Section R315-266-510 - Hazardous Waste Pharmaceuticals - Standards for the Management of Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals at Reverse DistributorsA 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 it complies with the following conditions:
(a) Standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.(1) Notification. A reverse distributor shall notify the Director, using the Site Identification Form, EPA Form 8700-12, that it is a reverse distributor operating under Sections R315-266-500 through R315-266-510. (i) A reverse distributor that already has an EPA identification number shall notify the Director, using the Site Identification Form, EPA Form 8700-12, that it is a reverse distributor, as defined in Section R315-266-500, within 60 days of the effective date of Sections R315-266-500 through R315-266-510, or within 60 days of becoming subject to Sections R315-266-500 through R315-266-510.(ii) A reverse distributor that does not have an EPA identification number shall obtain one by notifying the Director, using the Site Identification Form, EPA Form 8700-12, that it is a reverse distributor, as defined in Section R315-266-500, within 60 days of the effective date of Sections R315-266-500 through R315-266-510, or within 60 days of becoming subject to Sections R315-266-500 through R315-266-510.(2) Inventory by the reverse distributor. A reverse distributor shall maintain a current inventory of the potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on site. (i) A reverse distributor shall inventory each potentially creditable hazardous waste pharmaceutical within 30 calendar days of each waste arriving at the reverse distributor.(ii) 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.(iii) If the reverse distributor already meets the inventory requirements of Subsection R315-266-510(a)(2) because of other regulatory requirements, such as State Board of Pharmacy regulations, the facility is not required to provide a separate inventory pursuant to Section R315-266-510.(3) Evaluation by a reverse distributor that is not a manufacturer. 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 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. (i) 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 Subsection R315-266-510(b).(ii) A potentially creditable hazardous waste pharmaceutical that is destined for a permitted or interim status treatment, storage or disposal facility is considered an "evaluated hazardous waste pharmaceutical" and shall be managed in accordance with Subsection R315-266-501(c).(4) 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 Subsection R315-266-501(c). (5) Maximum accumulation time for hazardous waste pharmaceuticals at a reverse distributor. (i) 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 days start after the potentially creditable hazardous waste pharmaceutical has been evaluated and applies to any hazardous waste pharmaceuticals accumulated on site, regardless of whether they are destined for another reverse distributor, that is potentially creditable hazardous waste pharmaceuticals, or a permitted or interim status treatment, storage, or disposal facility, that is evaluated hazardous waste pharmaceuticals.(ii) Aging pharmaceuticals. Unexpired pharmaceuticals that are otherwise creditable but are awaiting their expiration date, in other words, aging in a holding morgue, can be accumulated for up to 180 days after the expiration date, provided that the unexpired pharmaceuticals are managed in accordance with Subsection R315-266-510(a) and the container labeling and management standards in Subsections R315-266-510(c)(4)(i) through R315-266-510(c)(4)(vi).(6) 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.(i) Examples of methods that may be used to prevent unknowing entry and minimize the possibility for unauthorized entry include, but are not limited to: (A) a 24-hour continuous monitoring surveillance system;(B) an artificial barrier such as a fence; or(C) a means to control entry, such as keycard access.(ii) If the reverse distributor already meets the security requirements of Subsection R315-266-510(a)(6) 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 Section R315-266-510.(7) 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 of Sections R315-262-250 through R315-262-265.(8) Closure of a reverse distributor. If closing an area where a reverse distributor accumulates potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, the reverse distributor shall comply with Subsections R315-262-17(a)(8)(ii) and R315-262-17(a)(8)(iii).(9) Reporting by a reverse distributor. (i) 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, for example, non-pharmaceutical hazardous waste, regulated medical waste. The reverse distributor shall prepare and submit an unauthorized waste report to the Director 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 applicable rules. The unauthorized waste report shall be signed by the owner or operator of the reverse distributor, or its authorized representative, and contain the following information: (A) the EPA identification number, name and address of the reverse distributor;(B) the date the reverse distributor received the unauthorized waste;(C) the EPA identification number, 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; and(F) a brief explanation of why the waste was unauthorized, if known.(ii) Additional reports. The Director may require reverse distributors to furnish additional reports concerning the quantities and disposition of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.(10) Recordkeeping by reverse distributors. A reverse distributor shall keep certain records, paper or electronic, readily available upon request by an inspector. The periods of retention referred to in Section R315-266-510 are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the Director. A reverse distributor shall keep the following records:(i) a copy of its notification on file for as long as the facility is subject to Sections R315-266-500 through R315-266-510;(ii) 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 three years from the date the shipment arrives at the reverse distributor; and(iii) a copy of its current inventory for as long as the facility is subject to Sections R315-266-500 through R315-266-510.(b) Additional standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor. A reverse distributor that does not have a permit or interim status shall comply with the following conditions, in addition to the requirements in Subsection R315-266-510(a), for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:(1) 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 days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow Subsection R315-266-510(c) for evaluated hazardous waste pharmaceuticals.(2) 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 days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow Subsection R315-266-510(c) for evaluated hazardous waste pharmaceuticals.(3) A reverse distributor shall ship potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with Section R315-266-509.(4) Recordkeeping by reverse distributors. A reverse distributor shall keep certain 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 three years from the date of shipment. The periods of retention referred to in Section R315-266-510 are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the Director. A reverse distributor shall keep the following records:
(i) the confirmation of delivery; and(ii) the DOT shipping papers prepared in accordance with 49 CFR part 172 subpart C, if applicable.(c) Additional standards for reverse distributors managing evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have a permit or interim status shall comply with the following conditions, in addition to the requirements of Subsection R315-266-510(a), for the management of evaluated hazardous waste pharmaceuticals:(1) Accumulation area at the reverse distributor. A reverse distributor shall designate an on-site accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals.(2) Inspections of on-site accumulation area. A reverse distributor shall inspect its on-site accumulation area at least once every seven days, looking at containers for leaks and for deterioration caused by corrosion or other factors, as well as for signs of diversion.(3) Personnel training at a reverse distributor. Personnel at a reverse distributor that handle evaluated hazardous waste pharmaceuticals are subject to the training requirements of Subsection R315-262-17(a)(7).(4) 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:(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 which 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 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 are considered to 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:(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; or(E) through other like means threaten human health or the environment; and(vi) accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of Subsection R315-268-3(c), for example, arsenic trioxide (P012), in separate containers from other evaluated hazardous waste pharmaceuticals at the reverse distributor.(5) Hazardous waste numbers. Prior to shipping evaluated hazardous waste pharmaceuticals off site, each container shall be marked with the applicable hazardous waste numbers, in other words 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. (6) 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 in Subsections R315-266-508(a) or R315-266-508(b).(7) 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 of Section R315-264-72 or R315-265-72, may accumulate the returned evaluated hazardous waste pharmaceuticals on site for up to an additional 90 days in the on-site accumulation area provided the rejected or returned shipment is managed in accordance with Subsections R315-266-510(a) and R315-266-510(c). Upon receipt of the returned shipment, the reverse distributor shall:(i) sign either: (A) item 18c of the original manifest, if the original manifest was used for the returned shipment; or(B) 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 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; and(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 Subsection R315-266-508(a) or R315-266-508(b).(8) Land disposal restrictions. Evaluated hazardous waste pharmaceuticals are subject to the land disposal restrictions of Rule R315-268. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off-site shall comply with the land disposal restrictions in accordance with the requirements of Subsection R315-268-7(a).(9) Reporting by a reverse distributor for evaluated hazardous waste pharmaceuticals. (i) Biennial reporting by a reverse distributor. 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 Section R315-262-41.(ii) Exception reporting by a reverse distributor for a missing copy of the manifest. (A) For shipments from a reverse distributor to a designated facility.(I) 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 reverse distributor shall contact the transporter or the owner or operator of the designated facility to determine the status of the evaluated hazardous waste pharmaceuticals.(II) 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 shall include: (1) a legible copy of the manifest for which the reverse distributor does not have confirmation of delivery; and(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.(B) For shipments rejected by the designated facility and shipped to an alternate facility.(I) 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.(II) 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 shall include:(1) a legible copy of the manifest for which the generator does not have confirmation of delivery; and(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.(10) Recordkeeping by a reverse distributor for evaluated hazardous waste pharmaceuticals. (i) A reverse distributor shall keep a log, written or electronic, of the inspections of the on-site accumulation area, required by Subsection R315-266-510(c)(2). This log shall be retained as a record for at least three years from the date of the inspection.(ii) A reverse distributor shall keep a copy of each manifest signed in accordance with Subsection R315-262-23(a) for three years or until it receives a signed copy from the designated facility that received the evaluated hazardous waste pharmaceutical. This signed copy shall be retained as a record for at least three years from the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter.(iii) A reverse distributor shall keep a copy of each biennial report for at least three years from the due date of the report.(iv) A reverse distributor shall keep a copy of each exception report for at least three years from the submission of the report.(v) A reverse distributor shall keep records to document personnel training, in accordance with Subsection R315-262-17(a)(7)(iv).(vi) Records shall be readily available upon request by an inspector. The periods of retention referred to in Section R315-266-510 are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the Director.(d) When a reverse distributor shall have a permit. A reverse distributor is an operator of a hazardous waste treatment, storage, or disposal facility and is subject to the requirements of Rules R315-264, and R315-265, and the permit requirements of Rule R315-270, if the reverse distributor: (1) does not meet the conditions of Section R315-266-510;(2) accepts manifested hazardous waste from off site; or(3) treats or disposes of hazardous waste pharmaceuticals on site.Utah Admin. Code R315-266-510
Adopted by Utah State Bulletin Number 2020-19, effective 9/14/2020