[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Pages 39331-39336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15706]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Sigrid Sanchez, M.D.; Decision and Order
On February 4, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Sigrid A. Sanchez, M.D. (Respondent), of Sunrise,
Florida. The Show Cause Order proposed the denial of Respondent's
pending application for a DEA Certificate of Registration as a
practitioner, on the ground that her ``registration would be
inconsistent with the public interest.'' GX 7, at 1 (citing 21 U.S.C.
823(f)).
More specifically, the Show Cause Order alleged that on May 19,
2010, Respondent had surrendered her previous DEA registration, and
that on July 29, 2010, she had applied for a new registration. Id. The
Show Cause Order further alleged that on April 30, 2010, the Florida
Department of Health had conducted ``a dispensing practitioner's
[[Page 39332]]
inspection'' at Respondent's former registered location, the Mercy
Wellness and Recovery Center of Fort Lauderdale, Florida, finding
violations of both federal and state law. Id.
The Order alleged that the federal violations included, inter alia,
failing to provide adequate supervision over employees who had access
to controlled-substance storage areas, failing to store controlled
substances in a securely locked cabinet, taking possession of
controlled substances at the clinic upon commencing her employment
while failing to conduct an inventory of the controlled substances,
failing to supervise the dispensing of controlled substances by clinic
employees, authorizing an employee to order schedule II controlled
substances without executing a Power of Attorney, and not having ``an
adequate system for monitoring the receipt, distribution and
disposition of controlled substances.'' Id. at 1-2 (citing 21 CFR
1301.71(a), (b)(11), (b)(14); 1301.75(b); 1304.21(a); 1304.22).
With respect to the state violations, the Show Cause Order alleged
that ``by the transfer of controlled substances,'' Respondent violated
various provisions of Floria law. Id. at 2 (citing Fla. Stat. Ann.
Sec. Sec. 499.0051(1), 499.006(10), and 499.0121(6) (all 2010)). The
Order also alleged that Respondent's ``failure to supervise and review
the dispensing of controlled substances'' violated both Florida
statutes and regulations. Id. (citing Fla. Stat. Ann. Sec.
893.04(1)(b) (2010); Fla. Admin. Code Ann. r. 64B16-27.1001(3) & (4)
(2010); id. r. 64B16-28.140(3) (2010)). Finally, the Show Cause Order
alleged that Respondent also violated state controlled substance
recordkeeping requirements. Id. (citing Fla. Stat. Ann. Sec. Sec.
893.07(1)(a) & (b); 893.07(2)).\1\
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\1\ The Show Cause Order also notified Respondent of her right
to request a hearing on the allegations or to submit a written
statement in lieu of a hearing, the procedures for electing either
option, and the consequences for failing to do so. GX 7, at 3.
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In a letter dated February 16, 2011, Respondent acknowledged
service of the Show Cause Order. In her letter, Respondent further
stated that she was waiving her right to a hearing but submitting a
``written statement regarding [her] position on the matters of fact and
law involved.'' GX 6. See also 21 CFR 1301.43(c). Respondent's
statement was made a part of the record. See GX 6. On September 20,
2011, the record was forwarded to my Office for Final Agency Action.
Having considered the entire record (including Respondent's
statement), I conclude that granting Respondent's application would be
inconsistent with the public interest. Accordingly, Respondent's
application will be denied. I make the following findings.
Findings
Respondent previously held a DEA Certificate of Registration as a
practitioner in schedules II through V. GX 1, at 1. On April 7, 2010,
Respondent changed her registered address to 2001 N E 48th St., Fort
Lauderdale, Florida. Id. This address was the location of the Mercy
Wellness and Recovery Center (hereinafter, Mercy), a pain management
clinic. GX 5, at 59. On or about April 13, 2010, Respondent, who is
board certified in internal medicine, became the clinic's medical
doctor. Id. at 1, 48, 60. According to a sworn statement Respondent
gave to Investigators of the Florida Department of Health (DOH), in
December 2009, she became a Dispensing Practitioner under Florida law,
which authorized her to sell medicinal drugs to patients in her office.
Id. at 60-61.
On April 30, 2010, DOH Investigators went to the Mercy Wellness
clinic to conduct a dispensing practitioner inspection; at the same
time, the Ft. Lauderdale Police Department executed a search warrant at
the clinic. GX 4, at 1. Upon their arrival, the DOH Investigators
observed that the clinic had an armed security guard at both the front
and back entrances and that it had ``a large waiting area filled with
patients.'' GX 5, at 47.
DOH Investigators interviewed several employees as well as
Respondent. According to an affidavit of one of the DOH Investigators,
at the time of the inspection a different doctor, M.W., was listed in
DOH's records as the dispensing practitioner of record and was ``the
intended subject of the inspection.'' GX 5, at 47. However, upon
arriving at the clinic, the Investigators determined that Dr. M.W. had
stopped working there on April 2nd and that Respondent ``was the
dispensing practitioner.'' Id.
According to the Investigator's affidavit, the clinic had ``one
examination room and a room directly adjacent to it which'' was
identified ``as the `Pharmacy.''' Id. The Pharmacy had a ``teller like
window where the prescription drug products [were] dispensed and sold
to the patient'' and the room was ``accessible to all [clinic]
personnel.'' Id. Inside the dispensing room were two safes, one of
which was open and contained drugs; ``[t]here were also unlabeled
bottles of prescription drug products located on a table in the
[dispensing room] which [J.F., a pharmacy technician] had been
preparing to be dispensed to patients.'' Id. at 55. Inside the
dispensing room, the Investigators also observed R.H., who was printing
out prescriptions from the patient charts on a computer. Id. at 48.
During her interview, Respondent ``admitted that she [did] not
verify [or] check the medications that [were] dispensed and sold to any
of the patients'' as this was done by J.F. Id. While Respondent stated
that she had signed at least three order forms (DEA-222) for schedule
II controlled substances, and admitted that she had ``no knowledge of
the amount of prescription drug products [that were] being ordered,''
the forms were completed by the pharmacy technician and then signed by
her. Id. at 52. Respondent stated, however, that she did not know
``when or how often [the] drugs [we]re delivered to the facility,'' and
``who receive[d] them.'' Id. In addition, Respondent did not know how
the invoices were paid or the combination to the safe where the drugs
were stored.\2\ Id.
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\2\ Respondent also stated that she saw 60 to 65 patients a day,
to whom she prescribed oxycodone 30mg and 15mg, muscle relaxants
such as carisoprodol, and Xanax (alprazolam), a combination of drugs
which this Agency has encountered in investigations of physicians
engaged in blatant drug dealing. See, e.g., Paul H. Volkman, 73 FR
30630 (2008); GX 5, at 63-64 (Respondent's sworn statement to
Investigators that she would issue two to four prescriptions to a
patient; ``It is a combination, anti-inflammatory, muscle relaxers,
pain killers. I really believe in them. You know the combination is
the key.''). Yet the Government made no allegation that Respondent
issued prescriptions outside of the usual course of professional
practice and lacking a legitimate medical purpose, 21 CFR
1306.04(a), and produced no evidence that any prescription she
issued was unlawful.
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During her interview, Respondent initially stated that J.F. was the
pharmacist and in charge of the pharmacy. Id. at 61. However,
Respondent then acknowledged that J.F. was only a pharmacy technician.
Id.
The DOH Investigators further noted that Dr. W. had left
prescription drug products at the clinic when he left its employment
and that these were ``allegedly transferred to'' Respondent. Moreover,
Respondent admitted that on April 20, 2010, she signed a DEA 222 form
to take possession of the controlled substances left by Dr. W. Id. at
37. However, according to a DOH Investigator, ``there was no
documentation to support that Dr. [W.] authorized such a transaction
either personally or through power of attorney.'' Id. at 7. In
addition, the DOH Investigator determined that ``DEA 222 forms revealed
that C-II prescriptions drugs were received between 04/02/10
[[Page 39333]]
and 04/13/10 at which time no licensed practitioner was working who
could legally possess the prescription drugs.'' Id. Moreover, because
there were no pedigree documents for any of the drugs, the DOH
Investigators determined that the drugs were adulterated under Florida
law and seized them in place. Id. at 9, 38. According to various
records, DOH seized several thousand dosage units of controlled
substances including oxycodone (in both 30mg and 15mg strength),
hydrocodone, alprazolam, diazepam, as well as carisoprodol, a drug
which was then controlled under Florida law but not Federal law. Id. at
69-72.
Respondent further admitted to a DOH Investigator that she ``never
completed an inventory of the medication present and did not know of
any inventory ever [having been] taken by others.'' Id. at 38.
Respondent also told a DOH Investigator that she did not ``know until
today that [J.F.] was not a pharmacist--[she] thought he was.'' Id.
However, when the Investigator then told Respondent that ``an 8
[frac12] x 11 printout stating that [J.F.] is a Registered Pharmacy
Technician [was] on the wall immediately inside her dispensing room,''
Respondent replied that she had ``never been in that room.'' Id.
During the inspection, Respondent agreed to voluntarily surrender
her DEA registration. Respondent completed a DEA Form 104 evidencing
her agreement. GX 5, at 67. On July 29, 2010, Respondent applied for a
new registration. GX 1.
As noted above, following service of the Show Cause Order,
Respondent submitted an unsworn written statement of position. GX 6.
Therein, Respondent stated that she had been placed at Mercy by All
Care Staffing, a temporary staffing agency and had started work there
on April 13, 2010. GX 6, at 1. Respondent further stated that she had
previously obtained work through All Care and that at the time of her
placement at Mercy, she had interviewed with two internal medicine
groups and while she was doing due diligence on them, contacted All
Care. Id. According to Respondent, ``All Care assured [her] that
[Mercy] was stable and ran an above-board, legitimate, compliant
practice.'' Id. Respondent also stated that because her time at Mercy
``was the first time in [her] professional career that [she] had been a
dispensing practitioner, [she] was completely unaware that [she] had
run afoul of the laws governing dispensing practitioners.'' Id.
Respondent then addressed the various violations found by the DOH
Investigators. First, she asserted that ``[t]o the best of [her]
knowledge, the prescription drugs at [Mercy] were at all times stored
and otherwise locked in a safe . . . and that access was restricted, in
compliance with 21 CFR 1301.75.'' Id. at 2. She asserted that when she
asked whether she should have the safe's combination, the owners told
her that this ``was not a legal requirement'' and that she ``could
inspect the safe at any time.'' Id. She also maintained that she
``believed that [Mercy] employed a pharmacist who was responsible for
and addressed all pharmacy and prescription issues'' and that ``[i]t
seemed reasonable . . . to rely upon the owners of [Mercy] to employ
properly trained and credentialed personnel in the pharmacy.'' Id.
Respondent further stated that ``upon the initial date'' of her
employment at Mercy, she ``did order medications pursuant to a form DEA
222'' and did so because she was told that she ``could not use the
medications that had been ordered by'' Dr. W., the previous doctor. Id.
Respondent maintained that she ``was provided with the DEA 222 form by
[clinic] personnel, but was unfortunately unaware of my obligations
regarding the DEA 222 form at the time.'' Id. She then explained that
she ``was informed that Dr. [W.] was responsible for addressing the
medications that he left behind as well as the DEA 222 forms associated
with him,'' and therefore, she ``did not address them or to [her]
knowledge dispense any medications that had previously been ordered by
Dr. [W.]'' Id. However, Respondent then stated that Mercy ``refused to
make Dr. [W.] available to [her], so in hindsight, proper transfer may
not have been possible.'' Id.
Respondent stated that because she ``worked three days a week for a
three week period of time, [she] did not do an inspection or complete
an inventory.'' Id. She then stated that ``no prior inventories or logs
were made available to'' her. Id.
Respondent ``acknowledge[d] that [she] did not personally check and
certify filled prescription[s] for accuracy prior to [the] patient
receiving'' them. Id. Respondent reiterated that she ``believed that
there was [a] pharmacist employed at [Mercy] that ensured compliance
with these issues'' and that because of her belief, she ``was not
always present when medications were dispensed nor did I initial all
prescription labels.'' Id. Regarding the DOH report's statement that
she had denied having been in the ``Pharmacy'' room, Respondent stated
that she ``had been in the dispensing room and had seen the technician
enter information into the . . . computer system, prepare labels, count
pills and place them in prescription bottles for dispensing.'' Id. She
also stated that she is now aware that she had ``an obligation to
verify that the personnel where I was providing services were properly
licensed to perform certain duties.'' Id.
Respondent further stated that following the inspection, she
terminated her employment at Mercy. However, she again reiterated that
she ``was improperly led to believe that [Mercy] was properly running
its practice, with the appropriate personnel, licenses, and permits,''
and that the dispensing of drugs was being ``done properly and in full
compliance with the law'' but that she had concluded that the ``many
compliance breaches in this matter clearly existed long before [her]
locum tenens assignment to'' Mercy. Id. at 2-3. Respondent further
stated that she has ``been practicing medicine for twenty-five years,
and prior to this, had an unblemished record'' and that ``[t]he
inspection and [her] very brief relationship with [Mercy] has been a
very painful and embarrassing learning process for'' her. Id. at 3.
Respondent also stated that the DOH ``inspection report evidences that
[she] was not evasive and fully answered all the questions asked from
the participants of the inspection.'' Id.
Respondent stated that she ``believed that it was not improper for
[her] to provide services [for Mercy] and that the practice was
operated appropriately'' and that she ``simply was not fully aware of
the obligations discussed in the paragraphs above and believed [she]
was in compliance with the laws.'' Id. Finally, Respondent stated that
``[t]his was the first time in [her] professional career that [she] had
been a dispensing practitioner and [that she is] not interested in
dispensing again after the experience [she] had with'' Mercy. Id.
Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
an application for a practitioner's registration may be denied upon a
determination ``that the issuance of such registration . . . would be
inconsistent with the public interest.'' 21 U.S.C. 823(f). 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.
[[Page 39334]]
(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.
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, 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 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 (D.C. Cir. 2005)).
In the case of a practitioner, the Government has the burden of
proving with substantial evidence that granting an application would be
inconsistent with the public interest. However, where the Government
makes out a prima facie case to deny an application, the burden shifts
to the applicant to show why granting the application would be
consistent with the public interest.\3\
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\3\ Where, as here, ``the Government has proved that a
registrant has committed acts inconsistent with the public interest,
a registrant must ```present sufficient mitigating evidence to
assure the Administrator that [he] can be entrusted with the
responsibility carried by such a registration.''''' Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72
FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932
(1988))), aff'd, Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx.
409 (6th Cir. 2008). ``Moreover, because `past performance is the
best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54
F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly held that where
a registrant has committed acts inconsistent with the public
interest, the registrant must accept responsibility for [his]
actions and demonstrate that [he] will not engage in future
misconduct.'' Medicine Shoppe, 73 FR at 387; accord Jackson, 72 FR
at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George
Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d
at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to
be an ``important factor[]'' in the public interest determination).
In addition, ``DEA properly considers the candor of the
physician and his forthrightness in assisting in the investigation
and admitting fault important factors in determining whether the
physician's registration'' is consistent with the public interest.''
Hoxie, 419 F.3d at 483.
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In this matter, I conclude that the Government's evidence with
respect to factors four and five establishes a prima facie case to deny
Respondent's application.\4\ While I have considered Respondent's
statement of position, I conclude that she has not provided substantial
evidence to show why, at this time, she can be entrusted with a new
registration.
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\4\ The only evidence in the record as to factor one (the
recommendation of the state licensing board) is the approximately
one year old DOH report which shows that Respondent still had a
state license at that time. However, DEA has repeatedly held that
while the possession of state licensure is a fundamental condition
for obtaining and maintaining a practitioner's registration, it is
not dispositive of the public interest inquiry.
As for factor three, the Government raises no contention that
Respondent has been convicted of a federal or state law offense
related to controlled substances. However, because there are
multiple reasons why an applicant or registrant may not have been
convicted or even prosecuted for such an offense, the absence of
such a conviction ``is of considerably less consequence in the
public interest inquiry.'' Dewey C. MacKay, 75 FR 49956, 49973
(2010), pet. for rev. denied 2011 WL 6739420 (10th Cir., Dec. 23,
2011). See also Jayam Krishna-Iyer, 74 FR at 459, 461 (2009); Edmund
Chein, 72 FR 6580, 6593 n.22 (2007), pet. for rev. denied 533 F.3d
828 (DC Cir. 2008). Accordingly, this factor is not dispositive.
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Factors Four and Five--Compliance With Applicable Laws Related to
Controlled Substances and Other Conduct Which May Threaten Public
Health and Safety
Based on the DOH Inspection, the Government alleges that Respondent
committed multiple violations of the CSA, its implementing regulations,
as well as Florida law and regulations. These violations include her
failure to conduct an initial inventory of the controlled substances,
her failure to institute sufficient security/diversion controls, and
her improper execution of a DEA 222 form for the transfer of controlled
substances from the clinic's prior doctor.
The CSA provides in relevant part that ``every registrant . . .
shall . . . as soon . . . as such registrant first engages in the
manufacture, distribution, or dispensing of controlled substances . . .
make a complete and accurate record of all stocks thereof on hand.'' 21
U.S.C. 827(a)(1).\5\ Respondent acknowledged that she failed to comply
with this provision. This was also a violation of Florida law. See Fla.
Stat. Ann. Sec. 893.07(1)(a).
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\5\ While the CSA exempts from the recordkeeping requirements
``the prescribing of controlled substances . . . by practitioners
acting in the lawful course of professional practice unless such
substance is prescribed in the course of maintenance or
detoxification treatment of an individual,'' 21 U.S.C. 827(c)(1)(A),
the evidence shows that Respondent was not only prescribing but also
dispensing controlled substances.
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The Government further argues that Respondent ``could not specify
what quantity of drugs she received from Dr. [W.'s] stock of controlled
substances, thus violating 21 CFR 1304.22.'' Req. for Final Agency
Action, at 5. This, however, is simply the same violation as set forth
in the preceding paragraph.\6\
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\6\ The Government also alleges that Respondent violated Federal
law when she ``signed a DEA Form 222 to take possession of
controlled substances that were abandoned by a former practitioner
at the clinic.'' Show Cause Order at 2. As noted above, in an
affidavit, a DOH Investigator stated that ``there was no
documentation to support that Dr. [W.] authorized such a transaction
either personally or through [a] power of attorney.'' GX 5, at 53.
Given the Government's assertion that the drugs ``were abandoned,''
it is not clear why it was necessary for Dr. W. to authorize the
transaction and why Respondent violated Federal law by signing a
Form 222. The Government makes no further argument that it was
unlawful for Respondent to acquire possession of the controlled
substances that were at the clinic when she commenced her employment
there because the clinic owners were not registered and could not
lawfully distribute the drugs to her.
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The Government also contends that Respondent violated Federal
regulations because she allowed other persons to order controlled
substances on her behalf and did not issue a Power of Attorney. The
Government argues that although Respondent signed several Schedule II
order forms which were ``completed by another individual, she did not
order the medications and she was not notified when controlled
substances were ordered on her behalf.'' Id. at 5; see also Show Cause
Order ] 2d (citing 21 CFR 1305.05(a)). As found above, Respondent
admitted that she did not know the amount of the drugs that were being
ordered under her registration. Yet other evidence establishes that the
DEA 222 forms were completed by the pharmacy technician and then signed
by Respondent.
Under the CSA, a schedule II controlled substance can only be
distributed pursuant to ``a written order of the person to whom such
substance is distributed, made on a form . . . issued by the Attorney
General [DEA-222].'' 21 U.S.C. 828(a). DEA regulations further provide,
in relevant part, that ``[o]nly persons who are registered . . . under
section 303 of the [CSA] to handle Schedule I or II controlled
substances . . . may obtain and used DEA Form 222 . . . for these
substances. Persons not registered to handle Schedule I or II
controlled substances . . . are not entitled to obtain Form 222.'' 21
CFR 1305.04(a). A registrant may, however, ``authorize one or more
individuals . . . to issue orders for Schedule I and II controlled
substances on the registrant's behalf by executing a power of attorney
for each such individual.'' Id. 1305.05(a).
The evidence does not, however, establish that Respondent violated
either the CSA or the Agency's regulations by signing the order forms
because the evidence shows that the forms were completed by the
pharmacy technician and then signed by Respondent. Thus, because
Respondent signed the form, she and not the pharmacy technician issued
the orders,
[[Page 39335]]
and Respondent was not required to execute a power of attorney form.
However, Respondent admitted that she did not know what controlled
substances were being ordered under her registration as well as when
they were being received, and the evidence shows that other scheduled
drugs including hydrocodone, alprazolam, and diazepam (which do not
require the execution of a Form 222 to order) were found at the clinic.
Moreover, other evidence establishes that the clinic did dispense
controlled substances (notwithstanding that Respondent had been at the
clinic for only seventeen days at the time of the inspection) which
were ordered under her registration. Under DEA's regulations applicable
to all registrants, a practitioner is required to institute and
maintain an adequate system ``for monitoring the receipt . . .
distribution, and disposition of controlled substances.'' 21 CFR
1301.71(b)(14). Respondent did not comply with this requirement.
The CSA also requires that ``every registrant . . . manufacturing,
distributing, or dispensing a controlled substance or substances shall
maintain, on a current basis, a complete and accurate record of each
such substance manufactured, received, sold, delivered, or otherwise
disposed of by him.'' Id. Sec. 827(a)(3). Florida law imposes a
similar obligation on persons engaged in the dispensing of controlled
substances. See Fla. Stat. Ann. Sec. 893.07(b). However, the record
does not establish whether the clinic was maintaining the invoices
documenting the receipt of controlled substances or a proper dispensing
log.
The Government also alleges that ``Respondent failed to store [the]
controlled substances in a securely locked cabinet'' and that DOH
Investigators observed that multiple employees had access to the drug
dispensing room. Req. for Final Agency Action, at 4 (citing 21 CFR
1301.71(b)(11) and 1301.75(b)). As for the failure to store the
controlled substances in a securely locked cabinet, the DOH
Investigators stated that drugs were observed both in an open safe and
on a table in the pharmacy area. It is not clear why this would
constitute a violation if the clinic was then open and preparing
prescriptions for dispensing.
As for the observation that multiple employees had access to the
dispensing room, under DEA regulations, ``[a]ll applicants and
registrants shall provide effective controls and procedures to guard
against theft and diversion of controlled substances.'' 21 CFR
1301.71(a). Among the factors which DEA considers is ``[t]he adequacy
of supervision over employees having access to manufacturing and
storage areas.'' Id. at 1301.71(b)(11) (emphasis added). While the
affidavits state that multiple employees had access to the dispensing
room, the record is devoid of evidence establishing whether the
supervision of these employees was adequate.\7\
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\7\ Agency regulations explicitly require that non-practitioner
registrants limit access to storage areas. See 21 CFR 1301.72(d)
(security requirements for non-practitioners; ``The controlled
substances storage areas shall be accessible only to an absolute
minimum number of specifically authorized employees.''). There is,
however, no similar requirement applicable to practitioners.
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The evidence also shows that clinic personnel (including
Respondent) violated various provisions of State law. More
specifically, the evidence showed that the clinic employee who filled
the prescriptions and dispensed them was not licensed as a pharmacist,
but rather only as a pharmacy technician, and that Respondent, who was
registered as a dispensing physician, admitted that she did not verify
the prescriptions that were dispensed to the patients. Under Florida
law in effect at the time of the events at issue here, ``[a] person may
not dispense medicinal drugs unless licensed as a pharmacist or
otherwise authorized under this chapter to do so, except that a
practitioner authorized by law to prescribe drugs may dispense such
drugs to her or his patients in the regular course of her or his
practice in compliance with this section.'' Fla. Stat. Sec.
465.0276(1).\8\ See also Fla. Admin. Code r.64B16-27.1001(3) (``Only a
pharmacist may make the final check of the completed prescription
thereby assuming the complete responsibility for its preparation and
accuracy.'').
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\8\ In addition, under Florida law, ``[a] person other than a
licensed pharmacist or pharmacy intern may not engage in the
practice of the profession of pharmacy, except that a licensed
pharmacist may delegate to pharmacy technicians who are registered
pursuant to this section duties, tasks, and functions that do not
fall within the purview of s. 465.003(13).'' Fla. Stat. Sec.
465.014(1). However, ``[a]ll such delegated acts shall be performed
under the direct supervision of a licensed pharmacist who shall be
responsible for all such acts performed by persons under his or her
supervision.'' Id. A dispensing practitioner ``must . . . [c]omply
with and be subject to all laws and rules applicable to pharmacists
and pharmacies, including, but not limited to'' chapter 465, which
regulates the practice of pharmacy. Id. Sec. 465.0276(2)(b).
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In her written statement, Respondent repeatedly asserted that she
believed that the pharmacy technician was actually a licensed
pharmacist. I do not find this credible because the affidavit of one of
the DOH Investigators establishes that ``on the wall immediately inside
the dispensing room,'' there was an 8\1/2\ by 11 printout stating that
the employee who did the dispensing was a Registered Pharmacy
Technician. See also Fla. Admin. Code r.64B16-27.100(4) (``The current
registration of each registered pharmacy technician shall be displayed,
when applicable, in a conspicuous place in or near the prescription
department, and in such a manner that can be easily read by patrons of
said establishment.''). In his affidavit, the Investigator further
stated that when Respondent said that she did not ``know until today
that [J.F.] was not a pharmacist,'' he confronted her with the
information regarding the printout, to which Respondent replied that
she had ``never been in that room.''
However, in her written statement, Respondent stated that she had
been in the dispensing room and seen the technician prepare the labels,
count the pills and place them in the bottles for dispensing.
Unexplained by Respondent is how she could then have been unaware that
J.F. was not a licensed pharmacist. I thus reject Respondent's
contention that she believed that J.F. was a pharmacist and could
lawfully dispense medications. Moreover, it is a violation of the
Florida Medical Practice Act to ``delegat[e] professional
responsibilities to a person when the licensee delegating such
responsibilities knows or has reason to know that such person is not
qualified by training, experience, or licensure to perform them.'' Fla.
Stat. Ann. Sec. 458.331(w).
The DOH Investigators further found that the clinic did not have
pedigree documents for any of the drugs that were on hand. As noted
above, Respondent admitted that drugs were ordered under her DEA
registration during her time there. Florida law provides in relevant
part that ``[a] drug or device is adulterated . . . [i]f it is a
prescription drug for which the required pedigree paper \9\ is
nonexistent.'' Id. Sec. 499.006(10). Moreover, under state
regulations, ``[a] copy of the pedigree paper must be maintained by
each recipient,'' Fla. Admin Code r. 64F-12.012(3)(d), and for a
``permittee[] located in the state . . . must be readily available and
immediately retrievable, i.e., subject to inspection at the
[[Page 39336]]
permitted establishment during the inspection.'' Id. r.64F-
12.012(6)(b).
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\9\ The pedigree paper ``must include either the proprietary
name or generic name with the name of the manufacturer, repackager,
or distributor as reflected on the label of the product; dosage
form; strength; container size; quantity by lot number; the name and
address of each owner of the prescription drug that is required to
be identified on the pedigree paper; the name and address of each
location from which it was shipped if different from the owner's;
and the transaction dates.'' Fla. Admin Code r. 64F-12.012(3)(a)1.
In addition, ``[t]he pedigree paper must clearly identify the
invoice to which it relate[s].'' Id.
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As the forgoing demonstrates, Respondent failed to comply with a
variety of federal and state controlled substance laws and regulations
as well as state pharmacy laws and rules. As for the latter, while
these laws and rules are applicable to all prescription drugs and not
just controlled substances, these violations are properly considered
under factor five as other conduct which may threaten public health and
safety for two reasons. First, the violations involved the dispensing
of controlled substances. Second, violations of state pharmacy rules
and food and drug safety provisions are relevant (even if the conduct
did not involve controlled substances) in assessing the likelihood of
an applicant's future compliance with the CSA. See Paul Weir
Battershell, 76 FR 44359, 44368 (2011); Wonderyears, Inc., 74 FR 457,
458 n.2 (2009).
On the other hand, the record in this matter establishes that
Respondent's record of non-compliance with the CSA was limited to a
seventeen-day period. While it may be that this conduct would have
continued but for the DOH inspection, Respondent stated in her letter
that following the inspection she terminated her relationship at the
clinic and there is no evidence disputing this.\10\
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\10\ Hanging over this matter is the dark cloud of evidence that
Mercy was a pain clinic and that Respondent was seeing some 60 to 65
patients a day to whom she was prescribing such drugs as oxycodone
30mg and 15mg, muscle relaxants such as carisoprodol, and Xanax
(alprazolam). However, evidence which creates only a suspicion of
wrongdoing does not constitute substantial evidence. See NLRB v.
Columbian Enameling & Stamping Co., Inc., 306 U.S. 292, 299-300
(1939). I therefore do not rely on it.
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It is also acknowledged that Respondent's letter demonstrated some
degree of contrition. However, I do not find credible Respondent's
numerous assertions that she believed that JF was a licensed
pharmacist. In addition, while Respondent emphasizes that her
employment at Mercy ``was the first time in [her] professional career
that [she] had been a dispensing practitioner,'' and that she ``was
completely unaware that [she] had run afoul of the laws governing
dispensing practitioners,'' GX 6, at 1, ignorance of the law is no
excuse. See Patrick W. Stodola, 74 FR 20727, 20735 (2009) (quoting
Hageseth v. Superior Ct., 59 Cal. Rptr.3d 385, 403 (Ct. App. 2007) (a
``licensed health care provider cannot `reasonably claim ignorance' of
state provisions regulating medical practice'')). Indeed, in her
statement, Respondent explained that at the time she took her position,
she ``was doing due diligence'' on two internal medicine groups. One
must wonder why she did not make a similar effort to familiarize
herself with the various requirements applicable to the dispensing of
controlled substances under both the CSA and state laws, as well as the
manner in which Mercy's business was operated.
DEA can, of course, consider deterrence interests in determining
whether to grant or deny an application. See Joseph Gaudio, 74 FR
10083, 10094 (2009) (citing Southwood Pharmaceuticals, Inc., 72 FR
36487, 36504 (2007)). As I have previously explained, ```even when a
proceeding serves a remedial purpose, an administrative agency can
properly consider the need to deter others from engaging in similar
acts.''' Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504
(citing Butz v. Glover Livestock Commission Co., Inc., 411 U.S. 182,
187-88 (1973)). ``The `[c]onsideration of the deterrent effect of a
potential sanction is supported by the CSA's purpose of protecting the
public interest,''' which is manifested in both 21 U.S.C. 823(f) and
824(a)(4). Gaudio, 74 FR at 10094 (quoting 72 FR at 36504).
All registrants are charged with knowledge of the CSA, its
implementing regulations, as well as applicable state laws and rules.
Moreover, those registrants who contemplate employment in circumstances
in which their registrations are used to operate clinics owned by non-
registrants need to recognize that there are serious consequences for
failing to comply with the Act and that they remain strictly liable for
all activities which occur under the authority of their registrations.
See, e.g., Robert Raymond Reppy, 76 FR 61154, 61157-58 (2011); Paul
Weir Battershell, 76 FR 44359, 44368 (2011); Paul Volkman, 73 FR 30630,
30643-44 (2008), pet. for rev. denied 567 F.3d 215 (6th Cir. 2009). It
is no excuse that the practitioner is not the employer of those persons
who perform controlled substance activities and lacks the power to hire
or fire the employee.
Accordingly, having considered the record as a whole, I conclude
that Respondent has not sufficiently demonstrated why she should be
entrusted with a new registration. I therefore hold that granting
Respondent's application would, at this time, be ``inconsistent with
the public interest.'' 21 U.S.C. 823(f). However, given that the
violations proved on this record were limited in both their scope and
duration, a new application should be given favorable consideration if
submitted no earlier than one year from the date of this Order,
provided that Respondent meets the following conditions: (1) That she
does not engage in any further misconduct, and (2) that she takes a
certified Continuing Medical Education course on controlled substance
handling and dispensing.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Sigrid Sanchez, M.D., for
a DEA Certificate of Registration as a practitioner, be, and it hereby
is, denied. This order is effective July 31, 2013
Dated: June 20, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-15706 Filed 6-28-13; 8:45 am]
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