- RECEIVED DEPARTHERT OF HEALTH STATE OF FLORIDA Gode ont HOY -3 PH 4:49 DEPARTMENT OF HEALTH | - , OFFICE OF THE CLERK > an DEPARTMENT OF HEALTH, by and So 8 ae through its BUREAU OF STATEWIDE Ge= oO ee PHARMACEUTICAL SERVICES, Sah as i 232 — 1 Petitioner, = = Pt eatin 3 ¥ ad! Vv. CASE NO.: < : ; . am 5 PARKE MEDICAL SUPPLY, INC., a Florida Corporation and KIRSTEN SAVERY, Respondents. i AMDINISTRATIVE COMPLAINT YOU ARE HEREBY NOTIFIED that the Petitioner, Florida Department of Health, by and through its Bureau of Statewide Pharmaceutical Services files and serves this administrative complaint against Respondents, Parke Medical Supply, Inc. and Kirsten Savery seeking to suspend or revoke Florida prescription drug wholesaler permit of Parke Medical Supply, Inc., permit number 22:00990 and to impose and administrative fine of $15,000 jointly and severally against both Respondents, or impose any other penalty on the Respondents authorized by law. In support of its complaint the Bureau states: . : 1. The Department of Health (hereinafter the “Department’), through the Bureau of Statewide Pharmaceutical Services (the “"Bureau’) is the state agency charged with regulating the wholesale distribution of prescription drugs from, in or into the State of Florida pursuant to Chapter 499, Florida Statutes, ("F.S.”) (the “Act”) and Florida Administrative Code Rule 64F-12. 2. Section 499.066(5), Florida Statutes, empowers the Secretary of the Department of Health (hereinafter, “the Secretary”) to issue an emergency order immediately suspending a permit, including the permit of a prescription drug wholesaler, if the department has determined that any condition in the permitted establishment presents a danger to the public health, safety, and welfare, Such orders are also governed by the provisions of Section 120.60(6), F.S. 3. Section 499.065(3), Florida Statutes further empowers the Department to require the immediate closure of a prescription drug wholesale establishment, among others, if it determines that establishment to be an imminent danger to the public health if the establishment fails to comply with applicable laws and rules and such failure presents an imminent threat to the public's health, safety or welfare. In particular the Legislature found at Section 499.065(3) that: For purposes of this section, a refusal to allow entry to the department for inspection at reasonable times, or a failure or refusal to provide the department with required documentation for purposes of inspection, constitutes an imminent danger to the public health. 4. The Bureau has issued Parke Medical Supply, Inc. located at 6500 West Rogers Circle, Suite 6000, Boca Raton, Palm Beach County, Florida 33487 (hereinafter “Parke”) a permit under the Florida Drug and Cosmetic Act, Chapter 499, F.S., ("the Act”) to operate at that location as a prescription drug wholesaler, permit number 22:00990. This permit is due to expire May 31, 2006, unless sooner suspended or revoked. 5. On or about October 12, 2005, at 12:15 pun., inspectors from the Bureau began a routine inspection of Parke under Section 499.051, Florida Statutes. After the inspectors requested records of Parke's wholesale purchases and sales of prescription drugs, however, Parke refused any opportunity to copy such records and demanded that the inspectors leave the establishment, refusing. the inspectors the ability to complete the inspection and copy records. Moreover, before Parke told the inspectors to leave, as to the records which the Bureau inspectors requested, Parke.had told the inspectors that the records were not available as they were boxed up. Upon further inspection of the premises, the agents discovered that in fact records related to the purchase and sale of prescription drugs were not boxed up but were filed in cabinets, easily accessible to the establishment managers and owners. The agents then 2 of 6 requested to inspect those records, were refused, and subsequently at about 5:15 p.m., October 12, 2005, Parke demanded that the Bureau's inspectors leave the premises. Even though © Parke subsequently permitted the bureau to complete its inspection and copying of the business records of Parke, Parke’s actions on October 12, 2005 violated Section 499.005(6) and (19), Florida Statutes. 6. In addition, although the Bureau's investigation of Parke is not complete and is on-going, the Bureau found that Parke failed to provide an accurate, verified pedigree paper whenever it sold a prescription drug to another prescription drug wholesaler within the calendar year 2005. In particular it provided purchasing wholesalers with pedigrees that falsely indicated the date of Parke’s acquisition of the prescription drug it was selling, as being the same date as the pending sale, regardless of the date of actual acquisition of the drug by Parke. This is a violation of section 499.0121(6)(d), Florida Statutes, and Florida Administrative Code Rules - 64F-12.012 and 64F-12.013(5)(d), and further constitutes continuing course of conduct that jeopardizes public health and safety by distributing drugs which by virtue of the false pedigrees of Parke are deemed adulterated pursuant to Section 499.006(10), Florida Statutes. 7. By denying the Bureau an opportunity to determine Parke’s compliance with Chapter 499, Florida Statutes and Florida Administrative Code Rule 64F-12 in violation of sections 499.005(6) and (19) and 499,051(3), Florida’ Statutes, Parke presents an imminent danger to public health pursuant to. Section 499.065(3), Florida Statutes. Moreover, by violating the drug pedigree requirements of Section 499.0121(6), Parke has introduced adulterated prescription drugs into the marketplace in violation of Sections 499.005(1), (2), (4) and (23), Florida Statutes, Parke’s continuation as a prescription drug wholesaler in Florida constitutes an unnecessary risk to the unsuspecting consuming public, especially those who are frail and seriously ill, and their prescribing healthcare practitioners. Consequently, the Secretary of the Florida Department of Health has issued an Emergency Suspension Order ("ESO"), suspending 3 of 6 the wholesaler permit of Parke effective October 15, 2005 and throughout the pendancy of the proceeding on this administrative complaint. 8. The violations by Parke alleged in this complaint evidence a substantial failure by Parke to comply with, and are substantial violations of, the Act, and pursuant to section 499.067(1)(a) and (b)4. and 5., and (2) and (3)(c), F.S., the department is thereby authorized to suspend or revoke the prescription drug wholesaler permit of Parke. 9. Furthermore, the violations of the Act by Parke as set forth in this complaint constitute sufficient grounds for DOH to impose an administrative fine of Fifteen Thousand Dollars ($15,000) or impose any other penalty authorized by Chapter 499, F.S., and Chapter 64F-12, Florida Administrative Code against Parke.- 10. While reserving the right to amend this complaint or file an additional complaint . depending on the outcome of its continuing investigation of Parke, the bureau asserts that Rule : 64F-12.024(4), Fla. Admin. Code sets the range of the penalty for the violations of the Florida Drug and Cosmetic Act, Chapter 499, F.S., alleged in this complaint. Pursuant to that rule, and the facts alleged in this complaint, the bureau is justified in, and intends to impose the following fines totaling $15,000 against Parke: a. . The rule authorizes a fine for failing to permit inspection in Violation of Section 499.005(6) ranging from $500 to $5,000 per violation per day and also authorizes the suspension or revocation of a permit with the fine. The bureau intends to fine Parke $5,000 for its refusal to allow inspection and capying of its business records on or about October 12, 2005 and intends to revoke Parke’s prescription drug wholesaler permit for this violation. b. The rule authorizes a fine for making a false or fraudulent statement to the department in violation of Section 499.005(19) ranging from $500 to $5,000 per violation per day and also authorizes the suspension or revocation of a permit with the fine. The bureau intends to fine Parke $5,000 for its false statements to the department 4 of 6 about the true location of its business records and intends to revoke Parke’s prescription drug wholesaler permit. c. The rule authorizes a fine for providing false pedigree papers with the sale of prescription drugs in violation of Section 499.005(1), (2), (4), (19) and (23) ranging from $500 to $5,000 per violation per day and also authorizes the suspension or revocation of a permit with a fine. The bureau intends to fine Parke $5,000 for false pedigrees it provided with the sale of prescription drugs and intends to revoke Parke's prescription drug wholesaler permit for this violation, 41. You have the right to request an administrative hearing pursuant to sections 120.569 and 120.57, F.S., if you wish to challenge the intended agency action to impose an administrative fine and revoke the prescription drug wholesaler permit for Parke Medical Supply, Inc. Such proceedings are governed by sections 120.569 and 120.57, F.S., and Rules 28-106 and 28-107, Florida Administrative Code. Request for a hearing, formal or informal, must comply with Rule 28-107.004, Florida Administrative Code. . (a) You have the right .to be represented by counsel or other ~ alified representative, at your expense; to present evidence and argument; to call and cross-examine witnesses; and to have subpoena and subpoena duces tecum issued on your behalf if a hearing is requested. (b) A petition for administrative hearing must be in writing and must be received by the Agency Clerk for the Department, within twenty-one (21) days from the receipt of this correspondence. The address of the Agency Clerk is 4052 Bald Cypress Way, BIN # A02, Tallahassee FL 32399-1703. The Agency Clerk's facsimile number is 850-410-1448, (c) Mediation is not available as an alternative remedy. (d) Your failure to submit a petition for hearing within 21 days from receipt of this complaint and notice will constitute a waiver of your fight to an administrative hearing, under Florida Administrative Code Rule 28-106.111 and this complaint shall become a "final order". 5 of 6 (e) Should this complaint and notice become a final order, a party who i ds adversely affected by it is entitled to judicial review pursuant to s 120.68, F.S. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings may be commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Department of Health and ; a second copy, accompanied by the filing fees required by law, with the Court of Appeal in the appropriate District Court. The notice must be filed within 30 days of rendition of the final order. 12. The undersigned certifies that a true copy of this administrative complaint was sent by U.S. Certified Mail, Return Receipt Requested, to Kristen K. Savery, and to Parke Medical Supply, Inc., both at 6500 West Rogers Circle, Suite 6000, Boca Raton, Florida 33487, as well as to their attorney, Pamela A. Thomas, Esquire at Holland & ane LLP, 315 South sta Calhoun Street, Suite 600, Tallahassee, Florida 32301 this - day of October, 2005. ief of Pharmaceutical Services 818-A Mahan Drive : Tallahassee, Florida 32308 Telephone: (850) 922-5190 oh Hil, ‘Phi, CPh. Copy also furnished to: Counsel for the Department: Robert P. Daniti, Senior Attorney 4052 Bald Cypress Way, Bin AQ2 Tallahassee, Florida 32399-1703 Telephone (850) 245-4005 Facsimile (B50) 413-8743 Florida Bar No. 191599 6 of 6

Docket for Case No: 05-004637