Mich. Admin. Code R. 299.9833 - Hazardous waste pharmaceuticals; standards for managing potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals at reverse distributors

Rule 833.

(1) 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 an operating license or without having interim status under these rules if the reverse distributor complies with all the following conditions:

(a) The reverse distributor shall notify the director using Michigan site identification form EQP 5150, that it is a reverse distributor operating under R 299.9824 to R 299.9833 and obtain a site identification number if it does not already have one. The notification must be submitted to the director within 60 days after the effective date of R 299.9824 to R 299.9833 or within 60 days after becoming subject to R 299.9824 to R 299.9833.

(b) The 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. The inventory must be conducted within 30 days of each waste arriving on-site and include the identity, by name or national drug code, and quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste pharmaceutical. If the reverse distributor already satisfies the inventory requirements because of other regulatory requirements, the distributor is not required to maintain a separate inventory under this subdivision.

(2) A reverse distributor that is not a pharmaceutical manufacturer shall evaluate a potentially creditable hazardous waste pharmaceutical within 30 calendar days of the waste arriving on-site to establish if it is destined for any of the following:

(a) Another reverse distributor for further evaluation or verification of manufacturer credit. A potentially creditable hazardous waste pharmaceutical that is destined for another reverse distributor is still considered a potentially creditable hazardous waste pharmaceutical and must be managed under subrule (12) of this rule.

(b) A potentially creditable hazardous waste pharmaceutical that is destined for a hazardous waste treatment, storage, or disposal facility is considered an "evaluated hazardous waste pharmaceutical" and must be managed under subrule (13) of this rule.

(3) A reverse distributor that is a pharmaceutical manufacturer shall evaluate a potentially creditable hazardous waste pharmaceutical to verify manufacturer credit within 30 days of the waste arriving at on-site and manage the evaluated hazardous waste pharmaceuticals. After the evaluation, the evaluated hazardous waste pharmaceuticals must be managed under subrule (13) of this rule.

(4) A reverse distributor may accumulate potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site for 180 days or less. The 180-day timeline starts after the potentially creditable hazardous waste pharmaceutical has been evaluated and applies to all hazardous waste pharmaceuticals accumulated on-site, whether destined for another reverse distributor as potentially creditable hazardous waste pharmaceuticals or to a hazardous waste treatment, storage, or disposal facility as evaluated hazardous waste pharmaceuticals.

(5) Unexpired pharmaceuticals that are otherwise creditable but are awaiting their expiration date can be accumulated for up to 180 days after the expiration date if the unexpired pharmaceuticals are managed under subrules (1) to (11) of this rule and the container labeling and management standards in subrules (13)(d) and (e) of this rule.

(6) A reverse distributor shall prevent unknowing entry and minimize the possibility for the unauthorized entry into the area where potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are accumulated. If the reverse distributor already meets the security requirements of this subrule because of other regulatory requirements, the distributor is not required to provide separate security measures under this subrule. Some methods that may be used to prevent unknowing entry and minimize the possibility for authorized entry include the following:

(a) A 24-hour continuous monitoring surveillance system.

(b) An artificial barrier, such as a fence.

(c) A means to control entry, such as keycard access.

(7) A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off-site shall prepare a contingency plan and comply with R 299.9307(1)(c).

(8) 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 R 299.9307(1)(k)(ii) and (iii).

(9) A reverse distributor shall submit an unauthorized waste report if the distributor receives waste from off-site that it is not authorized to accept. The reverse distributor shall prepare and submit an unauthorized waste report to the director within 45 days after the unauthorized waste arrives on-site. A copy of the unauthorized waste report must also be sent 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 must be signed by the owner or operator of the reverse distributor, or its authorized representative, and contain all the following information:

(a) The site identification number and name and address of the reverse distributor.

(b) The date the reverse distributor received the unauthorized waste.

(c) The site identification number and name and address of the healthcare facility that shipped the unauthorized waste, if available.

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

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

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

(10) The director may require reverse distributors to furnish additional reports on the quantities and disposition of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.

(11) A reverse distributor shall keep the following records for the specified time periods, unless automatically extended during any unresolved enforcement action regarding the regulated activity or requested by the director, and make them readily available to the department on request:

(a) A copy of its notification on file for as long as the distributor is subject to R 299.9824 to R 299.9833.

(b) A copy of the delivery confirmation and the shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals that it receives for not less than 3 years from the date the shipment arrives at the reverse distributor.

(c) A copy of each unauthorized waste report for not less than 3 years from the date the shipment arrives at the reverse distributor.

(d) A copy of its current inventory for as long as the facility is subject to R 299.9824 to R 299.9833.

(12) A reverse distributor that does not have an operating license or interim status under these rules shall comply with the following conditions, in addition to the requirements in subrules (1) to (11) of this rule, for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:

(a) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility or another reverse distributor shall send those potentially creditable hazardous waste pharmaceuticals to a reverse distributor or another reverse distributor, respectively, within 180 days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow subrule (13) of this rule for evaluated hazardous waste pharmaceuticals.

(b) Ship potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with R 299.9832.

(c) Keep the following records for each shipment of potentially creditable hazardous waste pharmaceuticals that it initiates to another reverse distributor for not less than 3 years from the date of shipment, unless automatically extended during any unresolved enforcement action regarding the regulated activity or requested by the director, and make the records readily available to the department on request:

(i) The confirmation of delivery.

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

(13) A reverse distributor that does not have an operating license or interim status under these rules shall comply with the following conditions, in addition to the requirements of subrules (1) to (11) of this rule, for the management of evaluated hazardous waste pharmaceuticals:

(a) Designate an on-site accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals.

(b) Inspect its on-site accumulation area not less than once every 7 days, looking at the containers for leaks, deterioration caused by corrosion or other factors, and signs of diversion.

(c) Ensure personnel that handle evaluated hazardous waste pharmaceuticals are trained in accordance with of R 299.9307(1)(f) to (h).

(d) A reverse distributor accumulating evaluated hazardous waste pharmaceuticals in containers in an on-site accumulation area must do all the following:

(i) Label the containers with the words "Hazardous Waste Pharmaceuticals".

(ii) Ensure the containers are in good condition and managed to prevent leaks.

(iii) 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.

(iv) Keep the containers closed if 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, intact, sealed packaging, they meet the closed container standard.

(v) 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:

(A) Generate extreme heat or pressure, fire or explosion, or violent reaction.

(B) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health.

(C) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions.

(D) Damage the structural integrity of the container of hazardous waste pharmaceuticals.

(E) Otherwise threaten human health or the environment.

(e) Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of 40 CFR 268.3(c) in separate containers from other evaluated hazardous waste pharmaceuticals.

(f) Before shipping evaluated hazardous waste pharmaceuticals off-site, ensure all containers are marked with the applicable hazardous waste numbers. A nationally recognized electronic system, such as bar coding or radio frequency identification, may be used to identify the hazardous waste numbers.

(g) Ship evaluated hazardous waste pharmaceuticals that are destined for a hazardous waste treatment, storage, or disposal facility in accordance with the applicable shipping standards in R 299.9831(1) or (2).

(h) 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 of R 299.9608, may accumulate the returned evaluated hazardous waste pharmaceuticals on-site for up to an additional 90 days in the on-site accumulation area if the rejected or returned shipment is managed in accordance with this subrule and subrules (1) to (12) of this rule. On receipt of the returned shipment, the reverse distributor shall do all of the following:

(i) Sign either item 18c of the original manifest if the original manifest was used for the returned shipment or item 20 of the new manifest if a new manifest was used for the returned shipment.

(ii) Provide the transporter a copy of the manifest.

(iii) Within 30 days of receipt 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.

(iv) Within 90 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 of R 299.9831(1) or (2).

(i) Evaluated hazardous waste pharmaceuticals are subject to the land disposal restrictions of 40 CFR part 268 . A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off-site shall comply with 40 CFR 268.7(a).

(j) A reverse distributor that ships evaluated hazardous waste pharmaceuticals off-site shall prepare and submit a single copy of a biennial report to the director by March 1 of each even numbered year in accordance with R 299.9312.

(k) If a reverse distributor does not receive a copy of the manifest with the signature of the owner or operator of the designated facility within 35 days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter, the distributor shall contact the transporter or the owner or operator of the designated facility to determine the status of the evaluated hazardous waste pharmaceuticals.

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

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

(ii) 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.

(m) 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 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.

(n) A reverse distributor shall submit an exception report to the director if it has not received a copy of the manifest with the signature of the owner or operator of the alternate facility within 45 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 must include the following:

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

(ii) 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.

(o) A reverse distributor shall keep a written or electronic log of inspections of the on-site accumulation area, required by subdivision (b) of this subrule. This log must be retained for not less than 3 years from the date of the inspection.

(p) A reverse distributor shall keep a copy of each manifest signed in accordance with R 299.9309 for 3 years or until it receives a signed copy from the designated facility that received the evaluated hazardous waste pharmaceutical. This signed copy must be retained as a record for not less than 3 years from the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter.

(q) A reverse distributor shall keep a copy of each biennial report for not less than 3 years from the due date of the report.

(r) A reverse distributor shall keep a copy of each exception report for not less than 3 years from the submission of the report.

(s) A reverse distributor shall keep records to document personnel training under R 299.9307(1)(i).

(t) All records must be readily available on request by an inspector. The periods of retention referred to in this subrule are extended automatically during any unresolved enforcement action regarding the regulated activity or as requested by the director.

(14) A reverse distributor is an operator of a hazardous waste treatment, storage, or disposal facility and is subject to the requirements of parts 5 to 7 of these rules, if the distributor does any of the following:

(a) Fails to meet the conditions of this rule.

(b) Accepts manifested hazardous waste from off-site.

(c) Treats or disposes of hazardous waste pharmaceuticals on-site.

Notes

Mich. Admin. Code R. 299.9833

2025 MR 8, Eff. 5/5/2025