LRBa1544/1
RLR:jld&nwn:jf
2009 - 2010 LEGISLATURE
SENATE AMENDMENT 1,
TO 2009 SENATE BILL 455
February 16, 2010 - Offered by Senators Robson and Sullivan.
SB455-SA1,1,11 At the locations indicated, amend the bill as follows:
SB455-SA1,1,3 21. Page 1, line 2: after "drugs" insert ", donating drugs, and dispensing
3donated drugs".
SB455-SA1,1,4 42. Page 1, line 3: before that line insert:
SB455-SA1,1,5 5" Section 1m. 255.056 (title) of the statutes is amended to read:
SB455-SA1,1,6 6255.056 (title) Cancer and chronic diseases drug Drug repository.
SB455-SA1, s. 2 7Section 2. 255.056 (1) (a) of the statutes is repealed.
SB455-SA1, s. 3 8Section 3. 255.056 (1) (am) of the statutes is repealed.
SB455-SA1, s. 4 9Section 4. 255.056 (1) (bg) of the statutes is created to read:
SB455-SA1,1,1010 255.056 (1) (bg) "Drug" has the meaning given in s. 450.01 (10).
SB455-SA1, s. 5 11Section 5. 255.056 (1) (h) of the statutes is amended to read:
SB455-SA1,1,1312 255.056 (1) (h) "Supplies" means items that are necessary to administer a
13cancer or chronic disease drug.
SB455-SA1, s. 6
1Section 6. 255.056 (2) of the statutes is amended to read:
SB455-SA1,2,142 255.056 (2) The department shall establish and maintain a cancer and chronic
3diseases
drug repository program, under which any person may donate a cancer or
4chronic disease
drug or supplies, other than a drug specified under sub. (2m), for use
5by an individual who meets eligibility criteria specified by rule by the department.
6Donation may be made on the premises of a medical facility or pharmacy that elects
7to participate in the program and meets requirements specified by rule by the
8department. The medical facility or pharmacy may charge an individual who
9receives a cancer or chronic disease drug or supplies under this subsection a handling
10fee that may not exceed the amount specified by rule by the department. A medical
11facility or pharmacy that receives a donated cancer or chronic disease drug or
12supplies under this subsection may distribute the cancer or chronic disease drug or
13supplies to another eligible medical facility or pharmacy for use under the program
14under this section.
SB455-SA1, s. 7 15Section 7. 255.056 (2m) of the statutes is created to read:
SB455-SA1,2,1716 255.056 (2m) None of the following drugs may be donated, accepted,
17distributed, or dispensed under this section:
SB455-SA1,2,1818 (a) A controlled substance, as defined in s. 961.01 (4).
SB455-SA1,2,2119 (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).
SB455-SA1, s. 8 22Section 8. 255.056 (3) of the statutes is amended to read:
SB455-SA1,2,2523 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:
SB455-SA1,3,3
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.
SB455-SA1,3,64 (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.
SB455-SA1,3,107 (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.
SB455-SA1,3,1311 (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.
SB455-SA1, s. 9 14Section 9. 255.056 (4) of the statutes is amended to read:
SB455-SA1,3,1615 255.056 (4) No cancer or chronic disease drug or supplies that are donated for
16use under this section may be resold.
SB455-SA1, s. 10 17Section 10. 255.056 (6) of the statutes is amended to read:
SB455-SA1,3,2418 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.
SB455-SA1,4,6
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.
SB455-SA1,4,107 (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.
SB455-SA1, s. 11 11Section 11. 255.056 (7) (a) (intro.) of the statutes is amended to read:
SB455-SA1,4,1412 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:
SB455-SA1, s. 12 15Section 12. 255.056 (7) (a) 2. of the statutes is amended to read:
SB455-SA1,4,1716 255.056 (7) (a) 2. Standards and procedures for accepting, safely storing, and
17dispensing donated cancer or chronic disease drugs or supplies.
SB455-SA1, s. 13 18Section 13. 255.056 (7) (a) 3. of the statutes is amended to read:
SB455-SA1,4,2219 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.
SB455-SA1, s. 14 23Section 14. 255.056 (7) (a) 4. of the statutes is amended to read:
SB455-SA1,5,3
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.
SB455-SA1, s. 15 4Section 15. 255.056 (7) (b) of the statutes is amended to read:
SB455-SA1,5,85 255.056 (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.
SB455-SA1, s. 16 9Section 16. 255.056 (7) (c) of the statutes is amended to read:
SB455-SA1,5,1210 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.
SB455-SA1, s. 17 13Section 17. 255.056 (7) (d) of the statutes is amended to read:
SB455-SA1,5,1714 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.
SB455-SA1, s. 18 18Section 18. 255.056 (7) (e) of the statutes is amended to read:
SB455-SA1,5,2319 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.
SB455-SA1, s. 19 24Section 19. 255.056 (7) (f) of the statutes is repealed.
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