Florida Senate - 2020                               CS for SB 58
       By the Committee on Health Policy; and Senators Book, Harrell,
       and Stewart
       588-00880-20                                            202058c1
    1                        A bill to be entitled                      
    2         An act relating to the Prescription Drug Donation
    3         Repository Program; creating s. 465.1902, F.S.;
    4         providing a short title; defining terms; creating the
    5         Prescription Drug Donation Repository Program within
    6         the Department of Health; specifying the purpose of
    7         the program; authorizing the department to contract
    8         with a third-party vendor to administer the program;
    9         specifying entities that are eligible donors;
   10         providing criteria and procedures for eligible
   11         donations; prohibiting donations to specific patients;
   12         providing that certain prescription drugs eligible for
   13         return to stock must be credited to Medicaid and may
   14         not be donated under the program; prohibiting the
   15         donation of certain drugs; clarifying that a
   16         repository is not required to accept donations of
   17         prescription drugs or supplies; requiring inspection
   18         of donated prescription drugs and supplies by a
   19         licensed pharmacist; providing inspection, inventory,
   20         and storage requirements for centralized and local
   21         repositories; requiring a local repository to notify
   22         the centralized repository within a specified
   23         timeframe after receiving a donation of prescription
   24         drugs or supplies; authorizing the centralized
   25         repository to redistribute prescription drugs or
   26         supplies; authorizing a local repository to transfer
   27         prescription drugs or supplies to another local
   28         repository with authorization from the centralized
   29         repository; requiring a local repository to notify the
   30         department of its intent to participate in the
   31         program; providing notification requirements;
   32         providing a procedure for a local repository to
   33         withdraw from participation in the program; requiring
   34         the department to adopt rules regarding the
   35         disposition of prescription drugs and supplies of a
   36         withdrawing local repository; specifying conditions
   37         for dispensing donated prescription drugs and supplies
   38         to eligible patients; providing intake collection form
   39         requirements; requiring a local repository to issue an
   40         eligible patient who completes an intake collection
   41         form a program identification card; prohibiting the
   42         sale of donated prescription drugs and supplies under
   43         the program; authorizing a repository to charge the
   44         patient a nominal handling fee for the preparation and
   45         dispensing of prescription drugs or supplies under the
   46         program; requiring repositories to establish a
   47         protocol for notifying recipients of a prescription
   48         drug recall; providing for destruction of donated
   49         prescription drugs under certain circumstances;
   50         providing recordkeeping requirements; requiring the
   51         centralized repository to submit annual reports to the
   52         department; requiring the department or contractor to
   53         establish, maintain, and publish a registry of
   54         participating local repositories and available donated
   55         prescription drugs and supplies; requiring the
   56         department to publish certain information and forms on
   57         its website; providing immunity from civil and
   58         criminal liability and from professional disciplinary
   59         action for participants under certain circumstances;
   60         providing immunity to pharmaceutical manufacturers,
   61         under certain circumstances, from any claim or injury
   62         arising from the donation of any prescription drug or
   63         supply under the program; requiring dispensers to
   64         provide certain notice to patients; authorizing the
   65         department to establish a direct-support organization
   66         to provide assistance, funding, and promotional
   67         support for program activities; providing
   68         organizational requirements for a direct-support
   69         organization; specifying direct-support organization
   70         purposes and objectives; prohibiting the direct
   71         support organization from lobbying; specifying that
   72         the direct-support organization is not a lobbying
   73         firm; prohibiting the direct-support organization from
   74         possessing prescription drugs on behalf of the
   75         program; providing limitations on expenditures of such
   76         direct-support organizations; specifying that the
   77         direct-support organization must operate under
   78         contract with the department; specifying required
   79         contract terms; providing for the direct-support
   80         organization board of directors; specifying the
   81         board’s membership requirements; specifying
   82         requirements for and requiring the department to adopt
   83         rules relating to a direct-support organization’s use
   84         of department property; specifying requirements for
   85         the deposit and use of funds by the direct-support
   86         organization; providing for annual audits of a direct
   87         support organization; providing for future legislative
   88         review and repeal of provisions relating to the
   89         direct-support organization; requiring the department
   90         to adopt rules; amending s. 252.36, F.S.; authorizing
   91         the Governor to waive program patient eligibility
   92         requirements during a declared state of emergency;
   93         providing an effective date.
   95  Be It Enacted by the Legislature of the State of Florida:
   97         Section 1. Section 465.1902, Florida Statutes, is created
   98  to read:
   99         465.1902 Prescription Drug Donation Repository Program.—
  100         (1) SHORT TITLE.—This section may be cited as the
  101  “Prescription Drug Donation Repository Program Act.”
  102         (2) DEFINITIONS.—As used in this section, the term:
  103         (a) “Centralized repository” means a distributor permitted
  104  under chapter 499 who is approved by the department or the
  105  contractor to accept, inspect, inventory, and distribute donated
  106  drugs and supplies under this section.
  107         (b) “Closed drug delivery system” means a system in which
  108  the actual control of the unit-dose medication package is
  109  maintained by the facility, rather than by the individual
  110  patient.
  111         (c) “Contractor” means the third-party vendor approved by
  112  the department to implement and administer the program as
  113  authorized in subsection (4).
  114         (d) “Controlled substance” means any substance listed under
  115  Schedule II, Schedule III, Schedule IV, or Schedule V of s.
  116  893.03.
  117         (e)“Direct-support organization” means the entity created
  118  under subsection (15).
  119         (f) “Dispenser” means a health care practitioner who,
  120  within the scope of his or her practice act, is authorized to
  121  dispense medicinal drugs and who does so under this section.
  122         (g) “Donor” means an entity specified in subsection (5).
  123         (h) “Eligible patient” means a resident of this state who
  124  is indigent, uninsured, or underinsured and who has a valid
  125  prescription for a prescription drug or supply that may be
  126  dispensed under the program.
  127         (i) “Free clinic” means a clinic that delivers only medical
  128  diagnostic services or nonsurgical medical treatment free of
  129  charge to low-income recipients.
  130         (j) “Health care practitioner” or “practitioner” means a
  131  practitioner licensed under this chapter, chapter 458, chapter
  132  459, chapter 461, chapter 463, chapter 464, or chapter 466.
  133         (k) “Indigent” means an individual whose family income for
  134  the 12 months preceding the determination of income is below 200
  135  percent of the federal poverty level as defined by the most
  136  recently revised poverty income guidelines published by the
  137  United States Department of Health and Human Services.
  138         (l) “Local repository” means a health care practitioner’s
  139  office, a pharmacy, a hospital with a closed drug delivery
  140  system, a nursing home facility with a closed drug delivery
  141  system, or a free clinic or nonprofit health clinic that is
  142  licensed or permitted to dispense medicinal drugs in this state.
  143         (m) “Nonprofit health clinic” means a nonprofit legal
  144  entity that provides medical care to patients who are indigent,
  145  uninsured, or underinsured. The term includes, but is not
  146  limited to, a federally qualified health center as defined in 42
  147  U.S.C. s. 1396d(l)(2)(B) and a rural health clinic as defined in
  148  42 U.S.C. s. 1396d(l)(1).
  149         (n) “Nursing home facility” has the same meaning as in s.
  150  400.021.
  151         (o) “Prescriber” means a health care practitioner who,
  152  within the scope of his or her practice act, is authorized to
  153  prescribe medicinal drugs.
  154         (p) “Prescription drug” has the same meaning as the term
  155  “medicinal drugs” or “drugs,” as those terms are defined in s.
  156  465.003(8), but does not include controlled substances or cancer
  157  drugs donated under s. 499.029.
  158         (q) “Program” means the Prescription Drug Donation
  159  Repository Program created by this section.
  160         (r) “Supplies” means any supply used in the administration
  161  of a prescription drug.
  162         (s) “Tamper-evident packaging” means a package that has one
  163  or more indicators or barriers to entry which, if breached or
  164  missing, can reasonably be expected to provide visible evidence
  165  to consumers that tampering has occurred.
  166         (t) “Underinsured” means a person who has third-party
  167  insurance or is eligible to receive prescription drugs or
  168  supplies through the Medicaid program or any other prescription
  169  drug program funded in whole or in part by the Federal
  170  Government, but who has exhausted these benefits or does not
  171  have prescription drug coverage for the drug prescribed.
  172         (u) “Uninsured” means a person who has no third-party
  173  insurance and is not eligible to receive prescription drugs or
  174  supplies through the Medicaid program or any other prescription
  175  drug program funded in whole or in part by the Federal
  176  Government.
  178  CREATION; PURPOSE.—The Prescription Drug Donation Repository
  179  Program is created within the department for the purpose of
  180  authorizing and facilitating the donation of prescription drugs
  181  and supplies to eligible patients.
  182         (4) PROGRAM IMPLEMENTATION; ADMINISTRATION.—The department
  183  may contract with a third-party vendor to administer the
  184  program.
  185         (5) DONOR ELIGIBILITY.—The centralized repository or a
  186  local repository may accept a donation of a prescription drug or
  187  supply only from:
  188         (a) Nursing home facilities with closed drug delivery
  189  systems.
  190         (b) Hospices that have maintained control of a patient’s
  191  prescription drugs.
  192         (c) Hospitals with closed drug delivery systems.
  193         (d) Pharmacies.
  194         (e) Drug manufacturers or wholesale distributors.
  195         (f) Medical device manufacturers or suppliers.
  196         (g) Prescribers who receive prescription drugs or supplies
  197  directly from a drug manufacturer, wholesale distributor, or
  198  pharmacy.
  201         (a) Only prescription drugs and supplies that have been
  202  approved for medical use in the United States and that meet the
  203  criteria for donation established by this section may be
  204  accepted for donation under the program. Donations must be made
  205  on the premises of the centralized repository or a local
  206  repository to a person designated by the repository. A drop box
  207  may not be used to accept donations.
  208         (b) The centralized repository or a local repository may
  209  accept a prescription drug only if:
  210         1. The drug is in its original sealed and tamper-evident
  211  packaging. Single-unit-dose drugs may be accepted if the single
  212  unit-dose packaging is unopened.
  213         2. The drug requires storage at normal room temperature per
  214  the manufacturer or the United States Pharmacopeia.
  215         3. The drug has been stored according to manufacturer or
  216  United States Pharmacopeia storage requirements.
  217         4. The drug does not have any physical signs of tampering
  218  or adulteration and there is no reason to believe that the drug
  219  is adulterated.
  220         5. The packaging does not have any physical signs of
  221  tampering, misbranding, deterioration, compromised integrity, or
  222  adulteration.
  223         6. The packaging indicates the lot number and expiration
  224  date of the drug. If the lot number is not retrievable, all
  225  specified medications must be destroyed in the event of a
  226  recall.
  227         7. The drug has an expiration date that is more than 3
  228  months after the date that the drug was donated.
  229         (c) The centralized repository or a local repository may
  230  accept supplies only if they are in their original, unopened,
  231  sealed packaging and have not been tampered with or misbranded.
  232         (d) Prescription drugs or supplies may not be donated to a
  233  specific patient.
  234         (e) Prescription drugs billed to and paid for by Medicaid
  235  in long-term care facilities which are eligible for return to
  236  stock under federal Medicaid regulations must be credited to
  237  Medicaid and may not be donated under the program.
  238         (f) Prescription drugs with an approved Federal Food and
  239  Drug Administration Risk Evaluation and Mitigation Strategy that
  240  includes Elements to Assure Safe Use are not eligible for
  241  donation under the program.
  242         (g) This section does not require the centralized
  243  repository or a local repository to accept a donation of
  244  prescription drugs or supplies.
  245         (7) INSPECTION AND STORAGE.—
  246         (a) A licensed pharmacist employed by or under contract
  247  with the centralized repository or a local repository shall
  248  inspect donated prescription drugs and supplies to determine
  249  whether they meet the requirements of subsections (5) and (6).
  250         (b) The inspecting pharmacist must sign an inspection
  251  record on a form prescribed by the department by rule which
  252  verifies that the prescription drugs and supplies meet the
  253  requirements of subsections (5) and (6) and must attach the
  254  record to the inventory required by paragraph (d). A local
  255  repository that receives drugs and supplies from the centralized
  256  repository is not required to reinspect them.
  257         (c) The centralized repository and local repositories shall
  258  store donated prescription drugs and supplies in a secure
  259  storage area under the environmental conditions specified by the
  260  manufacturer or the United States Pharmacopeia for the
  261  respective prescription drugs or supplies. Donated prescription
  262  drugs and supplies may not be stored with other inventory. A
  263  local repository shall quarantine donated prescription drugs or
  264  supplies until they are inspected and approved for dispensing
  265  under this section.
  266         (d) The centralized repository and local repositories shall
  267  maintain an inventory of all donated prescription drugs or
  268  supplies. Such inventory at local repositories must be recorded
  269  on a form prescribed by the department by rule.
  270         (e) A local repository shall notify the centralized
  271  repository within 5 days after receipt of any donation of
  272  prescription drugs or supplies to the program. The notification
  273  must be on a form prescribed by the department by rule.
  274         (f) The centralized repository may redistribute
  275  prescription drugs and supplies by transferring them to or from
  276  the centralized repository and a local repository, as needed. A
  277  local repository that receives donated prescription drugs or
  278  supplies may, with authorization from the centralized
  279  repository, distribute the prescription drugs or supplies to
  280  another local repository.
  281         (8) PROGRAM PARTICIPATION.—
  282         (a) A practitioner, pharmacy, facility, or clinic shall
  283  notify the department of its intent to participate in the
  284  program as a local repository before accepting or dispensing any
  285  prescription drugs or supplies pursuant to this section. The
  286  notification must be made on a form prescribed by the department
  287  by rule and must, at a minimum, include:
  288         1. The name, street address, website, and telephone number
  289  of the intended local repository and any license or registration
  290  number issued by the state to the intended local repository,
  291  including the name of the issuing agency.
  292         2. The name and telephone number of the pharmacist employed
  293  by or under contract with the intended local repository who is
  294  responsible for the inspection of donated prescription drugs and
  295  supplies.
  296         3. A statement signed and dated by the responsible
  297  pharmacist which affirms that the intended local repository
  298  meets the eligibility requirements of this section.
  299         (b) A local repository may withdraw from participation in
  300  the program at any time by providing written notice to the
  301  department or contractor, as appropriate, on a form prescribed
  302  by the department by rule. The department shall adopt rules
  303  addressing the disposition of prescription drugs and supplies in
  304  the possession of the withdrawing local repository.
  306         (a) Each eligible patient without a program identification
  307  card must submit an intake collection form to a local repository
  308  before receiving prescription drugs or supplies under the
  309  program. The department shall prescribe a form by rule, which
  310  must include at least all of the following:
  311         1. The name, street address, and telephone number of the
  312  eligible patient.
  313         2. The basis for eligibility, which must specify that the
  314  patient is indigent, uninsured, or underinsured.
  315         3. A statement signed and dated by the eligible patient
  316  which affirms that he or she meets the eligibility requirements
  317  of this section.
  318         (b) Upon receipt of a completed and signed intake
  319  collection form, the local repository shall issue him or her a
  320  program identification card, which is valid for 1 year after its
  321  date of issuance. The card must be in a form prescribed by the
  322  department by rule.
  323         (c)The local repository shall send to the centralized
  324  repository a summary of each intake collection form within 5
  325  days after receiving it.
  326         (d) A dispenser may dispense donated prescription drugs or
  327  supplies only to an eligible patient who has a program
  328  identification card or who has submitted a completed intake
  329  collection form.
  330         (e) A dispenser shall inspect the donated prescription
  331  drugs or supplies before dispensing them.
  332         (f) A dispenser may provide dispensing and consulting
  333  services to an eligible patient.
  334         (g) Donated prescription drugs and supplies may not be sold
  335  or resold under the program.
  336         (h) A dispenser of donated prescription drugs or supplies
  337  may not submit a claim or otherwise seek reimbursement from any
  338  public or private third-party payor for donated prescription
  339  drugs or supplies dispensed under this program. However, a
  340  repository may charge the patient a nominal handling fee,
  341  established by department rule, for the preparation and
  342  dispensing of prescription drugs or supplies under the program.
  344         (a) The centralized repository and each local repository
  345  shall establish and follow a protocol for notifying recipients
  346  in the event of a prescription drug recall.
  347         (b) Local repositories shall destroy all recalled or
  348  expired prescription drugs and all prescription drugs that are
  349  not suitable for dispensing in the repository. Local
  350  repositories must complete a destruction information form for
  351  all such drugs, in accordance with department rule.
  352         (11) RECORDKEEPING.—
  353         (a) Local repositories shall maintain records of
  354  prescription drugs and supplies that are accepted, donated,
  355  dispensed, distributed, or destroyed under the program.
  356         (b) All required records must be maintained in accordance
  357  with any applicable practice act. Local repositories shall
  358  submit these records quarterly to the centralized repository for
  359  data collection, and the centralized repository shall submit
  360  these records and the collected data in annual reports to the
  361  department.
  363         (a) The department or contractor shall establish and
  364  maintain a registry of all local repositories and of
  365  prescription drugs and supplies available under the program. The
  366  registry of local repositories must include each repository’s
  367  name, address, website, and telephone number. The registry of
  368  available prescription drugs and supplies must include the name,
  369  strength, available quantity, and expiration date of the
  370  prescription drug or supplies and the name and contact
  371  information of each repository where such drug or supplies are
  372  available. The department shall publish the registry on its
  373  website.
  374         (b) The department shall publish all forms required by this
  375  section on its website.
  377         (a) Any donor of prescription drugs or supplies and any
  378  participant in the program who exercises reasonable care in
  379  donating, accepting, distributing, or dispensing prescription
  380  drugs or supplies under the program is immune from civil or
  381  criminal liability and from professional disciplinary action by
  382  the state for any injury, death, or loss to person or property
  383  relating to such activities.
  384         (b) A pharmaceutical manufacturer who exercises reasonable
  385  care is not liable for any claim or injury arising from the
  386  donation of any prescription drug or supply under this section,
  387  including, but not limited to, liability for failure to transfer
  388  or communicate product or consumer information regarding the
  389  donated prescription drug, including its expiration date.
  390         (14)NOTICE TO PATIENTS.Before dispensing a donated
  391  prescription drug under the program, the dispenser must provide
  392  written notification to the eligible patient or his or her legal
  393  representative, receipt of which must be acknowledged in
  394  writing, of all of the following information:
  395         (a)The prescription drug was donated to the program.
  396         (b)The donors and participants in the program are immune
  397  from civil or criminal liability or disciplinary action.
  398         (c)The eligible patient is not required to pay for the
  399  prescription drug, but may be required to pay a nominal handling
  400  fee, which may not exceed the amount established by department
  401  rule.
  402         (15)DIRECT-SUPPORT ORGANIZATION.The department may
  403  establish a direct-support organization to provide assistance,
  404  funding, and promotional support for the activities authorized
  405  by this section.
  406         (a) Entity organization.The direct-support organization
  407  must operate in accordance with s. 20.058 and is:
  408         1.A Florida corporation not for profit incorporated under
  409  chapter 617, exempted from filing fees, and approved by the
  410  Department of State.
  411         2. Organized and operated to conduct programs and
  412  activities; raise funds and request and receive grants, gifts,
  413  and bequests of moneys; acquire, receive, hold, and invest, in
  414  its own name, securities, funds, objects of value, or other
  415  property, either real or personal; and make expenditures or
  416  provide funding to or for the direct or indirect benefit of the
  417  program.
  418         (b)Purposes and objectives.The purposes and objectives of
  419  the direct-support organization must be consistent with the
  420  goals of the department, in the best interest of the state, and
  421  in accordance with the adopted goals and the mission of the
  422  department.
  423         (c)Prohibition against lobbying.The direct-support
  424  organization is not considered a lobbying firm, as that term is
  425  defined in s. 11.045(1). All expenditures of the direct-support
  426  organization must be directly related to program administration
  427  within the requirements of this section. Funds of the direct
  428  support organization may not be used for the purpose of
  429  lobbying, as that term is defined in s. 11.045(1).
  430         (d) Possession of prescription drugs.The direct-support
  431  organization may not possess any prescription drugs on behalf of
  432  the program.
  433         (e)Contract.—The direct-support organization shall operate
  434  under a written contract with the department.
  435         1. The contract must require the direct-support
  436  organization to submit to the department, annually by August 1,
  437  the following information, which must be posted on the websites
  438  of the direct-support organization and the department:
  439         a.The articles of incorporation and bylaws of the direct
  440  support organization, as approved by the department.
  441         b.A proposed annual budget for the approval of the
  442  department.
  443         c.The code of ethics of the direct-support organization.
  444         d.The statutory authority or executive order that created
  445  the direct-support organization.
  446         e.A brief description of the direct-support organization’s
  447  mission and any results obtained by the direct-support
  448  organization.
  449         f.A brief description of the direct-support organization’s
  450  annual plan for each of the next 3 fiscal years.
  451         g.A copy of the direct-support organization’s most recent
  452  federal Internal Revenue Service Return Organization Exempt from
  453  Income Tax form (Form 990).
  454         h. Certification by the department that the direct-support
  455  organization is complying with the terms of the contract and
  456  operating in a manner consistent with the goals and purposes of
  457  the department and the best interest of the program and the
  458  state. Such certification must be made annually and reported in
  459  the official minutes of a meeting of the board of directors of
  460  the direct-support organization.
  461         2. The contract must, at a minimum, provide for:
  462         a. The reversion without penalty to the department, or to
  463  the state if the department ceases to exist, of all moneys and
  464  property held in trust by the direct-support organization for
  465  the benefit of the program if the direct-support organization
  466  ceases to exist or if the contract is terminated.
  467         b.A disclosure of material provisions of the contract and
  468  the distinction between the department and the direct-support
  469  organization to appear on all promotional and fundraising
  470  publications.
  471         c.A list of prescription drugs solicited by the direct
  472  support organization for distribution to the centralized
  473  repository or a local repository.
  474         (f) Board of directors.—The State Surgeon General shall
  475  appoint the board of directors, which must consist of at least 5
  476  members, but not more than 15 members, who serve at his or her
  477  pleasure. The board must elect a chair from among its members.
  478  Board members must serve without compensation but may be
  479  entitled to reimbursement of travel and per diem expenses in
  480  accordance with s. 112.061, if funds are available for this
  481  purpose.
  482         (g) Use of property.—The department may allow, without
  483  charge, appropriate use of fixed property, facilities, and
  484  personnel services of the department by the direct-support
  485  organization for purposes related to the program. For purposes
  486  of this paragraph, the term “personnel services” includes full
  487  time or part-time personnel, as well as payroll processing
  488  services.
  489         1. The department may prescribe any condition with which
  490  the direct-support organization must comply in order to use
  491  fixed property or facilities of the department.
  492         2. The department may not allow the use of any fixed
  493  property or facilities of the department by the direct-support
  494  organization if the organization does not provide equal
  495  membership and employment opportunities to all persons
  496  regardless of race, color, religion, sex, age, or national
  497  origin.
  498         3. The department shall adopt rules prescribing the
  499  procedures by which the direct-support organization is governed
  500  and any conditions with which a direct-support organization must
  501  comply to use property or facilities of the department.
  502         (h) Deposit of funds.—Any moneys of the direct-support
  503  organization may be held in a separate depository account in the
  504  name of the organization and subject to the provisions of the
  505  organization’s contract with the department.
  506         (i)Use of funds.Funds designated for the direct-support
  507  organization must be used for the enhancement of program
  508  projects and in a manner consistent with that purpose. Any
  509  administrative costs of running and promoting the purposes of
  510  the organization or program must be paid by private funds.
  511         (j) Audit.—The direct-support organization shall provide
  512  for an annual financial audit in accordance with s. 215.981.
  513         (k) Repeal.—This subsection is repealed on October 1, 2025,
  514  unless reviewed and saved from repeal by the Legislature.
  515         (16)RULEMAKING.—The department shall adopt rules necessary
  516  to administer this section. When applicable, the rules may
  517  provide for the use of electronic forms, recordkeeping, and
  518  meeting by teleconference.
  519         Section 2. Paragraph (o) is added to subsection (5) of
  520  section 252.36, Florida Statutes, to read:
  521         252.36 Emergency management powers of the Governor.—
  522         (5) In addition to any other powers conferred upon the
  523  Governor by law, she or he may:
  524         (o) Waive the patient eligibility requirements of s.
  525  465.1902.
  526         Section 3. This act shall take effect July 1, 2020.