Chapter NR 666

NR 666.503(6) (6)  Response to spills of potentially creditable hazardous waste pharmaceuticals at healthcare facilities. 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 this subchapter.

NR 666.503 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20; correction in (1) made under s. 35.17, Stats., Register August 2020 No. 776.

NR 666.504 NR 666.504 Healthcare facilities that are very small quantity generators for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste.

NR 666.504(1) (1)  Potentially creditable hazardous waste pharmaceuticals. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may send its potentially creditable hazardous waste pharmaceuticals to a reverse distributor.

NR 666.504(2) (2)  Off-site collection of hazardous waste pharmaceuticals generated by a healthcare facility that is a very small quantity generator. A healthcare facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may send its hazardous waste pharmaceuticals off-site to another healthcare facility, provided one of the following is met:

NR 666.504(2)(a) (a) The receiving healthcare facility meets the conditions specified in ss. NR 666.502 (a) and 666.503 (2), as applicable.

NR 666.504(2)(b) (b) The very small quantity generator healthcare facility meets the conditions specified in s. NR 662.014 (1) (e) 8. and the receiving large quantity generator meets the conditions specified in s. NR 662.017 (6).

NR 666.504(3) (3)  Long-term care facilities that are very small quantity generators. A long-term care facility that is a very small quantity generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may dispose of its hazardous waste pharmaceuticals, excluding contaminated personal protective equipment or clean-up materials, in an on-site collection receptacle of an authorized collector, as defined by the drug enforcement administration, that is registered with the drug enforcement administration provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable drug enforcement administration regulations for controlled substances.

NR 666.504(4) (4)  Long-term care facilities with 20 beds or fewer. A long-term care facility with 20 beds or fewer is presumed to be a very small quantity generator subject to s. NR 662.014 for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste and not subject to this subchapter, except for ss. NR 666.505 and 666.507 and the other optional provisions of this section. The department has the responsibility to demonstrate that a long-term care facility with 20 beds or fewer generates quantities of hazardous waste that are in excess of the very small quantity generator limits as defined in s. NR 660.10 (139). A long-term care facility with more than 20 beds that operates as a very small quantity generator under s. NR 662.014 shall demonstrate that it generates quantities of hazardous waste that are within the very small quantity generator limits as defined in s. NR 660.10.

NR 666.504 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.505 NR 666.505 Prohibition of sewering hazardous waste pharmaceuticals. All healthcare facilities, including very small quantity generators operating under s. NR 662.014 in lieu of this subchapter, and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. Healthcare facilities and reverse distributors remain subject to the prohibitions in 40 CFR 403.5 (b) (1).

NR 666.505 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.506 NR 666.506 Conditional exemptions for hazardous waste pharmaceuticals that are also controlled substances and household waste pharmaceuticals collected in a take-back event or program.

NR 666.506(1) (1)  Conditional exemptions. Provided the conditions of sub. (2) are met, all of the following are exempt from the requirements under chs. NR 662 to 673:

NR 666.506(1)(a) (a) Hazardous waste pharmaceuticals that are also listed on a schedule of controlled substances by the drug enforcement administration in 21 CFR part 1308.

NR 666.506(1)(b) (b) Household waste pharmaceuticals that are collected in a take-back event or program, including those that are collected by an authorized collector, as defined by the drug enforcement administration, registered with the drug enforcement administration that commingles the household waste pharmaceuticals with controlled substances from an ultimate user, as defined by the drug enforcement administration.

NR 666.506(2) (2)  Conditions for exemption. The hazardous waste pharmaceuticals shall be all of the following:

NR 666.506(2)(a) (a) Managed in compliance with the sewer prohibition under s. NR 666.505.

NR 666.506(2)(b) (b) Collected, stored, transported, and disposed of in compliance with all applicable drug enforcement administration regulations for controlled substances.

NR 666.506(2)(c) (c) Destr oyed by a method that the drug enforcement administration has publicly deemed in writing to meet its non-retrievable standard of destruction or combusted at one of the following:

NR 666.506(2)(c)1. 1. A permitted large municipal waste combustor, subject to 40 CFR part 62 subpart FFF or applicable state plan for existing large municipal waste combustors, or 40 CFR part 60 subpart Eb for new large municipal waste combustors.

NR 666.506(2)(c)2. 2. A permitted small municipal waste combustor, subject to 40 CFR part 62 subpart JJJ or applicable state plan for existing small municipal waste combustors, or 40 CFR part 60 subpart AAAA for new small municipal waste combustors.

NR 666.506(2)(c)3. 3. A permitted hospital, medical and infectious waste incinerator, subject to 40 CFR part 62 subpart HHH or applicable state plan for existing hospital, medical and infectious waste incinerators, or 40 CFR part 60 subpart Ec for new hospital, medical and infectious waste incinerators.

NR 666.506(2)(c)4. 4. A permitted commercial and industrial solid waste incinerator, subject to 40 CFR part 62 subpart III or applicable state plan for existing commercial and industrial solid waste incinerators, or 40 CFR part 60 subpart CCCC for new commercial and industrial solid waste incinerators.

NR 666.506(2)(c)5. 5. A permitted hazardous waste combustor subject to 40 CFR part 63 subpart EEE.

NR 666.506 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.507 NR 666.507 Residues of hazardous waste pharmaceuticals in empty containers.

NR 666.507(1) (1)  Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container (e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container.

NR 666.507(2) (2)  Syringes. A syringe is considered empty and the residues are not regulated as hazardous waste under this subchapter provided the contents have been removed by fully depressing the plunger of the syringe. If a syringe is not empty, the s yringe shall be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subchapter and any applicable federal, state, and local requirements for sharps containers and medical waste.

NR 666.507(3) (3)  Intravenous (IV) bags. An IV bag is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals in the IV bag have been fully administered to a patient. If an IV bag is not empty, the IV bag shall be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subchapter, unless the IV bag held non-acute hazardous waste pharmaceuticals and is empty as defined in s. NR 661.0007 (2) (a).

NR 666.507(4) (4)  Other containers, including delivery devices. Hazardous waste pharmaceuticals remaining in all other types of unused, partially administered, or fully administered containers shall be managed as non-creditable hazardous waste pharmaceuticals under this subchapter, unless the container held non-acute hazardous waste pharmaceuticals and is empty as defined in s. NR 661.0007 (2) (a) or (b). Examples of containers and delivery devices containing residues may include inhalers, aerosol cans, nebulizers, tubes of ointments, gels, or creams.

NR 666.507 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.508 NR 666.508 Shipping non-creditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor.

NR 666.508(1) (1)  Shipping non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility shall ship non-creditable hazardous waste pharmaceuticals and a reverse distributor shall ship evaluated hazardous waste pharmaceuticals off-site to a designated facility, for example a license or interim status treatment, storage, or disposal facility, in compliance with all of the following:

NR 666.508(1)(a) (a) Pretransport. Before transporting or offering hazardous waste for transportation off-site, a healthcare facility or reverse distributor shall do all of the following:

NR 666.508(1)(a)1. 1. `Packaging.' Package the waste in accordance with the applicable U.S. department of transportation regulations on packaging under 49 CFR parts 173, 178 and 180.

NR 666.508(1)(a)2. 2. `Labeling.' Label each package in accordance with the applicable U.S. department of transportation regulations on hazardous materials under 49 CFR part 172 subpart E.

NR 666.508(1)(a)3. 3. `Marking.'

NR 666.508(1)(a)3.a. a. Mark each package of hazardous waste in accordance with the applicable U.S. department of transportation regulations on hazardous materials under 49 CFR part 172 subpart D.

NR 666.508(1)(a)3.b. b. Mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of 49 CFR 172.304:

“HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or public safety authority or the U.S. Environmental Protection Agency.

Healthcare Facility's or Reverse distributor's Name and Address _____________.

Healthcare Facility's or Reverse distributor's EPA Identification Number_____________.

Manifest Tracking Number_____________.”

NR 666.508(1)(a)3.c. c. Lab packs that will be incinerated in compliance with s. NR 668.42 (3) are not required to be marked with EPA hazardous waste numbers, except D004, D005, D006, D007, D008, D010, and D011, where applicable. A nationally recognized electronic system, such as bar coding or radio frequency identification, may be used to identify the EPA hazardous waste numbers.

NR 666.508(1)(a)4. 4. `Placarding.' Placard or offer the initial transporter the appropriate placards according to U.S. department of transportation regulations for hazardous materials under 49 CFR part 172, subpart F.

NR 666.508(1)(b) (b) Manifesting. A healthcare facility shall comply with the manifest requirements of subch. B of ch. NR 662, except that:

NR 666.508(1)(b)1. 1. A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is not required to list all applicable EPA hazardous waste numbers, or hazardous waste codes, in Item 13 of EPA form 8700-22.

NR 666.508(1)(b)2. 2. A healthcare facility shipping non-creditable hazardous waste pharmaceuticals shall write the word “PHARMS” in Item 13 of EPA form 8700-22.

NR 666.508 Note Note: Healthcare facilities may use either PHARMS or PHRM in Item 13 of the manifest per EPA RCRA Online 14919, https://rcrapublic.epa.gov/rcraonline/.

NR 666.508(2) (2)  Exports. A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to subch. H of ch. NR 662.

NR 666.508(3) (3)  Imports. Any person that imports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to subch. H of ch. NR 662. A healthcare facility or reverse distributor may not accept imported non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals unless they have a license or interim status that allows them to accept hazardous waste from off-site.

NR 666.508 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20.

NR 666.509 NR 666.509 Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor.

NR 666.509(1) (1)  Shipping potentially creditable hazardous waste pharmaceuticals. A healthcare facility or a reverse distributor who transports or offers for transport potentially creditable hazardous waste pharmaceuticals off-site to a reverse distributor shall comply with all applicable U.S. department of transportation regulations in 49 CFR parts 171 to 180 for any potentially creditable hazardous waste pharmaceutical that meets the definition of hazardous material in 49 CFR 171.8.

NR 666.509 Note Note: For purposes of the department of transportation regulations, a material is considered a hazardous waste if it is subject to the hazardous waste manifest requirements specified in ch. NR 662. Because a potentially creditable hazardous waste pharmaceutical does not require a manifest, it is not considered hazardous waste under the department of transportation regulations.

NR 666.509(2) (2)  Delivery confirmation. Upon receipt of each shipment of potentially creditable hazardous waste pharmaceuticals, the receiving reverse distributor shall provide confirmation, paper or electronic, to the healthcare facility or reverse distributor that initiated the shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived at its destination and is under the custody and control of the reverse distributor.

NR 666.509(3) (3)  Procedures for when delivery confirmation is not received within 35 calendar days. If a healthcare facility or reverse distributor initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor and does not receive delivery confirmation within 35 calendar days from the date that the shipment of potentially creditable hazardous waste pharmaceuticals was sent, the healthcare facility or reverse distributor that initiated the shipment shall contact the carrier and the intended recipient , that is the reverse distributor, promptly to report that the delivery confirmation was not received and to determine the status of the potentially creditable hazardous waste pharmaceuticals.

NR 666.509(4) (4)  Exporting potentially creditable hazardous waste pharmaceuticals. A healthcare facility or reverse distributor that sends potentially creditable hazardous waste pharmaceuticals to a foreign destination shall comply with the applicable sections of subch. H of ch. NR 662, except the manifesting requirement under s. NR 662.083 (3), in addition to subs. (1) to (3).

NR 666.509(5) (5)  Importing potentially creditable hazardous waste pharmaceuticals. Any person that imports potentially creditable hazardous waste pharmaceuticals into the United States is subject to subs. (1) to (3) in lieu of subch. H of ch. NR 662. Immediately after the potentially creditable hazardous waste pharmaceuticals enter the United States, they are subject to all applicable requirements of this subchapter.

NR 666.509 History History: CR 19-082: cr. Register August 2020 No. 776, eff. 9-1-20; correction in (1) made under s. 35.17, Stats., Register August 2020 No. 776.

NR 666.510 NR 666.510 Standards for the management of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors. A reverse distributor may accept potentially creditable hazardous waste pharmaceuticals from off-site and accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on-site without a hazardous waste permit or without having interim status, provided that the reverse distributor complies with all of the following conditions:

NR 666.510(1) (1)  Standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.

NR 666.510(1)(a) (a) Notification. A reverse distributor shall notify the department using the site identification form EPA form 8700-12, that it is a reverse distributor operating under this subchapter. A reverse distributor shall do one of the following:

NR 666.510(1)(a)1. 1. A reverse distributor that already has an EPA identification number shall notify the department, using the site identification form EPA form 8700-12, that it is a reverse distributor, as defined in s. NR 666.500, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.

NR 666.510(1)(a)2. 2. A reverse distributor 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 reverse distributor, as defined in s. NR 666.500, within 60 calendar days of September 1, 2020, or within 60 calendar days of becoming subject to this subchapter.

NR 666.510(1)(b) (b) Inventory by the reverse distributor. A reverse distributor shall maintain a current inventory of all the potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on-site.

NR 666.510(1)(b)1. 1. A reverse distributor shall inventory each potentially creditable hazardous waste pharmaceutical within 30 calendar days of each waste arriving at the reverse distributor.

NR 666.510(1)(b)2. 2. The inventory shall include the identity, for example name or national drug code, and quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste pharmaceutical.

NR 666.510(1)(b)3. 3. If the reverse distributor already meets the inventory requirements of this paragraph because of other regulatory requirements, such as state board of pharmacy regulations, the facility is not required to provide a separate inventory pursuant to this section.

NR 666.510(1)(c) (c) Evaluation by a reverse distributor that is not a manufacturer. A reverse distributor who is not a pharmaceutical manufacturer shall evaluate a potentially creditable hazardous waste pharmaceutical within 30 calendar days of the waste arriving at the reverse distributor to establish whether it is destined for another reverse distributor for further evaluation or verification of manufacturer credit or for a permitted or interim status treatment, storage, or disposal facility. A potentially creditable hazardous waste pharmaceutical sent to a reverse distributor that is not a pharmaceutical manufacturer is subject to one of the following:

NR 666.510(1)(c)1. 1. A potentially creditable hazardous waste pharmaceutical that is destined for another reverse distributor is still considered a potentially creditable hazardous waste pharmaceutical and shall be managed in accordance with sub. (2).

NR 666.510(1)(c)2. 2. A potentially creditable hazardous waste pharmaceutical that is destined for a licensed or interim status treatment, storage, or disposal facility is considered an evaluated hazardous waste pharmaceutical and shall be managed in accordance with sub. (3).

NR 666.510(1)(d) (d) Evaluation by a reverse distributor that is a manufacturer. A reverse distributor that is a pharmaceutical manufacturer shall evaluate a potentially creditable hazardous waste pharmaceutical to verify manufacturer credit within 30 calendar days of the waste arriving at the facility and following the evaluation shall manage the evaluated hazardous waste pharmaceuticals in accordance with sub. (3).

NR 666.510(1)(e) (e) Maximum accumulation time for hazardous waste pharmaceuticals at a reverse distributor.

NR 666.510(1)(e)1. 1. A reverse distributor may accumulate potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site for 180 calendar days or less. The 180 calendar days start after the potentially creditable hazardous waste pharmaceutical has been evaluated and applies to all hazardous waste pharmaceuticals accumulated on-site, regardless of whether they are destined for another reverse distributor, such as potentially creditable hazardous waste pharmaceuticals, or a permitted or interim status treatment, storage, or disposal facility, such as evaluated hazardous waste pharmaceuticals.

NR 666.510(1)(e)2. 2. Unexpired pharmaceuticals that are otherwise creditable but are awaiting their expiration date, by aging in a holding morgue, can be accumulated for up to 180 calendar days after the expiration date, provided that the unexpired pharmaceuticals are managed in accordance with this subsection and the container labeling and management standards specified in sub. (3) (d) 1. to 6.

NR 666.510(1)(f) (f) Security at the reverse distributor facility. A reverse distributor shall prevent unknowing entry and minimize the possibility for the unauthorized entry into the portion of the facility where potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are kept. Examples of methods that may be used to prevent unknowing entry and minimize the possibility for unauthorized entry include any of the following:

NR 666.510(1)(f)1. 1. A 24-hour continuous monitoring surveillance system.

NR 666.510(1)(f)2. 2. An artificial barrier such as a fence.

NR 666.510(1)(f)3. 3. A means to control entry, such as keycard access.

NR 666.510(1)(f)4. 4. If the reverse distributor already meets the security requirements of this paragraph because of other regulatory requirements, such as drug enforcement administration or state board of pharmacy regulations, the facility is not required to provide separate security measures pursuant to this section.

NR 666.510(1)(g) (g) Contingency plan and emergency procedures at a reverse distributor. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off-site shall prepare a contingency plan and comply with the other requirements under subch. M of ch. NR 662.

NR 666.510(1)(h) (h) Closure of a reverse distributor. When closing an area where a reverse distributor accumulates potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, the reverse distributor shall comply with s. NR 662.017 (1) (h) 2. and 3.

NR 666.510(1)(i) (i) Reporting by a reverse distributor.

NR 666.510(1)(i)1. 1. `Unauthorized waste report.' A reverse distributor shall submit an unauthorized waste report if the reverse distributor receives waste from off-site that it is not authorized to receive, such as non-pharmaceutical hazardous waste, or regulated medical waste. The reverse distributor shall prepare and submit an unauthorized waste report to the department within 45 calendar days after the unauthorized waste arrives at the reverse distributor and shall send a copy of the unauthorized waste report to the healthcare facility or other entity that sent the unauthorized waste. The reverse distributor shall manage the unauthorized waste in accordance with all applicable regulations. The unauthorized waste report shall be signed by the owner or operator of the reverse distributor, or its authorized representative, and contain all of the following information:

NR 666.510(1)(i)1.a. a. The EPA identification number, name, and address of the reverse distributor.

NR 666.510(1)(i)1.b. b. The date the reverse distributor received the unauthorized waste.

NR 666.510(1)(i)1.c. c. The EPA identification number, name, and address of the healthcare facility that shipped the unauthorized waste, if available.