Florida Senate - 2018                        COMMITTEE AMENDMENT
       Bill No. CS for SB 710
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

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