10-000042 Life Worth Living Foundation, Inc. vs. Department Of Health Status: Closed Recommended Order on Wednesday, September 1, 2010.

Summary: Petitioner failed to prove entitlement to a Retail Pharmacy Drug Wholesaler Distribution Permit. Petitioner's pharmacy had serious violations sufficient to deny the license.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

LIFE WORTH LIVING FOUNDATION, )

INC., )

)

Petitioner, )

)

vs. ) Case No. 10-0042

)

DEPARTMENT OF HEALTH, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held before

Daniel M. Kilbride, Administrative Law Judge of the Division of

Administrative Hearings, on March 18, 2010, by video

teleconference between Orlando, Florida, and Tallahassee,

Florida.

APPEARANCES

For Petitioner: Dean F. Mosley, Esquire

Law Office of Dean F. Mosley

250 North Orange Avenue, Suite 550

Orlando, Florida 32801

For Respondent: Robert F. Jernigan, Esquire

Gary Asbell, Esquire

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1703

STATEMENT OF THE ISSUE

Whether Petitioner should be granted a Retail Pharmacy Drug

Wholesale Distribution Permit, pursuant to Subsection

499.01(2)(f), Florida Statutes (2009). 1

PRELIMINARY STATEMENT

On July 27, 2009, Respondent, Department of Health,

received an application from Petitioner, Life Worth Living

Foundation, Inc., for a Retail Pharmacy Drug Wholesale

Distributor Permit. On November 13, 2009, Respondent issued its

notice of intent to deny the permit. Petitioner challenged the

notice and filed a petition with Respondent on December 2, 2009.

Thereafter, the petition, along with a Motion to Dismiss

Petition, was filed with the Division of Administrative Hearings

on January 6, 2010. Following a hearing on the motion, the

motion to dismiss was granted with leave to amend. Petitioner

amended its petition, and this matter proceeded to hearing.

At the hearing, Respondent called three witnesses: Tram Vu

and David Lavea, both of whom the attorney for Petitioner cross-

examined, and Michael Ayotunde, whom Respondent called as an

adverse witness, after which, Petitioner’s counsel examined him.

Petitioner offered three exhibits, which were admitted into

evidence. Respondent offered Exhibits 1 through 15, which were

also admitted.

The Transcript of the final hearing was filed on April 20,

2010. At the conclusion of the hearing, the undersigned

Administrative Law Judge directed the parties to file their

proposed findings of fact and conclusions of law within ten days

of the filing of the Transcript. Petitioner filed a document

titled “Proposed Ruling and Order” on March 26, 2010.

Respondent filed its Proposed Recommended Order on April 30,

2010. Petitioner then filed a Proposed Recommended Order on

May 10, 2010, to which Respondent filed a motion to strike as

untimely. Thereafter, Petitioner filed a Motion for Enlargement

of Time to file its proposals, to which it attached the two

documents it had previously filed. Finding no prejudice to

Respondent, the motion to strike is denied.

FINDINGS OF FACT

I. Background

1. Petitioner holds Florida Community Pharmacy License

No. PH23699 (the “pharmacy license”), pursuant to Chapter 499,

Florida Statutes. The establishment is located at 1507 Park

Center Drive, Suite 1L, Orlando, Florida 32835

(“establishment”), where Petitioner’s records are stored.

2. On or about July 29, 2009, Petitioner submitted the

first portions an application to Respondent for a Retail

Pharmacy Wholesaler Distributor Permit, pursuant to Subsection

499.01(2)(f), Florida Statutes (“application”).

3. On September 16, 2009, Respondent's drug agents

conducted an onsite inspection of the establishment

(“inspection”) for purposes of assisting in Respondent’s

determination of whether to issue the permit to Petitioner.

4. On or about November 13, 2009, Respondent notified

Petitioner that Respondent intended to deny the application

(“notice”), and Petitioner filed a petition for administrative

review, raising disputes of material fact (“petition”).

II. Prescription Drug Inventory and

Petition as a “Retail Pharmacy”

5. To qualify as a retail pharmacy, Petitioner must have

adequate inventory on hand that would be required by the general

public for a variety of medical conditions.

6. On the date of inspection, there was inadequate

inventory on hand. There were only 18 commercially-available

prescription drugs. Many of the drugs were injectables, which

would only fill the needs of a very specific and limited patient

population.

7. At the time of inspection, Petitioner’s on-hand

inventory of prescription drugs lacked any opiate painkillers

and any drugs indicated for treatment or maintenance of (i) high

blood cholesterol levels, (ii) systemic bacterial infections

(oral antibiotics), (iii) osteoporosis, (iv) cough (syrups),

(v) viral infections, (vi) depression, and (vii) asthma. These

are some of the most commonly-required drugs in the

pharmacological arsenal.

8. Petitioner’s specialization in the area of compounded

prescription drugs is evidenced by Petitioner’s prescription

drug inventory and the nature of the prescriptions Petitioner

filled in the months leading up to inspection. Most of

Petitioner’s on-hand prescription drug inventory was composed of

compounded prescription drugs or ingredients to be used in

compounding prescription drugs. Less than eight percent of

Petitioner's prescription drugs, or about 18 items, consisted of

commercially-available prescription drugs in finished dosage

forms.

9. In the two-month period before September 29, 2009,

Petitioner did not dispense a single dose of commercially-

available, finished-form prescription drugs. All were

specially-prepared or “compounded” products tailored to the

specific needs of individual patients.

10. Petitioner, as a result of an inability to meet the

most basic and commonplace prescription drug needs of the

general public, lacked adequate inventory required by the

general public.

11. Petitioner served a specific and limited patient

population: i.e. , those patients requiring specially-compounded

prescription drugs and those rare patients whose needs could not

be met by commercially-available products.

12. Petitioner's explanation as to the reason for having

only 18 commercially-available prescription drugs available at

the time of inspection is not persuasive; Petitioner, therefore,

was not a retail pharmacy.

III. Life Specialty Pharmacy Medical Equipment

and Supplies, Inc.: Petitioner’s Unauthorized

Source for Prescription Drugs

13. Life Specialty Pharmacy Medical Equipment and

Supplies, Inc. (“Life Specialty”), a separate entity from

Petitioner, is under common control with Petitioner. It has the

same owners, principals, and pharmacy department manager. Life

Specialty holds Community and Special Parenteral/Enteral

Pharmacy License No. PH22346 for an establishment located at

1507 Park Center Drive, Suite 1L, Orlando, Florida 32835. It is

not authorized under Florida law to purchase, receive, own, or

distribute prescription drugs.

14. Petitioner’s prescription drug inventory at the time

of inspection included certain quantities of Sarapin, a

prescription drug. Life Specialty acquired and received Sarapin

from a Kmart pharmacy that is no longer in business. At the

time Life Specialty acquired and received the Sarapin from Kmart

pharmacy, that drug was readily available from Life Specialty’s

prescription drug wholesale suppliers. Life Specialty later

transferred the Sarapin to Petitioner. Life Specialty lacks any

permit or authorization under Part I of the Florida Drug and

Cosmetic Act, Chapter 499, Florida Statutes (Act), to engage in

the wholesale distribution of prescription drugs.

15. Petitioner, nevertheless, received prescription drugs

from Life Specialty, and many of these drugs were in

Petitioner’s prescription drug inventory at the time of

inspection, including prescription drugs compounded by Life

Specialty. Those drugs included:

(i) Sarapin

(ii) Ketamine Hydrochorlide USP

(iii) Progesterone Micro USP

(iv) Chloral Hydrate (CIV), Crystal USP

100% 125gm

(v) Testosterone Propionate Micro USP

(vi) Ketamine Hydrochloride USP 100%

Powder 25mg

(vii) Amphotericin B USP 100% Powder 1gm

(viii) Cyclobenzaprine HCl USP

IV. Recordkeeping and Pedigree Papers

16. During the course of the inspection, Respondent

requested the opportunity to review pedigree papers and other

source-related records for the prescription drugs Petitioner

received from Life Specialty. Specifically, Petitioner could

not produce any pedigree papers for prescription drugs received

from Life Specialty.

17. Petitioner received from Life Specialty, without a

valid pedigree paper, the following:

(i) Sarapin

(ii) Ketamine Hydrochorlide USP

(iii) Progesterone Micro USP

(iv) Testosterone Propionate Micro USP

(v) Cyclobenzaprine HCl USP

V. Recordkeeping

18. Petitioner did not acquire all of its pedigree papers

contemporaneously with the underlying transactions. Petitioner

acquired many of the pedigree papers for the prescription drugs

in its inventory after the Respondent's inspection.

19. Petitioner's explanation for these failures was not

credible.

CONCLUSIONS OF LAW

20. The Division of Administrative Hearings has

jurisdiction over the parties to and the subject matter of this

proceeding pursuant to Section 120.569 and Subsection 120.57(1),

Florida Statutes.

21. This permit application case arises under Part I of

the Act and the rules promulgated thereunder, Florida

Administrative Code Chapter 64F-12.

22. Petitioner, therefore, is subject to Respondent,

pursuant to its grant of authority under the Act, which

regulates, among other things, the preparation, manufacturing,

repackaging, and distribution of prescription drugs in and into

this state. See generally §§ 499.002(2) and 499.003(15), Fla.

Stat.

23. The Legislature intended that the Act should allow

Respondent to regulate the prescription drug industry: the

business of or trade in prescription drugs, as opposed to the

practice of a health care practitioner, such as medicine or

VI. The Permit and Qualifications

24. The permit sought is a Retail Pharmacy Drug Wholesale

Distributor Permit created by Subsection 499.01(1)(f), Florida

Statutes. Only a “retail pharmacy” may receive the permit.

§ 499.01(2)(f), Fla. Stat. This term is defined by statute to

include, among other qualifications, a pharmacy “that purchases

prescription drugs at fair market prices and provides

25. Providing prescription drugs to the public is defined

by rule: “holding the pharmacy out to the public through

prominently displayed pharmacy signs on the exterior of the

building and adequate inventory on-hand to fill a variety of

prescriptions for a variety of medical conditions that would be

required by the public generally.” Fla. Admin. Code R. 64F-

12.001(2)(f).

26. The permit would authorize Respondent to engage in a

certain amount of the “wholesale distribution” activity with

regard to prescription drugs activity that, in the absence of

the permit, would generally be prohibited under Florida law.

prescription drugs means “to sell; offer to sell; give away;

transfer, whether by passage of title, physical movement, or

both, deliver; or offer to deliver. The term does not mean to

administer or dispense.” § 499.003(17), Fla. Stat. The

“wholesale distribution” of prescription drugs refers to the

“distribution of prescription drugs to persons other than a

consumer or patient. . . .” § 499.003(53), Fla. Stat. Unless

specifically exempted from the definition, any business

transaction in prescription drugs not involving a patient, or in

the case of veterinary prescription drugs, an ultimate consumer

Stat.

27. Retail pharmacies in Florida may engage in limited

prescription drug wholesale distribution activity under certain

circumstances, only (i) after first having obtained a Retail

Pharmacy Drug Wholesale Distributor Permit and (ii) with respect

to certain specified customers: another retail pharmacy, a

Modified Class II institutional pharmacy or a health care

practitioner authorized by state law to prescribe prescription

drugs. See §§ 499.01(1)(f) and 499.01(2)(f)1. and (2)(f)4.,

Fla. Stat.

28. Closed pharmacies and other health care entities may

not engage in the wholesale distribution of prescription drugs.

§ 499.005(21)(a), Fla. Stat. (prohibiting the wholesale

distribution of a prescription drug purchased by a health care

permit before operating as a retail pharmacy drug wholesale

distributor); § 499.012(1)(d), Fla. Stat. (prohibiting the

issuance of the permit to the address of a health care entity or

to a pharmacy, other than a community (retail) pharmacy);

§ 499.03(1)(f), Fla. Stat. (prohibiting the unlicensed

possession of prescription drugs).

29. Engaging in the wholesale distribution of prescription

drugs in or into Florida without a permit, if a permit is

required under the Act for such activity, is prohibited.

§ 499.005(22), Fla. Stat. Likewise, purchasing or receiving

prescription drugs from a person not authorized under the Act to

distribute prescription drugs is also prohibited.

§ 499.005(15), Fla. Stat.

30. The permit does not authorize the manufacturing of

prescription drugs. § 499.01(1)(f) and (2)(f), Fla. Stat.; see

also § 499.01(1)(a) and (2)(a), Fla. Stat. (requiring a

Prescription Drug Manufacturer Permit before engaging in the

manufacturing and subsequent distribution of prescription

drugs). Prescription drug manufacturers must also register with

the U.S. Food and Drug Administration, pursuant to

21 U.S.C. Section 360.

VII. Pedigrees and Adulterated

Prescription Drugs

31. A “pedigree paper” is a “document in writing or

electronic form approved by the department which contains

information required by Section 499.01212, Florida Statutes,

regarding the sale and distribution of any given prescription

drug.” § 499.003(36), Fla. Stat. Therefore, a pedigree paper

documents each step in the sometimes separate ownership and

possession histories of a given prescription drug, beginning

with the manufacturer and ending just short of the transfer to

the patient or ultimate consumer. See generally § 499.01212,

Fla. Stat.; Fla. Admin. Code R. 64F-12.012(3).

32. Pursuant to Subsection 499.01212(1), Florida Statutes,

“[e]ach person who is engaged in the wholesale distribution of a

prescription drug must, prior to or simultaneous with each

wholesale distribution, provide a pedigree paper to the person

who receives the drug.” If a pedigree paper for a particular

prescription drug is “nonexistent, fraudulent, or incomplete

under the requirements of [the Act or the rules], or that has

been . . . sold or distributed at any time by a person not

authorized under federal or state law to do so,” then that

prescription drug is “adulterated.” Further, a prescription

§ 499.006(10), Fla. Stat.

VIII. Recordkeeping

33. The failure to keep records as required under the Act

is prohibited by Subsection 499.005(18), Florida Statutes. All

recipients of pedigree papers, including pharmacies, must

receive, keep and maintain copies of pedigree papers for all

prescription drugs received via wholesale distribution.

§ 499.121(6)(e), Fla. Stat.; Fla. Admin. Code R. 64F-

12.012(3)(a)2. and (3)(d).

34. Subsection 499.0121(6)(c), Florida Statutes,

concerning the general requirements for adequate prescription

drug recordkeeping, provides in pertinent part:

Records described in this section that are

kept at the inspection site or that can be

immediately retrieved by computer or other

electronic means must be readily available

for authorized inspection during the

retention period. Records that are kept at

a central location outside of this state and

that are not electronically retrievable must

be made available for inspection within 2

working days after a request by an

authorized official of a federal, state, or

local law enforcement agency. Records that

are maintained at a central location within

this state must be maintained at an

establishment that is permitted pursuant to

this part and must be readily available.

IX. Basis for Denial

35. Subsection 499.067(1)(a), Florida Statutes, provides

in pertinent part:

The department may deny, suspend, or revoke

a permit if it finds that there has been a

substantial failure to comply with this part

or chapter 465, chapter 501, or chapter 893,

the rules adopted under this part or those

chapters, any final order of the department,

or applicable federal laws or regulations or

other state laws or rules governing drugs,

devices, or cosmetics.

36. The Act and the rules do not explicitly identify which

failures to comply with the Act and the rules are “substantial”

within the meaning of Subsection 499.067(1)(a), Florida

Statutes, but the Act does impose significant criminal penalties

for many pertinent failures to comply therewith: (i) a

wholesale distributor failing to deliver a complete and accurate

pedigree paper, if and when required under the Act, concerning a

prescription drug wholesale distribution commits a third-degree

felony, Subsection 499.0051(1)(a), Florida Statutes ; (ii) a

purchaser or recipient failing to acquire a complete and

accurate pedigree paper, if and when required under the Act, for

a prescription drug in a wholesale distribution commits a third-

degree felony, Subsection 499.0051(1)(b), Florida Statutes;

(iii) a purchaser or recipient failing to authenticate the

matters contained in a pedigree paper, if and when required

under the Act, concerning a prescription drug wholesale

distribution, before further distribution of those drugs commits

a third-degree felony, Subsection 499.0051(2)(a), Florida

Statutes; (iv) a purchaser or recipient who knowingly takes

title or possession of prescription drugs from a person not

authorized to engage in wholesale distribution under the Act

commits a second-degree felony, Subsection 499.0051(4), Florida

Statutes; (v) a person knowingly in possession of contraband

prescription drugs who sells, delivers, or intends to sell or

deliver those drugs commits a second-degree felony, Subsection

499.0051(6), Florida Statutes. Possession, sale, or

distribution of adulterated or misbranded prescription drugs has

criminal consequences (second-degree misdemeanor). See

§ 499.0051(12), Fla. Stat.

37. Pursuant to Subsection 499.067(1)(b), Florida

Statutes, Respondent may also:

. . . [D]eny an application for a permit or

certification, or suspend or revoke a permit

or certification, if the department finds

that:

1. The applicant is not of good moral

character or that it would be a danger or

not in the best interest of the public

health, safety, and welfare if the applicant

were issued a permit or certification.

2. The applicant has not met the

requirements for the permit or

certification.

3. The applicant is not eligible for a

permit or certification for any of the

reasons enumerated in s. 499.012.

4. The applicant, permittee, or person

certified under s. 499.012(16) demonstrates

any of the conditions enumerated in s.

499.012.

5. The applicant, permittee, or person

certified under s. 499.012(16) has committed

any violation of ss. 499.005-499.0054.

X. Petitioner's Failure to meet the Minimum Permit

Requirements for Receiving the Permit

38. The minimum requirements for receiving the permit

include the applicant qualifying as a “retail pharmacy.” See

§ 499.01(2)(f), Fla. Stat. Petitioner, due to its scarce on-

hand prescription drug inventory, lacked the capacity to fill

some of the most common prescriptions for some of the most

common medical conditions afflicting the public generally,

including, without limitation, cholesterol-reducing medication,

oral antibiotics or drugs for the treatment or maintenance of

diabetes. Petitioner also served a limited patient population,

as evidenced by its narrowly-focused history of dispensing only

to patients requiring specially-compounded drugs and by its

limited on-hand inventory of prescription drugs suitable for

serving only this population.

39. Accordingly, Petitioner failed to meet the

definitional qualifications as a “retail pharmacy”: Petitioner

did not provide prescription services to the general public, in

that Petitioner lacked any record of having met the prescription

drug needs of the public generally, or any capacity to do so.

Therefore Petitioner was not a “retail pharmacy” as defined in

Subsection 499.003(50), Florida Statutes. Petitioner did not

meet the minimum requirements for receiving the permit set forth

in Subsection 499.01(2)(f), Florida Statutes.

XI. Petitioner’s Deficient Recordkeeping

40. Subsection 499.005(18), Florida Statutes, prohibits

the failure to maintain records as required under the Act and

the rules. Prescription drug records, including pedigree

papers, kept at the inspection site or that can be immediately

retrieved by computer or other electronic means must be readily

available for authorized inspection during the retention period.

§ 499.0121(6)(c), Fla. Stat.; see also Fla. Admin. Code

all such records, in pharmacies, wholesale distributors and

otherwise. “Readily Available” means that individual records

can be produced within minutes of Respondent's inspectors’

request, unless stored outside the state. Fla. Admin. Code

R. 64F-12.001(2)(t). All of Petitioner’s records are stored at

the establishment located in Florida. In response to the

Respondent’s request for pedigree papers for drugs Petitioner

received from Life Specialty, Petitioner required, in at least

five instances, approximately two weeks to obtain the pedigree

papers from Life Specialty's upstream sources. Accordingly,

Petitioner violated Subsection 499.005(18), Florida Statutes,

and denial of the permit is therefore appropriate, pursuant to

Subsection 499.067(1)(b)5., Florida Statutes.

XII. Petitioner received and trafficked

in Adulterated Prescription Drugs

41. Petitioner received prescription drugs from an

unauthorized source, thereby adulterating prescription drugs.

A. Subsection 499.005(14), Florida Statutes, prohibits the

purchase or receipt of a prescription drug from a person that is

not authorized under the Act to distribute prescription drugs to

that purchaser or recipient. Life Specialty was not authorized

under the Act to distribute prescription drugs to Petitioner.

Petitioner nevertheless purchased or received prescription drugs

from Life Specialty, in violation of Subsection 499.005(14),

Florida Statutes, and those drugs were in Petitioner’s

prescription drug inventory at the time of inspection.

42. The transfer of these prescription drugs from Life

Specialty, an unauthorized source, to Petitioner rendered those

drugs “adulterated.”

B. Petitioner received prescription drugs without valid

pedigree papers, resulting in the adulteration of prescription

drugs.

43. Section 499.01212, Florida Statutes, the section of

the Act principally governing pedigree papers, provides:

(1) APPLICATION.--Each person who is

engaged in the wholesale distribution of a

prescription drug must, prior to or

simultaneous with each wholesale

distribution, provide a pedigree paper to

the person who receives the drug.

(2) FORMAT.--A pedigree paper must contain

the following information:

(a) For the wholesale distribution of a

prescription drug within the normal

distribution chain:

1. The following statement: “This wholesale

distributor purchased the specific unit of

the prescription drug directly from the

manufacturer.”

2. The manufacturer’s national drug code

identifier and the name and address of the

wholesale distributor and the purchaser of

the prescription drug.

3. The name of the prescription drug as it

appears on the label.

4. The quantity, dosage form, and strength

of the prescription drug.

44. Pedigree requirements are not limited to prescription

drug suppliers: Florida law imposes an affirmative obligation

on a prescription drug recipient, a pharmacy or otherwise, to

acquire a valid pedigree paper before or concurrently with the

receipt of prescription drugs. Further, such recipients must

maintain pedigree papers in their records. Fla. Admin. Code

R. 64F-12.012(3)(a)2. and (3)(d).

45. Petitioner failed to acquire timely pedigree papers

and failed to maintain those records as required under the

rules. On at least five occasions, Petitioner acquired pedigree

papers, however incomplete and otherwise invalid, two weeks

after inspection and well after receiving the prescription drugs

in question.

46. Petitioner's explanation for the delay in acquiring

valid pedigree papers is not persuasive. Thus, Petitioner

violated Subsections 499.005(28) and (29), Florida Statutes, by

failing to acquire pedigree papers in a timely fashion, and

Subsection 499.005(18), Florida Statutes, by failing to maintain

prescription drug records as required under the Act and the

rules.

47. Petitioner received or purchased prescription drugs

from, among others, Life Specialty. Many of Petitioner’s

pedigree papers for prescription drugs were incomplete, in that

the pedigree papers failed to set forth the comprehensive

information required for a complete and accurate pedigree paper.

In the case of Sarapin, Petitioner acquired no pedigree paper

whatsoever. Several pedigree papers for prescription drugs in

Petitioner's inventory did not reference Life Specialty at all

and are therefore incomplete. In at least six instances,

Petitioner failed to acquire complete and accurate pedigree

papers.

48. Petitioner, nevertheless, retained these prescription

drugs and held and offered them for sale, in violation of

Subsections 499.005(28) and (29), Florida Statutes.

49. Subsections 499.005(28) and (29), Florida Statutes,

reads as follows:

It is unlawful for a person to perform or

cause the performance of any of the

following acts in this state:

* * *

(28) Failure to acquire or deliver a

pedigree paper as required under this part.

(29) The receipt of a prescription drug

pursuant to a wholesale distribution without

having previously received or simultaneously

receiving a pedigree paper that was attested

to as accurate and complete by the wholesale

distributor as required under this part.

50. The absence of a complete and valid pedigree paper for

these drugs rendered those drugs “adulterated,” Subsection

499.006(10), Florida Statutes, resulting in additional

violations. See § 499.005(1), (2), (3), and (4), Fla. Stat.

51. Petitioner committed multiple pedigree paper and

recordkeeping violations relative to the prescription drugs

received from Life Specialty and maintained adulterated

prescription drugs in its inventory. Each of these constitutes

a “substantial failure to comply” with the Act, providing

Respondent a valid basis for denying the permit.

§ 499.067(1)(a), Fla. Stat. Further, the recordkeeping and

pedigree paper violations, and the resulting adulteration-

related issues, constitute violations of Section 499.005,

Florida Statutes. Denial of the permit is therefore

appropriate, Subsection 499.067(1)(b)5., Florida Statutes.

RECOMMENDATION

Based on the Findings of Facts and the Conclusion of Law

cited above, it is

RECOMMENDED that the Department of Health enter a final

order, denying Petitioner's application for a permit to act as a

retail pharmacy drug wholesale distributor.

DONE AND ENTERED this 1st day of September, 2010, in

Tallahassee, Leon County, Florida.

S

DANIEL M. KILBRIDE

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

[phone]

Fax Filing [phone]

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 1st day of September, 2010.

ENDNOTE

1/ All references to Florida Statutes are to Florida Statutes

(2009), unless otherwise indicated.

COPIES FURNISHED :

Robert F. Jernigan, Esquire

Gary Asbell, Esquire

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399-1703

Dean F. Mosley, Esquire

Law Office of Dean F. Mosley

250 North Orange Avenue, Suite 550

Orlando, Florida 32801

Josefina M. Tamayo, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1701

R.S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A-02

Tallahassee, Florida 32399-1701

Dr. Ana M. Viamonte Ros, Secretary

State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A-00

Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.