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         499.003 Definitions 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         499.007 Misbranded 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  “PFASmeans 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         500.03 Definitions; 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 body’s 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         500.04 Prohibited 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         500.11 Food 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         499.01 Permits.—
  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  practitioner’s 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         499.05 Rules.—
  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.