Section 255.056. Drug repository.

 

(1)   Definitions. In this section:

(b) “Dispense" has the meaning given in s. 450.01 (7) .

(bg) “Drug" has the meaning given in s. 450.01 (10) .

(c) “Medical facility" has the meaning given in s. 943.145 (1) .

(d) “Pharmacist" has the meaning given in s. 450.01 (15) .

(e) “Pharmacy" means a pharmacy that is licensed under s. 450.06 .

(f) “Practitioner" has the meaning given in s. 450.01 (17) .

(g) “Prescription drug" has the meaning given in s. 450.01 (20) .

(h) “Supplies" means items that are necessary to administer a drug.

(2)  The department shall establish and maintain a drug repository program, under which any person may donate a 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 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 drug or supplies under this subsection may distribute the drug or supplies to another eligible medical facility or pharmacy for use under the program under this section.

(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).

(3)  A 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 drug or supplies are in their original, unopened, sealed, and tamper-evident packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.

(b) In the case of a drug, the drug bears an expiration date that is later than 90 days after the date that the drug was donated.

(c) The 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) 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.

(4)  No drug or supplies that are donated for use under this section may be resold.

(5)  Nothing in this section requires that a medical facility, pharmacy, pharmacist, or practitioner participate in the program under this section.

(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 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 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 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 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 drug or supply by a person whose act or omission involves reckless, wanton, or intentional misconduct.

(7)  The department shall promulgate all of the following as rules:

(a) Requirements for medical facilities and pharmacies to accept and dispense donated drugs or supplies under this section, including all of the following:

1. Eligibility criteria.

2. Standards and procedures for accepting, safely storing, and dispensing donated drugs or supplies.

3. Standards and procedures for inspecting donated drugs or supplies to determine if the drug or supplies are in their original, unopened, sealed, and tamper-evident packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.

4. Standards and procedures for inspecting donated drugs or supplies to determine that the drug or supplies are not adulterated or misbranded.

(b) Eligibility criteria for individuals to receive donated 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.

(c) A means, such as an identification card, by which an individual who is eligible to receive a donated drug or supplies may indicate that eligibility.

(d) Necessary forms for administration of the drug repository program, including forms for use by persons that donate, accept, distribute, or dispense drugs or supplies under the program.

(e) The maximum handling fee that a medical facility or pharmacy may charge for accepting, distributing, or dispensing donated 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.

(g) A list of drugs and supplies, arranged by category or by individual drug or supply, that the 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.

2003 a. 175 , 327 ; 2005 a. 16 ; 2009 a. 142 . Cross-reference: See also ch. DHS 148 , Wis. adm. code.