Florida Statutes 499.029 – Cancer Drug Donation Program
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(1) This section may be cited as the “Cancer Drug Donation Program Act.”
(2) There is created a Cancer Drug Donation Program within the department for the purpose of authorizing and facilitating the donation of cancer drugs and supplies to eligible patients.
(3) As used in this section:
(a) “Cancer drug” means a prescription drug that has been approved under s. 505 of the Federal Food, Drug, and Cosmetic Act and is used to treat cancer or its side effects or is used to treat the side effects of a prescription drug used to treat cancer or its side effects. “Cancer drug” does not include a substance listed in Schedule II, Schedule III, Schedule IV, or Schedule V of s. 893.03.
Terms Used In Florida Statutes 499.029
- Cosmetic: means an article, with the exception of soap, that is:(a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or(b) Intended for use as a component of any such article. See Florida Statutes 499.003
- Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
- Device: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:
(a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or(c) Intended to affect the structure or any function of the body of humans or other animals,and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. See Florida Statutes 499.003
- distribution: means to sell, purchase, trade, deliver, handle, store, or receive. See Florida Statutes 499.003
- Donor: The person who makes a gift.
- Drug: means an article that is:
(a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;(b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;(c) Intended to affect the structure or any function of the body of humans or other animals; or(d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003- Hospital: means a facility as defined in…. See Florida Statutes 499.003
- Manufacturer: means :
(a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under…. See Florida Statutes 499.003- Person: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. See Florida Statutes 499.003
- Pharmacist: means a person licensed under chapter 465. See Florida Statutes 499.003
- Pharmacy: means an entity licensed under chapter 465. See Florida Statutes 499.003
- Prescription drug: means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by…. See Florida Statutes 499.003
- Wholesale distributor: means a person, other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution. See Florida Statutes 499.003
(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) “Donor” means a patient or patient representative who donates cancer drugs or supplies needed to administer cancer drugs that have been maintained within a closed drug delivery system; health care facilities, nursing homes, hospices, or hospitals with closed drug delivery systems; or pharmacies, drug manufacturers, medical device manufacturers or suppliers, or wholesalers of drugs or supplies, in accordance with this section. “Donor” includes a physician licensed under chapter 458 or chapter 459 who receives cancer drugs or supplies directly from a drug manufacturer, wholesale distributor, or pharmacy.(d) “Eligible patient” means a person who the department determines is eligible to receive cancer drugs from the program.(e) “Participant facility” means a class II hospital pharmacy that has elected to participate in the program and that accepts donated cancer drugs and supplies under the rules adopted by the department for the program.(f) “Prescribing practitioner” means a physician licensed under chapter 458 or chapter 459 or any other medical professional with authority under state law to prescribe cancer medication.(g) “Program” means the Cancer Drug Donation Program created by this section.(h) “Supplies” means any supplies used in the administration of a cancer drug.(4) Any donor may donate cancer drugs or supplies to a participant facility that elects to participate in the program and meets criteria established by the department for such participation. Cancer drugs or supplies may not be donated to a specific cancer patient, and donated drugs or supplies may not be resold by the program. Cancer drugs billed to and paid for by Medicaid in long-term care facilities that are eligible for return to stock under federal Medicaid regulations shall be credited to Medicaid and are not eligible for donation under the program. A participant facility may provide dispensing and consulting services to individuals who are not patients of the hospital.(5) The cancer drugs or supplies donated to the program may be prescribed only by a prescribing practitioner for use by an eligible patient and may be dispensed only by a pharmacist.(6)(a) A cancer drug may only be accepted or dispensed under the program if the drug is in its original, unopened, sealed container, or in a tamper-evident unit-dose packaging, except that a cancer drug packaged in single-unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit-dose packaging is unopened with tamper-resistant packaging intact.(b) A cancer drug may not be accepted or dispensed under the program if the drug bears an expiration date that is less than 6 months after the date the drug was donated or if the drug appears to have been tampered with or mislabeled as determined in paragraph (c).(c) Prior to being dispensed to an eligible patient, the cancer drug or supplies donated under the program shall be inspected by a pharmacist to determine that the drug and supplies do not appear to have been tampered with or mislabeled.(d) A dispenser of donated cancer drugs or supplies may not submit a claim or otherwise seek reimbursement from any public or private third-party payor for donated cancer drugs or supplies dispensed to any patient under the program, and a public or private third-party payor is not required to provide reimbursement to a dispenser for donated cancer drugs or supplies dispensed to any patient under the program.(7)(a) A donation of cancer drugs or supplies shall be made only at a participant facility. A participant facility may decline to accept a donation. A participant facility that accepts donated cancer drugs or supplies under the program shall comply with all applicable provisions of state and federal law relating to the storage and dispensing of the donated cancer drugs or supplies.(b) A participant facility that voluntarily takes part in the program may charge a handling fee sufficient to cover the cost of preparation and dispensing of cancer drugs or supplies under the program. The fee shall be established in rules adopted by the department.(8) The department, upon the recommendation of the Board of Pharmacy, shall adopt rules to carry out the provisions of this section. Initial rules under this section shall be adopted no later than 90 days after the effective date of this act. The rules shall include, but not be limited to:(a) Eligibility criteria, including a method to determine priority of eligible patients under the program.(b) Standards and procedures for participant facilities that accept, store, distribute, or dispense donated cancer drugs or supplies.(c) Necessary forms for administration of the program, including, but not limited to, forms for use by entities that donate, accept, distribute, or dispense cancer drugs or supplies under the program.(d) The maximum handling fee that may be charged by a participant facility that accepts and distributes or dispenses donated cancer drugs or supplies.(e) Categories of cancer drugs and supplies that the program will accept for dispensing; however, the department may exclude any drug based on its therapeutic effectiveness or high potential for abuse or diversion.(f) Maintenance and distribution of the participant facility registry established in subsection (10).(9) A person who is eligible to receive cancer drugs or supplies under the state Medicaid program or under any other prescription drug program funded in whole or in part by the state, by any other prescription drug program funded in whole or in part by the Federal Government, or by any other prescription drug program offered by a third-party insurer, unless benefits have been exhausted, or a certain cancer drug or supply is not covered by the prescription drug program, is ineligible to participate in the program created under this section.(10) The department shall establish and maintain a participant facility registry for the program. The participant facility registry shall include the participant facility’s name, address, and telephone number. The department shall make the participant facility registry available on the department’s website to any donor wishing to donate cancer drugs or supplies to the program. The department’s website shall also contain links to cancer drug manufacturers that offer drug assistance programs or free medication.(11) Any donor of cancer drugs or supplies, or any participant in the program, who exercises reasonable care in donating, accepting, distributing, or dispensing cancer drugs or supplies under the program and the rules adopted under this section shall be immune from civil or criminal liability and from professional disciplinary action of any kind for any injury, death, or loss to person or property relating to such activities.(12) A pharmaceutical manufacturer is not liable for any claim or injury arising from the transfer of any cancer drug under this section, including, but not limited to, liability for failure to transfer or communicate product or consumer information regarding the transferred drug, as well as the expiration date of the transferred drug.(13) If any conflict exists between the provisions in this section and the provisions in this chapter or chapter 465, the provisions in this section shall control the operation of the Cancer Drug Donation Program.