Chapter NR 666

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.

NR 666.510(1)(i)1.d. d. A description and the quantity of each unauthorized waste the reverse distributor received.

NR 666.510(1)(i)1.e. e. The method of treatment, storage, or disposal for each unauthorized waste.

NR 666.510(1)(i)1.f. f. A brief explanation of why the waste was unauthorized, if known.

NR 666.510(1)(i)2. 2. ‘Additional reports.’ The department may require reverse distributors to furnish additional reports concerning the quantities and disposition of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.

NR 666.510(1)(j) (j) Recordkeeping by reverse distributors. 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. A reverse distributor shall keep all of the following records, paper or electronic, readily available upon request by an inspector:

NR 666.510(1)(j)1. 1. A copy of its notification on file for as long as the facility is subject to this subchapter.

NR 666.510(1)(j)2. 2. A copy of the delivery confirmation and the shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals that it receives, and a copy of each unauthorized waste report, for at least 3 years from the date the shipment arrives at the reverse distributor.

NR 666.510(1)(j)3. 3. A copy of its current inventory for as long as the facility is subject to this subchapter.

NR 666.510(2) (2) Additional standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor. A reverse distributor that does not have a license or interim status shall comply with all of the following conditions, in addition to the requirements specified in sub. (1), for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:

NR 666.510(2)(a) (a) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility shall send those potentially creditable hazardous waste pharmaceuticals to another reverse distributor within 180 calendar days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow sub. (3) for evaluated hazardous waste pharmaceuticals.

NR 666.510(2)(b) (b) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from another reverse distributor shall send those potentially creditable hazardous waste pharmaceuticals to a reverse distributor that is a pharmaceutical manufacturer within 180 calendar days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow sub. (3) for evaluated hazardous waste pharmaceuticals.

NR 666.510(2)(c) (c) A reverse distributor shall ship potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with s. NR 666.509.

NR 666.510(2)(d) (d) The periods of retention referred to in this paragraph are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the department. A reverse distributor shall keep all of the following records, paper or electronic, readily available upon request by an inspector for each shipment of potentially creditable hazardous waste pharmaceuticals that it initiates to another reverse distributor, for at least 3 years from the date of shipment:

NR 666.510(2)(d)1. 1. The confirmation of delivery.

NR 666.510(2)(d)2. 2. The DOT shipping papers prepared in accordance with 49 CFR part 172 subpart C, if applicable

NR 666.510(3) (3) Additional standards for reverse distributors managing evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have a license or interim status shall comply with all of the following conditions, in addition to the requirements of sub. (1), for the management of evaluated hazardous waste pharmaceuticals:

NR 666.510(3)(a) (a) Accumulation area at the reverse distributor. A reverse distributor shall designate an on-site accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals.

NR 666.510(3)(b) (b) Inspections of on-site accumulation area. A reverse distributor shall inspect its on-site accumulation area at least once every 7 calendar days, looking at containers for leaks and for deterioration caused by corrosion or other factors, as well as for signs of diversion.

NR 666.510(3)(c) (c) Personnel training at a reverse distributor. Personnel at a reverse distributor who handle evaluated hazardous waste pharmaceuticals are subject to the training requirements under s. NR 662.017 (1) (g).

NR 666.510(3)(d) (d) Labeling and management of containers at on-site accumulation areas. A reverse distributor accumulating evaluated hazardous waste pharmaceuticals in containers in an on-site accumulation area shall do all of the following:

NR 666.510(3)(d)1. 1. Label the containers with the words, “hazardous waste pharmaceuticals.”

NR 666.510(3)(d)2. 2. Ensure the containers are in good condition and managed to prevent leaks.

NR 666.510(3)(d)3. 3. Use containers that are made of or lined with materials that will not react with, and are otherwise compatible with, the evaluated hazardous waste pharmaceuticals, so that the ability of the container to contain the waste is not impaired.

NR 666.510(3)(d)4. 4. Keep containers closed, if the container is holding liquid or gel evaluated hazardous waste pharmaceuticals. If the liquid or gel evaluated hazardous waste pharmaceuticals are in their original, intact, sealed packaging or repackaged in intact, sealed packaging, they are considered to meet the closed container standard.

NR 666.510(3)(d)5. 5. Manage any container of ignitable or reactive evaluated hazardous waste pharmaceuticals, or any container of commingled incompatible evaluated hazardous waste pharmaceuticals so that the container does not have the potential to do any of the following:

NR 666.510(3)(d)5.a. a. Generate extreme heat or pressure, fire or explosion, or violent reaction.

NR 666.510(3)(d)5.b. b. Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health.

NR 666.510(3)(d)5.c. c. Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions.

NR 666.510(3)(d)5.d. d. Damage the structural integrity of the container of hazardous waste pharmaceuticals.

NR 666.510(3)(d)5.e. e. Through other like means threaten human health or the environment.

NR 666.510(3)(d)6. 6. Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition under s. NR 668.03 (3), for example arsenic trioxide (P012), in separate containers from other evaluated hazardous waste pharmaceuticals at the reverse distributor.

NR 666.510(3)(e) (e) Hazardous waste numbers. Prior to shipping evaluated hazardous waste pharmaceuticals off-site, all containers shall be marked with the applicable hazardous waste numbers, or hazardous waste codes. A nationally recognized electronic system, such as bar coding or radio frequency identification, may be used to identify the EPA hazardous waste numbers.

NR 666.510(3)(f) (f) Shipments. A reverse distributor shall ship evaluated hazardous waste pharmaceuticals that are destined for a permitted or interim status treatment, storage, or disposal facility in accordance with the applicable shipping standards specified in s. NR 666.508 (1) or (2).

NR 666.510(3)(g) (g) Procedures for a reverse distributor for managing rejected shipments. A reverse distributor that sends a shipment of evaluated 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 evaluated hazardous waste pharmaceuticals on-site for up to an additional 90 calendar days in the on-site accumulation area provided the rejected or returned shipment is managed in accordance with sub. (1) and this subsection. Upon receipt of the returned shipment, the reverse distributor shall do all of the following:

NR 666.510(3)(g)1. 1. Sign one of the following:

NR 666.510(3)(g)1.a. a. Item 18c of the original manifest, if the original manifest was used for the returned shipment.

NR 666.510(3)(g)1.b. b. Item 20 of the new manifest, if a new manifest was used for the returned shipment.

NR 666.510(3)(g)2. 2. Provide the transporter a copy of the manifest.

NR 666.510(3)(g)3. 3. Within 30 calendar days of receipt of the rejected shipment of the evaluated hazardous waste pharmaceuticals, send a copy of the manifest to the designated facility that returned the shipment to the reverse distributor.

NR 666.510(3)(g)4. 4. Within 90 calendar days of receipt of the rejected shipment, transport or offer for transport the returned shipment of evaluated hazardous waste pharmaceuticals in accordance with the applicable shipping standards under s. NR 666.508 (1) or (2).

NR 666.510(3)(h) (h) Land disposal restrictions. Evaluated hazardous waste pharmaceuticals are subject to the land disposal restrictions under ch. NR 668. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off-site shall comply with the land disposal restrictions in accordance with s. NR 668.07 (1) requirements.

NR 666.510(3)(i) (i) Reporting by a reverse distributor for evaluated hazardous waste pharmaceuticals.

NR 666.510(3)(i)1. 1. ‘Annual reporting by a reverse distributor.’ A reverse distributor that ships evaluated hazardous waste pharmaceuticals off-site shall prepare and submit a single copy of an annual report to the department by March 1 of each year in accordance with s. NR 662.041.

NR 666.510(3)(i)2. 2. ‘Exception reporting by a reverse distributor for a missing copy of the manifest - shipments from a reverse distributor to a designated facility.’

NR 666.510(3)(i)2.a. a. A reverse distributor who does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 35 calendar days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter, shall contact the transporter or the owner or operator of the designated facility to determine the status of the evaluated hazardous waste pharmaceuticals.

NR 666.510(3)(i)2.b. b. A reverse distributor shall submit an exception report to the department if it has not received a copy of the manifest with the signature of the owner or operator of the designated facility within 45 calendar days of the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter. The exception report shall include all of the following:

1) A legible copy of the manifest for which the reverse distributor does not have confirmation of delivery.

2) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.

NR 666.510(3)(i)3. 3. ‘Exception reporting by a reverse distributor for a missing copy of the manifest - shipments rejected by the designated facility and shipped to an alternate facility.’

NR 666.510(3)(i)3.a. a. A reverse distributor that does not receive a copy of the manifest with the signature of the owner or operator of the alternate facility within 35 calendar days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter shall contact the transporter or the owner or operator of the alternate facility to determine the status of the hazardous waste. The 35-day time frame begins the date the evaluated hazardous waste pharmaceuticals are accepted by the transporter forwarding the hazardous waste shipment from the designated facility to the alternate facility.

NR 666.510(3)(i)3.b. b. A reverse distributor shall submit an exception report to the department if it has not received a copy of the manifest with the signature of the owner or operator of the alternate facility within 45 calendar days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter. The 45-day timeframe begins the date the evaluated hazardous waste pharmaceuticals are accepted by the transporter forwarding the hazardous waste pharmaceutical shipment from the designated facility to the alternate facility. The exception report shall include all of the following:

1) A legible copy of the manifest for which the generator does not have confirmation of delivery.

2) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.

NR 666.510(3)(j) (j) Recordkeeping by a reverse distributor for evaluated hazardous waste pharmaceuticals.