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 offsite and accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals onsite without a hazardous waste permit, provided it complies with the following conditions: 1. Standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals. a. Notification. A reverse distributor shall notify the department using the site identification form (environmental protection agency form 8700-12) that it is a reverse distributor operating under sections 33.1-24-05-310 through 33.1-24-05-320. (1) A reverse distributor that already has an environmental protection agency identification number shall notify the department using the site identification form (environmental protection agency form 8700-12) that it is a reverse distributor, as defined in section 33.1-24-05-310, within sixty days of July 1, 2021, or within sixty days of becoming subject to the requirements in sections 33.1-24-05-310 through 33.1-24-05-320. (2) A reverse distributor that does not have an environmental protection agency identification number shall obtain one by notifying the department using the site identification form (environmental protection agency form 8700-12) that it is a reverse distributor, as defined in section 33.1-24-05-310, within 60 days of July 1, 2021, or within sixty days of becoming subject to the requirements in sections 33.1-24-05-310 through 33.1-24-05-320. b. Inventory by the reverse distributor. A reverse distributor shall maintain a current inventory of all potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated onsite. (1) A reverse distributor shall inventory each potentially creditable hazardous waste pharmaceutical within thirty calendar days of each waste arriving at the reverse distributor. (2) The inventory must include the identity, e.g., the name or national drug code, and quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste pharmaceutical. (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 subsection. c. 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 thirty 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. (1) 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 in accordance with subsection 2. (2) 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 must be managed in accordance with subsection 3. 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 thirty calendar days of the waste arriving at the facility and following the evaluation must manage the evaluated hazardous waste pharmaceutical in accordance with subsection 3. e. Maximum accumulation time for hazardous waste pharmaceuticals at a reverse distributor. (1) A reverse distributor may accumulate potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals onsite for one hundred eighty calendar days or less. The one hundred eighty days start after the potentially creditable hazardous waste pharmaceutical has been evaluated and applies to all hazardous waste pharmaceuticals accumulated onsite, regardless of whether they are destined for another reverse distributor, i.e., potentially creditable hazardous waste pharmaceuticals, or a permitted treatment, storage, or disposal facility, i.e., evaluated hazardous waste pharmaceuticals. (2) Unexpired pharmaceuticals that are otherwise creditable but are awaiting their expiration date, i.e., aging in a holding morgue, can be accumulated for up to one hundred eighty days after the expiration date, provided the unexpired pharmaceuticals are managed in accordance with subsection 1 and the applicable container labeling and management standards in subsection 3. 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. (1) Examples of methods that may be used to prevent unknowing entry and minimize the possibility for unauthorized entry include: (a) A twenty-four-hour continuous monitoring surveillance system; (b) An artificial barrier, such as a fence; or (c) A means to control entry, such as keycard access. (2) If the reverse distributor already meets the security requirements of this subdivision because of other regulatory requirements, the facility is not required to provide separate security measures pursuant to this section. g. Contingency plan and emergency procedures at a reverse distributor. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from offsite shall prepare a contingency plan and comply with the other requirements of sections 33.1-24-05-15 through 33.1-24-05-36. 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 the requirements in paragraphs 2 and 3 of subdivision h of subsection 1 of section 33.1-24-03-29. i. Reporting by a reverse distributor. (1) Unauthorized waste report. A reverse distributor shall submit an unauthorized waste report if the reverse distributor receives waste from offsite that it is not authorized to receive, e.g., nonpharmaceutical hazardous waste, regulated medical waste. The reverse distributor shall prepare and submit an unauthorized waste report to the department within forty-five calendar days after the unauthorized waste arrives at the reverse distributor and shall send a copy of the unauthorized waste report to the health care 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 the following information: (a) The environmental protection agency identification number, name, and address of the reverse distributor; (b) The date the reverse distributor received the unauthorized waste; (c) The environmental protection agency identification number, name, and address of the health care facility that shipped the unauthorized waste, if available; (d) A description of the type and quantity of each unauthorized waste received; (e) The method of treatment, storage, or disposal for each unauthorized waste received; and (f) A brief explanation of why the waste was unauthorized, if known. (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. j. Recordkeeping by reverse distributors. A reverse distributor shall keep the following records, paper or electronic, readily available upon request by an inspector. The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding regulated activity, or as requested by the department. (1) A copy of its notification on file for as long as the facility is subject to sections 33.1-24-05-310 through 33.1-24-05-320; (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 three years from the date the shipment arrives at the reverse distributor; (3) A copy of its current inventory for as long as the facility is subject to sections 33.1-24-05-310 through 33.1-24-05-320. 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 permit must comply with the following conditions, in addition to the requirements in subsection 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: a. A reverse distributor that receive potentially creditable hazardous waste pharmaceuticals from a health care facility shall send those potentially creditable hazardous waste pharmaceuticals to another reverse distributor within one hundred eighty days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow subsection 3 for evaluated hazardous waste pharmaceuticals. 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 one hundred eighty days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow subsection 3 for evaluated hazardous waste pharmaceuticals. c. A reverse distributor shall ship potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with section 33.1-24-05-319. d. Recordkeeping by reverse distributors. A reverse distributor shall keep 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 three years from the date of shipment. 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. (1) The confirmation of delivery; and (2) The department of transportation shipping papers prepared in accordance with title 49, Code of Federal Regulations, part 172, subpart C, if applicable. 3. Additional standards for reverse distributors managing evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have a permit shall comply with the following conditions, in addition to the requirements of subsection 1 of this section, for the management of evaluated hazardous waste pharmaceuticals: a. Accumulation area at the reverse distributor. A reverse distributor shall designate an onsite accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals. b. Inspection of onsite accumulation area. A reverse distributor shall inspect its onsite 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. c. Personnel training at a reverse distributor. Personnel at a reverse distributor that handle evaluated hazardous waste pharmaceuticals are subject to the training requirements of subdivision g of subsection 1 of section 33.1-24-03-29. d. Labeling and management of containers at onsite accumulation areas. A reverse distributor accumulating evaluated hazardous waste pharmaceuticals in containers in an onsite accumulation area shall: (1) Label the containers with the words "hazardous waste pharmaceuticals"; (2) Ensure the containers are in good condition and managed to prevent leaks; (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; (4) 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 in intact, sealed packaging, they are considered to meet the container closed standard; (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: (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. (6) Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of subsection 3 of section 33.1-24-05-252 (e.g., arsenic trioxide (P012)) in separate containers from other evaluated hazardous waste pharmaceuticals at the reverse distributor. e. Hazardous waste numbers. Prior to shipping evaluated hazardous waste pharmaceuticals offsite, all containers must be marked with the applicable hazardous waste number, i.e., hazardous waste codes. A nationally recognized electronic system, such as bar coding or radio frequency identification, may be used to identify the environmental protection agency hazardous waste number. f. Shipments. A reverse distributor must 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 subsection 1 or 2 of section 33.1-24-05-318. 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 of section 33.1-24-05-39, may accumulate the returned evaluated hazardous waste pharmaceuticals onsite for up to an additional ninety days in the onsite accumulation area provided the rejected or returned shipment is managed in accordance with subsections 1 and 3. Upon receipt of the returned shipment, the reverse distributor must: (1) 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; (2) Provide the transporter a copy of the manifest; (3) Within thirty days of receipt of the rejected shipment of evaluated hazardous waste pharmaceuticals, send a copy of the manifest to the designated facility that returned the shipment to the reverse distributor; and (4) Within ninety 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 1 or 2 of section 33.1-24-05-318. h. Land disposal restrictions. Evaluated hazardous waste pharmaceuticals are subject to the land disposal restrictions of sections 33.1-24-05-250 through 33.1-24-05-299. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from offsite must comply with the land disposal restrictions in accordance with subsection 1 of section 33.1-24-05-256. i. Reporting by a reverse distributor for evaluated hazardous waste pharmaceuticals. (1) Biennial reporting by a reverse distributor. A reverse distributor that ships evaluated hazardous waste pharmaceuticals offsite shall prepare and submit a single copy of a biennial report to the department by March first of each even-numbered year in accordance with section 33.1-24-03-14. (2) Exception reporting by a reverse distributor for a missing copy of the manifest. (a) For shipments from a reverse distributor to a designated facility. [1] 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 thirty-five 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. [2] 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 forty-five days of the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter. The exception report must include: [a] A legible copy of the manifest for which the reverse distributor does not have confirmation of delivery; and [b] 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. [1] 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 thirty-five 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 thirty-five-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. [2] 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 forty-five days of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter. The forty-five-day time frame 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: [a] A legible copy of the manifest for which the generator does not have confirmation of delivery; and [b] 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. j. Recordkeeping by a reverse distributor for evaluated hazardous waste pharmaceuticals. (1) A reverse distributor must keep a log, written or electronic, of the inspections of the onsite accumulation area, required by subdivision b of subsection 2. This log must be retained as a record for at least three years from the date of inspection. (2) A reverse distributor shall keep a copy of each manifest signed in accordance with subsection 1 of section 33.1-24-03-07 for three 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 at least three years from the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter. (3) A reverse distributor shall keep a copy of each biennial report for at least three years from the due date of the report. (4) A reverse distributor shall keep a copy of each exception report for at least three years from the submission of the report. (5) A reverse distributor shall keep records to document personnel training, in accordance with paragraph 5 of subdivision g of subsection 1 of section 33.1-24-03-29. (6) All records must be readily available upon request by an inspector. 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. 4. When a reverse distributor must 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 chapters 33.1-24-03 through 33.1-24-07, if the reverse distributor: a. Does not meet the conditions of this section; b. Accepts manifested hazardous waste from offsite; or c. Treats or disposes of hazardous waste pharmaceuticals onsite.