AB651-AA1,2,2119
(b) A drug for which the U.S. food and drug administration requires that a
20patient using the drug be enrolled in a registry as provided under
21 USC 355-1 (f)
21(3) (F).
AB651-AA1, s. 8
22Section
8. 255.056 (3) of the statutes is amended to read:
AB651-AA1,2,2523
255.056
(3) A
cancer or chronic disease drug or supplies may be accepted and
24dispensed under the program specified in sub. (2) only if all of the following
25requirements are met:
AB651-AA1,3,3
1(a) The
cancer or chronic disease drug or supplies are in their original,
2unopened, sealed, and tamper-evident
unit dose packaging or, if packaged in
3single-unit doses, the single-unit-dose packaging is unopened.
AB651-AA1,3,64
(b)
The cancer or chronic disease In the case of a drug, the drug bears an
5expiration date that is later than
6 months 90 days after the date that the drug was
6donated.
AB651-AA1,3,107
(c) The
cancer or chronic disease drug or supplies are not adulterated or
8misbranded, as determined by a pharmacist employed by, or under contract with, the
9medical facility or pharmacy, who shall inspect the drug or supplies before the drug
10or supplies are dispensed.
AB651-AA1,3,1311
(d)
The cancer or chronic disease For a prescription drug or supplies used to
12administer a prescription drug, the drug or supplies are prescribed by a practitioner
13for use by an eligible individual and are dispensed by a pharmacist
or practitioner.
AB651-AA1, s. 9
14Section
9. 255.056 (4) of the statutes is amended to read:
AB651-AA1,3,1615
255.056
(4) No
cancer or chronic disease drug or supplies that are donated for
16use under this section may be resold.
AB651-AA1,3,2418
255.056
(6) (a) Unless the manufacturer of a drug or supply exercises bad faith,
19the manufacturer is not subject to criminal or civil liability for injury, death, or loss
20to a person or property for matters related to the donation, acceptance, or dispensing
21of a
cancer or chronic disease drug or supply manufactured by the manufacturer that
22is donated by any person under this section, including liability for failure to transfer
23or communicate product or consumer information or the expiration date of the
24donated
cancer or chronic disease drug or supply.
AB651-AA1,4,6
1(b) Except as provided in par. (c), any person, except the manufacturer of a drug
2or supply, is immune from civil liability for injury to or the death of the individual
3to whom the
cancer or chronic disease drug or supply is dispensed and may not be
4found guilty of unprofessional conduct for his or her acts or omissions related to
5donating, accepting, distributing, or dispensing a
cancer or chronic disease drug or
6supply under this section.
AB651-AA1,4,107
(c) The immunity or the prohibition on a finding of guilty of unprofessional
8conduct under par. (b) does not extend to donation, acceptance, distribution, or
9dispensation of a
cancer or chronic disease drug or supply by a person whose act or
10omission involves reckless, wanton, or intentional misconduct.
AB651-AA1, s. 11
11Section
11. 255.056 (7) (a) (intro.) of the statutes is amended to read:
AB651-AA1,4,1412
255.056
(7) (a) (intro.) Requirements for medical facilities and pharmacies to
13accept and dispense donated
cancer or chronic disease drugs or supplies under this
14section, including all of the following:
AB651-AA1, s. 12
15Section
12. 255.056 (7) (a) 2. of the statutes is amended to read:
AB651-AA1,4,1716
255.056
(7) (a) 2. Standards and procedures for accepting, safely storing, and
17dispensing donated
cancer or chronic disease drugs or supplies.
AB651-AA1, s. 13
18Section
13. 255.056 (7) (a) 3. of the statutes is amended to read:
AB651-AA1,4,2219
255.056
(7) (a) 3. Standards and procedures for inspecting donated
cancer or
20chronic disease drugs or supplies to determine if the drug or supplies are in their
21original, unopened, sealed, and tamper-evident
unit dose packaging or, if packaged
22in single-unit doses, the single-unit-dose packaging is unopened.
AB651-AA1, s. 14
23Section
14. 255.056 (7) (a) 4. of the statutes is amended to read:
AB651-AA1,5,3
1255.056
(7) (a) 4. Standards and procedures for inspecting donated
cancer or
2chronic disease drugs or supplies to determine that the drug or supplies are not
3adulterated or misbranded.
AB651-AA1, s. 15
4Section
15. 255.056 (7) (b) of the statutes is amended to read:
AB651-AA1,5,85
255.056
(7) (b) Eligibility criteria for individuals to receive donated
cancer or
6chronic disease drugs or supplies dispensed under the program. The standards shall
7prioritize dispensation to individuals who are uninsured or indigent, but will permit
8dispensation to others if an uninsured or indigent individual is unavailable.
AB651-AA1, s. 16
9Section
16. 255.056 (7) (c) of the statutes is amended to read:
AB651-AA1,5,1210
255.056
(7) (c) A means, such as an identification card, by which an individual
11who is eligible to receive a donated
cancer or chronic disease drug or supplies may
12indicate that eligibility.
AB651-AA1, s. 17
13Section
17. 255.056 (7) (d) of the statutes is amended to read:
AB651-AA1,5,1714
255.056
(7) (d) Necessary forms for administration of the
cancer and chronic
15diseases drug repository program, including forms for use by persons that donate,
16accept, distribute, or dispense
cancer or chronic disease drugs or supplies under the
17program.
AB651-AA1, s. 18
18Section
18. 255.056 (7) (e) of the statutes is amended to read:
AB651-AA1,5,2319
255.056
(7) (e) The maximum handling fee that a medical facility or pharmacy
20may charge for accepting, distributing, or dispensing donated
cancer or chronic
21disease drugs or supplies The fee under this paragraph may not be less than 300
22percent of the dispensing fee permitted to be charged for prescription drugs for which
23coverage is provided under s. 49.46 (2) (b) 6. h.
AB651-AA1, s. 20
25Section
20. 255.056 (7) (g) of the statutes is amended to read:
AB651-AA1,6,4
1255.056
(7) (g) A list of
cancer or chronic disease drugs and supplies, arranged
2by category or by individual drug or supply, that the
cancer and chronic diseases drug
3repository program will not accept for dispensing. The list shall include a statement
4that specifies the reason that the drug or supplies are ineligible for donation.".