Chapter DHS 148

Register December 2010 No. 660

Chapter DHS 148

DRUG REPOSITORY PROGRAM

DHS 148.01   Authority and purpose.

DHS 148.02   Applicability.

DHS 148.03   Definitions.

DHS 148.04   Requirements for participation by pharmacies and medical facilities.

DHS 148.05   Recipient eligibility requirements.

DHS 148.06   Donations of drugs and supplies.

DHS 148.07   Dispensing requirements.

DHS 148.08   Handling fees.

DHS 148.09   Distribution of donated drugs and supplies.

DHS 148.10   Sale of donated drugs or supplies.

DHS 148.11   Recordkeeping requirements.

Ch. DHS 148 Note Note: Chapter HFS 148 was renumbered chapter DHS 148 under s. 13.92 (4) (b) 1., Stats., and corrections made under s. 13.92 (4) (b) 7., Stats., Register January 2009 No. 637.

DHS 148.01 DHS 148.01 Authority and purpose. This chapter is promulgated under the authority of s. 255.056, Stats., to establish and maintain a drug repository program under which unused drugs and supplies may be donated to a participating medical facility or pharmacy and dispensed to any Wisconsin resident.

DHS 148.01 History History: CR 04-142: cr. Register June 2005 No. 594, eff. 7-1-05; CR 06-018: am. Register July 2006 No. 607, eff. 8-1-06; CR 10-091: am. Register December 2010 No. 660, eff. 1-1-11.

DHS 148.02 DHS 148.02 Applicability.

DHS 148.02(1) (1) This chapter applies to the department and any person who donates, receives, dispenses or otherwise participates or wishes to participate in the drug repository program.

DHS 148.02(2) (2) Over-the-counter medications and supplies not used to administer drugs such as bandages or drainage bags are not subject to the provisions of this chapter. Accepting such items is at the discretion of the individual pharmacy or medical facility.

DHS 148.02 History History: CR 04-142: cr. Register June 2005 No. 594, eff. 7-1-05; CR 06-018: am. Register July 2006 No. 607, eff. 8-1-06; CR 10-091: am. Register December 2010 No. 660, eff. 1-1-11.

DHS 148.03 DHS 148.03 Definitions. In this chapter:

DHS 148.03(4) (4) “Department” means the Wisconsin department of health services.

DHS 148.03(5) (5) “Dispense” has the meaning given in s. 450.01 (7), Stats.

DHS 148.03(6) (6) “Distribute” has the meaning given in s. 450.01 (8), Stats.

DHS 148.03(7) (7) “Distributor” has the meaning given in s. 450.01 (9), Stats.

DHS 148.03(7g) (7g) “Drug” has the meaning given in s. 450.01 (10), Stats.

DHS 148.03(7r) (7r) “Drug repository” means a medical facility or pharmacy that has notified the department of its election to participate in the drug repository program.

DHS 148.03(8) (8) “Manufacturer” has the meaning given in s. 450.01 (12), Stats.

DHS 148.03(9) (9) “Medical facility” has the meaning given in s. 943.145 (1), Stats.

DHS 148.03(10) (10) “Pharmacist” has the meaning given in s. 450.01 (15), Stats.

DHS 148.03(11) (11) “Pharmacy” means a pharmacy that is licensed under s. 450.06, Stats.

DHS 148.03(11m) (11m) “Practitioner” has the meaning given in s. Med 17.02 (2).

DHS 148.03(12) (12) “Prescription drug” has the meaning given in s. 450.01 (20), Stats.

DHS 148.03(14) (14) “Single-unit-dose packaging” means a single-unit container for articles intended for administration as a single dose, direct from the container.

DHS 148.03(14m) (14m) “Supplies” has the meaning under s. 255.056 (1) (h), Stats.

DHS 148.03(15) (15) “Tamper-evident unit dose packaging” means a container within which a drug is sealed so that the contents cannot be opened without obvious destruction of the seal.

DHS 148.03 History History: CR 04-142: cr. Register June 2005 No. 594, eff. 7-1-05; CR 06-018: am. (1) to (3) and (13), cr. (3m) and (14m) Register July 2006 No. 607, eff. 8-1-06; correction in (4) made under s. 13.92 (4) (b) 6., Stats., Register January 2009 No. 637; CR 10-091: renum. (1) and (2) to be (7g) and (7r) and am., r. (3), (3m), (13), cr. (11m) Register December 2010 No. 660, eff. 1-1-11.

DHS 148.04 DHS 148.04 Requirements for participation by pharmacies and medical facilities.

DHS 148.04(1) (1) Eligibility. To be eligible for participation in the drug repository program a pharmacy or medical facility shall be in compliance with all applicable federal and state laws, and administrative rules.

DHS 148.04(2) (2) Notice of participation.

DHS 148.04(2)(a) (a) Participation in the drug repository program is voluntary. A pharmacy or medical facility may elect to participate in the drug repository program by providing written notification to the department of all of the following:

DHS 148.04(2)(a)1. 1. The name, street address, and telephone number of the pharmacy or medical facility.

DHS 148.04(2)(a)2. 2. The name and telephone number of a pharmacist or another contact as determined by the pharmacist who is employed by or under contract with the pharmacy or medical facility.

DHS 148.04(2)(a)3. 3. A statement indicating that the pharmacy or medical facility meets the eligibility requirements under sub. (1), and the chosen level of participation described in par. (b).

DHS 148.04(2)(b) (b) A pharmacy or medical facility may fully participate in the drug repository program by accepting, storing, and dispensing donated drugs and supplies, or may limit its participation to only accepting and storing donated drugs and supplies. If a pharmacy or facility chooses to limit its participation, the pharmacy or facility shall distribute any donated drugs to a fully participating drug repository following the requirements under s. DHS 148.09.

DHS 148.04 Note Note: Notices of participation in the drug repository program can be sent to the Department of Health Services, Division of Quality Assurance, 1 West Wilson St., Madison, WI 53701.

DHS 148.04(3) (3) Withdrawal from participation. A pharmacy or medical facility may withdraw from participation in the drug repository program at any time upon written notice to the department.

DHS 148.04 Note Note: A notice to withdraw participation from the drug repository program should be sent to the Department of Health Services, Division of Quality Assurance, 1 West Wilson St., Madison, WI 53701.

DHS 148.04 History History: CR 04-142: cr. Register June 2005 No. 594, eff. 7-1-05; CR 06-018: am. (1), (2) (a) (intro.), (b), (3) Register July 2006 No. 607, eff. 8-1-06; CR 10-091: am. (1), (2) (a) (intro.), (b), (3) Register December 2010 No. 660, eff. 1-1-11.

DHS 148.05 DHS 148.05 Recipient eligibility requirements. Any Wisconsin resident is eligible to receive drugs or supplies under the drug repository program in the order of priority established under s. DHS 148.07 (4).

DHS 148.05 History History: CR 04-142: cr. Register June 2005 No. 594, eff. 7-1-05; CR 06-018: am. Register July 2006 No. 607, eff. 8-1-06; CR 10-091: am. Register December 2010 No. 660, eff. 1-1-11.

DHS 148.06 DHS 148.06 Donations of drugs and supplies.

DHS 148.06(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:

DHS 148.06(1)(a) (a) An individual who is 18 years old or older.

DHS 148.06(1)(b) (b) A pharmacy, medical facility, manufacturer, or distributor, if the donated drugs have not been previously dispensed or administered.

DHS 148.06(2) (2) Drugs and supplies eligible for donation.

DHS 148.06(2)(a) (a) Drugs. A drug is eligible for donation under the drug repository program only if all of the following requirements are met:

DHS 148.06(2)(a)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.

DHS 148.06(2)(a)2. 2. The drug’s expiration date is at least 90 days later than the date that the drug was donated.

DHS 148.06(2)(a)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.

DHS 148.06(2)(a)4. 4. The drug is not adulterated or misbranded.

DHS 148.06(2)(b) (b) Supplies. Supplies are eligible for donation under the drug repository program only if the supplies meet all of the following requirements:

DHS 148.06(2)(b)1. 1. The supplies are not adulterated or misbranded.

DHS 148.06(2)(b)2. 2. The supplies are in their original, unopened, sealed packaging.

DHS 148.06(2)(b)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.

DHS 148.06 Note Note: Drug repository donor forms can be obtained from the Department’s website at http://www.dhs.wisconsin.gov/forms.

DHS 148.06(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:

DHS 148.06(3)(a) (a) Controlled substances as defined in s. 961.01 (4), Stats.

DHS 148.06(3)(b) (b) Drugs and supplies that do not meet the criteria under sub. (2).

DHS 148.06(3)(c) (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).

DHS 148.06(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.

DHS 148.06(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.

DHS 148.06 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.

DHS 148.07 DHS 148.07 Dispensing requirements.

DHS 148.07(1) (1) Drugs and supplies shall be dispensed by a licensed pharmacist consistent with the requirements in s. 450.11, Stats., and ch. Phar 7 or a practitioner consistent with the requirements in ch. Med 17.

DHS 148.07(2) (2) The pharmacist shall inspect drugs and supplies for adulteration, misbranding, and the date of expiration before dispensing. Drugs or supplies that are expired, adulterated, or misbranded may not be dispensed.