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(7)(7)“Non-hazardous waste pharmaceutical” means a pharmaceutical that is a solid waste, as defined in s. NR 661.0002, and is not listed in subch. D of ch. NR 661, and does not exhibit a characteristic identified in subch. C of ch. NR 661.
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)(a)(a) Has a reasonable expectation to receive manufacturer credit.
NR 666.500(10)(b)(b) Is in original manufacturer packaging, except pharmaceuticals that were subject to a recall.
NR 666.500(10)(c)(c) Is undispensed.
NR 666.500(10)(d)(d) Is unexpired or less than one year past expiration date.
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 666.501NR 666.501Applicability.
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:
NR 666.501(4)(a)(a) Sections NR 666.502 and 666.505 to 666.508 of this subchapter with respect to the management of all of the following:
NR 666.501(4)(a)1.1. Non-creditable hazardous waste pharmaceuticals.
NR 666.501(4)(a)2.2. Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor.
NR 666.501(4)(b)(b) Sections NR 666.502 (1), 666.503, 666.505 to 666.507, and 666.509 with respect to the management of potentially creditable hazardous waste pharmaceuticals that are prescription pharmaceuticals and are destined for a reverse distributor.
NR 666.501(5)(5)A reverse distributor is subject to ss. NR 666.505 to 666.510 of this subchapter in lieu of chs. NR 662 to 665 with respect to the management of hazardous waste pharmaceuticals.
NR 666.501(6)(6)Hazardous waste pharmaceuticals generated or managed by entities other than healthcare facilities and reverse distributors, for example pharmaceutical manufacturers and reverse logistics centers, are not subject to this subchapter. Other generators are subject to ch. NR 662 for the generation and accumulation of hazardous wastes, including hazardous waste pharmaceuticals.
NR 666.501(7)(7)All of the following are not subject to chs. NR 660 to 673, except as specified:
NR 666.501(7)(a)(a) Pharmaceuticals that are not solid waste, as defined in s. NR 661.0002, because they are legitimately used or reused (e.g., lawfully donated for their intended purpose) or reclaimed.
NR 666.501(7)(b)(b) Over-the-counter pharmaceuticals, dietary supplements, or homeopathic drugs that are not solid wastes, as defined in s. NR 661.0002, because they have a reasonable expectation of being legitimately used or reused (e.g., lawfully redistributed for their intended purpose) or reclaimed.
NR 666.501(7)(c)(c) Pharmaceuticals being managed in accordance with a recall strategy that has been approved by the food and drug administration in accordance with 21 CFR part 7 subpart C. This subchapter does apply to the management of the recalled hazardous waste pharmaceuticals after the food and drug administration approves the destruction of the recalled items.
NR 666.501(7)(d)(d) Pharmaceuticals being managed in accordance with a recall corrective action plan that has been accepted by the consumer product safety commission in accordance with 16 CFR part 1115. This subchapter does apply to the management of the recalled hazardous waste pharmaceuticals after the consumer product safety commission approves the destruction of the recalled items.