Final Order No.
DOH-I6-0535-
QA
MAI 1 0 2016
FILED DATE De a art nt
STATE OF FLORIDA
DEPARTMENT OF HEALTH
In Re:
By:
ealth
lam.
ty Agency Clerk
Emergency Restriction of the License of
Tyler J. Gustman, R.Ph.
Registered Pharmacist License Number PS 40327
Case Number 2016-07452
ORDER OF EMERGENCY RESTRICTION OF LICENSE
John H. Armstrong, M.D., F.A.C.S., State Surgeon General and
Secretary of Health, ORDERS the emergency restriction of the license of
Tyler J. Gustman, R.Ph., (Mr. Gustman) to practice pharmacy in the State of
Florida. Mr. Gustman holds registered pharmacist license number PS 40327.
Mr. Gustman's address of record is 7381 114th Avenue North, #405A, Largo,
Florida 33773. The following Findings of Fact and Conclusions of Law
support the emergency restriction of Mr. Gustman's license to practice as a
registered pharmacist in the State of Florida.
FINDINGS OF FACT
1.
The Department of Health (Department) is the state agency
charged with regulating the practice of pharmacy, pursuant to chapters 20,
456, and 465, Florida Statutes (2015). Section 456.073(8), Florida Statutes
(2015), authorizes the State Surgeon General to summarily restrict the
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
license of Mr. Gustman, in the State of Florida in accordance with Section
120.60(6), Florida Statutes (2015).
2.
At all times material to this Order, Mr. Gustman held a license to
practice as a registered pharmacist pursuant to chapter 465, Florida Statutes
(2015).
3.
Pursuant to Rule 64B16-27.104 of the Florida Administrative
Code, Mr. Gustman was the Prescription Department Manager of record
(PDM) for Sterile Compounding Pharmacy, LLC, doing business as SCP, LLC,
(Sterile Compounding Pharmacy) holding Special Sterile Compounding
Pharmacy Permit PH 27507 and Community Pharmacy Permit PH 27311.
4.
The PDM is responsible for maintaining all drug records,
providing for the security of the prescription department, and following such
other rules as relate to the practice of the profession of pharmacy. The PDM
is the licensee responsible for ensuring that pharmacies remain in
compliance with the laws and rules regulating pharmacies and ensuring that
all prescriptions filled or compounded at the pharmacy are safe for
consumption.
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
5.
On or about December 17, 2015, Department of Health Senior
Pharmacists M.C. and J.S. performed a routine pharmacy inspection at Sterile
Compounding Pharmacy (Inspection). Inspectors M.C. and J.S. found several
serious deficiencies regarding Sterile Compounding Pharmacy's compliance
with the laws and regulations governing pharmacies and the practice of
pharmacy.
Facts Relating to Sterile Compounding Pharmacy's Community
Pharmacy Permit PH 27311
6.
Pharmacies must have the adequate equipment necessary to
operate as a pharmacy. This requirement includes functioning, calibrated
scales.
7.
The Inspection revealed the pharmacy's scale was calibrated on
June 2013 with a calibration expiration of June 2014.
8.
Pharmacy shelves must be inspected every four months for
expired medications, and expired medications should not be in active stock.
9.
The Inspection revealed pharmaceutical ingredients in active
stock with a retest date of June 2015. Mr. Gustman did not keep evidence
of retesting.
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
10.
Sterile Compounding Pharmacy dispenses medications to
patients. Any medications dispensed to a patient must include a patient
profile, created and maintained by the pharmacy.
11.
The Inspection revealed Sterile Compounding Pharmacy's patient
profiles to be inadequate. Mr. Gustman did not ensure that patient records
contained a list of all new and refill prescriptions dispensed by Sterile
Compounding Pharmacy for the patient over the preceding two years.
12.
Furthermore, the records did not contain evidence of a
reasonable effort to obtain the patients' allergies, drug reactions,
idiosyncrasies, and chronic conditions or disease states of the patient.
Additionally, the records did not contain the identity of any other drugs,
including over-the-counter drugs, or devices currently being used by the
patient which may relate to the prospective drug review.
13.
Upon receipt of a new or refill prescription, the pharmacist must
ensure that a verbal and printed offer to counsel is made to the patient or
the patient's agent when applicable. If the delivery of the drugs to the patient
or the patient's agent is not made at the pharmacy the offer must be in
writing and must provide for toll-free telephone access to the pharmacist.
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
14.
A pharmacy is not to dispense a prescription when the
pharmacist knows, or has reason to believe, that a purported prescription is
not based upon a valid practitioner-patient relationship that includes a
documented patient evaluation, including history and a physical examination
adequate to establish the diagnosis for which any drug is prescribed.
15.
Some of the prescriptions Mr. Gustman permitted Sterile
Compounding Pharmacy to fill came from a doctor located in Connecticut
and another in Florida. The patients were located in states such as Hawaii,
Montana, Ohio, Washington, and Colorado. Subsequent Department
interviews with patients confirmed they were prescribed the drugs after
filling out a questionnaire on the internet or in a telephone call. Some of the
prescriptions were for human chorionic gonadotropin.1
Facts Relating to Sterile Compounding Pharmacy's Special Sterile
Compounding Pharmacy Permit PH 27311
16.
The Florida Board of Pharmacy adopted the minimum practice
and quality standards set forth in the United States Pharmacopeia (USP)
Chapters 797, 85, and 71, relating to the standards of practice for
1 In
molecular biology, human chorionic gonadotropin, commonly abbreviated as 'hCG[,]' is a hormone
produced by the embryo following implantation. hCG is a legend drug.
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
compounding sterile products in Board of Pharmacy Rule 64B16-27.797,
Florida Administrative Code.
17.
High-risk level Compounded Sterile Products (CSPs) are either
contaminated or at a high-risk of becoming contaminated before sterilization.
Contaminated CSPs are potentially most hazardous to patients when
administered into body cavities, central nervous and vascular systems, eyes,
and joints.
18.
PDMs of pharmacies that prepare high-risk level CSPs have the
responsibility of ensuring that the procedures, techniques, ingredients,
devices, and equipment used to prepare CSPs conform to the requirements
of USP Chapter 797, in order to minimize the risk of contamination and
potential harm.
19.
The Inspection revealed that Mr. Gustman permits Sterile
Compounding Pharmacy to use non-sterile vials and stoppers as part of its
compounding processes, and achieves terminal sterilization via filtration.
20.
Sterilization of high-risk level CSPs via filtration must be
performed with a sterile .2 or .22 micrometer nominal pore size filter which
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
is certified by the manufacturer to be sterile-grade.2 The identity, purity,
strength, and stability of the CSPs must be verified after filtration, to ensure
the filtration does not fundamentally affect the CSPs.
21.
The Inspection revealed that Mr. Gustman did not keep
documentation regarding the filters' certification as sterile-grade.
22.
The Inspection revealed that Mr. Gustman did not have proof of
the identity, purity, strength, and stability of the CSPs after filtration.
23.
Sterilizing filters must undergo an integrity test with the
parameters of the test set by the manufacturer.
24.
The Inspection revealed a lack of instructions from the
manufacturer regarding an integrity test for the pharmacy's filters. Instead,
Mr. Gustman set the parameters of the integrity test himself, by estimation
of the parameters.
2 USP 797 defines this certification as where the filter retains 107 microorganisms of Brevundimonas
(Pseudomonas) diminuta on each square centimeter of upstream filter surface area under conditions
similar to those in which the CSPs will be sterilized.
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
25.
In order to render glassware or containers used to compound
medications such as vials free from pyrogens3 and microbes,4 dry heat
depyrogenation5 must be used.
26.
A description of the dry heat depyrogenation cycle and
documentation of the duration for specific items must be maintained in the
pharmacy by the PDM. The effectiveness of the depyrogenation cycle must
be verified using endotoxin challenge vials.
27.
The Inspection revealed Mr. Gustman lacked documentation
regarding the pharmacy's depyrogenation cycle.
28.
The Inspection revealed that the depyrogenation cycle has not
been verified using endotoxin challenge vials.
29.
Any autoclave used in sterilization must be temperature mapped
to ensure that all areas of the oven reach the appropriate temperatures and
pressures evenly. A description of the autoclave cycle and instructions for
specific load items must also be maintained by the pharmacy and PDM.
Pyrogens are fever-producing substances.
Microbes are single-cell organisms.
5 Depyrogenation refers to the removal of pyrogens and is essentially incineration. Depyrogenation is a
separate and distinct process from sterilization.
8
3
4
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
30.
The Inspection revealed Mr. Gustman kept no documentation of
temperature mapping or description of the cycle. Instructions for different
load items relating to the autoclave has not been done or kept by the PDM
and pharmacy.
31.
Hazardous drugs are drugs where studies in animals or humans
indicate that exposures to those drugs have a potential for causing cancer,
developmental or reproductive toxicity, or harm to organs.
32.
Hazardous drugs must be compounded in their own negative
pressure buffer room. Hazardous drugs must be stored separately from nonhazardous drugs. Special hazardous waste bins must be available for safe
disposal of any hazardous drug. Additionally, compounding pharmacy
personnel must be given appropriate protective garments.
33.
Sterile Compounding Pharmacy compounds Human Chorionic
Gonadotropin (hCG).6
34.
Mr. Gustman did not ensure that Sterile Compounding Pharmacy
has a hazardous drug buffer room. Mr. Gustman permits compounding of
hCG causes reproductive and developmental toxicity and is therefore a hazardous drug.
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
hCG in a positive pressure room, potentially exposing the pharmacy and its
personnel to harmful vapors from hCG.
35.
Mr. Gustman permits Sterile Compounding Pharmacy to store the
hCG with other non-hazardous drugs.
36.
Mr. Gustman did not ensure that Sterile Compounding Pharmacy
has hazardous waste bins.
37.
Additionally, Mr. Gustman does not provide protective garments
which are rated for hazardous drugs for the pharmacy's personnel. This
places compounding personnel at risk of coming into contact with hazardous
and dangerous CSPs that can harm the compounding personnel.
38.
Compounding facilities must be physically designed and
environmentally controlled to minimize air-borne contamination from
contacting critical sites where compounding occurs and where CSPs are
stored.
39.
The number of potential contaminants in the air is categorized
by the "ISO" level. Clean rooms7 must meet ISO Class 7 criteria. Sterile
' The clean room is a compounding environment that is supplied with HEPA or HEPA-filtered air, the
access to which is limited to personnel trained and authorized to perform sterile compounding and facility
cleaning.
10
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
compounding must occur in a segregated area inside the clean room that
meets ISO Class 5 criteria with unidirectional airflow.8
40.
Air sampling must be conducted in the various rooms to verify
their ISO Class level, by incubating the air on a growth medium to reveal
hidden "colony forming units" of microbes. The results of the sampling must
be transformed into colony forming units per cubic meter of air. The purpose
of this is to provide standardized evaluation for adverse trends.
41.
The Inspection revealed that Mr. Gustman did not ensure that
Sterile Compounding Pharmacy transforms the results of the air sampling to
colony forming units per cubic meter of air.
42.
The Inspection revealed that Mr. Gustman allows Sterile
Compounding Pharmacy to compound hCG in vials which are partially
stoppered. The vials are then removed from the ISO Class 5 environment
and placed in a freezer, the ISO Class of which is unknown and without
unidirectional airflow. After freezing, the hCG is transported across the length
The maximum amount of contaminants permitted in a room decrease with the ISO Level. The maximum
amount of contaminants allowed in an ISO Class 7 Room is more than the maximum for an ISO Class 5
room.
11
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
of the buffer room and placed in a small lyophilizing9 chamber, which sits on
the floor between two shelving units.
43.
Therefore, the sterility of the hCG cannot be assured with this
process.
44.
Placement of devices in a buffer room is dictated by the devices'
effect on the designated environmental quality of atmospheres and surfaces,
and must be verified by monitoring.
45.
The Inspection revealed a freezer located in the buffer room. The
freezer's coils and compressor were exposed, causing condensation, which
is a source of contamination.
46.
Air flows from areas of high pressure to low pressure.
Compounding facilities must be divided into rooms that are maintained at
different air pressures to ensure that the clean room is a higher pressure
than the surrounding rooms.11 This prohibits air containing a large number
of potential contaminants from flowing into the clean room.
Lyophilization, commonly known as freeze-drying, is a dehydration process typically used to preserve a
perishable material or make the material more convenient for transport. Lyophilization works by freezing
the material and then reducing the surrounding pressure to allow the frozen water in the material to
sublimate directly from the solid phase to the gas phase.
10 Referred to as a "Positive Pressure" room
11 The surrounding rooms, or anteroom and buffer rooms, must be maintained at an ISO Class 7 or
better.
12
9
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
47.
The pressure readings between the clean-room and the ante-
room and the ante-room and the general pharmacy must be documented
separately; this documentation must include daily entries of the pressure
reading.
48.
The Inspection found the pressure readings between clean-room
and the ante-room and the ante-room and the general pharmacy
documented as one result. The Inspection revealed Mr. Gustman permits
staff to document only "PASS" or "FAIL[,]" and does not require
documentation of the actual pressure reading.
49.
Media-fill challenge testing must represent the most challenging
compounding process and be completed biannually by compounding
personnel. A media-fill challenge simulates high-risk level compounding to
assess the quality of the aseptic skill of the compounding personnel.
50.
The most challenging compounding process for Sterile
Compounding Pharmacy involves the sterilization, depyrogenation, and
lyophilization of hazardous drug vials with production of batches with more
than 100 units.
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
51.
Media fill challenges completed by Sterile Compounding
Pharmacy compounding personnel do not include the sterilization,
depyrogenation, and lyophilization process, and the test only produces a
batch with one unit. Therefore, Mr. Gustman is not ensuring Sterile
Compounding Pharmacy personnel's skill in compounding CSPs.
52.
Surface sampling must be done in all ISO Class 5, 7, and 8
rooms, with the results documented.
53.
The Inspection revealed that surface sampling is only being done
in the ISO Class 5 environment, and Mr. Gustman is not keeping
documentation. Mr. Gustman is not requiring surface sampling be done in
either the ISO Class 7 or 8 rooms.
54.
The surfaces, shelving, counters, cabinets, and carts/casters
throughout the pharmacy must have smooth, impervious surfaces, free from
cracks, crevices, and shedding materials.
55.
The Inspection revealed the design of Sterile Compounding
Pharmacy's shelving causes the shelving to have cracks and crevices which
makes cleaning and disinfecting extremely difficult, if not impossible, to
perform.
14
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
56.
All cleaning and disinfecting practices and policies for the
compounding of CSPs must be included in written standard operating
procedures and shall be followed by all compounding personnel.
57.
The Inspection revealed Mr. Gustman implemented a written list
of cleaning agents, but gave no direction on when and where to use each
one.
58.
Certain Beyond Use Dates (BUD) must be assigned for CSPs,
depending on the state of the CSP and the environment in which it is kept.
The purpose of a BUD is to ensure the potency and stability of a product.
59.
BUDs may be assigned in a different manner, but such
assignment must be supported by authoritative literature.
60.
The Inspection revealed the authoritative literature upon which
Mr. Gustman based the BUD assignment was not adequate.
61.
The BUD based on stability for hCG referenced a Merck Package
Insert which is not authoritative literature.
62.
Therefore, Mr. Gustman cannot assure the stability of Sterile
Compounding Pharmacy CSPs.
15
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No, PS40327
Dep't Case No. 2016,-07452
63.
Compounding personnel must be able to demonstrate
appropriate hand hygiene, garbing, and gloving competency.
64.
The Inspection revealed Mr. Gustman required no observational
assessments for hand hygiene, garbing, and gloving competency for
Pharmacy Technician S.B.
65.
Additionally, the Inspection revealed that Mr. Gustman's written
gowning policy was physically impossible to perform, in the current layout of
the pharmacy.
66.
Observational assessments of the media-fill challenge and proper
hygienic technique must be performed at least semi-annually.
67.
The Inspection revealed the last observational assessment of
compounding personnel occurred on December 8, 2014.
68.
Sterility testing must be conducted on all CSP batches greater
than 25 units. An alternative method may be used, but documentation
proving that the alternative method is equivalent or superior to the sterility
testing method must be provided.
69.
Mr. Gustman uses an alternative method of sterility testing.
16
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. P540327
Dep't Case No. 2016-07452
70.
The Inspection revealed the validation documentation regarding
Mr. Gustman's alternative method of testing was clearly marked as a draft,
and non-final document.
71.
Two percent of the batch, or 20 containers, whichever is the
lesser, must be subjected to sterility testing when the CSP batch is more
than 500 items.
72.
The Inspection revealed that 637 vials of cyanocobalamin12 were
compounded, but Mr. Gustman only sent 10 vials for sterility testing.
Comprehensive Findings of Fact
73.
High-risk level CSPs pose an inherent risk to public health.
Without the safeguard of terminal sterilization and strict adherence to the
standards set forth in USP 797 pertaining to practices and procedures of
preparing high-risk level CSPs, the public is at risk of the serious dangers,
including death, associated with contaminated preparations.
74.
The public places considerable amount of trust in pharmacists,
especially those who serve as the PDM of pharmacies that prepare CSPs. A
patient is unable to discern whether the medication he or she receives from
Cyanocobalamin is the most common and widely produced form of the chemical compounds that have
vitamin 812 activity. Cyanocobalamin is an over-the-counter vitamer.
17
12
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. P540327
Dept Case No. 2016-07452
a pharmacy is safe or dangerous, especially because the primary danger of
contamination occurs at the microscopic level. It is therefore essential for
pharmacies that prepare CSPs (especially high-risk level CSPs) to ensure that
their practices and procedures are in strict conformity to the standards that
have been set forth to minimize the inherent risk to the public and ensure
the safety of the patients receiving medication.
75.
The possibility of a compounded preparation becoming
contaminated is unpredictable. Therefore, pharmacies must take every
precaution in the preparation, handling, and storage of a CSP to protect
against the possibility of contamination. Once contaminated medication is
dispensed and administered, the danger to the public has the potential to be
widespread, and potentially deadly.
76.
Sterile Compounding Pharmacy, with Mr. Gustman as PDM, is
incapable of safely preparing CSPs.
77.
Sterile Compounding Pharmacy's facility design is inherently
flawed: the required buffer room for compounding hazardous drugs does not
exist. Without drastic changes in the physical design of the facility, extreme
18
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
risk exists that CSPs will be contaminated or that harm will befall
compounding personnel.
78.
Furthermore, Sterile Compounding Pharmacy's personnel are
engaged in compounding CSPs in an unapproved and dangerous fashion.
79.
Mr. Gustman demonstrated that he is incapable of performing
the duties of a registered pharmacist and PDM competently. This is
evidenced by the number of significant and dangerous violations he
committed in all aspects of practicing as the PDM at Sterile Compounding
Pharmacy.
80.
Mr. Gustman demonstrated, through the Inspection, that he is
either unaware of, or disregards, his obligations as a PDM of Sterile
Compounding Pharmacy.
81.
Additionally, Mr. Gustman demonstrated, through the
Inspection, that he is either unaware of, or disregards, the laws and rules of
the Board of Pharmacy and State of Florida regarding the practice of
pharmacy.
82.
Without drastic changes in operating procedures, sanitation,
record keeping and compounding, products produced by Mr. Gustman are
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
at an extreme risk of becoming contaminated or inherently unsafe for
consumption.
83.
Furthermore, Mr. Gustman exhibits significant shortcomings in
the competency necessary to safely operate a prescription department. Mr.
Gustman allows high-risk CSPs to be compounded in less than an ISO Class
5 environment and filters the CSP through a filter, the quality of which is
unknown. Mr. Gustman allows hCG to be compounded without a hazardous
drug buffer room, and in a positive pressure environment. Mr. Gustman
allows compounding personnel to handle, compound and interact with
hazardous drugs without the required protective equipment.
84.
Mr. Gustman also disregards, or has failed to investigate, the fact
that many of the prescriptions Sterile Compounding Pharmacy is filling are
not based upon a valid practitioner-patient relationship. Mr. Gustman does
not keep the required patient profiles needed to avoid adverse drug
interactions. Finally, Mr. Gustman does not provide patients with a written
offer of counseling.
85.
A restriction of Mr. Gustman's license to practice as a registered
pharmacist is necessary because he is presently incapable of, and unwilling
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
to, operate a pharmacy and prepare products and medications in
conformation with the various laws and rules of the Board of Pharmacy.
86.
A lesser restriction of Mr. Gustman's license other than the terms
outlined in this Order will not protect the public, because Mr. Gustman will
still be able to participate in the unsafe and dangerous operation as a PDM.
87.
Therefore, nothing short of the immediate restriction of Mr.
Gustman's license to practice pharmacy as a PDM will ensure the protection
of the public from his continued unrestricted practice of unsafely
compounding, dispensing, and selling products and medications.
CONCLUSIONS OF LAW
Based on the foregoing Findings of Fact, the State Surgeon General
concludes as follows:
1.
The State Surgeon General has jurisdiction over this matter
pursuant to Sections 20.43 and 456.073(8), Florida Statutes (2015), and
chapter 465, Florida Statutes (2015).
2.
Section 465.016(1)(r), Florida Statutes (2015), subjects a
registered pharmacist to discipline, including restriction, for violating any
provision of chapters 465 and 456, or any of the rules of the Board of
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R. Ph.
License No. PS40327
Dep't Case No. 2016-07452
Pharmacy.
3.
Section 465.022(11)(a), Florida Statutes (2015), provides that
"[t]he prescription department manager of a permittee must
obtain and maintain all drug records required by any state or
federal law to be obtained by a pharmacy, including, but not
limited to, records required by or under this chapter, chapter
499, or chapter 893. The prescription department manager must
ensure the permittee's compliance with all rules adopted under
those chapters as they relate to the practice of the profession of
pharmacy and the sale of prescription drugs."
4.
Rule 64B16-28.102(5)(b), Florida Administrative Code, provides
that a pharmacy shall have such other equipment as is necessary to meet
the needs of the professional practice of pharmacy.
5.
Mr. Gustman violated Section 465.016(1)(r), Florida Statutes
(2015), by violating Section 465.022(11)(a), Florida Statutes (2015), by
being the PDM of a pharmacy which violated Rule 64B16-28.102(5)(b),
Florida Administrative Code, by not having a properly calibrated scale for
use.
6.
Rule 64B16-28.110, Florida Administrative Code, requires
examination of the prescription department shelves at least every four
months, so that expired medications can be removed.
7.
Mr. Gustman violated Section 465.016(1)(r), Florida Statutes
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
(2015), by violating Section 465.022(11)(a), Florida Statutes (2015), by
being the PDM of a pharmacy which violated Rule 64B16-28.110, of the
Florida Administrative Code by failing to ensure pharmacy shelf inspection
every four months and disposing of expired medication, by having a
pharmaceutical ingredient in active stock which expired six months earlier.
8.
Rule 64B16-27.800, F.A.C., requires a reasonable effort be made
to obtain patient allergies, drug reactions, idiosyncrasies, and chronic
conditions or disease states of the patient and the identity of any other
drugs, including over-the-counter drugs, or devices currently being used by
the patient which may relate to prospective drug review.
9.
Mr. Gustman violated Section 465.016(1)(r), Florida Statutes
(2015), by violating Section 465.022(11)(a), Florida Statutes (2015), by
being the PDM of a pharmacy which violated Rule 64B16-27.800, F.A.C., by
failing to make a reasonable effort to obtain the aforementioned required
patient information.
10.
Section 465.023(1)(h), Florida Statutes (2015), subjects a
pharmacy permittee to discipline, including restriction, for dispensing any
medicinal drug based upon a communication that purports to be a
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
prescription, when the pharmacist knows, or has reason to believe, that the
purported prescription is not based upon a valid practitioner-patient
relationship that includes a documented patient evaluation, including history
and a physical examination adequate to establish the diagnosis for which
any drug is prescribed and any other requirement established by board rule
under Chapter 458, Chapter 459, Chapter 461, Chapter 463, Chapter 464,
or Chapter 466, Florida Statutes (2015).
11.
Mr. Gustman violated Section 465.016(1)(r), Florida Statutes
(2015), by violating Section 465.022(11)(a), Florida Statutes (2015), by
being the PDM of a pharmacy which violated Section 465.023(1)(h), Florida
Statutes (2015), by permitting the dispensing of medication which he knew,
or should have had reason to believe, was not based upon a valid
practitioner-patient relationship, by dispensing to patients throughout other
states who were prescribed drugs after filling out an internet questionnaire
or placing a telephone call.
12.
Rule 64B16-27.797(1)(a), Florida Administrative Code, provides
that all sterile compounding shall be performed in accordance with the
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
minimum practice and quality standards of USP Chapter 797.
13.
USP Chapter 797 requires that sterilization of high-risk level CSPs
via filtration shall be performed with a sterile .2 or .22 micrometer nominal
pore size filter which is certified by the manufacturer to be sterile-grade. The
identity, purity, strength, and stability of the CSPs must be verified after
filtration, to ensure the filtration does not fundamentally affect the CSPs.
14.
USP Chapter 797 requires sterilizing filters to undergo an
integrity test with the parameters of the test set by the manufacturer.
15.
Chapter 797 requires a description of the dry heat
depyrogenation cycle and documentation of the duration for specific items.
The effectiveness of the cycle must be verified using endotoxin challenge
vials.
16.
USP Chapter 797 requires any autoclave used in sterilization to
be temperature mapped to ensure that all areas of the oven reach the
appropriate temperatures and pressures. A description of the autoclave cycle
and instructions for specific load items shall also be maintained.
17.
USP Chapter 797 classifies hazardous drugs as drugs where
studies in animals or humans indicate that exposures to those drugs have a
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IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
potential for causing cancer, developmental or reproductive toxicity, or harm
to organs.
18.
USP Chapter 797 requires hazardous drugs to be compounded in
their own negative pressure buffer room.
19.
Hazardous drugs must be stored separately from non-hazardous
drugs.
20.
Special hazardous drug waste bins must be available for safe
disposal of any hazardous drug.
21.
Additionally, Compounding pharmacy personnel must be given
protective garments rated for hazardous drugs.
22.
USP Chapter 797 requires air sampling to be conducted in the
various rooms to verify their ISO Class level, by incubating the air on a
growth medium to reveal hidden "colony forming units" of microbes. USP
Chapter 797 requires the results of the sampling to be transformed into
colony forming units per cubic meter of air.
23.
USP Chapter 797 requires that sterile compounding must occur
in a segregated area inside the clean room that meets ISO Class 5 criteria
with unidirectional airflow.
26
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
24.
USP Chapter 797 states that placement of devices in a buffer
room is dictated by the devices' effect on the designated environmental
quality of atmospheres and surfaces, and shall be verified by monitoring.
25.
USP Chapter 797 requires that the pressure readings between
the clean-room and the ante-room and the ante-room and the general
pharmacy must be documented separately; this documentation must include
daily entries of the pressure reading.
26.
USP Chapter 797 mandates media-fill challenge testing
representing the most challenging compounding process to be completed
biannually.
27.
USP 797 requires surface sampling to be done in all ISO Class 5,
7, and 8 rooms, with the results documented.
28.
USP Chapter 797 requires the surfaces, shelving, counters,
cabinets and carts/casters throughout the pharmacy to have smooth,
impervious surfaces, free from cracks, and crevices, and shedding materials.
29.
USP Chapter 797 requires that all cleaning and disinfecting
practices and policies for the compounding of CSPs shall be included in
27
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
written standard operating procedures and shall be followed by all
compounding personnel.
30.
BUDs may be assigned in a different manner than prescribed by
USP Chapter 797, but such assignment must be supported by authoritative
literature.
31.
USP Chapter 797 requires compounding personnel to
demonstrate appropriate hand hygiene, garbing, and gloving competency.
Chapter 797 requires observational assessments of the media-fill
32.
challenge and proper hygienic technique to be performed at least semiannually.
33.
Mr. Gustman violated Section 465.016(1)(r), Florida Statutes
(2015), by violating Section 465.022(11)(a), Florida Statutes (2015), by
being the PDM of a pharmacy which violated Rule 64B16-27.797(1)(a),
Florida Administrative Code, by:
a. Not using a certified filter for sterilizing CSPs;
b. Not having documentation regarding the filters' certification as
sterile-grade.
c. Not verifying the identity, purity, strength, and stability of the
28
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
CSPs after filtration;
d. Not subjecting the sterilizing filters to an appropriate integrity
test;
e. Not having documentation regarding the depyrogenation cycle
and instructions for specific load items;
f. Not verifying the depyrogenation cycle using endotoxin challenge
vials;
g. Not having documentation regarding the temperature mapping,
description of the cycle, and instructions for different load items
relating to the autoclave;
h. Not having a hazardous drug buffer room;
i. Failing to maintain a negative pressure environment when
compounding hazardous drugs;
j. Co-mingling hazardous drugs with non-hazardous drugs;
k. Not having hazardous drug waste bins;
I. Not providing hazardous-drug-rated protective equipment to
pharmacy personnel who compound hazardous drugs;
m. Not transforming air sampling results into colony forming units
29
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
per cubic meter of air;
n. Performing high-risk sterile compounding in an environment
which is less than ISO Class 5;
o. Placing a freezer with exposed coils and compressor in the buffer
room;
p. Failing to adequately document pressure readings throughout
the pharmacy;
q. Failing to conduct appropriate media fill challenges;
r. Failing to conduct timely media fill challenges;
s. Failing to conduct appropriate surface sampling in the ISO Class
7 and 8 environments;
t. Failing to document the surface sampling conducted in the ISO
Class 5 environment;
u. Having shelving with difficult-to-clean cracks and crevices;
v. Failing to have an appropriate standard operating procedure
regarding cleaning and disinfection;
w. Failing to have supporting documentation regarding the
assignment of BUDs; and
30
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dept Case No. 2016-07452
x. Failing to adequately and timely assess personnel regarding hand
hygiene, gloving and gowning.
34.
Rule 64B16-27.797(1)(b), Florida Administrative Code, provides
that all sterile compounding shall be performed in accordance with the
minimum practice and quality standards of USP Chapter 71.
35.
USP Chapter 71 requires, among others, that should an
alternative sterility test be used, that the method be equivalent, or superior
to, the methods described in USP Chapter 797 and that documentation be
kept to demonstrate the method's equivalence or superiority to USP Chapter
797 methods.
36.
Mr. Gustman violated Section 465.016(1)(r), Florida Statutes
(2015), by violating 465.022(11)(a), Florida Statutes, by being the PDM of a
pharmacy which violated Rule 64B16-27.797(1)(b), of the Florida
Administrative Code, by:
a. Failing to use an alternative sterility test which is equivalent, or
superior, to USP Chapter 71;
31
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
b. Failing to have authoritative literature to demonstrate that the
alternative sterility test which is equivalent, or superior, to USP
Chapter 71; and
c. Failing to submit an adequate number of items as a proportion
of the CSP batch for sterility testing.
37.
Section 120.60(6), Florida Statutes (2015), authorizes the State
Surgeon General to summarily restrict a pharmacist's license to practice
pharmacy upon a finding that the pharmacy presents an immediate, serious
danger to the public health, safety, or welfare.
38.
Mr. Gustman's continued unrestricted practice as a registered
pharmacist constitutes an immediate, serious danger to the health, safety,
or welfare of the citizens of the State of Florida, and this summary procedure
is fair under the circumstances to adequately protect the public.
WHEREFORE, in accordance with Section 120.60(6), Florida Statutes
(2015), it is ORDERED THAT:
1.
The license of Tyler]. Gustman, R.Ph., license number PH 40327,
is immediately restricted from practicing pharmacy as a prescription
department manager of any pharmacy in the State of Florida.
32
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
2.
A proceeding seeking formal discipline of the license of Tyler 1
Gustman, R.Ph., to practice as a registered pharmacist will be promptly
instituted and acted upon in compliance with Sections 120.569 and
120.60(6), Florida Statutes (2015).
DONE and ORDERED this
day of
, 2016.
141,44:).
H. Armstrong, M.D., .A.C.S.,
ate Surgeon General &
Secretary of Health
COUNSEL FOR THE DEPARTMENT:
Francis A. Carbone, II, Esquire
Assistant General Counsel
Florida Bar Ng 105786
Department of Health, Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65
Tallahassee, Florida 32399
Telephone: 850.245.4444 ext. 8241
Facsimile: 850.245.4662
Email: Francis.Carbone@flhealth.gov
33
IN RE: The Emergency Restriction of the License of
Tyler Gustman, R.Ph.
License No. PS40327
Dep't Case No. 2016-07452
NOTICE OF RIGHT TO JUDICIAL REVIEW
Pursuant to Sections 120.60(6), and 120.68, Florida Statutes, the
Department's findings of immediate danger, necessity, and procedural
fairness shall be judicially reviewable. Review proceedings are governed by
the Florida Rules of Appellate Procedure. Such proceedings are commenced
by filing a Petition for Review, in accordance with Florida Rule of Appellate
Procedure 9.100, and accompanied by a filing fee prescribed by law with the
District Court of Appeal, and providing a copy of that Petition to the
Department of Health within thirty (30) days of the date this Order is filed.
34
