R 299.9826 Hazardous waste pharmaceuticals; standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals.

Rule 826. (1) The requirements of this rule apply to healthcare facilities managing potentially creditable hazardous waste pharmaceuticals under R 299.9824 to R 288.9833. Healthcare facilities shall determine if their potentially creditable pharmaceutical waste is a hazardous waste pharmaceutical. A healthcare facility may choose to manage its potentially creditable nonhazardous waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals. (2) A healthcare facility may accept potentially creditable hazardous waste pharmaceuticals from an offsite healthcare facility that is a very small quantity generator under R 299.9304, without an operating license or interim status under these rules, if the receiving healthcare facility meets all the following requirements: (a) Is under the control of the same person as the very small quantity generator healthcare facility that is sending the potentially creditable hazardous waste pharmaceuticals off-site or has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the very small quantity generator healthcare facility. As used in this subdivision, "control" means the power to direct the policies of the healthcare facility, whether by the ownership of stock, voting rights, or otherwise, except contractors that operate healthcare facilities on behalf of a different person do not control the healthcare facilities. (b) Is operating under R 299.9824 to R 299.9833 for the management of its potentially creditable hazardous waste pharmaceuticals. (c) Manages the potentially creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with R 299.9224 to R 299.9833. (d) Keeps records of the potentially creditable hazardous waste pharmaceuticals shipments it receives for 3 years from the date the shipment is received. (3) Healthcare facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a reverse distributor. (4) Healthcare facilities are not subject to biennial reporting requirements under R 299.9312 with respect to potentially creditable hazardous waste pharmaceuticals managed under R 299.9824 to R 299.9833. (5) A healthcare facility that initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor shall keep the following paper or electronic records for each shipment of potentially creditable hazardous waste pharmaceuticals for 3 years from the date of shipment, unless automatically extended during any unresolved enforcement action regarding the regulated activity or requested by the director, and make the records readily available to the director on request: (a) The confirmation of delivery. (b) The shipping papers prepared in accordance with 49 CFR part 172, subpart C, if applicable. (6) A healthcare facility shall immediately contain all spills of potentially creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with R 299.9824 to R 299.9833.