On September 25, 2015, the U.S. Environmental Protection Agency (EPA) published a proposed rule titled “Management Standards for Hazardous Waste Pharmaceuticals” in the Federal Register. 80 Fed. Reg. 58,014. Comments on the proposed rule must be received by EPA on or before November 24, 2015.

Overview

The proposed rule adds a new subpart P to 40 CFR Part 266 to address hazardous waste pharmaceuticals that are generated or managed by healthcare facilities and pharmaceutical reverse distributors. One of the purposes of the rule is to impose controls on the current practice of sending expired, unused, or un-administered pharmaceuticals that also are hazardous wastes to reverse distributors who then determine what if any credit the healthcare facilities will receive for those pharmaceuticals. Another purpose of the rule is to reduce the amount of pharmaceuticals disposed of through sewer systems.

The proposed rule includes a number of new terms including “hazardous waste pharmaceutical” which is defined as a pharmaceutical that is a solid waste pursuant to 40 CFR 261.2 that either is a listed hazardous waste or a characteristic hazardous waste. Examples of listed hazardous waste pharmaceuticals include arsenic trioxide (P012), smoking cessation products with nicotine as the sole active ingredient (P075), pharmaceuticals with greater than 0.3% warfarin (and salts) as the sole active ingredient (e.g., Coumadin) (P001), streptozotocin (U206), and pharmaceuticals with less than or equal to 0.3% warfarin (and salts) as the sole active ingredient (U248).

“Hazardous waste pharmaceuticals” are then divided into three groups – potentially creditable hazardous waste pharmaceuticals, non-creditable hazardous waste pharmaceuticals, and evaluated hazardous waste pharmaceuticals. A “potentially creditable hazardous waste pharmaceutical” is defined as:

  1. A hazardous waste pharmaceutical that has the potential to receive manufacturer’s credit and is: (i) [u]nused or un-administered; and (ii) [u]nexpired or less than one year past expiration date.
  2. The term does not include “evaluated hazardous waste pharmaceuticals,” residues of pharmaceuticals remaining in containers, contaminated personal protective equipment, and clean-up material from the spills of pharmaceuticals. 

A “non-creditable hazardous waste pharmaceutical” is defined as “a hazardous waste pharmaceutical that is not expected to be eligible for manufacturer’s credit.” An “evaluated hazardous waste pharmaceutical” is defined as “a hazardous waste pharmaceutical that was a potentially creditable hazardous waste pharmaceutical but has been evaluated by a pharmaceutical reverse distributor to establish whether it is eligible for manufacturer’s credit and will not be sent to another pharmaceutical reverse distributor for further evaluation or verification.”

The proposed rule only applies to hazardous waste pharmaceuticals generated or managed by two types of entities – healthcare facilities and pharmaceutical reverse distributors. The rule defines a “healthcare facility” as:

  1. Any person that: (i) [p]rovides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or (ii) [s]ells or dispenses over-the-counter or prescription pharmaceuticals.
  2. This definition includes, but is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals. 

A “pharmaceutical reverse distributor” is defined as “any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer’s credit. Any person, including forward distributors and pharmaceutical manufacturers, that processes pharmaceuticals for the facilitation or verification of manufacturer’s credit is considered a pharmaceutical reverse distributor.”

All pharmaceutical reverse distributors that handle hazardous waste pharmaceuticals are subject to the proposed rule. However, healthcare facilities that are classified as conditionally exempt small quantity generators (CESQGs) based on all of the hazardous wastes they generate [hazardous waste pharmaceuticals and any other hazardous wastes (e.g., spent solvents, certain cleaners, etc.)] remain subject to the CESQG requirements and not subpart P except for certain requirements (e.g., the prohibition on disposing of hazardous waste pharmaceuticals to the sewer). All other healthcare facilities that are small quantity or large quantity hazardous waste generators must comply with the requirements in subpart P for their hazardous waste pharmaceuticals.

Requirements for Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals

  1. Notification: Healthcare facilities are required to submit a new Site Identification Form to notify EPA that they are healthcare facilities operating under subpart P regardless of whether they already have an EPA identification number. The form must be submitted with the next biennial report if the facility is required to submit one or, if the facility is not required to submit a biennial report, within 60 days for the rule’s effective date, or within 60 days of becoming subject to the subpart. The notification must be retained for as long as the facility remains subject to subpart P.

If a healthcare facility becomes no longer subject to subpart P at some point in the future (e.g., becomes a CESQG and elects to withdraw from subpart P), it must file a Site Identification Form notifying EPA that it is withdrawing from the subpart before it can begin operating under the CESQG rules. A copy of the withdrawal must be retained for 3 years from the date of the signature on the notification form.

  1. Training: All employees that manage non-creditable hazardous waste pharmaceuticals must be trained to be familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.
  2. Waste determinations: Healthcare facilities must determine if waste pharmaceuticals are listed or characteristic hazardous wastes to determine if they are subject to subpart P. Alternatively, healthcare facilities can elect to manage all solid waste pharmaceuticals as hazardous waste pharmaceuticals.
  3. Container standards: Containers must be structurally sound, compatible with their contents, and lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. The rule imposes additional requirements if ignitable or reactive hazardous waste pharmaceuticals are managed or if incompatible hazard waste pharmaceuticals are mixed or commingled in the same container. Containers of non-creditable hazardous waste pharmaceuticals must be kept closed and secured to prevent unauthorized access to their contents. Generally, hazardous waste pharmaceuticals and non-hazardous pharmaceutical wastes can be accumulated in the same container. However, hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition in the land disposal restrictions regulation must be accumulated in separate containers.
  4. Labeling requirements: Containers of hazardous waste pharmaceuticals must be labeled or clearly marked with the phrase “Hazardous Waste Pharmaceuticals.”
  5. Maximum accumulation time: Hazardous waste pharmaceuticals can be accumulated on-site for up to one year without a permit or interim status. This time period can be extended if the requirements in proposed 40 CFR 266.502(f)(3) are satisfied. The healthcare facility must be able to demonstrate how long the hazardous waste pharmaceuticals have been accumulated on-site. Examples include marking or labeling the container, maintaining an inventory system, or placing the waste in a specific area so long as the method used identifies the date the hazardous waste pharmaceuticals first became a waste.
  6. Land disposal restrictions: Healthcare facilities that generate hazardous waste pharmaceuticals are required to comply with the land disposal restrictions but they are not required to identify the hazardous waste codes (e.g., D001, P075, etc.) that apply to the individual wastes.
  7. Managing rejected shipments of non-creditable hazardous waste pharmaceuticals: If a shipment of non-creditable hazardous waste pharmaceuticals is rejected back to the healthcare facility, the facility may accumulate the reject hazardous waste pharmaceuticals on-site for up to an additional 90 days so long as the facility complies with the container standards and labeling requirements. The facility also must sign the manifest for the rejected waste, provide a copy of the manifest to the transporter, send a copy of the manifest to the designated facility that rejected the waste within 30 days of the date the rejected waste was returned to the healthcare facility, and transport or offer for transport the returned shipment in accordance with the shipping standards for non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.
  8. Reporting requirements: Healthcare facilities are not subject to the biennial reporting requirements for non-creditable hazardous waste pharmaceuticals that are managed pursuant to subpart P. Exception reports must be filed for shipments of non-creditable hazardous waste pharmaceuticals if the healthcare facility does not received a copy of the manifest signed by the designated facility within 60 days of the shipment. Exception reports also must be filed if the designated facility rejects the shipment to an alternate facility and the healthcare facility does not receive a copy of the manifest signed by the alternate facility within 60 days of the date the designated facility shipped the waste to the alternate facility. EPA also can require the submission of additional reports concerning quantities and disposition of non-creditable hazardous waste pharmaceuticals.
  9. Recordkeeping requirements: Retain copies of manifests, exception reports, and records of any test results, waste analyses, or other information used to support the waste determinations for at least 3 years. Retention periods are extended automatically during unresolved enforcement actions regarding the regulated activity or as requested by EPA.
  10. Response to releases: Immediately contain all releases of non-creditable hazardous waste pharmaceuticals and residues from those pharmaceuticals. Determine if the material resulting from the release is a non-creditable hazardous waste pharmaceutical and, if so, manage it in accordance with subpart P. 
  11. Long-term care facilities: If individuals at the facility are administering their own pharmaceuticals, the unused non-creditable hazardous waste pharmaceuticals from those individuals must be collected and managed in accordance with subpart P.
  12. Accepting creditable and non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a CESQG: Healthcare facilities may accept creditable and non-creditable hazardous waste pharmaceuticals from off-site healthcare facilities if the off-site facilities are CESQGs provided the receiving healthcare facility: (a) is under the control of the same person as the off-site CESQG facility or there is a contract under which the receiving healthcare facility supplies pharmaceuticals to the off-site CESQG facility; (b) is operating under subpart P for its own hazardous waste pharmaceuticals; (c) manages the non-creditable hazardous waste pharmaceuticals received from off-site in compliance with subpart P; and (d) keeps records of the hazardous waste pharmaceuticals received from off-site for at least 3 years from the date the shipment was received. 

Requirements for Healthcare Facilities Managing Potentially Creditable Hazardous Waste Pharmaceuticals

  1. Waste determinations: Healthcare facilities must determine if their potentially creditable solid waste pharmaceuticals are listed or characteristic hazardous wastes. If so, those wastes are classified as potentially creditable hazardous waste pharmaceuticals. Alternatively, healthcare facilities can manage all potentially creditable solid waste pharmaceuticals as potentially creditable hazardous waste pharmaceuticals.
  2. Healthcare facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors.
  3. Healthcare facilities are not subject to the biennial reporting requirements for potentially creditable hazardous waste pharmaceuticals that are managed pursuant to subpart P.
  4. Recordkeeping requirements: Healthcare facilities that initiate shipments of potentially creditable hazardous waste pharmaceuticals must maintain the following records (electronic or paper) for at least 3 years from the date of shipment: (a) a copy of the advance notification sent to the pharmaceutical reverse distributor; (b) the confirmation of delivery of the potentially creditable hazardous waste pharmaceuticals; and (c) the shipping papers or bills of lading. Record retention periods are extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by EPA. 

Requirements for Healthcare Facilities that are CESQGs

  1. Potentially creditable hazardous waste pharmaceuticals: Healthcare facilities that are CESQGs may send their potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors.
  2. Off-site collection of hazardous waste pharmaceuticals generated by healthcare facilities that are CESQGs: Healthcare facilities that are CESQGs may send their hazardous waste pharmaceuticals to another healthcare facility provided that facility meets the requirements to accept creditable and non-creditable hazardous waste pharmaceuticals from off-site healthcare facility that are CESQGs as discussed above.
  3. Long-term care facilities that are CESQGs: Long-term care facilities that are CESQGs may dispose of their hazardous waste pharmaceuticals in collection receptacles of authorized collectors [as defined by the Drug Enforcement Administration (DEA)] that are registered with the DEA provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable DEA regulations for controlled substances. 

Prohibition on Discharging Hazardous Waste Pharmaceuticals to Sewer Systems

All healthcare facilities and pharmaceutical reverse distributers are prohibited from discharging hazardous waste pharmaceuticals to sewer systems that pass through to a publicly-owned treatment works (POTW). Therefore, the exclusion for mixtures of domestic sewage and other wastes that pass through sewer systems to POTWs does not apply to hazardous waste pharmaceuticals.

Conditional Exemption for Hazardous Waste Pharmaceuticals that are Controlled Substances

Hazardous waste pharmaceuticals that also are listed on a DEA schedule of controlled substances in 21 CFR 1308 and authorized collectors (as defined by the DEA) that are registered with the DEA that collect controlled substances collected from ultimate users (as defined by the DEA) and comingle them with hazardous waste pharmaceuticals that are exempt as household waste under 40 CFR 261.4(b)(1) are conditionally exempt from the requirements in 40 CFR 260-273. To satisfy this conditional exemption, the hazardous waste pharmaceuticals must be collected, stored, transported, destroyed and disposed of in compliance with all applicable DEA regulations for controlled substances and combusted in: (a) permitted large municipal waste combustors subject to specific requirements in either 40 CFR 60 or 62; (b) permitted small municipal waste combustors subject to specific requirements in either 40 CFR 60 or 62; or (c) units with a permit or interim status to burn hazardous waste that are covered by 40 CFR 63, Subpart EEE.

Management of Hazardous Waste Pharmaceutical Residues in Containers

  1. Dispensing and unit-dose containers: Dispensing bottles, vials, or ampules (less than or equal to 1 liter or 1000 pills) or unit-dose containers (e.g., unit-dose packets, cups, wrappers, blister packs, etc.) are considered empty and any residues are not regulated as hazardous waste if all pharmaceuticals have been removed from the container using practices commonly employed to remove materials from that type of container and any dispensing bottle or unit-dose container that is an original manufacturer’s product package is destroyed prior to disposal to prevent further use.
  2. Dispensed syringes: Residues in syringes are not regulated as hazardous waste if the syringe has been used to administer the pharmaceutical to a patient and the syringe is placed in a sharps container and managed in accordance with all applicable federal, state, and local medical waste requirements.
  3. Other containers including delivery devices: Residues in all other types of unused or used containers (e.g., IV bags and tubing, inhalers, aerosols, nebulizers, and tubes) that once held pharmaceuticals must be managed as hazardous waste pharmaceuticals if the residues are listed or characteristic hazardous wastes. 

Requirements for Shipping Non-Creditable Hazardous Waste Pharmaceuticals from Healthcare Facilities or Evaluated Hazardous Waste Pharmaceuticals from Pharmaceutical Reverse Distributors

Healthcare facilities shipping non-creditable hazardous waste pharmaceuticals and pharmaceutical reverse distributors shipping evaluated hazardous waste pharmaceuticals to permitted or interim status hazardous waste treatment, storage, or disposal (TSD) facilities must comply with the following requirements:

  1. Package the waste in accordance with applicable U.S. Department of Transportation (DOT) hazardous materials regulations.
  2. Label each package in accordance with applicable DOT hazardous materials regulations.
  3. Mark each package in accordance with applicable DOT hazardous materials regulations. Containers that are 119 gallons or less in capacity must be marked with a modified version of the traditional hazardous waste label that contains specific language.
  4. Placard or offer appropriate placards to the initial transporter pursuant to applicable DOT hazardous materials regulations.
  5. Prepare shipping papers in accordance with applicable DOT hazardous materials regulations.
  6. Comply with the hazardous waste manifest requirements except that healthcare facilities shipping non-creditable hazardous waste pharmaceuticals are not required to list the hazardous waste codes on the manifest. Instead, the words “hazardous waste pharmaceuticals” must be written in the special handling instructions and additional information box on the manifest. 

If non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals will be exported, comply with 40 CFR 262, subpart E. If non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals will be imported, comply with 40 CFR 262, subpart F. Healthcare facilities and pharmaceutical reverse distributors are prohibited from accepting imported non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals unless they have interim status or permits to accept hazardous waste from off-site.  Requirements for Shipping Potentially Creditable Hazardous Waste Pharmaceuticals from Healthcare Facilities or Pharmaceutical Reverse Distributors to Pharmaceutical Reverse Distributors

Healthcare facilities and pharmaceutical reverse distributors that ship potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors must comply with the following requirements:

  1. Provide advance notice (paper or electronic) to the receiving pharmaceutical reverse distributor of the intent to ship potentially creditable hazardous waste pharmaceuticals before each shipment is sent.
  2. Comply with the packaging, labeling, marking, placarding, and shipping paper requirements listed above for shipments of non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals except for the hazardous waste manifest requirement. 

Pharmaceutical reverse distributors that receive potentially creditable hazardous waste pharmaceuticals must provide confirmation (paper or electronic) to the healthcare facility or pharmaceutical reverse distributor that shipped the potentially creditable hazardous waste pharmaceuticals that it received the shipment. This confirmation must be provided upon receipt of the shipment.

If the healthcare facility or pharmaceutical reverse distributor that shipped the potentially creditable hazardous waste pharmaceuticals does not receive confirmation that the shipment was received within 7 calendar days from the date the shipment was sent, the healthcare facility or pharmaceutical reverse distributor must promptly contact the shipper and intended recipient pharmaceutical reverse distributor to report that confirmation was not received and determine the status of the shipment.

The proposed rule also contains requirements if health care facilities or pharmaceutical reverse distributors intend to export potentially creditable hazardous waste pharmaceuticals and if persons intend to import potentially creditable hazardous waste pharmaceuticals.

Requirements for Pharmaceutical Reverse Distributors Managing Potentially Creditable Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals

Pharmaceutical reverse distributors may accept potentially creditable hazardous waste pharmaceuticals from off-site and may accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on-site without a permit or interim status if the following requirements are satisfied:

  1. Notification: Pharmaceutical reverse distributors must notify EPA using the Site Identification Form that they are pharmaceutical reverse distributors operating under subpart P. Pharmaceutical reverse distributors that have EPA identification numbers must re-notify EPA within 60 days of the rule’s effective date or within 60 days of becoming subject to subpart P. Pharmaceutical reverse distributors that do not have EPA identification numbers must notify EPA within the same time periods.
  2. Inventory: Maintain an inventory of all potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that are accumulated on-site. Inventory each potentially creditable hazardous waste pharmaceutical upon arrival at the pharmaceutical reverse distributor. The inventory must include the identity (e.g., name or national drug code) and quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste pharmaceutical.
  3. Security: Prevent unknowing entry and minimize the possibility of unauthorized entry into the portion of the facility where potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are kept. Pharmaceutical reverse distributors that meet this requirement because of other applicable requirements (e.g., DEA regulations) are not required to provide separate security measures under this provision.
  4. Maximum accumulation time: Potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals may be accumulated at pharmaceutical reverse distributors for up to 90 calendar days. The 90 day period starts when the potentially creditable hazardous waste pharmaceutical arrives at the pharmaceutical reverse distributor and applies to all hazardous waste pharmaceuticals accumulated on-site regardless of whether they will be shipped to another pharmaceutical reverse distributor (i.e., potentially creditable hazardous waste pharmaceuticals) or a permitted or interim status TSD (i.e., evaluated hazardous waste pharmaceuticals). Extensions of the 90 day accumulation period are available in certain circumstances.
  5. Contingency plan and emergency procedures: Pharmaceutical reverse distributors that accept potentially creditable hazardous waste pharmaceuticals from off-site must prepare a contingency plan and comply with the other requirements of 40 CFR 265, subpart D.
  6. Closure: When an area where potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals are accumulated is closed, the pharmaceutical reverse distributor must control, minimize, or eliminate to the extent necessary to protect human health and the environment the post-closure escape of hazardous waste, leachate, contaminated run-off, or hazardous waste decomposition products to the ground or surface waters or to the atmosphere.
  7. Reporting requirements: Pharmaceutical reverse distributors that receive hazardous waste from off-site that they are not authorized to receive (e.g., non-creditable hazardous waste pharmaceuticals, non-pharmaceutical hazardous wastes) must submit an unauthorized hazardous waste report to EPA within 15 days of receipt of the waste and send a copy of the report to the healthcare facility or other entity that shipped the waste. The proposed rule specifies the information that must be contained in the unauthorized waste report. The pharmaceutical reverse distributor then must manage the unauthorized hazardous waste in accordance with the applicable requirements for generators of non-pharmaceutical hazardous wastes. 

EPA also can require pharmaceutical reverse distributors to provide additional reports regarding quantities and disposition of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.

  1. Recordkeeping requirements: Pharmaceutical reverse distributors are required to maintain copies of their notification to EPA and their inventory for as long as they are subject to subpart P. They also are required to maintain copies of advance notifications, delivery confirmations, and shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals received and copies of any unauthorized waste reports for at least 3 years from the date the shipment was received. Records can be retained in paper or electronic form. Retention periods are extended automatically during the course of unresolved enforcement actions regarding the regulated activity or as requested by EPA.
  2. Time period to evaluate potentially creditable hazardous waste pharmaceuticals: Pharmaceutical reverse distributors that are not pharmaceutical manufacturers must evaluate potentially creditable hazardous waste pharmaceuticals within 21 days of their arrival to determine if they must be shipped to another pharmaceutical reverse distributor for further evaluation or verification of manufacturer’s credit or to a permitted or interim status TSD. This 21 day period is part of the 90 day accumulation period. Potentially creditable hazardous waste pharmaceuticals that must be shipped to another pharmaceutical reverse distributor for evaluation or verification of credit remain potentially creditable hazardous waste pharmaceuticals and must be managed as discussed in paragraph 11 below. Potentially creditable hazardous waste pharmaceuticals that will be shipped to a permitted or interim status TSD are classified as evaluated hazardous waste pharmaceuticals and must be managed as discussed in paragraph 12 below.
  3. Pharmaceutical reverse distributors that also are pharmaceutical manufacturers must evaluate the potentially creditable hazardous waste pharmaceutical within 21 calendar days of receipt. The 21 day period is part of the 90 day accumulation period. The potentially creditable hazardous waste pharmaceutical then is classified as an evaluated hazardous waste pharmaceutical and must be managed as discussed in paragraph 12 below.
  4. Pharmaceutical reverse distributors that are not permitted or interim status TSDs and that manage potentially creditable hazardous waste pharmaceuticals that will be shipped to another pharmaceutical reverse distributor must comply with the following additional requirements:
    1. Potentially creditable hazardous waste pharmaceuticals received from healthcare facilities must be shipped to another pharmaceutical reverse distributor within 90 days of receipt or managed as evaluated hazardous waste pharmaceuticals as discussed in paragraph 12 below.
    2. Potentially creditable hazardous waste pharmaceuticals received from another pharmaceutical reverse distributor must be shipped as potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor that also is a pharmaceutical manufacturer within 90 days of receipt or managed as an evaluated hazardous waste pharmaceutical as discussed in paragraph 12 below.
    3. Pharmaceutical reverse distributors that will ship potentially creditable hazardous waste pharmaceuticals to another pharmaceutical reverse distributor must comply with the shipping requirements for potentially creditable hazardous waste pharmaceuticals.
    4. Pharmaceutical reverse distributors must maintain copies of the advanced notice provided to the receiving pharmaceutical reverse distributor, the confirmation of delivery, and the shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals from its facility for at least 3 years from the date of shipment. Records can be retained in paper or electronic form. 
  5. Pharmaceutical reverse distributors that are not permitted or interim status TSDs and that manage evaluated hazardous waste pharmaceuticals must comply with the following additional requirements:
    1. Designate an on-site accumulation area where the evaluated hazardous waste pharmaceuticals will be accumulated.
    2. Inspect the on-site accumulation area for container leaks, container deterioration, and signs of diversion at least weekly.
    3. Personnel handling evaluated hazardous waste pharmaceuticals are subject to the training requirements in 40 CFR 265.16.
    4. Containers in the on-site accumulation area must be labeled and managed as follows: 
      1. Label the containers with the words “hazardous waste pharmaceutical.”
      2. Ensure containers are in good condition and managed to prevent leaks.
      3. Use containers that are compatible with the hazardous waste pharmaceuticals.
      4. Keep containers holding liquid or gels closed. Liquid or gel evaluated hazardous waste pharmaceuticals in intact, sealed packaging, comply with this requirement.
      5. The rule imposes additional requirements if ignitable or reactive evaluated hazardous waste pharmaceuticals are managed or if incompatible evaluated hazardous waste pharmaceuticals are mixed or commingled in the same container.
      6. Evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition in the land disposal restrictions regulation must be accumulated in separate containers. 
    5. Containers holding evaluated hazardous waste pharmaceuticals must be marked with the applicable hazardous waste codes prior to shipment off-site.
    6. Ship evaluated hazardous waste pharmaceuticals to a permitted or interim status TSD in compliance with the requirements for shipping non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that were previously discussed.
    7. Evaluated hazardous waste pharmaceuticals that were shipped to a permitted or interim status TSD based on the understanding that the TSD can manage the wastes but the shipped wastes are rejected by the TSD and returned to the pharmaceutical reverse distributor can be accumulated on-site for up to an additional 90 days in the on-site accumulation area provided the rejected waste is managed in compliance with the management requirements previously discussed. In addition, the pharmaceutical reverse distributor must sign the manifest for the rejected waste, provide a copy of the manifest to the transporter, send a copy of the manifest to the designated facility that rejected the waste within 30 days of delivery of the rejected waste to the pharmaceutical reverse distributor, and comply with the requirements for shipping non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that were previously discussed.
    8. Comply with the land disposal restrictions requirements for the evaluated hazardous waste pharmaceuticals.
    9. Prepare and submit a single copy of the biennial report for evaluated hazardous waste pharmaceuticals that are shipped off-site in accordance with 40 CFR 262.41 except 40 CFR 262.41(a)(7). If the pharmaceutical reverse distributor does not receive a copy of the manifest signed by the designated facility within 35 days of the date the evaluated hazardous waste pharmaceuticals were shipped, the pharmaceutical reverse distributor must contact the transporter and designated facility to determine the status of the shipment. If a copy of the signed manifest is not received within 45 days of the date the evaluated hazardous waste pharmaceuticals were shipped, submit an exception report to EPA containing the information identified in the proposed rule. If the designated facility rejected the shipment and sent it to an alternate facility and the pharmaceutical reverse distributor does not receive a signed copy of the manifest from the alternate facility within 35 days of the date the evaluated hazardous waste was shipped from the designated facility to the alternate facility, the pharmaceutical reverse distributor must contact the transporter and alternate facility to determine the status of the waste. If a copy of the signed manifest is not received within 45 days of the date the evaluated hazardous waste pharmaceuticals were shipped from designated facility, submit an exception report to EPA containing the information identified in the proposed rule.
    10. Maintain a log (electronic or paper) of the weekly inspections of the on-site accumulation area for at least 3 years from the date of the inspection. Maintain copies of manifests for off-site shipments for at least 3 years from the date of shipment. Retain a copy of each biennial report for at least 3 years from the report’s due date. Retain a copy of each exception report for at least 3 years from the date of the report. Retain personnel training records. 
  6. If the pharmaceutical reverse distributor does not comply with the requirements discussed above, accepts manifested hazardous waste from off-site, or treats or disposes of hazardous waste on-site, it becomes subject to the TSD requirements in 40 CFR 264, 265, and 267 and the permit requirements in 40 CFR 270. 

Other Provisions

The proposed rule also revises the land disposal restrictions to address hazardous waste pharmaceuticals and revises the universal waste management rules to prohibit the addition of hazardous waste pharmaceuticals as a category of hazardous wastes subject to the universal waste rules.

The proposed rule also revises 40 CFR 261.5(c) to exclude hazardous waste pharmaceuticals managed pursuant to subpart P from the hazardous wastes that must be included when determining whether a facility is a large quantity generator, small quantity generator or CESQG. However, the proposed rule requires healthcare facilities to determine their initial generator status based on the total amount of hazardous waste generated per month, including hazardous waste pharmaceuticals as well as other hazardous wastes. Following that initial determination, the proposed rule allows healthcare facilities managing their hazardous waste pharmaceuticals pursuant to subpart P to exclude those hazardous waste pharmaceuticals when re-determining their generator status. For example, if a healthcare facility was a large quantity generator because it generated over 1 kg of a P-listed hazardous waste pharmaceutical per calendar month as well as some amount of other hazardous wastes and the hazardous waste pharmaceuticals are managed under subpart P, then the healthcare facility only needs to consider the non-pharmaceutical hazardous wastes to re-determine its generator status.

State Authorization

The proposed rule is issued under both HSWA and non-HSWA authorities. However, most of the proposal is under non-HSWA authority. Therefore, those portions of the proposed rule will not become effective in authorized states until the states adopt the regulations. Conversely, the prohibition of sewering pharmaceutical hazardous wastes is being issued under HSWA authority. Therefore, that prohibition will be effective in all states regardless of their authorization status on the rule’s effective date. Finally, EPA considers these rules to be more stringent than the current rules. For that reason, authorized states will be required to amend their regulations to incorporate the requirements in this rule.

In addition to the general authorization requirements, this rule provides an additional complication as it relates to states that have added hazardous waste pharmaceuticals to their universal waste programs. Currently, Michigan and Florida regulate hazardous waste pharmaceuticals as universal wastes. Because EPA considers this rule to be more stringent than the traditional hazardous waste rules or the universal waste rules, Michigan and Florida will be required to modify their programs to be at least as stringent as this rule. In addition, because EPA has determined it is not appropriate to add hazardous waste pharmaceuticals to the universal waste program, Michigan and Florida will need to remove hazardous waste pharmaceuticals from their universal waste programs and all states will be prohibited from adding hazardous waste pharmaceuticals to their universal waste programs in the future.