| 1 | A bill to be entitled |
| 2 | An act relating to blood establishments; amending s. |
| 3 | 381.06014, F.S.; prohibiting a local government from |
| 4 | restricting access to or use of public facilities or |
| 5 | infrastructure for the collection of blood or blood |
| 6 | components from volunteer donors based on certain |
| 7 | criteria; prohibiting blood establishments from |
| 8 | determining the price of blood or blood components based |
| 9 | on certain criteria; amending s. 499.003, F.S.; revising |
| 10 | the definition of the term "wholesale distribution" to |
| 11 | exclude certain drugs and products distributed by blood |
| 12 | establishments; amending s. 499.01, F.S.; excluding |
| 13 | certain blood establishments from the requirement to |
| 14 | obtain a prescription drug manufacturer permit; providing |
| 15 | an effective date. |
| 16 |
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| 17 | Be It Enacted by the Legislature of the State of Florida: |
| 18 |
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| 19 | Section 1. Subsections (5) and (6) are added to section |
| 20 | 381.06014, Florida Statutes, to read: |
| 21 | 381.06014 Blood establishments.- |
| 22 | (5) A local government may not restrict the access to or |
| 23 | use of any public facility or infrastructure for the collection |
| 24 | of blood or blood components from volunteer donors based on |
| 25 | whether the blood establishment is operating as a for-profit |
| 26 | organization or a not-for-profit organization. |
| 27 | (6) In determining the price of blood or blood components |
| 28 | that are received from volunteer donors and sold to hospitals or |
| 29 | other health care providers, a blood establishment may not base |
| 30 | the price of the blood or blood component solely on whether the |
| 31 | purchasing entity is a for-profit organization or a not-for- |
| 32 | profit organization. |
| 33 | Section 2. Paragraphs (e) and (f) of subsection (53) of |
| 34 | section 499.003, Florida Statutes, are redesignated as |
| 35 | paragraphs (f) and (g), respectively, and a new paragraph (e) is |
| 36 | added to that subsection to read: |
| 37 | 499.003 Definitions of terms used in this part.-As used in |
| 38 | this part, the term: |
| 39 | (53) "Wholesale distribution" means distribution of |
| 40 | prescription drugs to persons other than a consumer or patient, |
| 41 | but does not include: |
| 42 | (e) The sale, purchase, or trade or the offer to sell, |
| 43 | purchase, or trade, by a registered blood establishment that |
| 44 | qualifies as a health care entity of any: |
| 45 | 1. Drug indicated for a bleeding or clotting disorder or |
| 46 | anemia; |
| 47 | 2. Blood collection container approved under section 505 |
| 48 | of the Prescription Drug Marketing Act; |
| 49 | 3. Drug that is a blood derivative, or a recombinant or |
| 50 | synthetic form of a blood derivative; or |
| 51 | 4. Drug necessary to collect blood or blood components |
| 52 | from volunteer blood donors; for blood establishment personnel |
| 53 | to perform therapeutic procedures under the direction and |
| 54 | supervision of a licensed physician; and to diagnose, treat, |
| 55 | manage, and prevent any reaction of either a volunteer blood |
| 56 | donor or a patient undergoing a therapeutic procedure performed |
| 57 | under the direction and supervision of a licensed physician. |
| 58 |
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| 59 | A blood establishment's distribution of products is excluded |
| 60 | under this paragraph as long as all health care services |
| 61 | provided by the blood establishment are related to its |
| 62 | activities as a registered blood establishment or the health |
| 63 | care services provided by the blood establishment consisting of |
| 64 | collecting, processing, storing, or administering human |
| 65 | hematopoietic stem or progenitor cells or performing diagnostic |
| 66 | testing of specimens that are tested together with specimens |
| 67 | undergoing routine donor testing. A blood establishment must |
| 68 | satisfy the requirements of ss. 499.0121 and 499.01212. |
| 69 | Section 3. Paragraph (a) of subsection (2) of section |
| 70 | 499.01, Florida Statutes, is amended to read: |
| 71 | 499.01 Permits.- |
| 72 | (2) The following permits are established: |
| 73 | (a) Prescription drug manufacturer permit.-A prescription |
| 74 | drug manufacturer permit is required for any person that is a |
| 75 | manufacturer of a prescription drug and that manufactures or |
| 76 | distributes such prescription drugs in this state. |
| 77 | 1. A person that operates an establishment permitted as a |
| 78 | prescription drug manufacturer may engage in wholesale |
| 79 | distribution of prescription drugs manufactured at that |
| 80 | establishment and must comply with all of the provisions of this |
| 81 | part, except s. 499.01212, and the rules adopted under this |
| 82 | part, except s. 499.01212, that apply to a wholesale |
| 83 | distributor. |
| 84 | 2. A prescription drug manufacturer must comply with all |
| 85 | appropriate state and federal good manufacturing practices. |
| 86 | 3. A blood establishment, as defined in s. 381.06014, |
| 87 | operating in a manner consistent with 21 C.F.R. parts 211 and |
| 88 | 660-640 and manufacturing only the prescription drugs described |
| 89 | in s. 499.003(53)(d) is not required to obtain a permit as a |
| 90 | prescription drug manufacturer under this paragraph or register |
| 91 | products under s. 499.015. |
| 92 | Section 4. This act shall take effect upon becoming a law. |