LRB-1539/3
RLR:nwn:jf
2009 - 2010 LEGISLATURE
May 19, 2009 - Introduced by Representatives Nygren, Van Roy, Suder,
Montgomery, Ballweg, Benedict, Bies, Black, Friske, Gottlieb, Grigsby,
Gunderson, Kaufert, Kerkman, Knodl, Molepske Jr., Nass, A. Ott, Petersen,
Petrowski, Pope-Roberts, Ripp, Sherman, Smith, Soletski, Spanbauer,
Strachota, Tauchen, Townsend, Turner
and Vos, cosponsored by Senators
Robson, Lassa, Lehman, Vinehout, Taylor, Darling, Schultz, Risser, Olsen,
Miller, Harsdorf, Hansen, Cowles, Carpenter
and Wirch. Referred to
Committee on Public Health.
AB272,1,6 1An Act to repeal 255.056 (1) (a), 255.056 (1) (am) and 255.056 (7) (f); to amend
2255.056 (title), 255.056 (1) (h), 255.056 (2), 255.056 (3), 255.056 (4), 255.056 (6),
3255.056 (7) (a) (intro.), 255.056 (7) (a) 2., 255.056 (7) (a) 3., 255.056 (7) (a) 4.,
4255.056 (7) (b), 255.056 (7) (c), 255.056 (7) (d), 255.056 (7) (e) and 255.056 (7)
5(g); and to create 255.056 (1) (bg) and 255.056 (2m) of the statutes; relating
6to:
donating drugs and dispensing donated drugs.
Analysis by the Legislative Reference Bureau
Under current law, the Department of Health Services administers a drug
repository program under which people may donate certain drugs and supplies to a
medical facility or pharmacy and the medical facility or pharmacy may dispense the
drugs and supplies or distribute them to another medical facility or pharmacy for
dispensing. Only drugs for the treatment of cancer or a chronic disease, or supplies
used to administer such drugs, may be accepted and dispensed under the program.
Program requirements include that drugs and supplies are in their original,
unopened packaging; that the drugs or supplies are inspected by a pharmacist; that
the expiration date of the drugs is at least six months after the donation date; and
that the drugs or supplies are prescribed for a person and dispensed by a pharmacist.
Uninsured or indigent people have priority in obtaining drugs and supplies under
the program. A medical facility or pharmacy may charge a handling fee for the drugs,
but may not resell them. Finally, current law provides immunity from criminal and

civil liability to drug manufacturers and provides immunity from civil liability to
other people participating in the program.
This bill provides that any drug, with certain exceptions, and supplies to
administer drugs may be donated and dispensed under the drug repository program.
The exceptions provide that controlled substances and drugs for which the U.S. Food
and Drug Administration requires that a patient using the drug be enrolled in a
registry may not be donated or dispensed under the program. The bill also changes
the drug expiration date requirement for the program so that drugs with an
expiration date that is at least 90 days after the date of donation may be donated and
dispensed under the program. And, the bill provides that a practitioner, which is
defined as a person licensed to prescribe and administer drugs, may dispense
prescription drugs under the program.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB272, s. 1 1Section 1. 255.056 (title) of the statutes is amended to read:
AB272,2,2 2255.056 (title) Cancer and chronic diseases drug Drug repository.
AB272, s. 2 3Section 2. 255.056 (1) (a) of the statutes is repealed.
AB272, s. 3 4Section 3. 255.056 (1) (am) of the statutes is repealed.
AB272, s. 4 5Section 4. 255.056 (1) (bg) of the statutes is created to read:
AB272,2,66 255.056 (1) (bg) "Drug" has the meaning given in s. 450.01 (10).
AB272, s. 5 7Section 5. 255.056 (1) (h) of the statutes is amended to read:
AB272,2,98 255.056 (1) (h) "Supplies" means items that are necessary to administer a
9cancer or chronic disease drug.
AB272, s. 6 10Section 6. 255.056 (2) of the statutes is amended to read:
AB272,3,811 255.056 (2) The department shall establish and maintain a cancer and chronic
12diseases
drug repository program, under which any person may donate a cancer or
13chronic disease
drug or supplies, other than a drug specified under sub. (2m), for use
14by an individual who meets eligibility criteria specified by rule by the department.
15Donation may be made on the premises of a medical facility or pharmacy that elects

1to participate in the program and meets requirements specified by rule by the
2department. The medical facility or pharmacy may charge an individual who
3receives a cancer or chronic disease drug or supplies under this subsection a handling
4fee that may not exceed the amount specified by rule by the department. A medical
5facility or pharmacy that receives a donated cancer or chronic disease drug or
6supplies under this subsection may distribute the cancer or chronic disease drug or
7supplies to another eligible medical facility or pharmacy for use under the program
8under this section.
AB272, s. 7 9Section 7. 255.056 (2m) of the statutes is created to read:
AB272,3,1110 255.056 (2m) None of the following drugs may be donated, accepted,
11distributed, or dispensed under this section:
AB272,3,1212 (a) A controlled substance, as defined in s. 961.01 (4).
AB272,3,1513 (b) A drug for which the U.S. food and drug administration requires that a
14patient using the drug be enrolled in a registry as provided under 21 USC 355-1 (f)
15(3) (F).
AB272, s. 8 16Section 8. 255.056 (3) of the statutes is amended to read:
AB272,3,1917 255.056 (3) A cancer or chronic disease drug or supplies may be accepted and
18dispensed under the program specified in sub. (2) only if all of the following
19requirements are met:
AB272,3,2220 (a) The cancer or chronic disease drug or supplies are in their original,
21unopened, sealed, and tamper-evident unit dose packaging or, if packaged in
22single-unit doses, the single-unit-dose packaging is unopened.
AB272,3,2523 (b) The cancer or chronic disease In the case of a drug, the drug bears an
24expiration date that is later than 6 months 90 days after the date that the drug was
25donated.
AB272,4,4
1(c) The cancer or chronic disease drug or supplies are not adulterated or
2misbranded, as determined by a pharmacist employed by, or under contract with, the
3medical facility or pharmacy, who shall inspect the drug or supplies before the drug
4or supplies are dispensed.
AB272,4,75 (d) The cancer or chronic disease For a prescription drug or supplies used to
6administer a prescription drug, the
drug or supplies are prescribed by a practitioner
7for use by an eligible individual and are dispensed by a pharmacist or practitioner.
AB272, s. 9 8Section 9. 255.056 (4) of the statutes is amended to read:
AB272,4,109 255.056 (4) No cancer or chronic disease drug or supplies that are donated for
10use under this section may be resold.
AB272, s. 10 11Section 10. 255.056 (6) of the statutes is amended to read:
AB272,4,1812 255.056 (6) (a) Unless the manufacturer of a drug or supply exercises bad faith,
13the manufacturer is not subject to criminal or civil liability for injury, death, or loss
14to a person or property for matters related to the donation, acceptance, or dispensing
15of a cancer or chronic disease drug or supply manufactured by the manufacturer that
16is donated by any person under this section, including liability for failure to transfer
17or communicate product or consumer information or the expiration date of the
18donated cancer or chronic disease drug or supply.
AB272,4,2419 (b) Except as provided in par. (c), any person, except the manufacturer of a drug
20or supply, is immune from civil liability for injury to or the death of the individual
21to whom the cancer or chronic disease drug or supply is dispensed and may not be
22found guilty of unprofessional conduct for his or her acts or omissions related to
23donating, accepting, distributing, or dispensing a cancer or chronic disease drug or
24supply under this section.
AB272,5,4
1(c) The immunity or the prohibition on a finding of guilty of unprofessional
2conduct under par. (b) does not extend to donation, acceptance, distribution, or
3dispensation of a cancer or chronic disease drug or supply by a person whose act or
4omission involves reckless, wanton, or intentional misconduct.
AB272, s. 11 5Section 11. 255.056 (7) (a) (intro.) of the statutes is amended to read:
AB272,5,86 255.056 (7) (a) (intro.) Requirements for medical facilities and pharmacies to
7accept and dispense donated cancer or chronic disease drugs or supplies under this
8section, including all of the following:
AB272, s. 12 9Section 12. 255.056 (7) (a) 2. of the statutes is amended to read:
AB272,5,1110 255.056 (7) (a) 2. Standards and procedures for accepting, safely storing, and
11dispensing donated cancer or chronic disease drugs or supplies.
AB272, s. 13 12Section 13. 255.056 (7) (a) 3. of the statutes is amended to read:
AB272,5,1613 255.056 (7) (a) 3. Standards and procedures for inspecting donated cancer or
14chronic disease
drugs or supplies to determine if the drug or supplies are in their
15original, unopened, sealed, and tamper-evident unit dose packaging or, if packaged
16in single-unit doses, the single-unit-dose packaging is unopened.
AB272, s. 14 17Section 14. 255.056 (7) (a) 4. of the statutes is amended to read:
AB272,5,2018 255.056 (7) (a) 4. Standards and procedures for inspecting donated cancer or
19chronic disease
drugs or supplies to determine that the drug or supplies are not
20adulterated or misbranded.
AB272, s. 15 21Section 15. 255.056 (7) (b) of the statutes is amended to read:
AB272,5,2522 255.056 (7) (b) Eligibility criteria for individuals to receive donated cancer or
23chronic disease
drugs or supplies dispensed under the program. The standards shall
24prioritize dispensation to individuals who are uninsured or indigent, but will permit
25dispensation to others if an uninsured or indigent individual is unavailable.
AB272, s. 16
1Section 16. 255.056 (7) (c) of the statutes is amended to read:
AB272,6,42 255.056 (7) (c) A means, such as an identification card, by which an individual
3who is eligible to receive a donated cancer or chronic disease drug or supplies may
4indicate that eligibility.
AB272, s. 17 5Section 17. 255.056 (7) (d) of the statutes is amended to read:
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