Florida Senate - 2018                       CS for CS for SB 710
       By the Committees on Appropriations; and Health Policy; and
       Senator Book
       576-03811-18                                           2018710c2
    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; creating the Prescription
    5         Drug Donation Repository Program within the Department
    6         of Health; providing a purpose for the program;
    7         authorizing the department to contract with a third
    8         party to implement and administer the program;
    9         providing definitions; specifying entities that are
   10         eligible donors; providing criteria 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 under
   14         specified conditions and are not program eligible;
   15         prohibiting the donation of certain drugs pursuant to
   16         federal restrictions; authorizing repositories to
   17         refuse to accept donations of prescription drugs or
   18         supplies; providing inspection, inventory, and storage
   19         requirements for centralized and local repositories;
   20         requiring inspection of donated prescription drugs and
   21         supplies by a licensed pharmacist; requiring a local
   22         repository to notify the centralized repository within
   23         a specified timeframe after receiving a donation of
   24         prescription drugs or supplies; authorizing a
   25         centralized repository to redistribute prescription
   26         drugs or supplies; requiring local repositories to
   27         notify the department regarding participation in the
   28         program; providing conditions for dispensing donated
   29         prescription drugs and supplies to eligible patients;
   30         requiring repositories to establish a protocol for
   31         notifying recipients of a prescription drug recall;
   32         providing for destruction of donated prescription
   33         drugs in the event of a drug recall; providing
   34         recordkeeping requirements; requiring the department
   35         to establish, maintain, and publish a registry of
   36         participating local repositories and available donated
   37         prescription drugs and supplies; providing immunity
   38         from civil and criminal liability for participants
   39         under certain circumstances; specifying certain notice
   40         to patients; authorizing the department to establish a
   41         direct-support organization to provide assistance,
   42         funding, and promotional support for program
   43         activities; specifying direct-support organization
   44         purposes and objectives; prohibiting such direct
   45         support organization from lobbying and specifying that
   46         such direct-support organization is not a lobbying
   47         firm; specifying that the direct-support organization
   48         must operate under contract with the department;
   49         specifying required contract terms; providing for the
   50         direct-support organization board of directors;
   51         specifying the membership of such board; specifying
   52         requirements relating to a direct-support
   53         organization’s use of department property; specifying
   54         requirements for the deposit and use of funds by the
   55         direct-support organization; providing for annual
   56         audits of a direct-support organization; providing for
   57         future legislative review and repeal; requiring the
   58         department to adopt rules; amending s. 252.36, F.S.;
   59         authorizing the Governor to waive the patient
   60         eligibility requirements of s. 465.1902, F.S., during
   61         a declared state of emergency; providing an effective
   62         date.
   64  Be It Enacted by the Legislature of the State of Florida:
   66         Section 1. Section 465.1902, Florida Statutes, is created
   67  to read:
   68         465.1902 Prescription Drug Donation Repository Program.—
   69         (1) SHORT TITLE.—This section may be cited as the
   70  “Prescription Drug Donation Repository Program Act.”
   72  Prescription Drug Donation Repository Program is created within
   73  the Department of Health for the purpose of authorizing and
   74  facilitating the donation of prescription drugs and supplies to
   75  eligible patients. The department may contract with a third
   76  party to implement and administer the program.
   77         (3) DEFINITIONS.—As used in this section, the term:
   78         (a) “Centralized repository” means a distributor permitted
   79  pursuant to chapter 499 which is approved by the department or
   80  the contractor to accept, inspect, inventory, and distribute
   81  donated drugs and supplies under this section.
   82         (b) “Closed drug delivery system” means a system in which
   83  the actual control of the unit-dose medication package is
   84  maintained by the facility rather than by the individual
   85  patient.
   86         (c) “Contractor” means the third-party vendor approved by
   87  the department to implement and administer the program.
   88         (d) “Controlled substance” means any substance listed under
   89  Schedule II, Schedule III, Schedule IV, or Schedule V of s.
   90  893.03.
   91         (e) “Department” means Department of Health.
   92         (f)“Direct-support organization” means an entity that is
   93  established pursuant to s. 20.058 and is:
   94         1.A Florida corporation not for profit incorporated under
   95  chapter 617, exempted from filing fees, and approved by the
   96  Department of State.
   97         2. Organized and operated to conduct programs and
   98  activities; raise funds and request and receive grants, gifts,
   99  and bequests of moneys; acquire, receive, hold, and invest, in
  100  its own name, securities, funds, objects of value, or other
  101  property, either real or personal; and make expenditures or
  102  provide funding to or for the direct or indirect benefit of the
  103  program.
  104         (g) “Dispenser” means a dispensing health care practitioner
  105  or pharmacist licensed to dispense medicinal drugs in the state.
  106         (h) “Donor” means an entity that meets the requirements of
  107  subsection (4).
  108         (i) “Eligible patient” means a Florida resident who is
  109  indigent, uninsured, or underinsured and who has a valid
  110  prescription for a prescription drug or supply that is eligible
  111  for dispensing under the program.
  112         (j) “Free clinic” means a clinic that delivers only medical
  113  diagnostic services or nonsurgical medical treatment free of
  114  charge to all low-income recipients.
  115         (k) “Health care practitioner” or “practitioner” means a
  116  practitioner licensed under chapter 458, chapter 459, chapter
  117  461, chapter 463, chapter 464, chapter 465, or chapter 466.
  118         (l) “Indigent” means a person with an income that is below
  119  200 percent of the federal poverty level as defined by the most
  120  recently revised poverty income guidelines published by the
  121  United States Department of Health and Human Services.
  122         (m) “Local repository” means a health care practitioner’s
  123  office, a pharmacy, a hospital with a closed drug delivery
  124  system, a nursing home facility with a closed drug delivery
  125  system, a free clinic, or a nonprofit health clinic that is
  126  licensed or permitted to dispense medicinal drugs in the state.
  127         (n) “Nonprofit health clinic” means a nonprofit legal
  128  entity that provides medical care to patients who are indigent,
  129  uninsured, or underinsured, including, but not limited to, a
  130  federally qualified health center as defined in 42 U.S.C. s.
  131  1396d(l)(2)(B) and a rural health clinic as defined in 42 U.S.C.
  132  s. 1396d(l)(1).
  133         (o) “Nursing home facility” has the same meaning as in s.
  134  400.021(12).
  135         (p) “Prescriber” means a prescribing physician, prescribing
  136  practitioner, or other health care practitioner authorized by
  137  the laws of this state to prescribe medicinal drugs.
  138         (q) “Prescription drug” has the same meaning as defined in
  139  s. 465.003(8), but does not include controlled substances or
  140  cancer drugs donated under s. 499.029.
  141         (r) “Program” means the Prescription Drug Donation
  142  Repository Program created by this section.
  143         (s) “Supplies” means any supply used in the administration
  144  of a prescription drug.
  145         (t) “Tamper-evident packaging” means a package that has one
  146  or more indicators or barriers to entry which, if breached or
  147  missing, can reasonably be expected to provide visible evidence
  148  to consumers that tampering has occurred.
  149         (u) “Underinsured” means a person who has third-party
  150  insurance or is eligible to receive prescription drugs or
  151  supplies through the Medicaid program or any other prescription
  152  drug program funded in whole or in part by the Federal
  153  Government, but has exhausted these benefits or does not have
  154  prescription drug coverage for the drug prescribed.
  155         (v) “Uninsured” means a person who has no third-party
  156  insurance and is not eligible to receive prescription drugs or
  157  supplies through the Medicaid program or any other prescription
  158  drug program funded in whole or in part by the Federal
  159  Government.
  160         (4) DONOR ELIGIBILITY.—The program may only accept a
  161  donation of a prescription drug or supply from:
  162         (a) Nursing home facilities with closed drug delivery
  163  systems.
  164         (b) Hospices that have maintained control of a patient’s
  165  prescription drug.
  166         (c) Hospitals with closed drug delivery systems.
  167         (d) Pharmacies.
  168         (e) Drug manufacturers or wholesale distributors.
  169         (f) Medical device manufacturers or suppliers.
  170         (g) Prescribers who receive prescription drugs or supplies
  171  directly from a drug manufacturer, wholesale distributor, or
  172  pharmacy.
  174         (a) All prescription drugs and supplies that have been
  175  approved for medical use in the United States and meet the
  176  criteria for donation established by this section may be
  177  accepted for donation under the program.
  178         (b) The centralized repository or a local repository may
  179  accept a prescription drug only if:
  180         1. The drug is in its original sealed and tamper-evident
  181  packaging. Single-unit-dose drugs may be accepted if the single
  182  unit-dose packaging is unopened.
  183         2. The drug requires storage at normal room temperature per
  184  the manufacturer or the United States Pharmacopeia.
  185         3. The drug has been stored according to manufacturer or
  186  United States Pharmacopeia storage requirements.
  187         4. The drug does not have any physical signs of tampering
  188  or adulteration and there is no reason to believe that the drug
  189  is adulterated.
  190         5. The packaging does not have any physical signs of
  191  tampering, misbranding, deterioration, compromised integrity, or
  192  adulteration.
  193         6. The packaging contains the lot number and expiration
  194  date of the drug. If the lot number is not retrievable, all
  195  specified medications must be destroyed in the event of a
  196  recall.
  197         7. The drug has an expiration date that is more than 3
  198  months after the date that the drug was donated.
  199         (c) The central repository or a local repository may only
  200  accept supplies that are in their original, unopened, sealed
  201  packaging and have not been adulterated or misbranded.
  202         (d) Prescription drugs and supplies may be donated on the
  203  premises of the centralized repository or a local repository to
  204  a person designated by the repository. A drop box may not be
  205  used to accept donations.
  206         (e) Prescription drugs or supplies may not be donated to a
  207  specific patient.
  208         (f) Prescription drugs billed to and paid for by Medicaid
  209  in long-term care facilities which are eligible for return to
  210  stock under federal Medicaid regulations must be credited to
  211  Medicaid and are not eligible for donation under the program.
  212         (g) Prescription drugs that are subject to a Federal Food
  213  and Drug Administration Risk Evaluation and Mitigation Strategy
  214  with Elements to Assure Safe Use are not eligible for donation
  215  under the program.
  216         (h) Nothing in this section requires the central repository
  217  or a local repository to accept a donation of a prescription
  218  drug or supplies.
  219         (6) INSPECTION AND STORAGE.—
  220         (a) A licensed pharmacist employed by or under contract
  221  with the centralized repository or a local repository shall
  222  inspect donated prescription drugs and supplies to determine
  223  whether the donated prescription drugs or supplies:
  224         1. Are eligible for donation under the program;
  225         2. Have been adulterated or misbranded; and
  226         3. Are safe and suitable for dispensing.
  227         (b) The pharmacist who inspects the donated prescription
  228  drugs or supplies shall sign an inspection record on a form
  229  prescribed by the department and adopted in rule verifying that
  230  the criteria of paragraph (a) have been met and attach such
  231  record to the copy of the inventory record. If a local
  232  repository receives drugs and supplies from the centralized
  233  repository, the local repository is not required to reinspect
  234  the drugs and supplies.
  235         (c) The centralized repository and local repositories shall
  236  store donated prescription drugs and supplies in a secure
  237  storage area under the environmental conditions specified by the
  238  manufacturer or United States Pharmacopeia for the prescription
  239  drugs or supplies being stored. Donated prescription drugs and
  240  supplies may not be stored with nondonated inventory. A local
  241  repository shall quarantine any donated prescription drugs or
  242  supplies from all dispensing stock until the donated
  243  prescription drugs or supplies are inspected and approved for
  244  dispensing under the program.
  245         (d) A local repository shall maintain an inventory of all
  246  donated prescription drugs or supplies it receives. Such
  247  inventory shall be recorded on a form prescribed by the
  248  department and adopted in rule.
  249         (e) A local repository shall notify the centralized
  250  repository within 5 days after receipt of any donation of
  251  prescription drugs or supplies to the program. The notification
  252  shall be on a form prescribed by the department and adopted by
  253  rule.
  254         (f) The centralized repository shall maintain an inventory
  255  of all prescription drugs and supplies donated to the program.
  256         (g) The centralized repository may redistribute
  257  prescription drugs and supplies to facilitate dispensing to
  258  either the centralized repository or to a local repository, as
  259  needed.
  261         (a) A local repository must notify the department of its
  262  intent to participate in the program before accepting or
  263  dispensing any prescription drugs or supplies pursuant to this
  264  section. The notification shall be on a form prescribed by the
  265  department and adopted by rule and must, at a minimum, include:
  266         1. The name, street address, website, and telephone number
  267  of the local repository and any state-issued license or
  268  registration number issued to the local repository, including
  269  the name of the issuing agency.
  270         2. The name and telephone number of the pharmacist employed
  271  by or under contract with the local repository who is
  272  responsible for the inspection of donated prescription drugs and
  273  supplies.
  274         3. A statement signed and dated by the responsible
  275  pharmacist affirming that the local repository meets the
  276  eligibility requirements of this section.
  277         (b) A local repository may withdraw from participation in
  278  the program at any time by providing written notice to the
  279  department or contractor on a form prescribed by the department
  280  and adopted by rule. The department shall adopt rules addressing
  281  the disposition of any prescription drugs in the possession of
  282  the local repository.
  283         (8) DISPENSING.—
  284         (a) Each eligible patient without a program identification
  285  card must submit an intake collection form to a local repository
  286  before receiving prescription drugs or supplies under the
  287  program. The form shall be prescribed by the department and
  288  adopted by rule and, at a minimum, must include:
  289         1. The name, street address, and telephone number of the
  290  eligible patient.
  291         2. The basis for eligibility, which must specify that the
  292  patient is indigent, uninsured, or underinsured.
  293         3. A statement signed and dated by the eligible patient
  294  affirming that he or she meets the eligibility requirements of
  295  this section.
  296         (b) A local repository shall collect a signed and dated
  297  intake collection form from each eligible patient receiving
  298  prescription drugs or supplies under the program. The local
  299  repository must issue a program identification card upon receipt
  300  of a duly executed intake collection form. The program
  301  identification card is valid for 1 year after issuance and must
  302  be in a form prescribed by the department and adopted in rule.
  303         (c) A local repository must send a summary of the intake
  304  collection form data to the centralized pharmacy within 5 days
  305  after receipt of a duly executed intake collection form.
  306         (d) A dispenser may only dispense a donated prescription
  307  drug or supplies, if available, to an eligible patient with a
  308  program identification card or a duly executed intake collection
  309  form.
  310         (e) A dispenser shall inspect the donated prescription
  311  drugs or supplies prior to dispensing such drugs or supplies.
  312         (f) A dispenser may provide dispensing and consulting
  313  services to an eligible patient.
  314         (g) Donated prescription drugs and supplies may not be sold
  315  or resold under this program.
  316         (h) A dispenser of donated prescription drugs or supplies
  317  may not submit a claim or otherwise seek reimbursement from any
  318  public or private third-party payor for donated prescription
  319  drugs or supplies dispensed to any patient under this program.
  320  However, a repository may charge a nominal handling fee,
  321  established by department rule, for the preparation and
  322  dispensing of prescription drugs or supplies under the program.
  323         (i) A local repository that receives donated prescription
  324  drugs or supplies may, with authorization from the centralized
  325  repository, distribute the prescription drugs or supplies to
  326  another local repository.
  328  SUPPLIES.—
  329         (a) The centralized repository and a local repository shall
  330  be responsible for drug recalls and shall have an established
  331  protocol to notify recipients in the event of a prescription
  332  drug recall.
  333         (b) Local repositories shall destroy all of the recalled or
  334  expired prescription drugs or prescription drugs that are not
  335  suitable for dispensing in the repository and complete a
  336  destruction information form for all donated prescription drugs
  337  destroyed, in accordance with rules adopted by the department.
  338         (10) RECORDKEEPING.—
  339         (a) Local repositories shall maintain records of
  340  prescription drugs and supplies that were accepted, donated,
  341  dispensed, distributed, or destroyed under the program.
  342         (b) All records required to be maintained as a part of the
  343  program shall be maintained in accordance with any applicable
  344  practice acts. Local repositories shall submit these records
  345  quarterly to the centralized repository for data collection, and
  346  the centralized repository shall submit these records and the
  347  collected data in annual reports to the department.
  348         (11) REGISTRIES AND FORMS.—
  349         (a) The department shall establish and maintain registries
  350  of all local repositories and available drugs and supplies under
  351  the program. The registry of local repositories must include the
  352  repository’s name, address, website, and telephone number. The
  353  registry of available drugs and supplies must include the name,
  354  strength, available quantity, and expiration date of the drug or
  355  supply and the name and contact information of the repositories
  356  where such drug or supply is available. The department shall
  357  publish the registries on its website.
  358         (b) The department shall publish all forms required by this
  359  section on its website.
  360         (12) IMMUNITY.—
  361         (a) Any donor of prescription drugs or supplies, or any
  362  participant in the program, who exercises reasonable care in
  363  donating, accepting, distributing, or dispensing prescription
  364  drugs or supplies under the program, and the rules adopted
  365  pursuant thereto, is immune from civil or criminal liability and
  366  from professional disciplinary action of any kind for any
  367  injury, death, or loss to person or property relating to such
  368  activities.
  369         (b) A pharmaceutical manufacturer who exercises reasonable
  370  care is not liable for any claim or injury arising from the
  371  transfer of any prescription drug under this section, including
  372  but not limited to, liability for failure to transfer or
  373  communicate product or consumer information regarding the
  374  transferred drug, including the expiration date of the
  375  transferred drug.
  376         (13)NOTICE TO PATIENTS.–Before dispensing a prescription
  377  drug that has been donated under this program, the dispenser
  378  must provide written notification to the patient, or to his or
  379  her legal representative, receipt of which must be acknowledged
  380  in writing, that:
  381         (a)The prescription drug was donated to the program;
  382         (b)The donors and participants in the program are granted
  383  certain immunities as described in subsection (12); and
  384         (c)The patient may not be required to pay for the
  385  prescription drug, except for a nominal handling fee which may
  386  not exceed the amount established by department rule.
  387         (14)DIRECT-SUPPORT ORGANIZATION.-The department may
  388  establish a direct-support organization to provide assistance,
  389  funding, and promotional support for the activities authorized
  390  for the program.
  391         (a)Purposes and objectives.-The purposes and objectives of
  392  the direct-support organization of the program must be
  393  consistent with the goals of the department, in the best
  394  interest of the state, and in accordance with the adopted goals
  395  and mission of the department.
  396         (b)Prohibition against lobbying.–The direct-support
  397  organization is not considered a lobbying firm within the
  398  meaning of s. 11.045. All expenditures of the direct-support
  399  organization must be used for the program. No expenditures of
  400  the direct-support organization may be used for the purpose of
  401  lobbying as defined in s. 11.045.
  402         (c)Contract.—The direct-support organization shall operate
  403  under a written contract with the department. The contract must
  404  provide for a submission by the direct-support organization to
  405  the department, by each August 1, and posting on the direct
  406  support organization’s and department’s websites, the following
  407  information:
  408         1.The articles of incorporation and bylaws of the direct
  409  support organization as approved by the department.
  410         2.An annual budget for the approval of the department.
  411         3.The code of ethics of the direct-support organization.
  412         4.The statutory authority or executive order that created
  413  the direct-support organization.
  414         5.A brief description of the direct-support organization’s
  415  mission and any results obtained by the direct-support
  416  organization.
  417         6.A brief description of the direct-support organization’s
  418  plans for the next 3 fiscal years.
  419         7.A copy of the direct-support organization’s most recent
  420  federal Internal Revenue Service Return Organization Exempt from
  421  Income Tax form (Form 990).
  422         8. Certification by the department that the direct-support
  423  organization is complying with the terms of the contract and
  424  operating in a manner consistent with the goals and purposes of
  425  the department and the best interest of the program and the
  426  state. Such certification must be made annually and reported in
  427  the official minutes of a meeting of the direct-support
  428  organization.
  429         9. The reversion, without penalty, of moneys and property
  430  held in trust by the direct-support organization for the benefit
  431  of the program to the state if the department ceases to exist;
  432  or reversion to the department if the direct-support
  433  organization is no longer approved to operate or ceases to
  434  exist.
  435         10.The fiscal year of the direct-support organization,
  436  which must begin on July 1 of each year and end on June 30 of
  437  the following year.
  438         11. The disclosure of material provisions of the contract,
  439  and the distinction between the department and the direct
  440  support organization, to donors of gifts, contributions, or
  441  bequests, including such disclosure on all promotional and
  442  fundraising publications.
  443         12.All prescription drugs solicited by the direct-support
  444  organization to be distributed to the centralized repository or
  445  a local repository. The direct-support organization may not
  446  possess any prescription drugs on behalf of the program.
  447         (d) Board of directors.—The State Surgeon General shall
  448  appoint a board of directors of the direct-support organization.
  449  The board of directors shall consist of at least 5 members, but
  450  not more than 15 members, who serve at the pleasure of the State
  451  Surgeon General. The board members must elect a chair from among
  452  its members. Board members must serve without compensation but
  453  may be entitled to reimbursement of travel and per diem expenses
  454  in accordance with s. 112.061, if funds are available for this
  455  purpose.
  456         (e) Use of property.—The department may allow, without
  457  charge, appropriate use of fixed property, facilities, and
  458  personnel services of the department by the direct-support
  459  organization, subject to this subsection. For the purposes of
  460  this paragraph, the term “personnel services” includes full-time
  461  or part-time personnel, as well as payroll processing services.
  462         1. The department may prescribe any condition with which
  463  the direct-support organization must comply in order to use
  464  fixed property or facilities of the department.
  465         2. The department may not permit the use of any fixed
  466  property or facilities of the department by the direct-support
  467  organization if it does not provide equal membership and
  468  employment opportunities to all persons regardless of race,
  469  color, religion, sex, age, or national origin.
  470         3. The department shall adopt rules prescribing the
  471  procedures by which the direct-support organization is governed
  472  and any conditions with which a direct-support organization must
  473  comply to use property or facilities of the department.
  474         (f) Deposit of funds.—Any moneys may be held in a separate
  475  depository account in the name of the direct-support
  476  organization and subject to the provisions of the contract with
  477  the department.
  478         (g)Use of funds.-Funds designated for the direct-support
  479  organization must be used for the enhancement of the projects of
  480  the program and used in a manner consistent with that purpose.
  481  Any administrative costs of running and promoting the purposes
  482  of the corporation or program must be paid by private funds.
  483         (h) Audit.—The direct-support organization shall provide
  484  for an annual financial audit in accordance with s. 215.981.
  485         (i) Repeal.—This subsection shall stand repealed on October
  486  1, 2023, unless reviewed and saved from repeal by the
  487  Legislature.
  488         (15)RULEMAKING.—The department shall adopt rules necessary
  489  to implement the requirements of this section. When applicable,
  490  the rules may provide for the use of electronic forms,
  491  recordkeeping, and meeting by teleconference.
  492         Section 2. Paragraph (o) is added to subsection (5) of
  493  section 252.36, Florida Statutes, to read:
  494         252.36 Emergency management powers of the Governor.—
  495         (5) In addition to any other powers conferred upon the
  496  Governor by law, she or he may:
  497         (o) Waive the patient eligibility requirements of s.
  498  465.1902.
  499         Section 3. This act shall take effect July 1, 2018.