1. (1) Persons eligible to donate drugs or supplies. Any one of the following persons may donate legally obtained drugs or supplies to a drug repository, if the drugs or supplies meet the requirements under sub. (2), as determined by a pharmacist who is employed by or under contract with a drug repository:

   1. (a) An individual who is 18 years old or older.
   2. (b) A pharmacy, medical facility, manufacturer, or distributor, if the donated drugs have not been previously dispensed or administered.

2. (2) Drugs and supplies eligible for donation.

   1. (a) Drugs. A drug is eligible for donation under the drug repository program only if all of the following requirements are met:

      1. 1. The donation is accompanied by a completed drug repository donor form that is signed by the person making the donation or that person’s authorized representative.
      2. 2. The drug’s expiration date is at least 90 days later than the date that the drug was donated.
      3. 3. The drug is in its original, unopened, tamper-evident packaging that includes the drug’s lot number and expiration date. Single-unit dose drugs may be accepted if the single-unit-dose packaging is unopened.
      4. 4. The drug is not adulterated or misbranded.

   2. (b) Supplies. Supplies are eligible for donation under the drug repository program only if the supplies meet all of the following requirements:

      1. 1. The supplies are not adulterated or misbranded.
      2. 2. The supplies are in their original, unopened, sealed packaging.

      3. 3. The supplies are accompanied by a completed drug repository donor form that is signed by the person making the donation or that person’s authorized representative.

         Note: Drug repository donor forms can be obtained from the Department’s website at http://www.dhs.wisconsin.gov/forms.

3. (3) Drugs and supplies not eligible for donation. All of the following drugs are ineligible for donation or acceptance under the drug repository program:

   1. (a) Controlled substances as defined in s. 961.01 (4), Stats.
   2. (b) Drugs and supplies that do not meet the criteria under sub. (2).
   3. (c) 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).
4. (4) Locations where donations may be made. Drugs and supplies may be donated on the premises of a drug repository to a person designated by the repository. A drop box may not be used to deliver or accept donations.
5. (5) Storage. Drugs and supplies donated under the drug repository program shall be stored in a secure storage area under environmental conditions appropriate for the drugs or supplies being stored. Donated drugs and supplies may not be stored with non-donated inventory.

History

History: CR 04-142: cr. Register June 2005 No. 594, eff. 7-1-05; CR 06-018: am., (1), (2) (a) (intro.), (a) 1., (b) (intro.), (b) 3., (3) (intro.), (4) and (5) Register July 2006 No. 607, eff. 8-1-06; CR 10-091: am. (title), (1) (intro.), (2) (a) (intro.), 1. to 3., (b) (intro.), 3., (3) (intro.), (a), (4), (5), cr. (3) (c) Register December 2010 No. 660, eff. 1-1-11.