Florida Senate - 2013 COMMITTEE AMENDMENT Bill No. SB 966 Barcode 541434 LEGISLATIVE ACTION Senate . House Comm: RCS . 03/15/2013 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Bean) recommended the following: 1 Senate Amendment to Amendment (373656) (with title 2 amendment) 3 4 Between lines 737 and 738 5 insert: 6 Section 23. Paragraph (b) of subsection (54) of section 7 499.003, Florida Statutes, is amended to read: 8 499.003 Definitions of terms used in this part.—As used in 9 this part, the term: 10 (54) “Wholesale distribution” means distribution of 11 prescription drugs to persons other than a consumer or patient, 12 but does not include: 13 (b) Any of the following activities, which is not a 14 violation of s. 499.005(21) if such activity is conducted in 15 accordance with rules established by the department: 16 1. The sale, purchase, or trade of a prescription drug 17 among federal, state, or local government health care entities 18 that are under common control and are authorized to purchase 19 such prescription drug. 20 2. The sale, purchase, or trade of a prescription drug or 21 an offer to sell, purchase, or trade a prescription drug for 22 emergency medical reasons. For purposes of this subparagraph, 23 the term “emergency medical reasons” includes transfers of 24 prescription drugs by a retail pharmacy to another retail 25 pharmacy to alleviate a temporary shortage. 26 3. The transfer of a prescription drug acquired by a 27 medical director on behalf of a licensed emergency medical 28 services provider to that emergency medical services provider 29 and its transport vehicles for use in accordance with the 30 provider’s license under chapter 401. 31 4. The revocation of a sale or the return of a prescription 32 drug to the person’s prescription drug wholesale supplier. 33 5. The donation of a prescription drug by a health care 34 entity to a charitable organization that has been granted an 35 exemption under s. 501(c)(3) of the Internal Revenue Code of 36 1986, as amended, and that is authorized to possess prescription 37 drugs. 38 6. The transfer of a prescription drug by a person 39 authorized to purchase or receive prescription drugs to a person 40 licensed or permitted to handle reverse distributions or 41 destruction under the laws of the jurisdiction in which the 42 person handling the reverse distribution or destruction receives 43 the drug. 44 7. The transfer of a prescription drug by a hospital or 45 other health care entity, either directly or through the 46 hospital's or health care entity's supplier, to a person 47 licensed under this part to repackage prescription drugs for the 48 purpose of repackaging the prescription drug for use by that 49 hospital, or other health care entity and other health care 50 entities that are under common control, if ownership of the 51 prescription drugs remains with the hospital or other health 52 care entity at all times. In addition to the recordkeeping 53 requirements of s. 499.0121(6) and the requirements for 54 repackagers in s. 499.01212(2), the hospital or health care 55 entity that transfers prescription drugs pursuant to this 56 subparagraph must reconcile all drugs transferred and returned 57 and resolve any discrepancies in a timely manner. 58 Section 24. Paragraph (b) of subsection (2) of section 59 499.01, Florida Statutes, is amended to read 60 499.01 Permits.— 61 (2) The following permits are established: 62 (b) Prescription drug repackager permit.—A prescription 63 drug repackager permit is required for any person that 64 repackages a prescription drug in this state or any person 65 located in another state that repackages and distributes 66 prescription drugs in or into this state that are received in a 67 transfer pursuant to s. 499.003(54)(b)7. 68 1. A person that operates an establishment permitted as a 69 prescription drug repackager may engage in wholesale 70 distribution of prescription drugs repackaged at that 71 establishment and must comply with all the provisions of this 72 part and the rules adopted under this part that apply to a 73 wholesale distributor. 74 2. A prescription drug repackager must comply with all 75 appropriate state and federal good manufacturing practices. 76 Section 25. Paragraph (a) of subsection (2) of section 77 499.01212, Florida Statutes, is amended to read: 78 499.01212 Pedigree paper.— 79 (2) FORMAT.—A pedigree paper must contain the following 80 information: 81 (a) For the wholesale distribution of a prescription drug 82 within the normal distribution chain or pursuant to a transfer 83 described in s. 499.003(54)(b)7: 84 1. The following statement: “This wholesale distributor 85 purchased the specific unit of the prescription drug directly 86 from the manufacturer.” 87 2. The manufacturer’s national drug code identifier and the 88 name and address of the wholesale distributor and the purchaser 89 of the prescription drug. 90 3. The name of the prescription drug as it appears on the 91 label. 92 4. The quantity, dosage form, and strength of the 93 prescription drug. 94 95 The wholesale distributor must also maintain and make 96 available to the department, upon request, the point of origin 97 of the prescription drugs, including intracompany transfers, the 98 date of the shipment from the manufacturer to the wholesale 99 distributor, the lot numbers of such drugs, and the invoice 100 numbers from the manufacturer. When a repackager further 101 distributes prescription drugs to a hospital or other health 102 care entity pursuant to s. 499.003(54)(b)7, the pedigree paper 103 must contain the statement from the wholesale distributor in 104 this subsection, along with the lot numbers of the prescription 105 drugs, the name and address of the repackager and his or her 106 signature, the date of receipt, and the name and address of the 107 person authorized by law to purchase prescription drugs for the 108 purpose of administering or dispensing the drug, as defined in 109 s. 465.003. 110 111 ================= T I T L E A M E N D M E N T ================ 112 And the title is amended as follows: 113 Delete line 1024 114 and insert: 115 Rules to develop and implement the program; amending 116 s. 499.003, F.S.; exempting prescription drugs 117 transferred either directly or through a hospital’s or 118 health care entity’s supplier for the purpose of 119 repackaging from the definition of “wholesale 120 distribution”; amending s. 499.01, F.S.; requiring a 121 permit for prescription drug repackagers located in 122 other states that repackage and distribute drugs for 123 limited purposes into this state; amending s. 124 499.01212, F.S.; requiring pedigree papers for 125 transfers pursuant to s. 499.03(54)(b)7, F.S., to 126 include specified information; amending