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 s ystems, 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 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.
NR 666.501 NR 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.
NR 666.501(7)(e) (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.
NR 666.501(7)(f) (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 apply 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.
NR 666.501(7)(g) (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).
NR 666.501 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20; correction in (4) (b) made under s. 13.92 (4) (b) 7., Stats., Register April 2021 No. 784.
NR 666.502 NR 666.502Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals.
NR 666.502(1)(1)Notification and withdrawal from this subchapter for healthcare facilities managing hazardous waste pharmaceuticals.
NR 666.502(1)(a) (a) Notification. A healthcare facility shall notify the department, using the site identification form, EPA form 8700-12, that it is a healthcare facility operating under this subchapter. A healthcare facility is not required to fill out box 10.B., waste codes for federally regulated hazardous waste, of the site identification form with respect to its hazardous waste pharmaceuticals. A healthcare facility shall submit a separate notification, using a site identification form, for each site or EPA identification number.
NR 666.502(1)(a)1. 1. A healthcare facility that already has an EPA identification number shall notify the department, using the site identification form EPA form 8700-12, that it is a healthcare facility as part of its next annual report, if it is required to submit one; or if not required to submit an annual report, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.
NR 666.502(1)(a)2. 2. A healthcare facility that does not have an EPA identification number shall obtain one by notifying the department, using the site identification form EPA form 8700-12, that it is a healthcare facility as part of its next annual report, if it is required to submit one; or if not required to submit an annual report, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.
NR 666.502(1)(a)3. 3. A healthcare facility shall keep a copy of its notification on file for as long as the healthcare facility is subject to this subchapter.
NR 666.502(1)(b) (b) Withdrawal. A healthcare facility that operated under this subchapter but is no longer subject to this subchapter, because it is a very small quantity generator under s. NR 662.014, and elects to withdraw from this subchapter, shall notify the department using the site identification form EPA form 8700-12 that it is no longer operating under this subchapter. A healthcare facility is not required to fill out box 10.B., waste codes for federally regulated hazardous waste, of the site identification form with respect to its hazardous waste pharmaceuticals. A healthcare facility shall submit a separate notification, using a site identification form, for each EPA identification number.
NR 666.502(1)(b)1. 1. A healthcare facility shall submit the site identification form notifying that it is withdrawing from this subchapter before it begins operating under the conditional exemption under s. NR 662.014.
NR 666.502(1)(b)2. 2. A healthcare facility shall keep a copy of its withdrawal on file for 3 years from the date of signature on the notification of its withdrawal.
NR 666.502(2) (2)Training of personnel managing non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall ensure that all personnel that manage non-creditable hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.
NR 666.502(3) (3)Hazardous waste determination for non-creditable pharmaceuticals. A healthcare facility that generates a solid waste that is a non-creditable pharmaceutical shall determine whether that pharmaceutical is a hazardous waste pharmaceutical, because it exhibits a characteristic identified in ch. NR 661 subchapter C or is listed in ch. NR 661 subchapter D, in order to determine whether the waste is subject to this subchapter. A healthcare facility may choose to manage its non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals under this subchapter.
NR 666.502(4) (4)Standards for containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities.
NR 666.502(4)(a) (a) A healthcare facility shall place non-creditable hazardous waste pharmaceuticals in a container that is structurally sound, compatible with its contents, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.
NR 666.502(4)(b) (b) A healthcare facility that manages ignitable or reactive non-creditable hazardous waste pharmaceuticals, or that mixes or commingles incompatible non-creditable hazardous waste pharmaceuticals shall manage the container so that it does not have the potential to do any of the following:
NR 666.502(4)(b)1. 1. Generate extreme heat or pressure, fire or explosion, or violent reaction.
NR 666.502(4)(b)2. 2. Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health.
NR 666.502(4)(b)3. 3. Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions.
NR 666.502(4)(b)4. 4. Damage the structural integrity of the container of non-creditable hazardous waste pharmaceuticals.
NR 666.502(4)(b)5. 5. Threaten human health or the environment through other like means.
NR 666.502(4)(c) (c) A healthcare facility shall keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.
NR 666.502(4)(d) (d) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals and non-hazardous non-creditable waste pharmaceuticals in the same container, except that non-creditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition under s. NR 668.03 (3) shall be accumulated in separate containers and labeled with all applicable hazardous waste numbers, or hazardous waste codes.
NR 666.502(5) (5)Labeling containers used to accumulate non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall label or clearly mark each container of non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.”
NR 666.502(6) (6)Maximum accumulation time for non-creditable hazardous waste pharmaceuticals at healthcare facilities.
NR 666.502(6)(a)(a) A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals on-site for one year or less without a license or having interim status.
NR 666.502(6)(b) (b) A healthcare facility that accumulates non-creditable hazardous waste pharmaceuticals on-site shall demonstrate the length of time that the non-creditable hazardous waste pharmaceuticals have been accumulating, starting from the date the pharmaceuticals first become a waste. A healthcare facility may make this demonstration by any of the following methods:
NR 666.502(6)(b)1. 1. Marking or labeling the container of non-creditable hazardous waste pharmaceuticals with the date that the non-creditable hazardous waste pharmaceuticals became a waste.
NR 666.502(6)(b)2. 2. Maintaining an inventory system that identifies the date the non-creditable hazardous waste pharmaceuticals being accumulated first became a waste.
NR 666.502(6)(b)3. 3. Placing the non-creditable hazardous waste pharmaceuticals in a specific area and identifying the earliest date that any of the non-creditable hazardous waste pharmaceuticals in the area became a waste.
NR 666.502(7) (7)Land disposal restrictions for non-creditable hazardous waste pharmaceuticals. The non-creditable hazardous waste pharmaceuticals generated by a healthcare facility are subject to the land disposal restrictions under ch. NR 668. A healthcare facility that generates non-creditable hazardous waste pharmaceuticals shall comply with the land disposal restrictions in accordance with s. NR 668.07 (1) requirements, except that it is not required to identify the hazardous waste numbers or hazardous waste codes on the land disposal restrictions notification.
NR 666.502(8) (8)Procedures for healthcare facilities for managing rejected shipments of non-creditable hazardous waste pharmaceuticals. A healthcare facility that sends a shipment of non-creditable hazardous waste pharmaceuticals to a designated facility with the understanding that the designated facility can accept and manage the waste, and later receives that shipment back as a rejected load in accordance with the manifest discrepancy provisions under s. NR 664.0072 or 665.0072 may accumulate the returned non-creditable hazardous waste pharmaceuticals on-site for up to an additional 90 calendar days provided the rejected or returned shipment is managed in accordance with subs. (4) and (5). Upon receipt of the returned shipment, the healthcare facility shall do all of the following:
NR 666.502(8)(a) (a) Sign one of the following:
NR 666.502(8)(a)1. 1. Item 18c of the original manifest, if the original manifest was used for the returned shipment.
NR 666.502(8)(a)2. 2. Item 20 of the new manifest, if a new manifest was used for the returned shipment.
NR 666.502(8)(b) (b) Provide the transporter a copy of the manifest.
NR 666.502(8)(c) (c) Within 30 calendar days of receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility.
NR 666.502(8)(d) (d) Within 90 calendar days of receipt of the rejected shipment, transport or offer for transport the returned shipment in accordance with the shipping standards under s. NR 666.508 (1).
NR 666.502(9) (9)Reporting by healthcare facilities for non-creditable hazardous waste pharmaceuticals.
NR 666.502(9)(a) (a) Annual reporting by healthcare facilities. A healthcare facility is not subject to annual reporting requirements under s. NR 662.041 with respect to non-creditable hazardous waste pharmaceuticals managed under this subchapter.
NR 666.502(9)(b) (b) Exception reporting by healthcare facilities for a missing copy of the manifest.
NR 666.502(9)(b)1. 1. `Shipments from a healthcare facility to a designated facility.' For shipments from a healthcare facility to a designated facility, all of the following exception reporting requirements apply:
NR 666.502(9)(b)1.a. a. If a healthcare facility does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 60 calendar days of the date the non-creditable hazardous waste pharmaceuticals were accepted by the initial transporter, the healthcare facility shall submit all of the following to the department:
1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery.
2) A handwritten or typed note on the original manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
NR 666.502(9)(b)2. 2. `Shipments rejected by the designated facility and shipped to an alternate facility.' For shipments rejected by the designated facility and shipped to an alternate facility, all of the following exception reporting requirements apply:
NR 666.502(9)(b)2.a. a. If a healthcare facility does not receive a copy of the manifest for a rejected shipment of the non-creditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an alternate facility using appropriate manifest procedures, with the signature of the owner or operator of the alternate facility, within 60 calendar days of the date the non-creditable hazardous waste was accepted by the initial transporter forwarding the shipment of non-creditable hazardous waste pharmaceuticals from the designated facility to the alternate facilit y, the healthcare facility shall submit all of the following to the department:
1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery.
2) A handwritten or typed note on the original manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
NR 666.502(9)(c) (c) Additional reports. The department may require healthcare facilities to furnish additional reports concerning the quantities and disposition of non-creditable hazardous waste pharmaceuticals.
NR 666.502(10) (10)Recordkeeping by healthcare facilities for non-creditable hazardous waste pharmaceuticals.
NR 666.502(10)(a) (a) A healthcare facility shall keep a copy of each manifest signed in accordance with s. NR 662.023 (1) for 3 years or until it receives a signed copy from the designated facility that received the non-creditable hazardous waste pharmaceuticals. This signed copy shall be retained as a record for at least 3 years from the date the waste was accepted by the initial transporter.
NR 666.502(10)(b) (b) A healthcare facility shall keep a copy of each exception report for a period of at least 3 years from the date of the report.
NR 666.502(10)(c) (c) A healthcare facility shall keep records of any test results, waste analyses, or other determinations made to support its hazardous waste determination consistent with s. NR 662.011 (6), for at least 3 years from the date the waste was last sent to on-site or off-site treatment, storage, or disposal. A healthcare facility that manages all of its non-creditable non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations.
NR 666.502(10)(d) (d) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the department.
NR 666.502(10)(e) (e) All records shall be readily available upon request by the department.
NR 666.502(11) (11)Response to spills of non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility shall immediately contain all spills of non-creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non-creditable hazardous waste pharmaceuticals in accordance with the requirements of this subchapter.
NR 666.502(12) (12)Accepting non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator under s. NR 662.014, without a license or without having interim status, provided the receiving healthcare facility meets all of the following:
NR 666.502(12)(a) (a) Is under the control of the same person, as defined in s. NR 660.10 (90), as the very small quantity generator healthcare facility that is sending the non-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. “Control,” for the purposes of this section, means the power to direct the policies of the healthcare facilit y, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person as defined in s. NR 660.10 may not be deemed to “control” such healthcare facilities.
NR 666.502(12)(b) (b) Is operating under this subchapter for the management of its non-creditable hazardous waste pharmaceuticals.
NR 666.502(12)(c) (c) Manages the non-creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter.
NR 666.502(12)(d) (d) Keeps records of the non-creditable hazardous waste pharmaceuticals shipments it receives from off-site for 3 years from the date that the shipment is received.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.