Wis. Stat. § 255.056 — WI Code / Chapter 255 / Section 255.056
Section 255.056
Status: in_force

(8)

(a) Prior to the first donation of a drug or supplies from a person that has not previously donated to the recipient, a recipient must verify and record all of the following:

1. That the person meets the definition of “donor” provided in sub. (1) (bd) .

2. The donor’s name, phone number, and license number, if applicable.

3. That the donor will make donations of drugs or supplies only in accordance with sub. (2m) .

4. If applicable, that the donor will remove or redact any patient names and prescription numbers on donated drugs or supplies or will otherwise maintain patient confidentiality by executing a confidentiality agreement with the recipient.

(b) No record about a donor, other than the records described under par. (a) , may be required prior to or with a donation.

(9) A drug or supplies accepted under the program described in sub. (2) that does not meet the requirements of subs. (2m) and (3) shall be disposed of by returning the drug or supplies to the donor, destroying the drug or supplies by an incinerator, licensed waste hauler, or other lawful method, or transferring the drug or supplies to a returns processor. A record of the disposed drug or supplies shall consist of the disposal method described in this subsection, the date of disposal, and the name, strength, and quantity of each drug or supply disposed of. No record, other than the record described under this subsection, may be required for disposal of a drug or supplies.

(10) All donated drugs or supplies received under the program described in sub. (2) but not yet accepted into a recipient’s inventory shall be kept in a separate, designated area. Prior to or upon accepting or transferring a donation into inventory, a recipient shall maintain a written or electronic inventory of the donation that consists of the name, strength, and quantity of each accepted drug or supply, if applicable, and the name and phone number of the donor. A written or electronic inventory is not required if the 2 parties to the donation are under common ownership or control. No record of the acceptance or transfer of a donation, other than the written or electronic inventory described under this subsection, may be required.

(11) A recipient shall store and maintain drugs donated under the program described in sub. (2) physically or electronically separate from other inventory and in a secure and temperature-controlled environment that meets the drug manufacturer’s recommendations and U.S. Pharmacopeial Convention standards.

(12) A recipient shall label repackaged drugs or supplies that were donated under the program described in sub. (2) with the drug name, strength, and expiration date. If a recipient repackages multiple packaged donated drugs or supplies with varied expiration dates together, the recipient shall use the earliest expiration date.

(13) To the extent permitted by other laws, a recipient may dispense or administer a donated prescription drug received under the program described in sub. (2) to an eligible patient.

(14) The donation, transfer, receipt, or facilitation of donations, transfers, and receipt of drugs pursuant to this section does not constitute wholesale distribution and does not require licensure as a wholesale distributor. A drug manufacturer, repackager, dispenser, or wholesaler other than a returns processor participating in the program described in sub. (2) shall comply with the requirements of 21 USC 360eee-1 to 360eee-4 relating to drug supply chain security.

(15) When performing any action associated with the program described under sub. (2) or otherwise processing donated drugs or supplies for tax, manufacture, or other credit, a recipient is considered to be acting as a returns processor and shall comply with all recordkeeping requirements for nonsaleable returns under federal law.

(16) All records required under this section shall be retained by a recipient in physical or electronic format, on or off the recipient’s premises, for a period of 6 years. A recipient may contract with a donor or a 3rd party to create or maintain records on the recipient’s behalf. Except as provided under this subsection, an identifier, such as a serial number or bar code, may be used in place of any information required for a record or label under this section if it allows for the information to be readily retrievable. Upon request by a state or federal regulator, the identifier used for a requested record shall be replaced with the original information. An identifier may not be used on patient labels when dispensing or administering a drug.

(17) For purposes of this section, a donation or other transfer of possession or control of drugs or supplies is not a change of ownership unless it is specified as such by the recipient. If a record of the donation’s transaction information or history is required by a state or federal regulator, the record of the history shall begin with the donor of the drug or supplies, shall include all prior donations, and, if the drug or supply was previously dispensed, shall include only drug or supplies information that is required to be included on the patient label in accordance with rules promulgated by the pharmacy examining board.

(18) An entity participating in a drug donation or repository program operated by another state may participate in the program described in sub. (2) and, in the case of a pharmacy, may dispense donated drugs and supplies to the residents of this state. The entity shall comply with all laws and administrative rules in this state, unless the laws or administrative rules differ or conflict with the laws or rules in the state in which the entity is located.

(19)

(a) A recipient may dispense or administer a substitute for a donated, prescribed drug for any of the following:

1. A drug that is in stock and that is a therapeutically equivalent drug.

2. For a prescribed drug that is a biological product, an interchangeable biological product.

(b) A substitution under par. (a) may include any of the following:

1. Splitting a combination drug into 2 or more drugs.

2. Combining 2 or more drugs into a combination drug.

3. A different form of the prescribed drug, including an oral tablet or capsule.

(c) If a recipient dispenses or administers a substitute described in par. (a) , the recipient shall inform the patient and the prescribing practitioner of the substitution, unless the recipient’s substitution policy for the program described in sub. (2) is readily available on the recipient’s website.

(20) A recipient operating primarily for the purpose of participating in the program described in sub. (2) is not required to possess a comprehensive or minimum supply of medicine.

History: 2003 a. 175 , 327 ; 2005 a. 16 ; 2009 a. 142 ; 2025 a. 231 ; s. 35.17 correction in (1) (d), (2h) (intro.), (a), (c), (3m) (intro.), (a), (b), (9), (10), (17).