STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 86-2258

) GAMY DISCOUNT PHARMACY, INC., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to Notice, this cause was heard by Linda M. Rigot, the assigned Hearing Officer of the Division of Administrative Hearings, on November 7, 1986, in Miami, Florida.

Petitioner Department of Professional Regulation, Board of Pharmacy was represented by Bruce D. Lamb, Esquire, Tallahassee, Florida, and Respondent Gamy Discount Pharmacy, Inc. was represented by Enrique Miranda, Esquire, Miami, Florida.

By Administrative Complaint filed on May 21, 1986, Petitioner Department of Professional Regulation, Board of Pharmacy charged Respondent Gamy Discount Pharmacy, Inc., a community pharmacy, with numerous violations of Chapter 465, Florida Statutes, and the rules promulgated thereunder. Respondent timely requested a formal hearing. Accordingly, the issues for determination herein are whether Respondent is guilty of the allegations contained within that Administrative Complaint, and, if so, what disciplinary action should be taken, if any.

Petitioner presented the testimony of Brooks C. Harle, Charles C. Samen, and Constantine Lopirato. Additionally, Petitioner's Exhibits numbered 1-3 were admitted in evidence. Respondent presented no witnesses and no exhibits.

Only the Petitioner submitted posthearing proposed findings of fact in the form of a proposed recommended order. Petitioner's proposed findings of fact numbered 1-5, 8-10, 14, 18-20, 22, 23, 26, 27, and 29 have been adopted either verbatim or in substance in this Recommended Order. However, Petitioner's proposed findings of fact numbered 6, 7, 11, 13, 15-17, 21, 24, 25, and 28 have been rejected as not constituting findings of fact but rather as constituting conclusions of law. Lastly, Petitioner's proposed finding of fact numbered 12 has been rejected since no evidence was introduced in support of that proposed finding.

FINDINGS OF FACT

1. Respondent holds community pharmacy permit number 0007857, which is issued for the location of 7121 West Flagler Street, Miami, Florida 33144.

2. Filimon Galo is the president, and Miriam Galo is the secretary of Gamy Discount Pharmacy, Inc.

   
   

3. On December 9, 1985 and on December 11, 1985, investigators for the Department of Professional Regulation conducted a routine pharmacy inspection of Gamy Discount Pharmacy, Inc. They re-inspected Respondent on January 22, 1986. During each of those inspections, Respondent's prescription department was unclean, unsanitary, and overcrowded.

   
   

4. During those inspections, the investigators located several outdated medications in the prescription department. Those medications seized on January 22, 1986, bore expiration dates more than 4 months prior to the date of that inspection.

   
   

5. Those medications which were seized by Petitioner contained medicinal drugs and are also known as pharmaceuticals.

   
   

6. During the January inspection Respondent had no sign displayed stating the hours when the prescription department is open.

   
   

7. During each of Petitioner's inspections, the pharmacy had no sign posted concerning generically equivalent drugs.

   
   

8. There was no negative drug formulary in the pharmacy at the time of the inspections.

   
   

9. On January 22, 1986, the investigators found one container of a prescription drug--prolizin, a medicinal drug-- which was located outside of the prescription department.

   
   

10. During the January inspection, no pharmacist was employed at Respondent's pharmacy.

    
    

11. During the January inspection, one vial was seized which bore a handwritten label stating "Diabinol." This vial actually contained a generic equivalent of Diabinol. The vial was misbranded in that it was false or misleading by being labeled with the "brand name" instead of the generic name and did not contain the name and place of business of the manufacturer.

    
    

12. During the January inspection, a second vial was located which bore no label. This vial contained a medicinal drug Tranxene and was misbranded in that it did not contain the name and place of business of the manufacturer.

    
    

13. During the inspections, prescriptions for controlled substances were discovered which did not contain the name and address of the person for whom the controlled substance was dispensed, the initials of the pharmacist filing the prescription, or the date on which the prescription was filled.

    
    

14. During the inspections, Respondent pharmacy had no current drug compendium.

    
    

    CONCLUSIONS OF LAW

    
    

15. The Division of Administrative Hearings has jurisdiction over the parties hereto and the subject matter hereof. Section 120.57(1), Florida Statutes.

16. Section 465.025(7), Florida Statutes, requires that every community pharmacy display prominently a sign of certain specifications advising the public of the availability of less expensive generically equivalent drugs. Petitioner has met its burden of proving that Respondent violated this statutory requirement as alleged in the Administrative Complaint herein. Section 465.018, Florida Statutes, requires that a licensed pharmacist be designated before a community pharmacy permit can be issued. The Administrative Complaint filed herein alleges that there was no pharmacist on duty or employed at Respondent pharmacy on a certain date. That allegation simply does not relate to the requirement that a pharmacist be designated in an application for a permit. Accordingly, Petitioner has failed to prove that Respondent violated Section 465.018, Florida Statutes, as alleged in the Administrative Complaint.

    
    

17. Sections 499.007(1 and (2)(a), Florida Statutes, provide that a drug is deemed to be misbranded if its label is false or misleading or unless it bears a label containing the name and place of business of the manufacturer. Petitioner has clearly met its burden of proving that Respondent pharmacy has violated these statutory requirements.

    
    

18. Section 893.04(1), Florida Statutes, regulates the manner in which a pharmacist may dispense controlled substances. That section requires, inter alia, that a prescription contain the full name and address of the person for whom the controlled substance was dispensed, the initials of the pharmacist filling the prescription, and the date on which that prescription was filled. Petitioner has clearly sustained its burden of proving that Respondent pharmacy has violated the requirements of Section 893.04(1)(c)1. and 6., Florida Statutes.

    
    

19. The Board of Pharmacy has promulgated rules implementing the provisions of Chapter 465, Florida Statutes. Respondent herein is charged with violating several provisions of those rules found in Chapter 21S, Florida Administrative Code. Section 21S-1.07 provides for the revocation or suspension of a pharmacy permit when the pharmacy is found guilty of operating a prescription department which is unclean, unsanitary or overcrowded. Petitioner has met its burden of proving herein that Respondent pharmacy has violated that rule.

    
    

20. Section 21S-1.10, Florida Administrative Code, provides for the minimal equipment required to be maintained in the prescription department of a pharmacy. Among other items, a current pharmacy reference compendium is required to be available. Petitioner has clearly proven that Respondent has violated this rule.

    
    

21. Section 21S-1.17, Florida Administrative Code, requires that qualified persons examine the stock of a prescription department at a minimum interval of four months at which time all deteriorated pharmaceuticals or pharmaceuticals which bear a expiration date which has been reached must be removed from the pharmacy's stock. Petitioner has proven Respondent's violation of this requirement as alleged in the Administrative Complaint.

    
    

22. Section 21S-1.24, Florida Administrative Code, regulates the minimum hours during which a prescription department of a pharmacy must be open and further requires that a sign displaying those hours be prominently displayed. Since no sign existed at Respondent's pharmacy stating the hours during which the prescription department is open, Petitioner has proven Respondent's violation of this regulation.

23. Section 465.003(7), Florida Statutes, defines medicinal drugs, and Section 21S-1.44, Florida Administrative Code, requires that all such medicinal drugs be stored within the confines of the prescription department of a community pharmacy. Respondent has clearly violated this regulation.

    
    

24. The Administrative Complaint further charges Respondent with violating Section 21S-5.01, Florida Administrative Code, by failing to maintain on the premises a negative drug formulary. That Section does not specifically require the maintenance of a negative drug formulary. Therefore, Petitioner has failed to meet its burden of proof in regard to that allegation.

    
    

25. Section 465.023(1)(c), Florida Statutes, provides for the revocation or suspension of the permit of any pharmacy which has violated any of the requirements of Chapters 465, 499 or 893, Florida Statutes, or has violated any of the rules of the Board of Pharmacy. Petitioner has met its burden of proving numerous violations of those requirements by the Respondent herein.

    Accordingly, Petitioner has also proven that Respondent has committed numerous violations of Section 465.023, Florida Statutes.

    
    

26. Respondent presented no evidence in defense of any of the allegations contained within the Administrative Complaint filed herein and further presented no evidence in mitigation of the penalty to be imposed herein. Petitioner in its proposed recommended order suggests that in view of the numerous and continuing violations Respondent's community pharmacy permit be revoked. That recommendation is clearly appropriate.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is, therefore,

RECOMMENDED that a Final Order be entered revoking Respondent's community pharmacy permit.

DONE and RECOMMENDED this 19th day of December, 1986, at Tallahassee, Florida.

LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32301

(904 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 19th day of December, 1986.

COPIES FURNISHED:

Rod Presnell, Executive Director Board of Pharmacy

130 North Monroe Street Tallahassee, Florida 32301

Bruce D. Lamb, Esquire Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Enrique Miranda, Esquire 2542 SW 6th Street Miami, Florida 33135

Fred Roche, Secretary Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Wings S. Benton, Esquire Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Docket for Case No: 86-002258

Orders for Case No: 86-002258