[Federal Register Volume 69, Number 193 (Wednesday, October 6, 2004)]
[Notices]
[Pages 59956-59960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22422]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 02-10]
Kathy A. Morall, M.D.; Revocation of Registration
I. Background
On September 28, 2001, the Deputy Assistant Administrator, Office
of Diversion Control, Drug Enforcement Administration issued an Order
to Show Cause to Kathy A. Morall, M.D., (Respondent), proposing to
revoke her DEA Certificate of Registration. The Basis for the Order to
Show Cause was that Respondent's registration would be inconsistent
with the public interest as that term is used 21 U.S.C. 823(f). More
specifically, the OTSC alleged that in November 1998, DEA was alerted
that Respondent had ordered large amounts of phentermine and Meridia
(Schedule IV controlled substances) for delivery to her home address.
DEA notified the Respondent that she could not have controlled
substances delivered to her home because she was registered elsewhere.
Respondent then asked for a change of address on her registration.
In December 1998, DEA investigators conducted an inspection of
Respondent's registered location--her home. When the investigators
arrived and asked Respondent where she kept the controlled substances,
she initially denied having any controlled substances at home. When the
investigators asked her about the whereabouts of the phentermine and
Meridia that she had recently ordered, she admitted that the drugs were
in her home. When shown the location of the drugs, the investigators
noted that the drugs were in a box in a closet, and were not stored in
a securely locked, substantially constructed cabinet, as required.
When the investigators asked for the Respondent's dispensing
records, she said that they were in her former office in Denver. She
agreed to send them to the investigators, but later changed her mind,
explaining that she wanted to talk to an attorney first. When finally
received, the dispensing records were incomplete. The Respondent failed
to provide any records of inventories, theft/loss reports or drug
destruction reports.
On January 5, 1999, during the execution of an administration
inspection warrant, the Respondent admitted that her record keeping was
inadequate and that she had failed to maintain any inventories of
controlled substances. She also admitted that the dispensing records
that she provided had been created from memory. The Respondent was also
unable to provide patient charts, because she had been evicted from her
offices and no longer had access.
During the inspection, the investigators found two phentermine
vials, one empty and one partially full. Both were issued in the name
of a purported patient. The Respondent told the investigators that the
drugs were prescribed for her uncle. The Respondent's husband told the
investigators, however, that the ``uncle'' was really just a friend of
the family.
Accountability audits of the Respondent's handling of phentermine
and Meridia form 1997 to 1999 showed various overages and/or underages
of the drugs. The investigators also learned that Respondent had filed
a report with the police concerning the theft from her offices of
controlled substances, but she had not notified DEA, as required by
regulation.
The Respondent requested a hearing on the issues raised in the
Order to Show Cause and the matter was placed on the docket of
Administrative Law Judge Mary Ellen Bittner (the ALJ). Following
prehearing procedures, testimony was presented before the ALJ on June
19 and 20, 2002, in Arlington, Virginia. The Government presented
testimony from one witness and had admitted several exhibits into
evidence. In addition to her own testimony, the Respondent presented
two witnesses and also had several exhibits admitted into evidence.
After the hearing, both parties submitted Proposed Findings of Fact,
Conclusions of Law and Argument.
On July 24, 2003, the ALJ certified and transmitted the record to
the Acting Administrator of DEA. The record included, among other
things, the Opinion and Recommended Rulings, Findings of Fact,
Conclusions of Law and Decision of the Administrative Law Judge, the
findings of fact and conclusions of law proposed by all parties, all of
the exhibits and affidavits, and the transcript of the hearing
sessions. In her opinion, the ALJ recommended that Respondent's DEA
registration not be revoked.
II. Final Order
The Deputy Administrator does not adopt the Opinion and Recommended
Ruling, Findings of Fact, Conclusions of Law, and Decision of the
Administrative Law Judge. The Deputy Administrator has carefully
reviewed the entire record in this matter, as defined above, and hereby
issues this final rule and final order prescribed by 21 CFR 1316.67 and
21 CFR 1301.46, based upon the following findings of fact and
conclusions of law.
A. Findings of Fact
On July 9, 1997, the Respondent was assigned DEA Certificate of
Registration number BM5412868, in Schedules II through V. The
registration was issued to the Respondent at 128 Steele Street, Suite
200, Denver, Colorado (the Denver clinic). That registered location was
known as the Life-Plan Weight Loss Center and was affiliated with the
Holland Center for Family Health, and Arizona professional corporation.
The Life-Plan Weight Loss Center was owned by Joshua Holland, M.D., and
Arizona based medical practitioner, who was also registered with DEA in
the State of Arizona. Dr. Holland had previously operated a successful
weight loss clinic in Arizona and he sought to open a similar clinic in
the Denver area. To that end, he placed an advertisement in a
newspaper, seeking a physician to run the Denver clinic. The Respondent
was ultimately hired for the position. As the only physician at the
Denver clinic, the Respondent was responsible for ordering controlled
substances under her DEA registration number.
[[Page 59957]]
The Respondent's business arrangement with Dr. Holland dissolved
sometime during November 1997 based upon financial differences between
the two. Sometime after November 1997, the Respondent left the employ
of Dr. Holland and relocated from Suite 200 to Suite 202 of the 128
Steele Street location, where she intended to maintain her own clinic
under the name Total Health Care Systems.
At the hearing, a DEA Diversion Investigator (DI) testified about
the instigation of the investigation of the Respondent. She introduced
a swore statement from a registration technician (RT) at DEA's Denver
Division. In the statement, the RT stated that on November 12, 1998,
she received a voice mail message from the Respondent. In the message,
the Respondent stated that she needed to obtain the controlled
substance phentermine as soon as possible. Before returning the
Respondent's call, the RT was instructed by her supervisor to return a
previous call from a representative of Horizon Wholesale (Horizon)
concerning a request by the Respondent to have controlled substances
delivered to an unregistered address.
On the same day, the RT placed a call to Horizon. The Horizon
representative expressed concern that when the Respondent placed an
order for controlled substances, the return telephone number that she
gave was for an answering service. He expressed further concern that
Horizon could not obtain a business telephone number for the
Respondent. The RT instructed the Horizon representative not to ship
controlled substances to the Respondent at an address different from
her registered address. The RT also requested the telephone number to
the answering service that was provided by the Respondent.
After a number of attempts, the RT was able to get in touch with
the Respondent. The Respondent informed the RT that she needed to order
drugs so that they could be shipped to her home address. When asked
whether she was storing controlled substances at her home, the
Respondent replied in the affirmative and told the RT that she had a
safe at the location to store the controlled substances. The DI also
testified that the Respondent also informed another DEA employee that
she had a safe at her home.
The RT informed the Respondent that she was not allowed to store
controlled substances at her home for the sake of convenience, and
could only store controlled substances at a registered location. The
Respondent further added that she did not store or dispense controlled
substances from the Steele Street location.
Following discussions on the proper manner to modify a DEA
registration, the Respondent faxed to the DEA Denver office a request
to modify her registration to reflect her home address, 8285 South
Marion Way, Littleton, Colorado (the South Marion Way location). The
Respondent's request to have controlled substances delivered to her
home triggered DEA's investigation.
Following the modification of the Respondent's DEA registration,
the DEA investigators received information from Horizon that the
Respondent ordered approximately 3000 dosage units of phentermine and
200 dosage units of Meridia to be delivered to the Respondent's home.
In the interest of assessing the security of the ordered drugs, and to
seek accountability and justification for their use, DEA investigators
went to the Respondent's home on December 1, 1998.
When they arrived at the Respondent's home, the DEA investigators
asked to review records of the Respondent's handling of controlled
substances. Specifically, the investigators requested dispensing
records, records of theft or losses, records of drug destructions or
any disposals of controlled substances. The Respondent did not provide
any of the requested records, including inventories. The Respondent
informed the investigators that all of her records were still at her
Steele Street office location. The Respondent further stated that she
was in the process of moving her practice from the Steele Street
location to her home address. When asked if she was seeing patients at
her home location, the Respondent answered in the negative.
The investigators then asked to see the controlled substances that
were ordered by the Respondent. She told the investigators that the
controlled substances were at the Steele Street location. When reminded
that controlled substances were to be stored at a registered premise,
the Respondent changed her story, claiming that she was not in
possession of any controlled substances at any location. When the
investigators asked about the 3,000 dosage units of controlled
substances that were shipped to her home by Horizon, the Respondent
finally admitted that the controlled substances ere in her home, and
retrieved them out of an open box in a closet.
The box was small and made of cardboard. In addition to the bottles
of pills, it contained trash, cotton, candy wrappers and loose pills.
The Respondent informed the investigators that the loose pills came
from a previous shipment. Approximately half of the controlled
substances that Respondent had ordered were gone, and some of the
bottles of phentermine were opened. There were also empty bottles of
Meridia in the box. Investigators then asked to see the Respondent's
safe. Although she had told RT that she had a safe in her home, she
admitted that she did not have one, but intended to get one.
The Respondent told the investigators that she dispensed the
missing drugs to her patients but that she had not seen any patients in
the previous few weeks. The Respondent then admitted that she had not
any patients in here home at all, but had dispensed the medications by
mailing them to patients. The Respondent also informed investigators
that her husband and son had access to various areas of the house. The
DI testified that the controlled substances were not stored or secured
as required by DEA laws and regulations.
The investigators had a discussion with the Respondent about the
need for maintaining proper records, and the Respondent agreed that any
controlled substance records remaining at the Steele Street location
were to be transferred to the new registered location. The
investigators then conducted a physical count of controlled substances
on hand. According to physical count, there were 735 15mg. phentermine
tablets and 785 30mg. phentermine tablets.
With respect to controlled substance records that were not
provided, arrangements were made with the Respondent to provide the
requested records the following day. The DI further requested that the
Respondent provide records dating back two years. On December 2, 1998,
the mail message from the Respondent saying that she had the requested
records and that they were in the mail. However, on December 4, the DI
received a second voice mail from the Respondent in which the
Respondent stated that she wished to consult with an attorney before
turning over the records.
The Respondent eventually sent what she called controlled substance
records to DEA on December 21, 1998. Although DEA requested records
dating back two years, the Respondent only provided records dating back
two months, and only covering the shipments from Horizon. The
investigators found that some of the records sent by Respondent
appeared to have been ``manufactured.''For example, they found that
receipt date of the drugs was incorrect and that the dates of
dispensation were in chronological
[[Page 59958]]
order up until December 11, 1998, when the next entry reflected a date
of December 3, 1998. In addition, the totals of the drugs on the date
of the December 1, 1998, inventory did not match the records provided
by the Respondent on December 21. Again, the Respondent failed to
provide an initial inventory, and her controlled substance records were
incomplete and inaccurate.
Upon receipt and inspection of the copied records received from the
Respondent, the DI called the Respondent and requested original
records. When the Respondent did not respond to the request, the DI
applied for an administrative inspection warrant to inspect the
Respondent's new registered location. The DI sought the inspection
warrant in order to verify the correctness of inventories, records,
reports and other documents required to be kept under the CSA.
On January 5, 1999, the DEA investigators returned to the
Respondent's registered location to execute the administrative
inspection warrant. The investigators found that Respondent's records
were intermingled; patient sheets were found among personal papers,
financial data, and the like. The investigators also found a yellow
notepad where Respondent had apparently attempted to reconcile the
quantities of drugs given to patients.
The investigators also found loose pieces of paper entitled
``Medication Accountability'' in a desk, and in a box in the closet.
These records were not part of the patient charts. The investigators
also collected 15 patient charts for inspection. Two of the charts had
no information in them. In many of the other charts, the last entry for
the patients was either September or October 1997. In addition, these
records were not of patients who purportedly received dispensations
over the previous two months.
The investigators also found a prescription bottle for phentermine
for Carl Ousley, which listed the Respondent as the prescribing
physician. When the investigators asked the identity of Mr. Ousley, the
Respondent said he was her uncle. The Respondent's husband, however,
stated that Mr. Ousley was only a friend.
In the garage of the Respondent's home, the investigators found an
empty bulk manufacturer's bottle of 100-count tablets of phentermine.
Although the investigators attempted to obtain from the Respondent the
name of the supplier of the drugs, they were never able to determine
its origins. The Respondent could not even provide the names of
wholesalers from whom she purchased controlled substances. Although the
Respondent informed the investigators that she had dispensed these
medications to patients, she could not provide documentation to support
this claim. There were no original receipts for drug purchases and the
Respondent did not know where they could be located.
The DEA investigators found prescription vials for various
controlled substances in different parts of the Respondent's home.
Investigators also inspected a filing cabinet in which controlled
substances were stored. The cabinet was not locked and it contained two
empty bottles of Meridia and three opened bottles of phentermine. The
investigators also found an empty prescription vial in the master
bedroom closet. The investigators could not determine the identity of
the drug, the patient or the prescriber because the label had been
peeled off.
DEA investigators asked the Respondent if she personally used
phentermine. The Respondent acknowledged that she had been given a
prescription from her previous business partner, Dr. Holland, and had
taken the drug during the previous holiday. The Respondent further
stated that she didn't have any more pills from that prescription, but
doubted that Dr. Holland would vouch for the prescription because of
the bad breakup of their business arrangement. The Respondent further
denied any personal use of any phentermine from bottles and vials found
around her home.
The DEA investigators also discussed with the Respondent the last
time she dispensed controlled substances from her new registered
locations. The Respondent informed investigators that she had not
dispensed from that location since December 1, 1998. The Respondent
also informed investigators that they were free to inspect the Steele
Street location because that was where the remainder of her dispensing
records were maintained.
The Respondent was asked about inconsistencies in the records that
she had previously mailed to DEA. When asked how she planned to
reconcile these inconsistencies, the Respondent stated that she could
do it from memory. As noted above, during the January 5 inspection, the
Respondent informed DEA investigators that she had not dispensed
controlled substances from her new registered location since December
1, 1998. However, the results of the physical count performed during
that inspection revealed different totals: for example, the December 1,
1998, physical count for phentermine 735 tables; on January 5, 1999,
the physical count was 542. The physical count for December 1 should
have matched that for January 5.
The investigators further noted that when comparing the records
mailed by the Respondent to those seized by investigators on January 5,
the records did not match as well. For example, the mailed records for
phentermine 30mg. showed one full bottle of 1,000 tablets and one
partial bottle of 220, for a balance of 1,220 on hand. However, the
physical count that day was 735 tablets.
Following the January 5 inspection, DEA performed two
accountability audits of controlled substances handled by the
Respondent. The first audit period chosen was from November 1, 1998 to
December 1, 1998, and covered the drugs phentermine (30mg. and 15mg.)
and Meridia (15mg. and 10mg.). The audit resulted in a shortage of 740
dosage units of phentermine products. DEA investigators performed a
second accountability audit, covering the period of November 1, 1998 to
January 5, 1999. The audit for that time period reflected shortages and
overages of phentermine products.
The investigators had ongoing discussions with the Respondent to
inspect the Steele Street location, in order to acquire the remaining
dispensing records that Respondent said were there, and reconcile the
discrepancies found in DEA's audits. However, the Respondent failed to
inform the DEA investigators that she had been evicted from that
location. Some time in January 1999, the building manager of the Steele
Street location informed DEA that Respondent had been evicted for
``nonpayment.'' Despite the Respondent's assurances that she was
agreeable to a meeting at that location, she never actually agreed to a
meeting there on a set date.
In light of the Respondent's refusal to cooperate with the
investigators, they applied for a search warrant for the Steele Street
location (Suite 202). The warrant was executed on May 6, 1999. During
the inspection of Suite 202, the investigators took photos of the
premises. Various controlled substances were found at that location as
well as miscellaneous records.
The investigators generated an inventory of controlled substances
found in Suite 202. These drugs were found on a cart, which had been
secured by the building manager. The cart had no locking mechanism, and
the drugs in the cart were not secured in any fashion when found by the
building manager. The Investigators also determined that these
controlled substances were ordered under the Respondent's DEA
registration number from Quality Care
[[Page 59959]]
Pharmaceuticals, a controlled substance distributor. The investigators
found that these drugs had expired. They were counted, treated as
abandoned, and put aside for destruction. These drug products were
identified as phentermine 30mg. in various quantities and number of
containers.
Copies of ``Dispense-Quick-Log'' sheets (labels) had been provided
with vials of drugs from Quality Care Pharmaceuticals. The labels did
not meet DEA record keeping requirements because they did not list
which drug was dispensed or the quantity dispensed. These log sheets
were found tossed in miscellaneous boxes throughout the office.
The DEA investigators also seized patient files from Suite 202. The
investigators tried but failed to find current dispensing records of
what drugs the Respondent had purchased from Horizon. An example in
this regard was the patient record for patient S.S. The patient file
did not contain dispensing information for controlled substances, i.e.,
quantities, etc. The other patient files seized were fairly
representative of the record keeping in all of the files, in that the
last entries in the files were dates in 1997 and early 1998.
Following the execution of the search warrant, further
accountability audits were conducted. These audits covered the period
of November 25, 1997 and January 5, 1999, and again, the controlled
substances audited were phentermine (30mg. and 15 mg.) and Meridia (5,
10 and 15mg.). [Id.] The revised audits were designed to include
information obtained from the inspection of the Steele Street location,
the Respondent's new registered location, and information obtained from
a second drug supplier, Quality Care Pharmaceuticals. These audits were
also conducted to give the Respondent credit for the miscellaneous
papers, receipts, and dispensation notes, even though these items did
not meet DEA record keeping requirements.
The results of DEA's initial audit (excluding records that were not
maintained pursuant to DEA requirements) revealed that the Respondent
was unable to account for 11,148 dosage units of controlled substances.
Through the use of the records that the Respondent supplied, DEA found
that Respondent was unable to account for 7,154 dosage units of
controlled substances.
DEA's investigation also revealed that Respondent did not maintain
a record of the transfer of controlled substances. In a call to Quality
Care Pharmaceuticals, DEA investigators learned that quantities of
Redux and Pondimin (both Schedule IV controlled substances) were
transferred from Respondent's Steele Street office to Quality Care. The
Respondent had previously told investigators that she had not destroyed
or returned any drugs.
B. Conclusions of Law
Pursuant to 21 U.S.C. 823(f) and section 824(a)(4) the Deputy
Administrator of the Drug Enforcement Administration may revoke a DEA
Certificate of Registration if she determines that the continued
registration of the registrant would be inconsistent with the public
interest. Pursuant to 21 U.S.C. 823(f), in determining the public
interest, the following factors will 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 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.
These factors are to be considered in the disjunctive; the Deputy
Administrator may relay on any one or combination of factors and may
give each factor the weight she deems appropriate in determining
whether a registration should be revoked or application for
registration be denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16,422
(1989).
In this case, factors two, four and five are relevant in
determining whether Respondent's DEA Certificate of Registration should
be revoked and her pending application for renewal of that registration
should be denied.
1. Factors Two and Four--Experience in Dispensing Controlled Substances
and Compliance With Applicable State and Federal Law \1\
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\1\ Most of the conduct at issue regarding the Respondent's
experience dispensing controlled substances while not complying with
DEA recordkeeping requirements also involve and further demonstrate
Respondent's history of failing to comply with state and federal
laws concerning controlled substances. Therefore, the Government's
analysis under 21 U.S.C. Sec. 823(f)(2) and (4) has been combined.
See Service Pharmacy, Inc., 61 FR 10,791, 10,795 (1996).
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Factors two and four are also relevant with respect to
Respondent's: (1) Failure to maintain a record of her return of
Schedule IV controlled substances to a supplier, as required by 21 CFR
1307.12; (2) failure to obtain a DEA registration for the South Marion
location prior to dispensing controlled substances from that location,
as required by 21 CFR 1301.11 and 1301.12; (3) failure to store
Schedule IV controlled substances in a securely locked, substantially
constructed cabinet at her former registered location at 128 Steele
Street location, Suite 202, as well as the modified registered location
at South Marion Way, as required by 21 CFR 1301.75(a); (4) failure to
maintain complete and accurate records with respect to the receipt and
dispensing of controlled substances, as required by 21 U.S.C.
827(a)(3), and 21 CFR 1304.03, 1304.04 and 1304.21(a) (these statutory
provisions are further relevant to Respondent's failure to account for
between 7,000 to over 11,000 dosage units of Schedule IV controlled
substances); (5) failure to take an initial inventory of controlled
substances on hand on the date she engaged in the dispensing of
controlled substances as required by 21 U.S.C. 827(a)(1) and 21 CFR
1304.11; and (6) failure to maintain inventories and records of
controlled substances, either separately from all other records, and in
a readily retrievable fashion, as required by 21 CFR 1304.04(f)(2) and
(g).
Thus, the Respondent committed numerous violations of the
Controlled Substances Act by failing to adhere to proper record-
keeping. The importance of the DEA system of record-keeping is well
settled. The purpose of the enactment of the 1970 Uniformed Controlled
Substances Act (the ``Act'') was to provide a system for the control of
drug traffic and to prevent the abuse of drugs. The statutory scheme
envisioned by the Act is one of control through record-keeping. United
States v. Stidham, 938 F. Supp. 808, 814 (S.D. Ala. 1996). Congress
sought measures to monitor the drug transactions of registrants, who,
with authority to dispense drugs, have the greatest access to
controlled substances, and therefore the greatest opportunity for
diversion. United States v. Moore, 423 U.S. 122, 135, (1975).
In some cases, revocation of a DEA registration is an appropriate
measure for failure to maintain adequate controlled substance records
and inventories. Compliance with Federal laws and regulations relating
to the handling, record keeping, reporting, and security of controlled
substances are essential to assure that adequate control is maintained
to prevent the diversion of controlled substances from legitimate
channels. North American Medical, Inc., 53 FR 39,543 (1988). DEA has
also found grounds for revocation of a DEA
[[Page 59960]]
registration in situations involving poor record keeping practices,
even where no personal use or criminal convictions involving controlled
substances were determined. RX Returns, Inc., 61 FR 37081 (1996).\2\
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\2\ While the Deputy Administrator in RX Returns found
revocation appropriate, the revocation was stayed and a one year
period of probation was imposed. [Id. at 37,090]
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2. Factor Five--Conduct Which May Threaten the Public Health and Safety
The Respondent testified at the hearing concerning the reasons for
her very poor record-keeping. She had no assistance to help with
record-keeping and during the period at issue, she was going through
extremely stressful circumstances. She developed a condition involving
her pituitary gland that lowered her voice, caused her to grow a beard
and lose hair. She thought that she might have to have brain surgery.
At the same time, her son had a seizure and was diagnosed with a
disease related to sickle cell anemia. Several friends died, included
one suicide. She was very depressed during this period, and as a
result, her recordkeeping suffered.
These circumstances may very well partly excuse some of the
Respondent's record-keeping failures. The Deputy Administrator is
particularly disturbed, however, by the numerous occasions that the
Respondent provided false information to DEA investigators and
repeatedly frustrated their attempts to conduct their investigation. At
the hearing, the Respondent claimed that she had never meant to mislead
the investigators and denied making false statements. The Deputy
Administrator finds, however, that the Respondent has no credibility,
because it is absolutely clear that she lied to the investigators on
numerous occasions.
The Respondent lied about possessing controlled substances at her
house. She lied about having a safe in her house in which to store
controlled substances. She lied about treating patients from her home.
She lied about the true identity of a friend for whom she had written
prescriptions for controlled substances. She misled the investigators
about the existence of patient records. She continually maintained that
she had controlled substance records at her office, when in truth she
did not. She later admitted that she had tried to create the records
from memory. The Respondent's refusal to cooperate with DEA
investigators led DEA to request the issuance of an administrative
inspection warrant of her South Marion Way location and subsequently,
the Steele Street location.
Moreover, the Respondent agreed to assist DEA investigators in
their inspection of the Steele Street location, without telling them
that she had been evicted from that location. The Respondent's failure
to cooperate with the investigators in their efforts to inspect the
former registered location necessitated the execution of a search
warrant. The Respondent also made false statements regarding the
transfer of drugs. Despite her denials the investigators discovered
that the Respondent had transferred Schedule IV controlled substances
to Quality Care Pharmaceuticals.
The circumstances surrounding the Respondent's treatment of
patients from her home is also troubling. As noted above, the
Respondent was unable to account for between 7,000 and 11,000 dosage
units of controlled substances. While the Respondent asserted that the
controlled substances were legitimately dispensed to patients, she had
no records to support her assertion. The Respondent's attempts at
creating controlled substance records could not reconcile the
shortages. Even the Respondent's own patient records did not bear out
her assertions that she continued to dispense drugs to patients
throughout 1998, as many of the records showed entries which ended in
1997 and early 1998.
The Deputy Administrator does not necessarily find that these
controlled substances were diverted. Nevertheless, the lack of proper
documentation to account for the shortage of large quantities of drugs;
the Respondent's admission to the use of phentermine; her demonstrated
lack of candor; empty drug vials around her home of which she was
unable to account for their origins or disposition, all suggest
possible drug use on the Respondent's part, or by someone close to her.
III. Conclusion
The preponderance of evidence demonstrates that the Respondent's
continued registration would be contrary to the public interest. If the
Respondent's only failures involved record-keeping, the Deputy
Administrator might find it appropriate to impose a lesser sanction
than revocation of the Respondent's DEA registration. The Respondent's
false and misleading statements, however, cannot be excused. DEA cannot
maintain the integrity of its regulatory system if its registrants,
when asked to provide information required by law, provide false
information. Accordingly, the Deputy Administrator, pursuant to the
authority vested in her by 21 U.S.C. 823 and 824 and 28 CFR 0.100 and
0.104, hereby orders that the Respondent's DEA Registration be, and it
hereby is, revoked, and that any requests for renewal or modification
be, and hereby are, denied. This order is effective November 5, 2004.
Dated: September 28, 2004.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 04-22422 Filed 10-5-04; 8:45 am]
BILLING CODE 4410-09-M