. Deputy Agenoy Clark STATE OF FLORIDA CLERK vette Laweon-Proctor DEPARTMENT OF BUSINESS & PROFESSIONAL REGULAT| ome 7744/2013 Fie? DEPARTMENT OF BUSINESS & PROFESSIONAL REGULATION, Petitioner, ¥v. CASE NO.: 2013-024069 RED PARROT DISTRIBUTION, INC., Respondent. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Business & Professional Regulation (‘Department’), and files this Administrative Complaint against Respondent, Red Parrot Distribution, Inc., (“Respondent” or “Red Parrot"), 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 permitted by the Department as a prescription drug wholesale distributor, having received Permit number 22:20190 on or about May 19, 2011. 3. Respondent's permitted addrass of record is 202 10" Avenue North, Suite A, Safety Harbor, Florida 34695. 4. On or about June 12 and 13, 2013, Department inspectors conducted a routine compliance inspection at the Respondent’s permitted address. 5. Inspectors observed Red Parrot’s operations, interviewed key personnel, and reviewed Red Parrot’s business records. 6. During the inspection, Inspectors spoke with Mr. Joseph P. Spinosa, President, Mrs. Heather Spinosa, Certified Designated Representative, Vice President and registered Agent of the company. 7. Inspectors also spoke with Red Parrot’s warehouse manager, and with warehouse staff. 8. Red Parrot employees advised Department inspectors that with each distribution of prescription drugs, the customer receives an invoice. 9. Red Parrot employees also advised the Department that inbound pedigrees are authenticated by the following process: a. Employee verifies that the prescription drug that is received is the drug the company ordered. b. An employee looks at the vendor's inbound invoice /packing slip and compares it to the firm’s purchase order. c. An employee verifies the drug’s NDC number, lot number, strength, and expiration date. d. Once the employee verifies that what was ordered is what was received, the employee puts on the pedigree the date the information was verified, the Red Parrot purchase order number, and the initials of the person verifying the information. e. Once verified, the prescription drugs are placed into inventory in a designated bin. 10. Red Parrot does not authenticate each transaction on the pedigree papers it receives in the manner required by Section 499.0121(4)(d), Florida Statutes, and Rule 61N-1.013(5)(d), Fiorida Administrative Code. 11. Red Parrot does not provide a prescription drug pedigree to customers to whom Red Parrot distributes prescription drugs, unless the customer requests the pedigree. 12. Specifically, Respondent distributed the following prescription drugs in May and June 2013: a. From on or about May 16, 2013, to on or about June 15, 2013, Red Parrot distributed 57 prescription drugs to Trinity Pharmacy, 11130 Seminole Blvd., Seminole, Florida 33778 (‘Trinity’), using invoice numbers 29637, 29758, 29760, 29904, 30112, 30173, and 30181. b. From on or about May 8, 2013, to on or about June 7, 2013, Red Parrot distributed 142 prescription drugs to The RX Shop, Rang, Inc., 810 South F Harrison Avenue, Clearwater, Florida 33756 (“RX Shop’), using invoice numbers 29590, 59618, 29715, 29753, 29747, 29751, 29783, 29784, 29638, 29822, 29854, 29906, 29969, 29994, 30012, 30035, 30066, 30064, 30096, 30118, 30164, 30160, 30164, and 30178. Cc. From on or about May 13, 2013, to on or about June 6, 2013, Red Parrot distributed 40 prescription drugs to ASAP Pharmacy, 8609 66" Street North, Suite C, Pinellas Park, Florida 33782 (“ASAP”), using invoice numbers 29711, 29712, 29818, 29819, 29869, 29870, 30092, 30094, 30153, and 30156. d. From on or about May 8, 2013 to on or about June 7, 2013, Red Parrot distributed 207 prescription drugs to Superior Pharmacy, LLC, Superior Pharmacy Vital Care, 5416 Town N Country Bivd., Tampa, Florida 33615, (Superior), using invoice numbers 29605, 29609, 29614, 29615, 29625, 29684, 29720, 29721, 29722, 29727, 29774, 29781, 29796, 29797, 29802, 29856, 29865, 29888, 29892, 29895, 29902, 29934, 29943, 29977, 30019, 30048, 30049, 30076, 30099, 30111, 30142, 30155, 30159, 30161, 30170, and 30174. e. From on or about May 20, 2013 to on or about June 1, 2013, Red Parrot distributed 11 prescription drugs to Advanced Medical Pharmacy, Inc., 3614 West Kennedy Bivd., Suite C, Tampa, Florida 33609 (“Advance"), using invoice numbers 29717, 29718, 29771, 29954, and 30085. 13. Red Parrot did not provide a prescription drug pedigree prior to or simultaneously with the distribution of the 457 separate prescription drugs referenced in paragraph 12 a.-e. 14. Section 499.01212, Florida Statutes provides: 499.01212 Pedigree paper.— (1) APPLICATION.—Each person who is engaged in the wholesale distribution of a prescription drug must, prior to or simultaneous with each wholesale distribution, provide a pedigree paper to the person who receives the drug. (2) FORMAT.—A pedigree paper must contain the following information: (a) For the wholesale distribution of a prescription drug within the normal distribution chain: 1. The following statement: “This wholesale distributor purchased the specific unit of the prescription drug directly from the manufacturer.” 2. The manufacturers national drug code identifier and the name and address of the wholesale distributor and the purchaser of the prescription drug. 3. The name of the prescription drug as it appears on the label. 4. The quantity, dosage form, and strength of the prescription drug. The wholesale distributor must also maintain and make available to the department, upon request, the point of origin of the prescription drugs, including intracompany transfers, the date of the shipment from the manufacturer to the wholesale distributor, the Jot numbers of such drugs, and the invoice numbers from the manufacturer. (b) For all other wholesale distributions of prescription drugs: 1. The quantity, dosage form, and strength of the prescription drugs. 2. The lot numbers of the prescription drugs. 3. The name and address of each owner of the prescription drug and his or her signature. 4. Shipping information, including the name and address of each person certifying delivery or receipt of the prescription drug. 5. An invoice number, a shipping document number, or another number uniquely identifying the transaction. 6. A certification that the recipient wholesale distributor has authenticated the pedigree papers. 7. The unique serialization of the prescription drug, if the manufacturer or repackager has uniquely serialized the individual prescription drug unit. 8. The name, address, telephone number, and, if available, e-mail contact information of each wholesale distributor involved in the chain of the prescription drug’s custody. 15. Section 499.0121(4)(d), Florida Statutes, provides: 499.0121 Storage and handling of prescription drugs; recordkeeping.— (4) EXAMINATION OF MATERIALS AND RECORDS.— (a) Upon receipt, each outside shipping container must be visually examined for identity and to prevent the acceptance of contaminated prescription drugs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents. (b) Each outgoing shipment must be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have expired or been damaged in storage or held under improper conditions. (c) The recordkeeping requirements in subsection (6) must be followed for all incoming and outgoing prescription drugs. (d) Upon receipt, a wholesale distributor must review records required under this section for the acquisition of prescription drugs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the wholesale distributors involved. This includes authenticating each transaction listed on a pedigree paper, as defined in s. 499.003(37). [Emphasis supplied]. 16. Prescription drug transactions listed in a pedigree must be authenticated using one of the methods set forth in Rule 61N-1.013(5)(d), Florida Administrative Code. 17. Section 499.006(10), Florida Statutes (2012), 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 18. Red Parrot adulterated each of the 457 prescription drugs referenced in paragraphs 12 a.-e. above, that it delivered without a prescription drug pedigree, as required by Sections 499.01212, and 499.005(28), Florida Statutes (2012). 19. Red Parrot failed to authenticate the pedigrees it received during the months of May and June, 2013, in the manner required in Section 499.0121(4)(d), Florida Statutes (2012), and Rule 61N-1.013(5)(d), Florida Administrative Code. COUNT ONE 20. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count one. 21. Section 499.005(28), Florida Statutes (2012), provides that the failure to acquire or deliver a prescription drug pedigree as required under Part !, Chapter 499, is unlawful. 22. Red Parrot failed to deliver prescription drug pedigrees either prior to, or simultaneously with, the 57 prescription drugs that it distributed to Trinity during the months of May and June, 2013. 23. Based on the foregoing, Red Parrot violated Section 499.005(28), Florida statutes (2012), by failing to deliver a prescription drug pedigree prior to or simultaneously with each of the 57 prescription drugs it distributed to Trinity. COUNT TWO 24. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count two. 25. Section 499.005(28), Florida Statutes (2012), provides that the failure to acquire or deliver a prescription drug pedigree as required under Part |, Chapter 499, is unlawful. 26. Red Parrot failed to deliver prescription drug pedigrees either prior to, or simultaneously with, the 142 prescription drugs that it distributed to RX Shop during the months of May and June, 2013. 27. Based on the foregoing, Red Parrot violated Section 499.005(28), Florida Statutes (2012), by failing to deliver a prescription drug pedigree prior to or simultaneously with each of the 57 prescription drugs it distributed to RX Shop, during the months of May and June, 2013. COUNT THREE 28. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count three. 29. Section 499.005(28), Florida Statutes (2012), provides that the failure to acquire or deliver a prescription drug pedigree as required under Part |, Chapter 499, is unlawful. 30. Red Parrot failed to deliver prescription drug pedigrees either prior to, or simultaneously with, the 40 prescription drugs that it distributed to ASAP during the months of May and June, 2013. 31. Based on the foregoing, Red Parrot violated Section 499.005(28), Florida Statutes (2012), by failing to deliver a prescription drug pedigree prior to or simultaneously with each of the 40 prescription drugs it distributed to ASAP, during the months of May and June, 2013 COUNT FOUR 32. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count four. 33. Section 499.005(28), Florida Statutes (2012), provides that the failure to acquire or deliver a prescription drug pedigree as required under Part |, Chapter 499, is untawful. 34. Red Parrot failed to deliver prescription drug pedigrees either prior to, or simultaneously with, the 207 prescription drugs that it distributed to Superior during the months of May and June, 2013. 35. Based on the foregoing, Red Parrot violated Section 499.005(28), Florida Statutes (2012), by failing to deliver a prescription drug pedigree prior to or simultaneously with each of the 207 prescription drugs it distributed to Superior, during the months of May and June, 2013 COUNT FIVE 36. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein in this count five. 37. Section 499.005(28), Florida Statutes (2012), provides that the failure to acquire or deliver a prescription drug pedigree as required under Part !, Chapter 499, is unlawful. 38. Red Parrot failed to deliver prescription drug pedigrees either prior to, or simultaneously with, the 11 prescription drugs that it distributed to Advanced during the months of May and June, 2013. 39. Based on the foregoing, Red Parrot violated Section 499.005(28), Florida Statutes (2012), by failing to deliver a prescription drug pedigree prior to or simultaneously with each of the 11 prescription drugs it distributed to Advanced, during the months of May and June, 2013 COUNT Six 40. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count six. 41. Section 499.005(2), Florida Statutes (2012), provides that the adulteration or misbranding of any drug, device or cosmetic is unlawful. 42. Red Parrot adulterated, within the meaning of Section 499.006(10) Florida Statutes (2012), each of the 57 prescription drugs that it distributed to Trinity without a prescription drug pedigree, as required by Section 499.01212, Florida Statutes. 43. Based upon the foregoing, Red Parrot violated Section 499.005(2), Florida Statutes (2012), by adulterating each of the 57 prescription drugs it distributed to Trinity without a prescription drug pedigree. COUNT SEVEN 44. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count seven. 45. Section 499.005(2), Florida Statutes (2012), provides that the adulteration or misbranding of any drug, device or cosmetic is unlawful. 46. Red Parrot adulterated, within the meaning of Section 499.006(10) Florida Statutes (2012), each of the 142 prescription drugs that it distributed to RX Shop without a prescription drug pedigree, as required by Section 499.01212, Florida Statutes. 47. Based upon the foregoing, Red Parrot violated Section 499.005(2), Florida Statutes (2012), by adulterating each of the 142 prescription drugs it distributed to RX Shop without a prescription drug pedigree. COUNT EIGHT 48. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count eight. 49. Section 499.005(2), Florida Statutes (2012), provides that the adulteration or misbranding of any drug, device or cosmetic is unlawful. 50. Red Parrot adulterated, within the meaning of Section 499.006(10) Florida Statutes (2012), each of the 40 prescription drugs that it distributed to ASAP without a prescription drug pedigree, as required by Section 499.01212, Florida Statutes. 10 51. Based upon the foregoing, Red Parrot violated Section 499.005(2), Florida Statutes (2012), by adulterating each of the 40 prescription drugs it distributed to ASAP without a prescription drug pedigree. COUNT NINE 52. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count nine. 53. Section 499.005(2), Florida Statutes (2012), provides that the adulteration or misbranding of any drug, device or cosmetic is unlawful. 54. Red Parrot adulterated, within the meaning of Section 499.006(10) Florida Statutes (2012), each of the 207 prescription drugs that it distributed to Superior without a prescription drug pedigree, as required by Section 499.01212, Florida Statutes. 55. Based upon the foregoing, Red Parrot violated Section 499.005(2), Florida Statutes (2012), by adulterating each of the 207 prescription drugs it distributed to Superior without a prescription drug pedigree. COUNT TEN 56. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count ten. 57. Section 499.005(2), Florida Statutes (2012), provides that the adulteration or misbranding of any drug, device or cosmetic is unlawful. 58. Red Parrot adulterated, within the meaning of Section 499.006(10) Florida Statutes (2012), each of the 11 prescription drugs that it distributed to Advanced without a prescription drug pedigree, as required by Section 499.01212, Florida Statutes. 11 59. Based upon the foregoing, Red Parrot violated Section 499.005(2), Florida Statutes (2012), by adulterating each of the 11 prescription drugs it distributed to Advanced without a prescription drug pedigree. COUNT ELEVEN 60. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein this count eleven. 61. Section 499.005(28), Florida Statutes (2012), provides that the failure to acquire or deliver a pedigree, is unlawful. 62. Red Parrot advised the Department that it failed to acquire a prescription drug pedigree for each prescription drug that it received. 63. Based on the foregoing, Red Parrot violated Section 499.005(28), Florida Statutes (2012), by failing to acquire a prescription drug pedigree for each prescription drug that it received. COUNT TWELVE 64. Petitioner re-alleges and incorporates paragraphs 1-19 as if fully set forth herein in this count twelve. 65. Section 499.005(4), Florida Statutes (2012), provides that the sale, distribution, purchase, trade, holding or offering of any drug, device or cosmetic in violation of this part, is unlawful. 66. Section 499.0121(4)(d), Florida Statutes (2012), requires prescription drug distributors to authenticate each transaction on a pedigree paper. Rule 61N-013(5)(d), sets forth the methods by which a prescription drug pedigree transaction must be authenticated and authorizes a prescription drug wholesale distributor to choose any, 12 all, or a combination of the methods for authentication enumerated in the rule. At a minimum, a prescription drug wholesale distrioutor must contact the seller as part of the verification process. 67. Red Parrot’s method of authenticating pedigrees by merely checking to see whether the drugs received were the drugs that were ordered, and initialing the invoice, fails to comply with the statutory and rule requirements for authentication. 68. Based on the foregoing, Red Parrot violated Section 499.005(4), Florida Statutes (2012), by holding and offering prescription drugs for sale when Red Parrot had failed to authenticate each transaction on the pedigrees it received from sellers, as required by Section 499.0121(4)(d), and Rule 61N-1.013 (5)(d), Florida Administrative Code. PRAYER FOR RELIEF WHEREFORE, Petitioner respectfully requests an order imposing the following penalties: the imposition of administrative fines in accordance with the disciplinary guidelines, suspension, revocation, and such other and further relief as is provided by Dated this (ey of sjehy , 2013. law. BY: DBPR - Drugs, Devices and Sosmetics Division 1940 North Monroe Street, Suite 26A Tallahassee, FL 32399-1047 Telephone: (850) 717-1800 Facsimile: (850) 414-8240 13 Prepared by: Kathryn E. Pri Chief Attorne’ 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. 14

Docket for Case No: 13-004973