(c) The cancer or chronic disease drug or supplies are not adulterated or misbranded, as determined by a pharmacist employed by, or under contract with, the medical facility or pharmacy, who shall inspect the drug or supplies before the drug or supplies are dispensed.
(d) The cancer or chronic disease For a prescription drug or supplies used to administer a prescription drug, the drug or supplies are prescribed by a practitioner for use by an eligible individual and are dispensed by a pharmacist or practitioner.
142,9 Section 9. 255.056 (4) of the statutes is amended to read:
255.056 (4) No cancer or chronic disease drug or supplies that are donated for use under this section may be resold.
142,10 Section 10. 255.056 (6) of the statutes is amended to read:
255.056 (6) (a) Unless the manufacturer of a drug or supply exercises bad faith, the manufacturer is not subject to criminal or civil liability for injury, death, or loss to a person or property for matters related to the donation, acceptance, or dispensing of a cancer or chronic disease drug or supply manufactured by the manufacturer that is donated by any person under this section, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated cancer or chronic disease drug or supply.
(b) Except as provided in par. (c), any person, except the manufacturer of a drug or supply, is immune from civil liability for injury to or the death of the individual to whom the cancer or chronic disease drug or supply is dispensed and may not be found guilty of unprofessional conduct for his or her acts or omissions related to donating, accepting, distributing, or dispensing a cancer or chronic disease drug or supply under this section.
(c) The immunity or the prohibition on a finding of guilty of unprofessional conduct under par. (b) does not extend to donation, acceptance, distribution, or dispensation of a cancer or chronic disease drug or supply by a person whose act or omission involves reckless, wanton, or intentional misconduct.
142,11 Section 11. 255.056 (7) (a) (intro.) of the statutes is amended to read:
255.056 (7) (a) (intro.) Requirements for medical facilities and pharmacies to accept and dispense donated cancer or chronic disease drugs or supplies under this section, including all of the following:
142,12 Section 12. 255.056 (7) (a) 2. of the statutes is amended to read:
255.056 (7) (a) 2. Standards and procedures for accepting, safely storing, and dispensing donated cancer or chronic disease drugs or supplies.
142,13 Section 13. 255.056 (7) (a) 3. of the statutes is amended to read:
255.056 (7) (a) 3. Standards and procedures for inspecting donated cancer or chronic disease drugs or supplies to determine if the drug or supplies are in their original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.
142,14 Section 14. 255.056 (7) (a) 4. of the statutes is amended to read:
255.056 (7) (a) 4. Standards and procedures for inspecting donated cancer or chronic disease drugs or supplies to determine that the drug or supplies are not adulterated or misbranded.
142,15 Section 15. 255.056 (7) (b) of the statutes is amended to read:
255.056 (7) (b) Eligibility criteria for individuals to receive donated cancer or chronic disease drugs or supplies dispensed under the program. The standards shall prioritize dispensation to individuals who are uninsured or indigent, but will permit dispensation to others if an uninsured or indigent individual is unavailable.
142,16 Section 16. 255.056 (7) (c) of the statutes is amended to read:
255.056 (7) (c) A means, such as an identification card, by which an individual who is eligible to receive a donated cancer or chronic disease drug or supplies may indicate that eligibility.
142,17 Section 17. 255.056 (7) (d) of the statutes is amended to read:
255.056 (7) (d) Necessary forms for administration of the cancer and chronic diseases drug repository program, including forms for use by persons that donate, accept, distribute, or dispense cancer or chronic disease drugs or supplies under the program.
142,18 Section 18. 255.056 (7) (e) of the statutes is amended to read:
255.056 (7) (e) The maximum handling fee that a medical facility or pharmacy may charge for accepting, distributing, or dispensing donated cancer or chronic disease drugs or supplies The fee under this paragraph may not be less than 300 percent of the dispensing fee permitted to be charged for prescription drugs for which coverage is provided under s. 49.46 (2) (b) 6. h.
142,19 Section 19. 255.056 (7) (f) of the statutes is repealed.
142,20 Section 20. 255.056 (7) (g) of the statutes is amended to read:
255.056 (7) (g) A list of cancer or chronic disease drugs and supplies, arranged by category or by individual drug or supply, that the cancer and chronic diseases drug repository program will not accept for dispensing. The list shall include a statement that specifies the reason that the drug or supplies are ineligible for donation.
142,21m Section 21m. 450.01 (23) (k) of the statutes is amended to read:
450.01 (23) (k) The donation or distribution of a prescription drug under s. 255.056 or under 21 CFR 203.39.
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