2009 WISCONSIN ACT
142
An Act
to repeal
255.056 (1) (a), 255.056 (1) (am) and 255.056 (7) (f);
to amend
255.056 (title), 255.056 (1) (h), 255.056 (2), 255.056 (3), 255.056 (4), 255.056 (6), 255.056 (7) (a) (intro.), 255.056 (7) (a) 2., 255.056 (7) (a) 3., 255.056 (7) (a) 4., 255.056 (7) (b), 255.056 (7) (c), 255.056 (7) (d), 255.056 (7) (e), 255.056 (7) (g) and 450.01 (23) (k); and
to create
255.056 (1) (bg) and 255.056 (2m) of the statutes;
relating to:
the wholesale distribution of prescription drugs, donating drugs, and dispensing donated drugs.
The people of the state of Wisconsin, represented in senate and assembly, do enact as follows:
Section
1m
.
255.056 (title) of the statutes is amended to read:
255.056
(title)
Cancer and chronic diseases drug
Drug
repository.
Section
2
.
255.056 (1) (a) of the statutes is repealed.
Section
3
.
255.056 (1) (am) of the statutes is repealed.
Section
4
.
255.056 (1) (bg) of the statutes is created to read:
255.056
(1)
(bg) "Drug" has the meaning given in s. 450.01 (10).
Section
5
.
255.056 (1) (h) of the statutes is amended to read:
255.056
(1)
(h) "Supplies" means items that are necessary to administer a
cancer or chronic disease
drug.
Section
6
.
255.056 (2) of the statutes is amended to read:
255.056
(2)
The department shall establish and maintain a
cancer and chronic diseases
drug repository program, under which any person may donate a
cancer or chronic disease
drug or supplies
, other than a drug specified under sub. (2m),
for use by an individual who meets eligibility criteria specified by rule by the department. Donation may be made on the premises of a medical facility or pharmacy that elects to participate in the program and meets requirements specified by rule by the department. The medical facility or pharmacy may charge an individual who receives a
cancer or chronic disease
drug or supplies under this subsection a handling fee that may not exceed the amount specified by rule by the department. A medical facility or pharmacy that receives a donated
cancer or chronic disease
drug or supplies under this subsection may distribute the
cancer or chronic disease
drug or supplies to another eligible medical facility or pharmacy for use under the program under this section.
Section
7
.
255.056 (2m) of the statutes is created to read:
255.056
(2m)
None of the following drugs may be donated, accepted, distributed, or dispensed under this section:
(a) A controlled substance, as defined in s. 961.01 (4).
(b) A drug for which the U.S. food and drug administration requires that a patient using the drug be enrolled in a registry as provided under
21 USC 355-1
(f) (3) (F).
Section
8
.
255.056 (3) of the statutes is amended to read:
255.056
(3)
A
cancer or chronic disease
drug or supplies may be accepted and dispensed under the program specified in sub. (2) only if all of the following requirements are met:
(a) The
cancer or chronic disease
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.
(b)
The cancer or chronic disease
In the case of a drug, the
drug bears an expiration date that is later than
6 months
90 days
after the date that the drug was donated.
(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
.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
Section
19
.
255.056 (7) (f) of the statutes is repealed.
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.
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
.
