2016 Colorado Revised Statutes
Title 12 - Professions and Occupations
Article 42.5 - Pharmacists, Pharmacy Businesses, and Pharmaceuticals
Part 1 - General Provisions
§ 12-42.5-133. Unused medication - licensed facilities - correctional facilities - reuse - rules
(1) As used in this section, unless the context otherwise requires:
(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.
(a.5) "Licensed facility" means a hospital, hospital unit, community mental health center, acute treatment unit, hospice, nursing care facility, assisted living residence, or any other facility that is required to be licensed pursuant to section 25-3-101, C.R.S., or a licensed long-term care facility as defined in section 25-1-124 (2.5) (b), C.R.S.
(b) "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 part 801.
(c) "Medical supply" means a consumable supply item that is disposable and not intended for reuse.
(d) "Medication" means a prescription that is not a controlled substance.
(2) (a) (I) If donated by the patient, resident, or the patient's or resident's next of kin, a licensed facility may return unused medications 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.
(II) (A) A licensed facility or a prescription drug outlet may donate materials to a nonprofit 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 medications to the nonprofit entity.
(B) Nothing in this subparagraph (II): Creates or abrogates any liability on behalf of a prescription drug manufacturer for the storage, donation, acceptance, or dispensing of a medication or product; or creates any civil cause of action against a prescription drug manufacturer in addition to that which is available under applicable law.
(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, and in compliance with this section.
(III) A correctional facility may return unused medications 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 medication 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 prescribe the materials.
(b) Medications are only available to be dispensed to another person or donated to a nonprofit entity under this section if the medications are:
(I) Liquid and the vial is still sealed and properly stored;
(II) Individually packaged and the packaging has not been damaged; or
(III) In the original, unopened, sealed, and tamper-evident unit dose packaging.
(c) The following medications may not be donated:
(I) Medications packaged in traditional brown or amber pill bottles;
(II) Controlled substances;
(III) Medications that require refrigeration, freezing, or special storage;
(IV) Medications that require special registration with the manufacturer; or
(V) Medications that are adulterated or misbranded, as determined by a person legally authorized to dispense the medications on behalf of the nonprofit entity.
(3) Medication dispensed or donated pursuant to this section must not be expired. A medication shall not be dispensed that will expire before the use by the patient based on the prescribing practitioner's directions for use.
(3.5) Medication, medical supplies, and medical devices donated pursuant to this section may not be resold for profit. The entity that receives the donated materials may charge the end user a handling fee, which shall not exceed the amount specified by rule of the board.
(4) The board shall adopt rules that allow a pharmacist to redispense medication pursuant to this section and section 25.5-5-502, C.R.S., and to donate medication pursuant to this section.
(5) Nothing in this section or section 25.5-5-502, C.R.S., creates or abrogates any liability on behalf of a prescription drug manufacturer for the storage, donation, acceptance, or dispensing of an unused donated medication or creates any civil cause of action against a prescription drug manufacturer in addition to that which is available under applicable law.
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