STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

VETCO INTERNATIONAL, INC., ) d/b/a POMPANO VET SUPPLY, )

)

Petitioner, )

)

vs. ) CASE NO. 87-0832

) DEPARTMENT OF HEALTH AND ) REHABILITATIVE SERVICES, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, James E. Bradwell, held a public hearing in this case on August 18, 1987. The parties were allowed through October 16, 1987, to submit post-hearing memoranda which was considered by me in preparation of this Recommended Order. Proposed findings of fact which are not incorporated herein are the subject of specific rulings in an Appendix to the Recommended Order.

APPEARANCES

For Petitioner: Karen Coolman Amlong, Esquire

Amlong & Amlong, P.A.

101 Northeast Third Avenue Fort Lauderdale, Florida 33301

For Respondent: John Rodriguez, Esquire

Department of Health and Rehabilitative Services

2727 Mahan Drive

Fort Knox Executive Building Tallahassee, Florida 32308

ISSUE PRESENTED

Whether the wholesale drug permit applied for by Petitioner on December 6, 1986, should be granted.

INTRODUCTION AND BACKGROUND

On approximately December 6, 1985, Vetco International, Inc., d/b/a Pompano Vet Supply (Vetco) applied for a wholesale drug permit (No. 0300375) with the Pharmacy Office, Health Program Office, Department of Health and Rehabilitative Services (DHRS). (Respondent's Exhibit 6). In the application, Vetco listed its business operating hours as 10:00 a.m. to 4:00 p.m., Tuesday through Friday.

On various occasions during February, March, June, July and October, 1986, DHRS's agent attempted to inspect Petitioner's facility to determine if Vetco

was in compliance with the "Florida Drug and Cosmetic Act," pursuant to Chapter 499, Florida Statutes and Rule Chapter 10D-45, Florida Administrative Code.

On December 15, 1986, the Pharmacy Program Office of DHRS received an application for a 1987 drug wholesale permit renewal together with the appropriate fees from Thomas Karpinski, owner of Vetco. (Petitioner's Exhibit 1).

On December 17, 1986, the Administrator of the Pharmacy Program Office, DHRS, denied Vetco's application for a wholesale drug permit renewal stating, in summary fashion, that pertinent rules and regulations required that the Petitioner's facility where drugs are held and products, labeling of products and records, including purchase invoices, sales, shipping and receiving documents, be made available for inspection; that on several occasions, Vetco's facility was not made available to authorized agents of DHRS for inspection; that Petitioner's denial of inspections to DHRS agents constituted a substantial violation of Chapters 499, Florida Statutes and 10D-45, Florida Administrative Code, and therefore the denial of Vetco's permit renewal was warranted.

Petitioner has challenged that denial and requested a formal hearing to contest the proposed agency action.

Petitioner contends that it has fulfilled all legal requirements for renewal of its permit, that the denial was without properly delegated authority and finally, the inspection attempts were unreasonable. At hearing, Petitioner raised and preserved a challenge to the constitutionality of section 499.051, Florida Statutes and rules promulgated thereunder, both facially and as applied to it.

DHRS presented five witnesses in support of its position: Richard Grant, Theodore Tober, Charles Sanchez, Robert Loudis and Gregory Jones. Petitioner did not call any witnesses on its behalf but requested that administrative notice be taken of various statutes, rules and case law. Administrative notice was taken of pertinent statutes, rules and decisional authority.

FINDINGS OF FACT

Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I make the following relevant factual findings:

1. Petitioner, Vetco International, Inc., d/b/a Pompano Vet Supply, is holder of drug permit No. 0300375 issued for a facility at 125-B South Dixie Highway, Pompano Beach, Florida. (Petitioner's Exhibit 6).

   
   

2. Respondent, Department of Health and Rehabilitative Services, (DHRS), is the regulatory agency charged with the administration of Chapter 499, Florida Statutes, which includes the issuance of permits to operate a drug wholesale facility.

   
   

3. Petitioner's initial permit was issued effective January 18, 1985.

   
   

4. Petitioner filed an application to renew its permit for 1986 in December of 1985.

5. Respondent issued an order of emergency suspension of Petitioner's 1985 permit on December 20, 1985, and shortly thereafter filed an administrative complaint alleging various violations of Chapter 499, Florida Statutes.

   
   

6. Citing the allegations of the order of emergency suspension and administrative complaint, Respondent denied the renewal of Petitioner's permit for 1986. Thereafter, on April 27, a notice of dismissal of the administrative complaint was filed and on April 30, 1986, an order was entered "lifting" the order of emergency suspension.

   
   

7. During the normal course of business, DHRS sent a notice of renewal to Petitioner 60 days before expiration of its 1986 permit. Petitioner's renewal application for 1987 was received in DHRS's Pharmacy Program Office on or about December 15, 1986. Petitioner's renewal application was timely filed and the proper fees were attached to the application.

   
   

8. By letter dated December 17, 1986, Petitioner's renewal application was denied by Richard R. Grant, Administrator, Pharmacy Program Office. (Petitioner's Exhibit 2). It is that denial which is the subject of this proceeding.

   
   

9. Respondent presented evidence of twelve attempts to gain entry into Petitioner's facility for the purpose of conducting an inspection and monitoring of the facility to determine compliance with proper labeling, storage and other requirements as set forth in Chapter 499, Florida Statutes.

   
   

10. DHRS's drug inspectors Charles Sanchez and Malcom Gregory Jones attempted to inspect Petitioner's place of business on February 19, 1986. They could not gain access through the front door despite the fact that they knocked loudly on the front door and window. They also went around to the back of the facility and knocked. No one answered. The inspectors presented themselves during Petitioner's stated hours of doing business. Inspector Jones was able to identify Mr. Karpinski on the inside of the facility.

    
    

11. On Monday, March 17, 1986, Sanchez and Jones along with other agents again visited Petitioner's place of business to attempt an inspection. Petitioner's normal business days were Tuesday through Friday. On that occasion, DHRS agents spoke with owner Karpinski who told them that his attorney had advised him not to permit entry to the agents. Karpinski followed the advice of his counsel and refused entry to the agents.

    
    

12. On the following day, Sanchez and Jones returned to attempt an inspection without success.

    
    

13. On June 4, 1986, DHRS inspector Robert Loudis visited Petitioner's place of business to perform a routine inspection. Loudis also made unsuccessful attempts to inspect Petitioner's facility on June 4, June 6, June 18 and June 20, 1986.

    
    

14. On July 9, 1986, inspector Grant, accompanied by Sanchez, visited Petitioner's facility to conduct an inspection. The agents were unable to gain access to the facility to conduct the inspection.

    
    

15. On July 18, 1986, Loudis returned to Petitioner's facility at 2:45

    p.m. He was unable to gain access to the facility to conduct the inspection.

16. On October 14, 1986, inspector Loudis reached Thomas Karpinski by telephone. Karpinski agreed to permit an inspection at 2:00 p.m. the following day. Loudis arrived at approximately 2:00 p.m. as agreed to conduct the inspection. He knocked on the door several times and did not received a reply.

    
    

17. Petitioner contends that the only time that any agent of Petitioner refused an inspection to DHRS agents was on a non-business day during the time when Petitioner's permit was suspended or the denial of entry was pursuant to advice of counsel. Secondly, Petitioner contends that there is no requirement that a drug warehouse facility be open at any given time, including the days or hours that is specified on the application as "normal business hours." Finally, Petitioner contends that DHRS failed to prove that it delegated to Grant, the authority to deny Petitioner's renewal application. In this regard, DHRS submitted post-hearing, pursuant to leave granted from the undersigned, a delegation of authority which shows that Richard Grant was authorized to grant or deny wholesale drug renewal applications.

    
    

18. On December 17, 1986, the Administrator of the Pharmacy Program Office denied Vetco's application for a wholesale permit renewal. This denial was based upon Vetco's refusal to allow inspections of its facility by Pharmacy Program Office Inspectors. (Petitioner's Exhibit 2).

    
    

    CONCLUSIONS OF LAW

    
    

19. The Division of Administrative Hearings has jurisdiction over the subject matter and parties to this action. Subsection 120.57(1), Florida Statutes, (Supp. 1986).

    
    

20. The parties were duly noticed pursuant to the notice provision of Chapter 120, Florida Statutes.

    
    

21. The authority of Respondent, DHRS, is derived from Chapters 120 and 489, Florida Statutes and Rule Chapter 10D-45, Florida Administrative Code.

    
    

22. The Administrator of the Pharmacy Program Office has been properly delegated the authority to administer Chapter 499, Florida Statutes and Chapter 10D-45, Florida Administrative Code.

    
    

23. To enforce the provisions of Chapter 499, agents of DHRS are authorized to inspect, monitor and investigate all drug and cosmetic wholesalers. See Chapter 499.051, Florida Statutes and subsection 10D- 45.545(4), Florida Administrative Code. In this regard, subsection 10D- 45.545(1) paraphrases subsection 499.051, Florida Statutes, cited above. Subsection (2) of the rule adds:

    
    

    Inspections may be announced or unannounced at the discretion of the Department. Any owner, officer, or employee of the establishment or business shall make the premises available to the inspecting officer and shall make all records and other information required by Chapter 499 and the rules promulgated thereunder available to the inspecting officer.

    Additionally, Chapter 499.067, Florida Statutes authorizes DHRS to:

    
    

    ...deny,... a permit in any case in which it finds that there has been a substantial failure to comply with the provisions of Section 499... or the rules promulgated under such sections, or the procedures and protocols...

    
    

24. Competent and substantial evidence was offered herein to establish that Petitioner, by denying DHRS inspector's access to its facilities during the referenced times in 1986 constitutes a substantial failure to comply with the requirement that the licensed premises be available for inspections by employees of the department, at its discretion, either announced or unannounced as is provided in Chapter 499.051 Florida Statutes and Rule 10D-45.545(1) and (2), Florida Administrative Code.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED:

Petitioner's application for renewal of its wholesale drug permit No.

0300375, be DENIED.

RECOMMENDED this 28th day of March, 1988, in Tallahassee, Florida.

COPIES FURNISHED:

John Rodriguez, Esquire Assistant General Counsel Department of Health and Rehabilitative Services 2727 Mahan Drive

Fort Knox Executive Building Tallahassee, Florida 32308

JAMES E. BRADWELL

Hearing Officer

Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32399-1550

(904) 488-9675

Filed with the Clerk of the Division of Administrative Hearings this 28th day of March, 1988.

Karen Coolman Amlong, Esquire Amlong & Amlong, P.A.

101 Northeast Third Avenue Fort Lauderdale, Florida 33301

Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard

Tallahassee, Florida 32399-0700

Docket for Case No: 87-000832

Orders for Case No: 87-000832