STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORIDA BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 76-331

) HISPANIA INTERAMERICA, INC., ) JOSE E. VALDES and MARIA J. ) VALDES, )

)

Respondent. )

)

RECOMMENDED ORDER

A hearing was held in the above-captioned matter, after due notice to the parties, at Miami, Florida on March 31, 1976, before the undersigned Hearing Officer.

APPEARANCES

For Petitioner: Stanley P. Kaplan, Esquire

404 Biscayne Building Miami, Florida

For Respondent: Seymour M. Litman, Esquire

10 Northwest 14 Avenue Miami, Florida 33125

ISSUE PRESENTED

Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.22(1)(c), 465.18(1)(b), 465.18(2)(b) F.S., and Rule 21S-1.14 F.A.C.

At the hearing, Petitioner withdrew Count-I of the Complaint. Respondent's Motion To Dismiss Counts II and III of the Complaint at the conclusion of Petitioner's case in chief was denied.

FINDINGS OF FACT

1. Respondent presently holds and did so hold at the time of the events alleged in the Complaint a permit to operate a pharmacy issued by Petitioner (Stipulation.)

   
   

2. Prior to the events alleged in the Complaint, Petitioner's agent, Vernon K. Bell, an inspector, obtained an authentic prescription from another pharmacy that had not been picked up by a customer, for use in investigations of other pharmacies. The prescription was issued by Dr. George A. Fernandez, Miami, Florida, Number 012194, dated December 11, 1975, to Fela Rivias and was for twenty-one tablets of Erythrocin, 250 miligrams. Erythrocin is an

   antibiotic prescription drug used for various infections (Testimony of Bell, Petitioner's Exhibit 1.)

   
   

3. On December 19, 1975, Bell visited Respondent's pharmacy and observed that the door to the prescription area was unlocked. On December 22, 1975, at approximately 3:30 P.M., Reynaldo Santiago, another agent of the Board of Pharmacy, entered Respondent's pharmacy with the prescription referred to in paragraph 2 above that had been given to him by Bell. Santiago gave it to the cashier to be filled. He observed her go to the prescription department, open a door, and place the prescription on a counter. He then observed Hildelisa Hernandez go to the prescription department and start filling the prescription. Thereafter, Ms. Hernandez, accompanied by Mr. Jose E. Valdez, came out of the prescription area and Hernandez gave a pill bottle to the cashier. The cashier in turn gave it to Santiago for the price of $3.95 or $4.00. The bottle contained 21 tablets and a label affixed thereon contained pertinent information as set forth in the prescription that Santiago had given to that cashier, including the name of the drug, doctor, prescription number and name of patient (Testimony of Santiago, Petitioner's Exhibit 2.)

   
   

4. Santiago took the bottle of pills outside and then he and Bell re- entered the Pharmacy. Bell identified himself to Mr. Valdez and asked him who was his registered pharmacist and if he had a pharmacist on duty. Mr. Valdez stated that Hal Glass was his pharmacist, but that he had left the store at 2:00

   P.M. Bell then asked Valdez if he had filled the prescription which Santiago had taken into the store and, after some hesitation, Bell asked Hernandez if she had filled it. She replied in the affirmative. She stated that she was not a licensed pharmacist in Florida, but had been a pharmacist in Cuba. Bell then wrote a violation and left the store. Neither he nor Santiago recalled seeing a sign indicating that the prescription department was closed on December 22 (Testimony of Bell, Santiago.)

   
   

5. Jose E. Valdez testified that although he formerly had two pharmacists at his previous pharmacy, in August or September of 1975 he was forced to cut back to one part-time pharmacist because of the bad economic situation. He conceded that Ms. Hernandez was not a registered Florida pharmacist. He also stated that he was not aware of the rules requiring that the prescription department be locked when no pharmacist was present until this incident occurred and that, in fact, the door to the prescription area had not been locked although a sign indicating that the prescription department was closed had always been used. He further testified that on February 1, 1976, he hired a full-time pharmacist who is present at all times when the pharmacy is open and that the prescription department is now always locked when she is not present.

   
   

   CONCLUSIONS OF LAW

   
   

6. Petitioner seeks to suspend or revoke the Respondent's permit to operate a pharmacy under the authority of Section 465.22(1)(c), Florida Statutes, for alleged violations of Sections 465.18 (1)(b) and 465.18(2)(b), and violation of Rule 21S-1.14, Florida Administrative Code. These statutory and regulatory provisions state in pertinent part as follow:

   
   

   465.18 Violation and penalties.-

   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:

      * * *

      (b) In which a person not licensed as a pharma- cist in this state, or not registered as an intern in this state, or an intern who is not acting under the direct and immediate personal super- vision of a licensed pharmacist, fills, com- pounds or dispenses any prescription, or dispenses medicinal drugs.

      * * *

   2. It is unlawful for any person:

   * * *

   1. To fill, compound or dispense prescriptions or to dispense medicinal drugs when such person is not licensed as a pharmacist in this state or is not registered as an intern in this state, or is an intern not acting under the direct and immediate personal supervision of a licensed pharmacist.

      
      

      465.22 Authority to revoke or suspend pharmacy permits.

      (1) The board of pharmacy may revoke or suspend the permit of any pharmacy after giving reasonable notice and an opportunity to be heard to any permittee who shall have:

      * * *

   2. Violated any of the requirements of this chapter or any of the rules and regulations of the board of pharmacy

   
   

   21S-1.14 Prescription Department; Padlock; Sign: Prescription Department Closed-.

   If a community pharmacy is open for business and a Florida registered pharmacist is not present and on duty, the prescription department shall be considered closed; and a sign shall be dis- played in a prominent place in the prescription department in such manner that it can be easily read by patrons of said establishment, and each letter on said sign shall be not less than (4) inches in width and height, in bold print, and such a sign shall read: "Prescription Depart- ment Closed"; provided that at all times when the prescription department is closed, either because of the absence of a Florida registered pharmacist or for any other reason, the said prescription department shall be separated from the remainder of the community pharmacy by part- ition or other means of enclosure, and said en- closure shall be locked or padlocked so as to

   prevent the entry into said department by persons not licensed to practice pharmacy in Florida and

   
   

   at such times no person other than a person lic- ensed to practice pharmacy in Florida shall enter or be permitted to enter the prescription depart- ment of any community pharmacy provided, further, that at all such times only a Florida registered

   pharmacist shall have the means to gain access to the said prescription department....

   
   

7. As to Count II - Petitioner in this Count alleges that Respondent permitted the unlawful practice of pharmacy at its pharmacy in that Hildelisa Hernandez who was not licensed and registered as a pharmacist or pharmacy intern in Florida filled and dispensed a prescription legend drug, 21 Erythrocin 250 mg. tablets, to R. Santiago on December 22, 1975. Although Petitioner did not submit evidence to show that Ms. Hernandez was not licensed and registered as a pharmacist or pharmacy intern in Florida, she admitted to Bell at the time of the incident that she was not so licensed and Jose E. Valdez testified to the same effect. Additionally, Hernandez admitted in a voluntary statement to Bell that she did fill and dispense the prescription drug in question to Santiago on the date in question. Accordingly, it is concluded that Respondent violated Section 465.18(1)(b), as alleged, which authorized Petitioner wider Section 465.22(1)(c), to take adverse action with respect to its permit for violation of one of the requirements of Chapter 465. However, Section 465.18(2)(b) is not considered applicable because it is directed only to the person who filled or dispensed prescription drugs while in an unlicensed or unregistered status.

   
   

8. As to Count III - In this Count, Petitioner seeks adverse action as to Respondent's permit for violating Rule 21S-1.14 by permitting the prescription department in its pharmacy to remain unlocked when a licensed pharmacist was not present for duty and for also failing to display a sign in the prescription department which states that the department was then closed, on December 22, 1975. As to this alleged offense, it was admitted by Mr. Valdez that the prescription department customarily remained unlocked through ignorance of the regulation, but that a sign as required was always used when a pharmacist was not present. Although such a sign was not noted by Bell and Santiago during their inspection on December 22nd, they were unable to definitely state that it was not displayed. Therefore, it is determined that Respondent violated the aforesaid rule by failure to keep the prescription department locked at 3:30

   P.M. on December 22, 1975.

   
   

9. Although Respondent at the hearing expressed regret for violation of the law and has taken remedial steps to ensure that such violations do not occur again, it is considered necessary that appropriate disciplinary action be taken in the matter. In considering the severity of and sanction to be imposed it is well to consider that the drug in question, although not dispensed by a licensed Florida Pharmacist, was filled by an individual who had been a pharmacist in Cuba, therefore lessening the possibility that the public would be harmed by improper or incompetent actions on her part. Further, the fact that Respondent's owner, Jose E. Valdez, admitted his derelictions and showed present compliance with all requirements of the law, justifies consideration of a moderate penalty. It is therefore believed that, in lieu of suspension or revocation of Respondent's permit, a civil penalty in the sum of $250.00 be imposed under the authority of Section 465.101(3).

RECOMMENDATION

That a civil penalty in the sum of $250.00 be imposed against Respondent in lieu of suspension or revocation of its permit, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code

DONE and ENTERED this 26th day of April, 1976, in Tallahassee, Florida.

THOMAS C. OLDHAM

Hearing Officer

Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304

COPIES FURNISHED:

Stanley Kaplan, Esquire

404 Biscayne Building Miami, Florida

Seymour M. Litman, Esquire

10 Northwest 14 Avenue Miami, Florida 33125

Docket for Case No: 76-000331

Orders for Case No: 76-000331