ae DEPARTMENT OF HEALTH, | . through its BUREAU OF . - the bu bureau state -_ “STATE OF FLORIDA oy oS : DEPARTMENT OF HEALTH ' APR 18 py 2: 1g PHARMACY SERVICES, Petitioner, Case No: vs. Bo (DOH: 99-03772) FLORIDA GENETICS CENTER, INC., a Florida Corporation, and RITA BUENO, Individually, Respondents. ADMINISTRATIVE. COMPLAINT Notice is hereby provided that Petitioner, Department of Health by and through its Bureau of Pharmacy Services (the "bureau”), intends to impose against Respondents, Florida Genetics Center, Inc., (“Florida Genetics”), a Florida corporation, and Rita Bueno, Individually, an administrative fine in the amount of forty-four thousand dollars ($44,000), pursuant to section 499.066(3), Florida Statutes, and deny the renewal applications of Florida Genetics Center, Inc., to operate as a prescription drug wholesaler (permit number 22: 00880) and veterinary legend drug retailer (permit number ‘25: 00026) in Florida. In In suppor of the intended final al agency é action : implementing and enforcing the. provisions of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, including the regulation of the acquisition and distribution of prescription drugs in Florida as well as the permitting of entities to engage i in this activity. The prescription drug Drug and Cosmetic Act, Chapter 4 499, Florida a Statutes. wholesaler permit and v =terinary legend drug retailer permit are established under the Florida . : aiting the per d De (2) Respondent, Florida Genetics Center, Inc., is a Florida registered corporation whose principal place of business is 175 Fontainebleau Boulevard, Suite 2J2, Miami, Dade County, Florida, 33172, “Respondent is - permitted asa prescription drug wholesaler (permit number 22:00880) pursuant to the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. This permit will expire on February 28, 2001. Respondent is also permitted as a veterinary legend drug retailer {permit number 25: 00026) pursuant to the Florida Drug and Cosmetic Act, Chapter 490, Florida Statutes. This permit will also expire on February 28, 2001. (3) Respondent, Rita Bueno, is the president of Florida Genetics Center, Inc., and was at all times material hereto responsible for and involved in the prescription drug wholesale operations of Florida Genetics. (4) Florida Genetics submitted to the bureau renewal applications for permit numbers 22:00880 and 25:00025. The bureau received these applications and requisite fees on January 16, 2001. (5) Section 499.005 (15), F.S. prohibits the sale or transfer of a legend drug toa person that is not authorized under the law of the jurisdiction i in which the person receives the drug to purchase or possess the legend drugs. (6) Respondents transferred prescription drugs, in at least forty-four transactions o7 t through May 28, 1999, to persons not authorized to ‘Possess prescription drugs | in Miami, Florida, in violation of 8. 499. 005(15), | F. Ss. Ml Controlled Substance i ink Florida. * chaster 99-1 86, Laws of "Florida which became effective on July 4, 1999, permanently scheduléd Ketamine 2 asa ‘Schedule Mt Controlled Substance at Ss. 893. 031946) F F. S. A Schedule mM Controlled Substance has a potential for abuse less than the ‘substances contained in Schedules | and i and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to moderate or low physical dependence or high psychological dependence. (8) Respondents delivery of Ketaset to individuals not licensed or permitted to purchase or possess prescription drugs in Miami, Florida is a violation of the Florida Comprehensive Drug Abuse Prevention and Control Act, specifi ically, s. 893. 13(1)(a)2., F.S. . (9) Section 499. 0121(9), FE S., requires a wholesale drug distributor to operate in compliance with applicable federal, state, and local laws and regulations and specifically in : subparagraph (b) of that section, requires a wholesale drug distributor that deals in controlled substances to comply with all applicable state, local, and federal laws. The delivery by Florida Genetics of Ketaset ‘to individuals not authorized to possess ‘prescription drugs in Miami, Florida, as alleged i in paragraphs (6) and (8) of this compliant violates s. 499.0121(9), F.S. (10) Some of the Ketaset that Respondents sold and distributed, as alleged in paragraphs (6) through (8) of this complaint, was not exported to a person authorized to purchase or possess prescription drugs as indicated on Florida Genetics' invoices, but was ‘ diverted to another person or persons and remained in the United States. The purchasing and distribution practices of prescription drugs by Respondents facilitated such diversion. (11) ‘The violations of Chapter 499, F. S, by Respondents as set forth i in this complaint constitute suffi cient ‘grounds for ‘DOH: to impose an administrative fine ine of forty-four thousand dollars ($44, 000) or impose any other penalty authorized by chapter 499, F S. and chapter 64F- 12, Fis. Admin. Code aga inst the Respondents. (12) @ The intended fi ine is within the limits prescribed for such violations by section 499.066(3), F.S. and Rule 84F-12.024, Fla. Admin. Code due to the threat to public health posed by these violations. In particular, Respondents’ violations jeopardize public health ; because in forty-four sales transactions Respondents distributed prescription drugs that were also controlled substances in Florida to a person not authorized under the Florida Drug and ‘ k E i ® aA Cosmetic Act, Chapter 499, Florida Statutes, and the rules adopted thereunder, to possess presoription drugs. Furthermore, at least. some of the prescription drugs distributed by _ Respondents i in the forty-four sales transactions were diverted. (b) Rule 64F-12. 024 @), Fla. Admin. Code sets the range of the penalty for the distribution of a prescription drug to an unauthorized.recipient at $250 to $1,000 per violation per day. Since the prescription drug involved in this compliant v was a controlled substance in Florida at the time of the transactions, the allegations warrant the upper level of the range. (13) (a) Section 499.067(1 ), Florida Statutes (F.S.), authorizes the department to deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with ss, 499. 001-499, 081 or chapter 465, chapter 893, or chapter 501, or the rules adopted under any of those sections or chapters. (b) In ‘addition, s. 499. 067(3)(c), F.S., authorizes the department to deny, suspend or revoke a permit if the permittee has violated any provisions of ss. 499.001-499.084 or rules adopted under those sections. (c) Furthermore, s. 499. 067(1 )(b), F. S. , authorizes the department to deny an application for a permit if it is shown that the applicant i is Not of good moral character or that it would be a danger or rot in the best interest of the publ health, safety, and welfare if the applicant were issued a permit. PREGA (14) “The violations alleged i in this complaint evidence a substantial failure to > comply and 2 are substantial violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. The unlawful distribution practices of Respondents facilitated the diversion of a Florida controlled substance. Additionally, the Respondents' purchasing and distribution practices regarding prescription drugs present a Public health threat. _Respondents retention of the authority to “engage in in the wholesale distribution of prescription drugs or the retail sale of veterinary legend drugs, therefore, poses a danger and is not in the best interest of public health, , safety and welfare. Finally, Respondents’ ‘drug distribution Practices, as alleged in this pr eg ee re Pape mee ge meee “complaint, represent a substantial disregard by the Respondents for the regulatory scheme regarding the possession and wholesaling of prescription drugs. The Legisiature intended this regulatory scheme to protect the public health. Respondents’ conduct therefore warrants denial of the renewal applications to engage in the wholesale distribution of Prescription drugs under permit 22: 00880 and the retail sale of veterinary legend drugs under permit 25:00025. (15) 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 imposition of the administrative fine and the intended agency action to deny renewal of permits 22: oosso and 25:00025 Such proceedings are governed by Rule 28-106, Florida Administrative Code. In order to obtain a formal proceeding under section 120.57(1), F.S., your request for an : administrative hearing must ‘conform to the requirements of Rule 28- 106. 201, Fla. Admin. Code, and must state which i issues of material fact you dispute. Failure to dispute material issues of fact in your request for a hearing may ‘be treated by the department as an election by you of an informal proceeding pursuant to section 120.57(2), FS. A petition for administrative hearing must be in wting and must be received by Mr. Theodore M. Henderson, Agency Clerk for the Department, within twenty- -one (21) days from the receipt of this complaint. The address of the Agency Clerk i is 4052 Bald Cypress Way, BIN # A02, Tallahassee FL 32399-1703 The Agency Clerk's facsimile number i is 850-410-1448. “Mediation is not available as an alternative remedy. - ) days rom receipt of this complaint a will, constitute ‘a waiver of your right to an administrative hearing, under Fla. Admin. Code Rule 28-106.1 11 and this complaint shall become afi nal order". n al order, a party \ ho is adversely affected by it is entitled | to judi review pursuant to section 120. 68, Fla. Stat. Review Proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings may be commenced by fi iling one copy of a Notice of Appeal with the Agency Clerk of the Department of Health and ce a eee rere a second copy, accompanied by the fi ng fe 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. (16) The undersigned certifies that a true Copy of this administrative complaint was sent by U.S. Certified Mail, Return Receipt Requested, to Ms. Rita Bueno, individually and as President of Florida Genetics at 175 Fontainebleau Boulevard, Suite 2J2, Miami, Florida 33172, this 2lo*? day of Februar fuary 2001. Chiéf of Pharmacy Services 2818-A Mahan Drive Tallahassee, Florida 32308 Telephone: (850) 922-5190 Copy also furnished to: Counsel for the Department: Robert P. Daniti Senior Attorney 4052 Bald Cypress Way Bin #A02 Tallahassee, Florida 32399 ; (850) 245-4005 ° . APPLICA” N FOR PERMIT RENEWAL UNDER CH’ “TER 499, FS. BUREAU OF P.. MACY SERVICES, FLORIDA DEPAR1_, NT OF HEALTH This application form provides information as required by the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. PERMIT TO BERENEWED: 22: 00880. PRESCRIPTION DRUG WHOLESALER © | | Ee OG EXPIRATION DATE: 228/01 RECEIVER ¢ Ean Bees fe ee a Permit and Bhysixak Adress: 9: | g Mailing Address: JAN 16 2001 175 FONTAINEBLEAU BOULEVARD FLORIDA GENETICS CENTER, INC. SUITE 232 Blviscde fe 175 FONTAINEBLEAU BOULEVARD Bureau of MIAML FL 310M (#15) R/T Pharmacy Serviews Telephone: (305) 2268827) NCS MIAMI, FL 33172 Operating Hours: 09:00 - 05:00 ~ CONTACT IN CASE OF EMERGENCY: RITA BUENO (305)553-1799 Provide residence address and residence telephone number for a contact person if this information has changed from your last application: IF THERE HAS BEEN A CHANGE IN OWNERSHIP, THIS PERMIT CANNOT BE RENEWED. A NEW PERMIT IS REQUIRED. “Provide correct information above if any change has occurred in the company name, mailing address, physical address, telephone number or operating hours v There have been no changes to the owners, partners or corporate officers. OR " _.__. There has been a change in the partners or corporate officers. (Attach current information: names, positions & dates of birth.) SINCE YOUR PREVIOUS APPLICATION WAS SUBMITTED, HAS THE APPLICANT, OWNER(S), OFFICERS, AND/OR ANY EMPLOYEES: . 1. Been found guilty (regardless of adjudication) or pled nolo contendere in a court in Florida or any other YES NO jurisdiction of a violation of law that directly relates to a drug, device, or cosmetic? uw 2. Been fined or disciplined by a regulatory agency in any state (including Florida ) for any offense that would constitute a violation of Chapter 499, F.S.? : “ 3. Been convicted of any felony under a federal, state, or local law? . — v ¥ MANAGER(S)-IN-CHARGE, ANY 4. Had any current or previous permit or license suspended or revoked which was issued by a federal, state or local governmental agency relating to the manufacture or distribution of drugs, devices, or cosmetics? 5. Been denied a permit or license related to an activity regulated under Chapter 499, F.S., in any state? ANY “YES” RESPONSE MUST BE DISCUSSED ON AN ATTACHED SHEET. OUT-OF-STATE PRESCRIPTION-DRUG WHOLESALERS ONLY: Current valid license number in resident state: Expires: (Attach a:-copy of the current permit.) RETAIL PHARMACY WHOLESALERS ONLY: Current valid Community Pharmacy Permit # (Attach a copy of the current permit.) "REMIT $700.00 " if you have muitiple mar _IFNOT POSTMARKED BY ——_2/28/01_ YOU MUST INCLUDE A $100 DELINQUENT FEE. Changes in the Physical Address of a Retail Pharmacy Wholesaler, Out-Of-State Prescription Drug Wholesaler, or Complimentary Drug Distributor ring permits, only pay for the one with the highest fee. The others are complimentary. “- located outside of Florida require an additional $25. Other permittees must pay applicable Change of Address fees as required by Rule 64F- 12.018(4), Fla. Admin. Code. Make check payable to: Florida Drugs, Devices, and Cosmetics Trust Fund. Mail to: DOH Bureau of Pharmacy Services 2818-A Mahan Drive, Tallahassee, Florida 32308 Telephone (850) 487-1257 . |AFFIDAVIT ~ Ido solemnly swear and affirm that I have read and agree and the rules adopted thereunder; that changes to information reflected on previous applications, will be communicated in writing to the department prior to the change; and that all statements made on this sheet and : Title and subscribed before me this BHI ndihe of der oath.) hi ; 4b-G6I- o EXPIRES: September 12°2002 “4p'° O" Person under oath.) _has as identification. banded Tru Noey Pubs Uncen Commission # =A 4 Expiration Date: Print Notary’s Name here: “©. @ an CHECK NUMBER & AMOUNT “. DOH-FORM 1034, JANUARY 1997 cere + eee cee epee age ee ooo terre . — APPLICA" ON FOR PERMIT RENEWAL UNDER CB‘ TER 499, FS. BUREAU OF}. ‘RMACY SERVICES, FLORIDA DEPAR\ NT OF HEALTH | This application form provides information as required by the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, oo PERMIT TOBE RENEWED: 25:00025 VETERINARY LEGEND DRUG RETAILER EXPIRATIONDATE: - _2/28/01 e WEN oo Lara ; RECEIVED Permit and Physical hadPas; 9 Pi >. Mailing Address: 175 FONTAINEBLEAU BOULEVARD & 1g FLORIDA GENETICS CENTER, INC. JAN 16 2001 SUITE 232 Visi 175 FONTAINEBLEAU BOULEVARD MIAMI, FL 33172. “OMiN/< IRA uA SUITE 232 Bureau of Telephone: (305) 228-88H1F ARs gal /VE MIAML FL 3317200 Pharmacy Servlees = Qyerating Hours: 09:00 - 05:00 CONTACT IN CASE OF EMERGENCY: RITA BUENO (305)553-1799 Provide residence address and residence telephone number for a contact person if this ‘information has changed from your last ~“ application: : IF THERE HAS BEEN A CHANGE IN OWNERSHIP, THIS PERMIT CANNOT BE RENEWED. A NEW PERMIT IS REQUIRED. Provide correct information above if any change has occurred in the company name, mailing address, physical address, telephone number or i operating hours . i Y There have been no changes to the owners, partners or corporate officers. OR . There has been a change in the partners or corporate officers. (Attach current information: names, positions & dates of birth.) SINCE YOUR PREVIOUS APPLICATION WAS SUBMITTED, HAS THE APPLI OFFICERS, AND/OR ANY EMPLOYEES:. ICANT, OWNER(S), MANAGER(S)-IN-CHARGE, ANY 1, Been found guilty (regardless of adjudication) or pled nolo contendere in a court in Florida or any other YES NO jurisdiction of a violation of law that directly relates to a drug, device, or cosmetic? _ =— 2. Been fined or disciplined by a regulatory agency in any state (including Florida ) for any offense that would constitute a violation of Chapter 499, F.S.? . _ =< 3. Been convicted of any felony under a federal, state, or local law? _ roa 4. Had any current or previous permit or license suspended or revoked which was issued by a federal, state or local governmental agency relating to the manufacture or distribution of drugs, devices, or cosmetics? _ = 5. Been denied a permit or license related to an activity regulated under Chapter 499, F.S., in any state? _ a ANY “YES” RESPONSE MUST BE DISCUSSED ON AN ATTACHED SHEET. OUT-OF-STATE PRESCRIPTION-DRUG WHOLESALERS ONLY: Current valid license number in resident state: Expires: (Attach a copy of the current permit.) RETAIL PHARMACY WHOLESALERS ONLY: Current valid Community Pharmacy Permit # foe ger ene op eee Expires: (Attach a copy of the current permit.) REMIT $500.00 If you have multiple manufacturing permits, only pay for the one with the highest fee. The others are complimentary. ” IF NOT POSTMARKED BY 2/28/01 YOU MUST INCLUDE A $100 DELINQUENT FEE. Changes in the Physical Address of a Retail Pharmacy Wholesaler, Out-Of-State Prescription Drug Wholesaler, or Complimentary Drug Distributor located outside of Florida require an additional $25, Other permittees must pay applicable Change of Address fees as required by Rule 64F- 12.018(4), Fla. Admin. Code. oe oe : . oF Make check payable to: Florida Drugs, Devices, and Cosmetics Trust Fund. . Mail to: DOH Bureau of Pharmacy Services 2818-A Mahan Drive, Tallahassee, Florida 32308 Telephone (850) 487-1257 |AFFIDAVIT Ido solemnly swear and affirm that I have read and agree to comply with Chapter 499, Florida Statutes, and the rules adopted .|thereunder; that changes to information reflected on previous applications, if not reported on this application, will be communicated in writing to the _{Separtment prior to the change; that I am the person authorized to sign. this application; and that all statements made on this sheet and |page(s) ofvattachments are true and correct in all respects, \-G-0| Ro S Date i day of = are $9200 1, and is _- personally kno e. “61. has vw P DR: G500-p135 2 Hb & be Qecation. Commission #_CC EXPIRES: September 12, 2002 REEEES Bonded Thru Notary Pubic Underwriters Expiration Date: F }¥a] S00 5 4 Signatre be ; Print Notary’s Name here: _“Syo oy = E Boo aS DOH-FORM 1034, JANUARY 1997 ; CHECK NUMBER & AMOUNT . A t t t os _ RESI9I7

Docket for Case No: 01-001499