Standards for health care facilities managing potentially creditable hazardous waste pharmaceuticals

1. Hazardous waste determination for potentially creditable pharmaceuticals. A health care facility that generates a solid waste that is a potentially creditable pharmaceutical shall determine whether the potentially creditable pharmaceutical is a potentially creditable hazardous waste pharmaceutical, i.e., it is listed in sections 33.1-24-02-15 through 33.1-24-02-189 or exhibits a characteristic identified in sections 33.1-24-02-10 through 33.1-24-02-14. A health care facility may choose to manage its potentially creditable nonhazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals under sections 33.1-24-05-310 through 33.1-24-05-320. 2. Accepting potentially creditable hazardous waste pharmaceuticals from an offsite health care facility that is a very small quantity generator. A health care facility may accept potentially creditable hazardous waste pharmaceuticals from an offsite health care facility that is a very small quantity generator under section 33.1-24-03-26 without a permit, provided the receiving health care facility: a. Is under the control of the same person, as defined in section 33.1-24-03-26, as the very small quantity generator health care facility that is sending the potentially creditable hazardous waste pharmaceuticals offsite, or has a contractual or other documented business relationship whereby the receiving health care facility supplies pharmaceuticals to the very small quantity generator health care facility; b. Is operating under sections 33.1-24-05-310 through 33.1-24-05-320 for the management of its potentially creditable hazardous waste pharmaceuticals; c. Manages the potentially creditable hazardous waste pharmaceuticals that it receives from offsite in compliance with sections 33.1-24-05-310 through 33.1-24-05-320; and d. Keeps records of the potentially creditable hazardous waste shipments it receives from offsite for three years from the date that the shipment is received. 3. Prohibition. Health care facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a reverse distributor. 4. Biennial reporting by health care facilities. Health care facilities are not subject to biennial reporting requirements under section 33.1-24-03-14 with respect to potentially creditable hazardous waste pharmaceuticals managed under this subpart. 5. Recordkeeping by health care facilities. a. A health care facility that initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor shall keep the following records, paper or electronic, for each shipment of potentially creditable hazardous waste pharmaceuticals for three years from the date of shipment: (1) The confirmation of delivery; and (2) The shipping papers prepared in accordance with title 49, Code of Federal Regulations, part 172, subpart C, if applicable. b. The periods of retention referred to in this section are extended automatically during any unresolved enforcement action regarding the regulated activity, or as requested by the department. c. All records must be readily available upon request by an inspector. 6. Response to spills of potentially creditable hazardous waste pharmaceuticals at health care facilities. A health care facility immediately shall contain all spills of potentially creditable hazardous waste pharmaceuticals and manage the spill cleanup materials as noncreditable hazardous waste pharmaceuticals in accordance with sections 33.1-24-05-310 through 33.1-24-05-320.