| 2 | | - | CS for CS for CS for SB 196 First Engrossed 2025196e1 1 A bill to be entitled 2 An act relating to chemicals in consumer products; 3 amending s. 499.003, F.S.; revising the definition of 4 the term drug; defining the term vaccine or vaccine 5 material; amending s. 499.007, F.S.; deeming a drug 6 misbranded if it is a food containing a vaccine or 7 vaccine material, but its label does not include 8 specified information; creating s. 499.0095, F.S.; 9 defining terms; requiring that, beginning on a 10 specified date, cosmetics manufactured, sold, offered 11 or distributed for sale, or distributed for use in 12 this state provide notice of specified added 13 ingredients on a website that is created and 14 maintained by the cosmetics manufacturer and made 15 available to the public regarding such added 16 ingredients; prohibiting, by a specified date, 17 cosmetics that release formaldehyde from being 18 manufactured, sold, offered or distributed for sale, 19 or distributed for use in this state, unless it is a 20 natural byproduct with no functional or technical 21 purpose; providing an exception; providing 22 construction; providing penalties and remedies; 23 providing applicability; authorizing the Department of 24 Business and Professional Regulation to adopt rules; 25 amending s. 500.03, F.S.; defining the term messenger 26 ribonucleic acid vaccine or mRNA vaccine; amending 27 s. 500.04, F.S.; prohibiting the use of fruits and 28 vegetables to deliver an mRNA vaccine; amending s. 29 500.11, F.S.; deeming a food misbranded if it contains 30 a vaccine or vaccine material, but its label does not 31 include specified information; amending ss. 499.01 and 32 499.05, F.S.; conforming cross-references; providing 33 an effective date. 34 35 Be It Enacted by the Legislature of the State of Florida: 36 37 Section 1.Present subsections (47), (48), and (49) of 38 section 499.003, Florida Statutes, are redesignated as 39 subsections (48), (49), and (50), respectively, a new subsection 40 (47) is added to that section, and subsections (17) and (40) of 41 that section are amended, to read: 42 499.003Definitions of terms used in this part.As used in 43 this part, the term: 44 (17)Drug means an article that is: 45 (a)Recognized in the current edition of the United States 46 Pharmacopoeia and National Formulary, official Homeopathic 47 Pharmacopoeia of the United States, or any supplement to any of 48 those publications; 49 (b)Intended for use in the diagnosis, cure, mitigation, 50 treatment, therapy, or prevention of disease in humans or other 51 animals; 52 (c)Intended to affect the structure or any function of the 53 body of humans or other animals; or 54 (d)Intended for use as a component of any article 55 specified in paragraph (a), paragraph (b), or paragraph (c), and 56 includes active pharmaceutical ingredients, but does not include 57 devices or their nondrug components, parts, or accessories; or 58 (e)Food as defined in s. 500.03 which contains a vaccine 59 or vaccine material. 60 (40)Prescription drug means a prescription, medicinal, 61 or legend drug, including, but not limited to, finished dosage 62 forms or active pharmaceutical ingredients subject to, defined 63 by, or described by s. 503(b) of the federal act or s. 465.003, 64 s. 499.007(13), subsection (31), or subsection (48) (47), except 65 that an active pharmaceutical ingredient is a prescription drug 66 only if substantially all finished dosage forms in which it may 67 be lawfully dispensed or administered in this state are also 68 prescription drugs. 69 (47)Vaccine or vaccine material means a substance 70 authorized or approved by the United States Food and Drug 71 Administration which is intended for use in humans to stimulate 72 the production of antibodies and provide immunity against 73 disease and which is prepared from the causative agent of a 74 disease, its products, or a synthetic substitute and is treated 75 to act as an antigen without inducing the disease. 76 Section 2.Present subsection (17) of section 499.007, 77 Florida Statutes, is redesignated as subsection (18), and a new 78 subsection (17) is added to that section, to read: 79 499.007Misbranded drug or device.A drug or device is 80 misbranded: 81 (17)If it is a food as defined in s. 500.03 and contains a 82 vaccine or vaccine material, but its label does not bear, in 83 type of uniform size and prominence, the words contains vaccine 84 or vaccine material and does not specify that the food is 85 classified as a drug under the Florida Drug and Cosmetic Act. 86 Section 3.Section 499.0095, Florida Statutes, is created 87 to read: 88 499.0095Presence of certain ingredients in cosmetics; 89 notice required. 90 (1)As used in this section, the term: 91 (a)Incidental ingredient means a substance that has no 92 technical or functional effect in the cosmetics but is present 93 by reason of having been incorporated into the cosmetics as an 94 ingredient of another cosmetic ingredient. 95 (b)Ingredient means: 96 1.Any chemical or mixture of chemicals intentionally used 97 in the manufacturing of cosmetics. The term does not include any 98 incidental ingredient that is present in cosmetics at 99 insignificant levels or that has no technical or functional 100 effect; or 101 2.A processing aid, including any of the following: 102 a.A substance that is used in the processing of cosmetics 103 but is removed from the cosmetics in accordance with good 104 manufacturing practices before the cosmetics are packaged in 105 their finished form. 106 b.A substance that is used in the processing of cosmetics 107 for its technical or functional effect to produce the cosmetics 108 and is then converted to a substance the same as constituents of 109 a declared ingredient, in accordance with good manufacturing 110 practices, and does not significantly increase the concentration 111 of such constituents before the cosmetics are packaged in their 112 finished form. 113 c.A substance that is used in the processing of cosmetics 114 for its technical or functional effect to produce the cosmetics 115 in accordance with good manufacturing practices, that is present 116 in the cosmetics finished form at insignificant concentrations, 117 and that does not have any technical or functional effect in 118 such cosmetics. 119 (c)Ortho-phthalates means esters of ortho-phthalic acid. 120 (d)Perfluoroalkyl and polyfluoroalkyl substances or 121 PFAS means a class of fluorinated organic chemicals containing 122 at least one fully fluorinated carbon atom. 123 (2)Except as provided in subsection (5), beginning July 1, 124 2026, cosmetics manufactured, sold, offered or distributed for 125 sale, or distributed for use in this state must provide notice 126 on a website that is created and maintained by the cosmetics 127 manufacturer and made available to the public regarding the 128 following intentionally added chemicals or chemical classes: 129 (a)Ortho-phthalates. 130 (b)PFAS. 131 (c)Formaldehyde as identified in CAS 50-00-0. 132 (d)Methylene glycol as identified in CAS 463-57-0. 133 (e)Mercury as identified in CAS 7439-97-6. 134 (f)Triclosan as identified in CAS 3380-34-5. 135 (g)M-phenylenediamine or its salt derivatives as 136 identified in CAS 108-45-2. 137 (h)O-phenylenediamine or its salt derivatives as 138 identified in CAS 95-54-5. 139 (3)Except as provided in subsection (5), beginning July 1, 140 2026, cosmetics manufactured, sold, offered or distributed for 141 sale, or distributed for use in this state must provide notice 142 on a website that is created and maintained by the cosmetics 143 manufacturer and made available to the public regarding any lead 144 or lead compounds as identified by CAS 7439-92-1, whether 145 intentionally added or naturally occurring, at 10 parts per 146 million or more, or as otherwise determined by department rule. 147 (4)Except as provided in subsection (5), beginning July 1, 148 2026, cosmetics manufactured, sold, offered or distributed for 149 sale, or distributed for use in this state may not release 150 formaldehyde as identified in paragraph (2)(c) unless it is a 151 natural byproduct with no functional or technical purpose. 152 (5)A retailer in possession of cosmetics that do not 153 comply with the requirements of this section as of July 1, 2026, 154 may exhaust its existing stock through sales to the public until 155 July 1, 2027. 156 (6)A violation of this section is subject to the penalties 157 and remedies provided in s. 499.066. 158 (7)This section does not apply to cosmetic products 159 regulated as drugs by the United States Food and Drug 160 Administration. 161 (8)The department may adopt rules necessary to implement 162 this section. 163 Section 4.Present paragraphs (t) through (z) of subsection 164 (1) of section 500.03, Florida Statutes, are redesignated as 165 paragraphs (u) through (aa), respectively, and a new paragraph 166 (t) is added to that subsection, to read: 167 500.03Definitions; construction; applicability. 168 (1)For the purpose of this chapter, the term: 169 (t)Messenger ribonucleic acid vaccine or mRNA vaccine 170 means a vaccine that uses laboratory-produced messenger 171 ribonucleic acid to trigger the human bodys immune system to 172 generate an immune response. 173 Section 5.Subsection (12) is added to section 500.04, 174 Florida Statutes, to read: 175 500.04Prohibited acts.The following acts and the causing 176 thereof within the state are prohibited: 177 (12)The use of a fruit or vegetable as a delivery 178 mechanism for an mRNA vaccine as defined in s. 500.03. 179 Section 6.Paragraph (q) is added to subsection (1) of 180 section 500.11, Florida Statutes, to read: 181 500.11Food deemed misbranded. 182 (1)A food is deemed to be misbranded: 183 (q)If it contains a vaccine or vaccine material as defined 184 in s. 499.003, unless its label bears, in type of uniform size 185 and prominence, the words contains vaccine or vaccine material 186 and specifies that the food is classified as a drug under the 187 Florida Drug and Cosmetic Act. 188 Section 7.Paragraphs (a), (b), and (h) of subsection (2) 189 of section 499.01, Florida Statutes, are amended to read: 190 499.01Permits. 191 (2)The following permits are established: 192 (a)Prescription drug manufacturer permit.A prescription 193 drug manufacturer permit is required for any person that is a 194 manufacturer of a prescription drug and that manufactures or 195 distributes such prescription drugs in this state. 196 1.A person that operates an establishment permitted as a 197 prescription drug manufacturer may engage in distribution of 198 prescription drugs for which the person is the manufacturer and 199 must comply with s. 499.0121 and all other provisions of this 200 part and rules adopted under this part. The department shall 201 adopt rules for issuing a virtual prescription drug manufacturer 202 permit to a person who engages in the manufacture of 203 prescription drugs but does not make or take physical possession 204 of any prescription drugs. The rules adopted by the department 205 under this section may exempt virtual manufacturers from certain 206 establishment, security, and storage requirements set forth in 207 s. 499.0121. 208 2.A prescription drug manufacturer must comply with all 209 appropriate state and federal good manufacturing practices. 210 3.A blood establishment, as defined in s. 381.06014, 211 operating in a manner consistent with the provisions of 21 212 C.F.R. parts 211 and 600-640, and manufacturing only the 213 prescription drugs described in s. 499.003(49)(j) s. 214 499.003(48)(j) is not required to be permitted as a prescription 215 drug manufacturer under this paragraph or to register products 216 under s. 499.015. 217 (b)Prescription drug repackager permit.A prescription 218 drug repackager permit is required for any person that 219 repackages a prescription drug in this state. 220 1.A person that operates an establishment permitted as a 221 prescription drug repackager may engage in distribution of 222 prescription drugs repackaged at that establishment and must 223 comply with all of the provisions of this part and the rules 224 adopted under this part that apply to a prescription drug 225 manufacturer. 226 2.A prescription drug repackager must comply with all 227 appropriate state and federal good manufacturing practices. 228 3.A prescription drug repackager permit is not required 229 for distributing medicinal drugs or prepackaged drug products 230 between entities under common control which each hold either an 231 active Class III institutional pharmacy permit under chapter 465 232 or an active health care clinic establishment permit under 233 paragraph (r). For purposes of this subparagraph, the term 234 common control has the same meaning as in s. 499.003(49)(a)3. 235 s. 499.003(48)(a)3. 236 (h)Restricted prescription drug distributor permit. 237 1.A restricted prescription drug distributor permit is 238 required for: 239 a.Any person located in this state who engages in the 240 distribution of a prescription drug, which distribution is not 241 considered wholesale distribution under s. 499.003(49)(a) s. 242 499.003(48)(a). 243 b.Any person located in this state who engages in the 244 receipt or distribution of a prescription drug in this state for 245 the purpose of processing its return or its destruction if such 246 person is not the person initiating the return, the prescription 247 drug wholesale supplier of the person initiating the return, or 248 the manufacturer of the drug. 249 c.A blood establishment located in this state which 250 collects blood and blood components only from volunteer donors 251 as defined in s. 381.06014 or pursuant to an authorized 252 practitioners order for medical treatment or therapy and 253 engages in the wholesale distribution of a prescription drug not 254 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health 255 care entity. A mobile blood unit operated by a blood 256 establishment permitted under this sub-subparagraph is not 257 required to be separately permitted. The health care entity 258 receiving a prescription drug distributed under this sub 259 subparagraph must be licensed as a closed pharmacy or provide 260 health care services at that establishment. The blood 261 establishment must operate in accordance with s. 381.06014 and 262 may distribute only: 263 (I)Prescription drugs indicated for a bleeding or clotting 264 disorder or anemia; 265 (II)Blood-collection containers approved under s. 505 of 266 the federal act; 267 (III)Drugs that are blood derivatives, or a recombinant or 268 synthetic form of a blood derivative; 269 (IV)Prescription drugs that are identified in rules 270 adopted by the department and that are essential to services 271 performed or provided by blood establishments and authorized for 272 distribution by blood establishments under federal law; or 273 (V)To the extent authorized by federal law, drugs 274 necessary to collect blood or blood components from volunteer 275 blood donors; for blood establishment personnel to perform 276 therapeutic procedures under the direction and supervision of a 277 licensed physician; and to diagnose, treat, manage, and prevent 278 any reaction of a volunteer blood donor or a patient undergoing 279 a therapeutic procedure performed under the direction and 280 supervision of a licensed physician, as long as all of the 281 health care services provided by the blood establishment are 282 related to its activities as a registered blood establishment or 283 the health care services consist of collecting, processing, 284 storing, or administering human hematopoietic stem cells or 285 progenitor cells or performing diagnostic testing of specimens 286 if such specimens are tested together with specimens undergoing 287 routine donor testing. The blood establishment may purchase and 288 possess the drugs described in this sub-subparagraph without a 289 health care clinic establishment permit. 290 2.Storage, handling, and recordkeeping of these 291 distributions by a person required to be permitted as a 292 restricted prescription drug distributor must be in accordance 293 with the requirements for wholesale distributors under s. 294 499.0121. 295 3.A person who applies for a permit as a restricted 296 prescription drug distributor, or for the renewal of such a 297 permit, must provide to the department the information required 298 under s. 499.012. 299 4.The department may adopt rules regarding the 300 distribution of prescription drugs by hospitals, health care 301 entities, charitable organizations, other persons not involved 302 in wholesale distribution, and blood establishments, which rules 303 are necessary for the protection of the public health, safety, 304 and welfare. 305 5.A restricted prescription drug distributor permit is not 306 required for distributions between pharmacies that each hold an 307 active permit under chapter 465, have a common ownership, and 308 are operating in a freestanding end-stage renal dialysis clinic, 309 if such distributions are made to meet the immediate emergency 310 medical needs of specifically identified patients and do not 311 occur with such frequency as to amount to the regular and 312 systematic supplying of that drug between the pharmacies. The 313 department shall adopt rules establishing when the distribution 314 of a prescription drug under this subparagraph amounts to the 315 regular and systematic supplying of that drug. 316 6.A restricted prescription drug distributor permit is not 317 required for distributing medicinal drugs or prepackaged drug 318 products between entities under common control that each hold 319 either an active Class III institutional pharmacy permit under 320 chapter 465 or an active health care clinic establishment permit 321 under paragraph (r). For purposes of this subparagraph, the term 322 common control has the same meaning as in s. 499.003(49)(a)3. 323 s. 499.003(48)(a)3. 324 Section 8.Paragraphs (i) and (l) of subsection (1) of 325 section 499.05, Florida Statutes, are amended to read: 326 499.05Rules. 327 (1)The department shall adopt rules to implement and 328 enforce this chapter with respect to: 329 (i)Additional conditions that qualify as an emergency 330 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or 331 s. 499.82. 332 (l)The recordkeeping, storage, and handling with respect 333 to each of the distributions of prescription drugs specified in 334 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14). 335 Section 9.This act shall take effect July 1, 2025. |
|---|
| 2 | + | Florida Senate - 2025 CS for CS for CS for SB 196 By the Committee on Rules; the Appropriations Committee on Agriculture, Environment, and General Government; the Committee on Regulated Industries; and Senators Gruters and Calatayud 595-03665-25 2025196c3 1 A bill to be entitled 2 An act relating to chemicals in consumer products; 3 amending s. 499.003, F.S.; revising the definition of 4 the term drug; defining the term vaccine or vaccine 5 material; amending s. 499.007, F.S.; deeming a drug 6 misbranded if it is a food containing a vaccine or 7 vaccine material, but its label does not include 8 specified information; creating s. 499.0095, F.S.; 9 defining terms; requiring that, beginning on a 10 specified date, cosmetics manufactured, sold, offered 11 or distributed for sale, or distributed for use in 12 this state provide notice of specified added 13 ingredients on the single-use packaging of such 14 cosmetics; prohibiting, by a specified date, cosmetics 15 that release formaldehyde from being manufactured, 16 sold, offered or distributed for sale, or distributed 17 for use in this state, unless it is a natural 18 byproduct with no functional or technical purpose; 19 providing an exception; providing construction; 20 providing penalties and remedies; providing 21 applicability; authorizing the Department of Business 22 and Professional Regulation to adopt rules; amending 23 s. 500.03, F.S.; defining the term messenger 24 ribonucleic acid vaccine or mRNA vaccine; amending 25 s. 500.04, F.S.; prohibiting the use of fruits and 26 vegetables to deliver an mRNA vaccine; amending s. 27 500.11, F.S.; deeming a food misbranded if it contains 28 a vaccine or vaccine material, but its label does not 29 include specified information; amending ss. 499.01 and 30 499.05, F.S.; conforming cross-references; providing 31 an effective date. 32 33 Be It Enacted by the Legislature of the State of Florida: 34 35 Section 1.Present subsections (47), (48), and (49) of 36 section 499.003, Florida Statutes, are redesignated as 37 subsections (48), (49), and (50), respectively, a new subsection 38 (47) is added to that section, and subsections (17) and (40) of 39 that section are amended, to read: 40 499.003Definitions of terms used in this part.As used in 41 this part, the term: 42 (17)Drug means an article that is: 43 (a)Recognized in the current edition of the United States 44 Pharmacopoeia and National Formulary, official Homeopathic 45 Pharmacopoeia of the United States, or any supplement to any of 46 those publications; 47 (b)Intended for use in the diagnosis, cure, mitigation, 48 treatment, therapy, or prevention of disease in humans or other 49 animals; 50 (c)Intended to affect the structure or any function of the 51 body of humans or other animals; or 52 (d)Intended for use as a component of any article 53 specified in paragraph (a), paragraph (b), or paragraph (c), and 54 includes active pharmaceutical ingredients, but does not include 55 devices or their nondrug components, parts, or accessories; or 56 (e)Food as defined in s. 500.03 which contains a vaccine 57 or vaccine material. 58 (40)Prescription drug means a prescription, medicinal, 59 or legend drug, including, but not limited to, finished dosage 60 forms or active pharmaceutical ingredients subject to, defined 61 by, or described by s. 503(b) of the federal act or s. 465.003, 62 s. 499.007(13), subsection (31), or subsection (48) (47), except 63 that an active pharmaceutical ingredient is a prescription drug 64 only if substantially all finished dosage forms in which it may 65 be lawfully dispensed or administered in this state are also 66 prescription drugs. 67 (47)Vaccine or vaccine material means a substance 68 authorized or approved by the United States Food and Drug 69 Administration which is intended for use in humans to stimulate 70 the production of antibodies and provide immunity against 71 disease and which is prepared from the causative agent of a 72 disease, its products, or a synthetic substitute and is treated 73 to act as an antigen without inducing the disease. 74 Section 2.Present subsection (17) of section 499.007, 75 Florida Statutes, is redesignated as subsection (18), and a new 76 subsection (17) is added to that section, to read: 77 499.007Misbranded drug or device.A drug or device is 78 misbranded: 79 (17)If it is a food as defined in s. 500.03 and contains a 80 vaccine or vaccine material, but its label does not bear, in 81 type of uniform size and prominence, the words contains vaccine 82 or vaccine material and does not specify that the food is 83 classified as a drug under the Florida Drug and Cosmetic Act. 84 Section 3.Section 499.0095, Florida Statutes, is created 85 to read: 86 499.0095Presence of certain ingredients in cosmetics; 87 notice required. 88 (1)As used in this section, the term: 89 (a)Incidental ingredient means a substance that has no 90 technical or functional effect in the cosmetics but is present 91 by reason of having been incorporated into the cosmetics as an 92 ingredient of another cosmetic ingredient. 93 (b)Ingredient means: 94 1.Any chemical or mixture of chemicals intentionally used 95 in the manufacturing of cosmetics. The term does not include any 96 incidental ingredient that is present in cosmetics at 97 insignificant levels or that has no technical or functional 98 effect; or 99 2.A processing aid, including any of the following: 100 a.A substance that is used in the processing of cosmetics 101 but is removed from the cosmetics in accordance with good 102 manufacturing practices before the cosmetics are packaged in 103 their finished form. 104 b.A substance that is used in the processing of cosmetics 105 for its technical or functional effect to produce the cosmetics 106 and is then converted to a substance the same as constituents of 107 a declared ingredient, in accordance with good manufacturing 108 practices, and does not significantly increase the concentration 109 of such constituents before the cosmetics are packaged in their 110 finished form. 111 c.A substance that is used in the processing of cosmetics 112 for its technical or functional effect to produce the cosmetics 113 in accordance with good manufacturing practices, that is present 114 in the cosmetics finished form at insignificant concentrations, 115 and that does not have any technical or functional effect in 116 such cosmetics. 117 (c)Ortho-phthalates means esters of ortho-phthalic acid. 118 (d)Perfluoroalkyl and polyfluoroalkyl substances or 119 PFAS means a class of fluorinated organic chemicals containing 120 at least one fully fluorinated carbon atom. 121 (2)Except as provided in subsection (5), beginning July 1, 122 2026, cosmetics manufactured, sold, offered or distributed for 123 sale, or distributed for use in this state must provide notice 124 on such cosmetics single-use packaging of the following 125 intentionally added chemicals or chemical classes: 126 (a)Ortho-phthalates. 127 (b)PFAS. 128 (c)Formaldehyde as identified in CAS 50-00-0. 129 (d)Methylene glycol as identified in CAS 463-57-0. 130 (e)Mercury as identified in CAS 7439-97-6. 131 (f)Triclosan as identified in CAS 3380-34-5. 132 (g)M-phenylenediamine or its salt derivatives as 133 identified in CAS 108-45-2. 134 (h)O-phenylenediamine or its salt derivatives as 135 identified in CAS 95-54-5. 136 (3)Except as provided in subsection (5), beginning July 1, 137 2026, cosmetics manufactured, sold, offered or distributed for 138 sale, or distributed for use in this state must provide notice 139 on such cosmetics single-use packaging of any lead or lead 140 compounds as identified by CAS 7439-92-1, whether intentionally 141 added or naturally occurring, at 10 parts per million or more, 142 or as otherwise determined by department rule. 143 (4)Except as provided in subsection (5), beginning July 1, 144 2026, cosmetics manufactured, sold, offered or distributed for 145 sale, or distributed for use in this state may not release 146 formaldehyde as identified in paragraph (2)(c) unless it is a 147 natural byproduct with no functional or technical purpose. 148 (5)A retailer in possession of cosmetics that do not 149 comply with the requirements of this section as of July 1, 2026, 150 may exhaust its existing stock through sales to the public until 151 July 1, 2027. 152 (6)A violation of this section is subject to the penalties 153 and remedies provided in s. 499.066. 154 (7)This section does not apply to cosmetic products 155 regulated as drugs by the United States Food and Drug 156 Administration. 157 (8)The department may adopt rules necessary to implement 158 this section. 159 Section 4.Present paragraphs (t) through (z) of subsection 160 (1) of section 500.03, Florida Statutes, are redesignated as 161 paragraphs (u) through (aa), respectively, and a new paragraph 162 (t) is added to that subsection, to read: 163 500.03Definitions; construction; applicability. 164 (1)For the purpose of this chapter, the term: 165 (t)Messenger ribonucleic acid vaccine or mRNA vaccine 166 means a vaccine that uses laboratory-produced messenger 167 ribonucleic acid to trigger the human bodys immune system to 168 generate an immune response. 169 Section 5.Subsection (12) is added to section 500.04, 170 Florida Statutes, to read: 171 500.04Prohibited acts.The following acts and the causing 172 thereof within the state are prohibited: 173 (12)The use of a fruit or vegetable as a delivery 174 mechanism for an mRNA vaccine as defined in s. 500.03. 175 Section 6.Paragraph (q) is added to subsection (1) of 176 section 500.11, Florida Statutes, to read: 177 500.11Food deemed misbranded. 178 (1)A food is deemed to be misbranded: 179 (q)If it contains a vaccine or vaccine material as defined 180 in s. 499.003, unless its label bears, in type of uniform size 181 and prominence, the words contains vaccine or vaccine material 182 and specifies that the food is classified as a drug under the 183 Florida Drug and Cosmetic Act. 184 Section 7.Paragraphs (a), (b), and (h) of subsection (2) 185 of section 499.01, Florida Statutes, are amended to read: 186 499.01Permits. 187 (2)The following permits are established: 188 (a)Prescription drug manufacturer permit.A prescription 189 drug manufacturer permit is required for any person that is a 190 manufacturer of a prescription drug and that manufactures or 191 distributes such prescription drugs in this state. 192 1.A person that operates an establishment permitted as a 193 prescription drug manufacturer may engage in distribution of 194 prescription drugs for which the person is the manufacturer and 195 must comply with s. 499.0121 and all other provisions of this 196 part and rules adopted under this part. The department shall 197 adopt rules for issuing a virtual prescription drug manufacturer 198 permit to a person who engages in the manufacture of 199 prescription drugs but does not make or take physical possession 200 of any prescription drugs. The rules adopted by the department 201 under this section may exempt virtual manufacturers from certain 202 establishment, security, and storage requirements set forth in 203 s. 499.0121. 204 2.A prescription drug manufacturer must comply with all 205 appropriate state and federal good manufacturing practices. 206 3.A blood establishment, as defined in s. 381.06014, 207 operating in a manner consistent with the provisions of 21 208 C.F.R. parts 211 and 600-640, and manufacturing only the 209 prescription drugs described in s. 499.003(49)(j) s. 210 499.003(48)(j) is not required to be permitted as a prescription 211 drug manufacturer under this paragraph or to register products 212 under s. 499.015. 213 (b)Prescription drug repackager permit.A prescription 214 drug repackager permit is required for any person that 215 repackages a prescription drug in this state. 216 1.A person that operates an establishment permitted as a 217 prescription drug repackager may engage in distribution of 218 prescription drugs repackaged at that establishment and must 219 comply with all of the provisions of this part and the rules 220 adopted under this part that apply to a prescription drug 221 manufacturer. 222 2.A prescription drug repackager must comply with all 223 appropriate state and federal good manufacturing practices. 224 3.A prescription drug repackager permit is not required 225 for distributing medicinal drugs or prepackaged drug products 226 between entities under common control which each hold either an 227 active Class III institutional pharmacy permit under chapter 465 228 or an active health care clinic establishment permit under 229 paragraph (r). For purposes of this subparagraph, the term 230 common control has the same meaning as in s. 499.003(49)(a)3. 231 s. 499.003(48)(a)3. 232 (h)Restricted prescription drug distributor permit. 233 1.A restricted prescription drug distributor permit is 234 required for: 235 a.Any person located in this state who engages in the 236 distribution of a prescription drug, which distribution is not 237 considered wholesale distribution under s. 499.003(49)(a) s. 238 499.003(48)(a). 239 b.Any person located in this state who engages in the 240 receipt or distribution of a prescription drug in this state for 241 the purpose of processing its return or its destruction if such 242 person is not the person initiating the return, the prescription 243 drug wholesale supplier of the person initiating the return, or 244 the manufacturer of the drug. 245 c.A blood establishment located in this state which 246 collects blood and blood components only from volunteer donors 247 as defined in s. 381.06014 or pursuant to an authorized 248 practitioners order for medical treatment or therapy and 249 engages in the wholesale distribution of a prescription drug not 250 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health 251 care entity. A mobile blood unit operated by a blood 252 establishment permitted under this sub-subparagraph is not 253 required to be separately permitted. The health care entity 254 receiving a prescription drug distributed under this sub 255 subparagraph must be licensed as a closed pharmacy or provide 256 health care services at that establishment. The blood 257 establishment must operate in accordance with s. 381.06014 and 258 may distribute only: 259 (I)Prescription drugs indicated for a bleeding or clotting 260 disorder or anemia; 261 (II)Blood-collection containers approved under s. 505 of 262 the federal act; 263 (III)Drugs that are blood derivatives, or a recombinant or 264 synthetic form of a blood derivative; 265 (IV)Prescription drugs that are identified in rules 266 adopted by the department and that are essential to services 267 performed or provided by blood establishments and authorized for 268 distribution by blood establishments under federal law; or 269 (V)To the extent authorized by federal law, drugs 270 necessary to collect blood or blood components from volunteer 271 blood donors; for blood establishment personnel to perform 272 therapeutic procedures under the direction and supervision of a 273 licensed physician; and to diagnose, treat, manage, and prevent 274 any reaction of a volunteer blood donor or a patient undergoing 275 a therapeutic procedure performed under the direction and 276 supervision of a licensed physician, as long as all of the 277 health care services provided by the blood establishment are 278 related to its activities as a registered blood establishment or 279 the health care services consist of collecting, processing, 280 storing, or administering human hematopoietic stem cells or 281 progenitor cells or performing diagnostic testing of specimens 282 if such specimens are tested together with specimens undergoing 283 routine donor testing. The blood establishment may purchase and 284 possess the drugs described in this sub-subparagraph without a 285 health care clinic establishment permit. 286 2.Storage, handling, and recordkeeping of these 287 distributions by a person required to be permitted as a 288 restricted prescription drug distributor must be in accordance 289 with the requirements for wholesale distributors under s. 290 499.0121. 291 3.A person who applies for a permit as a restricted 292 prescription drug distributor, or for the renewal of such a 293 permit, must provide to the department the information required 294 under s. 499.012. 295 4.The department may adopt rules regarding the 296 distribution of prescription drugs by hospitals, health care 297 entities, charitable organizations, other persons not involved 298 in wholesale distribution, and blood establishments, which rules 299 are necessary for the protection of the public health, safety, 300 and welfare. 301 5.A restricted prescription drug distributor permit is not 302 required for distributions between pharmacies that each hold an 303 active permit under chapter 465, have a common ownership, and 304 are operating in a freestanding end-stage renal dialysis clinic, 305 if such distributions are made to meet the immediate emergency 306 medical needs of specifically identified patients and do not 307 occur with such frequency as to amount to the regular and 308 systematic supplying of that drug between the pharmacies. The 309 department shall adopt rules establishing when the distribution 310 of a prescription drug under this subparagraph amounts to the 311 regular and systematic supplying of that drug. 312 6.A restricted prescription drug distributor permit is not 313 required for distributing medicinal drugs or prepackaged drug 314 products between entities under common control that each hold 315 either an active Class III institutional pharmacy permit under 316 chapter 465 or an active health care clinic establishment permit 317 under paragraph (r). For purposes of this subparagraph, the term 318 common control has the same meaning as in s. 499.003(49)(a)3. 319 s. 499.003(48)(a)3. 320 Section 8.Paragraphs (i) and (l) of subsection (1) of 321 section 499.05, Florida Statutes, are amended to read: 322 499.05Rules. 323 (1)The department shall adopt rules to implement and 324 enforce this chapter with respect to: 325 (i)Additional conditions that qualify as an emergency 326 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or 327 s. 499.82. 328 (l)The recordkeeping, storage, and handling with respect 329 to each of the distributions of prescription drugs specified in 330 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14). 331 Section 9.This act shall take effect July 1, 2025. |
|---|