STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

LIFE WORTH LIVING FOUNDATION, INC.,

Petitioner,

vs.

DEPARTMENT OF HEALTH,

Respondent.

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) Case No. 10-0042

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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

1. 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”).

2. Prescription Drug Inventory and Petition as a “Retail Pharmacy”

   
   

   1. 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.

   2. 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.

   3. 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.

   4. 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.

   5. 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.

   6. 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.

   7. 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.

   8. 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.

3. Life Specialty Pharmacy Medical Equipment

   and Supplies, Inc.: Petitioner’s Unauthorized Source for Prescription Drugs

   
   

   1. 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.

   2. 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.

   3. 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:

      1. Sarapin

         
         

      2. Ketamine Hydrochorlide USP

         
         

      3. Progesterone Micro USP

         
         

      4. Chloral Hydrate (CIV), Crystal USP 100% 125gm

         
         

      5. Testosterone Propionate Micro USP

         
         

      6. Ketamine Hydrochloride USP 100%

         Powder 25mg

         
         

      7. Amphotericin B USP 100% Powder 1gm

         
         

      8. Cyclobenzaprine HCl USP

         
         

4. Recordkeeping and Pedigree Papers

   
   

   1. 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.

   2. Petitioner received from Life Specialty, without a valid pedigree paper, the following:

      1. Sarapin

         
         

      2. Ketamine Hydrochorlide USP

         
         

      3. Progesterone Micro USP

         
         

      4. Testosterone Propionate Micro USP

         
         

      5. Cyclobenzaprine HCl USP

         
         

5. Recordkeeping

   
   

   1. 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.

   2. Petitioner's explanation for these failures was not credible.

      CONCLUSIONS OF LAW

      
      

   3. 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.

   4. This permit application case arises under Part I of the Act and the rules promulgated thereunder, Florida Administrative Code Chapter 64F-12.

      
      

   5. 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.

   6. 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 pharmacy. §§ 499.002(11) and 456.001(4) and (7), Fla. Stat.

6. The Permit and Qualifications

   
   

   1. 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 prescription services to the public.” § 499.003(50), Fla. Stat.

   2. 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).

   3. 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.

      § 499.01(1)(f) and (2)(f), Fla. Stat. The “distribution” of 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 constitutes a “wholesale distribution.” § 499.003(53), Fla.

      Stat.

      
      

   4. 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.

   5. 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 entity); § 499.01(1)(f) and (2)(f), Fla. Stat. (requiring the 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).

   6. 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.

      
      

   7. 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.

      
      

7. Pedigrees and Adulterated Prescription Drugs

   
   

   1. 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).

   2. 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 drug received from an unauthorized source is also “adulterated.”

      § 499.006(10), Fla. Stat.

      
      

8. Recordkeeping

   
   

   1. 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).

   2. 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.

      
      

9. Basis for Denial

   
   

   1. 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.

      
      

   2. 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.

      
      

   3. 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.

      
      

10. Petitioner's Failure to meet the Minimum Permit Requirements for Receiving the Permit

    
    

    1. 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.

       
       

    2. 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.

11. Petitioner’s Deficient Recordkeeping

    
    

    1. 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

       
       

       R. 64F-12.012(1), (2), and (3)(a)2. This requirement applies to 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.

12. Petitioner received and trafficked in Adulterated Prescription Drugs

1. Petitioner received prescription drugs from an unauthorized source, thereby adulterating prescription drugs.

   1. 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.

2. The transfer of these prescription drugs from Life Specialty, an unauthorized source, to Petitioner rendered those drugs “adulterated.”

   
   

   1. Petitioner received prescription drugs without valid pedigree papers, resulting in the adulteration of prescription drugs.

3. 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.

   
   

4. 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).

5. 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.

6. 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.

7. 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.

8. Petitioner, nevertheless, retained these prescription drugs and held and offered them for sale, in violation of Subsections 499.005(28) and (29), Florida Statutes.

9. 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:

   
   

   * * *

   
   

   1. Failure to acquire or deliver a pedigree paper as required under this part.

      
      

   2. 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.

   
   

10. 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.

11. 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

(850) 488-9675

Fax Filing (850) 921-6847 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.

Docket for Case No: 10-000042

Orders for Case No: 10-000042