Section NR 666.501 - Applicability(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.(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 compl ying with sub. (4) for the management of its hazardous waste pharmaceuticals as an alternative to compl ying with s. NR 662.014 and the optional provisions under s. NR 666.504.(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.(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: (a) Sections NR 666.502 and 666.505 to 666.508 of this subchapter with respect to the management of all of the following: 1. Non-creditable hazardous waste pharmaceuticals.2. Potentially creditable hazardous waste pharmaceuticals if they are not destined for a reverse distributor.(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.(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.(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.(7) All of the following are not subject to chs. NR 660 to 673, except as specified: (a) Pharmaceuticals that are not solid waste, as defined in s. NR 661.0002, because they are legitimate ly used or reused (e.g., lawful ly donated for their intended purpose) or reclaimed.(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 legitimate ly used or reused (e.g., lawful ly redistributed for their intended purpose) or reclaimed.(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 app ly to the management of the recalled hazardous waste pharmaceuticals after the food and drug administration approves the destruction of the recalled items.(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.(e) Pharmaceuticals stored according to a preservation order, or during an investigation or judicial proceeding until after the preservation order, investigation, or judicial proceeding has concluded or a decision is made to discard the pharmaceuticals.(f) Investigational new drugs for which an investigational new drug application is in effect in accordance with the food and drug administration's regulations in 21 CFR part 312 . This subchapter does app ly to the management of the investigational new drug after the decision is made to discard the investigational new drug or the food and drug administration approves the destruction of the investigational new drug, if the investigational new drug is a hazardous waste.(g) Household waste pharmaceuticals, including those that have been collected by an authorized collector, as defined by the drug enforcement administration, provided the authorized collector complies with the conditional exemption under s. NR 666.506(1) (b) and (2).Wis. Admin. Code Department of Natural Resources NR 666.501
Adopted by, CR 19-082: cr. Register August 2020 No. 776, eff. 9/1/2020Amended by, correction in (4) (b) made under s. 13.92(4) (b) 7, Stats., Register April 2021 No. 784, eff. 5/1/2021