state action against gustman

8/18/2019 State action against Gustman

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Final Order No. DOH-I6-0535-

A

FILED DATE

-

MA I 1 0 2016

De a

art • nt

alth

lam

ty Agency Clerk

T TE OF FLORID

DEP RTMENT OF HE LTH

By:

In Re:

mergency 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 FA CT

1.

he 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


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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

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.


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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.


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License No. PS40327


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.


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License No. PS40327


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.

5


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License No. PS40327


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

6


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IN RE: T he Emergency Restriction of the License of


License No. PS40327


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 10

7 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.

7


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IN RE : The Emergency R estriction of the License of


License No. PS4032 7


25.

In order to render glassware or containers used to compound

medications such as vials free from pyrogens

3

and microbes,

4

dry heat

depyrogenation

5

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.

3

Pyrogens are fever-producing substances.

4

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.

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License No. PS40327


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 non-

hazardous 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

6

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


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

he 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.

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License No. PS40327


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

8

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.

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License No. PS40327


of the buffer room and placed in a small lyophilizing

9

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.

9

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.

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License No. PS40327


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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License No. PS40327


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.

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License No. PS40327


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.

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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.

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License No. P540327


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 cyanocobalamin

2

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

12

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.

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License No. P540327


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

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License No. PS40327


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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License No. PS40327


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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License No. PS40327


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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Tyler Gustman, R. Ph.

License No. PS40327


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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License No. PS40327



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


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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License No. PS40327


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.



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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License No. PS40327


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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License No. PS40327


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.

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License No. PS40327


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

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License No. PS40327


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.

32.

Chapter 797 requires observational assessments of the media-fill

challenge and proper hygienic technique to be performed at least semi-

annually.

33.



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

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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

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License No. PS40327


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

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License No. PS40327


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.


(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;

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License No. PS40327


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.

he 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.

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License No. PS40327


2.

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

ay of

2016.

4 :

H. Armstrong, M.D., .A.C.S.,

ate Surgeon General &

Secretary of Health

COUNSEL FOR THE DEPARTM ENT:

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: [email protected]

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License No. PS40327


NOTICE OF RIGHT TO JUDICI L 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

state action against gustman

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