Bill Text: FL S0094 | 2011 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Blood Establishments
Spectrum: Bipartisan Bill
Status: (Engrossed - Dead) 2011-05-07 - Indefinitely postponed and withdrawn from consideration [S0094 Detail]
Download: Florida-2011-S0094-Introduced.html
Bill Title: Blood Establishments
Spectrum: Bipartisan Bill
Status: (Engrossed - Dead) 2011-05-07 - Indefinitely postponed and withdrawn from consideration [S0094 Detail]
Download: Florida-2011-S0094-Introduced.html
Florida Senate - 2011 SB 94 By Senator Gaetz 4-00007A-11 201194__ 1 A bill to be entitled 2 An act relating to blood establishments; amending s. 3 381.06014, F.S.; defining the term “volunteer donor”; 4 prohibiting local governments from restricting access 5 to public facilities or infrastructure for certain 6 activities based on whether a blood establishment is 7 operating as a for-profit organization or not-for 8 profit organization; prohibiting a blood establishment 9 from considering whether certain customers are 10 operating as for-profit organizations or not-for 11 profit organizations when determining service fees for 12 selling blood or blood components; requiring that 13 certain blood establishments disclose specified 14 information on the Internet; amending s. 483.201, 15 F.S.; providing for disciplinary action against 16 clinical laboratories that fail to disclose specified 17 information on the Internet; providing a maximum 18 annual administrative fine that may be imposed 19 annually against certain clinical laboratories for 20 failure to comply with such disclosure requirement; 21 amending s. 499.003, F.S.; redefining the term “health 22 care entity” to clarify that a blood establishment may 23 be a health care entity and engage in certain 24 activities; amending s. 499.005, F.S.; clarifying 25 provisions prohibiting the unauthorized wholesale 26 distribution of a prescription drug that was purchased 27 by a hospital or other health care entity, to conform 28 to changes made by the act; amending s. 499.01, F.S.; 29 exempting certain blood establishments from the 30 requirements to be permitted as a prescription drug 31 manufacturer and register products; requiring that 32 certain blood establishments obtain a restricted 33 prescription drug distributor permit under specified 34 conditions; limiting the prescription drugs that a 35 blood establishment may distribute under a restricted 36 prescription drug distributor permit; authorizing the 37 Department of Health to adopt rules; providing an 38 effective date. 39 40 Be It Enacted by the Legislature of the State of Florida: 41 42 Section 1. Section 381.06014, Florida Statutes, is amended 43 to read: 44 381.06014 Blood establishments.— 45 (1) As used in this section, the term: 46 (a) “Blood establishment” means any person, entity, or 47 organization, operating within the state, which examines an 48 individual for the purpose of blood donation or which collects, 49 processes, stores, tests, or distributes blood or blood 50 components collected from the human body for the purpose of 51 transfusion, for any other medical purpose, or for the 52 production of any biological product. 53 (b) “Volunteer donor” means a person who does not receive 54 remuneration, other than an incentive, for a blood donation 55 intended for transfusion, and the product container of the 56 donation from the person qualifies for labeling with the 57 statement “volunteer donor” under 21 C.F.R. s. 606.121. 58 (2) Any blood establishment operating in the state may not 59 conduct any activity defined in paragraph (1)(a)subsection (1)60 unless that blood establishment is operated in a manner 61 consistent with the provisions of Title 21 C.F.R. parts 211 and 62 600-640, Code of Federal Regulations. 63 (3) Any blood establishment determined to be operating in 64 the state in a manner not consistent with the provisions of 65 Title 21 C.F.R. parts 211 and 600-640, Code of Federal66Regulations,and in a manner that constitutes a danger to the 67 health or well-being of donors or recipients as evidenced by the 68 federal Food and Drug Administration’s inspection reports and 69 the revocation of the blood establishment’s license or 70 registration isshall bein violation of this chapter and shall 71 immediately cease all operations in the state. 72 (4) The operation of a blood establishment in a manner not 73 consistent with the provisions of Title 21 C.F.R. parts 211 and 74 600-640, Code of Federal Regulations,and in a manner that 75 constitutes a danger to the health or well-being of blood donors 76 or recipients as evidenced by the federal Food and Drug 77 Administration’s inspection process is declared a nuisance and 78 inimical to the public health, welfare, and safety. The Agency 79 for Health Care Administration or any state attorney may bring 80 an action for an injunction to restrain such operations or 81 enjoin the future operation of the blood establishment. 82 (5) A local government may not restrict the access to or 83 use of any public facility or infrastructure for the collection 84 of blood or blood components from volunteer donors based on 85 whether the blood establishment is operating as a for-profit 86 organization or not-for-profit organization. 87 (6) In determining the service fee of blood or blood 88 components received from volunteer donors and sold to hospitals 89 or other health care providers, a blood establishment may not 90 base the service fee of the blood or blood component solely on 91 whether the purchasing entity is a for-profit organization or 92 not-for-profit organization. 93 (7) A blood establishment that collects blood or blood 94 components from volunteer donors must disclose on the Internet 95 information to educate and inform donors and the public about 96 the blood establishment’s activities. A hospital that collects 97 blood or blood components from volunteer donors for its own use 98 or for health care providers that are part of its business 99 entity is exempt from the disclosure requirements in this 100 subsection. The information required to be disclosed under this 101 subsection may be cumulative for all blood establishments within 102 a business entity. Disciplinary action against the blood 103 establishment’s clinical laboratory license may be taken as 104 provided in s. 483.201 for a blood establishment that is 105 required to disclose but fails to disclose on its website all of 106 the following information: 107 (a) A description of the steps involved in collecting, 108 processing, and distributing volunteer donations, presented in a 109 manner appropriate for the donating public. 110 (b) By March 1 of each year, the number of units of blood 111 components, identified by component, which were: 112 1. Produced by the blood establishment during the preceding 113 calendar year; 114 2. Obtained from other sources during the preceding 115 calendar year; 116 3. Distributed during the preceding year to health care 117 providers located outside this state. However, if the blood 118 establishment collects donations in a county outside this state, 119 distributions to health care providers in that county shall be 120 excluded. Such information shall be aggregated by health care 121 providers located within the United States and its territories 122 or outside the United States and its territories; and 123 4. Distributed during the preceding year to entities that 124 are not health care providers. Such information shall be 125 aggregated by purchasers located within the United States and 126 its territories or outside the United States and its 127 territories. 128 129 For purposes of this paragraph, the components that must be 130 reported include whole blood, red blood cells, leukoreduced red 131 blood cells, fresh frozen plasma or the equivalent, recovered 132 plasma, platelets, and cryoprecipitated antihemophilic factor. 133 (c) The blood establishment’s conflict-of-interest policy, 134 policy concerning related-party transactions, whistleblower 135 policy, and policy for determining executive compensation. If a 136 change to any of these documents occurs, the revised document 137 must be available on the blood establishment’s website by the 138 following March 1. 139 (d)1. The most recent 3 years of the Return of Organization 140 Exempt from Income Tax, Internal Revenue Service Form 990, if 141 the business entity for the blood establishment is eligible to 142 file such return. The Form 990 must be available on the blood 143 establishment’s website within 30 calendar days after it is 144 filed with the Internal Revenue Service; or 145 2. If the business entity for the blood establishment is 146 not eligible to file the Form 990 return, a balance sheet, 147 income statement, and statement of changes in cash flow, along 148 with the expression of an opinion thereon by an independent 149 certified public accountant who audited or reviewed such 150 financial statements. Such documents must be available on the 151 blood establishment’s website within 120 days after the end of 152 the blood establishment’s fiscal year and must remain on the 153 blood establishment’s website for at least 36 months. 154 Section 2. Subsection (11) is added to section 483.201, 155 Florida Statutes, to read: 156 483.201 Grounds for disciplinary action against clinical 157 laboratories.—In addition to the requirements of part II of 158 chapter 408, the following acts constitute grounds for which a 159 disciplinary action specified in s. 483.221 may be taken against 160 a clinical laboratory: 161 (11) For a blood establishment that collects blood or blood 162 components from volunteer donors, failing to disclose 163 information concerning its activities as required by s. 164 381.06014. Each day of violation constitutes a separate 165 violation and each separate violation is subject to a separate 166 fine. If multiple licensed establishments operated by a single 167 business entity fail to meet such disclosure requirements, the 168 agency may assess fines against only one of the business 169 entity’s clinical laboratory licenses. The total administrative 170 fine may not exceed $10,000 for each annual reporting period. 171 Section 3. Subsection (23) of section 499.003, Florida 172 Statutes, is amended to read 173 499.003 Definitions of terms used in this part.—As used in 174 this part, the term: 175 (23) “Health care entity” means a closed pharmacy or any 176 person, organization, or business entity that provides 177 diagnostic, medical, surgical, or dental treatment or care, or 178 chronic or rehabilitative care, but does not include any 179 wholesale distributor or retail pharmacy licensed under state 180 law to deal in prescription drugs. However, a blood 181 establishment may be a health care entity and engage in the 182 wholesale distribution of prescription drugs under s. 183 499.01(2)(g)1.c. 184 Section 4. Subsection (21) of section 499.005, Florida 185 Statutes, is amended to read: 186 499.005 Prohibited acts.—It is unlawful for a person to 187 perform or cause the performance of any of the following acts in 188 this state: 189 (21) The wholesale distribution of any prescription drug 190 that was: 191 (a) Purchased by a public or private hospital or other 192 health care entity, except as authorized in s. 499.01(2)(g)1.c.; 193 or 194 (b) Donated or supplied at a reduced price to a charitable 195 organization. 196 Section 5. Paragraphs (a) and (g) of subsection (2) of 197 section 499.01, Florida Statutes, are amended to read: 198 499.01 Permits.— 199 (2) The following permits are established: 200 (a) Prescription drug manufacturer permit.—A prescription 201 drug manufacturer permit is required for any person that is a 202 manufacturer of a prescription drug and that manufactures or 203 distributes such prescription drugs in this state. 204 1. A person that operates an establishment permitted as a 205 prescription drug manufacturer may engage in wholesale 206 distribution of prescription drugs manufactured at that 207 establishment and must comply with all of the provisions of this 208 part, except s. 499.01212, and the rules adopted under this 209 part, except s. 499.01212, whichthatapply to a wholesale 210 distributor. 211 2. A prescription drug manufacturer must comply with all 212 appropriate state and federal good manufacturing practices. 213 3. A blood establishment, as defined in s. 381.06014, 214 operating in a manner consistent with the provisions of Title 21 215 C.F.R. parts 211 and 600-640, and manufacturing only the 216 prescription drugs described in s. 499.003(54)(d) is not 217 required to be permitted as a prescription drug manufacturer 218 under this paragraph or to register products under s. 499.015. 219 (g) Restricted prescription drug distributor permit.— 220 1. A restricted prescription drug distributor permit is 221 required for: 222 a. Any person that engages in the distribution of a 223 prescription drug, which distribution is not considered 224 “wholesale distribution” under s. 499.003(54)(a). 225 b.1.AnyAperson who engages in the receipt or 226 distribution of a prescription drug in this state for the 227 purpose of processing its return or its destructionmust obtain228a permit as a restricted prescription drug distributorif such 229 person is not the person initiating the return, the prescription 230 drug wholesale supplier of the person initiating the return, or 231 the manufacturer of the drug. 232 c. A blood establishment located in this state which 233 collects blood and blood components only from volunteer donors 234 as defined in s. 381.06014 or pursuant to an authorized 235 practitioner’s order for medical treatment or therapy and 236 engages in the wholesale distribution of a prescription drug not 237 described in s. 499.003(54)(d) to a health care entity. The 238 health care entity receiving a prescription drug distributed 239 under this sub-subparagraph must be licensed as a closed 240 pharmacy or provide health care services at that establishment. 241 The blood establishment must operate in accordance with s. 242 381.06014 and may distribute only: 243 (I) Prescription drugs indicated for a bleeding or clotting 244 disorder or anemia; 245 (II) Blood-collection containers approved under s. 505 of 246 the federal act; 247 (III) Drugs that are blood derivatives, or a recombinant or 248 synthetic form of a blood derivative; or 249 (IV) Prescription drugs that are identified in rules 250 adopted by the department and that are essential to services 251 performed or provided by blood establishments and authorized for 252 distribution by blood establishments under federal law, 253 254 as long as all of the health care services provided by the blood 255 establishment are related to its activities as a registered 256 blood establishment or the health care services consist of 257 collecting, processing, storing, or administering human 258 hematopoietic stem cells or progenitor cells or performing 259 diagnostic testing of specimens if such specimens are tested 260 together with specimens undergoing routine donor testing. 261 2. Storage, handling, and recordkeeping of these 262 distributions by a person permitted as a restricted prescription 263 drug distributor must comply with the requirements for wholesale 264 distributors under s. 499.0121, but not those set forth in s. 265 499.01212 if the distribution occurs pursuant to sub 266 subparagraph 1.a. or sub-subparagraph 1.b. 267 3. A person who applies for a permit as a restricted 268 prescription drug distributor, or for the renewal of such a 269 permit, must provide to the department the information required 270 under s. 499.012. 271 4. The department may adopt rules regarding the 272 distribution of prescription drugs by hospitals, health care 273 entities, charitable organizations, or other persons not 274 involved in wholesale distribution, and blood establishments; 275 which rules are necessary for the protection of the public 276 health, safety, and welfare. The department may adopt rules 277 related to the transportation, storage, and recordkeeping of 278 prescription drugs that are essential to services performed or 279 provided by a blood establishment, including requirements for 280 the use of prescription drugs in mobile blood-collection 281 vehicles. 282 Section 6. This act shall take effect July 1, 2011.