STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) PHARMACY, )

)

Petitioner, )

)

vs. )

)

STICH ENTERPRISES, d/b/a )

SKYCREST PHARMACY, )

)

Respondent. )

Case No. 00-0220

)

)

DEPARTMENT OF HEALTH, BOARD OF ) PHARMACY, )

)

Petitioner, )

)

vs. )

)

ALBERT F. WILLIAMS, )

)

Respondent. )

Case No. 00-0315

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by Administrative Law Judge, Fred L. Buckine, held a formal hearing in the above-styled cause on November 17, 2000, in Clearwater, Florida.

APPEARANCES

For Petitioner: Lawrence F. Kranert, Jr., Esquire

Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317

For Respondent: B. Edwin Johnson, Esquire

1433 South Fort Harrison Avenue Suite C

Clearwater, Florida 33756 STATE OF THE ISSUES

Whether Respondent, Albert F. Williams, licensed pharmacist and sole owner of Stich Enterprises, d/b/a Skycrest Pharmacy, a licensed community pharmacy, violated Section 499.005(1), and 465.018, Florida Statutes, when (a) he allowed previously dispensed and returned prescription medication returned to the active shelf, none of which were in a sealed unit dose delivery system; (b) prescriptions which had been dispensed were not dated by the prescribing physician, and (c) C-II medication had been received without the DEA 222 forms being filled in as being received.

PRELIMINARY STATEMENT

On January 20, 2000, the Agency for Health Care Administration (AHCA) filed complaint No. 98-10401 against Albert F. Williams, licensed pharmacist, and was assigned Division of Administrative Hearings (DOAH) Case No. 00-0315. On January 20, 2000, ACHA filed complaint No. 98-10645 against Stich Enterprises, d/b/a Skycrest Pharmacy, licensed pharmacy and was assigned DOAH Case No. 00-0220.

On February 16, 2000, a Notice of Hearing, re: DOAH Case No. 00-0220 was entered scheduling the final hearing for May 9,

2000. On February 24, 2000, Notice of Hearing, re: DOAH Case No. 00-0315, was entered scheduling the final hearing for May 16, 2000.

On March 21, 2000, Petitioner filed its Motion to Abate Case Nos. 00-0220 and 00-0315, and an Order Granting Abeyance was entered on March 24, 2000.

On March 7, 2000, Petitioner's Motion to Consolidate Case Nos. 00-0220 and 00-0315 for trial purposes was filed and an Order Granting Consolidation was entered March 24, 2000.

On July 20, 2000, Petitioner's Motion To Compel Discovery and Tax Cost and Award Attorney's Fees was filed and an Order compelling discovery and denying taxing cost and attorney's fees entered August 3, 2000.

On August 23, 2000, an Order scheduling both cases for final hearing on November 16 and 17, 2000, was entered. By stipulation the parties agreed the final hearing would require one day, November 17, 2000.

The Administrative Law Judge accepted and by reference incorporates herein Petitioner's and Respondent's joint stipulation to the following facts:

1. As of November 17, 2000, Stich Enterprises d/b/a Skycrest pharmacy, (hereinafter Skycrest) was no longer a viable Florida business entity having been administratively dissolved by the Office of the Secretary of State.

2. Stich Enterprises, as of November 17, 2000, ceased conducting its pharmacy business.

3. Stich Enterprises d/b/a Skycrest Pharmacy possessed a Florida community pharmacy license, numbered 0012143.

4. Mr. Albert F. Williams, sole owner of Stich Enterprises, will surrender to ACHA, pharmacy license numbered 0012143.

5. Petitioner's evidentiary allegations shall include the (Skycrest) pharmacy because items to be introduced into evidence were found in the pharmacy.

6. Penalties, if any, will be imposed against Mr. Albert F. Williams, individually, and/or against the pharmacist license No. 0008425 issued to Mr. Albert F. Williams.

Prior to presentation of its case, Petitioner requested the Administrative Law Judge to take official notice of the penal provisions pursuant to Chapter 455.627(5), renumbered 456.079(5), Florida Statutes; Subchapters 456, Disciplinary actions; Chapter 465 Pharmacy Practice Act; and Chapter 499, Cosmetics Act. Additionally, Petitioner requested official notice be taken of Chapter 893, Controlled Substance Act, and Rule 64B14, Florida Administrative Code, neither of which was a part of the Administrative Complaint.

Respondent objected to official notice being taken of any and all statutes and rules not cited in the complaint.

Respondent based his objection on the principle that official notice of Florida Statutes and Administrative Rules' violations, not charged in the Administrative Complaint, and first presented

at the final hearing constituted trial by ambush, and was therefore a denial of Respondent's due process right.

Respondent constantly raised objections during the hearing over evidence offered to demonstrate violation of an administrative rule or statute which were not a part of the Administrative Complaint.

This Administrative Law Judge took official notice of all Florida Statutes and Administrative Rules cited in the Administrative Complaint and alleged to have been violated by the specific conduct specified in the Administrative Complaint.

Petitioner called two witnesses, Albert F. Williams, Respondent, and Mr. Wayne Rowe, ACHA's investigator. Respondent called one witness, Mr. Albert F. Williams. Petitioner's Exhibits 1, 3, 4, 5, 6, 7, 8, and 9 were admitted into evidence. Respondent submitted no exhibits.

The Transcript was delivered on December 4, 2000, and the parties were given 15 days thereafter for submission of their respective proposed findings of fact, conclusions of law, memoranda of law and closing arguments, if any. Respondent delivered his Proposed Findings of Fact, Conclusions of Law, and Recommended Order on December 18, 2000. Petitioner, Department of Health, Board of Pharmacy, did not submit a proposed finding of fact, conclusions of law, or recommended order.

FINDINGS OF FACT

1. The Department of Health, Board of Pharmacy, pursuant to Chapter 465.004, Florida Statutes, has authority to adopt rules pursuant to Sections 120.536(1) and 120.54, Florida Statutes, and to implement the provisions of Chapter 465, Florida Statutes, conferring duties upon the Board.

2. At all times material hereto, Albert F. Williams was the holder of pharmacist license No. 0008425 issued by the State of Florida, Board of Pharmacy, and was also licensed as a consulting pharmacist.1

3. At all times material hereto, Stich Pharmacy, d/b/a Skycrest Pharmacy (Skycrest) was the holder of Pharmacy license No. 0012143, issued in 1950 by the State of Florida, Board of Pharmacy, for operation of a community pharmacy.2 By reference, the six statements of facts above listed in the preliminary statement and stipulated to by the Petitioner and Respondent are incorporated herein.

4. At all times material hereto, Albert F. Williams was the sole owner of Skycrest Pharmacy and was employed by Skycrest as its prescription department manager. As pharmacy manager, Albert Williams knew from previous experience that he was the person responsible for compliance by all Skycrest employees, including pharmacist, trainees, pharmacist-technicians, and

   delivery person, with Florida Statutes, administrative rules, and federal regulations governing pharmacy and pharmaceuticals in the operation of a community pharmacy business servicing both institutional and public clients, to include, but not limited to, maintaining all drug records and providing for the security of the prescription department.

5. At all times material hereto, Skycrest, a community pharmacy, filled and refilled prescriptions received from nursing homes, refilled prescriptions received from Assisted Living Facilities (hereinafter ALFs) and refilled prescriptions received from the general public as walk-in clients.

6. At all times material hereto, Skycrest accepted the return of previously dispensed pharmaceuticals contained in vials and contained in cassettes, from numerous nursing homes, from numerous ALFs, and from persons who represented themselves to Skycrest employees as "family" or "caretakers" of persons residing in various nursing homes or residing in various ALFs.

7. At all times material hereto, Skycrest took back cassettes containing previously dispensed inpatient medications. Skycrest redispensed medications and returned both previously dispensed medications and redispensed medications in cassettes to residents in nursing homes and ALFs. The prescription labels on the bottom of incoming cassettes were not changed to reflect

   redispensing of additional medications prior to those cassettes being redelivered to the respective nursing homes and ALFs.

8. At all times material hereto, Skycrest employed a driver, who every seventh or eighth day, picked up Opus system3 cassettes from various nursing homes and ALFs. These cassettes were returned to Skycrest, whereupon empty and partially used unit dose compartments would be refilled with redispensed medications. Redispensed and unused previously dispensed medications were then returned to the respective nursing homes and ALFs in the refilled and redispensed Opus system cassettes.

9. At all times, material hereto, Albert Williams, admittedly directed the business of the Skycrest pharmacy department to accept "returned previously dispensed mediations, not given to patients nor paid for by the nursing homes or ALFs, because such medications are owned by Skycrest; that additional redispensed medications were also owned by Skycrest until nursing homes and ALFs made monthly payment for the medications given to their patients, and that all payments to Skycrest from various nursing homes and ALFs were to be computed from and based upon the Medical Administration Records4 (herein after MAR) maintained by Skycrest and maintained at each nursing home and each ALF serviced by Skycrest."

10. At all times material hereto, Skycrest received and accepted controlled substance medications in vials brought in by

    "caretakers" and/or "family" members of residents living in nursing homes and ALFs; took controlled substance medications from returned vials, added controlled substance medication to the returned controlled substance medication taken from the vials and thereafter redispensed controlled substance medication in the Opus system cassettes to licensed nursing homes and licensed ALFs.

11. Mr. Alfred Williams, as pharmacy manager of Skycrest, operated the pharmacy on his belief that the law provided that Skycrest could take back medications, and those medications previously dispensed but not ingested could be redispensed. Mr. Williams acted on his belief that the law was written because many pharmacies were taking back previously dispensed

    medications and redispensing, and that the law was aimed to help reduce the burden of expense on patients' families. Mr.

    Williamss admitted that he does not know whether or not the law upon which he operated Skycrest and relied upon applied to institutional pharmacies only and not to community pharmacies servicing ALFs and nursing homes.

12. Petitioner does not contest the fact that the Board of Pharmacy has approved the Opus cassette system as an acceptable closed unit dose system when employed in accordance with applicable rules.

13. The expiration dates for medications found in Skycrest pharmacy are written on the containers in which the pharmacy received the medication from a pharmaceutical wholesaler.

14. At all times material hereto, Skycrest would accept vials of outdated, returned controlled medication and would keep those vials for an undetermined length of time in a box for disposal; or should a customer or caretaker come back and ask for his/her vials, they were returned to those customers. Mr. Alfred Williams did not keep a separate record of the date each vial was returned to the pharmacy; to ascertain a return date Mr. Williams would refer to Skycrest's copy of the MARs.

15. At all times material hereto, Mr. Alfred Williams knew that when dispensing controlled substance medications, the dispensing pharmacist must instruct the recipient of the controlled substance that if it is not used by the patient, that it has to be destroyed at that location. The returned vials of dated controlled medication would be kept by Skycrest for a year after return for either use by the customer or ultimate disposal by Skycrest.

16. Mr. Alfred William admitted that the destruction of controlled substance medications at the patient's location did not occur in the Opus unit dose system which he, as manager of Skycrest pharmacy department, instituted and continued in the exchange every seven days, resulting in returned controlled

    substance medication ending up in possession of Skycrest pharmacy department after having been redispensed.

17. Mr. Williams' response to allegation (b) of the complaint, was that his pharmacy, following the accepted standard of practice in the pharmacy profession, when confronted with prescriptions without dates, would call the prescribing physician's office to confirm missing dates (and other needed information, if any) and the information provided was entered into Skycrest's computer system. With "missing date" information from the face of the prescription, but contained in Skycrest's computer system, compliance with the purpose and intent of the rule is accomplished.

18. On or about March 31, 1998, agency employees, William Herbert, investigator; Wayne Rowe, investigator trainee; and Dennis Force, photographer, conducted an unannounced inspection of Skycrest pharmacy. During the investigation, the investigators made observations of vials containing legend medications and controlled substance medications on active dispensing shelves. Petitioner's Exhibit No. 4 contains the name of the medication, prescription number and dispensed date of cassettes with Skycrest pharmacy labels; medication in vials from various Walgreen pharmacies, medication in cassettes with labels from other than Skycrest pharmacy, and unit dose pre- packaged medications from various pharmacies. Exhibit No. 5 is

    comprised of photos of cassettes containing medications assigned to various ALFs with each ALF's name taped on the bottom of each active shelf. Exhibit No. 6 is comprised of two original prescriptions and one prescription from Dental Emergency Room, PA,.

19. Based on experience as an agency field investigator, William Herbert professed familiarity with pharmacy licensing requirements and with Chapters 499 and Chapter 893, Florida Statutes, regarding controlled substance and adulterated pharmaceuticals and medicines. His uncontroverted testimony was that only three ALFs in Pasco, Pinellas, and Hernando counties are licensed to have on-site pharmacies and a consulting pharmacist, which permits resident patients of those facilities to return scheduled medications back to the dispensing on-site pharmacy for redispensing.5

20. Skycrest, a community licensed pharmacy, is limited in its business to dispensing medications to patients on a carry- out basis and can dispense to patients who are housed in short- term or long-term facilities only when each prescription is patient specific.

21. The ALFs and nursing homes, which were serviced by Skycrest via redispensing medication through the Opus unit dose closed system did not have a class I nor II institutional pharmacy license. Accordingly, neither resident patients of

    those not-licensed-institutions nor the institutions themselves were authorized by statute to return unused medications to non- resident pharmacies, including Skycrest, for redispensing.

22. Notwithstanding the classification of licensure held, institutional class I or class II, neither the nursing homes nor the ALFs are permitted to return controlled substance medication to a dispensing pharmacy for destruction under existing US Drug Enforcement Agency (DEA) rules.

23. Mr. Williams testified that the DEA 222 form is in triplicate. He explained that the one copy taken from his pharmacy by the investigator was incomplete because the controlled substance ordered from the pharmaceutical distributor (one copy sent with order) had not been either shipped by the distributor and/or received by Skycrest at that time. The testimony was that when controlled substances are ordered from distributors one copy of the DEA 222 accompanies that order. Second, when controlled substances are received from distributors, the recipient pharmacy completes the remaining two copies by inserting the date shipment received, source, kind, and quality of materials received. One completed copy of the DEA 222 form is returned to the distributor, and one completed copy is attached to the order and retained by the pharmacy as required by the rule. No evidence was introduced by Petitioner

    to contradict or challenge Mr. Williams' testimony regarding this system of dating DEA 222 form.

24. Skycrest accepted returned vials containing controlled substance medications and cassettes containing controlled substance and legend medications from non-institutional licensed ALFs and non-institutional licensed nursing homes neither of which had an on-site pharmacy or employed a licensed consulting pharmacist manager.

    CONCLUSIONS OF LAW

    
    

25. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this cause. Section 120.57, Florida Statutes.

26. The standard of proof required to discipline a licensee is that of clear and convincing evidence. See Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987); quoting Reid v. Florida Real Estate Commission, 188 So. 2d 846, 861 (Fla. 2nd DCA 1996) which stated that;

    The power to revoke a license should be exercised with no less careful circumspection that the original granting of it. And the penal sanctions should be directed only toward those who by their conduct have forfeited their right to the privilege, and then only upon clear and convincing proof of substantial causes justifying the forfeiture.

27. The Administrative Complaint alleges that Mr. Williams violated Sections 499.005(1) and 465.018, Florida Statutes, when he allowed in Skycrest pharmacy, in the disjunctive;

    1. previously dispensed and returned prescription medication were returned to active shelf, none of which were in a sealed unit dose delivery system;

       
       

    2. Prescriptions, which had been dispensed, were not dated by the prescribing physician.

       
       

    3. C-II medication had been received without DEA 222 forms being filed in as being received.

       
       

28. Section 499.005, Florida Statutes, delineates prohibited acts by those engaged in dispensing drug, cosmetic, and household products in Florida. Subsection (1), in pertinent part, prohibits:

    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.

    
    

29. The above subsection of the statute has two elements.

    
    

    First, there must be either "manufacture(ing)" or "repackaging" or "sale" or "delivery" of "holding" or "offering" for sale a drug. The second element, regarding those drugs identified in element one, is that they shall have been either/or "adulterated" or "misbranded" or "otherwise rendered "unfit" for human or animal use.

30. As to the first element, the credible evidence of record clearly demonstrated that Mr. Williams, through Skycrest pharmacy, repackaged, delivered, sold, and offered for sale, medications in the approved Opus unit dose system. Additionally, the credible evidence of record demonstrated that prescriptions, from Skycrest's walk-in clients, "relatives" or "caretakers" of residents in ALFs and/or nursing homes, as well as its ALF and nursing home Opus unit dose system clients, were filled and refilled from bulk stock ordered by the pharmacy. Petitioner offered not one scintilla of evidence to support any claim of "adulteration" of the vials and cassettes taken from the pharmacy. Neither was evidence presented regarding "misbranding" of prescription medication dispensed to walk-in clients or to ALFs and/or nursing homes clients using the Opus system for refills and redispensing of medication by Skycrest.

    Accordingly, Petitioner has failed to carry its burden regarding both elements of allegation (a) in the Administrative Complaint.

31. The credible evidence clearly demonstrates that Mr. Williams' pharmacy, Skycrest, utilized the approved (Petitioner's counsel agreed the Opus is approved by Board of Pharmacy) closed unit dose Opus cassette system for the

    redispensing, sale, and delivery of legend and controlled drugs to ALFs and nursing homes served by Skycrest pharmacy.

    Petitioner's evidence, testimony of its investigator and

    examination of Mr. Williams, regarding the security or lack thereof of the snap top on each cassette compartment failed to achieve the clear and convincing standard.

32. Petitioner's attempt to demonstrate a possibility of contamination by direct and cross-examination of Mr. Williams, to wit, that he could not guarantee that "any (some) one could have touched, handled, dropped and replaced a pill" prior to the time the Opus system cassettes were delivered to respective ALFs and nursing homes or that Mr. Williams "could not guarantee" that no pill in the unit dose compartments had not been touched by other than Skycrest authorized employees before ingestion, is pure speculation, and not supported by the evidence of record. There was no direct or indirect evidence presented by Petitioner that Mr. Williams "adulterated" or "misbranded" any medication contained in or redispensed through the Opus unit dose system or redispensed in the vials found on the pharmacy dispensing shelves. Of the many vials and cassettes taken and introduced into evidence, not one was shown to have been either "adulterated" or "misbranded" by Respondent.

33. Turning next to alleged violations of Subsections 499.005(1) and 465.018, Florida Statutes, contained in paragraph

    (b) of the Administrative Complaint, which states that Mr. Williams possessed:

    Prescriptions, which were dispensed, were not dated by the prescribing physician.

    
    

34. Neither Subsection 499.005(1), Florida Statutes, herein above cited nor Section 465.018, Florida Statutes, herein below applies to paragraph (b) of the Administrative Complaint:

    Any person desiring a permit to operate a community pharmacy shall apply to the department. If the board office certifies that the application complies with the laws of the state and 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 following such other rules as relate to the practice of the profession of pharmacy. The permittee and the newly designated prescription department manager shall notify the department within

    10 days of any change in prescription department manager.

    
    

35. Neither Section 465.018 nor Subsection 499.005(1), Florida Statutes, cited herein above, prohibits possession of "prescriptions, which were dispensed, not dated by the physicians." Additionally, Petitioner's Administrative Complaint cites no administrative rule which prohibits possession of "prescriptions, which were dispensed, not dated by the physicians" as illegal conduct.

36. "It is a basic tenet of common law pleading that the allegata and probata must correspond and agree." See Rose v.

    State, 507 So. 2d 630 (Fla. 5th DCA 1987). The Court explained

    
    

    that principle thus:

    
    

    This is basic due process of law and means that not only must the proof at trial or hearing be that conduct charged in the accusatorial [Administrative Complaint] document, but also that the conduct proved must legally fall within the statute [s.499.005(1) or s. 465.018] or rule [no rule cited in complaint] claimed to have been violated.

    
    

37. The Administrative Complaint in a licensure revocation case, at a minimum, must adequately detail the reasons or grounds and the specific statutes and/or administrative rules alleged to have been violated, upon which an agency would seek termination or revocation of Respondent's pharmacy license. See Woods v. Department of Transportation, 325 So. 2d 25 (Fla 4th

    DCA 1976) and Goldberg v. Kelly, 397 U.S. 254, 90 S. Ct. 1011,

    
    

    25 L. Ed.2d 287 (1970).

    
    

38. It was at the final hearing, over objections from Respondent, that Petitioner introduced evidence that medication remaining in the unit dose Opus system violated Rule 64B16- 28.118, Florida Administrative Code, because the ALFs serviced by Skycrest were not properly licensed to operate a pharmacy whereby sealed compartment unit dose medication could be returned for redispensing in the same sealed unit. The evidence of record showed that a majority of Respondent's business income was derived from servicing ALFs and nursing homes by and through

    refilling and redispensing through the Opus closed unit dose system.

39. That Skycrest was not properly licensed or was required to be licensed to conduct this specific type of pharmacy business was clearly a charge not contained in the administrative complaint filed in this case. The record here in wholly inadequate to support a finding that Respondent was fully apprised of specific matters to be considered at this hearing as possible grounds for his license revocation.

40. Respondent could not have known with any reasonable degree of certainty the nature of alleged violations or grounds for revocation of his license until after Petitioner had offered its evidence (statutes and rule violations) at the final hearing. See Lusskin v. State of Florida Agency for Health Care Administration, Board of Medicine, 731 So. 2d 67, 68 (Fla. 4th DCA 1999), from Woods v. Department of Transportation, 325 So. 2d 25 (Fla. 4th DCA 1976).

41. Respondent's telephonic (or other electronic methods) acquisition of missing dates does not violate the statutes or rules cited by Petitioner. Accordingly, Petitioner has failed to present credible, clear and convincing evidence, thereby failing to carry its burden of proof regarding paragraph (b) of the Administrative Complaint.

42. With respect to paragraph (c) of the Administrative Complaint:

    C-II medication has been received without the DEA 222 forms being filled in as being received.

    
    

43. The Administrative Complaint charges that the above allegation, if shown to be true, violates Section 465.016(1)(e), and Section 465.018, Florida Statutes. Neither of the above- cited sections of the Florida Statutes is applicable to the paragraph (c) allegation of the complaint. On that point alone, Petitioner has failed to meet its burden.

44. However, Section 893.07, Florida Statutes, does address the issue and in pertinent part, states:

    (2) The record of controlled substances received shall in every case show:

    1. The date of receipt.

    2. The name and address of the person from whom received.

    3. The kind and quantity of controlled substances received.

    
    

45. Assuming arguendo, that one copy of the DEA 222 form

was incomplete on or about the March 26, 1998, date of Mr. Herbert's initial inspection and gathering of evidence, no evidence that a follow-up inspection (checking receipt of medication and/or checking whether an order was, in fact, entered) was presented in either cross-examination or rebuttal phrases of the hearing. Accordingly, Petitioner has failed to prove by clear and convincing evidence that Respondent violated

any statute or rule by merely having in his possession one copy of a DEA 222 form missing a date.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Department of Health, Board of Pharmacy, enter a final order of dismissal with prejudice the complaint herein filed against Mr. Albert F. Williams, Registered Pharmacist. It is further recommended that the Board of Pharmacy, order Mr. Albert F. Williams to forthwith surrender Pharmacy license no. 0012143 issued to Stich Enterprises, Inc., d/b/a Skycrest Pharmacy as stipulated by the parties.

DONE AND ENTERED this 9th day of January, 2001, in Tallahassee, Leon County, Florida.

FRED L. BUCKINE

Administrative Law Judge

Division of Administrative Hearings The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399-3060

(850) 488-9675 SUNCOM 278-9675

Fax Filing (850) 921-6847 www.doah.state.fl.us

Filed with the Clerk of the Division of Administrative Hearings this 9th day of January, 2001.

ENDNOTES

1/ Section 465.003(3), Florida Statutes, defines "consulting pharmacist" as a pharmacist licensed by the department and certified as a consultant pharmacist pursuant to Section

465.0125, Florida Statutes. Section 465.0125 requires additional training in the practice of institutional pharmacy in additional to regular pharmacy. A consulting pharmacist shall be responsible for maintaining all drug records required by law and for establishing drug handling procedures for the safe handling and storage of drugs.

2/ Section 465.003(11), Florida Statutes, defines the term "community pharmacy" to includes every location where medical drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis. Nothing in this section of the Florida Statutes prohibits a community pharmacy from accepting prescriptions, and dispensing and redispensing medication to ALFs and nursing homes who are not licensed to have on-site pharmacies.

3/ Cassettes with eight individual unit dose compartments, each compartment sealed with a plastic snap cap, are referred to as the Opus Closed System for unit dose dispensing of medication.

The prescription authorizing this medication is glued on the bottom of each cassette; Petitioner's Exhibits 1 and 2 are examples.

4/ The Medical Administration Record (MAR) is a chart, maintained by the dispensing agent at each care facility, which records each patient, daily medication dosage prescribed, daily medication dose taken and the name or initials of the person giving each patient his/her daily medication dosage. At the end of each month, this record of medications taken by each patient is the basis for computing monthly payment to be made by each nursing home or ALF to Skycrest for medications ingested by patients.

5/ Section 465.019, Florida Statutes, defines "Institutional pharmacies" as Class I and Class II pharmacies. Class I pharmacies are those in which medicinal drugs are administered from individual prescription containers to the individual patient and in which medicinal drugs are not dispensed on the premises. Class Is are limited in that "no medicinal drugs may be dispensed therein. Class II pharmacies are pharmacies which employ the services of a registered pharmacist who shall provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution. Medicinal drugs may be dispensed in a Class II institutional pharmacy, but only in accord with the provisions of Section 465.019, Florida Statutes. Petitioner does not charge Respondent with violation of this section of the Florida

Statutes. Conversely, ALFs or nursing homes not possessing a Class II license, and who send their residents

prescriptions to community pharmacies such as Skycrest for dispensing and redispensing may be subject to allegations of violating Section 465.019, Florida Statutes.

COPIES FURNISHED:

B. Edwin Johnson, Esquire

1433 South Fort Harrison Avenue Suite C

Clearwater, Florida 33756

Lawrence F. Kranert, Jr., Esquire Agency for Health Care Administration Post Office Box 14229

Tallahassee, Florida 32317-4229

William W. Large, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Theodore M. Henderson, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

John Taylor, R.Ph., Executive Director Board of Pharmacy

Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.

Docket for Case No: 00-000315

Orders for Case No: 00-000315