| 1 | Representative Bean offered the following: |
| 2 |
|
| 3 | Amendment (with title amendment) |
| 4 | On page 3, between lines 19 and 20, |
| 5 |
|
| 6 | insert: |
| 7 | Section 3. Subsection (29) of section 499.005, Florida |
| 8 | Statutes, is amended to read: |
| 9 | 499.005 Prohibited acts.--It is unlawful for a person to |
| 10 | perform or cause the performance of any of the following acts in |
| 11 | this state: |
| 12 | (29) The receipt of a prescription drug pursuant to a |
| 13 | wholesale distribution without either first receiving a pedigree |
| 14 | paper that was attested to as accurate and complete by the |
| 15 | wholesale distributor or complying with the provisions of s. |
| 16 | 499.0121(6)(f)6. |
| 17 | Section 4. Paragraph (f) of subsection (6) of section |
| 18 | 499.0121, Florida Statutes, is amended to read: |
| 19 | 499.0121 Storage and handling of prescription drugs; |
| 20 | recordkeeping.--The department shall adopt rules to implement |
| 21 | this section as necessary to protect the public health, safety, |
| 22 | and welfare. Such rules shall include, but not be limited to, |
| 23 | requirements for the storage and handling of prescription drugs |
| 24 | and for the establishment and maintenance of prescription drug |
| 25 | distribution records. |
| 26 | (6) RECORDKEEPING.--The department shall adopt rules that |
| 27 | require keeping such records of prescription drugs as are |
| 28 | necessary for the protection of the public health. |
| 29 | (f)1. Effective July 1, 2006, each person who is engaged |
| 30 | in the wholesale distribution of a prescription drug and who is |
| 31 | not the manufacturer of that drug must, before each wholesale |
| 32 | distribution of such drug, provide to the person who receives |
| 33 | the drug a pedigree paper as defined in s. 499.003(31). |
| 34 | 2. A repackager must comply with this paragraph. |
| 35 | 3. The pedigree paper requirements in this paragraph do |
| 36 | not apply to compressed medical gases or veterinary legend |
| 37 | drugs. |
| 38 | 4. Each wholesale distributor of prescription drugs must |
| 39 | maintain separate and distinct from other required records all |
| 40 | statements that are required under subparagraph 1. |
| 41 | 5. In order to verify compliance with subparagraph (d)1., |
| 42 | each manufacturer of a prescription drug sold in this state must |
| 43 | make available upon request distribution documentation related |
| 44 | to its sales of prescription drugs, regardless of whether the |
| 45 | prescription drug was sold directly by the manufacturer to a |
| 46 | person in Florida. |
| 47 | 6. The requirement of subparagraph 1. is satisfied when a |
| 48 | wholesale distributor takes title to, but not possession of, a |
| 49 | prescription drug and the prescription drug's manufacturer ships |
| 50 | the prescription drug directly to a person authorized by law to |
| 51 | purchase prescription drugs for the purpose of administering or |
| 52 | dispensing the drug, as defined under s. 465.003, or a member of |
| 53 | an affiliated group, as described in paragraph (h), except a |
| 54 | repackager. |
| 55 | a. The wholesale distributor must deliver to the recipient |
| 56 | of the prescription drug, within 14 days after the shipment |
| 57 | notification from the manufacturer, an invoice and a sworn |
| 58 | statement that "This wholesale distributor purchased the |
| 59 | specific unit of the prescription drug listed in the invoice |
| 60 | directly from the manufacturer and the specific unit of |
| 61 | prescription drug was shipped by the manufacturer directly to a |
| 62 | person authorized by law to administer or dispense the legend |
| 63 | drug pursuant to s. 465.003, Florida Statutes, or a member of an |
| 64 | affiliated group, as described in s. 499.0121(6)(h), Florida |
| 65 | Statutes, except a repackager." The invoice must contain a |
| 66 | unique cross-reference to the shipping document sent by the |
| 67 | manufacturer to the recipient of the prescription drug. |
| 68 | b. The recipient of the prescription drug must acquire, |
| 69 | within 14 days after receipt of the prescription drug, a |
| 70 | shipping document from the manufacturer that contains, at a |
| 71 | minimum: |
| 72 | (I) The name and address of the manufacturer, including |
| 73 | the point of origin of the shipment; the wholesaler; and such |
| 74 | purchaser. |
| 75 | (II) The name of the prescription drug as it appears on |
| 76 | the label. |
| 77 | (III) The quantity, dosage form, and strength of the |
| 78 | prescription drug. |
| 79 | (IV) The date of the shipment from the manufacturer. |
| 80 |
|
| 81 | The wholesale distributor must also maintain and make available |
| 82 | to the department, upon request, the lot number of the |
| 83 | prescription drug if the lot number is not contained in the |
| 84 | shipping document acquired by the recipient. |
| 85 | 7. Failure of the recipient to acquire, or the wholesale |
| 86 | distributor to deliver, the documentation required under |
| 87 | subparagraph 6. shall constitute failure to acquire or deliver a |
| 88 | pedigree paper under s. 499.0051. Forgery by recipient or the |
| 89 | wholesale distributor of the documentation required to be |
| 90 | acquired or delivered under subparagraph 6. shall constitute |
| 91 | forgery of a pedigree paper under s. 499.0051. |
| 92 | 8. The department may by rule define alternatives to |
| 93 | compliance with subparagraph 1. for a prescription drug in the |
| 94 | inventory of a permitted prescription drug wholesaler as of June |
| 95 | 30, 2006, and the return of a prescription drug purchased prior |
| 96 | to July 1, 2006. The department may specify time limits for such |
| 97 | alternatives. |
| 98 |
|
| 99 | ========= T I T L E A M E N D M E N T ========= |
| 100 | On page 1, lines 2-10, |
| 101 | remove: all of said lines |
| 102 |
|
| 103 | and insert: |
| 104 | An act relating to pharmacy; amending s. 465.026, F.S.; |
| 105 | deleting a provision authorizing certain community |
| 106 | pharmacies to transfer prescriptions for Schedule II |
| 107 | medicinal drugs under certain conditions; creating s. |
| 108 | 465.0266, F.S.; authorizing the dispensing or refilling of |
| 109 | a prescription without a transferred prescription under |
| 110 | specified conditions; amending s. 499.005, F.S.; revising |
| 111 | a prohibition relating to pedigree papers; amending s. |
| 112 | 499.0121, F.S.; requiring certain wholesale distributors |
| 113 | taking title to a prescription drug to provide an invoice |
| 114 | to the purchaser containing certain information; requiring |
| 115 | a recipient of a prescription drug to acquire from the |
| 116 | manufacturer a shipping document containing specified |
| 117 | information; requiring a wholesale distributor to make |
| 118 | certain information available to the department; providing |
| 119 | for penalties; authorizing the department to adopt certain |
| 120 | rules relating to the inventory and return of certain |
| 121 | prescription drugs; providing an effective |