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.