Florida Senate - 2020                          SENATOR AMENDMENT
       Bill No. CS for SB 58
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       Senator Book moved the following:
    1         Senate Amendment (with title amendment)
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 465.1902, Florida Statutes, is created
    6  to read:
    7         465.1902Prescription Drug Donation Repository Program.—
    8         (1)SHORT TITLE.—This section may be cited as the
    9  “Prescription Drug Donation Repository Program Act.”
   10         (2)DEFINITIONS.—As used in this section, the term:
   11         (a)“Closed drug delivery system” means a system in which
   12  the actual control of the unit-dose medication package is
   13  maintained by the facility, rather than by the individual
   14  patient.
   15         (b)“Controlled substance” means any substance listed in
   16  Schedule II, Schedule III, Schedule IV, or Schedule V of s.
   17  893.03.
   18         (c)“Dispenser” means a health care practitioner who,
   19  within the scope of his or her practice act, is authorized to
   20  dispense medicinal drugs and who does so under this act.
   21         (d)“Free clinic” means a clinic that delivers only medical
   22  diagnostic services or nonsurgical medical treatment free of
   23  charge to low-income recipients.
   24         (e)“Health care practitioner” or “practitioner” means a
   25  practitioner licensed under this chapter, chapter 458, chapter
   26  459, chapter 461, chapter 463, chapter 464, or chapter 466.
   27         (f)“Indigent” means having a family income during the 12
   28  months preceding the determination of income that is below 200
   29  percent of the federal poverty level as defined by the most
   30  recently revised poverty income guidelines published by the
   31  United States Department of Health and Human Services.
   32         (g)“Nonprofit health clinic” means a nonprofit legal
   33  entity that provides medical care to patients who are indigent,
   34  uninsured, or underinsured. The term includes, but is not
   35  limited to, a federally qualified health center as defined in 42
   36  U.S.C. s. 1396d(l)(2)(B) and a rural health clinic as defined in
   37  42 U.S.C. s. 1396d(l)(1).
   38         (h)“Nursing home facility” has the same meaning as in s.
   39  400.021.
   40         (i)“Prescriber” means a health care practitioner who,
   41  within the scope of his or her practice act, is authorized to
   42  prescribe medicinal drugs.
   43         (j)“Prescription drug” has the same meaning as the terms
   44  “medicinal drugs” or “drugs,” as those terms are defined in s.
   45  465.003(8), but does not include controlled substances, cancer
   46  drugs donated under s. 499.029, or drugs with an approved United
   47  States Food and Drug Administration risk evaluation and
   48  mitigation strategy that includes elements to assure safe use.
   49         (k)“Program” means the Prescription Drug Donation
   50  Repository Program created by this section.
   51         (l)“Supply” means a material or an instrument used to
   52  administer a prescription drug.
   53         (m)“Tamper-evident packaging” means a package that has one
   54  or more indicators or barriers to access which, if breached or
   55  missing, can reasonably be expected to provide visible evidence
   56  to consumers that tampering has occurred. The term includes, but
   57  is not limited to, unopened unit-dose packaging, multiple-dose
   58  packaging, and medications with a seal on their immediate,
   59  outer, secondary, or tertiary packaging.
   60         (n)“Underinsured” means having health care coverage or
   61  prescription drug coverage, but having exhausted these benefits
   62  or not having prescription drug coverage for the drug
   63  prescribed.
   64         (o)“Uninsured” means not having health care coverage and
   65  being ineligible for prescription drug coverage under a program
   66  funded in whole or in part by the Federal Government.
   68  CREATION; PURPOSE.—The Prescription Drug Donation Repository
   69  Program is created within the department to facilitate the
   70  donation of prescription drugs and supplies to eligible
   71  patients.
   72         (4)REPOSITORIES.—
   73         (a)A repository may accept and dispense eligible donations
   74  to eligible patients under the program. The repository must
   75  inspect, store, and dispense donations and report to the
   76  department in accordance with this section.
   77         (b)The following entities may participate as a repository:
   78         1.A health care practitioner’s office.
   79         2.A pharmacy.
   80         3.A hospital with a closed drug delivery system.
   81         4.A nursing home facility with a closed drug delivery
   82  system.
   83         5.A free clinic or nonprofit health clinic that is
   84  licensed or permitted to dispense medicinal drugs in this state.
   85         (c)An eligible entity must notify the department of its
   86  intent to participate in the program as a repository before
   87  accepting or dispensing any donations under the program. The
   88  notification must be made on a physical or an electronic form
   89  prescribed by the department in rule and must, at a minimum,
   90  include:
   91         1.The name, street address, website, and telephone number
   92  of the intended repository and any license or registration
   93  number issued by the state to the intended repository, including
   94  the name of the issuing agency.
   95         2.The name and telephone number of the pharmacist employed
   96  by or under contract with the intended repository who is
   97  responsible for the inspection of donated prescription drugs and
   98  supplies.
   99         3.A signed and dated statement by the responsible
  100  pharmacist affirming that the intended repository meets the
  101  eligibility requirements of this subsection.
  102         (d)A repository may withdraw from participation in the
  103  program at any time by providing written notice to the
  104  department, as appropriate, on a physical or an electronic form
  105  prescribed by department rule. The department shall adopt rules
  106  addressing the disposition of prescription drugs and supplies in
  107  the possession of the withdrawing repository.
  108         (5)ELIGIBLE DONORS.—The following entities may donate
  109  prescription drugs or supplies to a repository under the
  110  program:
  111         (a)Nursing home facilities with closed drug delivery
  112  systems.
  113         (b)Hospices that have maintained control of a patient’s
  114  prescription drugs.
  115         (c)Hospitals with closed drug delivery systems.
  116         (d)Pharmacies.
  117         (e)Drug manufacturers or wholesale distributors.
  118         (f)Medical device manufacturers or suppliers.
  119         (g)Prescribers who receive prescription drugs or supplies
  120  directly from a drug manufacturer, wholesale distributor, or
  121  pharmacy.
  123  DONATIONS.—
  124         (a)An eligible donor may donate a prescription drug to a
  125  repository only if:
  126         1.The drug is approved for medical use in the United
  127  States.
  128         2.The drug is in unopened, tamper-evident packaging.
  129         3.The drug requires storage at normal room temperature per
  130  the manufacturer or federal storage requirements.
  131         4.The drug has been stored according to manufacturer or
  132  federal storage requirements.
  133         5.The drug does not have any physical signs of tampering
  134  or adulteration and there is no reason to believe that the drug
  135  is adulterated.
  136         6.The packaging does not have any physical signs of
  137  tampering, misbranding, deterioration, compromised integrity, or
  138  adulteration.
  139         7.The packaging indicates the expiration date of the drug.
  140  All specified medications must be destroyed in the event of a
  141  recall if the lot number is not retrievable.
  142         8.The drug has an expiration date that is more than 3
  143  months after the date on which the drug was donated.
  144         (b)An eligible donor may donate a prescription drug or
  145  supply to a repository only if it is in unopened, tamper-evident
  146  packaging.
  147         (c)Donations must be made on the premises of a repository
  148  to a person designated by the repository. A drop box may not be
  149  used to accept donations.
  150         (d)A prescription drug or supply may not be donated to a
  151  specific patient.
  152         (7)INSPECTION AND STORAGE.—
  153         (a)Upon receipt of a proposed donation, a licensed
  154  pharmacist employed by or under contract with a repository shall
  155  inspect the donation to determine whether it meets the
  156  requirements of subsections (5) and (6). The repository shall
  157  quarantine a donation until such inspection is complete and the
  158  donation is approved for dispensing.
  159         (b)If a donation is approved for dispensing, the
  160  inspecting pharmacist shall sign an inspection record on a
  161  physical or an electronic form prescribed by the department in
  162  rule which verifies that the prescription drug or supply meets
  163  the criteria of subsections (5) and (6) and shall attach the
  164  record to the inventory required in paragraph (d). A repository
  165  that receives prescription drugs and supplies from another
  166  repository is not required to reinspect such drugs and supplies.
  167         (c)A repository shall store donations in a secure storage
  168  area under the environmental conditions specified by the
  169  manufacturer or federal storage requirements. Donations may not
  170  be stored with other inventory.
  171         (d)A repository shall maintain an inventory of the name,
  172  strength, available quantity, and expiration date of donations;
  173  the transaction date; and the name, street address, and
  174  telephone number of the donor. The repository shall record such
  175  inventory on a physical or an electronic form prescribed by
  176  department rule.
  177         (e)By the 5th day of each month, a repository shall submit
  178  to the department its inventory records of donations received
  179  during the previous month.
  180         (f)The department may facilitate the redistribution of
  181  donations between repositories. A repository that receives
  182  donations may, after notifying the department, distribute the
  183  donations to another repository.
  186         (a)A repository may dispense an eligible donation to a
  187  state resident who is indigent, uninsured, or underinsured and
  188  who has a valid prescription for such donation, as applicable.
  189         (b)Each new eligible patient must submit an intake
  190  collection form to a repository to receive a donation using a
  191  physical or an electronic form prescribed by the department in
  192  rule. Such form shall, at a minimum, include:
  193         1.The name, street address, and telephone number of the
  194  eligible patient.
  195         2.The basis for the patient’s eligibility, which must
  196  specify that the patient is indigent, uninsured, or
  197  underinsured.
  198         3.A statement physically or electronically signed and
  199  dated by the patient affirming that the patient meets the
  200  eligibility requirements of this section and will inform the
  201  repository if the patient’s eligibility changes.
  202         4.Notice that the prescription drug or supply was donated
  203  to the program, that the donors and participants in the program
  204  are immune from civil or criminal liability or disciplinary
  205  action, and that the eligible patient is not required to pay for
  206  the prescription drug or supply.
  207         5.A statement physically or electronically signed and
  208  dated by the eligible patient acknowledging receipt of notice
  209  required under this paragraph.
  210         (c)By the 5th day of each month, a repository shall submit
  211  to the department a summary of each intake collection form
  212  received during the previous month.
  213         (d)A dispenser may dispense donations, if available, only
  214  to an eligible patient who has submitted a completed intake
  215  collection form.
  216         (e)A dispenser may provide dispensing and consulting
  217  services to an eligible patient.
  218         (f)Donations may not be sold or resold.
  219         (g)A dispenser may not submit a claim or otherwise seek
  220  reimbursement from any public or private third-party payor for
  221  donations.
  223         (a)Each repository shall establish and follow a protocol
  224  for notifying recipients in the event that a prescription drug
  225  donated under the program is recalled.
  226         (b)A repository shall destroy all donated prescription
  227  drugs that are recalled, expired, or unsuitable for dispensing.
  228  A repository shall complete a destruction form for all such
  229  drugs using a physical or an electronic form prescribed by the
  230  department in rule.
  231         (10)RECORDKEEPING.—
  232         (a)A repository shall maintain records of prescription
  233  drugs and supplies that are accepted, donated, dispensed,
  234  distributed, or destroyed under the program using a physical or
  235  an electronic form prescribed by department rule.
  236         (b)All required records must be maintained in accordance
  237  with any applicable practice act. A repository shall submit
  238  these records monthly to the department for data collection.
  240         (a)The department shall establish and maintain registries
  241  of all repositories and prescription drugs and supplies
  242  available under the program. The registry of repositories must
  243  include each repository’s name, street address, website, and
  244  telephone number. The registry of available prescription drugs
  245  and supplies must include the name, strength, available
  246  quantity, and expiration date of the prescription drugs or
  247  supplies and the name and contact information of each repository
  248  where such drugs or supplies are available. The department shall
  249  publish the registries on its website.
  250         (b)The department shall publish all forms required by this
  251  section on its website.
  253         (a)Any donor of prescription drugs or supplies and any
  254  participant in the program who exercises reasonable care in
  255  donating, accepting, distributing, or dispensing prescription
  256  drugs or supplies under the program is immune from civil or
  257  criminal liability and professional disciplinary action by the
  258  state for any injury, death, or loss to person or property
  259  relating to such activities.
  260         (b)A pharmaceutical manufacturer who exercises reasonable
  261  care is not liable for any claim or injury arising from the
  262  donation of any prescription drug or supply under this section,
  263  including, but not limited to, liability for failure to transfer
  264  or communicate product or consumer information regarding the
  265  donated prescription drug or supply, including its expiration
  266  date.
  267         (13)RULEMAKING.—The department shall adopt rules necessary
  268  to administer this section.
  269         Section 2. Paragraph (o) is added to subsection (5) of
  270  section 252.36, Florida Statutes, to read:
  271         252.36 Emergency management powers of the Governor.—
  272         (5) In addition to any other powers conferred upon the
  273  Governor by law, she or he may:
  274         (o)Waive the patient eligibility requirements of s.
  275  465.1902.
  276         Section 3. This act shall take effect July 1, 2020.
  278  ================= T I T L E  A M E N D M E N T ================
  279  And the title is amended as follows:
  280         Delete everything before the enacting clause
  281  and insert:
  282                        A bill to be entitled                      
  283         An act relating to the Prescription Drug Donation
  284         Repository Program; creating s. 465.1902, F.S.;
  285         providing a short title; defining terms; creating the
  286         Prescription Drug Donation Repository Program within
  287         the Department of Health; specifying the purpose of
  288         the program; specifying entities that may participate
  289         as repositories; requiring a repository to notify the
  290         department of its intent to participate in the
  291         program; providing notification requirements;
  292         providing a procedure for a repository to withdraw
  293         from participation in the program; requiring the
  294         department to adopt rules regarding the disposition of
  295         prescription drugs and supplies of a withdrawing
  296         repository; specifying entities that may donate
  297         prescription drugs or supplies under the program;
  298         providing criteria and procedures for eligible
  299         donations; prohibiting donations to specific patients;
  300         providing inspection, inventory, and storage
  301         requirements for repositories; requiring inspection of
  302         donated prescription drugs and supplies by a licensed
  303         pharmacist; requiring a repository to submit its
  304         inventory records to the department monthly;
  305         authorizing the department to facilitate the
  306         redistribution of donated prescription drugs and
  307         supplies; authorizing a repository to transfer
  308         prescription drugs and supplies to another repository
  309         after notifying the department; specifying patients
  310         eligible to receive donated prescription drugs and
  311         supplies; specifying conditions for dispensing donated
  312         prescription drugs and supplies to eligible patients;
  313         providing intake collection form requirements;
  314         requiring that such form provide certain notice to
  315         patients; prohibiting the sale of donated prescription
  316         drugs and supplies under the program; prohibiting
  317         dispensers from seeking reimbursement from public or
  318         private third-party payors for donations dispensed
  319         under the program; requiring repositories to establish
  320         a protocol for notifying recipients of a prescription
  321         drug recall; providing for destruction of donated
  322         prescription drugs under certain circumstances;
  323         providing recordkeeping requirements; requiring the
  324         department to establish, maintain, and publish a
  325         registry of participating repositories and available
  326         donated prescription drugs and supplies; requiring the
  327         department to publish certain information and forms on
  328         its website; providing immunity from civil and
  329         criminal liability and professional disciplinary
  330         action for program donors and participants under
  331         certain circumstances; providing specified immunity to
  332         pharmaceutical manufacturers under certain
  333         circumstances; requiring the department to adopt
  334         rules; amending s. 252.36, F.S.; authorizing the
  335         Governor to waive program patient eligibility
  336         requirements during a declared state of emergency;
  337         providing an effective date.