FILED Department of Business and Professional feguiation Deputy Agency Clerk STATE OF FLORIDA CLERK vette Lawveon-Proctor DEPARTMENT OF BUSINESS & PROFESSIONAL REGULATIG pxe 7/20/2015 File? DEPARTMENT OF BUSINESS & PROFESSIONAL REGULATION, DIVISION OF DRUGS, DEVICES, AND COSMETICS Petitioner, v. CASE NO.: 2014-002081 SALOMON MELGEN, M.D. Respondent. I 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, Salomon Melgen, M.D. (“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 is a licensed medical doctor, having been issued license number ME 48581 by the Department of Health on or about June 26, 1986. 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 tules 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 Avastin and Lucentis and had the drugs shipped to Eastern Pharmacy, 2046 West Silver Springs Boulevard, Ocala, Florida 34475 (Eastern) for repackaging into single dose syringes. 7. Eastern holds no permits with the Department. Eastern holds permit number PH26673 with the Department of Health. 8. 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. 9. 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. 10. 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. 11. In or about 2011, the Food and Drug Administration (FDA) issued an alert to health care professionals which stated, in relevant part: Health care professionals should be aware that repackaging sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections. Health care professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered. 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 July and December 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 Respondent. 16. Respondent paid Eastern to repackage Avastin from single use vials into single dose syringes and to ship the syringes to Respondent. 17. Respondent paid Eastern to repackage Lucentis from single dose vials into single dose syringes and to ship the syringes to Respondent. 18. “Repackage” and “repackager” are defined in Sections 499.003(48) and (49), Florida Statutes (2012-2013), as: 499.003 Definitions.-- * * * (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. 19. 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). 20. Section 499.01(1)(b) and (2)(b), Florida Statutes (2012-2013), provides: 499.01 Permits.— (1) Prior to operating, a permit is required for each person and establishment that intends to operate as: * * * (b) A prescription 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. Aprescription drug repackager must comply with all appropriate state and federal good manufacturing practices. 21. Eastern does not add any medications or substances to the Avastin when it removes the drugs from the single use vials and repackages the drugs into single dose syringes. 22. Eastern does not add any medications or substances to the Lucentis when it removes the drugs from the single dose vials and repackages the drugs into single dose syringes. 23. Eastern was not authorized to repackage Avastin and was not authorized to distribute the repackaged Avastin to Respondent. 24. Eastern was not authorized to repackage Lucentis and was not authorized to distribute the repackaged Lucentis to Respondent. 25. Respondent did not obtain the records required by Rule 61N-1.012, Florida Administrative Code, from Eastern when Respondent received the repackaged Avastin from Eastern. 26. Respondent did not obtain the records required by Rule 61N-1.012, Florida Administrative Code, from Eastern when Respondent received the repackaged Lucentis from Eastern. 27. When Respondent received the repackaged drugs from Eastern, there was no labeling on the drugs. The individual syringes were packed inside individual plastic covers and several covered syringes were packed into a clear plastic bag labeled only as “Avastin “ or “Lucentis.” 28. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with the name and place of business of the manufacturer. 29. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with the quantity of drug ingredient per unit. 30. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with adequate directions for use. 31. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with the “Rx only” statement or other verbiage to identify the contents as prescription drugs. 32. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with Lot numbers. 33. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with expiration dates. 34. Bags containing several single dose syringes labeled as “Avastin” or “Lucentis” were not labeled with a barcode. 35. 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. 36. Rule 61N-1.012, Florida Administrative Code, provides: 61N-1.012 Records of Drugs, Cosmetics and Devices. (1)(a) Records to document the movement of drugs, devices or cosmetics must provide a complete audit trail from a person’s receipt or acquisition to sale or other disposition of the product or component. A complete audit trail includes_records which document each transaction or step in the receipt, manufacture, shipping, transfer, or other steps in the channel of trade of that person, whether or not physical possession or handling of the product_or component occurs. At a minimum, records shall consist_of invoices from the supplier or source which documents acquisition of each product by the person and invoices of sale or other transfer by the person to the recipient. Retail sales transactions to the consumer of over-the- counter drugs, non-restricted devices, or cosmetics are exempt from the requirements of this rule. Additional recordkeeping is required for persons permitted by the department as further stated in this rule. (b) A person engaged in the distribution of drugs, devices, or cosmetics is not required to maintain documentation from a common carrier that the designated recipient received the product shipped; however, the person must obtain such documentation from the common carrier and make it available to the department upon specific request of the department. (2) Any person engaged in the manufacture of prescription drugs, the wholesale distribution of prescription drugs, or otherwise receiving or distributing prescription drugs must maintain records as follows: a) For each step in the channel of trade, records containing the information required by Section 499.0121(6)(a), F.S., and the Florida permit or license number which authorizes the source to possess and transfer prescription drugs in or into Florida must _appear_on one document. If delivery of prescription drugs is made to a person other than the purchaser, the name, address or location where the prescription drugs are delivered, and the state license, permit or registration number for that location must be included also. (b) The state permit or registration number of the purchaser may be omitted if the prescription drugs are exported; but a validated airway bill, bill of lading or other appropriate documentation must_be maintained to evidence the exportation of the product. (c)_ Invoices _must_reflect_the_amount_billed_per_ prescription drug product. (d) Records to document the distribution of prescription drugs required by Section 499.0121(6), F.S., and this rule are to be created during the transaction (i.e., at the time of order, receipt, processing, picking or shipping) and not retroactively created. A pharmacy or other person authorized to possess prescription drugs that transfers prescription drugs to an establishment performing reverse distribution services or destruction activities must prepare or have prepared an inventory or other record of the prescription drugs so transferred prior to the prescription drugs leaving the premises. In addition to the name, address, and license number of the sender and the name, address, and license number of the receiving establishment, the record must include the elements set forth in paragraph 61N-1.023(3)(a), F.A.C. [Emphasis Added] 37. Section 499.007, Florida Statutes, provides: 499.007 Misbranded drug or device.—A drug or device is misbranded: (1) If its labeling is in any way false or misleading. (2) If in package form, it does not bear a label containing: (a) The name and place of business of the manufacturer, repackager, or distributor of the finished dosage form of the drug. For the purpose of this paragraph, the finished dosage form of a prescription drug is that form of the drug which is, or is intended to be, dispensed or administered to the patient and requires no further manufacturing or processing other than packaging, reconstitution, and labeling; and (b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. However, under this section, reasonable variations are permitted, and the department shall establish by rule exemptions for small packages. (3) If it is an active pharmaceutical ingredient in bulk form and does not bear a label containing: (a) The name and place of business of the manufacturer, repackager, or distributor; and (b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. (4) If any word, statement, or other information required by or under this part to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood under customary conditions of purchase and use. (5) If itis a drug and is not designated solely by a name recognized in an official compendium and its label does not bear: (a) The common or usual name of the drug, if any; and (b) In case it is fabricated from two or more ingredients, the common or usual name and quantity of each active ingredient. (6) If its labeling does not bear: (a) Adequate directions for use; and (6) Adequate warnings against use in those pathological conditions in which its use may be dangerous to health or against use by children if its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users. (7) If it purports to be a drug the name of which is recognized in the official compendium and it is not packaged and labeled as prescribed therein. However, the method of packaging may be modified with the consent of the department. (8) If it has been found by the department to be a drug liable to deterioration and it is not packaged in such form and manner COUNT ONE 38. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count one. 39. 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. 40. Respondent purchased repackaged prescription drug Avastin in single- dose syringes from Eastern, when Eastern was not authorized under Chapter 499, Florida Statutes, to repackage prescription drugs or to distribute repackaged prescription drugs to Respondent. 41. Based on the foregoing, Respondent violated Section 499.005(14), Florida Statutes (2012-2013), by purchasing the prescription drug Avastin in single-dose syringes from Eastern when Eastern was not authorized under Chapter 499, Florida Statutes, to repackage or to distribute the drugs to Respondent. COUNT TWO 42. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count two. 43. 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. 44 Respondent purchased repackaged prescription drug Lucentis in single dose syringes from Eastern when Eastern was not authorized under Chapter 499, Florida Statutes, to repackage prescription drugs or to distribute repackaged prescription drugs to Respondent. 45. Based on the foregoing, Respondent violated Section 499.005(14), Florida Statutes (2012-2013), by purchasing individual single-dose syringes of the prescription drug Lucentis from Eastern when Eastern was not authorized under Chapter 499, Florida Statutes, to repackage or to distribute the drugs to Respondent. COUNT THREE 46. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count three. 47. The prescription drug Avastin which Respondent received from Eastern was adulterated because Eastern had no permit to repackage or distribute the repackaged drugs to Respondent and thus the drug had been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. 48. 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. 49. Respondent received adulterated repackaged Avastin from Eastern and delivered the same to Respondent's patients. 50. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2012-2013), by receiving adulterated repackaged Avastin from Eastern and delivering the same to patients. 10 COUNT FOUR 51. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count four. 52. The prescription drug Lucentis which Respondent received from Eastern in single-dose syringes was adulterated because Eastern had no permit to repackage drugs or distribute the repackaged drugs to Respondent and thus the drug had been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so. 53. 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. 54. Respondent received adulterated repackaged Lucentis from Eastern and delivered the same to Respondent's patients. 55. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2012-2013), by receiving adulterated prescription drugs and delivering the same to patients. COUNT FIVE 56. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count five. 57. The prescription drug Avastin which Respondent received from Eastern was misbranded because the drug lacked labeling information required by Section 499.007, Florida Statutes (2012-2013). 11 58. 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. 59. Respondent received misbranded repackaged Avastin from Eastern and delivered the same to Respondent's patients. 60. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2012-2013), by receiving misbranded repackaged Avastin from Eastern and delivering the same to patients. COUNT SIX 61. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count six. 62. The prescription drug Lucentis which Respondent received from Eastern was misbranded because the drug lacked labeling information required by Section 499.007, Florida Statutes (2012-2013). 63. 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. 64. Respondent received misbranded repackaged Lucentis from Eastern and delivered the same to Respondent's patients. 65. Based on the foregoing, Respondent violated Section 499.005(3), Florida Statutes (2012-2013), by receiving misbranded repackaged Lucentis from Eastern and delivering the same to patients. 12 COUNT SEVEN 66. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count seven. 67. — Section 499.005(18), Florida Statutes, provides that the failure to maintain records as required by Chapter 499 and rules adopted pursuant to Chapter 499, is unlawful. 68. Respondent received repackaged Avastin from Eastern without the documentation required by Rule 61N-1.012, Florida Administrative Code. 69. Based on the foregoing, Respondent violated Section 499.005(18), Florida Statutes (2012-2013), by failing to maintain records as required by Rule 61N-1.012, Florida Administrative Code COUNT EIGHT 70. Petitioner re-alleges and incorporates paragraphs 1-37 as if fully set forth in this count eight. 71. Section 499.005(8), Florida Statutes (2012-2013), provides that the failure to maintain records as required by Chapter 499 and rules adopted pursuant to Chapter 499, is unlawtul. 72. Respondent received repackaged Lucentis from Eastern without the documentation required by Rule 61N-1.012, Florida Administrative Code. 73. Based on the foregoing, Respondent violated Section 499.005(18), Florida Statutes (2012-2013), by failing to maintain records as required by Rule 61N-1.012, Florida Administrative Code 13 PRAYER FOR RELIEF WHEREFORE, Petitioner respectfully requests an order imposing the following penalties: administrative fines and such other and further relief as is provided by law. Dated this | ( day of _\ i Ly 2015. KEN LAWSON, SECRETARY BY: 1940 No Monroe Street, Suite 26A Tallahassee, FL 32399-1047 Telephone: (850) 717-1800 Facsimile: (850) 414-8240 Prepared by: Wed Kathryn E. Phi \ Assistant Gene ounsel Department of Business & Professional Regulation Division of Drugs, Devices and Cosmetics 1940 North Monroe Street, Suite 26A Tallahassee, Florida 32399-1047 14 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. 15

Docket for Case No: 15-004719PL