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Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Final Rule

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General

  • 1. Why is EPA finalizing management standards for hazardous waste pharmaceuticals?

    EPA has two primary reasons for this final rule. First, to address concerns raised by stakeholders regarding the difficulty in implementing the industry-oriented Resource Conservation and Recovery Act (RCRA) hazardous waste regulations for the management of hazardous waste pharmaceuticals generated at healthcare facilities and managed at reverse distributors. This rule revises and tailors the hazardous waste regulations to improve the management of hazardous waste pharmaceuticals by the healthcare sector and thereby enhance protection of human health and the environment.

    Second, a number of studies have documented the presence of various pharmaceutical active ingredients and metabolic by-products in surface waters and groundwater in the United States. The pharmaceuticals entering the environment, through flushing or other means, are having a negative effect on aquatic ecosystems and on fish and animal populations. These findings highlight the increasing importance of pharmaceutical use and management, and have led EPA to finalize a prohibition on disposing hazardous waste pharmaceuticals down the drain by those entities subject to this rule.

  • 2. What environmental benefits does EPA expect from new management standards for hazardous waste pharmaceuticals?

    EPA’s final rule will reduce the risk caused by hazardous waste pharmaceuticals that enter the environment through flushing down the sink or toilet. Specifically, this final rule is projected to prevent the flushing of 1,644 to 2,300 tons of hazardous waste pharmaceuticals annually by banning the drain disposal (flushing, sewering) of hazardous waste pharmaceuticals.

    With this final rule, EPA strives to improve compliance at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors that generate and manage hazardous waste pharmaceuticals in order to improve environmental protection. Specifically, EPA enhances public health protection by decreasing the risk of diversion of unused hazardous waste prescription pharmaceuticals onto the black market by requiring basic tracking of these pharmaceuticals from healthcare facilities to reverse distributors. Additionally, this final rule creates an environmentally preferable, convenient and practical management system that EPA encourages the healthcare sector to use for all waste pharmaceuticals.

  • 3. Who is affected by this final rule?

    Healthcare facilities and reverse distributors that generate and manage hazardous waste pharmaceuticals will follow these new, tailored standards for managing their hazardous waste pharmaceuticals instead of the industry-oriented hazardous waste generator regulations.

    This rule does not apply to pharmaceutical manufacturers (unless they act as reverse distributors), production facilities or other generators of hazardous waste pharmaceuticals.

    In addition, anyone who generates or manages discarded Food and Drug Administration (FDA)-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) is also affected by the amendment to the P075 listing for nicotine that is also part of this final rule. See the Question & Answer below for more information on the amendment to the P075 listing for nicotine that is part of this final rule.

  • 4. Which pharmaceuticals are considered hazardous waste?

    As thousands of over-the-counter and prescription drugs are currently approved for sale in the United States, it is difficult to provide a precise number of pharmaceuticals that are considered hazardous waste. However, as with any other waste, a solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in title 40 of the Code of Federal Regulations (40 CFR) Part 261.

    There are approximately 30 commercial chemical products listed on the P and U hazardous waste lists that have pharmaceutical uses. As the P and U lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar and Procytox, are all designated as a U058 hazardous waste for cyclophosamide.

    In addition, waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. For example, solutions containing more than 24 percent alcohol exhibit the ignitability characteristic. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide.

    Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (hazardous waste code D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011).

  • 5. Why is management of hazardous waste pharmaceuticals difficult under the RCRA subtitle C hazardous waste generator regulations?

    Hazardous waste generation and management practices at healthcare facilities differ from practices of industrial hazardous waste generators in several ways that make the application of RCRA subtitle C hazardous waste regulations difficult. Pharmaceutical waste is typically generated at a large number of points in relatively small quantities across a facility, such as at nursing stations, pharmacies and patient, emergency and operating rooms. Furthermore, generators of hazardous waste pharmaceuticals tend to generate hundreds of different types of pharmaceutical waste while, in contrast, many industrial generators tend to generate only a few predictable waste streams in large quantities at relatively few generation points. Some of the difficulties that generators of hazardous pharmaceutical wastes have expressed concerning the current hazardous waste generator regulations relate to making the waste determination, generator status upgrade due to generation of acutely hazardous waste, hazardous waste listings, and accumulation time limits.

  • 6. Why do hazardous waste pharmaceuticals need new management standards?

    Healthcare workers and retail pharmacy employees are often unfamiliar with or confused by RCRA hazardous waste management requirements, prompting them to dispose of hazardous pharmaceuticals as municipal waste or medical waste. This final rule streamlines the current regulations governing these wastes, ensuring that larger quantities of hazardous pharmaceutical wastes are managed properly. Additionally, the rule finalizes a tailored set of management standards specifically designed to reduce the complexity of the RCRA hazardous waste regulations for hazardous waste pharmaceuticals. It streamlines the collection and handling requirements for widely-dispersed hazardous wastes and facilitates their inclusion in the hazardous waste management system.

    Under this final rule, EPA expects that the management of hazardous waste pharmaceuticals to improve and the regulatory burden for many hazardous waste pharmaceutical generators will decrease. This final rule provides a solution to many of the issues facing healthcare facilities. By finalizing a convenient and practical system for the management of hazardous waste pharmaceuticals that is easy to comply with, EPA encourages healthcare facilities to manage all of their pharmaceutical waste - non-hazardous and hazardous - under the final rule.

  • 7. How will discarded over-the-counter nicotine replacement therapies be regulated?

    This final rule exempts discarded FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) from regulation as a RCRA hazardous waste (specifically, these wastes are exempt from the RCRA Hazardous Waste Code P075 for nicotine). Therefore, under the federal hazardous waste regulations, generators of these wastes (e.g., retail stores) may discard them as non-hazardous waste. This provision of the final rule must be in effect in your state to use this exemption. See EPA’s map of where the amendment to the P075 nicotine listing is currently in effect. See below for additional questions and answers related to the P075 nicotine listing amendment.

  • 8. How do these final regulations differ from the current hazardous waste generator regulations?

    Under previous requirements, any facility that generates hazardous waste pharmaceuticals was subject to the RCRA hazardous waste generator regulations. These regulations vary depending on the total amount and type of hazardous waste generated at the site in a calendar month. Many healthcare facilities are considered large quantity generators (LQGs) because they generate more than 1 kilogram (kg) of acute hazardous waste per month. Under the final management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under 40 CFR part 266, subpart P instead of the standard RCRA generator regulations found in 40 CFR part 262. Compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits: 

    1. A healthcare facility will not become a LQG, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
    2. A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
    3. A healthcare facility will not need to specify hazardous waste codes on manifests;
    4. A healthcare facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
    5. A healthcare facility will have basic training requirements.

    Additionally, the final standards are tailored to how reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at reverse distributors.

  • 9. When will this final rule go into effect?

    This final rule will be effective at the federal level six months after the rule is published in the Federal Register

    Authorized states are required to adopt this final rule and to modify their RCRA programs in order to retain their authorized status because this rule is more stringent than current RCRA generator regulations. This rule will not become effective in states authorized for the RCRA program until states have adopted the rule, with one exception.

    The exception is the ban on flushing hazardous waste pharmaceuticals. This particular requirement is being finalized under the Hazardous and Solid Waste Amendments (HSWA). Requirements promulgated under HSWA authority become effective in all states on the effective date of the federal regulation, which is six months after publication of the final rule in the Federal Register.

    The exemption from the P075 listing for FDA-approved over-the-counter nicotine replacement therapies is less stringent than current regulation. Authorized states are not required to adopt less stringent regulations. The exemption for over-the-counter nicotine replacement therapies will not become effective in states authorized for the RCRA program until states have adopted the exemption.

  • 10. How are discarded over-the-counter nicotine replacement therapies regulated?

    This final rule exempts discarded FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) from regulation as a RCRA hazardous waste (specifically, these wastes are exempt from the RCRA Hazardous Waste Code P075 for nicotine). Therefore, under the federal hazardous waste regulations, generators of these wastes (e.g., retail stores) may discard them as non-hazardous waste. This provision of the final rule must be in effect in your state to use this exemption. See EPA’s map of where the amendment to the P075 nicotine listing is currently in effect. See below for additional questions and answers related to the P075 nicotine listing amendment.

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Definitions

  • 1. What is a “healthcare facility” under this final rule?

    Healthcare facility means any person that is lawfully authorized to—

    1. Provide 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
    2. Distribute, sell, or dispense pharmaceuticals. This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals.

    The definition of healthcare facility does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers. See 40 CFR section 266.500.

    We note that a healthcare facility that is co-located within a facility that is not a healthcare facility (e.g. a clinic at a military base, school, or manufacturer), must operate as a healthcare facility under 40 CFR Part 266 Subpart P. However, if the entire facility is a very small quantity generator (VSQG), the co-located clinic does not have to operate as a healthcare facility under 40 CFR Part 266 Subpart P, except that the clinic must comply with the sewer prohibition and the new empty container standards in 40 CFR section 266.507.

  • 2. Is a long-term care facility such as a “nursing home” considered a “healthcare facility” under this final rule?

    Yes. A “long-term care facility” is a type of healthcare facility. This rule defines a long-term care facility to mean a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. See 40 CFR section 266.500.

    Not included within the scope of this definition are:  group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities. See 40 CFR section 266.500.

  • 3. What is the definition of reverse distributor under the final rule?

    Reverse distributors are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need. Reverse distributors generally have contracts with healthcare facilities to help the healthcare facility manage its unused and sometimes expired waste pharmaceuticals.

    Healthcare facilities send their unused pharmaceuticals to a reverse distributor they have a contract with and the reverse distributor reviews the unused pharmaceuticals received and works with the pharmaceutical manufacturer to facilitate providing manufacturer credit back to the healthcare facility. Then reverse distributor sends the waste pharmaceuticals for disposal.

    In the final rule, a reverse distributor is defined as:

    any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.

  • 4. What is a pharmaceutical for purposes of the Hazardous Waste Pharmaceuticals Final Rule?

    The definition of a pharmaceutical includes drugs for human or animal use, including prescription and over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, compounded drugs, investigational new drugs, as well as nicotine e-liquids packaged for retail sale and electronic nicotine delivery systems (e.g., e-cigarette or vaping pen).


Sewer Ban

  • 1. The Resource Conservation and Recovery Act (RCRA) Hazardous Waste Pharmaceuticals Final Rule (February 22, 2019; volume 84 of the Federal Register starting on page 5816) prohibits the sewering (i.e., flushing or pouring down the drain) of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors (see 40 CFR section 266.505). To which pharmaceuticals does the sewer prohibition apply?

    Section 266.505 of title 40 of the CFR prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW). The sewer prohibition applies to RCRA hazardous waste pharmaceuticals that are also controlled substances under the Drug Enforcement Administration (DEA) regulations and collected household pharmaceuticals (see 40 CFR section 266.506). We note that although the sewer prohibition applies to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical in any setting (with few exceptions, such as sterile water, 0.9 percent sodium chloride (saline) and Ringer’s lactate solution).

  • 2. Does a healthcare facility that is a very small quantity generator (VSQG) have to comply with the sewer prohibition?

    Yes. All healthcare facilities, including VSQGs, must comply with the sewer prohibition for hazardous waste pharmaceuticals. See 40 CFR section 266.505.

  • 3. When is the sewer prohibition effective?

    The sewer prohibition is effective August 21, 2019, in all states, territories and Indian Country.  This is because this portion of the Rule was promulgated pursuant to the 1984 Hazardous and Solid Waste Amendments (HSWA). The sewer prohibition is the only provision of the Hazardous Waste Pharmaceuticals Final Rule that was promulgated under HSWA authority. As a HSWA provision, the sewer prohibition goes into effect on the effective date of the rule (August 21, 2019) regardless of whether a government has received authorization to implement RCRA or has adopted Subpart P.

  • 4. When the sewer prohibition becomes effective on August 21, 2019, are healthcare facilities and reverse distributors required to submit a notification (i.e., Site Identification Form 8700-12) to EPA that they are operating under Part 266 Subpart P?

    Healthcare facilities and reverse distributors that are in an authorized state or territory that has not yet adopted Subpart P do not have to submit a notification to EPA until after the state or territory adopts Subpart P. Because the sewer prohibition is a HSWA provision, it becomes effective on August 21, 2019 in all states, territories and Indian Country regardless of whether the government is authorized to implement RCRA or has adopted Subpart P. However, the rest of Subpart P, including requirements for healthcare facilities and reverse distributors to submit a notification, is not effective in an authorized state or territory until the state or territory adopts this final rule.

    Healthcare facilities and reverse distributors that are in Indian Country, territories other than Guam, or unauthorized states (Alaska and Iowa), are required to notify EPA by 20 October 2019 (using form 8700-12) or 01 March 2020 (for those who choose to notify via their Biennial Report).

  • 5. Who will be responsible for enforcing the sewer prohibition?

    The sewer prohibition of Subpart P will be enforced through RCRA inspections of healthcare facilities and reverse distributors by state or federal officials. The Clean Water Act’s NPDES pretreatment program could also potentially apply and result in enforcement of requirements of the sewer prohibition if such requirements are adopted as part of a publicly owned treatment works’ approved pretreatment program.  Further, elements of the sewer prohibition may be reflected currently in the specific prohibitions on discharge by indirect users of POTWs in EPA’s Pretreatment Regulations at 40 CFR Part 403.

  • 6. Can hazardous waste pharmaceuticals that contain a radioactive component be discharged to the sewer?

    No. Hazardous waste pharmaceuticals that also contain a radioactive component subject to the Atomic Energy Act of 1954 (i.e., “mixed waste”) are regulated by multiple agencies. The hazardous waste component is regulated under EPA or the authorized state RCRA programs, while either the Nuclear Regulatory Commission or the Department of Energy regulates the radioactive component of the waste under the Atomic Energy Act. Therefore, a “mixed waste” pharmaceutical that is both radioactive and RCRA hazardous waste is prohibited from being discharged to the sewer.

  • 7. Can hazardous waste pharmaceuticals be discharged to septic tanks?

    No, 40 CFR section 261.4(a)(1)(ii) allows the discharge of what would otherwise be a hazardous waste to publicly owned treatment works (POTWs), without being considered solid or hazardous waste. The prohibition on discharges of hazardous waste pharmaceuticals that was promulgated as part of the Hazardous Waste Pharmaceuticals final rule reduces the scope of the exclusion in the existing regulations. Discharges of hazardous waste to other types of sewage systems, such as septic tanks, privately owned treatment works and federally owned treatment works are not allowed by the exclusion in 40 CFR section 261.4(a)(1)(ii). Therefore, the discharge of hazardous wastes to septic tanks, privately owned treatment works and federally owned treatment works is already prohibited, even though it is not explicitly stated in the sewer prohibition of Subpart P.

  • 8. Can hazardous waste pharmaceuticals be discharged to the sewer from a healthcare facility or reverse distributor that has a pretreatment permit?

    No, 40 CFR section 266.505 prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW), regardless of whether the POTW or state has issued a pretreatment permit to the healthcare facility or reverse distributor.

  • 9 .The Clean Water Act General Pretreatment Regulations for Existing and New Sources of Pollution, 40 CFR Part 403, already contain several sewer bans of hazardous wastes (e.g., liquid ignitable D001 hazardous wastes and some D002 and D003 hazardous wastes) under 40 CFR section 403.5(b). Should the HSWA sewer prohibition for hazardous waste pharmaceuticals be incorporated as another “Specific Prohibition” into local Sewer Use Ordinances (SUOs)?

    No. The HSWA sewer prohibition for hazardous waste pharmaceuticals is not required to be added to local SUOs. However, a locality may elect to add a new sewer prohibition to its SUO if it has legal authority to do so.

    EPA notes that the existing Clean Water Act (CWA) specific discharge prohibitions at 40 CFR section 403.5(b) are broader than just pharmaceuticals and apply beyond healthcare facilities and reverse distributors. Specifically, these CWA prohibitions (e.g., discharge of pollutants creating a fire or explosive hazard, causing corrosive damage) would typically ban any industrial user discharges of the following RCRA characteristic hazardous wastes (RCRA and CWA regulatory citations, respectively, are included):

    • hazardous waste discharges of D001 ignitable liquids (sections 261.21(a)(1) and 403.5(b)(1))
    • acidic D002 hazardous wastes (sections 261.22(a)(1) and 403.5(b)(2))
    • D003 reactive hazardous wastes that

    (1) react violently with water (sections 261.23(a)(2) and 403.5(b)(1)) or

    (2) form potentially explosive mixtures with water (sections 261.23(a)(3) and 403.5(b)(1)) or

    (3) when mixed with water, result in the presence of toxic gases, vapors or fumes within the POTW in a quantity that may cause acute worker health and safety problems (sections 261.23(a)(4) and 403.5(b)(7)) or

    (4) it is a cyanide or sulfide bearing waste which, when exposed to pH conditions between two (2) and 12.5, can generate toxic gases, vapors or fumes in a quantity sufficient to present a danger to human health or the environment (sections 261.23(a)(5) and 403.5(b)(7)).

  • 10. Does the sewer prohibition apply to pharmaceutical manufacturers?

    The sewer prohibition does not apply to pharmaceutical manufacturers unless those same facilities are also reverse distributors.  A reverse distributor is defined in 40 CFR section 266.500, “as any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.”

    While the sewer prohibition legally applies only to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical in any setting (with few exceptions, as noted in an earlier question). EPA promulgated Effluent Guidelines and Standards for Pharmaceutical Manufacturing at 40 CFR Part 439, which address CWA discharges of pollutants associated with this industry.

  • 11. What are the oversight and enforcement responsibilities of a Clean Water Act control authority regarding healthcare facilities?

    EPA has not established technology-based standards for discharges from healthcare facilities to POTWs, thus healthcare facilities are not categorical industrial users (CIUs). Healthcare facilities continue to be industrial users (IUs), defined broadly at 40 CFR section 403.3(j) as a “Source of Indirect Discharge,” and may be significant industrial users (SIU), defined at 40 CFR section 403.3(v).

    40 CFR section 403.8(f) directs POTWs to establish procedures and standards to identify all IUs to ensure compliance with the general and specific prohibitions to protect against pass through and interference. Control authorities, however, have discretion and flexibility on what those requirements should be for IUs (non-CIUs and non-SIUs). As a POTW’s procedures are uniquely tailored to the capacity and capability of each POTW, as well as the NPDES permit requirements for the individual receiving water body, control authorities should refer to their programs’ procedures and NPDES permit conditions to understand their requirements as they relate to all industrial users. Control authorities have the option to modify their programs to adapt their otherwise applicable procedures. This option may be considered a substantial modification, which has special requirements described in 40 CFR section 403.18. Control authorities may work with their approval authority for assistance with questions on handling specific oversight, enforcement or program modification questions.

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Reverse Distribution/Reverse Logistics

  • 1. Can a non-prescription pharmaceutical be sent to a reverse distributor?

    Yes, under some circumstances. EPA has concluded that a healthcare facility may send a non-prescription hazardous waste pharmaceutical to a reverse distributor provided the non-prescription pharmaceutical:

    1. has a reasonable expectation of receiving manufacturer credit,
    2. is in original manufacture packaging,
    3. is undispensed,
    4. is unexpired or less than one year past expiration, and
    5. is managed as a potentially creditable hazardous waste pharmaceutical under Part 266 Subpart P.

    Under Subpart P, a non-prescription pharmaceutical sent to a reverse logistics facility (which is different from a reverse distributor) is not a solid waste if it has a reasonable expectation of being used/reused or reclaimed. On the other hand, a prescription pharmaceutical sent to a reverse distributor is a solid waste and/or hazardous waste.

    When generators choose to send a non-prescription hazardous waste pharmaceutical to a reverse distributor as a potentially creditable hazardous waste pharmaceutical – rather than sending it to a reverse logistics facility as a non-waste – we would consider this practice to be “over-management” of the non-prescription hazardous waste pharmaceutical (i.e., for practical reasons generators may sometimes choose to manage certain materials along with other wastes subject to more stringent regulatory requirements).

    Although reverse distributors primarily manage prescription pharmaceuticals, EPA has learned that in some cases, healthcare facilities send their non-prescription pharmaceuticals to a reverse distributor to receive manufacturer credit. For example, a small hospital may have a contract only with a reverse distributor, not a reverse logistics center. Another example is that pharmacies keep some non-prescription pharmaceuticals behind the counter with their prescription pharmaceuticals (e.g., DEA regulations require pharmaceuticals containing pseudoephedrine (e.g., Sudafed) to be kept behind the counter of the pharmacy). EPA believes that clarifying that healthcare facilities may continue to send non-prescription hazardous waste pharmaceuticals to reverse distributors, consistent with the criteria described above, makes practical sense and the resultant, voluntary “over-management” of these materials does not present any concerns.

    We caution, however, that if the non-prescription hazardous waste pharmaceutical has no reasonable expectation of receiving manufacturer credit, or otherwise does not meet the above criteria, then it would be a solid and hazardous waste at the healthcare facility and prohibited from being sent to a reverse distributor. Instead, it must be managed under part 266 subpart P as a non-creditable hazardous waste pharmaceutical and must be sent to a RCRA designated facility (e.g., a permitted or interim status treatment, storage or disposal facility) via a hazardous waste transporter.

    Background

    The preamble to the Hazardous Waste Pharmaceuticals Final Rule includes a thorough discussion of the distinction between reverse distribution and reverse logistics (see pages 5827-5835 of 84 FR 5816; February 22, 2019).

    In brief, at the request of commenters, part 266 subpart P adopts the terminology commonly used in the healthcare industry. “Reverse distribution” is used to refer to the reverse flow of prescription pharmaceuticals. Healthcare facilities send unused prescription pharmaceuticals to reverse distributors to determine if they are eligible to receive manufacturer credit. Once credit has been verified, the prescription pharmaceuticals are discarded by the reverse distributor. Because they are not redistributed (e.g., sold on the secondary market, donated) by the reverse distributor, the prescription pharmaceuticals are considered waste at the healthcare facility before they are sent to a reverse distributor. That said, these wastes have value in the form of potential manufacturer credit, which has allowed EPA to take a more tailored and flexible regulatory approach for this particular type of hazardous waste pharmaceutical.

    “Reverse logistics” refers to the reverse flow of non-prescription pharmaceuticals and other unsold retail items. Reverse logistics centers evaluate whether items can be sold on the secondary market, donated or recycled. If non-prescription pharmaceuticals and other unsold retail items have a reasonable expectation of being legitimately used/reused (e.g., sold or donated) or reclaimed, then they can be sent to a reverse logistics center without being considered waste at the healthcare facility.

  • 2. Can a healthcare facility that is in a state where part 266 subpart P is in effect send a potentially creditable hazardous waste pharmaceutical to a reverse distributor that is in a state where part 266 subpart P is not in effect?

    Part 266 subpart P is considered more stringent than the previous regulations for the management of hazardous waste pharmaceuticals; therefore, authorized states must adopt part 266 subpart P into their authorized state programs. As a result, we view this question as a temporary issue that will be resolved when all states have adopted subpart P.

    Prior to finalizing part 266 subpart P, EPA had articulated its regulatory interpretation regarding pharmaceuticals sent to reverse distributors or manufacturers in two RCRA policy letters released in 1981 and 1991. In the first memo (May 13, 1981, RCRA Online Number 11012), EPA agreed that pharmaceuticals did not become wastes until the decision to discard was made at a manufacturing plant. EPA’s interpretation at the time was based on the understanding that the decision to either return goods for reclamation or dispose of them took place only at the manufacturing plant. In the second memo (May 16, 1991, RCRA Online Number 11606), EPA agreed that pharmaceuticals returned to a manufacturer, wholesaler, or third-party service company would not be considered wastes until a decision to discard has been made. In this 1991 memo, EPA specifically noted that, “to the extent that the materials involved are unused commercial chemical products with a reasonable expectation of being recycled in some way when returned, the materials are not considered waste until a determination to discard them is made.”

    As part of the part 266 subpart P final rule, EPA revised its position reflected in these two interpretive letters after we concluded that, because they are not redistributed by the reverse distributor for reuse or sent for reclamation, the prescription pharmaceuticals are considered waste at the healthcare facility before they are sent to a reverse distributor. We were aware that by discussing our revised position at proposal, it would raise the question of what EPA’s policy would be prior to finalizing the subpart P regulations. Consequently, in the preamble to the proposed rule, we stated, “until this rule is final and effective, EPA’s current position will remain in effect” (see 80 FR 58068 and see 80 FR 58043 for similar language). Therefore, in states that have been following the previous federal interpretation reflected in the two policy letters discussed above, and have not yet adopted subpart P, the previous interpretation remains in effect.

    In other words, a healthcare facility that is in a state where part 266 subpart P is in effect can send potentially creditable hazardous waste pharmaceuticals to a reverse distributor that is in a state where subpart P is not yet in effect. In this scenario, the healthcare facility must comply with the applicable subpart P regulations for potentially creditable hazardous waste pharmaceuticals. For example, a healthcare facility must comply with the shipping requirements in section 266.509 and the recordkeeping requirements in section 266.503(e), including maintaining a record of delivery confirmation for each shipment to the reverse distributor. Although the reverse distributor in this scenario is not subject to subpart P, as a practical matter it would still need to comply with some portions of subpart P in order to ensure the healthcare facility can maintain compliance with subpart P. These portions of subpart P would include providing a delivery confirmation for shipments received from healthcare facilities. This burden upon the reverse distributor is minimal, however, and will be satisfied if the healthcare facility requires signature by the reverse distributor upon delivery and utilizes the electronic tracking system offered by most common carriers.

  • 3. Is a reverse distributor required to issue manufacturer credit to a healthcare facility within 30 days of receiving a shipment of potentially creditable hazardous waste pharmaceuticals?

    No. Subpart P does not regulate when manufacturer credit is issued to a healthcare facility. Rather, the subpart P regulations state that a reverse distributor “must 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” (see 40 CFR 266.510(a)(3)). In other words, within 30 calendar days of receiving a shipment of potentially creditable hazardous waste pharmaceuticals, a reverse distributor must determine whether it is the reverse distributor that will be issuing manufacturer credit for a particular potentially creditable hazardous waste pharmaceutical at some point in the future (and thus the reverse distributor responsible for sending the hazardous waste pharmaceuticals to a permitted or interim status treatment storage and disposal facility) or whether a different reverse distributor will be issuing manufacturer credit for that particular pharmaceutical. The subpart P reverse distributor regulations specify a 30-day timeframe for evaluating the potentially creditable hazardous waste pharmaceuticals to determine whether or not they need to go to another reverse distributor; the regulations do not specify a timeframe for issuing manufacturer credit.

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Manifest

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Nicotine

  • 1. Is nicotine still considered a hazardous waste?

    Yes. Nicotine is still a listed acute hazardous waste with the waste code P075. In 2019, EPA removed FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges) from the P075 listing. All other nicotine waste is still considered a hazardous waste with the waste code P075 if it meets the hazardous waste listing criteria (e.g., nicotine e-liquids and e-cigarettes, prescription forms of nicotine, nicotine used in manufacturing or research).

  • 2. Are all nicotine wastes exempt from RCRA?

    No. The amendment to the P075 listing promulgated in the pharmaceuticals final rule only applies to FDA-approved over-the-counter nicotine replacement therapies (i.e., patches, gums and lozenges). All other nicotine waste that meets the P075 listing is still considered acute hazardous waste and must be managed in accordance with all applicable hazardous waste regulations.

  • 3. What regulations apply to generators of nicotine hazardous wastes that are still regulated as P075?

    In the context of the pharmaceuticals final rule, the answer depends on two things: 1) whether the generator is a healthcare facility and 2) whether the nicotine hazardous waste is a pharmaceutical. A healthcare facility must manage its hazardous waste pharmaceuticals under 40 CFR part 266 subpart P. This includes nicotine-containing pharmaceuticals such as e-liquids, e-cigarettes and prescription forms of nicotine. All other, non-pharmaceutical forms of nicotine hazardous waste (e.g., nicotine used in manufacturing or research) are regulated under 40 CFR part 262 even when generated by healthcare facilities (or possibly as a universal waste under part 273 if it is a pesticide). Additionally, if a non-healthcare facility generates nicotine hazardous waste pharmaceuticals, it is regulated under 40 CFR part 262.

  • 4. What is an FDA-approved over-the-counter nicotine replacement therapy?

    FDA has determined that over-the-counter nicotine replacement therapies can be used safely and effectively by people without a healthcare professional’s supervision when used in accordance with their label instructions. Currently, FDA has only approved nicotine patches, gums, and lozenges for sale over the counter as nicotine replacement therapies; therefore, these are the only three types of nicotine replacement therapies that have been removed from the P075 nicotine listing at this time.

  • 5. Are e-cigarettes considered an FDA-approved over-the-counter nicotine replacement therapy?

    No. As of today, FDA has not approved any e-cigarettes, (or as FDA refers to them, electronic nicotine delivery systems) for sale as an over-the-counter nicotine replacement therapy. In the future, if FDA does approve an electronic nicotine delivery device as an over-the-counter drug, it will not automatically become exempt from the P075 nicotine listing; EPA would need to undertake a new rulemaking to amend the P075 listing. Therefore, e-cigarettes and nicotine liquid that is prepackaged for sale for use in electronic nicotine delivery devices are considered hazardous waste pharmaceuticals when disposed and must be managed under the part 266 subpart P regulations.

  • 6. I represent a pharmacy that keeps FDA-approved over-the-counter nicotine replacement therapies behind the counter for instances when they are prescribed. Are these wastes exempt from the P075 listing?

    Yes. As long as the waste is an FDA-approved over-the-counter nicotine replacement therapy (i.e., patches, gums, and lozenges) it is exempt from the P075 nicotine listing irrespective of whether there may be instances when they are prescribed. Thus, their location within a retail pharmacy, hospital pharmacy, etc. is not relevant, and nicotine patches, gums and lozenges are exempt from the P075 nicotine listing whether they are behind a pharmacy counter or in the front of a store.

  • 7. I represent a VSQG healthcare facility that is not subject to part 266 subpart P (other than the sewer ban, the empty container standards and the optional provisions in 266.504). Do I have to opt into part 266 subpart P to use the nicotine amendment?

    No. The amendment to the P075 nicotine listing is a stand-alone regulation the applicability of which (including the exclusion from the listing for nicotine replacement therapy wastes) is independent of the regulations in part 266 subpart P. The amendment to the P075 nicotine listing applies to wastes generated at all facilities regardless of whether they are operating under part 266 subpart P and regardless of their generator category (i.e., VSQG, SQG, or LQG). Therefore, it is not necessary to opt into part 266 subpart P in order for the amended P075 listing to apply. However, please note that states must first adopt the amendment to the P075 nicotine listing before it is in effect for generators in that state. In other words, you must continue to manage your nicotine patches, gums and lozenges under applicable existing hazardous waste requirements until your state has adopted the amendment to the P075 nicotine listing. The amendment to the P075 nicotine listing is considered less stringent than the previous regulations which means that authorized states (all but Iowa and Alaska) are not required to adopt it. Click here to view EPA’s map of where the amendment to the P075 nicotine listing is currently in effect and check with your state environmental agency for further state-specific information.

  • 8. Does the nicotine P075 hazardous waste listing amendment only apply to healthcare facilities and reverse distributors as defined in 266.500?

    No. The amendment to the P075 nicotine listing is not limited to healthcare facilities and reverse distributors operating under part 266 subpart P. The amendment to the P075 nicotine listing modifies the P075 listing for nicotine in 40 CFR 261, which means that it applies to the waste regardless of who generates or manages it. For example, a manufacturing facility that is not considered a healthcare facility under part 266 subpart P can use the nicotine listing amendment. However, the amendment to the P075 nicotine listing must first be adopted by an authorized state before facilities in that state can take advantage of the nicotine listing amendment. See EPA’s map of where the amendment to the P075 nicotine listing is currently in effect.

  • 9. Do e-cigarettes qualify for the nicotine P075 hazardous waste listing amendment?

    No. All forms of nicotine-containing e-cigarettes, e-liquids, electronic nicotine delivery systems, etc., are still considered hazardous waste with the waste code P075 when discarded.

  • 10. Can FDA-approved over-the-counter nicotine replacement therapy wastes that are exempt from being P075 be thrown in the municipal solid waste trash?

    Yes, nicotine wastes that are exempt from being P075 can be thrown in the municipal solid waste trash, but only in states where the nicotine listing amendment is in effect (i.e., authorized states that have adopted the amendment, Indian Country, territories and non-authorized states). Even after the nicotine listing amendment is in effect in a state, EPA recommends as a best practice that healthcare facilities, including retailers, place the nicotine patches, gums and lozenges in trash receptacles with controlled access to prevent illicit diversion (i.e., dumpster diving) and mitigate risk to the public, as well as limit liability. Some examples include dumpsters that have locking lids, or dumpsters that are surrounded by a locking fence.

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Pharmaceutical Take-Backs

  • 1. Can household pharmaceuticals collected in a kiosk be burned at a crematorium?

    No. EPA has determined that the human body should not be considered 'solid waste.' Therefore, human crematories as well as animal crematoriums are not solid waste combustion units. As a result, crematoriums are not regulated under the Clean Air Act and typically do not use air pollution control devices to limit toxic air pollutant such as mercury and dioxins and furans. Therefore, crematoriums would not provide adequate public health and environmental protection when burning collected household pharmaceuticals. If solid wastes, such as collected household pharmaceuticals, are burned in a crematorium, it would make the crematorium subject to the Clean Air Act waste incineration regulations.

  • 2. Can household pharmaceuticals collected in a kiosk be combusted by law enforcement in a burn barrel?

    No. Open burning of residential, commercial, institutional, or industrial solid waste is prohibited under the RCRA Subtitle D regulations in 40 CFR section 257.3-7(a). Additionally, in many cases, state laws and local ordinances strictly limit or prohibit open burning of household waste.

    Because emissions from open burning are generally not controlled, open burning of pharmaceuticals from take-back events may pose health risks to law enforcement officers and members of the surrounding communities. This is due to the potential formation, release and exposure to pollutants formed as byproducts during open burning of the pharmaceuticals and their plastic, glass, multi-laminate films, and cardboard packaging. These pollutants, such as dioxins, furans, particulate matter, sulfur dioxide, lead, mercury, and hexachlorobenzene may cause immediate and long-term adverse health effects such as cancer, respiratory illness and reproductive disorders. It is also possible that barrels with fans (sometimes referred to as burn barrels), may pose similar risks from emissions. Further, given the comparatively low combustion temperature, and the difficulty in controlling the combustion temperature, it is not evident that open burning or burn barrels would achieve the DEA’s non-retrievable standard for the destruction of controlled substances. See the memorandum dated September 11, 2018. .

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