1. (1) As used in this section, unless the context otherwise requires:

   1. (a) Correctional facility means a facility under the supervision of the United States, the department of corrections, or a similar state agency or department in a state other than Colorado in which persons are or may be lawfully held in custody as a result of conviction of a crime; a jail or an adult detention center of a county, city, or city and county; and a private contract prison operated by a state, county, city, or city and county.
   2. (b) Licensed facility means a hospital, hospital unit, behavioral health safety net provider, hospice, nursing care facility, assisted living residence, or any other facility that is required to be licensed pursuant to section 25-3-101 or a licensed long-term care facility as defined in section 25-1-124 (2.5)(b).
   3. (c) Medical device means an instrument, apparatus, implement, machine, contrivance, implant, or similar or related article that is required to be labeled pursuant to 21 CFR 801.
   4. (d) Medical supply means a consumable supply item that is disposable and not intended for reuse.

   5. (e)

      1. (I) Medicine means prescription drugs.

      2. (II) Medicine includes:

         1. (A) A prescription drug that requires refrigeration, freezing, or special storage if the prescription drug has been continually maintained by a donor pursuant to the manufacturer's storage requirements, so long as the cold chain can be verified; and
         2. (B) Prescription supplies and devices.

      3. (III) Medicine does not include:

         1. (A) Compounded drugs;
         2. (B) Prescription drugs dispensed by pharmacies outside of the United States;
         3. (C) Prescription drugs that are subject to risk evaluation and mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3) unless all of the required guidelines for the medicine are followed or REMS drugs that were initially dispensed by a pharmacy pursuant to a restricted REMS distribution channel; or
         4. (D) Controlled substances.

2. (2)

   1. (a)

      1. (I) If donated by the patient, the resident, or the patient's or resident's next of kin, a licensed facility may return unused medicine or medical supplies and used or unused medical devices to a pharmacist within the licensed facility or a prescription drug outlet in order for the materials to be redispensed to another patient or donated to a nonprofit entity that has the legal authority to possess the materials or to a practitioner authorized by law to dispense the materials.

      2. (II)

         1. (A) A licensed facility or a prescription drug outlet may donate materials to an entity that has legal authority to possess the materials or to a person legally authorized to dispense the materials. A licensed pharmacist shall review the process of donating the unused medicine to the entity.
         2. (B) Nothing in this subsection (2)(a)(II) creates or abrogates any liability on behalf of a prescription drug manufacturer for the storage, donation, acceptance, or dispensing of medicine or a product or creates any civil cause of action against a prescription drug manufacturer in addition to that which is available under applicable law.
         3. (C) A person or entity is not subject to civil or criminal liability or professional disciplinary action for donating, accepting, dispensing, or facilitating the donation of materials in good faith, without negligence or willful or wanton misconduct, and in compliance with this section.
      3. (III) A correctional facility may return unused medicine or medical supplies and used or unused medical devices to the pharmacist within the correctional facility or a prescription drug outlet in order for the medicine to be redispensed to another patient or donated to an entity that has the legal authority to possess the materials or to a practitioner authorized by law to prescribe the materials.

   2. (b) Medicine is only available to be dispensed to another person or donated to an entity under this section if the medicine is:

      1. (I) Liquid and the vial is still sealed and properly stored;
      2. (II) Individually packaged and the packaging has not been damaged;
      3. (III) In unopened, tamper-evident packaging; or
      4. (IV) For medicine that requires refrigeration, freezing, or special storage, continually maintained by the donor pursuant to the manufacturer's storage requirements, so long as the cold chain can be verified.

   3. (c) The following medicine is not acceptable for donation:

      1. (I) Medicine that is not packaged in a traditional dispensing system, as defined by the board by rule;
      2. (II) Controlled substances;
      3. (III) Except as provided in subsection (2)(b)(IV) of this section, medicine that requires refrigeration, freezing, or special storage;
      4. (IV) Repealed.
      5. (V) Medicine that is adulterated or misbranded, as determined by a person legally authorized to dispense the medicine on behalf of the nonprofit entity or a person legally authorized to dispense the medicine;
      6. (VI) Compounded medicine;
      7. (VII) Medicine dispensed by pharmacies outside of the United States; or
      8. (VIII) Medicine that is subject to risk evaluation and mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3) unless all of the required guidelines for the medicine are followed or REMS drugs that were initially dispensed by a pharmacy pursuant to a restricted REMS distribution channel.
3. (3) Medicine dispensed or donated pursuant to this section must not be expired. A prescribing practitioner shall not dispense medicine that will expire before the use by the patient based on the prescribing practitioner's directions for use.
4. (4) Medicine, medical supplies, and medical devices donated pursuant to this section shall not be resold and are considered nonsaleable; except that handling, dispensing, or usual and customary charges to an eligible patient, health plan, pharmacy benefit manager, pharmacy service, administrative organization, government agency, or other entity is not considered reselling. If the donation recipient is a for-profit entity, these charges must not exceed the donation recipient's cost of providing the medicine, including the current and anticipated costs of educating eligible donors and individual donors, providing technical support to participating donors and individual donors, shipping and handling, labor, storage, licensing, utilities, advertising, technology, supplies, and equipment. Except as described in this subsection (4), the amount of these charges is not subject to additional limitations.
5. (5) Repealed.

6. (6)

   1. (a) Except as provided in subsection (6)(b) of this section, nothing in this section or section 25.5-5-502 creates or abrogates any liability on behalf of a prescription drug manufacturer for the storage, donation, acceptance, or dispensing of unused donated medicine or creates any civil cause of action against a prescription drug manufacturer in addition to that which is available under applicable law.
   2. (b) A manufacturer of a prescription drug that is subject to risk evaluation and mitigation strategies (REMS) is not subject to criminal prosecution or liability in tort or other civil action for injury, death, or loss to person or property for matters related to the donation, acceptance, or dispensing of a REMS drug manufactured by the drug manufacturer that is donated by any person pursuant to the program, including liability for failure to transfer or communicate product or consumer information or the expiration date of the donated prescription drug.

Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1482, § 1, effective October 1. L. 2022: (1)(b) amended, (HB 22-1278), ch. 222, p. 1588, § 216, effective July 1, 2024. L. 2025: (1)(e), (2)(a), IP(2)(b), (2)(b)(II), (2)(b)(III), IP(2)(c), (2)(c)(I), (2)(c)(III), (2)(c)(V), (3), (4), and (6) amended, (2)(b)(IV), (2)(c)(VI), (2)(c)(VII), and (2)(c)(VIII) added, and (2)(c)(IV) and (5) repealed, (SB 25-289), ch. 273, p. 1411, § 1, effective August 6.

Editor's note: This section is similar to former § 12-42.5-133 as it existed prior to 2019.