STATE OF FLORIDA DEPARTMENT OF BUSINESS & PROFESSIONAL REGULATI¢ File ® DEPARTMENT OF BUSINESS & PROFESSIONAL REGULATION, DIVISION OF DRUGS, DEVICES, AND COSMETICS Petitioner, v. CASE NO.: 2014-002094 VITREO-RETINAL CONSULTANTS OF THE PALM BEACHES, P.A. Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Business & Professional Regulation, Division of Drugs, Devices, and Cosmetics, (“Petitioner’ or "Department’), and files this Administrative Complaint against Respondent, Vitreo-Retinal Consultants of the Palm Beaches, P.A. (“Respondent”), and in support thereof alleges: 1. Petitioner is the state department charged with regulating Drugs, Devices, and Cosmetics pursuant to Section 20.165 and Chapter 499, Florida Statutes. 2. Respondent holds no permits with the Department. Respondent's address of record is 2521 Metrocentre Bivd., West Palm Beach, FL 33407. 3. Petitioner is authorized by Section 499.051(2) to enter any establishment for the purpose of establishing compliance with Chapter 499, Florida Statutes, and the rules adopted under that statute, regarding any drug, device, or cosmetic. 4. On or about January 16, 2014, Department inspectors began an inspection at the above address after receiving a report of an adverse incident from the Department of Health. 5. The inspection was conducted on or about January 16, 2014 through June 3, 2014. 6. Inspectors obtained records that showed that the Respondent purchased single use vials of the prescription drug Avastin and single use vials of the prescription drug Lucentis and had the drugs shipped to Eastern Pharmacy (Eastern), 2046 West Silver Springs Boulevard, Ocala, Florida 34475. 7. Inspectors obtained records that showed that the Respondent paid Eastern for repackaging single use vials of the prescription drug Avastin and single use vials of the prescription drug Lucentis, and shipping the drugs to Respondent. 8. Eastern holds no permits with the Department. Eastern holds permit number PH26673 with the Department of Health. 9. Avastin, (generic name bevacizumub), manufactured by Genentech, is an injectable prescription drug approved by the Food and Drug Administration (“FDA”) to treat cancer. Avastin is commonly used to treat wet age-related macular degeneration, a disease of the eye that can lead to vision loss. 10. Avastin is manufactured in 100mg (4mL) or 400mg (16mL) vials with no preservatives. The labeling includes the words, “single use vial” and a directive to discard any unused portion. The manufactured drug includes an instruction insert with instructions for use. 11. For treatment of macular degeneration, only a small amount of the medication, usually 1.25 to 2.5 milligrams, is needed. Typically, one 100mg vial of Avastin can produce 80 single-dose syringes and one 400mg vial of Avastin can produce 300 single-dose syringes. 12. Lucentis (generic name ranibizumab), is a prescription drug approved by the FDA to treat wet age-related macular degeneration. Lucentis is manufactured and distributed in glass vials containing a single dose (0.5mL) for injecting into one eye for treatment of macular degeneration. 13. The label for Lucentis includes a directive to store the drug in the original carton until time of use. Lucentis was manufactured with an insert with instructions for use. 14. Between June 18, 2013 and December 26, 2013, Respondent purchased Avastin and Lucentis from Besse Medical and Genentech and had the drugs delivered to Eastern to be repackaged. Once repackaged, Eastern delivered the drugs to Dr. Salomon Melgen. 15. | Respondent paid Eastern to repackage Avastin from single use vials into single-dose syringes and to ship the syringes to Respondent. 16. Respondent paid Eastern to repackage Lucentis from single dose vials into single-dose syringes and to ship the syringes to Respondent. 17. “Repackage” and “repackager” are defined in Sections 499.003(48) and (49), Florida Statutes (2012-2013), as: 499.003 Definitions.-- 18. 19. provides: (48) “Repackage” includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic. (49) “Repackager’ means a person who repackages. The term excludes pharmacies that are operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter. Section 499.006(10), Florida Statutes (2012-2013), provides: 499.006 Adulterated drug or device.—A drug or device is adulterated: * * *€ (10) If it is a prescription drug for which the required pedigree paper is nonexistent, fraudulent, or incomplete under the requirements of this part or applicable rules, or that has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so; or * * * (Emphasis Added). Section 499.01(1)(b) and (2)({b), Florida Statutes (2012-2013), 499.01 Permits.— (1) Prior to operating, a permit is required for each person and establishment that intends to operate as: * * * (b) Aprescription drug repackager; (2) The following permits are established: * * * (b) Prescription drug repackager permit—A prescription drug repackager permit is required for any person that repackages a prescription drug in this state. 1. A person that operates an establishment permitted as a prescription drug repackager may engage in wholesale distribution of prescription drugs repackaged at that establishment and must comply with all the provisions of this part and the rules adopted under this part that apply to a wholesale distributor. 2. A prescription drug repackager must comply with all appropriate state and federal good manufacturing practices. 20. Eastern does not add any medications or substances to the Avastin or to the Lucentis when it removes the drugs from the single use vials and repackages the drugs into single dose syringes. 21. Eastern was not authorized to repackage or distribute the repackaged drugs to Respondent. 22. Respondent holds no permit with the Department as a prescription drug wholesale distributor. 23. Section 499.006(10), Florida Statutes (2013), provides that a prescription drug is adulterated if it has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. COUNT ONE 24. Petitioner re-alleges and incorporates paragraphs 1-23 as if fully set forth in this count one. 25. Section 499.005(14), Florida Statutes (2012-2013), provides that the purchase or receipt of a prescription drug from a person that is not authorized under this chapter to distribute prescription drugs to that purchaser or recipient, is unlawful. 26. On at least eight separate occasions, Respondent paid Eastern to repackage the prescription drug Avastin and received the repackaged Avastin from Eastern when Eastern was not authorized under Chapter 499, Florida Statutes (2012- 2013), to distribute prescription drugs to Respondent. 27. Based on the foregoing, Respondent violated Section 499.005(14), Florida Statutes (2012-2013), by receiving individual single-dose syringes of the prescription drug Avastin from Eastern when Eastern was not authorized under Chapter 499, Florida Statutes, to distribute the drugs to Respondent. COUNT TWO 28. Petitioner re-alleges and incorporate paragraphs 1-23 as if fully set forth in this count two. 29. Section 499.005(14), Florida Statutes (2012-2013), provides that the purchase or receipt of a prescription drug from a person that is not authorized to under this chapter to distribute prescription drugs to that purchaser or recipient, is unlawful. 30. On at least nine separate occasions, Respondent paid Eastern to repackage the prescription drug Lucentis and received the repackaged drugs from Eastern when Eastern was not authorized under Chapter 499, Florida Statutes, to distribute prescription drugs to Respondent. 31. Based on the foregoing, Respondent violated Section 499.005(14), Florida Statutes (2012-2013), by receiving individual single-dose syringes of the prescription drug Lucentis when Eastern was not authorized under Chapter 499, Florida Statutes, to distribute the drugs to Respondent. COUNT THREE 32. Petitioner re-alleges and incorporates paragraphs 1-23 as if fully set forth in this count three. 33. The prescription drug Avastin which Respondent received from Eastern in single-dose syringes was adulterated because it had been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. 34. Section 499.005(3), Florida Statutes (2012-2013), provides that the receipt of any drug that is adulterated or misbranded and the delivery or proffered delivery of such drug, device, or cosmetic, is unlawful. 35. On at least eight occasions, Respondent received adulterated repackaged Avastin from Eastern and sold the same to patients. 36. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2013), by receiving adulterated prescription drugs and delivering the same to patients. COUNT FOUR 37. Petitioner re-alleges and incorporates paragraphs 1-23 as if fully set forth in this count four. 38. The prescription drug Lucentis which Respondent received from Eastern in single-dose syringes was adulterated because it had been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. 39. Section 499.005(3), Florida Statutes (2012-2013), provides that the receipt of any drug that is adulterated or misbranded and the delivery or proffered delivery of such drug, device, or cosmetic, is unlawful. 40. On at least nine occasions, Respondent received adulterated repackaged Lucentis from Eastern and sold the same to patients. 41. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2013), by receiving adulterated prescription drugs and delivering the same to patients. PRAYER FOR RELIEF WHEREFORE, Petitioner respectfully requests an order imposing the following penalties: administrative fines up to Thirty-one Thousand, Five Hundred Dollars ($31,500), and such other and further relief as is provided by law. thy = Dated this |Tday of uly , 2015. BY: 1940 North Monroe Street, Suite 264 Tallahassee, FL 32399-1047 Telephone: (850) 717-1800 Facsimile: (850) 414-8240 Prepared ky: . Kat piige asst t, ral Counsel Department of Business & Professional Regulation Division of Drugs, Devices and Cosmetics 1940 North Monroe Street, Suite 26A Tallahassee, Florida 32399-1047 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Sections 120.569 and 120.57, Florida Statutes, to 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.

Docket for Case No: 15-004720