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