NR 666.360 HistoryHistory: CR 05-032: cr. Register July 2006 No. 607, eff. 8-1-06. NR 666.500NR 666.500 Definitions. The following definitions apply to this subchapter: NR 666.500(1)(1) “Evaluated hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with s. NR 666.510 (1) (c) and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit. NR 666.500(2)(2) “Hazardous waste pharmaceutical” means a pharmaceutical that is a solid waste, as defined in s. NR 661.0002, and exhibits one or more characteristics identified in subch. C of ch. NR 661 or is listed in subch. D of ch. NR 661. A pharmaceutical is not a solid waste, as defined in s. NR 661.0002, and therefore not a hazardous waste pharmaceutical, if it is legitimately used, reused, for example lawfully donated for its intended purpose, or reclaimed. An over-the-counter pharmaceutical, dietary supplement, or homeopathic drug is not a solid waste, as defined in s. NR 661.0002, and therefore not a hazardous waste pharmaceutical, if it has a reasonable expectation of being legitimately used, reused, for example lawfully redistributed for its intended purpose, or reclaimed. NR 666.500(3)(3) “Healthcare facility” means any person that is lawfully authorized to do any of the following: NR 666.500(3)(a)(a) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body. NR 666.500(3)(b)(b) Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. Including wholesale distribution, third-party logistics that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers. NR 666.500(5)(5) “Long-term care facility” means a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities. NR 666.500(6)(6) “Non-creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used, reused, or reclaimed. This includes investigational drugs, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings, and clean-up material from the spills of pharmaceuticals. NR 666.500(8)(8) “Non-pharmaceutical hazardous waste” means a solid waste, as defined in s. NR 661.0002, that is listed in subch. D of ch. NR 661, or exhibits one or more characteristics identified in subch. C of ch. NR 661, but is not a pharmaceutical, as defined in this section. NR 666.500(9)(9) “Pharmaceutical” means any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system, for example electronic cigarette or vaping pen; or any liquid nicotine, or e-liquid, packaged for retail sale for use in electronic nicotine delivery systems, such pre-filled cartridges or vials. This definition includes dietary supplements, as defined by the federal food, drug and cosmetic act; prescription drugs, as defined by 21 CFR 203.3 (y); over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non-empty containers; personal protective equipment contaminated with pharmaceuticals; and clean-up material from spills of pharmaceuticals. This definition does not include dental amalgam or sharps. NR 666.500(10)(10) “Potentially creditable hazardous waste pharmaceutical” means a prescription hazardous waste pharmaceutical that is all of the following: NR 666.500(10)(b)(b) Is in original manufacturer packaging, except pharmaceuticals that were subject to a recall. NR 666.500(10)(e)(e) The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including over-the-counter drugs, homeopathic drugs, and dietary supplements. NR 666.500(11)(11) “Reverse distributor” means any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor. NR 666.500 HistoryHistory: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20. NR 666.501(1)(1) A healthcare facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, remains subject to s. NR 662.014 and is not subject to this subchapter, except for ss. NR 666.505 and NR 666.507 and the optional provisions under s. NR 666.504. NR 666.501(2)(2) A healthcare facility that is a very small quantity generator when counting all of its hazardous waste, including both its hazardous waste pharmaceuticals and its non-pharmaceutical hazardous waste, has the option of complying with sub. (4) for the management of its hazardous waste pharmaceuticals as an alternative to complying with s. NR 662.014 and the optional provisions under s. NR 666.504. NR 666.501(3)(3) A healthcare facility or reverse distributor remains subject to all applicable hazardous waste regulations with respect to the management of its non-pharmaceutical hazardous waste. NR 666.501(4)(4) With the exception of healthcare facilities identified in sub. (1), a healthcare facility is subject to the all of the following in lieu of chs. NR 662 to 665: