6 Colo. Code Regs. § 1011-1 Chapter 02, pt. 9

Current through Register Vol. 47, No. 20, October 25, 2024

Part 9 - MEDICATIONS, MEDICAL DEVICES, AND MEDICAL SUPPLIES

9.1Use of Reprocessed Single Use Medical Devices

9.1.1 This Part 9.1 applies to all facilities and agencies except those addressed in 6 CCR 1011-1, Chapter 15-Dialysis Treatment Clinics.

9.1.2 A facility or agency may use a reprocessed single use device:

(A) Obtained from a reprocessor registered with the U.S. Food and Drug Administration (FDA) and in compliance with FDA regulations, including but not limited to, standards regarding the validation of infection control procedures and product integrity for the reprocessed single use device. The facility or agency shall make available, upon Department request, documentation evidencing reprocessor compliance with FDA regulations.

(B) For which the number of times the device has been subjected to reprocessing is tracked when such data is relevant to ensuring optimal product function.

9.2Donation of Unused Medications, Medical Devices, and Medical Supplies

9.2.1 A facility or agency may accept unused medications or medical supplies, and used or unused medical devices from a client or a client's personal representative.

(A) In accordance with Section 12-280-135, C.R.S., the facility or agency may choose to either:

(1) return the medications, medical supplies, or medical devices to a pharmacist within the licensed facility or a prescription drug outlet, or

(2) donate to a third party who has the legal authority to possess the medications, medical supplies, or medical devices.

9.2.2 A facility or agency may donate unused medications or medical supplies, and used or unused medical devices, that are in the facility's or agency's possession, to a nonprofit entity that has legal authority to possess the materials or to a person legally authorized to dispense the materials.

(A) A licensed pharmacist shall review the facility's or agency's process of donating unused medications to a nonprofit entity.

9.2.3 Medication dispensed or donated under this Part must meet the following requirements:

(A) The medication must not be expired, and shall not be dispensed if it will expire before use by the patient based on the prescribing practitioner's directions for use.

(B) Medications are only available to be dispensed to another client or donated to a nonprofit entity if the medications are:

(1) Liquid and the vial is still sealed and properly stored,

(2) Individually packaged and the packaging has not been damaged, or

(3) In the original, unopened, sealed, and tamper-evident unit-dose packaging.

(C) The following medications may not be donated:

(1) Medications packaged in traditional brown or amber pill bottles,

(2) Controlled substances,

(3) Medications that require refrigeration, freezing, or special storage,

(4) Medications that require special registration with the manufacturer, or

(5) Medications that are adulterated or misbranded, as determined by a person legally authorized to dispense the medications on behalf of the nonprofit entity.

9.2.4 Medications, medical supplies, and medical devices donated pursuant to this Part shall not be resold for profit.

9.2.5 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 material in good faith, without negligence, and in compliance with Colorado law.

6 CCR 1011-1 Chapter 02, pt. 9