Jan 7 2010 13:58 P.@S JAN-G?-2618 14:89 STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO, 2008-26044 LIFE SPECIALTY PHARMACY MEDICAL EQUIPMENT & SUPPLIES, INC., RESPONDENT. / ee ADMINISTRATIVE COMPLAINT a EE Petitioner Department of Health (Department), by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy (Board) against Respondent Life Specialty Pharmacy Medical Equipment & Supplies, Inc., and in support alleges: 1. Petitioner is the state department charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this Administrative Complaint, ri Respondent was 4 permitted as a community pharmacy within the state of Florida, having been issued permit number PH 22346. Jan 7 2010 13:58 JAN-G?-2618 14:89 3. Respondent’s address of record is 1507 Park Center Drive, Suite ik, Orlando, Florida 32835. 4. At all times material to this Complaint, Respondent was a Florida corporation, with a principal place of business at 1507 Park Center Drive, Suite 1K, Orlando, Florida 32835. 2. From on or about July 12, 2007, through on or about November 4, 2008, Respondent sold, transferred or delivered prescription druas to clinics and/or physicians, who were not consumers or patients, to then be dispensed by the clinics and/or physicians to patients, including, but not limited to, specifically, the following prescription drugs sold, transferred or delivered to Hanley Pain & Rehab, and/or various physicians affiliated with that clinic, Orlando, Florida: Depo-Medrol 40mgq/ml Pneumovax (pneumoccal vaccine) Tetanus & Diphtheria Toxoids (vaccine) Fluvirin Flumazenil 0.1mg/ml Hydroxyzine HCL 50mg Clotrimazole Jan 7 2010 13:59 a? JAN-G?-2618 14:18 P.B Fluconazole 150m L-tyrozine Tubersol Engerix-B 10mcg/0.5ml Diazepam 5mg Phenobarbital 65mq/ml Ceftriaxone igm Alpha-Lipoic Acid 50mg Atropine img/ml Flumazenit 0,1mg/ml Gabapentin 300mg 6. Section 499.003(15), Florida Statutes (2007), provides: “Distribute or distribution’ means to sell; offer to sell; give away; transfer, whether by passage of title, physical movement, or both; deliver; or offer to deliver. The term does not mean to administer or dispense.” 7. — Section 499.003(17), Florida Statutes (2008), provides: ““Distribute’ or ‘distribution’ means to sell? offer to sell; give away; transfer, whether by passage of title, physical movement, or both; deliver; or offer to deliver. The term does not mean to administer or dispense.” Jan 7 2010 13:59 JAN-G?-2618 14:18 P.@8 8. Section 499.012(1)(a), Florida Statutes (2007), provides that “wholesale distribution” means distribution of prescription drugs to a person _other than a consumer or patient,” subject to exceptions not here applicable. 4 9. Section 499.012(1)(b), Florida Statutes (2007), provides that “wholesale distributor” means any person engaged in wholesale distribution of prescription drugs in or into this state, including, but not limited to, “... retail pharmacies; and the agents thereof that conduct wholesale distributions.” 10. Section 499.003(53), Florida Statutes (2008), provides that “wholesale distribution” means “distribution of prescription drugs to a person other than a consumer or patient,” subject to exceptions not here applicable. 11. Section 499.003(54), Florida Statutes (2008), provides that “wholesale distributor” means any person engaged in wholesale distribution of prescription drugs in or into this state, including, but not limited to, “... retail pharmacies; and the agents thereof that conduct wholesale distributions.” 12. Section 499.003(32), Florida Statutes (2007), and Section o 499,003(38), Florida Statutes (2008), each provides that “person” means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, Jan 7 2010 13:59 P.@9 JAN-G?-2618 14:18 division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any group or combination of the foregoing.” 13. Section 499.01(1), Florida Statutes (2007), provides that prior to operating, a permit is required for each person and establishment that intends to operate as: (g) A prescription drug wholesaler: (m) A retail pharmacy drug wholesaler ... . 14. Section 499.01(1), Florida Statutes (2008), provides that prior to operating, a permit is required for each berson and establishment that intends to operate as: (d) A prescription drug wholesale distributor; (f) A retail pharmacy drug wholesale distributor ... . b | f Jan 7 2010 13:59 JAN-G?-2618 14:18 P.18 15. From on or about July 12, 2007, through on or about November 4, 2008, Respondent engaged in wholesale distribution by selling, transferring or delivering prescription drugs to clinics and/or physicians, who are persons other than the consumer or patient. 16. At all times material hereto, Respondent was not permitted by the Department of Health or otherwise authorized to engage in the wholesale distribution of prescription drugs in or into the State of Florida. 17, Section 499.005(22), Florida Statutes (2007), provides that failure to obtain a permit or registration, or operating without a valid permit when @ permit or registration is required by ss, 499.001-495.081 for that activity, is unlawful. 18. Section 499,005(22), Florida Statutes (2008), provides that failure to obtain @ permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity, is untawful. 19. Section 465.023(1)(c), Florida Statutes (2007-2008), provides in pertinent part that violation of Chapter 499, Florida Statutes, known as the Florida Drug and Cosmetic Act, constitutes grounds for disciplinary action by the Board of Pharmacy. Jan 7 2010 14:00 JAN-G?-2618 14:11 P.ii I. 20. Based on the foregoing, Respondent violated Section 465.023(1)(c), Florida Statutes (2007-2008), by violating Sections 499.01(1), and 499.005(22) Florida Statutes (2007-2008), by failing to obtain a prescription drug wholesaier’s permit or a retail pharmacy drug wholesaler’s permit under 2007 law, and/or a wholesale distributor permit or a retail pharmacy wholesale permit under 2008 law, prior to engaging in wholesale distribution of prescription drugs. WHEREFORE, Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the foliowing penalties on Respondent: permanent revocation or suspension of permit, restriction of practice, administrative fine, reprimand, probation, corrective action, refund of fees billed or collected, remedial education, and any other relief that the Board deems appropriate. aot SIGNED this 22 day of Ady , 2009. See Ana M. Viamonte Ros, M.D., M.RH. ee Le "State Surgeon General DEPARTMENT OF HEALTH: DEPUTY GLERK SLERK: ULngetan ae DATE, “1 ayne L. Schiefelbein Assistant General Counsel Florida Bar Number 0265047 Department of Health Prosecution Services Unit Jan 7 2010 14:00 JAN-G?-2618 14:11 P.12 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (850) 245-4640 (850) 245-4682 fax PCP 2.0.04 PCP Members: ¢/y,,5 Risch NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, te be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses, and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess Costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on Respondent in addition to any other discipline imposed. Life Specialty Pharmacy Medical Equipment & Supplies, Inc, Case No. 2008-26044

Docket for Case No: 10-000055