STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

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RECOMMENDED ORDER

Pursuant to notice, a formal hearing was conducted in these consolidated cases on July 15, 1993, in Miami, Florida, before Stuart M. Lerner, a duly designated Hearing Officer of the Division of Administrative Hearings.

APPEARANCES

For Department: Charles Faircloth, Esquire

William A. Bausch, Qualified Representative

Department of Business and Professional Regulation

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

For Carlos A. Haro: Steve Polatnick, Esquire

10691 Kendall Drive, Suite 101

Miami, Florida 33176

For Rome, Inc.: Philip M. Schutzer, Esquire

999 Ponce de Leon Boulevard Suite 1000, 10th Floor

Coral Gables, Florida 33134

STATEMENT OF THE ISSUES

1. Whether Respondents committed the offenses described in the Amended Administrative Complaints?

   
   

2. If so, what disciplinary action should be taken against them?

PRELIMINARY STATEMENT

Case No: 91-6297: Pre-consolidation

On August 14, 1991, the Department of Professional Regulation (now the Department of Business and Professional Regulation and hereinafter referred to as the "Department") issued an Administrative Complaint against Carlos A. Haro, a Florida-licensed pharmacist, charging him with various statutory and rule violations that, according to the Administrative Complaint, warranted the taking of disciplinary action against him pursuant to Chapter 465, Florida Statutes, the "Florida Pharmacy Act."

Haro denied the allegations of wrongdoing advanced in the Administrative Complaint and requested a formal hearing. On October 1, 1991, the Department referred the matter to the Division of Administrative Hearings for the assignment of a hearing officer to conduct the formal hearing Haro had requested. The case was docketed as DOAH Case No. 91-6297.

On December 13, 1991, the Department filed an unopposed motion for leave to amend the Administrative Complaint against Haro. By order issued December 31, 1991, the motion was granted. The Administrative Complaint, as amended by the Department (hereinafter referred to as the "Amended Complaint/Haro"), contains

16 counts and alleges that Haro violated the following statutory and rule provisions on or about December 4 and 5, 1990, when he was the prescription department manager at La Generosa Pharmacy: Rule 21S-1.014 (now Rule 21S- 28.109), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Count I); Section 465.015(1)(b), Florida Statutes, and, therefore, Section 465.016(1)(e), Florida Statutes (Count II); Rule 21S-1.017 (now Rule 21S-28.110), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Count III); Section 499.005(1), Florida Statutes, and, therefore, Section 465.016(1)(e), Florida Statutes (Counts IV and VIII); Section 499.005(9) (now Section 499.005(10)), Florida Statutes, and, therefore, Section 465.016(1)(e), Florida Statutes (Count V); Rule 21S-1.016 (now Rule 21S-27.102), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Counts VI and X); Rule 10D-45.039(5), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Count VII); Rule 10D-45.0365(15), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Count IX); Rule 21S-1.010(1) (now Rule 21S-28.107(1)), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Counts XI and XIII); Rule 21S-1.010(3) (now Rule 21S-28.107(3)), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Count XII); Rule 21S-1.044(1) (now Rule 21S- 28.120(1)), Florida Administrative Code, and, therefore, Section 465.016(1)(n), Florida Statutes (Count XIV); Section 893.04(1), Florida Statutes, and, therefore, Section 465.016(1)(e), Florida Statutes (Count XV); and Section 893.07(1)(a), Florida Statutes, and, therefore, Section 465.016(1)(e), Florida Statutes (Count XVI).

The final hearing in Case No. 91-6297 was originally scheduled to commence on February 18, 1992. On February 10, 1992, the Department filed a motion

requesting that the hearing be cancelled and that the matter be held in abeyance pending the Board of Pharmacy's consideration of the settlement stipulation into which the parties had entered. The motion was granted.

The Board of Pharmacy rejected the parties' settlement stipulation and offered a counter-stipulation which Haro found unacceptable. After being notified of these developments, the Hearing Officer vacated the order of abeyance he had previously issued and rescheduled the final hearing for December 4, 1992. The hearing was subsequently continued at the request of the parties and rescheduled for March 5, 1993.

Case No. 92-0227: Pre-consolidation

On May 14, 1991, the Department issued an Administrative Complaint against Rome, Inc. (hereinafter referred to as "Rome"), the holder of the permit authorizing La Generosa Pharmacy to operate as a community pharmacy, charging it with various statutory and rule violations that, according to the Administrative Complaint, warranted the taking of disciplinary action against it pursuant to Chapter 465, Florida Statutes, the "Florida Pharmacy Act."

Rome denied the allegations of wrongdoing advanced in the Administrative Complaint. On January 13, 1992, the Department referred the matter to the Division of Administrative Hearings for the assignment of a hearing officer to conduct a formal hearing on the matter. The case was docketed as DOAH Case No. 92-0227.

On April 17, 1992, the Department filed an unopposed motion for leave to amend the Administrative Complaint against Rome. By order issued May 4, 1992, the motion was granted. The Administrative Complaint, as amended by the Department (hereinafter referred to as the "Amended Complaint/Rome"), contains

13 counts and alleges that Rome violated the following statutory and rule provisions on or about December 4 and 5, 1990: Rule 21S-28.109(1) (formerly Rule 21S-1.014), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count I); Rule 21S-28.404 (formerly Rule 21S- 1.024), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count II); Section 465.015(1)(b), Florida Statutes, and, therefore, Section 465.023(1)(c), Florida Statutes (Count III); Rule 10D- 45.0365(3), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count IV); Rule 21S-28.110 (formerly Rule 21S-1.017), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count V); Section 499.007(1), Florida Statutes, and, therefore, Section 465.023(1)(c), Florida Statutes (Counts VI and VIII); Rule 21S-27.102 (formerly Rule 21S-1.016), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Counts IX and XI); Rule 10D-45.039(5), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count X); Rule 21S-28.107(1) (formerly 21S-1.010(1)), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count XII); and Rule 21S-27.500 (formerly 21S-5.001), Florida Administrative Code, and, therefore, Section 465.023(1)(c), Florida Statutes (Count XIII).

The final hearing in Case No. 92-0227 was originally scheduled to commence on May 21, 1992. At the request of Rome, it was rescheduled for July 31, 1992. On July 8, 1992, the Department filed a motion requesting that the hearing be cancelled and that the matter be held in abeyance pending the Board of Pharmacy's consideration of the settlement stipulation into which the parties had entered. The motion was granted.

The Board of Pharmacy rejected the parties' settlement stipulation and offered a counter-stipulation which Rome found unacceptable. After being notified of these developments, the Hearing Officer vacated the order of abeyance he had previously issued and rescheduled the final hearing for March 10, 1993.

Consolidation

On February 22, 1993, the Department filed an unopposed motion requesting that Case Nos. 91-6297 and 92-0227 be consolidated. On that same date it also filed an unopposed motion requesting that the final hearings previously scheduled in these cases be continued. Both motions were granted and the final hearing in these consolidated cases was scheduled for June 4, 1993. At the request of Rome, the hearing was subsequently continued and rescheduled for July 15, 1993.

Final Hearing

At the final hearing held in these consolidated cases on July 15, 1993, four witnesses testified: Harold Gluck, a Florida-licensed pharmacist who is employed as an investigator with the Department; Cesar Arias, a drug inspector supervisor with the Department of Health and Rehabilitative Services (hereinafter referred to as "HRS"); Haro; and Roger Diaz, the proprietor of La Generosa Pharmacy. In addition to the testimony of these four witnesses, a total of nine exhibits (Petitioner's Exhibits 1-8 and Haro's Exhibit 1) were offered and received into evidence. At the conclusion of the evidentiary portion of the hearing, the Hearing Officer, on the record, advised the parties of their right to file post-hearing submittals and established a deadline for the filing of such submittals.

Post-Hearing Submittals

On September 3, 1993, and September 7, 1993, respectively, the Department and Haro filed proposed recommended orders. To date, Rome has not filed any post hearing submittal.

The Department's and Haro's proposed recommended orders contain what are labelled as proposed "findings of fact." These proposed "findings of fact" have been carefully considered and are specifically addressed in the Appendix to this Recommended Order.

FINDINGS OF FACT

Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made:

1. The Department is a state government licensing and regulatory agency.

   
   

2. Haro is now, and has been since April of 1980, a licensed pharmacist in the State of Florida.

   
   

3. He holds license number PS 0017949.

   
   

4. Rome is now, and has been since February of 1978, the holder of permit number PH 0007008, which authorizes it to operate La Generosa Pharmacy (hereinafter referred to as "La Generosa" or the "Pharmacy") as a community

   pharmacy in Dade County, Florida. At no time in the past has Rome, as the holder of permit number PH 0007008, been disciplined by the Board of Pharmacy.

   
   

5. For the past eighteen years, Roger Diaz has been Rome's sole corporate shareholder and the owner of the Pharmacy.

   
   

6. Haro was employed as the prescription department manager of La Generosa and its only pharmacist from approximately October 16, 1990, until some time after the dates of the alleged violations in these consolidated cases. He worked full-time (40 hours a week).

   
   

7. Harold Gluck is an investigator with the Department.

   
   

8. On December 4, 1990, at approximately 2:00 p.m., Gluck attempted to conduct a routine annual inspection of the Pharmacy, which had last been inspected 13 months previous.

   
   

9. Upon entering the Pharmacy, Gluck found that there was no pharmacist on duty. Diaz was there, however.

   
   

10. The lights in the prescription department were off and a "closed" sign was posted. A door to the prescription department, although closed, was unlocked. Gluck opened the door, walked in and turned on the lights. He saw Haro's license hanging on the wall. On the counter, he observed prescription vials containing pharmaceuticals. It appeared to Gluck that someone had been in the process of filling these vials and had been interrupted before completing the task.

    
    

11. Gluck inquired of Diaz as to the whereabouts of the pharmacist. Diaz, in response to Gluck's inquiry, indicated that Haro had taken the day off to tend to some personal business. Gluck then asked Diaz who was filling the prescription vials "if the pharmacist isn't here." Diaz responded, "I don't know."

    
    

12. Gluck continued his inspection.

    
    

13. On the shelves in the prescription department he discovered a large number of expired drugs, some of which had expiration dates that predated the last inspection of the Pharmacy that had been conducted 13 months previous.

    None of the drugs that had been outdated for more than 13 months had been on the shelves during the last inspection.

    
    

14. Gluck's inspection on December 4, 1990, also revealed prescription drugs in the Pharmacy outside of the prescription department.

    
    

15. After cursorily examining the premises, Gluck left the Pharmacy. He told Diaz that he would be paying a return visit the following day to speak with Haro and to conduct a more thorough inspection. He warned Diaz not to enter the prescription department and asked him to lock the doors leading into that area of the Pharmacy. Diaz indicated that he would comply.

    
    

16. Later that day at around 5:00 p.m., following Glucks's departure, Haro went to the Pharmacy "to observe how [it] was functioning."

    
    

17. As he had promised, Gluck returned to the Pharmacy on December 5, 1990. He was accompanied by another of the Department's investigators, as well as three HRS drug inspectors.

18. The prescription department was closed and Haro was nowhere to be seen. Diaz was present and Gluck asked him whether Haro had reported to work that day. Diaz told Gluck that Haro had again taken the day off to take care of a personal matter.

    
    

19. Gluck tried to open the door he had used the day before to enter the prescription department, but it was locked and Diaz claimed not to know where to find a key to unlock the door.

    
    

20. With Diaz's permission, Gluck and one of the HRS drug inspectors, Cesar Arias, walked into a back storage room that was adjacent the prescription department (hereinafter referred to as the "storage room") to ascertain if there was another entrance to the prescription department. There they spotted an unlocked door that led to the prescription department. After obtaining Diaz's authorization, they pushed the door open. In so doing, they moved an appliance, that had been behind the door, out of the way. They then walked into the prescription department.

    
    

21. While in the prescription department, Gluck and Arias noticed a doorway that was covered, but not completely, by a piece of paneling. They removed the piece of paneling and then walked into the room (hereinafter referred to as the "hidden room").

    
    

22. The December 5, 1990, inspection of the Pharmacy revealed the following:

    
    

    1. Of the approximately 2,000 containers

       on the shelves in the prescription department, approximately 200 contained expired pharmaceuticals.

    2. Expired pharmaceuticals that Haro had removed from the shelves were in boxes in the storage room.

    3. There were containers of pharmaceuticals on the shelves in the prescription department that had labels which understated the quantity of pharmaceuticals in the container.

    4. There were containers of pharmaceuticals on the shelves in the prescription department that had labels which inaccurately described the strength of the pharmaceuticals in the container.

    5. On the shelves in the prescription department were containers of pharmaceuticals to which samples, that had been removed from their original packaging, had been added.

    6. According to records in the prescription department, prescriptions had been filled on December 4, 1990.

    7. Prescriptions for controlled substances that had been filled by Haro within the past month were lacking the date the prescription had been filled, the patient's name and address, the dispensing pharmacist's initials and/or the prescribing physician's DEA registration number.

    8. A bottle of Uropol, which Haro had for his

       own personal use, was in the prescription department. Uropol is a foreign drug that has not been approved for use in the United States.

    9. Vials containing prescription drugs that had been dispensed by Jorge's Pharmacy, another local pharmacy, were in the hidden room, as well as in bags, ready for customer pick-up, in the storage area. These vials had labels prepared by Jorge's Pharmacy. References to Jorge's Pharmacy's appear- ing on the labels, however, had been "whited out" so as to make it appear that Jorge's Pharmacy's

       was not the dispensing pharmacy. Furthermore, some of these vials contained lesser quantities of drugs than indicated on their labels.

    10. As Diaz candidly admitted to the inspection team during the inspection, Jorge's Pharmacy had filled these prescriptions pursuant to an arrangement that it had with Diaz. These were Medicaid prescriptions. Jorge's Pharmacy was a participant

        in the Medicaid program. La Generosa had been suspended from the program and therefore, unlike Jorge's Pharmacy, was not able to fill Medicaid prescriptions. Wanting to keep his Medicaid customers, Diaz had devised and implemented a scheme that allowed him to continue to do business with these customers. He had his Medicaid customers present their prescriptions to him or Blanca Uzman, one of his subordinates, at a counter outside of the

        store's prescription department (hereinafter referred to as the "outside counter"). The prescriptions were thereafter taken to Jorge's Pharmacy, where they were filled. The labeled vials containing the dispensed drugs were then delivered to La Generosa, where they were ultimately picked up, at the outside counter, but not before an effort had been made to obliterate,

        by using white-out, all references to Jorge's Pharmacy appearing on the vials' labels. Although Haro knew

        of this scheme, he was in no way involved in it.

    11. A prescription balance and prescription weights were in the hidden room.

    12. Neither a copy of the laws and rules governing the practice of pharmacy, a negative formulary, nor a biennial inventory record of controlled substances were located by the inspection team, although these items were on the premises.

        
        

23. Following the December 5, 1990, inspection of La Generosa, administrative charges were brought against both Haro and Rome.

    
    

24. Subsequent inspections of the Pharmacy established that "everything was in proper order."

    
    

    CONCLUSIONS OF LAW

    
    

    General Legal Principles

    
    

25. The Board of Pharmacy (hereinafter referred to as the "Board") is statutorily empowered to take disciplinary action against a Florida-licensed pharmacist, such as Haro, based upon any of the grounds enumerated in Section 465.016(1), Florida Statutes, and to take disciplinary action against a

    community pharmacy permittee, such as Rome, based upon any of the grounds enumerated in Section 465.023(1), Florida Statutes. Such disciplinary action may include one or more of the following penalties: pharmacist- license revocation; license suspension; imposition of an administrative fine not to exceed $1,000 for each count or separate offense; issuance of a reprimand; and placement of the pharmacist on probation; permittee- permit revocation;

    permit suspension; imposition of an administrative fine; and placement of the permittee on probation. Sections 465.016(2) and 465.023(1), Fla. Stat.

    
    

26. Where the disciplinary action sought is the revocation or suspension of the pharmacist's license or the permittee's permit, the proof of guilt must be clear and convincing. See Ferris v. Turlington, 510 So.2d 292 (Fla. 1987); Pic N' Save v. Department of Business Regulation, 601 So.2d 245 (Fla. 1st DCA 1992); Munch v. Department of Professional Regulation, 592 So.2d 1136 (Fla. 1st DCA 1992); Newberry v. Florida Department of Law Enforcement, 585 So.2d 500 (Fla. 3d DCA 1991). "The evidence must be of such weight that it produces in the mind of the trier of fact a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established." Slomowitz v. Walker, 429 So.2d 797, 800 (Fla. 4th DCA 1983).

    
    

27. Where the discipline does not involve the loss of licensure or of a permit, the accused's guilt need be established by only a preponderance of the evidence. See Allen v. School Board of Dade County, 571 So.2d 568, 569 (Fla. 3d DCA 1990).

    
    

28. Regardless of the disciplinary action taken, it may be based only upon the violations specifically alleged in administrative complaint. See Kinney v. Department of State, 501 So.2d 129, 133 (Fla. 5th DCA 1987); Hunter v. Department of Professional Regulation, 458 So.2d 842, 844 (Fla. 2d DCA 1984).

    
    

29. Furthermore, in determining whether Section 465.016(1) or Section 465.023(1), Florida Statutes, has been violated in the manner charged in the administrative complaint, one "must bear in mind that [they are], in effect, . .

    . penal statute[s]. . . This being true the statute[s] must be strictly construed and no conduct is to be regarded as included within [them] that is not reasonably proscribed by [them]. Furthermore, if there are any ambiguities included such must be construed in favor of the . . . licensee" or permittee.

    Lester v. Department of Professional and Occupational Regulations, 348 So.2d 923, 925 (Fla. 1st DCA 1977).

    
    

    Disposition of Alleged Violations: Case No. 91-6297

    
    

30. The Amended Administrative Complaint issued in Case No. 91-6297 charges that Haro committed sixteen separate violations of the "Florida Pharmacy Act" on December 4 and 5, 1990, while acting in his capacity as La Generosa's prescription department manager, who, by statute, specifically Section 465.018, Florida Statutes, was "responsible for maintaining all drug records, providing for the security of the prescription department, and following such other rules as relate to the practice of the profession of pharmacy."

    
    

31. Count I of the Amended Complaint/Haro alleges that Haro "has violated Rule 21S-1.014, Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes," inasmuch as "[o]n December 4, 1990, the Department of Professional Regulation inspector discovered the door to the prescription department open but no pharmacist on duty."

32. Section 465.016(1)(n), Florida Statutes, authorizes the Board to discipline a Florida-licensed pharmacist for "[v]iolating a rule of the board or department or violating an order of the board or department previously entered in a disciplinary hearing."

    
    

33. Among the rules of the Board in effect on December 4, 1990, was Rule 21S-1.014 (now Rule 21S-28.109), Florida Administrative Code, which provided, in pertinent part, that "[a]t all times when the prescription department [of a community pharmacy] is closed, either because of the absence of a Florida registered pharmacist or for any other reason, it shall be separated from the remainder of the establishment by partition or other means of enclosure," which "shall be securely locked or padlocked."

    
    

34. The evidence clearly and convincingly establishes that on December 4, 1990, when Gluck went to La Generosa to conduct his annual inspection, the prescription department was closed and that at least one of the doors to the prescription department was unlocked in violation of the provisions of former Rule 21S-1.014, Florida Administrative Code. Because he was, at the time, the Pharmacy's prescription department manager statutorily charged with the duty of "providing for the security of the prescription department," Haro should be held responsible and disciplined, pursuant to Section 465.016(1)(n), Florida Statutes, for the violation of this Board rule, as alleged in Count I of the Amended Complaint/Haro.

    
    

35. Count II of the Amended Complaint/Haro alleges that Haro "has violated Section 465.015(1)(b), Florida Statutes, and is therefore subject to discipline as provided by Section 465.016(1)(e), Florida Statutes," inasmuch as, when Haro was La Generosa's prescription department manager, "[p]rescription and medicinal drugs [were] dispensed from the prescription department when [Haro, the only pharmacist employed at the Pharmacy, was] not on duty."

36. Section 465.015(1)(b), Florida Statutes, provides as follows: 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:

    
    

    In which a person not licensed as a pharmacist in this state or not registered as an intern in this state or in which an

    intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist fills, compounds, or dispenses any prescription or dispenses medicinal drugs.

    
    

37. Section 465.016(1)(e), Florida Statutes, authorizes the Board to discipline a Florida-licensed pharmacist for, among other things, "[v]iolating any of the requirements of this chapter."

    
    

38. While the proof submitted may raise some suspicions regarding the matter, it is not sufficient to establish that an unlicensed or unauthorized person was dispensing prescription or medicinal drugs in La Generosa's prescription department at any time during Haro's tenure as manager of that department. Accordingly, Count II of the Amended Complaint/Haro should be dismissed.

39. Count III of the Amended Complaint/Haro alleges that Haro "has violated Rule 21S-1.017, Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes," inasmuch as, during the December, 1990, inspection of La Generosa, "[t]he inspectors discovered expired medicinal drugs on the shelves in the prescription department."

    
    

40. Rule 21S-1.017 (now Rule 21S-28.110), Florida Administrative Code, was among the Board rules in effect at the time of the December, 1990, inspection of La Generosa. It provided as follows:

    
    

    Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of four months, and shall remove all deteriorated pharmaceuticals, or pharmaceuticals which

    bear upon the container an expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon the container an expiration

    date which has been reached be sold or dispensed to the public.

    
    

41. The evidence clearly and convincingly establishes that there were numerous containers on the shelves in the prescription department (a) that bore "an expiration date which date ha[d] been reached" at the time of the December, 1990, inspection of the Pharmacy, and (b) that obviously, given their expiration dates, had been there for more than four months. As the Pharmacy's prescription department manager, in accordance with the provisions of former Rule 21S-1.017, Florida Administrative Code, Haro should have removed all of these containers from the prescription department shelves prior to the inspection. Having failed to do so, Haro should be found guilty of this violation of the Board's rules and disciplined therefor pursuant to Section 465.016(1)(n), Florida Statutes, as alleged in Count III of the Amended Complaint/Haro.

    
    

42. Counts IV and V of the Amended Complaint/Haro allege that Haro violated Section 499.005(1), Florida Statutes (Count IV), and Section 499.005(9), Florida Statutes (Count V), and "is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes," as a result of his role in the whiting-out of the name of the dispensing pharmacy on labels of prescription vials that had been filled by Jorge's Pharmacy and then delivered to La Generosa and kept in a "back room" of the Pharmacy for customer pick-up.

    
    

43. The preponderance of the evidence establishes that, although he was aware of this scheme to conceal the true identity of the dispensing pharmacy, Haro did not in any way participate in the scheme. Accordingly, Counts IV and V of the Amended Complaint/Haro should be dismissed.

    
    

44. Counts VI and X of the Amended Complaint/Haro alleges that Haro "has violated Rule 21S-1.016, Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes," inasmuch as, during the December, 1990, inspection of La Generosa, "[t]he inspectors discovered bottles of medicinal drugs [on the shelves in the prescription department] which contained different strengths than indicated on the labels" (Count VI), as well as "a bottle which contained samples of medicinal drugs" (Count X).

45. Rule 21S-1.016 (now Rule 21S-27.102), Florida Administrative Code, was among the Board rules in effect at the time of the December, 1990, inspection of La Generosa. It provided as follows:

    
    

    No pharmacist or pharmacy employee shall transfer, or cause to be transferred from the original container of a sample package, any drug or drug preparation which bears upon the package a lot number or date of expiration except to be placed directly into the container of a legitimate prescription, in hand, and under no circumstances will drugs or drug preparations be placed into any container

    which is not properly labeled in accordance with the Florida Drug and Cosmetic Law, or into any container which contains a drug which differs in any manner whatsoever from said drug or drug preparation either by strength, manufacturer, date of expiration, lot number and any other material factor.

    
    

46. While the inspectors, during their December, 1990, inspection of La Generosa, "discovered bottles of medicinal drugs [on the shelves in the prescription department] which contained different strengths than indicated on the labels," as well as "a bottle which contained samples of medicinal drugs," as alleged in Counts VI and X, respectively, of the Amended Complaint/Haro, the evidence is insufficient to establish that Haro (rather than someone else, such as his predecessor at the Pharmacy) had placed any drugs into these containers or was otherwise responsible for their contents. In the absence of such proof, Counts VI and X of the Amended Complaint/Haro should be dismissed.

    
    

47. Counts VII and IX of the Amended Complaint/Haro allege that Haro violated Rule 10D-45.039(5), Florida Administrative Code (Count VII), and Rule 10D-45.0365(15), Florida Administrative Code (Count IX), and "is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes."

    
    

48. Rule 10D-45.039(5), Florida Administrative Code, and Rule 10D- 45.0365(15), Florida Administrative Code, are rules of HRS, not the Board.

    
    

49. The Board is authorized to impose discipline pursuant Section 465.016(1)(n), Florida Statutes, for the violation of Board rules, but not HRS rules. Accordingly, Counts VII and IX of the Amended Complaint/Haro should be dismissed.

    
    

50. Count VIII of the Amended Complaint/Haro alleges that Haro "has violated Section 499.005(1), Florida Statutes, and is therefore subject to discipline as provided by Section 465.016(1)(e), Florida Statutes" inasmuch as, during the December, 1990, inspection of La Generosa, "[t]he inspectors discovered bottles of medicinal drugs [on the shelves in the prescription department] which contained different strengths than indicated on the labels," as well as "bottles of medicinal drugs which contained different quantities than indicated on the labels."

    
    

51. Section 465.016(1)(e), Florida Statutes, authorizes the Board to discipline a licensed pharmacist for, among other things, "[v]iolating chapter 499."

52. Section 499.005(1), Florida Statutes, is part of Chapter 499, Florida Statutes, and provides as follows:

    
    

    It is unlawful to perform or cause the performance of any of the following acts in this state:

    
    

    1. 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.

       
       

53. A drug or device is "misbranded," within the meaning of Section 499.005(1), Florida Statutes, "[i]f its labeling is false or misleading in any particular." Section 499.007(1), Fla. Stat.

    
    

54. The evidence clearly and convincingly establishes that, at the time of the December, 1990, inspection of La Generosa, such "misbranded" drugs were being held for sale on the shelves in the Pharmacy's prescription department in violation of the provisions of Section 499.005(1), Florida Statutes. Because he was at the time in charge of the prescription department's operations, Haro may be held responsible and disciplined, pursuant to Section 465.016(1)(e), Florida Statutes, for the violation of this provision of Chapter 499, Florida Statutes, as alleged in Count VIII of the Amended Complaint/Haro.

    
    

55. Counts XI and XIII of the Amended Complaint/Haro alleges that Haro "has violated Rule 21S-1.010(1), Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes," inasmuch as, at the time of the December, 1990, inspection of La Generosa, "[t]he prescription department was not equipped with a current copy of the laws and rules governing the practice of pharmacy in the State of Florida" (Count XI), nor was it "equipped with a negative formulary" (Count XIII).

    
    

56. The preponderance of the evidence establishes that the Pharmacy's prescription department was indeed equipped with these items, as required by Rule 21S-1.010(1) (now Rule 21S-28.107), Florida Administrative Code, at the time of the December, 1990, inspection, notwithstanding that the inspection team was unable to locate them. Accordingly, Counts XI and XIII of the Amended Complaint/Haro should be dismissed.

    
    

57. Count XII of the Amended Complaint/Haro alleges that Haro "has violated Rule 21S-1.010(3), Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes," inasmuch as, at the time of the December, 1990, inspection of La Generosa, "[t]he prescription department was not equipped with weights and balances."

    
    

58. The preponderance of the evidence establishes that the Pharmacy's prescription department was indeed equipped with the weights and balances required by Rule 21S-1.010(3) (now Rule 21S-28.107(3)), Florida Administrative Code, at the time of the December, 1990, inspection. Accordingly, Count XII of the Amended Complaint/Haro should be dismissed.

    
    

59. Count XIV of the Amended Complaint/Haro alleges that Haro "has violated Rule 21S-1.044(1), Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.016(1)(n), Florida Statutes,"

    inasmuch as, during the December, 1990, inspection of La Generosa, "[m]edicinal drugs were discovered outside of the prescription department."

    
    

60. Rule 21S-1.044(1) (now Rule 21S-28.120(1), Florida Administrative Code, was among the Board rules in effect at the time of the December, 1990, inspection of La Generosa. It provided as follows:

    
    

    All medicinal drugs or drug preparations as defined in section 465.003(7), F.S., within a community pharmacy shall be stored within the confines of the prescription department.

    
    

61. "Medicinal drugs" or "drugs" are defined in Section 465.003(7), Florida Statutes, as "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."

    
    

62. The evidence clearly and convincingly establishes that, at the time of the December, 1990, inspection of La Generosa, there were expired "medicinal drugs" in the Pharmacy outside of the prescription department that Haro had placed there in violation of the provisions of former Rule 21S-1.044(1), Florida Administrative Code. Accordingly, Haro should be found guilty of this violation of the Board's rules and disciplined therefor pursuant to Section 465.016(1)(n), Florida Statutes, as alleged in Count XIV of the Amended Complaint/Haro.

    
    

63. Count XV of the Amended Complaint/Haro alleges that Haro "has violated Section 893.04(1), Florida Statutes, and is therefore subject to discipline as provided by Section 465.016(1)(e), Florida Statutes," inasmuch as, during the December, 1990, inspection of La Generosa, "[u]pon checking the prescription record, the inspectors found prescriptions for controlled substances that did not display the initials of a dispensing pharmacist, the date dispensed, the patient's name and addresses, DEA numbers or marked refills."

    
    

64. Section 465.016(1)(e), Florida Statutes, authorizes the Board to discipline a licensed pharmacist for, among other things, "[v]iolating . . . chapter 893."

    
    

65. Section 893.04(1), Florida Statutes, is among the statutory provisions that comprise Chapter 893, Florida Statutes. It provides in part as follows:

    
    

    A pharmacist in good faith and in the course of professional practice, may dispense controlled substances upon a written or oral prescription of a practitioner, under the following conditions:

    1. Oral prescriptions must be promptly reduced to writing by the pharmacist.

    2. The written prescription must be dated and signed by the prescribing practitioner on the day when issued.

    3. There shall appear on the face of the prescription or written record thereof for the controlled substance the following information:

       1. The full name and address of the person for whom, or the animal for which, the controlled substance is dispensed.

       2. The full name and address of the prescribing practitioner and his federal controlled substance registration number [DEA number] shall be printed thereon.

       3. If the prescription is for an animal, the species of animal for which the controlled substance is prescribed.

       4. The name of the controlled substance prescribed and the strength, quantity, and directions for use thereof.

       5. The number of the prescription, as recorded in the prescription files of the pharmacy in which it is filled.

       6. The initials of the pharmacist filling the prescription and the date filled.

    4. The prescription shall be retained on file by the proprietor of the pharmacy in which it is filled for a period of 2 years.

    
    

66. The evidence clearly and convincingly establishes that, during the time he was La Generosa's prescription department manager, in violation of the provisions of Section 893.04(1), Florida Statutes, Haro filled prescriptions that did not contain the patient's name and address, as well as prescriptions for controlled substances that were lacking the prescribing physician's DEA registration number, and he did not always indicate on the face of the prescription or written record thereof his initials and the date the prescription was filled. Accordingly, Haro should be found guilty of this violation of Chapter 893, Florida Statutes, and disciplined therefor pursuant to Section 465.016(1)(e), Florida Statutes, as alleged in Count XV of the Amended Complaint/Haro.

    
    

67. Count XVI of the Amended Complaint/Haro alleges that Haro "has violated Section 893.07(1)(a), Florida Statutes, and is therefore subject to discipline as provided by Section 465.016(1)(e), Florida Statutes," inasmuch as, during the December, 1990, inspection of La Generosa, "[t]he inspectors discovered that a biennial inventory record [of controlled substances] was not maintained by [Haro]."

    
    

68. The preponderance of the evidence establishes that Haro had indeed taken the biennial inventory required by Section 893.07(1)(a), Florida Statutes, notwithstanding that the inspection team was unable to locate the record of this inventory during its December, 1990, inspection of the Pharmacy. Accordingly, Count XVI of the Amended Complaint/Haro should be dismissed.

    
    

    Disposition of Alleged Violations: Case No. 92-0227

    
    

69. The Amended Administrative Complaint issued in Case No. 92-0227 charges that Rome committed thirteen separate violations of the "Florida Pharmacy Act" on December 4 and 5, 1990, while acting in its capacity as the permittee authorized to operate La Generosa as a community pharmacy.

    
    

70. Count I of the Amended Complaint/Rome alleges that Rome "has violated Rule 21S-28.109(1) (formerly Rule 21S-1.014), Florida Administrative Code, and is therefore subject to discipline as "provided by Section 465.023(1)(c),

    Florida Statutes," inasmuch as "[o]n or about December 4, 1990, a DPR inspector arrived to inspect [La Generosa] and discovered the door to the prescription department open, unlocked with no pharmacist on duty."

    
    

71. Section 465.023(1)(c), Florida Statutes, authorizes the Board to discipline a community pharmacy permittee for, among other things "[v]iolat[ing]

    . . . any of the rules of the Board of Pharmacy."

    
    

72. As noted above, Rule 21S-1.014 (now Rule 21S-28.109), Florida Administrative Code, was among the rules of the Board in effect on December 4, 1990, and the evidence clearly and convincingly establishes that on that date, when Gluck went to La Generosa to conduct his annual inspection, the prescription department was closed and at least one of the doors to the prescription department was unlocked in violation of the provisions of former Rule 21S-1.014, Florida Administrative Code. As the permittee authorized to operate La Generosa as a community pharmacy, Rome should be held responsible and disciplined, pursuant to Section 465.023(1)(c), Florida Statutes, for the violation of this Board rule, as alleged in Count I of the Amended Complaint/Rome.

    
    

73. Count II of the Amended Complaint/Rome alleges that Rome "has violated Rule 21S-28.404 (formerly Rule 21S-1.024), Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes," inasmuch as, when Haro was La Generosa's prescription department manager, he was "the only pharmacist employed by [Rome and he] work[ed] less than 20 hours weekly, although the store [wa]s open for eleven hours each day."

    
    

74. Former Rule 21S-1.024, Florida Administrative Code, was among the rules of the Board in effect during the time period that Haro was La Generosa's prescription department manager. It provided as follows:

    
    

    Any person who receives a community pharmacy permit pursuant to Section 465.018, Florida Statutes, and commences to operate such an establishment shall, for the benefit of the public health and welfare, keep the prescription department of the establishment open for a minimum of forty hours per week. The prescription department must also be open at least sixty percent (60 percent) of the total hours that the establishment is open each day and offering its products and services to the general public or at least

    12 hours if the store is open 24 hours.

    
    

75. The evidence is not sufficient to establish that La Generosa's prescription department was not open the number of hours required by former Rule 21S-1.024, Florida Administrative Code, during the time period that Haro served as its manager. Accordingly, Count II of the Amended Complaint/Rome should be dismissed.

    
    

76. Count III of the Amended Complaint/Rome alleges that Rome "violated Section 465.015(1)(b), Florida Statutes, and is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes," inasmuch as, when Haro was La Generosa's prescription department manager, "[p]rescriptions [were] received and medicinal drugs [were] dispensed from [the Pharmacy's] prescription department when the pharmacist [was] not on duty."

77. As noted above, the evidence is not sufficient to establish that, during Haro's tenure as La Generosa's prescription department manager, any unlicensed or unauthorized person was dispensing medicinal drugs from the Pharmacy's prescription department. Accordingly, Count III of the Amended Complaint/Rome should be dismissed.

    
    

78. Counts IV and X of the Amended Complaint/Rome allege that Rome violated Rule 10D-45.0365(15), Florida Administrative Code (Count IV), and Rule 10D-45.039(5), Florida Administrative Code (Count X), and "is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes."

    
    

79. As noted above, Rule 10D-45.0365(15), Florida Administrative Code, and Rule 10D-45.039(5), Florida Administrative Code, are rules of HRS, not the Board.

    
    

80. The Board is authorized to impose discipline pursuant Section 465.023(1)(c), Florida Statutes, for the violation of Board rules, but not HRS rules. Accordingly, Counts IV and X of the Amended Complaint/Rome should be dismissed.

    
    

81. Count V of the Amended Complaint/Rome alleges that Rome "violated Rule 21S-28.110 (formerly Rule 21S-1.017), Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes," inasmuch as, during the December, 1990, inspection of La Generosa, "[i]n the prescription department, the inspectors discovered expired medicinal drugs on the prescription department shelves."

    
    

82. As noted above, the evidence clearly and convincingly establishes that there were numerous containers on the shelves in the prescription department that bore "an expiration date which date ha[d] been reached" at the time of the December, 1990, inspection of the Pharmacy and that should have been removed from the shelves in accordance with former Rule 21S-1.017, Florida Administrative Code, prior to the inspection. As the Pharmacy's permittee, Rome should be held responsible and disciplined, pursuant to Section 465.023(1)(c), Florida Statutes, for the violation of this Board rule, as alleged in Count V of the Amended Complaint/Rome.

    
    

83. Counts VI and VII of the Amended Complaint/Rome allege that Rome violated Section 499.007(1), Florida Statutes (Count VI), and former Section 499.005(9) (now Section 499.005(10)), Florida Statutes (Count VII), and "is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes," as a result of its role in the whiting-out of the name of the dispensing pharmacy on labels of prescription vials that had been filled by Jorge's Pharmacy and then delivered to La Generosa for customer pick-up.

    
    

84. Section 499.007(1), Florida Statutes, simply describes circumstances under which a drug or device will "be deemed to be misbranded." It itself does not prohibit such "misbranding" or any other activity for that matter. Accordingly, Count VI of the Amended Complaint/Rome, which alleges that Rome violated this statutory provision, should be dismissed.

    
    

85. Former Section 499.005(9), Florida Statutes, on the other hand, did proscribe conduct, specifically "[t]he forging; counterfeiting; simulating; falsely representing; or, without proper authority, using any mark, stamp, tag, label, or other identification device authorized or required by rules promulgated under the provisions of ss. 499.001-499.081."

86. The evidence clearly and convincingly establishes that Rome, through the involvement of its sole shareholder, Diaz, in the scheme to conceal the true identity of the pharmacy that actually filled the Medicaid prescriptions of La Generosa's customers, engaged in conduct violative of former Section 499.005(9), Florida Statutes, for which Rome should be disciplined pursuant to Section 465.023(1)(c), Florida Statutes, as alleged in Count VII of the Amended Complaint/Rome.

    
    

87. Count VIII of the Amended Complaint/Rome, like Count VI thereof, alleges that Rome "violated Section 499.007(1), Florida Statutes, and is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes." For the same reason that Count VI should be dismissed, to wit: the non-proscriptive nature of the statutory provision allegedly violated, so too should Count VIII.

    
    

88. Counts IX and XI of the Amended Complaint/Rome alleges that Rome "violated Rule 21S-27.102 (formerly Rule 21S-1.016), Florida Administrative Code, and is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes," inasmuch as, during the December, 1990, inspection of La Generosa, "[t]he inspectors discovered bottles of medicinal drugs [on the shelves in the prescription department] which contained different strengths than indicated on the labels" (Count IX), as well as "a bottle which contained samples of medicinal drugs" (Count XI).

    
    

89. The evidence clearly and convincingly establishes that Rome, through one or more of its employees or agents, committed the rule violations alleged in Counts IX and XI of the Amended Complaint/Rome, for which it should be disciplined pursuant to Section 465.023(1)(c), Florida Statutes.

    
    

90. Counts XII and XIII of the Amended Complaint/Rome allege that Rome violated Rule 21S-28.107(1) (formerly Rule 21S-1.010), Florida Administrative Code (Count XII), and Rule 21S-27.500 (formerly Rule 21S-5.001), Florida Administrative Code (Count XIII), and "is therefore subject to discipline as provided by Section 465.023(1)(c), Florida Statutes," inasmuch as, at the time of the December, 1990, inspection of La Generosa, the "prescription department was not equipped with a current copy of the laws and rules governing the practice of pharmacy in the State of Florida" (Count XII), nor was it "equipped with a negative formulary" (Count XIII).

    
    

91. As noted above, the preponderance of the evidence establishes that the Pharmacy's prescription department was indeed equipped with these items, as required by the Board's rules, at the time of the December, 1990, inspection, notwithstanding that the inspection team was unable to locate them.

    Accordingly, Counts XII and XIII of the Amended Complaint/Rome should be dismissed.

    
    

    Penalties

    
    

92. In determining what disciplinary action should be taken against Haro and Rome for having committed the violations found above, it is necessary to consult Chapter 21S-30, Florida Administrative Code, which contains the disciplinary guidelines adopted by the Board. Cf. Williams v. Department of Transportation, 531 So.2d 994, 996 (Fla. 1st DCA 1988)(agency is required to comply with its disciplinary guidelines in taking disciplinary action against its employees).

93. Subsection (2) of Rule 21S-30.001, Florida Administrative Code, sets forth "the range of penalties which will normally be imposed" for a "single count violation" of particular statutory and rule provisions.

    
    

94. For a "single count" of fraudulent misbranding of legend drugs and for a "single count" violation of Rule 21S-27.102 (formerly Rule 21S-1.016), Florida Administrative Code, the normal range of penalties, as prescribed by subsection

    1. of Rule 21S-30.001, Florida Administrative Code, is a minimum of a one year suspension up to revocation. For a "single count" violation of Rule 21S-28.120 (formerly Rule 21S-1.044), Florida Administrative Code, it is a minimum of a reprimand up to a maximum of a one year suspension and for a "single count" violation of Rule 21S-28.110 (formerly 21S-1.017), Florida Administrative Code, it is a minimum of a letter of guidance up to a maximum of "[o]ne (1) year probation and $1,000.00 fine (of drugs dispensed, one (1) year suspension)."

    
    

95. Subsection (3) of Rule 21S-30.001, Florida Administrative Code, provides that the Board may impose a penalty outside the normal range where there are mitigating or aggravating circumstances.

    
    

96. The mitigating or aggravating circumstances that may warrant such a deviation are described in subsection (3)(a) of Rule 21S-30.001, Florida Administrative Code, as follows:

    
    

    Aggravating circumstances: circumstances which may justify deviating from the above set forth disciplinary guidelines and cause enhancement of a penalty beyond the maximum level of discipline in the guidelines shall include but not be limited to the following:

    1. History of previous violations of the practice act and rules promulgated thereto.

    2. In the case of negligent acts, the magnitude and scope of the damage or potential damage inflicted upon the patient or the general public by the licensee's misfeasance.

    3. Evidence of violation of professional practice acts in other jurisdictions wherein the licensee has been disciplined by the appropriate regulatory authority.

    4. Violation of a provision of the practice act wherein a letter of guidance as provided in F.S. 455.255(3) has previously been issued to the licensee.

    (b) Mitigating circumstances; circumstances which may justify deviating from the above set forth disciplinary guidelines and cause the lessening of a penalty beyond the minimum

    level of discipline in the guidelines shall include but not be limited to the following:

    1. In cases of negligent acts, the minor nature of the damage or potential damage to the patient's or the public's health, safety and welfare resulting from the licensee's misfeasance.

    2. Lack of previous disciplinary history in this or any other jurisdiction wherein the licensee practices his profession.

    3. Restitution of any monetary damage suffered by the patient.

    4. The licensee's professional standing among his peers.

    5. Steps taken by the licensee to insure the non-occurrence of similar violations in the future including continuing education.

    6. The degree of financial hardship incurred by a licensee as a result of the imposition

    of fines or the suspension of his practice.

    
    

97. Subsection (1) of Rule 21S-30.002, Florida Administrative Code, lists those statutory and rule violations that the Board, in accordance with Section 455.225(3), Florida Statutes, has determined are "minor violations under this [statutory] provision that do not endanger the public health, safety, and welfare and which do not demonstrate a serious inability to practice the profession." Among the statutory and rule violations listed in subsection (1) of Rule 21S-30.002, Florida Administrative Code, are the following: "[m]isbranded or adulterated products held for sale- 499.005, F.S.;" "[i]nformation required on controlled substance prescriptions: practitioner's address, practitioner's DEA registration number, patient's address- 893.04;" and "[c]losed sign missing, prescription department not padlocked- 21S-28.109."

    
    

98. Subsection (2) of Rule 21S-30.002, Florida Administrative Code, provides that a Department investigator may issue a "Notice of Deficiencies" when an inspection reveals the existence of such "minor violations," and if these "minor violations" are "correct[ed]" in a timely manner no further disciplinary action will be taken against the licensee.

    
    

99. Having carefully considered the facts of the instant case in light of the provisions of Chapter 21S-30, Florida Administrative Code, set forth above, the Hearing Officer concludes that the Board should discipline Haro for having committed the violations (alleged in Counts I, III, VIII, VIV, and XV of the Amended Complaint/Haro) found above by suspending his license for a period of 60 days, placing him on probation for a period of one year following the end of his suspension subject to such terms as the Board may specify, and requiring him to pay an administrative fine in the amount of $1,500.00, and it should discipline Rome for having committed the violations (alleged in Counts I, V, VII, IX, and XI of the Amended Complaint/Rome) found above by suspending its permit to operate La Generosa as a community pharmacy for a period of two years, placing it on probation for a period of one year following the end of its suspension subject to such terms as the Board may specify, and requiring it to pay an administrative fine in the amount of $2,500.00.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board, with respect to Case No. 91-6297, enter a final order finding Haro guilty of the violations alleged in Counts I, III, VIII, VIV, and XV of the Amended Complaint/Haro and disciplining him for having committed these violations by suspending his license for a period of 60 days, placing him on probation for a period of one year following the end of his suspension subject to such terms as the Board may specify, and requiring him to pay an administrative fine in the amount of $1,500.00, and, with respect to Case No. 92-0227, enter a final order finding Rome guilty of the violations alleged in Counts I, V, VII, IX, and XI of the Amended Complaint/Rome and disciplining it for having committed these violations by suspending its permit to operate La

Generosa as a community pharmacy for a period of two years, placing it on probation for a period of one year following the end of its suspension subject to such terms as the Board may specify, and requiring it to pay an administrative fine in the amount of $2,500.00.

DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of September, 1993.

STUART M. LERNER

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 27th day of September, 1993.

ENDNOTES

1/ Rome objected to the admission of Petitioner's Exhibits 6 and 7 on the ground that they were the product of an illegal search and seizure. "Although the exclusionary rule is generally inapplicable [in an administrative proceeding], . . . a narrow exception to this rule may be found under circumstances involving 'egregious violations of Fourth Amendment or other liberties that might transgress notions of fundamental fairness and undermine the probative value of the evidence obtained.'" Valdez v. Department of Revenue, 18 FLW D1624 (Fla. 1st DCA July 19, 1993). There is no evidence that such "egregious violations," warranting the application of the exclusionary rule to render inadmissible Petitioner's Exhibits 6 and 7, were committed in the instant case.

2/ Both Haro and Diaz had a key to the door.

3/ Gluck had been unaware of the existence of this hidden room at the time of his prior inspection of the Pharmacy 13 months previous.

4/ Haro had been the Pharmacy's prescription manager for only approximately a month and half at the time of the inspection.

5/ The "misbranding" of drugs is prohibited, but by Section 499.005(2), Florida Statutes, a statutory provision that Rome was not charged with violating in the Amended Complaint/Rome.

APPENDIX TO RECOMMENDED ORDER, CASE NOS. 92-6297 and 92-227

The following are the Hearing Officer's specific rulings on the "findings of facts" proposed by the Department and Haro in their post-hearing submittals:

The Department's Proposed Findings

1-10. Accepted and incorporated in substance, although not necessarily repeated verbatim, in this Recommended Order.

11a. To the extent that this proposed finding states that the inspection revealed that "prescriptions were being filled" by someone other than a "registered pharmacist," it has been rejected because it is not supported by sufficiently persuasive competent substantial evidence. Otherwise, it has been accepted and incorporated in substance.

11b-h. Accepted and incorporated in substance.

11i. First sentence: To the extent that this proposed finding states that neither "a copy of the laws and rules governing pharmacy," nor "a negative formulary" were found by the inspection team, it has been accepted and incorporated in substance. To the extent that it states that these items were not in the Pharmacy at the time of the inspection, it has been rejected because it is contrary to the greater weight of the evidence; Second sentence:

Accepted and incorporated in substance.

11j-15. Accepted and incorporated in substance.

1. Rejected because it is contrary to the greater weight of the evidence.

2. Accepted and incorporated in substance.

3. Rejected because it is contrary to the greater weight of the evidence.

4. Accepted and incorporated in substance.

Haro's Proposed Findings

1. Fifth sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact based on such testimony; Seventh sentence: Rejected because it is more in the nature of argument regarding the sufficiency of the record evidence than a finding of fact based upon such evidence; Remaining sentences: Accepted and incorporated in substance.

2. Last sentence: Accepted and incorporated in substance; Remaining sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact based on such testimony.

3. First and second sentences: Accepted and incorporated in substance; Third and fourth sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact based on such testimony.

4, 5. Last two sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact based on such testimony; Remaining sentences: Accepted and incorporated in substance.

6, 7, 8. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the state of the evidentiary record.

1. First sentence: Accepted and incorporated in substance; Second and third sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact based on such testimony.

2. First sentence: Accepted and incorporated in substance; Second sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the state of the evidentiary record.

3. First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact based on such testimony; Second sentence: Accepted and incorporated in substance.

4. Rejected because it is more in the nature of a summary of testimony than a finding of fact based on such testimony.

5. First sentence: Rejected because it is more in the nature of a summary of testimony than a finding of fact based on such testimony; Second sentence: Accepted and incorporated in substance.

6. Accepted and incorporated in substance.

7. First sentence: Accepted and incorporated in substance; Second sentence: Rejected because it is not supported by sufficiently persuasive competent substantial evidence; Third sentence: Rejected as a finding of fact because it is more in the nature of argument regarding the state of the evidentiary record.

8. First and second sentences: Rejected because they are more in the nature of summaries of testimony than findings of fact based on such testimony; Third sentence: Accepted and incorporated in substance.

COPIES FURNISHED:

Charles Faircloth, Esquire

William A. Bausch, Qualified Representative Department of Business and Professional

Regulation

1940 North Monroe Street, Suite 60

Tallahassee, Florida 32399-0792

Steve Polatnick, Esquire

10691 Kendall Drive, Suite 101

Miami, Florida 33176

Philip M. Schutzer, Esquire 999 Ponce de Leon Boulevard Suite 1000, 10th Floor

Coral Gables, Florida 33134

John Taylor, Executive Director Board of Pharmacy

Department of Business and Professional Regulation

1940 North Monroe Street Tallahassee, Florida 32399-0792

Jack McRay, Esquire General Counsel

Department of Business and 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 10 days in which to submit written exceptions. Some agencies allow a larger period of time 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.

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

AGENCY FINAL ORDER

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

STATE OF FLORIDA

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION BOARD OF PHARMACY

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION,

Respondent.

/

FINAL ORDER

THIS CAUSE came on to be heard before the Florida State Board of Pharmacy at a regularly scheduled meeting held in Panama City, Florida, on March 28, 1994, at the result of a Recommended Order entered in this cause by Hearing Officer Stuart M. Lerner on September 27, 1993. The Board accepted the proposed findings of fact of the Hearing Officer, however, exceptions were filed as to certain of the conclusions of law.

The Petitioner, Department of Business and Professional Regulation filed exceptions to the Hearing Officer's conclusions of law set forth in paragraphs 48, 49, 78, 79 and 80 of the Recommended Order. In those findings, the Hearing Officer determined that the provisions of Section 465.Q16(1)(n), F.S., relating to Respondent, Haro and Section 465.023(1)(c), F.S., relating to Respondent, Rome, Inc., only encompass violations of Chapter 499, F.S., and do not encompass violations of rules promulgated thereunder by the Department of Health and Rehabilitative Services and contained in various provisions of Chapter 10D-45,

F.A.C. It was the position of the Petitioner that insofar as, Section 465.016(1)(n), F.S., and Section 465.023(1)(c), F.S. make violations of Chapter

499 violations of the applicable provisions of Chapter 465, and thus subject licensees and permittees to discipline for such transgressions, that the rules promulgated under Chapter 499, also are included in the various violations of Chapter 465.

The Board has consistently taken the position that the provisions of Chapter 465.016(1)(n), F.S., and 465.023 (1)(c), F.S., also include therein by necessity those provisions of Rule 10D-45, F.A.C., which relate to the practice of pharmacy and the operations of a pharmacy. In the Boards opinion, it is axiomatic that if provisions of Florida law such as Chapter 499 include the authority on the part of the implementing agency to adopt rules explaining and further refining the statute, then the rules are simply extensions of the statute and for disciplinary purposes are identical to the statute. As such therefore, while it might be more appropriate to plead any violations of Chapter 10D 45, by annotating the applicable provisions of Chapter 499 which are being

implemented by the DHRS Rule, it is apparent that a violation of Chapter 10D-45, at least as regards those sections which implement the provisions of Chapter 499 which impact pharmacy practice is indeed a violation of Chapter 499, and thus within the statutory mandate Chapter 465.

Thus, it is the determination of the Board of Pharmacy that the various counts of the Administrative Complaint relating to Respondents, Carlos Haro and Rome, Inc. that were dismissed by the Hearing Officer for the reasons set forth above are hereby reinstated, and the Respondents are found to be in violation of the provisions of Chapter 465 set forth therein by violating Chapter 499 and the rules promulgated thereto.

Notwithstanding the foregoing, the Board has determined that the Hearing Officer's recommended penalty in this matter is appropriate, and with the above- mentioned modification, the conclusions of law and recommended penalty are accepted by the Board of Pharmacy.

It is hereby ORDERED and ADJUDGED that based upon the foregoing, Respondent Rome, Inc., is hereby found to be in violation of the charges set forth in Counts,1,4,5,7,9,10 and 11, and is hereby FINED $2500,00 to be due and owing within ninety (90) days of the issuance of this Order. Further, Respondent's license to operate a pharmacy in the State of Florida is hereby SUSPENDED for a period of one year followed by a period of five (5) years PROBATION under the following terms and conditions:

1. Respondent shall not violate the laws and rules governing the practice of pharmacy in the State of Florida.

   
   

2. During probation, there shall be two additional inspections per year by pharmacy inspectors employed by the Department of Business and Professional Regulation at any pharmacy wherein Respondent is employed as a pharmacist. The cost of inspections shall be borne by Respondent.

   
   

3. Respondent and employer shall submit three (3) quarterly reports during the first three years to the Board of Pharmacy as to the quality of Respondent's practice of his profession, and Respondent shall immediately notify the Board of any change of employment.

DONE and ORDERED this 12th day of April 1994, by the Florida Board of Pharmacy.

JOHN D. TAYLOR EXECUTIVE DIRECTOR

COPIES FURNISHED:

Carlos A. Haro

Stuart M. Lerner, Hearing Officer Phillip Schutzer, Esquire

Kim M. Fluharty, Esquire

Docket for Case No: 91-006297

Orders for Case No: 91-006297