| 1 | A bill to be entitled |
| 2 | An act relating to veterinarian prescription drugs; |
| 3 | amending s. 499.01, F.S.; requiring a permit to operate as |
| 4 | a veterinary drug distributor who distributes veterinary |
| 5 | legend drugs and certain human drugs; amending s. |
| 6 | 499.0121, F.S.; exempting approved human drugs sold |
| 7 | directly to veterinarians from pedigree paper |
| 8 | requirements; providing an effective date. |
| 9 |
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| 10 | Be It Enacted by the Legislature of the State of Florida: |
| 11 |
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| 12 | Section 1. Paragraphs (p) and (q) of subsection (1) of |
| 13 | section 499.01, Florida Statutes, are amended, and paragraph (r) |
| 14 | is added to said section, to read: |
| 15 | 499.01 Permits; applications; renewal; general |
| 16 | requirements.-- |
| 17 | (1) Prior to operating, a permit is required for each |
| 18 | person and establishment that intends to operate as: |
| 19 | (p) A complimentary drug distributor; or |
| 20 | (q) A restricted prescription drug distributor; or |
| 21 | (r) A veterinary drug distributor distributing both |
| 22 | veterinary legend drugs and human drugs approved by the |
| 23 | department. |
| 24 | Section 2. Paragraph (f) of subsection (6) of section |
| 25 | 499.0121, Florida Statutes, is amended to read: |
| 26 | 499.0121 Storage and handling of prescription drugs; |
| 27 | recordkeeping.--The department shall adopt rules to implement |
| 28 | this section as necessary to protect the public health, safety, |
| 29 | and welfare. Such rules shall include, but not be limited to, |
| 30 | requirements for the storage and handling of prescription drugs |
| 31 | and for the establishment and maintenance of prescription drug |
| 32 | distribution records. |
| 33 | (6) RECORDKEEPING.--The department shall adopt rules that |
| 34 | require keeping such records of prescription drugs as are |
| 35 | necessary for the protection of the public health. |
| 36 | (f)1. Effective July 1, 2006, each person who is engaged |
| 37 | in the wholesale distribution of a prescription drug intended |
| 38 | for sale to a human recipient and who is not the manufacturer of |
| 39 | that drug must, before each wholesale distribution of such drug, |
| 40 | provide to the person who receives the drug a pedigree paper as |
| 41 | defined in s. 499.003(31). |
| 42 | 2. A repackager must comply with this paragraph. |
| 43 | 3. The pedigree paper requirements in this paragraph do |
| 44 | not apply to compressed medical gases, or veterinary legend |
| 45 | drugs, or approved human drugs sold directly to veterinarians. |
| 46 | 4. Each wholesale distributor of prescription drugs must |
| 47 | maintain separate and distinct from other required records all |
| 48 | statements that are required under subparagraph 1. |
| 49 | 5. In order to verify compliance with subparagraph (d)1., |
| 50 | each manufacturer of a prescription drug sold in this state must |
| 51 | make available upon request distribution documentation related |
| 52 | to its sales of prescription drugs, regardless of whether the |
| 53 | prescription drug was sold directly by the manufacturer to a |
| 54 | person in Florida. |
| 55 | Section 3. This act shall take effect July 1, 2005. |