STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 92-5276

) SOUTH MIAMI HEIGHTS PHARMACY, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, William J. Kendrick, held a formal hearing in the above-styled case on January 13, 1993, in Miami, Florida.

APPEARANCES

For Petitioner: Wayne H. Mitchell, Esquire

Staff Attorney

Department of Professional Regulation 1940 North Monroe Street

Tallahassee, Florida 32399-0752

For Respondent: George M. Santamarina, Esquire

Toledo Center, Suite 204 7175 Southwest 8th Street Miami, Florida 33144

STATEMENT OF THE ISSUES

At issue in this proceeding is whether respondent committed the offenses charged in the administrative complaint and, if so, what disciplinary action should be taken.

PRELIMINARY STATEMENT

By administrative complaint dated January 8, 1992, petitioner charged that respondent, a registered community pharmacy in the State of Florida, was subject to disciplinary action pursuant to Section 465.023(1)(c), Florida Statutes, for having: (1) held medicinal drugs with an expired expiration date on the licensed premises, in violation of Rule 10D-45.0535(5), Florida Administrative Code, and Section 499.005(1), Florida Statutes, (Count I); (2) held, stored or kept an unapproved new drug on the licensed premises, in violation of Rule 10D- 45.0365(15), Florida Administrative Code, (Count II); and, (3) held a quantity of misbranded medicinal drugs on the licensed premises, in violation of Section 499.005(1), Florida Statutes, (Count III).

Respondent executed an election of rights which disputed the allegations of fact contained in the administrative complaint, and the matter was referred to the Division of Administrative Hearings for the assignment of a Hearing Officer to conduct a formal hearing pursuant to Section 120.57(1), Florida Statutes.

At hearing, petitioner called Agustin Garcia and Cesar Arias as witnesses, and its exhibits A and B were received into evidence. Respondent called Pablo Hernandez and Eva Hernandez as witnesses, but offered no exhibits.

During the course of hearing, respondent objected to testimony offered to support Count III of the administrative complaint based on petitioner's answers to interrogatories which stated that it would not pursue such count.

Respondent's objection was sustained and, subsequent to hearing, petitioner voluntarily dismissed Count III. [Petitioner's proposed recommended order]. Accordingly Count III of the administrative complaint is not at issue.

The transcript of hearing was filed January 29, 1993, and the parties were granted leave until February 8, 1993, to file proposed findings of fact. The parties' proposals have been addressed in the appendix to this recommended order.

FINDINGS OF FACT

1. Petitioner, Department of Professional Regulation (Department), is the state agency charged with regulating the practice of pharmacy and the operation of pharmacies pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 465, Florida Statutes.

   
   

2. At all times material hereto, respondent, South Miami Heights Pharmacy, was a registered community pharmacy in the State of Florida, having been issued license number PH 0000880. Respondent's business is located at 11503 Quail Roost Drive, Miami, Florida 33157-6547.

   
   

3. On or about July 9, 1991, an inspection was conducted of respondent's premises by the Department's investigator, Agustin Garcia, and a Department of Health and Rehabilitative Services (HRS) drug agent supervisor, Cesar Arias. Such inspection revealed approximately fifty nine (59) containers of expired medicinal drugs within the pharmacy dispensing area; however, only approximately seventeen (17) containers clearly bore an expiration date that was over four months old at the time of the inspection. [Petitioner's exhibit B]. Additionally, five (5) containers of Salbutan Inhalor, a foreign-made version of a domestic product that has not been approved for use in the United States, was found immediately adjacent to, but not within, the pharmacy dispensing area.

   
   

4. In addition to the expired medicinal drugs located in the pharmacy dispensing area, a number of expired pharmaceuticals were located outside the pharmacy dispensing area. Such pharmaceuticals, the quantity of which does not appear of record, were, however, properly secured or "quarantined" for ultimate return to the manufacturer in accordance with the provisions of Rule 10D- 45.0535(6), Florida Administrative Code.

   
   

5. Mr. Pablo Hernandez, the owner of petitioner, South Miami Heights Pharmacy, was not present when the aforesaid inspection occurred, nor had he been on the premises for some time prior thereto. Rather, Mr. Hernandez had been absent since April 12, 1991, when he underwent an operation for prostate problems, and did not return until July 30, 1991. In the interim, Mr. Hernandez' wife, Eva, supervised petitioner's business operations, but, since

   she was not a licensed pharmacist, never entered or supervised the pharmacy operation.

   
   

   CONCLUSIONS OF LAW

   
   

6. The Division of Administrative Hearings has jurisdiction over the parties to, and the subject matter of, these proceedings. Sections 120.57(1) and 120.60(7), Florida Statutes.

   
   

7. Where, as here, petitioner seeks to revoke a professional license, it bears the burden of proving the charges set forth in the administrative complaint by clear and convincing evidence. Ferris v. Turlington, 510 So.2d 292 (Fla. 1987). Petitioner has, in part, met its burden of proof.

   
   

8. Here, petitioner charges that respondent is subject to disciplinary action under the provisions of Section 465.023(1)(c), Florida Statutes, for having violated the provisions Section 499.005(5), Florida Statutes, and Rule 10D-45.0535(5), Florida Administrative Code (Count I), and Rule 10D-45.0365(15), Florida Administrative Code (Count II).

9. Pertinent to Count I, Section 499.005, Florida Statutes, provides: The following acts, and the causing thereof,

   within this state are prohibited: (l) The

   manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.

   
   

   And, Rule 10D-45.0535(5), Florida Administrative Code, provides:

   
   

   Owners of drugs shall have all such drugs examined not less often than every 4 months and shall remove all deteriorated drugs, and all drugs which bear upon the label or container an expiration date, which expiration date has been exceeded. Under no circumstances will any deteriorated drug or any drug which has exceeded the expiration date be sold or made available in any way to the public. A drug which has exceeded the expiration date shown on the label is adulterated.

   
   

10. Under the provisions of Rule 10D-45.053(5), Florida Administrative Code, the obligation to inventory drugs within the pharmacy dispensing area, and to remove those drugs with an expired label, is established at "not less than every 4 months." Implicit within such mandate is the understanding that during the period between inventories drugs may exist within the pharmacy dispensing area that have expired since the last inventory; however, the pharmacist is constrained from dispensing them. Accordingly, while approximately 59 containers of drugs with expired labels were found during the subject investigation, it can only be concluded that those with an expiration date of at least four months preceding the investigation were "adulterated" under the provisions of the rule such that disciplinary action would be appropriate. So

    found, petitioner has sustained its burden of proof with regard to approximately

    17 containers of expired drugs, but not as to the remaining containers.

    
    

11. Pertinent to Count II, Rule 10D-45.0365(15), Florida Administrative Code, prohibits the following:

The manufacturing, packaging, repackaging, processing, holding, storing, keeping, selling, offering to sell, or shipping an unapproved new drug.

Respondent's "holding, storing [or] keeping" five containers of Salbutan Inhalor, an unapproved new drug, violated Rule 10D-45.0365(15), Florida Administrative Code.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be rendered finding respondent guilty of

violating Section 499.055(5), Florida Statutes, and Rules 10D-45.0535(5) and 10D-45.0365(15), Florida Administrative Code, which places respondent's license on probation for a term of two (2) years, subject to such terms and conditions as the Board of Pharmacy deems appropriate, and which imposes an administrative fine of $1,000.00.

DONE AND ENTERED in Tallahassee, Leon County, Florida, this 19th day of February 1993.

WILLIAM J. KENDRICK

Hearing Officer

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 19th day of February 1993.

APPENDIX TO RECOMMENDED ORDER

Petitioner's proposed findings of fact are addressed as follows:

1. Addressed in paragraph 2.

2-4. Addressed in paragraph 3, otherwise rejected as contrary to the credible proof.

Respondent submitted a proposed recommended order which did not set forth any proposed findings of fact. To the extent the section denoted "Background" could be so constructed, it is rejected as recitation of testimony and argument, and not findings of fact.

COPIES FURNISHED:

Wayne H. Mitchell, Esquire

Department of Professional Regulation 1940 North Monroe Street

Tallahassee, Florida 32399-0752

George M. Santamarina, Esquire Toledo Center, Suite 204

7175 Southwest 8th Street Miami, Florida 33144

John Taylor, Executive Director Board of Pharmacy

Department of Professional Regulation 1940 North Monroe Street

Tallahassee, Florida 32399-0792

Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street

Tallahassee, Florida 32399-0792

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this recommended order. All agencies allow each party at least ten days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to 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: 92-005276

Orders for Case No: 92-005276