To allow Respondent the opportunity to refute the 
fact of which I am taking official notice, publication of this final 
order shall be withheld for fifteen days, which shall begin on the 
date of service by placing this order in the mail.
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    With respect to the events which are the subject of this 
proceeding, Respondent's registered location was initially 203 Willow 
St., Suite 303, San Francisco, CA. On December 1, 2003, Respondent's 
registered location was changed to 120 Broadway St. Suite 3, Richmond, 
CA. Gov. Ex. 2.
    On November 5, 1996, Chuka Ogele founded International Surplus 
Medical Products, Inc. (ISMP), which was organized for charitable 
purposes under section 501(c)(3), of the Internal Revenue Code. Resp. 
Ex. 10, at 2. According to its articles of incorporation, ISMP's 
purpose was ``to distribute medical supplies in developing nations.'' 
Id. Ogele appointed himself Chairman and Managing Director. Resp. Ex. 
12.
    Sometime in either 2001 or 2002, Respondent was introduced to Ogele 
by Sherrone Smith, an ISMP board member who had taught Ogele at the 
College of Alameda. Tr. at 66-67, 262. Respondent met with Ogele, who 
told her that ISMP had been in existence for six or seven years and 
that the entity provided vitamins to developing countries. Id. at 262-
63. Ogele told Respondent that he wanted to provide medications to 
treat HIV/AIDS. Id. at 263. Ogele offered Respondent a position on 
ISMP's board gave her the title of Associate Medical Director. Id. 263.
    Respondent subsequently gave Ogele a copy of her state medical 
license and her DEA registration. Id. 327. Respondent maintained that 
she did so to enable Ogele to order supplies, that ``[a]ll the 
suppliers require that you give them both licenses,'' and that she had 
``never had one, even if [she was not] ordering * * * controlled 
substances, [that] didn't request both licenses.'' Id. Respondent 
further testified that she provided her DEA registration to Ogele 
without checking out his background. Id. at 329.

The DEA Investigation

    Respondent first came to the attention of DEA in September 2003, 
when R &

[[Page 4037]]

S Sales notified the DEA Louisville office of Respondent's excessive 
purchases of controlled substances including hydrocodone, acetaminophen 
with codeine, and promethazine with codeine. ALJ at 4 (citing Tr. 12-
13). The information was forwarded to a Diversion Investigator (DI) 
with the San Francisco Diversion Group.
    The DI went to Respondent's registered location at 203 Willow 
Street, San Francisco only to find that her office was vacant. Tr. 14-
15. The DI inquired with the building's management company as to 
Respondent's whereabouts; the DI was told that, in March 2003, she had 
retired and vacated her office. Id. 15.
    The DI subsequently contacted R & S Sales. R & S advised the DI 
that, on September 10, 2003, an additional purchase of a controlled 
substance had been made with Respondent's registration. Tr. 15-16. The 
purchase was for 300 bottles, each containing 500 tablets of 
hydrocodone/apap. Gov. Ex. 17. The invoice lists the name ``CHUKA'' 
under the Purchase Order Number. Id. It also indicates that ISMP was to 
be billed for the order and that the drugs were to be shipped to 
Respondent at the Willow St. office which she had since vacated. Id.
    The DI contacted UPS to ascertain whether the shipment had been 
delivered. Tr. at 16. UPS informed the DI that it had attempted two 
deliveries at Respondent's former office and that someone had changed 
the address of the delivery to ISMP's office at 120 Broadway in 
Richmond. Id. UPS subsequently delivered the drugs to Chuka Ogele at 
this address. Id.
    On November 26, 2003, the DI received a voicemail message from 
Respondent. In this message, Respondent stated that Chuka Ogele, ISMP's 
chairman, had been attempting to call the DI regarding the ordering of 
supplies. Id. at 17. In the message, Respondent also stated that she 
was ISMP's medical director and that ISMP ``was using her medical 
license to order medical supplies.'' Id. Respondent requested that the 
DI call her. Id. at 18.
    The DI phoned Respondent. Respondent told the DI that R & S would 
not deliver medical products to ISMP's office because it was not 
registered under her name and address. Id. The DI told Respondent that 
she needed to change the address of her registration. Id. According to 
the DI, Respondent said during the call that ``she was not ordering 
controlled substances, but was ordering * * * AIDS drugs such as AZT.'' 
Id.
    Subsequently, Respondent submitted a letter requesting a change of 
the address of her registered location. Id. On December 1, 2003, DEA 
changed the address of her registered location to ISMP's office. Id. at 
19.
    Shortly thereafter, the DI received another phone call from R & S. 
Id. During this call, the DI was informed that on November 26, 2003, 
another order for controlled substances had been placed using 
Respondent's registration and her former office as the address that the 
drugs were to be shipped to. Id.; see also Gov. Ex. 16, at 2. This 
order was for 504 bottles each containing 500 count of hydrocodone/apap 
7.5/750mg.\3\
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    \3\ The order also included one bottle of 100 ativan (2 mg.) 
tablets. Gov. Ex. 16, at 2.
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    Following the receipt of this information, the DI obtained an 
administrative inspection warrant for the ISMP's office. Tr. 19. On 
December 10, 2003, the DI, along with other DEA investigators, 
attempted to serve the warrant. Id. Upon their arrival at ISMP's 
office, the DIs could not serve the warrant because no one was present. 
Id. at 20.
    On January 15, 2004, the DI, accompanied by another DI and a 
Special Agent, went to Respondent's residence to interview her 
regarding the large quantities of controlled substances that were being 
ordered using her registration. Id. at 20-21. During the interview, 
Respondent told the investigators that she was the medical director of 
ISMP, that the organization assisted AIDS patients in Nigeria, and that 
Chuka Ogele was the chairman. Id. at 21.
    Respondent further told the DIs that Ogele was using her DEA number 
to order medical supplies from R & S Sales and that she had not 
personally placed any of the orders. Id. at 23. Respondent told the DI 
that ``she did not know what types of controlled substances [were] 
being ordered by Ogele,'' id., but indicated that the drugs were being 
ordered for AIDS patients. Id. at 24. Respondent did not have any 
records documenting the purchases of the controlled substances but 
thought that the records might be at ISMP's office. Id. Respondent did 
not, however, have access to the office as Ogele ``had the only key.'' 
Id.
    During the interview, the other DI told Respondent that she was 
liable for giving her registration to another person and not knowing 
what drugs were being ordered. Id. at 25. Respondent stated that she 
understood. Id. The investigators also told Respondent that they needed 
to see the records. Id. Respondent contacted Ogele, who agreed to meet 
with the investigators later that day at ISMP's office. Id. at 25-26.
    The investigators subsequently met with Ogele at ISMP's office. Id. 
at 26. During the meeting, Ogele told the investigators that he was 
ISMP's chairman and that the controlled substances he was ordering from 
R & S were for Nigerian AIDS patients. Id. at 27-28. Ogele provided the 
investigators with several documents from officials of the Government 
of Benue State, Nigeria. Id. at 30; see also Gov. Ex. 6 & 7. While 
these documents show that Benue State Ministry of Health requested that 
ISMP supply it with various drugs for treating HIV and other 
opportunistic infections, Benue State officials did not request that 
ISMP supply any controlled substances. See Gov. Exs. 6 & 7.
    As for the controlled substance records, Ogele provided the 
investigators with four invoices for the purchase of controlled 
substances. Tr. 30. Subsequently, a DI determined that about thirteen 
orders for controlled substances had, in fact, been placed with R & S 
using Respondent's registration. Id. at 29.
    Moreover, Ogele did not provide any records documenting the 
distribution of the controlled substances. Id. at 27. During the 
interview, Ogele stated that he would sometimes take controlled 
substances to Nigeria in his luggage. Id. at 31. Ogele also stated that 
sometimes Nigerian diplomats would come to San Francisco to obtain the 
controlled substances and take them back to Nigeria. Id. Ogele did not 
hold any DEA registration and Respondent was not registered as an 
exporter. Id. at 31-32. The investigators told Ogele that he did not 
have the registration required under federal law to export controlled 
substances. Id. at 31. The investigators also determined that there 
were controlled substances on the premises and took an inventory. Id. 
at 32.
    On January 22, 2004, an employee of Dr. Randall Weil (who had 
purchased Respondent's former office) contacted DEA. Id. at 32-33. Dr. 
Weil's employee informed DEA that the office had received a shipment of 
controlled substances that had been shipped to Respondent. Id. at 33. 
The next day, the DI and her supervisor went to Dr. Weil's office and 
retrieved one box holding 36 bottles, each containing 500 tablets, of 
hydrocodone/apap 7.5/750. Id. at 34. The shipment's packing slip, which 
was dated August 14, 2003, indicated that a total of 180 bottles (five 
boxes) of the drug had been ordered. Resp. Ex 3, at 2. The 
investigators have not been able to determine the disposition of the 
other 144 bottles. Tr. 34.

[[Page 4038]]

    On January 26, 2004, the DI obtained and served another 
administrative inspection warrant at ISMP's office. Id. at 34-35. DEA 
personnel went to ISMP's office but found no one present. Id. at 37. 
The investigators then contacted Ogele by phone. Id. Following Ogele's 
arrival, the investigators informed Ogele that he was improperly using 
Respondent's registration. Id. at 39. The investigators then seized 
approximately 300 bottles of hydrocodone/apap and codeine/apap, which 
were taken to the DEA office. Id. at 39-40; Gov. Ex. 8. The 
investigators subsequently contacted Respondent and offered to arrange 
for the drugs to be returned to R & S with a credit to her account. Id. 
at 40.
    Respondent agreed and, on January 30, 2004, went to the DEA office 
to assist in the inventory. Id. at 40-41. The inventory differed, 
however, from the inventory that was taken during the January 26 
administrative inspection by one bottle of hydrocodone/apap. Id. at 
171.
    During this meeting, the DI told Respondent that DEA was concerned 
about the large orders of controlled substances that were placed with 
her registration. Id. at 41. The DI also told Respondent that it was 
improper to allow Ogele to use her DEA registration to order controlled 
substances for export to Nigeria.\4\ Id. The DI also discussed with 
Respondent the shipment that DEA had retrieved from her former office. 
Id. at 42. Respondent told the DIs that she had not ordered those 
drugs. Id.
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    \4\ On some date which the record does not clearly establish, 
Ogele played for the ISMP board a tape recording of a phone message 
from a Mr. Dan Neeson, an employee of the Department of Commerce's 
Bureau of Export Administration. The message stated that ``[m]ost 
medical products do not require an export license. And if you do 
require a license it would be for a particular country for a 
particular transaction. If you want more information, give me a 
call.'' Resp. Ex. 36. Respondent asserted that Ogele told the board 
that he had contacted DEA and that Mr. Neeson had left the above 
message. Tr. 293. The Bureau of Export Administration is not part of 
DEA and does not enforce the Controlled Substances Act.
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    The DI advised Respondent that DEA was seeking to suspend her 
registration. Id. at 45-46. The DI asked Respondent whether she would 
voluntarily surrender her registration. Id. Respondent refused. Id. at 
46.
    The investigators subsequently obtained from R & S Sales, copies of 
the invoices documenting the controlled substance purchases made using 
Respondent's registration between August 15, 2002, and December 29, 
2003. Tr. 52, Gov. Exs. 12 & 17. The Government also introduced into 
evidence a compilation of the purchases. See Gov. Ex.13.
    The compilation shows that Ogele used Respondent's registration to 
obtain from R & S, 1,537,500 tablets of hydrocodone/apap in various 
strengths and 450,000 dosage units of codeine/apap in various 
strengths; these drugs are schedule III controlled substances. See 21 
CFR 1308.13(e). The compilation further shows that Respondent's 
registration was used to purchase from R & S, 97,340 dosage units of 
lorazepam (in various strengths), 19,900 dosage units of phenobarbital 
(in various strengths), 9700 dosage units of ativan (2mg.), 400 tablets 
of diazepam, and 3100 tablets of flurazepam. All of these drugs are 
schedule IV controlled substances. Id. 1308.14(c). Finally, the 
compilation shows that Respondent's registration was used to order 
13,800 tablets of diphenoxylate/atropine sulfate, and 455,040 
milliliters of promethazine/codeine cough syrup; both drugs are 
schedule V controlled substances. Id. 1308.15
    The investigation also determined that Ogele used Respondent's 
registration to order controlled substances from an additional 
supplier, Priority Healthcare, between July 16, 2003, and September 15, 
2004.\5\ See Gov. Ex. 10. The compilation of these purchases shows that 
Ogele obtained 285,900 dosage units of codeine (30mg.)/apap and 135,900 
dosage units of codeine (60 mg.)/apap. See Gov. Ex. 11, ALJ at 3. The 
compilation also shows that Ogele obtained 77,100 dosage units of 
hydrocodone/apap (of various strengths). Id. Finally, the compilation 
shows that Ogele obtained 46,694 sixteen oz. bottles of promethazine w/
codeine, the wholesale price of this medication was approximately 
$664,900.
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    \5\ DEA did not become aware that Ogele had also made purchases 
from Priority Healthcare until after his arrest on September 22, 
2004, at Hobby Airport in Houston, Texas.
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    Ogele purchased the majority of the drugs from Priority after the 
service of the Notice of Immediate Suspension. See Gov. Exs. 10 & 11. 
Respondent did not become aware of the purchases from Priority until a 
few months before the hearing when Ogele's wife apparently found an 
invoice or some other document from Priority and told Respondent. Tr. 
347. Respondent did not provide DEA with any records related to the 
receipt and distribution of these drugs. Id. 54-55.
    DEA has been unable to determine the disposition of the great 
majority of the drugs Ogele ordered using Respondent's registration. 
See ALJ at 15; Tr. at 53, 55, 64. The only drugs which can be accounted 
for are those which DEA retrieved from Respondent's former office and 
those seized during the execution of the warrant at ISMP's office. Tr. 
53.
    On September 2, 2004, Ogele was arrested by local authorities at 
the George Bush Intercontinental Airport in Houston, Texas. Id. at 55. 
At the time, Ogele was carrying $975,481 in cash and 395 Vicodin 
tablets for which he lacked a prescription. Id.; see also Gov. Ex. 22. 
During an interview with Houston police, Ogele claimed that the cash 
had been donated to ISMP. Tr. 56. Ogele further stated that a person 
named Mike, who lived in Houston, would sometimes hold fundraisers at 
churches for ISMP. Id. at 56-57. Ogele did not, however, know Mike's 
last name or his address. Id. Initially, Ogele told the police that he 
did not know how to contact Mike. Id. at 57. Ogele later changed his 
story and stated that Mike had called him upon his arrival at his hotel 
and brought the cash to him. Id. Subsequently, Ogele waived his 
interest in the cash and forfeited it. Gov. Ex. 22. He was also charged 
with unlawful possession of controlled substances. Tr. 58.
    On September 22, 2004, Ogele was arrested at another Houston 
airport (William P. Hobby). Gov. Ex. 19. On this occasion, Ogele was 
carrying $7774 in cash and various controlled substances including 24 
Vicodin tablets, 135 Ativan tablets, and two Lortab tablets. Id. at 2. 
He did not have a valid prescription for any of these drugs. Tr. 58. He 
also had in his possession thirteen invoices from Priority Healthcare. 
Id. at 58-59. The cash was again seized and forfeited. Id. at 58. Ogele 
was subsequently convicted of delivery of a controlled substance, a 
felony offense under Texas law, and sentenced to eight years of 
community supervision. Gov. Ex. 20.

Respondent's Knowledge of Ogele's Use of Her DEA Registration

    One of the central issues in this case is whether Respondent knew 
that Ogele was using her DEA registration to order controlled 
substances. Both in her testimony and her post-hearing brief, 
Respondent has maintained that prior to the January 15, 2004 interview 
with DEA, she ``did not know about the ordering of [the] controlled 
substances and is not responsible for record keeping involved with such 
orders.'' Resp. Br. at 20. See also id. at 6 (Respondent ``did no[t] 
anticipate that there would be any controlled substances ordered to be 
used in the project.'').
    In reference to Respondent's giving her DEA registration to Ogele, 
the ALJ found that ``Respondent credibly

[[Page 4039]]

testified that she told Mr. Ogele that she understood that ISMP would 
order `medications, primarily AIDS and AIDS-related medications, but no 
IV injectables and no narcotics.''' ALJ at 5-6 (FOF 17) (quoting Tr. at 
351). The ALJ also found that ``Respondent did not anticipate that 
there would be any controlled substances ordered by ISMP. '' Id. at 6 
(quoting Tr. at 351).
    In her testimony, Respondent further maintained that she did not 
become aware that Ogele was using her registration to order controlled 
substances until January 15, 2004, when she was told this while being 
interviewed by DEA investigators. During cross examination, Respondent 
was asked whether she knew ``there were any controlled substances being 
ordered?'' Tr. 326. Respondent answered ``No.'' Id. The Government then 
asked Respondent: ``[Y]ou didn't know there were any controlled 
substances being ordered until DEA informed you in January of 2004, 
correct?'' Id. Respondent answered: ``Yes.'' Id.
    The ALJ found, however, that a preponderance of the evidence 
``supports the conclusion that * * * Respondent knew that controlled 
substances were being ordered using her DEA registration.'' ALJ at 16 
(FOF 61). Among other evidence, the ALJ noted the testimony of Dr. 
Green, another ISMP board member. Dr. Green testified that she had 
knowledge that Respondent allowed her registration to be used to obtain 
AIDS and pain medications, and that she and Ogele had also visited a 
company in the Midwest after which ISMP began receiving from it AIDS 
and ``pain medications.'' Tr. 236.
    The ALJ's finding does not, however, specify at what point in time 
Respondent knew that Ogele was using her registration to order 
controlled substances. Another finding appears to credit Respondent's 
testimony that she did not learn of this until the January 2004 DEA 
meeting and ``was surprised'' to find that Ogele was ordering 
controlled substances. ALJ at 10 (FOF 42).
    To the extent this finding was intended to credit Respondent's 
testimony that she did not learn of the controlled substance purchases 
until January 2004, I reject it. Instead, I find that Respondent knew 
at least as early as May 2003, that Ogele was using her registration to 
order controlled substances.
    In her letter requesting a hearing, Respondent filed a lengthy 
point by point response to the allegations of the Show Cause Order. See 
ALJ Ex. 2. In this filing, Respondent ``admit[ted] that between May 
2003 and August 2003 she authorized the ordering of hydrocodone or 
vicodin from R & S Sales.'' ALJ 2 at 2. Respondent further stated that 
``[t]he purpose of these orders was to ship the vicodin to Nigeria to 
aid in the treatment of women with AIDS and HIV.'' Id. More 
specifically, Respondent ``admit[ted] to authorizing the ordering of 
three hundred bottles of hydrocodone (vicodin) from R & S * * * between 
May 2003 and August 2003,'' that the ``drugs were ordered on behalf 
of'' ISMP, and that they ``were purchased under [Respondent's] license 
for the purposes of export to Nigeria to fulfill existing commitments 
that [ISMP] has with the Nigerian military and other Nigerian 
government entities.'' Id.
    In this same document, Respondent further stated that in her 
November 24, 2003 telephone conversation with a DEA investigator, she 
``never said she was `not ordering controlled substances' because 
vicodin and [T]ylenol 3 is an integral part of the treatment 
of AIDS/HIV in Nigeria.'' Id. at 3-4. Moreover, with respect to the 
order that was placed with R & S on November 26, 2003, Respondent 
``denie[d] ever having told the DEA agent that she was not ordering 
[V]icodin and Tylenol  4 for the Nigeria project.'' Id. at 4. 
Respondent further ``admit[ted] authorizing the order and that the 
drugs were shipped to the Broadway Street address.'' Id. Finally, 
Respondent stated that she ``may not always have known the quantities 
of the substances ordered but she always knew what the drugs were that 
were being ordered and shipped. The orders are for standard quantities 
of particular drugs and do not vary very much, order to order.'' Id. at 
4-5.
    The ALJ did not acknowledge these admissions and thus did not 
discuss the fundamental inconsistencies between them and Respondent's 
statements under oath at the hearing. While I am mindful that the ALJ 
observed Respondent's testimony, deference to the ALJ's findings is 
clearly not appropriate where, as here, a witness tells two materially 
different tales and the ALJ gives no explanation as to why one is more 
credible than the other. Based on her written admissions, I thus find 
disingenuous Respondent's testimony on cross-examination that she did 
not become aware that Ogele was ordering controlled substances until 
the January 2004 interview with DEA investigators. And consistent with 
her admissions, I further find that Respondent knew at least as early 
as May 2003 that Ogele was ordering controlled substances.

Respondent's Response to Ogele's Misuse of Her Registration

    On January 15, 2004, DEA investigators informed Respondent that an 
excessive amount of controlled substances had been ordered under her 
registration. Tr. 302. Furthermore, on January 26, 2004, DEA executed 
an administrative search warrant at ISMP's office and seized a 
substantial quantity of controlled substances.
    Notwithstanding these two events, Respondent did not demand that 
Ogele produce the invoices. Furthermore, she did not even talk to Ogele 
about the matter until ``probably April.'' Id. at 313.
    In her testimony, Respondent asserted that the reason she did not 
talk to Ogele about the matter was because he ``left the country * * * 
early the next morning.'' Id. Respondent testified, however, that Ogele 
had called her on January 26, 2004, the day that DEA investigators 
served the administrative warrant and told her that the investigators 
had already shown up at ISMP's office. Id. at 304. Respondent further 
testified that Ogele called her and asked her to go to the DEA office 
to conduct an inventory of the controlled substances because he ``was 
getting ready to leave the country.'' Id. at 305. The inventory 
occurred on January 30. While Respondent did not testify as to the date 
this phone call occurred, it is clear that Ogele was in the country for 
a substantial period of time following Respondent's receipt of 
information that her registration was being misused (during the January 
15, 2004 interview) and that she made no effort to investigate the 
matter for at least three months.
    Respondent had long known that R & S Sales was one of ISMP's 
primary suppliers. Respondent testified that R & S was sending orders 
to her medical practice and that she contacted R & S in an attempt to 
have the orders shipped to the ISMP office. Id. at 267. Respondent did 
not, however, contact R & S during the period between the January 15 
interview and service of the Show Cause Order to obtain copies of the 
invoices for the orders that had been placed under her registration. 
Furthermore, even following the service of the Show Cause Order, 
Respondent did not promptly contact R & S to obtain the invoices. Id. 
at 347; ALJ Ex. 2, at 5. While the record does not specify when 
Respondent finally contacted R & S, in her response to the Show Cause 
Order, Respondent stated that ISMP ``has records of each drug 
shipment,'' ALJ Ex. 2, at 5, and made no mention that she had obtained 
or was then attempting to

[[Page 4040]]

obtain the records from R & S. Furthermore, when asked whether after 
service of the Show Cause Order she had ``ask[ed] any of the suppliers 
for records?,'' Respondent answered: ``[n]ot at that time.'' Tr. 347. 
Respondent further testified that she did not contact R & S until 
``later.'' Id.
    Respondent did not obtain copies of the invoices from Priority 
Healthcare until ``a few months'' before the hearing, when Ogele's wife 
found some invoices from Priority and contacted it to obtain copies of 
them for her. Id. Finally, Respondent did not testify that she ever 
attempted to exercise her right as a director of ISMP to examine its 
books, records, and documents. See, e.g., Cal. Corp. Code section 6334 
(West 2006).

Discussion

    Section 304(a) of the Controlled Substances Act 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 [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, the Act 
requires the consideration of the following factors:

    (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.

Id. section 823(f).

    ``[T]hese 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 may give each factor the weight [I] 
deem[] appropriate in determining whether a registration should be 
revoked.'' Id. Moreover, case law establishes that I am ``not required 
to make findings as to all of 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).
    Finally, section 304(d) provides that ``[t]he Attorney General may, 
in his discretion, suspend any registration simultaneously with the 
institution of proceedings under this section, in cases where he finds 
that there is an imminent danger to the public health or safety.'' 21 
U.S.C. 824(d). In this case I conclude that Factors Four and Five 
conclusively establish that allowing Respondent to hold a registration 
would be inconsistent with the public interest.\6\ Analyzing these 
factors, I also conclude that Respondent's conduct created ``an 
imminent danger to the public health or safety,'' id., and thus affirm 
the immediate suspension of her registration.\7\
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    \6\ Having considered all of the factors, I deem it unnecessary 
to make findings on factors one, two, and three.
    \7\ While Respondent's registration has expired and she did not 
submit a renewal application, this case began with the immediate 
suspension of her registration and thus is not moot. See William R. 
Lockridge, 71 FR 77791, 77796-97 (2006). Furthermore, Respondent 
testified that while she had closed her office, she might return to 
the practice of medicine.
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Factor Four--Respondent's Compliance With Applicable Laws

    The evidence in this case establishes that Respondent acted with 
complete disregard for the obligations imposed on her as a registrant 
under federal law and regulations. These actions included entrusting 
her registration to someone she had no effective control over and knew 
little about, her total failure to comply with the CSA's recordkeeping 
requirements and to ensure the security of controlled substances, and 
her authorizing Ogele to use her registration to obtain controlled 
substances knowing that they would be exported to a foreign country 
without a registration. While the record shows that Respondent was 
motivated by humanitarian concerns and was likely duped by Ogele, 
Respondent's disregard for federal law cannot be excused.
    As the evidence shows, Respondent entrusted her DEA number to Ogele 
shortly after meeting him and joining the ISMP board. She did so 
without investigating Ogele's background \8\ and even though she had no 
effective control over him. Respondent's conduct violated the CSA 
because the Act does not authorize a registrant to allow an 
unregistered person to use her registration to handle controlled 
substances unless the latter is the employee or agent of the 
registrant. See 22 U.S.C. 822(c) (exempting from registration ``an 
agent or employee'' of a registrant but only ``if such agent or 
employee is acting in the usual course of his business or 
employment'').
---------------------------------------------------------------------------

    \8\ DEA regulations provide that a ``registrant shall not employ 
as an agent or employee who has access to controlled substances, any 
person who has been convicted of a felony offense relating to 
controlled substances.'' 21 CFR 1301.76(a). As explained in the 
text, Ogele was neither an employee nor an agent of Respondent. 
While by its terms the regulation does not apply to Respondent, it 
nonetheless demonstrates the recklessness of Respondent's 
authorizing Ogele to use her registration without conducting a 
background investigation.
---------------------------------------------------------------------------

    Respondent argues that authorizing Ogele to use her DEA number is 
``no different[t]'' than ``what goes on in the normal medical 
practice'' where ``[t]he doctor tells her nurse to order drugs under 
her number and the nurse does it on the doctor's behalf.'' ALJ Ex. 2 at 
4. Contrary to Respondent's contention, there is a fundamental 
difference between what she did and what goes on in normal medical 
practices because Ogele was not her employee and thus was not subject 
to her control through the measures employers customarily use to 
discipline employees.
    Moreover, Ogele was not Respondent's agent. The evidence clearly 
shows that Ogele did not act on Respondent's behalf but rather on 
behalf of ISMP and himself. The evidence further shows that Ogele was 
not Respondent's agent because while Respondent was a member of ISMP's 
board, she could not unilaterally remove him and had no effective means 
of controlling him. See, e.g., Restatement (Second) of Agency section 1 
(1958) (comment a) (``The relation of agency is created as a result of 
conduct by two parties manifesting that one of them is willing for the 
other to act for him subject to his control * * *. [T]he agent must act 
or agree to act on the principal's behalf and subject to his 
control.''); \9\ Resp. Ex. 11. Respondent thus violated the CSA by 
entrusting her registration to Ogele, who was neither her employee nor 
her agent.
---------------------------------------------------------------------------

    \1\ Cf. id. Sec.  14 C (comment b) (``An individual director * * 
* has no power of [her] own to act on the corporation's behalf, but 
only as one of the body of directors acting as a board.'') (emphasis 
added).
---------------------------------------------------------------------------

    Respondent's conduct in authorizing Ogele to use her registration 
to order controlled substances violated the CSA for an additional 
reason. Respondent clearly contemplated that the drugs were being 
ordered to be shipped to Nigeria. A practitioner's registration, 
however, grants its holder authority to obtain controlled substances 
only for the limited purposes of conducting research or dispensing them 
to an ultimate user. See 21 U.S.C. 802(10) & (21); section 822(b). It 
does not provide its holder with authority to export a controlled 
substance. Id. section 822(b) (``Persons registered * * * under this 
subchapter to * * * dispense controlled substances * * * are authorized 
to possess * * * or dispense [controlled] substances * * * to the 
extent authorized by their registration.''). See also id. section 
957(a) (``No person may * * * export from the United States any

[[Page 4041]]

controlled substance * * * unless there is in effect with respect to 
such person a registration issued * * * under section 958 of this 
title.'').
    Consistent with the statutory scheme, DEA regulations provide that 
dispensing and exporting are activities which are ``deemed to be 
independent of each other,'' 21 CFR 1301.13(e); exporting is not a 
``coincident activity'' which is authorized under a practitioner's 
registration. Id. (Table). DEA regulations further require that ``[a]ny 
person who engages in more than one group of independent activities 
shall obtain a separate registration for each group of activities.'' 
Id. 1301.13(e).
    While there is some question regarding the extent to which the 
controlled substances were actually exported to Nigeria (as opposed to 
being sold by Ogele in this country)--largely because of Respondent's 
failure to ensure that proper records were being maintained--Ogele told 
DEA investigators that he was personally carrying drugs to Nigeria. 
Moreover, Respondent made numerous admissions that show that she was 
aware that the controlled substances were being ordered for the purpose 
of export to Nigeria. Thus, it is clear that Respondent violated 21 
U.S.C. Sec.  957(a) by exporting controlled substances without a 
registration.
    Respondent also violated the Act by failing to adequately supervise 
Ogele's activities. Under DEA regulations, a registrant ``shall provide 
effective controls and procedures to guard against theft and diversion 
of controlled substances,'' 21 CFR 1301.71(a), including adequate 
systems ``for monitoring the receipt, * * * distribution, and 
disposition of controlled substances in its operations. Id. 
1301.71(b)(14). Cf. id. 1301.71(b)(11) (require an assessment of 
``[t]he adequacy of supervision over employees having access'' to 
controlled substances).
    Respondent's supervision of Ogele's use of her registration was 
non-existent. As Respondent admitted, she ``may not always have known 
the quantities of the substances ordered.'' ALJ Ex. 2, at 4. Indeed, 
Respondent was clueless as to the scope of Ogele's ordering of 
controlled substances. See Tr. 328-29 (``I didn't supervise him'' 
(Ogele) to ensure that he was keeping records.); id. at 329 (``I wasn't 
following those records, no.'').
    As the ALJ found, this was because Respondent did not ensure that 
the required records documenting the purchase and distribution of 
controlled substances were maintained. ALJ at 34; see, e.g., 21 CFR 
1304.21(a) (``Every registrant required to keep records * * * shall 
maintain on a current basis a complete and accurate record of each such 
substance * * * received, sold, delivered, exported, or otherwise 
disposed of * * *.''). See also 21 CFR 1304.22. Nor did she ensure that 
the required inventories were conducted. See id. 1304.11.
    The direct consequence of Respondent's abdication of her 
obligations as a registrant is that the disposition of an extraordinary 
quantity of controlled substances cannot be accounted for and the drugs 
have likely been diverted. Of the drugs Ogele obtained from R & S, more 
than 2.1 million dosage units are unaccounted for. Moreover, none of 
the drugs Ogele obtained from Priority Healthcare (which included 
nearly 47,000 dosage units of promethazine with codeine cough syrup, 
with a wholesale price of nearly $ 65,000) have been accounted for.
    To be sure, Ogele ordered many of the drugs from Priority after DEA 
had told him to stop and Respondent was likely unaware of this. The 
fact remains, however, that Ogele would not have been able to do so if 
Respondent had never entrusted her registration to him in the first 
place. This Agency has previously held that a registrant who allows a 
non-registrant to use her registration is strictly liable for any 
misuse of the registration. See Anthony L. Cappelli, 59 FR 42,288 
(1994).
    Finally, the record establishes that Respondent authorized the 
ordering of controlled substances that were shipped to her former 
office in San Francisco which remained her registered location until 
December 1, 2003. Because Respondent had sold and vacated her office 
some eight months earlier, she had no effective means of securing the 
drugs that were delivered to this address. The record also establishes 
that with Respondent's authorization, controlled substances were being 
stored at ISMP's Richmond office even though this facility was not a 
registered location. Indeed, she did not even have a key for the 
office. Both the shipping of drugs to her former office and the 
shipping of drugs to the ISMP office when it was not her registered 
location violated the CSA.\10\
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    \10\ Under the CSA, ``[a] separate registration [is] required at 
each principal place of business or professional practice where the 
[registrant] * * * distributes, or dispenses controlled 
substances.'' 21 U.S.C. 822(e). The primary purpose of this 
requirement is to ensure that adequate security exists at each 
location. See 21 CFR 1301.71.
---------------------------------------------------------------------------

    I thus conclude that Respondent's record of non-compliance with 
federal law is extensive and egregious. As the ALJ explained, 
Respondent's conduct ``evidences a reckless disregard for the legal 
obligations and responsibilities'' of a registrant. ALJ at 34. The 
direct consequence of Respondent's indifference to her obligations 
under the CSA was to provide a drug dealer with the means to obtain his 
wares and to create an ``imminent danger to the public health or 
safety.'' 21 U.S.C. 824(d).
    I thus affirm the immediate suspension of Respondent's 
registration. I further conclude that this factor provides reason alone 
to conclude that allowing Respondent to hold a DEA registration would 
be ``inconsistent with the public interest.'' 21 U.S.C. 823(f).

Factor Five: Such Other Conduct Which May Threaten Public Health and 
Safety

    As explained above, because of Respondent's failure to comply with 
the CSA and DEA regulations, it is likely that over two million dosage 
units of controlled substances have been diverted. Respondent, however, 
engaged in additional conduct which threatened public health and safety 
by failing to take prompt and reasonable action to investigate the 
circumstances surrounding Ogele's misuse of her registration.
    On January 15, 2004, DEA investigators told Respondent that an 
excessive amount of controlled substances had been ordered under her 
registration. Tr. 302. Moreover, on January 26, 2004, DEA seized 
controlled substances that Ogele had ordered under her registration. 
Notwithstanding the seriousness of each of these events, Respondent did 
not demand that Ogele produce the invoices. Indeed, she did not even 
talk to Ogele about the matter until ``probably April.'' Id. at 313. 
Nor did she contact R & S Sales to independently obtain the invoices 
until some date after May 3, 2004.
    Relatedly, the Show Cause Order, which was served on Respondent on 
April 5, 2004, alleged that ``the bulk of the controlled substances 
ordered under [her] * * * registration,'' which ``include[d] over 
750,000 dosage units of Schedule III controlled substances'' could not 
be accounted for. Show Cause Order at 7. Furthermore, while there is 
conflicting evidence as to whether Respondent then attempted to obtain 
the invoices from Ogele, even giving her the benefit of the doubt on 
the issue,\11\

[[Page 4042]]

Respondent did not then contact R & S to independently verify whether 
Ogele had provided her with all of the invoices. See Tr. 347. Those 
invoices would have shown that Ogele had ordered large amounts of 
additional controlled substances such as promethazine cough syrup with 
codeine and various benzodiazepines that were unrelated to ``the 
Nigeria project.'' Gov. Ex. 12 at 8, 13, 15, & 20. Nor did she exercise 
her right as a director of ISMP to inspect its books, records, and 
documents. See Cal. Corp. Code section 6334 (West 2006) (``Every 
director shall have the absolute right at any reasonable time to 
inspect and copy all books, records and documents of every kind * * * 
of the corporation of which such person is a director.'').
---------------------------------------------------------------------------

    \11\ Compare Tr. 334 (Respondent answered ``no'' to Government's 
question regarding whether she had then attempted to obtain the 
invoices from Ogele) with ALJ Exh. 2 at 9 (listing in response to 
Show Cause Order seven different purchases of controlled 
substances).
---------------------------------------------------------------------------

    By the date the Show Cause Order was served on her, Ogele had 
obtained other drugs from R & S and had also placed numerous orders 
with Priority Healthcare. See Gov. Ex. 11. Taking timely action such as 
obtaining the invoices from R & S would have uncovered the fact that 
Ogele was ordering additional controlled substances and engaged in 
diversion. Furthermore, exercising her right as a director to inspect 
all of ISMP's records including its accounts payable and checking 
account records would likely have shown that Ogele was ordering from an 
additional supplier.
    To be sure, Ogele may have attempted to obstruct any such inquiry 
by withholding documents that showed that he was ordering controlled 
substances from Priority Healthcare. Respondent did not, however, take 
anything bordering on timely action to investigate the extent of 
Ogele's illegal use of her registration. Her failure to take even the 
most rudimentary steps to investigate the misuse of her registration 
was a breach of her duty as a registrant. Moreover, it likely allowed 
Ogele to continue his criminal activity well past the point at which it 
should have been stopped.
    Consistent with a registrant's obligation to ``provide effective 
controls and procedures to guard against theft and diversion of 
controlled substances,'' 21 CFR 1301.71(a), every registrant has a duty 
to conduct a reasonable investigation upon receiving credible 
information to suspect that a theft or diversion has occurred. 
Performing a reasonable investigation is essential to preventing the 
continuation of criminal activity. While the precise scope of this duty 
necessarily depends upon the facts and circumstances, doing nothing for 
months--as Respondent did here--clearly warrants a finding that a 
registrant has committed acts which threaten public health and safety.
    In her analysis of factor five, the ALJ further observed that 
Respondent ``exhibited no remorse for her conduct at the hearing'' and 
``downplayed her misconduct.'' Id. at 36-37. I agree. Beyond that, I am 
especially disturbed by Respondent's testimony under oath that she did 
not know that Ogele was ordering controlled substances until DEA 
investigators informed her of this during the January 15, 2004 meeting. 
As explained above, this testimony was fundamentally inconsistent with 
the letter Respondent submitted in response to the Show Cause Order in 
which she stated that she had authorized the ordering of 300 bottles of 
hydrocodone and vicodin between May 2003 and August 2003. See, e.g., 
ALJ Ex. 2, at 2. Of course, Respondent's written statement was 
submitted before Ogele was arrested and pled guilty to drug offenses. I 
thus conclude that Respondent lied under oath to downplay her 
responsibility for supplying Ogele with the means to obtain his wares. 
Such conduct buttresses the conclusion that Respondent cannot be 
entrusted with a registration.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824, as well as 
28 CFR 0.100(b) & 0.104, the order of immediate suspension of DEA 
Certificate of Registration, AL8962993, issued to Rose Mary Jacinta 
Lewis, M.D., is hereby affirmed. The Office of Diversion Control is 
further directed to cancel Respondent's DEA number. This order is 
effective February 28, 2007.

    Dated: January 19, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-1318 Filed 1-26-07; 8:45 am]
BILLING CODE 4410-09-P