HB 59 — Prescription Drug Donation Repository Program

specifying requirements and requiring the department to adopt rules relating to a direct-support organization's use of department property;

specifying requirements for the deposit and use of funds by the direct-support organization;

providing for annual audits of a direct- support organization;

providing for future legislative review and repeal of provisions relating to the direct-support organization;

93 Be It Enacted by the Legislature of the State of Florida:

95 Section 1.

Page(a) 4"Closed drug delivery system" means a system in which the actual control of 21the CODING:unit-dose medication package is maintained by the facility, rather than by the individual patient.

Words(b) stricken"Controlled aresubstance" deletions;means any substance listed under Schedule II, Schedule III, Schedule IV, or Schedule V of s.

words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 (a) "Centralized repository" means a distributor permitted under chapter 499 who is approved by the department or the contractor to accept, inspect, inventory, and distribute donated drugs and supplies under this section.

(b) "Closed drug delivery system" means a system in which the actual control of the unit-dose medication package is maintained by the facility, rather than by the individual patient.

(c) "Contractor" means the third-party vendor approved by the department to implement and administer the program as authorized in subsection (4).

(d) "Controlled substance" means any substance listed under Schedule II, Schedule III, Schedule IV, or Schedule V of s.

(e)(c) "Direct-support"Dispenser" organization" means a health care practitioner who, within the entityscope createdof his or her practice act, is authorized to dispense medicinal drugs and who does so under subsectionthis (15).act.

(f)Page "Dispenser"3 means a health care practitioner who, within the scope of his14 orCODING: her practice act, is authorized to dispense medicinal drugs and who does so under this act.

(g) "Donor" means an entity specified in subsection (5).

(h) "Eligible patient" means a Florida resident who is indigent, uninsured, or underinsured and who has a valid prescription for a prescription drug or supply that may be dispensed under the program.

(i) "Free clinic" means a clinic that delivers only Page 5 of 21 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 (d) "Free clinic" means a clinic that delivers only medical diagnostic services or nonsurgical medical treatment free of charge to low-income recipients.

(j)(e) "Health care practitioner" or "practitioner" means a practitioner licensed under this chapter, chapter 458, chapter 459, chapter 461, chapter 463, chapter 464, or chapter 466.

(k)(f) "Indigent" means anhaving individuala whose family income for the 12 months preceding the determination of income that is below 200 percent of the federal poverty level as defined by the most recently revised poverty income guidelines published by the United States Department of Health and Human Services.

(l)(g) "Local"Nonprofit repository" means a health careclinic" practitioner'smeans office, a pharmacy, a hospital with a closed drug delivery system, a nursing home facility with a closed drug delivery system, or a free clinic or nonprofit healthlegal clinicentity that isprovides licensedmedical orcare permitted to dispensepatients medicinalwho drugsare inindigent, theuninsured, state.or underinsured.

(m) "Nonprofit health clinic" means a nonprofit legal entity that provides medical care to patients who are indigent, uninsured, or underinsured.

(n)(h) "Nursing home facility" has the same meaning as in s.

(o)(i) "Prescriber" means a health care practitioner who, within the scope of his or her practice act, is authorized to Pageprescribe 6medicinal ofdrugs. 21 CODING:

(j) "Prescription drug" has the same meaning as the term "medicinal drugs" or "drugs," as those terms are defined in s.

465.003(8), but does not include controlled substances, cancer Page 4 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 prescribedrugs medicinaldonated drugs.under s.

(p)499.029, "Prescriptionor drug"drugs haswith thean sameapproved meaningFederal asFood theand termDrug "medicinalAdministration drugs"risk orevaluation "drugs,"and asmitigation thosestrategy termsthat areincludes definedelements into s.assure safe use.

465.003(8),(k) but"Program" doesmeans notthe includePrescription controlledDrug substancesDonation orRepository cancerProgram drugscreated donatedby underthis s.section.

499.029.(l) "Supply" means a material or an instrument used to administer a prescription drug.

(q)(m) "Program""Tamper-evident packaging" means thea Prescriptionpackage Drugthat Donationhas Repositoryone Programor createdmore byindicators thisor section.barriers to access which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.

(r)The "Supplies"term meansincludes, anybut supplyis usednot inlimited theto, administrationunopened ofunit-dose packaging, multiple-dose packaging, and medications with a prescriptionseal drug.on their immediate, outer, secondary, or tertiary packaging.

(s)(n) "Tamper-evident"Underinsured" packaging" means ahaving packagehealth thatcare hascoverage one or moreprescription indicatorsdrug orcoverage, barriersbut tohaving entryexhausted which,these ifbenefits breached or missing,not canhaving reasonablyprescription bedrug expectedcoverage tofor providethe visibledrug evidenceprescribed. to consumers that tampering has occurred.

(t)(o) "Underinsured""Uninsured" means anot personhaving whohealth hascare third-partycoverage insuranceand orbeing isineligible eligiblefor to receive prescription drugsdrug orcoverage suppliesunder througha the Medicaid program or any other prescription drug program funded in whole or in part by the Federal Government,Government. but who has exhausted these benefits or does not have prescription drug coverage for the drug prescribed.

(u) "Uninsured" means a person who has no third-party insurance and is not eligible to receive prescription drugs or supplies through the Medicaid program or any other prescription drug program funded in whole or in part by the Federal Government.

PageCREATION; 7 of 21 CODING:

PURPOSE.—The Prescription Drug Donation Repository Program is created within the department to facilitate the donation of prescription drugs and supplies to eligible Page 5 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 CREATION;patients.

PURPOSE.—The(4) PrescriptionREPOSITORIES.— Drug(a) DonationA Repositoryrepository Programmay isaccept createdand withindispense theeligible departmentdonations forto theeligible purposepatients ofunder authorizing and facilitating the donationprogram. of prescription drugs and supplies to eligible patients.

(4)The PROGRAMrepository IMPLEMENTATION;must inspect, store, and dispense donations and report to the department in accordance with this section.

ADMINISTRATION.—The(b) departmentThe following entities may contractparticipate withas a third-partyrepository: vendor to administer the program.

(5)1. DONOR ELIGIBILITY.—The centralized repository or a local repository may accept a donation of a prescription drug or supply only from:

A health care practitioner's office.

2.

A pharmacy.

3.

A hospital with a closed drug delivery system.

4.

A nursing home facility with a closed drug delivery system.

5.

A free clinic or nonprofit health clinic that is licensed or permitted to dispense medicinal drugs in the state.

(c) An eligible entity must notify the department of its intent to participate in the program as a repository before accepting or dispensing any donations under the program.

The notification must be made on a physical or an electronic form prescribed by the department in rule and must, at a minimum, include:

1.

The name, street address, website, and telephone number of the intended repository and any license or registration number issued by the state to the intended repository, including the name of the issuing agency.

Page 6 of 14 CODING:

Words stricken are deletions;

words underlined are additions.

hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/CS/HB 59 2019 2.

The name and telephone number of the pharmacist employed by or under contract with the intended repository who is responsible for the inspection of donated prescription drugs and supplies.

3.

A signed and dated statement by the responsible pharmacist affirming that the intended repository meets the eligibility requirements of this subsection.

(d) A repository may withdraw from participation in the program at any time by providing written notice to the department, as appropriate, on a physical or an electronic form prescribed by the department in rule.

The department shall adopt rules addressing the disposition of prescription drugs and supplies in the possession of the withdrawing repository.

(5) ELIGIBLE DONORS.—The following entities may donate prescription drugs or supplies to a repository under the program:

(g) Prescribers who receive prescription drugs or supplies directlyPage from7 aof drug14 manufacturer,CODING: wholesale distributor, or pharmacy.

(6) PRESCRIPTION DRUGS AND SUPPLIES ELIGIBLE FOR DONATION;

DONATION REQUIREMENTS;

PROHIBITED DONATIONS.— (a) Only prescription drugs and supplies that have been approved for medical use in the United States and that meet the Page 8 of 21 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 criteriadirectly forfrom donationa establisheddrug bymanufacturer, thiswholesale sectiondistributor, mayor bepharmacy. accepted for donation under the program.

Donations(6) mustELIGIBLE beDONATIONS; made on the premises of the centralized repository or a local repository to a person designated by the repository.

ADONATION dropREQUIREMENTS; box may not be used to accept donations.

(b)PROHIBITED TheDONATIONS.— centralized(a) repositoryAn oreligible adonor local repository may acceptonly donate a prescription drug onlyto a repository if:

The drug is inapproved itsfor originalmedical sealeduse andin tamper-evidentthe packaging.United States.

Single-unit-dose drugs may be accepted if the single- unit-dose packaging is unopened.

The drug requiresis storagein atunopened, normaltamper-evident roompackaging. temperature per the manufacturer or the United States Pharmacopeia.

The drug hasrequires beenstorage storedat accordingnormal toroom manufacturertemperature orper Unitedthe Statesmanufacturer Pharmacopeiaor federal storage requirements.

The drug doeshas notbeen havestored anyaccording physicalto signsmanufacturer of tampering or adulterationfederal andstorage thererequirements. is no reason to believe that the drug is adulterated.

The packagingdrug does not have any physical signs of tampering,tampering misbranding,or deterioration,adulteration compromisedand integrity,there oris adulteration.no reason to believe that the drug is adulterated.

The packaging indicatesdoes thenot lothave numberany andphysical expirationsigns date of thetampering, drug.misbranding, deterioration, compromised integrity, or adulteration.

If the lot number is not retrievable, all specified medications must be destroyed in the event of a recall.

The drugpackaging hasindicates anthe expiration date that is more than 3 Page 9 of 21the CODING:drug.

If the lot number is not retrievable, all specified medications must be destroyed in the event of a recall.

8.

The drug has an expiration date that is more than 3 months after the date on which the drug was donated.

(b) An eligible donor may donate a prescription drug or Page 8 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 monthssupply afterto thea daterepository thatonly theif drugit wasis donated.in unopened, tamper-evident packaging.

(c) TheDonations centralizedmust repositorybe ormade aon localthe repositorypremises mayof accepta suppliesrepository onlyto ifa theyperson aredesignated inby theirthe original,repository. unopened, sealed packaging and have not been tampered with or misbranded.

(d)A Prescriptiondrop drugsbox or supplies may not be donatedused to aaccept specificdonations. patient.

(e)(d) PrescriptionA drugsprescription billeddrug toor andsupply paid for by Medicaid in long-term care facilities which are eligible for return to stock under federal Medicaid regulations must be credited to Medicaid and may not be donated underto thea program.specific patient.

(f)(7) PrescriptionINSPECTION drugsAND withSTORAGE.— an(a) approvedUpon Federalreceipt Foodof anda Drugproposed Administrationdonation, Riska Evaluationlicensed andpharmacist Mitigationemployed Strategyby thator includesunder Elementscontract towith Assurea Saferepository Useshall areinspect notthe eligibledonation forto donationdetermine underwhether it meets the program.requirements of subsections (5) and (6).

(g)The Thisrepository sectionshall doesquarantine nota requiredonation theuntil centralizedsuch repositoryinspection oris acomplete localand repositorythe to accept a donation ofis prescriptionapproved drugsfor ordispensing. supplies.

(7)(b) INSPECTIONThe ANDinspecting STORAGE.—pharmacist (a)must Asign licensedan pharmacistinspection employedrecord byon a physical or underan contractelectronic withform theprescribed centralizedby repositorythe ordepartment ain localrule repositorywhich shallverifies inspectthat donatedthe prescription drugsdrug andor suppliessupply tomeets determine whether they meet the requirementscriteria of subsections (5) and (6).(6) and must attach the record to the inventory required by paragraph (d).

(b)A Therepository inspectingthat pharmacistreceives mustprescription signdrugs anand inspectionsupplies recordfrom onanother arepository formis prescribednot byrequired theto departmentreinspect bysuch rule which verifies that the prescription drugs and suppliessupplies. meet the Page 10 of 21 CODING:

(c) A repository shall store donations in a secure storage area under the environmental conditions specified by the manufacturer or federal storage requirements.

Donations may not Page 9 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 criteriabe ofstored subsectionswith (5)other andinventory. (6) and must attach the record to the inventory required by paragraph (d).

(d) A local repository thatshall receivesmaintain drugsan andinventory suppliesof from the centralizedname, repositorystrength, isavailable notquantity, requiredand toexpiration reinspectdate them.of donations;

(c) The centralized repository and local repositories shall store donated prescription drugs and supplies in a secure storage area under the environmentaltransaction conditionsdate; specified by the manufacturer or the United States Pharmacopeia for the respective prescription drugs or supplies.

Donatedand prescriptionthe drugsname, andstreet suppliesaddress, mayand nottelephone benumber storedof withthe otherdonor. inventory.

AThe local repository shall quarantinerecord donatedsuch prescriptioninventory drugson ora suppliesphysical untilor theyan areelectronic inspectedform andprescribed approvedby forthe dispensingdepartment underin thisrule. section.

(d)(e) TheBy centralizedthe repository5th andday localof repositorieseach month, a repository shall maintainsubmit anto the department its inventory records of alldonations donatedreceived prescriptionduring drugsthe orprevious supplies.month.

Such(f) inventoryThe atdepartment localmay repositoriesfacilitate shallthe beredistribution recordedof ondonations abetween formrepositories. prescribed by the department by rule.

(e) A local repository shallthat notifyreceives thedonations centralizedmay, repository within 5 days after receiptnotifying ofthe anydepartment, donationdistribute ofthe prescriptiondonations drugs or supplies to theanother program.repository.

The(8) notificationELIGIBLE mustPATIENTS; be on a form prescribed by the department by rule.

(f)DISPENSING TheREQUIREMENTS; centralized repository may redistribute prescription drugs and supplies by transferring them to or from the centralized repository and a local repository, as needed.

APATIENT localNOTICE; repository that receives donated prescription drugs or Page 11 of 21 CODING:

WordsPROHIBITIONS.— stricken(a) areA deletions;repository may dispense an eligible donation to a state resident who is indigent, uninsured, or underinsured, and who has a valid prescription for such donation, as applicable.

words(b) underlinedEach arenew additions.eligible patient must submit an intake collection form to a repository to receive a donation using a physical or an electronic form prescribed by the department in rule.

hb0059-02-c2Such Fform Lshall, Oat Ra Iminimum, Dinclude: A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 supplies may, with authorization from the centralized repository, distribute the prescription drugs or supplies to another local repository.

(8) PROGRAM PARTICIPATION.— (a) A practitioner, pharmacy, facility, or clinic must notify the department of its intent to participate in the program as a local repository before accepting or dispensing any prescription drugs or supplies pursuant to this section.

The notification must be made on a form prescribed by the department by rule and must, at a minimum, include:

The name, street address, website, and telephone number of the intendedeligible localpatient. repository and any license or registration number issued by the state to the intended local repository, including the name of the issuing agency.

2.Page 10 of 14 CODING:

The name and telephone number of the pharmacist employed by or under contract with the intended local repository who is responsible for the inspection of donated prescription drugs and supplies.

3.

A signed and dated statement by the responsible pharmacist affirming that the intended local repository meets the eligibility requirements of this section.

(b) A local repository may withdraw from participation in the program at any time by providing written notice to the department or contractor, as appropriate, on a form prescribed by the department by rule.

The department shall adopt rules Page 12 of 21 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 addressing2. the disposition of prescription drugs and supplies in the possession of the withdrawing local repository.

(9)The DISPENSINGbasis REQUIREMENTS;for the patient's eligibility, which must specify that the patient is indigent, uninsured, or underinsured.

PROHIBITIONS.— (a) Each eligible patient without a program identification card must submit an intake collection form to a local repository before receiving prescription drugs or supplies under the program.

The department shall prescribe a form by rule, which must include at least all of the following:

1.

The name, street address, and telephone number of the eligible patient.

2.

The basis for eligibility, which must specify that the patient is indigent, uninsured, or underinsured.

A statement physically or electronically signed and dated by the eligible patient affirming that hethe orpatient she meets the eligibility requirements of this section.section and will inform the repository if the patient's eligibility changes.

(b)4. Upon receipt of a completed and signed intake collection form, the local repository shall issue him or her a program identification card, which is valid for 1 year after its date of issuance.

TheNotice cardthat mustthe beprescription drug or supply was donated to the program, that the donors and participants in athe formprogram prescribedare byimmune from civil or criminal liability or disciplinary action, and that the departmenteligible bypatient rule.is not required to pay for the prescription drug or supply.

(c)5. The local repository shall send a summary of each intake collection form to the centralized pharmacy within 5 days after receiving it.

(d) A dispenserstatement mayphysically dispenseor donatedelectronically prescriptionsigned drugsand ordated suppliesby onlythe to an eligible patient whoacknowledging hasreceipt aof programnotice Pagerequired 13under ofthis 21paragraph. CODING:

(c) By the 5th day of each month, a repository shall submit to the department a summary of each intake collection form obtained during the previous month.

(d) A dispenser may dispense donations, if available, only to an eligible patient who has submitted a completed intake collection form.

(e) A dispenser may provide dispensing and consulting services to an eligible patient.

(f) Donations may not be sold or resold.

(g) A dispenser may not submit a claim or otherwise seek Page 11 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 identificationreimbursement cardfrom orany whopublic hasor submittedprivate athird-party completedpayor intakefor collectiondonations. form.

(e)(9) ARECALLED dispenserPRESCRIPTION DRUGS.— (a) Each repository shall inspectestablish and follow a protocol for notifying recipients in the donatedevent that a prescription drugsdrug ordonated suppliesunder beforethe dispensingprogram them.is recalled.

(f)(b) A dispenserrepository mayshall providedestroy dispensingall anddonated consultingprescription servicesdrugs tothat anare eligiblerecalled, patient.expired, or unsuitable for dispensing.

(g)A Donatedrepository prescriptionmust drugscomplete anda suppliesdestruction mayform notfor beall soldsuch drugs using a physical or resoldan underelectronic form prescribed by the program.department in rule.

(h)(10) RECORDKEEPING.— (a) A dispenserrepository ofshall donatedmaintain records of prescription drugs orand supplies maythat notare submitaccepted, adonated, claimdispensed, distributed, or otherwisedestroyed seekunder reimbursementthe fromprogram anyusing publica physical or privatean third-partyelectronic payorform forprescribed donatedby prescriptionthe drugsdepartment orin suppliesrule. dispensed under this program.

(10)(b) RECALLEDAll PRESCRIPTIONrequired DRUGSrecords ANDmust SUPPLIES.—be (a)maintained The centralized repository and each local repository shall establish and follow a protocol for notifying recipients in theaccordance eventwith ofany aapplicable prescriptionpractice drugact. recall.

(b)A Localrepository repositories shall destroysubmit allthese recalledrecords ormonthly expiredto prescriptionthe drugsdepartment and all prescription drugs that are not suitable for dispensingdata incollection. the repository.

Local(11) repositoriesREGISTRIES; must complete a destruction information form for all such drugs, in accordance with department rule.

(11)PUBLICATION RECORDKEEPING.—OF FORMS.— (a) LocalThe repositoriesdepartment shall establish and maintain recordsregistries of prescriptionall drugsrepositories and suppliesof thatprescription aredrugs accepted,and donated,supplies dispensed,available distributed, or destroyed under the program.

PageThe 14registry of 21repositories CODING:must include each repository's name, street address, website, and telephone number.

The registry of available prescription drugs Page 12 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 (b)and Allsupplies requiredmust recordsinclude mustthe bename, maintainedstrength, inavailable accordancequantity, withand anyexpiration applicabledate practiceof act.the prescription drugs or supplies and the name and contact information of each repository where such drugs or supplies are available.

Local repositories shall submit these records quarterly to the centralized repository for data collection, and the centralized repository shall submit these records and the collected data in annual reports to the department.

(12) REGISTRIES;

PUBLICATION OF FORMS.— (a) The department or contractor shall establish and maintain registries of all local repositories and of prescription drugs and supplies available under the program.

The registry of local repositories must include each repository's name, address, website, and telephone number.

The registry of available prescription drugs and supplies must include the name, strength, available quantity, and expiration date of the prescription drug or supplies and the name and contact information of each repository where such drug or supplies are available.

(13)(12) IMMUNITY FROM LIABILITY,LIABILITY; DISCIPLINARY ACTION.— (a) Any donor of prescription drugs or supplies and any participant in the program who exercises reasonable care in donating, accepting, distributing, or dispensing prescription drugs or supplies under the program is immune from civil or Page 15 of 21 CODING:

DISCIPLINARY ACTION.— (a) Any donor of prescription drugs or supplies and any participant in the program who exercises reasonable care in donating, accepting, distributing, or dispensing prescription drugs or supplies under the program is immune from civil or criminal liability and from professional disciplinary action by the state for any injury, death, or loss to person or property relating to such activities.

(b) A pharmaceutical manufacturer who exercises reasonable care is not liable for any claim or injury arising from the donation of any prescription drug or supply under this section, including, but not limited to, liability for failure to transfer or communicate product or consumer information regarding the donated prescription drug or supply, including its expiration date.

(13) RULEMAKING.—The department shall adopt rules necessary to administer this section.

Section 2.

Paragraph (o) is added to subsection (5) of Page 13 of 14 CODING:

hb0059-02-c2hb0059-03-c3 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HBCS/CS/CS/HB 59 2019 criminalsection liability252.36, andFlorida fromStatutes, professional disciplinary action by the state for any injury, death, or loss to personread: or property relating to such activities.

(b) A pharmaceutical manufacturer who exercises reasonable care is not liable for any claim or injury arising from the donation of any prescription drug or supply under this section, including, but not limited to, liability for failure to transfer or communicate product or consumer information regarding the donated prescription drug, including its expiration date.

(14) NOTICE TO PATIENTS.—Before dispensing a donated prescription drug under the program, the dispenser must provide written notification to the eligible patient or his or her legal representative, receipt of which must be acknowledged in writing, of all of the following information:

(a) The prescription drug was donated to the program.

(b) The donors and participants in the program are immune from civil or criminal liability or disciplinary action.

(c) The eligible patient is not required to pay for the prescription drug.

(15) DIRECT-SUPPORT ORGANIZATION.—The department may establish a direct-support organization to provide assistance, funding, and promotional support for the activities authorized under the act.

(a) Entity organization.—The direct-support organization must operate in accordance with s.

20.058 and is:

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Words stricken are deletions;

words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 1.

A Florida corporation not for profit incorporated under chapter 617, exempted from filing fees, and approved by the Department of State.

2.

Organized and operated to conduct programs and activities;

raise funds and request and receive grants, gifts, and bequests of moneys;

acquire, receive, hold, and invest, in its own name, securities, funds, objects of value, or other property, either real or personal;

and make expenditures or provide funding to or for the direct or indirect benefit of the program.

(b) Purposes and objectives.—The purposes and objectives of the direct-support organization must be consistent with the goals of the department, in the best interest of the state, and in accordance with the adopted goals and the mission of the department.

(c) Prohibition against lobbying.—The direct-support organization is not considered a lobbying firm, as that term is defined in s.

11.045(1).

All expenditures of the direct-support organization must be directly related to program administration within the requirements of this section.

Funds of the direct- support organization may not be used for the purpose of lobbying, as that term is defined in s.

11.045(1).

(d) Possession of prescription drugs.—The direct-support organization may not possess any prescription drugs on behalf of the program.

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Words stricken are deletions;

words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 (e) Contract.—The direct-support organization shall operate under a written contract with the department.

1.

The contract must require the direct-support organization to submit to the department, annually by August 1, the following information, which must be posted on the websites of the direct-support organization and the department:

a.

The articles of incorporation and bylaws of the direct- support organization, as approved by the department.

b.

A proposed annual budget for the approval of the department.

c.

The code of ethics of the direct-support organization.

d.

The statutory authority or executive order that created the direct-support organization.

e.

A brief description of the direct-support organization's mission and any results obtained by the direct- support organization.

f.

A brief description of the direct-support organization's annual plan for each of the next 3 fiscal years.

g.

A copy of the direct-support organization's most recent federal Internal Revenue Service Return Organization Exempt from Income Tax form (Form 990).

h.

Certification by the department that the direct-support organization is complying with the terms of the contract and operating in a manner consistent with the goals and purposes of the department and the best interest of the program and the Page 18 of 21 CODING:

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words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 state.

Such certification must be made annually and reported in the official minutes of a meeting of the board of directors of the direct-support organization.

2.

The contract must, at a minimum, provide for:

a.

The reversion without penalty to the department, or to the state if the department ceases to exist, of all moneys and property held in trust by the direct-support organization for the benefit of the program if the direct-support organization ceases to exist or if the contract is terminated.

b.

A disclosure of material provisions of the contract and the distinction between the department and the direct-support organization to appear on all promotional and fundraising publications.

c.

A list of prescription drugs solicited by the direct- support organization for distribution to the centralized repository or a local repository.

(f) Board of directors.—The State Surgeon General shall appoint the board of directors, which must consist of at least 5 members, but not more than 15 members, who serve at his or her pleasure.

The board must elect a chair from among its members.

Board members must serve without compensation but may be entitled to reimbursement of travel and per diem expenses in accordance with s.

112.061, if funds are available for this purpose.

(g) Use of property.—The department may allow, without Page 19 of 21 CODING:

Words stricken are deletions;

words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 charge, appropriate use of fixed property, facilities, and personnel services of the department by the direct-support organization for purposes related to the program.

For purposes of this paragraph, the term "personnel services" includes full- time or part-time personnel, as well as payroll processing services.

1.

The department may prescribe any condition with which the direct-support organization must comply in order to use fixed property or facilities of the department.

2.

The department may not allow the use of any fixed property or facilities of the department by the direct-support organization if the organization does not provide equal membership and employment opportunities to all persons regardless of race, color, religion, sex, age, or national origin.

3.

The department shall adopt rules prescribing the procedures by which the direct-support organization is governed and any conditions with which a direct-support organization must comply to use property or facilities of the department.

(h) Deposit of funds.—Any moneys of the direct-support organization may be held in a separate depository account in the name of the organization and subject to the provisions of the organization's contract with the department.

(i) Use of funds.—Funds designated for the direct-support organization must be used for the enhancement of program Page 20 of 21 CODING:

Words stricken are deletions;

words underlined are additions.

hb0059-02-c2 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S CS/CS/HB 59 2019 projects and in a manner consistent with that purpose.

Any administrative costs of running and promoting the purposes of the organization or program must be paid by private funds.

(j) Audit.—The direct-support organization shall provide for an annual financial audit in accordance with s.

215.981.

(k) Repeal.—This subsection is repealed on October 1, 2024, unless reviewed and saved from repeal by the Legislature.

(16) RULEMAKING.—The department shall adopt rules necessary to administer this section.

When applicable, the rules may provide for the use of electronic forms, recordkeeping, and meeting by teleconference.

Section 2.

Paragraph (o) is added to subsection (5) of section 252.36, Florida Statutes, to read:

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