STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 83-3916

)

DORA VILLANUEVA, )

)

Respondent. )

) DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 83-3919

)

CENTURY PHARMACY, )

)

Respondent. )

)

RECOMMENDED ORDER

These matters came on for hearing on June 14, 1984, in Miami, Florida, before the Division of Administrative Hearings and its duly appointed Hearing Officer, R.T. Carpenter. The parties were represented by:

APPEARANCES

For Petitioner: Bruce D. Lamb, Esquire

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

For Respondent: Blas E. Padrino, Esquire

2355 Salzedo Street, Suite 309 Coral Gables, Florida 33134

These matters arose on Petitioner's Administrative Complaints alleging that Respondents sold medicinal drugs without prescriptions on August 5, 17 and 22, 1983; that an unlicensed employee dispensed medicinal drugs on August 5, 1983 and that an audit of records covering the period January 1, 1983 through September 8, 1983 revealed shortages in medicinal drugs.

Petitioner submitted proposed findings of fact and conclusions of law. To the extent these proposed findings have not been adopted or otherwise incorporated herein, they are found to be subordinate, cumulative, immaterial, unnecessary or not supported by the evidence.

FINDINGS OF FACT

1. Respondent Dora Villanueva, is a licensed pharmacist, having been issued license number PS 0014957, and whose last known address is 3017 Southwest 107the Avenue, Miami, Florida 33165. At all times material hereto, Respondent Villanueva was the prescription department manager and part-owner of Century Pharmacy, 3017 Southwest 107th Avenue, Miami, Florida 33165.

   
   

2. Respondent Century is permitted to operate a community pharmacy under the laws of the State of Florida, having been issued permit number PH 0006839 and operating at 3017 Southwest 107th Avenue, Miami, Florida 33165.

   
   

3. On or about August 5, 1983, a Department of Professional Regulation investigator purchased 20 Librax and 20 Donnatal from Century Pharmacy, without first presenting a prescription.

   
   

4. The aforementioned Librax and Donnatal were dispensed by Jose Ceferino Calvera, not a licensed pharmacist in the State of Florida.

   
   

5. Librax and Donnatal are medicinal drugs as defined in Subsection 465.003(7), Florida Statutes (1983)(F.S.), and require a prescription to be dispensed.

   
   

6. Respondent Dora Villanueva was not present in the pharmacy when the Librax and Donnatal were dispensed on August 5, 1983, and the prescription department of the pharmacy had a sign stating that the prescription department was closed.

   
   

7. On or about August 17, 1983, a Department of Professional Regulation investigator purchased ten Dalmane, 20 Librax and 20 Donnatal, from Respondent Villanueva at the Respondent Century Pharmacy, Inc. without first furnishing a prescription.

   
   

8. Dalmane, Librax and Donnatal are medicinal drugs as defined in Section 465.003(7), F.S. and require a prescription to be dispensed.

   
   

9. On or about August 22, 1983, a Department of Professional Regulation investigator purchased ten Tranxene 7.5 mg and ten Dalmane, 30 mg, from Respondent Villanueva at the Respondent Century Pharmacy, Inc., without a prescription.

   
   

10. Tranxene and Dalame are medicinal drugs as defined in Section 465.003(7), F.S., and require a prescription to be dispensed.

    
    

11. On or about September 8, 1983, an audit was conducted of the controlled substances at Respondent Century Pharmacy, Inc., for the time period of January 1, 1983 through September 8, 1983.

    
    

12. Said audit revealed the following shortages in the drugs which were audited:

    
    

    DRUG SHORTAGE

    Dalmane 30 mg 1,590

    Dalmane 15 mg 799

    Ativan 1 mg 151

    Ativan 2 mg 4,163

    Talwin Injectable 22

13. Dalmane, Ativan and Talwin are controlled substances as defined in Chapter 893, F.S. and are medicinal drugs as defined in Subsection 465.003(7), F.S.

    
    

14. Respondent Villanueva denied making the August 17, 1983 sale. However, she did remember Petitioner's investigator from the August 22, 1983, transaction. Since Petititoner's investigator kept a contemporaneous record of her purchases, Respondent's denial is rejected as not credible.

    
    

15. Both Respondent Villanueva and Petitioners investigator are immigrants from Cuba. Respondents claim the investigator was allowed to make the August 22, 1983 purchase without a prescription because she stated she had recently arrived from Cuba and had no doctor or money to pay one. Even if this were an accurate account of the transaction (which Petitioner denies) it would not provide grounds for dispensing controlled drugs without a prescription.

    
    

    CONCLUSIONS OF LAW

    
    

16. Section 465.015, F.S. provides in part:

    
    

    1. It is unlawful for any person to own, operate, maintain, open, establish, conduct, or have charge of, either alone or with another person or persons, a pharmacy:

       * * *

       1. In which a person not licensed as a pharmacist in this state or not regis- tered as an intern in this state or in which an intern who ins not acting under the direct and immediate personal super- vision of a licensed pharmacist fills, compounds, or dispenses any prescription or dispenses medicinal drugs.

       2. To sell or dispense drugs as defined in s. 465.003(7) without first being furnished with a prescription.

       * * * Section 465.003(7), F.S. provides:

       'Medicinal drugs' or drugs' means those substances or preparations commonly known as 'prescription' or 'legend' drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined.

       
       

       Section 465.018, F.S. provides:

       
       

       Any person desiring a permit to operate a community pharmacy shall apply to the department. If the board certifies that the application complies with the laws of the state and the rules of the board

       governing pharmacies, the department shall issue the permit. No permit shall be issued unless a licensed pharmacist is designated as the prescription department manager responsible for maintaining all drug records, providing for the security of the prescription department, and fol- lowing such other rules as relate to the practice of the profession of pharmacy.

       The permittee shall notify the department within 10 days of any change in prescrip- tion department manager.

       
       

17. Respondent Century Pharmacy holds a community pharmacy permit under the above provision and Respondent Villanueva was at all times relevant its prescription department manager and part-owner.

    
    

18. On August 5, 17 and 22, 1983, sales of medicinal drugs were made without the necessary prescriptions in violation of Subsection 465.015(1)(c), F.S., quoted above Further, on August 5, 1983, an unlicensed person was permitted to dispense medicinal drugs in violation of Subsection 465.015(1)(b), F.S., quoted above. Therefore, Respondents are guilty of violating these provisions as charged in the administrative complaints.

    
    

19. Section 893.07, F.S., provides in part:

    
    

    1. Every person who engages in the compounding, mixing,... or in the dispensing, ... of controlled substances shall:

       1. On or after January 1, 1974, main- tain, on a correct basis, a complete and accurate record of each substance... received, sold, delivered, or otherwise disposed of by him, except that this subsection shall not require the main- tenance of a perpetual inventory.

          * * *

          (4) In either case, records shall

          be kept and made available for a period of at least two (2) years for inspection and copying by law enforcement officers whose duty it is to enforce the laws of this State relating to controlled substances.

          
          

20. The shortages indicated by the audit establish that Respondents failed to keep adequate records of the controlled substances they had received, sold, or otherwise disposed of. Respondent Villanueva therefore violated bother Section 893.07(1)(b), F.S., for failing to maintain accurate records, and Section 465.016(1)(e), F.S., (quoted below), by violating a requirement of Chapter 893, F.S. Respondent Villanueva is responsible for the maintenance of these records since she was the prescription department manager as defined in Section 465.018, F.S., which also establishes this responsibility. Respondent Century Pharmacy, Inc., also violated Subsection 893.07(1)(b), F.S., and therefore Subsection 465.023(1)(c), F.S., (quoted below), as well, by violating a requirement of Chapter 893, F.S.

21. Section 465.016, F.S., provides in part:

    
    

    1. The following acts shall be grounds for disciplinary action set forth in this section:

       * * *

       1. Permitting any person not licensed as a pharmacist in this state or not registered as an intern in this state, or permitting a registered intern who is

       not acting under the direct and immediate personal supervision of a licensed phar- macist, to fill, compound, or dispense any prescriptions in a pharmacy owned and operated by such pharmacist or in a phar- macy where such pharmacist is employed or on duty.

       * * *

       (e) Violating any of the requirements of this chapter; or Chapter 893.

       * * *

    2. When the board finds any person quilty of any of the grounds set forth in subsection (1), it may enter an order imposing one or more of the following penalties:

       1. Refusal to certify to the department an application for licensure.

       2. Revocation or suspension of a license.

       3. Imposition of an administrative fine not to exceed $1,000 for each count or separate offense.

       4. Issuance of a reprimand.

       5. Placement of the pharmacist on pro- bation for a period of time and subject to such conditions as the board may specify, including requiring the pharmacist to submit to treatment, to attend continuing education courses, to submit to reexamina- tion, or to work under the supervision of another pharmacist.

          
          

          Section 465.023, F.S., provides in part:

          
          

          1. The department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy per- mittee who has:

             * * *

             (c) Violated any of the requirements of this chapter or of chapter 893;

             
             

22. The above provisions provide for the revocation or suspension of Respondents' license permit for the violations which were proven herein. Since there was no evidence of prior violations and no evidence that Respondents

corruptly profited from their acts and omissions, suspension rather than revocation is appropriate.

RECOMMENDATION

Based on the foregoing, it is RECOMMENDED:

That Petitioner issue a final order suspending the license of Respondent Dora Villanueva and the permit of Century Pharmacy, Inc. for a period of 90 days.

DONE and ENTERED this 31st day of July, 1984 in Tallahassee, Florida.

R. T. CARPENTER, 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 31st day of July, 1984.

COPIES FURNISHED:

Bruce D. Lamb, Esquire Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

Blas E. Padrino, Esquire

2355 Salzedo Street, Suite 309 Coral Gables, Florida 33134

Wanda Willis, Executive Director Board of Pharmacy

130 North Monroe Street Tallahassee, Florida 32301

Fred M. Roche, Secretary Department of Professional

Regulation

130 North Monroe Street Tallahassee, Florida 32301

=================================================================

AGENCY FINAL ORDER

=================================================================

STATE OF FLORIDA

DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF PHARMACY

DEPARTMENT OF PROFESSIONAL REGULATION,

Petitioner,

vs. CASE NO. 83-3916

0038881

DORA VILLANUEVA,

Respondent.

/ DEPARTMENT OF PROFESSIONAL REGULATION,

Petitioner,

vs. CASE NO. 83-3919

0038451

CENTURY PHARMACY,

Respondent.

/

FINAL ORDER

THIS CAUSE came on to be heard by the Florida Board of Pharmacy of the Department of Professional Regulation at a regularly scheduled meeting held on October 19, 1984, in Miami, Florida.

Appearance for Petitioner: Bruce D. Lamb

Staff Attorney

Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

Appearance for Respondent: Blas E. Padrino, Esquire

2355 Salzedo Street, Suite 309 Coral Cables, Florida 33134

After reviewing the complete record the Board determined to modify the recommended penalty of the Hearing Officer to fine Respondent's permit and license $2,000.00 (two thousand dollars) each for a TOTAL of $4,000.00 (four thousand dollars). The first $1,000.00 (one thousand dollars) to be paid within thirty days, the remainder of the fine to be paid $1,000.00 (one thousand dollars) each ninety days thereafter. Respondent's permit and license are

further placed on PROBATION for a period of ONE YEAR with a requirement of the probation being that there be two inspections and one audit of controlled substances at Respondent's pharmacy and at Respondent's expense during the one year period. This Order shall take effect upon filing with the Office of the Clerk of the Department of Professional Regulation.

DONE AND ORDERED this 5th day of November, 1984.

C. ROD PRESNELL, Executive Director Florida Board of Pharmacy

Copies furnished to:

Bruce D. Lamb, Esq. Blas E. Padrino, Esq.

Docket for Case No: 83-003916

Orders for Case No: 83-003916