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?
  2. What environmental benefits does EPA expect from new management standards for hazardous waste pharmaceuticals?
  3. Who is affected by this final rule?
  4. Which pharmaceuticals are considered hazardous waste?
  5. Why is management of hazardous waste pharmaceuticals difficult under the RCRA subtitle C hazardous waste generator regulations?
  6. Why do hazardous waste pharmaceuticals need new management standards?
  7. How will discarded over-the-counter nicotine replacement therapies be regulated?
  8. How do these final regulations differ from the current hazardous waste generator regulations?
  9. When will this final rule go into effect?
  10. How are discarded over-the-counter nicotine replacement therapies regulated?

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. Refer to 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. Refer to EPA’s map of where the amendment to the P075 nicotine listing is currently in effect. Refer to the additional questions and answers below 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. Refer to EPA’s map of where the amendment to the P075 nicotine listing is currently in effect. Refer to the additional questions and answers below related to the P075 nicotine listing amendment.

Applicability

1. Who must manage their hazardous waste pharmaceuticals under part 266 subpart P?
2. Is a healthcare facility that is a VSQG subject to part 266 subpart P?
3. How should a healthcare facility determine whether it generates above VSQG amounts of hazardous waste in a calendar month?
4. How does a healthcare facility or reverse distributor that is operating under part 266 subpart P for its hazardous waste pharmaceuticals calculate its generator category for its other hazardous waste?
5. How does a healthcare facility or reverse distributor that is operating under part 266 subpart P for its hazardous waste pharmaceuticals manage its hazardous wastes that are not pharmaceuticals?
6. How does a generator that is not a healthcare facility or reverse distributor manage its hazardous waste pharmaceuticals?
7. Does a reverse distributor have a choice whether to comply with Part 266 subpart P for the management of its hazardous waste pharmaceuticals?
8. Does a healthcare facility have a choice whether to comply with Part 266 subpart P for the management of its hazardous waste pharmaceuticals?
9. Does a healthcare facility that is a VSQG have a choice whether to comply with part 266 subpart P for the management of its hazardous waste pharmaceuticals?
10. How should pharmaceuticals that are in aerosol cans be managed? Under part 266 subpart P as hazardous waste pharmaceuticals or under part 273 as universal waste?
11. Would the fulfillment center of an online retailer of pharmaceuticals be considered a healthcare facility that should operate under subpart P for the management of its hazardous waste pharmaceuticals?

1. Who must manage their hazardous waste pharmaceuticals under part 266 subpart P?

There are two types of facilities that are subject to the regulations in 40 CFR part 266 subpart P: healthcare facilities and reverse distributors (check out the definitions for these terms in section 266.500).

All reverse distributors must manage their hazardous waste pharmaceuticals under 40 CFR part 266 subpart P.

All healthcare facilities that generate above VSQG amounts of hazardous waste (refer to Question 3 in this section for more information) must manage their hazardous waste pharmaceuticals under 40 CFR part 266 subpart P.

2. Is a healthcare facility that is a VSQG subject to part 266 subpart P?

Healthcare facilities that generate above VSQGs amounts of hazardous waste (i.e., SQG or LQG) must manage their hazardous waste pharmaceuticals under 40 CFR part 266 subpart P. Healthcare facilities that generate VSQG amounts of hazardous waste are subject to the hazardous waste generator regulations for VSQGs in 40 CFR section 262.14, as well as three sections of part 266 subpart P:

  1. the prohibition of sewering hazardous waste pharmaceuticals in 40 CFR section 266.505
  2. the empty containers standards in 40 CFR section 266.507, and
  3. the optional provisions for VSQGs in 40 CFR section 266.504.

Alternatively, any healthcare facility that is a VSQG of hazardous waste has the choice of opting into 40 CFR part 266 subpart P, in which case, that facility is subject to all of the required provisions applicable to healthcare facilities in 40 CFR part 266 subpart P (also refer to Question 8 in this section).

3. How should a healthcare facility determine whether it generates above VSQG amounts of hazardous waste in a calendar month?

40 CFR section 260.10 defines very small quantity generator as a generator who generates less than or equal to the following amounts in a calendar month:

(1) 100 kilograms (220 lbs) of non-acute hazardous waste; and

(2) 1 kilogram (2.2 lbs) of acute hazardous waste listed in §261.31 or §261.33(e) of this chapter; and

(3) 100 kilograms (220 lbs) of any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste listed in §261.31 or §261.33(e) of this chapter.

To determine whether a healthcare facility generates above VSQG amounts of hazardous waste, a healthcare facility must count all of the hazardous waste it generates in a calendar month — both pharmaceutical and non-pharmaceutical.

Healthcare facilities that generate above VSQGs amounts of hazardous waste must manage their hazardous waste pharmaceuticals under 40 CFR part 266 subpart P. When operating under part 266 subpart P, there are no generator categories with respect to hazardous waste pharmaceuticals. However, a healthcare facility must determine its generator category for its other hazardous wastes which would be based solely on the non-pharmaceutical hazardous waste amounts (refer to question 4).

4. How does a healthcare facility or reverse distributor that is operating under part 266 subpart P for its hazardous waste pharmaceuticals calculate its generator category for its other hazardous waste?

Part 266 subpart P only applies to the management of hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Most, if not all, healthcare facilities and reverse distributors operating under 40 CFR part 266 subpart P for their hazardous waste pharmaceuticals will also generate other hazardous wastes that are not pharmaceuticals. These non-pharmaceutical hazardous wastes are not regulated under part 266 subpart P; they continue to be regulated under the Part 262 hazardous waste generator regulations (or other applicable regulations, such as Universal Waste).

Once a healthcare facility or reverse distributor has determined that part 266 subpart P applies to the management of its hazardous waste pharmaceuticals, the next step is for the healthcare facility to determine its generator category under part 262 so it knows how to manage its non-pharmaceutical hazardous waste. At this point, a healthcare facility does not need to count its hazardous waste pharmaceuticals in determining its generator category for its non-pharmaceutical hazardous waste. In fact, it is not necessary to include any of the hazardous wastes identified in 40 CFR section 262.13 (c) and (d). Put another way, a healthcare facility managing its hazardous waste pharmaceuticals under subpart P does not have a generator category for the hazardous waste pharmaceuticals, but it will be a VSQG, SQG or LQG for its non-pharmaceutical hazardous waste.

It is possible that a healthcare facility or reverse distributor managing its hazardous waste pharmaceuticals under part 266 subpart P may become a VSQG with respect to its non-pharmaceutical hazardous waste, in which case, they would be subject to the regulations in 40 CFR section 262.14 for their non-pharmaceutical hazardous waste.

It is important to note that a healthcare facility or reverse distributor must be managing its hazardous waste pharmaceuticals under part 266 subpart P in order to have the benefit of not counting its hazardous waste pharmaceuticals toward determining its generator category.

For a flow chart and additional explanation, refer to pages 5863-5866 and 5933-5934 of the preamble of the Final Rule.

5. How does a healthcare facility or reverse distributor that is operating under part 266 subpart P for its hazardous waste pharmaceuticals manage its hazardous wastes that are not pharmaceuticals?

Healthcare facilities and reverse distributors operating under 40 CFR part 266 subpart P for their hazardous waste pharmaceuticals may also generate other hazardous wastes that are not pharmaceuticals. Healthcare facilities and reverse distributors must manage their non-pharmaceutical hazardous wastes under other applicable parts of the RCRA regulations. Most non-pharmaceutical hazardous wastes will continue to be managed under the standard generator regulations in 40 CFR part 262. However, healthcare facilities and reverse distributors may also generate universal wastes, such as mercury lamps or batteries, which may be managed under the Universal Waste regulations in 40 CFR part 273.

6. How does a generator that is not a healthcare facility or reverse distributor manage its hazardous waste pharmaceuticals?

40 CFR Part 266 subpart P was designed specifically for the healthcare sector. A generator that is not a healthcare facility or reverse distributor must manage its hazardous waste pharmaceuticals under the hazardous waste generator regulations in 40 CFR part 262.

7. Does a reverse distributor have a choice whether to comply with Part 266 subpart P for the management of its hazardous waste pharmaceuticals?

No. All reverse distributors must manage their hazardous waste pharmaceuticals under part 266 subpart P. 

8. Does a healthcare facility have a choice whether to comply with Part 266 subpart P for the management of its hazardous waste pharmaceuticals?

All healthcare facilities that generate above VSQG amounts of hazardous waste must manage their hazardous waste pharmaceuticals under the regulations in 40 CFR part 266 subpart P (also refer to Questions 2, 3 and 9 in this section for discussion of healthcare facilities that are VSQGs).

9. Does a healthcare facility that is a VSQG have a choice whether to comply with part 266 subpart P for the management of its hazardous waste pharmaceuticals?

Yes. A healthcare facility that is a VSQG may choose to opt into 40 CFR part 266 subpart P for the management of its hazardous waste pharmaceuticals (also refer to questions 2 and 3 in this section). If a VSQG healthcare facility chooses to opt into 40 CFR part 266 subpart P, it must notify the Region or authorized state using the Site Identification Form (Form 8700-12) and comply with all the required provisions of 40 CFR part 266 subpart P that are applicable to healthcare facilities.

Alternatively, a healthcare facility that is a VSQG may continue to operate under the VSQG regulations in 40 CFR section 262.14 and use the optional provisions for VSQG healthcare facilities in 40 CFR section 266.504. If a healthcare facility that is a VSQG chooses to use the optional provisions of 40 CFR section 266.504, it will not be considered to have opted into 40 CFR part 266 subpart P and does not have to submit a notification. Conversely, healthcare facilities that opt into 40 CFR part 266 subpart P may not use the optional provisions in 40 CFR section 266.504.

All healthcare facilities in all states are subject to the sewering prohibition in 40 CFR section 266.505, including all VSQG healthcare facilities, regardless of whether the VSQG healthcare facility has opted into 40 CFR part 266 subpart P.

10. How should pharmaceuticals that are in aerosol cans be managed? Under part 266 subpart P as hazardous waste pharmaceuticals or under part 273 as universal waste?

Under the RCRA regulations, if a device meets the definition of aerosol can as defined in 40 CFR section 260.10 and contains a pharmaceutical as defined in 40 CFR section 266.500, healthcare facilities and reverse distributors may choose to manage the hazardous waste pharmaceutical in an aerosol can under 40 CFR part 266 subpart P rather than under 40 CFR part 273. Please refer to page 79 of the Response to Comments document for the Aerosol Cans Universal Waste Final Rule. However, there are standards and regulations other than RCRA that may also apply. For example, the security requirements of auditing entities such as The Joint Commission and state Board of Pharmacy regulations may require aerosol cans which contain pharmaceuticals to be managed securely as pharmaceutical waste. So, please check those organizations’ standards and regulations.

11. Would the fulfillment center of an online retailer of pharmaceuticals be considered a healthcare facility that should operate under subpart P for the management of its hazardous waste pharmaceuticals?

Yes. The fulfillment center of an online retailer of pharmaceuticals would be considered a healthcare facility, and if it generates above VSQG amounts of hazardous waste in a calendar month (refer to Question 3 in this section), it must operate under part 266 subpart P with respect to the management of its hazardous waste pharmaceuticals.

The definition of “healthcare facility” in 40 CFR section 266.500 is broad and includes some entities that do not ordinarily refer to themselves as healthcare facilities (emphasis added in bold): 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, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription 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. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.

Further, as we stated in the preamble to the final rule (refer to page 5851): The final definition of ‘‘healthcare facility’’ includes locations that sell pharmaceuticals over the internet, through the mail, or through other distribution mechanisms.

A healthcare facility that distributes, sells or dispenses any type or types of pharmaceutical, as defined by 40 CFR section 266.500, (e.g., over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, prescription pharmaceuticals, e-cigarettes, or e-liquids) is subject to subpart P for the management of hazardous waste pharmaceuticals, if it generates above VSQG amounts of hazardous waste during a calendar month. 

Definitions

Definitions - Facility Related

  1. What is the definition of healthcare facility under this final rule?
  2. Is a long-term care facility such as a nursing home considered a healthcare facility under this final rule?
  3. What is the definition of reverse distributor under the final rule?
  4. Is a clinic at a military base, manufacturer or school, required to operate as a healthcare facility under part 266 subpart P?
  5. Is a retail facility such as a pharmacy considered a healthcare facility under this final rule?
  6. Are pharmaceutical manufacturers subject to part 266 subpart P when they discard hazardous waste pharmaceuticals?
  7. Is a wholesale distributor considered a healthcare facility under this final rule?

Definitions - Waste Related

  1. What is a pharmaceutical for purposes of the Hazardous Waste Pharmaceuticals Final Rule?
  2. What is a potentially creditable hazardous waste pharmaceutical?
  3. Should PPE that is contaminated with hazardous waste pharmaceuticals be managed under part 266 subpart P?
  4. Isopropyl alcohol is used at healthcare facilities to both clean wounds and to clean instruments and surfaces. When is it considered a pharmaceutical?
  5. Are dietary supplements considered pharmaceuticals?
  6. Are medical devices, such as diagnostic kits, considered pharmaceuticals?
  7. Sodium azide is an acute listed hazardous waste with the waste code P105. If a COVID-19 rapid test kit has sodium azide as an ingredient, would the test kit be P105 acute hazardous waste when discarded?

Definitions - Facility Related

1. What is the definition of “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.

This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers. Refer to 40 CFR section 266.500

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. A long-term care facility means:

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.

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. Refer to 40 CFR section 266.500. EPA has also determined that intermediate care facilities are not considered long-term care facilities. Refer to RCRA Online memo 14917

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 the reverse distributor with which they have a contract. The reverse distributor reviews the unused pharmaceuticals it receives and works with the pharmaceutical manufacturer to provide manufacturer credit back to the healthcare facility. Then the reverse distributor sends the waste pharmaceuticals for treatment and/or disposal.

In the final rule, a reverse distributor is defined as (refer to 40 CFR section 266.500):

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. Is a clinic at a military base, manufacturer or school, required to operate as a healthcare facility under part 266 subpart P?

Yes. A clinic that is co-located within a facility that is not a healthcare facility (e.g. a clinic at a military base or manufacturer, or a nurses’ office at a school), must operate as a healthcare facility under 40 CFR part 266 subpart P if the entire facility is a small quantity generator (SQG) or large quantity generator (LQG).

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 and can instead choose to comply the VSQG regulations in 40 CFR section 262.14. Regardless of whether such a clinic operates under part 266 subpart P or under the VSQG regulations in 40 CFR section 262.14, the clinic must comply with the sewer prohibition in 40 CFR section 266.505 and the empty containers standards in 40 CFR section 266.507.

5. Is a retail facility such as a pharmacy considered a healthcare facility under this final rule?

Yes. Any facility that distributes, sells, or dispenses pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals, is considered a healthcare facility under part 266 subpart P. This includes pharmacies, long-term care pharmacies, mail-order pharmacies, and retailers of pharmaceuticals. Refer to 40 CFR section 266.500.

6. Are pharmaceutical manufacturers subject to part 266 subpart P when they discard hazardous waste pharmaceuticals?

No. 40 CFR part 266 subpart P applies to the management of hazardous waste pharmaceuticals only by healthcare facilities and reverse distributors. Other entities, such as pharmaceutical manufacturers, that generate hazardous waste pharmaceuticals are subject to the generator regulations in 40 CFR part 262.

Keep in mind that if a manufacturer has an on-site healthcare facility like a clinic or nurse’s office, that healthcare facility co-located within the larger facility would be required to operate under 40 CFR part 266 subpart P. Refer to question 4 in this section for further discussion.

7. Is a wholesale distributor considered a healthcare facility under this final rule?

Yes. Any facility that distributes, sells, or dispenses pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals, is considered a healthcare facility under 40 CFR part 266 subpart P. This includes wholesale distributors, third-party logistics providers that serve as forward distributors, and military medical logistics facilities. However, any facility that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit is considered a reverse distributor, and not a healthcare facility, under this rule (refer to question 3 in this section).

Definitions - Waste Related

1. 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).

2. What is a potentially creditable hazardous waste pharmaceutical?

A potentially creditable hazardous waste pharmaceutical is defined as:

A prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and is:

(1) In original manufacturer packaging (except pharmaceuticals that were subject to a recall);

(2) Undispensed; and

(3) Unexpired or less than one year past expiration date.

The term does not include evaluated hazardous waste pharmaceuticals or nonprescription pharmaceuticals including, but not limited to, over-the-counter drugs, homeopathic drugs, and dietary supplements (refer to 40 CFR section 266.500).

Whether a potentially creditable hazardous waste pharmaceutical will ultimately receive manufacturer credit is determined solely by the manufacturer’s return policy. EPA understands that the return policies of manufacturers change regularly. As a result, healthcare facilities are often not aware at the time a pharmaceutical is pulled from the shelves if that particular pharmaceutical will ultimately receive manufacturer credit. A healthcare facility that sends a potentially creditable hazardous waste pharmaceutical to a reverse distributor does not have to definitively know whether that particular pharmaceutical will receive manufacturer credit, but the healthcare facility must have a reasonable expectation that it will. Conversely, if a healthcare facility knows that a specific waste pharmaceutical will not receive manufacturer credit, that item would be considered a non-creditable hazardous waste pharmaceutical which cannot be sent to a reverse distributor.

3. Should PPE that is contaminated with hazardous waste pharmaceuticals be managed under part 266 subpart P

The final definition of pharmaceutical includes items contaminated with or containing pharmaceuticals, such as personal protective equipment contaminated with pharmaceuticals. Only personal protective equipment that is already considered hazardous waste under the ‘‘contained in’’ policy because it is contaminated with pharmaceuticals will fall under the definition of pharmaceutical. For example, the contained in policy would not apply to gloves that have touched a warfarin pill during the course of patient care. However, if a healthcare worker spills a hazardous waste pharmaceutical on their personal protective equipment and it cannot be removed from the personal protective equipment, the personal protective equipment would be considered a hazardous waste pharmaceutical and must be managed under part 266 subpart P. If the personal protective equipment only has trace amounts of contamination it would not be considered a hazardous waste and therefore not be considered a hazardous waste pharmaceutical (refer to page 5842 of the preamble of the Final Rule).

4. Isopropyl alcohol is used at healthcare facilities to both clean wounds and to clean instruments and surfaces. When is it considered a pharmaceutical?

When isopropyl alcohol is used to clean wounds, it is labeled with “Drug Facts.” If an over-the-counter product, such as isopropyl alcohol, is required by the Food and Drug Administration to include ‘‘Drug Facts’’ on the label, it would be considered a pharmaceutical and, if it is a hazardous waste, it would have to be managed under part 266 subpart P when discarded by healthcare facilities. For other uses, such as cleaning instruments and surfaces, isopropyl alcohol would not be labeled with “Drug Facts” and would be a non-pharmaceutical hazardous waste that would have to be managed under part 262 when discarded.

5. Are dietary supplements considered pharmaceuticals?

Yes. Dietary supplements are considered pharmaceuticals under the final rule, and some dietary supplements are considered hazardous waste pharmaceuticals when disposed.  As retailers of pharmaceuticals, stores like GNC and Vitamin Shoppe would meet our definition of healthcare facility. EPA expects, however, that many of the smaller retail establishments would generate small enough quantities of hazardous waste in a calendar month to be very small quantity generators (VSQGs) and therefore only subject to the sewer prohibition in 40 CFR section 266.505, the empty containers standards in 40 CFR section 266.507, and the optional provisions in 40 CFR section 266.504.

6. Are medical devices, such as diagnostic kits, considered pharmaceuticals?

No. Medical devices, including diagnostic kits, are not themselves considered pharmaceuticals under the final rule. EPA’s definition of pharmaceutical is based upon the FDA’s definition of drug and the FDA does not consider medical devices to be drugs.

However, some medical devices, such as delivery devices, may contain pharmaceuticals. FDA calls these “combination products.” Examples of combination products include prefilled drug delivery systems such as syringes, insulin injector pens, metered dose inhalers. If a drug delivery systems contains a pharmaceutical that meets the definition of hazardous waste, then the contents of the device would be regulated as a hazardous waste pharmaceutical under 40 CFR part 266 subpart P, unless the device is considered empty, as defined by 40 CFR section 266.507.

Other medical devices that are or contain non-pharmaceutical hazardous waste, should be managed under the 40 CFR part 262 regulations (or other applicable hazardous waste regulations), not under part 266 subpart P.

7. Sodium azide is an acute listed hazardous waste with the waste code P105. If a COVID-19 rapid test kit has sodium azide as an ingredient, would the test kit be P105 acute hazardous waste when discarded? 

No. A P-listing applies when the listed chemical is the sole active ingredient in the commercial chemical product. If the sodium azide in a COVID-19 rapid test kit is used as a preservative, it is not considered an active ingredient; therefore, the P105 listing would not apply. Refer to RO 11405 and RO 13530 for prior interpretations that preservatives are not active ingredients.

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 (refer to 40 CFR section 266.505). To which pharmaceuticals does the sewer prohibition apply?
  2. Does a healthcare facility that is a very small quantity generator (VSQG) have to comply with the sewer prohibition?
  3. When is the sewer prohibition effective?
  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?
  5. Who will be responsible for enforcing the sewer prohibition?
  6. Can hazardous waste pharmaceuticals that contain a radioactive component be discharged to the sewer?
  7. Can hazardous waste pharmaceuticals be discharged to septic tanks?
  8. Can hazardous waste pharmaceuticals be discharged to the sewer from a healthcare facility or reverse distributor that has a pretreatment permit?
  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)?
  10. Does the sewer prohibition apply to pharmaceutical manufacturers?
  11. What are the oversight and enforcement responsibilities of a Clean Water Act control authority regarding healthcare facilities?

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 (refer to 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 (refer to 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. Refer to 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 (refer to question # 6 under Definitions, and 40 CFR section 266.500 for the regulatory definition of reverse distributor). Nevertheless, pharmaceutical manufacturers must meet certain pretreatment standards and requirements to be allowed to sewer what otherwise might be classified as hazardous waste. 

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 question #1 of this section).

Furthermore, there are Clean Water Act regulations that place limits on discharges by pharmaceutical manufacturers.

First, EPA promulgated Effluent Guidelines and Standards for Pharmaceutical Manufacturing at 40 CFR Part 439, which address CWA discharges of pollutants associated with this industry. The effluent guidelines apply to pharmaceutical manufacturers with any amount of discharges; there is no exemption for de minimis amounts of discharges.

Second, the Clean Water Act regulations contain several discharge prohibitions (sewer bans) of what otherwise would be classified as hazardous wastes that apply to industrial users (e.g., liquid ignitable D001 hazardous wastes and some D002 and D003 hazardous wastes) under 40 CFR section 403.5(b) (refer to question #9 of this section)

Third, the Clean Water Act regulations require industrial users, including pharmaceutical manufacturers, to report discharges of what would otherwise be classified as hazardous waste (refer to Office of Water fact sheet):

40 CFR section 403.12(p)(2) …Discharge of more than fifteen kilograms of non-acute hazardous wastes in a calendar month, or of any quantity of acute hazardous wastes as specified in 40 CFR section 261.30(d) and 261.33(e), requires a one-time notification.

This latter notification does not mean that the hazardous discharge to the (POTW) is authorized. To ensure that the industrial user carries out its obligations to implement “a program in place to reduce the volume and toxicity of the hazardous wastes” (refer to 40 CFR section 403.12(p)(4)) and other applicable regulations, the POTW could include such provisions in the permit:

  • Prohibition of the discharge
  • Effluent guidelines (e.g., for pharmaceutical manufacturers)
  • Local limits (which may include Best Management Practices for the reduction or elimination of the waste, or specific conditions regarding its disposal).

Therefore, industrial users must get approval from their POTW before intentionally discharging anything that would otherwise be classified as hazardous waste. Finally, as a best practice, EPA recommends that anyone wishing to discharge anything that would otherwise be classified as hazardous waste to a POTW should contact the POTW before doing so.

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.

Reverse Distribution/Reverse Logistics

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

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 (refer to 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” (refer to 80 FR 58068 and 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” (refer to 40 CFR section 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.

Manifest

  1. I work for a healthcare facility that is subject to 40 CFR 266 subpart P and I need to initiate a shipment of non-creditable hazardous waste pharmaceuticals to a hazardous waste incinerator. I understand that the regulations require PHARMS on the manifest in lieu of waste codes, but I’m having issues fitting the 6-character “PHARMS” in item 13 on a paper manifest. What should I do?
  2. Can I include waste codes on the manifest in addition to the PHARMS/PHRM code for shipments of non-creditable hazardous waste pharmaceuticals?
  3. What information is required in item 13 of the manifest if I am shipping non-creditable hazardous waste pharmaceuticals from a state where 40 CFR part 266 subpart P is in effect to one where it is not?

1. I work for a healthcare facility that is subject to 40 CFR 266 subpart P and I need to initiate a shipment of non-creditable hazardous waste pharmaceuticals to a hazardous waste incinerator. I understand that the regulations require PHARMS on the manifest in lieu of waste codes, but I’m having issues fitting the 6-character “PHARMS” in item 13 on a paper manifest. What should I do?

Healthcare facilities may choose to use either PHARMS or PHRM in item 13 of the paper or electronic hazardous waste manifest as EPA explained in the following guidance memo, Johnson to Divison Directors, December 19, 2019 (RCRA Online #14919).

However, to assist implementation and consistency, EPA requests that implementing Regions and authorized states encourage healthcare facilities to use the four-character code PHRM on both paper manifests and electronic manifests.

2. Can I include waste codes on the manifest in addition to the PHARMS/PHRM code for shipments of non-creditable hazardous waste pharmaceuticals?

Yes. Waste codes are allowed, although not required, on the manifest for shipments of non-creditable hazardous waste pharmaceuticals.

3. What information is required in item 13 of the manifest if I am shipping non-creditable hazardous waste pharmaceuticals from a state where 40 CFR part 266 subpart P is in effect to one where it is not?

Healthcare facilities that are subject to 40 CFR part 266 subpart P are required to write PHARMS or PHRM in item 13 of the manifest but are not required to include individual waste codes. In states that have not yet adopted part 266 subpart P, healthcare facilities are subject to the standard 40 CFR part 262 generator regulations for their hazardous waste pharmaceuticals, which require healthcare facilities to include all applicable waste codes on the manifest. Therefore, we recommend that the healthcare facility/vendor check with those states regarding whether they require all applicable waste codes to be on the manifest for non-creditable hazardous waste pharmaceuticals being shipped from a healthcare facility operating under subpart P but passing through a state or going to a TSDF in a state that has not yet adopted subpart P. In this circumstance, if the state that has not yet adopted subpart P chooses to require waste codes on the manifest, then PHARMS or PHRM, as well as all applicable waste codes, would be required on the manifest. This is allowable as explained in the following memo, Johnson to Divison Directors, December 19, 2019 (RCRA Online #14919).

Nicotine

  1. Is nicotine still considered a hazardous waste?
  2. Are all nicotine wastes exempt from RCRA?
  3. What regulations apply to generators of nicotine hazardous wastes that are still regulated as P075?
  4. What is an FDA-approved over-the-counter nicotine replacement therapy?
  5. Are e-cigarettes considered an FDA-approved over-the-counter nicotine replacement therapy?
  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?
  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?
  8. Does the nicotine P075 hazardous waste listing amendment only apply to healthcare facilities and reverse distributors as defined in 266.500?
  9. Do e-cigarettes qualify for the nicotine P075 hazardous waste listing amendment?
  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?

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 part 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. Refer to 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.

Pharmaceutical Take-Backs

  1. Can household pharmaceuticals collected in a kiosk be burned at a crematorium?
  2. Can household pharmaceuticals collected in a kiosk be combusted by law enforcement in a burn barrel?

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. Refer to the memorandum dated September 11, 2018. 

Hazardous Wastes that are also DEA Controlled Substances

  1. Which pharmaceuticals are both a RCRA hazardous waste and a DEA controlled substance?
  2. What are the regulations in part 266 subpart P for healthcare facilities and reverse distributors that dispose of a pharmaceutical that is both a RCRA hazardous waste and a DEA controlled substance?
  3. What are the regulations in part 266 subpart P for household waste pharmaceuticals collected in kiosks (what DEA refers to as “collection receptacles”) at a retail or hospital pharmacy?
  4. If a healthcare facility puts leftover, partially administered pharmaceuticals into an on-site drug “sequestration unit,” can that unit be placed in the trash?
  5. Some healthcare facilities use specialized containers to accumulate waste pharmaceuticals, particularly those that are DEA controlled substances. These sequestration devices typically have some material inside such as activated carbon.  Are these sequestration devices considered allowable generator treatment?
  6. Do household pharmaceuticals that are collected at kiosks at law enforcement locations have to meet the terms of the conditional exemption in 40 CFR section 266.506?

1. Which pharmaceuticals are both a RCRA hazardous waste and a DEA controlled substance?

EPA is aware of a handful of pharmaceuticals that are both a RCRA hazardous waste and a DEA controlled substance (refer to table below). This list should not be considered exhaustive or all-inclusive; there may be additional pharmaceuticals that are both a RCRA hazardous waste and a DEA controlled substance. Check out the DEA's list of controlled substances (pdf)(764 KB) for more information.

Name of Drug Other Name(s) Medical Uses RCRA HW Code DEA Schedule Comment

Chloral/ Chloral hydrate

  

Acetaldehyde, trichloro-;  Aquachloral
Noctec
Somnote
Supprettes

 Sedative

U034
Toxic

 IV Used in hospital pediatric units; common ingredient in vet anesthetics
Fentanyl sublingual spray Subsys Analgesic D001
Ignitable		 II Ignitable due to alcohol content
Phenobarbital

Bellergal-S
Donnatal
Luminal

 Anticonvulsant D001
Ignitable		 IV Ignitable due to alcohol content
Testosterone gels/solutions

Androgel
Axiron
Fortesta
Testim

 Hormone D001
Ignitable		 III Ignitable due to gel base
Valium injectable/gel

Diazepam
Diastat

 Anti-anxiety D001
Ignitable		 IV Ignitable due to alcohol content

2. What are the regulations in part 266 subpart P for healthcare facilities and reverse distributors that dispose of a pharmaceutical that is both a RCRA hazardous waste and a DEA controlled substance?

Until this final rule, pharmaceuticals that are both RCRA hazardous waste and DEA controlled substances were dually regulated which meant that they had to be disposed in compliance with both the RCRA hazardous waste regulations and the DEA regulations for controlled substances. As part of 40 CFR part 266 subpart P, EPA eliminated the dual regulation by finalizing a conditional exemption for healthcare facilities and reverse distributors that generate or manage pharmaceuticals that are both RCRA hazardous waste and DEA controlled substances (refer to 40 CFR section 266.506).

That is, the hazardous waste pharmaceuticals that are also DEA controlled substances are exempt from RCRA hazardous waste regulations, provided they are managed according to the following conditions:

  • Not sewered, and
  • Managed in compliance with DEA regulations, and
  • Destroyed by a method that the DEA has publicly deemed in writing to meet their non-retrievable standard, or
  • Combusted at one of the following types of permitted facilities
    • Large or small municipal waste combustor (MWC)
    • Hospital, medical and infectious waste incinerator (HMIWI)
    • Commercial and industrial solid waste incinerator (CISWI) or
    • Hazardous waste combustor

3. What are the regulations in part 266 subpart P for household waste pharmaceuticals collected in kiosks (what DEA refers to as “collection receptacles”) at a retail or hospital pharmacy?

In order to promote the collection of household waste pharmaceuticals, EPA finalized in part 266 subpart P a conditional exemption for household waste pharmaceuticals that are collected in kiosks at retail or hospital pharmacies. The collected household pharmaceuticals continue to be exempt household hazardous waste and we have identified the types of permitted combustors (or other treatment methods that DEA identifies as meeting their non-retrievable standard) that are able to accept the collected household pharmaceuticals. More specifically, the collected household waste pharmaceuticals are exempt from RCRA hazardous waste regulation, provided they are managed according to the following conditions:

  • Not sewered, and
  • Managed in compliance with DEA regulations, and
  • Destroyed by a method that the DEA has publicly deemed in writing to meet their non-retrievable standard, or
  • Combusted at one of the following types of permitted facilities
    • Large or small municipal waste combustor (MWC)
    • Hospital, medical and infectious waste incinerator (HMIWI)
    • Commercial and industrial solid waste incinerator (CISWI) or
    • Hazardous waste combustor

4. If a healthcare facility puts leftover, partially administered pharmaceuticals into an on-site drug “sequestration unit,” can that unit be placed in the trash?

Not in most cases. If a sequestration unit contains any hazardous waste pharmaceuticals, it cannot be disposed of in the trash.

Drug sequestration units are often marketed to hospitals for the collection of leftover, partially administered pharmaceuticals (what DEA refers to as “pharmaceutical wastage”). According to DEA’s policy, pharmaceutical wastage of DEA controlled substances does not have to be destroyed to meet the DEA’s non-retrievable standard; therefore, pharmaceutical wastage of controlled substances may be placed in sequestration units.

EPA recommends that healthcare facilities take a conservative approach by assuming the likely scenario that healthcare workers will use the sequestration units to collect a combination of pharmaceutical wastage, including:

  1. Regulated RCRA hazardous wastes
  2. Conditionally exempt RCRA hazardous wastes that are also DEA controlled substances (refer to 40 CFR section 266.506), and
  3. DEA controlled substances.

In this case, the sequestration unit may not be put in trash. Nor would the unit would be eligible for the conditional exemption in 40 CFR section 266.506. In this case, the unit would be subject to the 40 CFR part 266 subpart P container standards during accumulation and pre-transportation. Furthermore, because the treatment standard under the land disposal restrictions is combustion for most hazardous waste pharmaceuticals, the unit must go to a hazardous waste combustor for treatment, and then to a hazardous waste landfill for disposal. For additional detail, refer to page 5901 of the preamble to the Hazardous Waste Pharmaceuticals Final Rule (84 FR 5816; February 22, 2019).

If a healthcare facility uses the sequestration unit only for collecting pharmaceutical wastage of DEA controlled substances that are not RCRA hazardous wastes, the unit may go in the trash. However, we expect that this is an unlikely scenario.

5. Some healthcare facilities use specialized containers to accumulate waste pharmaceuticals, particularly those that are DEA controlled substances. These sequestration devices typically have some material inside such as activated carbon.  Are these sequestration devices considered allowable generator treatment?

Drug sequestration units are often marketed to hospitals for the collection of leftover, partially administered pharmaceuticals (what DEA refers to as “pharmaceutical wastage”). According to DEA’s policy, pharmaceutical wastage of DEA controlled substances does not have to be destroyed to meet the DEA’s non-retrievable standard; therefore, pharmaceutical wastage of controlled substances may be placed in sequestration units.

As we stated in our Response to Comments document that accompanies the Hazardous Waste Pharmaceuticals Final Rule (refer to pages 92 and 570):

EPA’s understanding is that these containers are designed to accumulate hazardous waste pharmaceuticals and that these systems are designed to deter access. If the containers meet the standards under subpart P, healthcare facilities can use these containers to accumulate non-creditable hazardous waste pharmaceuticals. It is not necessary to determine whether treatment is occurring in these types of units because EPA would allow them to be used as accumulation units.

6. Do household pharmaceuticals that are collected at kiosks at law enforcement locations have to meet the terms of the conditional exemption in 40 CFR section 266.506?

No. Part 266 subpart P applies only to healthcare facilities and reverse distributors; it does not apply to law enforcement. However, in coordination with DEA, DOT and USPS, EPA has developed guidance for law enforcement on the proper management and disposal of collected household pharmaceuticals to ensure the protection of human health and the environment. Refer to the memorandum dated September 11, 2018.

Land Disposal Restrictions

1. When a healthcare facility accumulates non-creditable hazardous waste pharmaceuticals on site, or a reverse distributor accumulates evaluated hazardous waste pharmaceuticals on site, are they required to use separate accumulation containers for certain metal-bearing hazardous waste pharmaceuticals if the healthcare facility or reverse distributor uses lab packs as the initial accumulation containers or intends to use lab-packs later for shipping the hazardous waste pharmaceuticals?

Overpacked drums, also known as ”lab packs,” are a commonly used form of waste packaging for a variety of hazardous wastes – not just hazardous waste pharmaceuticals – where many small containers such as vials or bottles containing compatible hazardous waste are placed into a larger container with sorbent material. In some cases, lab packs are used by generators as accumulation containers at the initial point of accumulation of the hazardous waste. In other cases, hazardous waste is lab packed later by a vendor, as the hazardous waste is prepared to be shipped off site for treatment and disposal. Lab packs are typically treated by combustion.

In the Hazardous Waste Pharmaceuticals final rule, EPA required that healthcare facilities and reverse distributors segregate certain metal-bearing hazardous waste pharmaceuticals in separate containers. The Agency’s reasoning was that while combustion is the required treatment standard under the Land Disposal Restrictions (LDRs) for most hazardous waste pharmaceuticals, the combustion of a few metal-bearing hazardous wastes is prohibited. Therefore, a healthcare facility or reverse distributor must accumulate those particular metal-bearing hazardous waste pharmaceuticals in a separate container at the initial point of accumulation, and label them with the appropriate hazardous waste codes in order to prevent them from being combusted inadvertently. The use of lab packs at the initial point of accumulation or at a later point in the management of the hazardous waste pharmaceuticals does not change this requirement.

Additionally, the shipping standards for non-creditable and evaluated hazardous waste pharmaceuticals requires that lab packs that contain D004 (arsenic), D005 (barium), D006 (cadmium), D007 (chromium), D008 (lead), D010 (selenium) or D011 (silver) must be marked or labeled with the EPA hazardous waste numbers (refer to 40 CFR section 266.508(a)(1)(iii)(C)). These specific metals must be identified because § 268.42(c)(4) requires any incinerator residues from lab packs that contain any of these specific metals to undergo further treatment prior to land disposal.

Fuller Explanation of the Answer:

The standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals includes a provision related to metal-bearing pharmaceuticals that are subject to the dilution prohibition under the Land Disposal Restrictions (LDRs) in 40 CFR section 268.3. Specifically, the Hazardous Waste Pharmaceuticals final rule at 40 CFR section 266.502(d)(4) states:

A healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals and non-hazardous non-creditable waste pharmaceuticals in the same container, except that non-creditable hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition of § 268.3(c) must be accumulated in separate containers and labeled with all applicable hazardous waste numbers (i.e., hazardous waste codes).

The standards for reverse distributors managing evaluated hazardous waste pharmaceuticals includes an analogous provision. Specifically, 40 CFR section 266.510(c)(4)(vi) states:

A reverse distributor…must…[a]ccumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of § 268.3(c) (e.g., arsenic trioxide (P012)) in separate containers from other evaluated hazardous waste pharmaceuticals at the reverse distributor.

The healthcare facility standards and the reverse distributor standards both cite the LDR dilution prohibition found in 40 CFR section 268.3(c), which states:

Combustion of the hazardous waste codes listed in Appendix XI of this part is prohibited, unless the waste, at the point of generation, or after any bona fide treatment such as cyanide destruction prior to combustion, can be demonstrated to comply with one or more of the following criteria (unless otherwise specifically prohibited from combustion):

(1) The waste contains hazardous organic constituents or cyanide at levels exceeding the constituent-specific treatment standard found in §268.48;
(2) The waste consists of organic, debris-like materials (e.g., wood, paper, plastic, or cloth) contaminated with an inorganic metal-bearing hazardous waste;
(3) The waste, at point of generation, has reasonable heating value such as greater than or equal to 5000 BTU per pound;
(4) The waste is co-generated with wastes for which combustion is a required method of treatment;
(5) The waste is subject to Federal and/or State requirements necessitating reduction of organics (including biological agents); or
(6) The waste contains greater than 1% Total Organic Carbon (TOC).

Appendix XI of Part 268 is a table of 51 metal-bearing hazardous wastes, some of which are pharmaceuticals. In some cases, metal-bearing hazardous waste pharmaceuticals contain more than 1% total organic carbon (TOC), in which case they can be combusted and they do not need to be accumulated separately (refer to 40 CFR section 268.3(c)(6)). Other hazardous waste pharmaceuticals that do not contain more than 1% TOC (or do not meet any other exceptions in 268.3(c)(1)-(5)), must be accumulated separately in accordance with 266.502(d)(4) and 266.510(c)(4)(vi) because they are prohibited from being combusted due to the dilution prohibition. Arsenic trioxide is an example of a hazardous waste pharmaceutical that does not contain > 1% TOC and therefore must be accumulated separately.

In some cases, a healthcare facility or reverse distributor will use lab-packs for its hazardous waste pharmaceuticals as allowed per the alternative LDR treatment standard of 40 CFR section 268.42(c), which states:

As an alternative to the otherwise applicable subpart D treatment standards, lab packs are eligible for land disposal provided the following requirements are met:

(1) The lab packs comply with the applicable provisions of 40 CFR section 264.316 and 40 CFR section 265.316;
(2) The lab pack does not contain any of the wastes listed in Appendix IV to part 268;
(3) The lab packs are incinerated in accordance with the requirements of 40 CFR part 264, subpart O or 40 CFR part 265, subpart O; and
(4) Any incinerator residues from lab packs containing D004, D005, D006, D007, D008, D010, and D011 are treated in compliance with the applicable treatment standards specified for such wastes in subpart D of this part.

However, the 17 hazardous wastes listed in Appendix IV of Part 268 are not eligible for this alternative LDR treatment standard, and thus are prohibited from being lab-packed for incineration (refer to 40 CFR section 268.42(c)(2)). As shown in the table below, there are several hazardous waste pharmaceuticals among the 17 hazardous wastes listed in Appendix IV of Part 268. These hazardous waste pharmaceuticals are prohibited from being included in lab packs that will be incinerated under the alternative LDR treatment standard; therefore, the result is that these also must be accumulated separately, because, as with the dilution prohibition, they are prohibited from being incinerated:

Examples of Hazardous Waste Pharmaceuticals Listed in Part 268
Appendix IV that are Prohibited from being Lab-Packed and Incinerated

Hazardous Waste Code Hazardous Waste Chemical Name
D009 Mercury (toxicity characteristic)
P012 Arsenic Trioxide
P076

Nitric Oxide
U151

Mercury

Vape Shops

  1. Are e-cigarettes hazardous waste when discarded?
  2. Are e-cigarettes considered pharmaceuticals under part 266 subpart P of RCRA?
  3. Are e-cigarettes considered hazardous waste pharmaceuticals under part 266 subpart P?
  4. Are vape shops considered healthcare facilities under part 266 subpart P of RCRA?
  5. When is a vape shop regulated under part 266 subpart P?
  6. How is a vape shop that is a VSQG regulated under RCRA?
  7. How is a vape shop that is not a VSQG regulated under RCRA?

1. Are e-cigarettes hazardous waste when discarded?

Yes. Nicotine is an acute hazardous waste with the hazardous waste code P075. Therefore, when discarded, nicotine-containing e-cigarettes, e-liquids, electronic nicotine delivery systems, etc., are considered acute hazardous waste with the hazardous waste code P075. Refer to RCRA Online #14850 for a detailed explanation. Most e-cigarettes also have lithium-ion batteries which are likely at least ignitable hazardous waste with the RCRA hazardous waste code D001.

E-cigarettes that are discarded at a household are not subject to the federal RCRA hazardous waste regulations; however, households should consider any state or local requirements or restrictions that may apply to the disposal of e-cigarettes within household trash. Further, we strongly encourage people to seek alternatives to household trash disposal, such as household hazardous waste collection sites.

2. Are e-cigarettes considered pharmaceuticals under part 266 subpart P of RCRA?

Yes. For the limited purposes of part 266 subpart P of the RCRA regulations, which govern the disposal of hazardous waste pharmaceuticals, e-cigarettes are considered pharmaceuticals.

Under part 40 CFR part 266 subpart P of the RCRA regulations, the definition of 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) [emphasis added].

When defining pharmaceutical, EPA refers to the FDA’s definition of drug; however, EPA’s definition of pharmaceutical is much broader than FDA’s definition of drug. EPA chose to use a single, umbrella term – pharmaceutical – to encompass the various types of items being regulated under part 266 subpart P, even though some of the items are not considered drugs by FDA. For example, e-cigarettes are not considered drugs by FDA, but they are considered pharmaceuticals for the purposes of the RCRA hazardous waste regulations under part 266 subpart P (refer to FDA’s Final Rule for when e-cigarettes would be considered drugs.)

It is important to note that the EPA definition of pharmaceutical, which determines how e-cigarettes are regulated when they become waste, does not alter and has no bearing on how FDA or others regulate e-cigarettes as products.

3. Are e-cigarettes considered hazardous waste pharmaceuticals under part 266 subpart P?

Yes. For the limited purposes of part 266 subpart P of the RCRA regulations, e-cigarettes are considered hazardous waste pharmaceuticals. E-cigarettes meet the definition of hazardous waste (refer to question #1of this section) and pharmaceutical (refer to question #2 of this section); therefore, they meet the definition of hazardous waste pharmaceutical and are subject to the regulations in 40 CFR part 266 subpart P when discarded by healthcare facilities or reverse distributors.

4. Are vape shops considered healthcare facilities under part 266 subpart P of RCRA?

Yes. For the limited purposes of part 266 subpart P of the RCRA regulations, which govern the disposal of hazardous waste pharmaceuticals, vape shops are considered healthcare facilities. Vape shops are regulated as healthcare facilities under 40 CFR part 266 subpart P of the RCRA hazardous waste regulations because they sell e-cigarettes and pre-packaged nicotine e-juices, which are considered pharmaceuticals when they are discarded.

Under 40 CFR part 266 subpart P, any facility that sells a pharmaceutical is considered a healthcare facility, and nicotine e-juices that are pre-packaged for retail sale and e-cigarettes are considered pharmaceuticals (refer to question #2 of this section). Therefore, as with other retailers of pharmaceuticals, vape shops meet the definition of healthcare facility under 40 CFR part 266 subpart P. EPA chose to use a single, umbrella term – healthcare facility – to encompass the various types hazardous waste generators being regulated under part 266 subpart P, even though it may seem counterintuitive to call vape shops healthcare facilities.

It is important to note that the EPA definition of healthcare facility does not alter and has no bearing on how FDA or others regulate vape shops.

5. When is a vape shop regulated under part 266 subpart P?

Vape shops sell nicotine-containing products that are regulated as hazardous waste pharmaceuticals when discarded. Nicotine is an acute hazardous waste that is listed as hazardous waste code P075 due to its acute toxicity. If a vape shop generates in a calendar month more than 1 kg (2.2 pounds) of acute hazardous waste, or more than 100 kg (220 pounds) of non-acute hazardous waste, it must comply with 40 CFR part 266 subpart P of RCRA for the management and disposal of its discarded e-cigarette and e-juices, which are considered hazardous waste pharmaceuticals (refer toquestion #3 in the Applicability section).

Part 266 subpart P did not newly apply RCRA regulations to discarded e-cigarettes. E-cigarettes have always been considered hazardous waste; therefore, generators of these hazardous wastes have always been subject to regulation under RCRA. When EPA promulgated 40 CFR part 266 subpart P, it changed the way healthcare facilities, and thus vape shops, that generate hazardous waste pharmaceuticals are regulated. Prior to the promulgation of 40 CFR part 266 subpart P, a vape shop that generated more than 1 kg of acute hazardous waste in a calendar month was regulated as a large quantity generator (LQG) under 40 CFR part 262.

A vape shop that generates less than or equal to 1 kg of acute hazardous waste and less than or equal to 100 kg of non-acute hazardous waste, continues to be subject to the very small quantity generator (VSQG) regulations in 40 CFR part 262. However, a VSQG vape shop is also subject to several provisions of part 266 subpart P: the sewer prohibition at § 266.505, the empty container standards at § 266.507, and the optional provisions of § 266.504. Vape shops in authorized states that have not yet adopted part 266 subpart P are subject to the applicable standards in 40 CFR part 262 until their state adopts the Hazardous Waste Pharmaceuticals Rule. Refer to question #2 in the Applicability section for more information.

6. How is a vape shop that is a VSQG regulated under RCRA?

Healthcare facilities, such as vape shops, that generate above VSQGs amounts of hazardous waste (i.e., SQG or LQG) must manage their hazardous waste pharmaceuticals under 40 CFR part 266 subpart P (refer to question #7 of this section). Healthcare facilities that generate VSQG amounts of hazardous waste are subject to the hazardous waste generator regulations for VSQGs in 40 CFR section 262.14, as well as three sections of part 266 subpart P:

  1. the prohibition of sewering hazardous waste pharmaceuticals in 40 CFR section 266.505
  2. the empty containers standards in 40 CFR section 266.507, and
  3. the optional provisions for VSQGs in 40 CFR section 266.504.

Alternatively, any healthcare facility (e.g., vape shop) that is a VSQG of hazardous waste has the choice of opting into 40 CFR part 266 subpart P, in which case, that facility is subject to all of the required provisions applicable to healthcare facilities in 40 CFR part 266 subpart P (also refer to Question #8 in the Applicability section).

7. How is a vape shop that is not a VSQG regulated under RCRA?

A vape shops that generates above VSQG amounts of hazardous waste (refer to question #5 of this section) is regulated under 40 CFR part 266 subpart P for the management and disposal of its hazardous waste pharmaceuticals.

Under subpart P, the nicotine e-cigarettes and e-liquid wastes that a vape shop generates are considered non-creditable hazardous waste pharmaceuticals. The requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals on site are in 40 CFR section 266.502 of subpart P. In brief, a vape shop must comply with standards related to the on-site accumulation, as well as the off-site transportation, treatment, and disposal of the hazardous waste pharmaceuticals. More specifically, a vape shop that is regulated under subpart P may accumulate the hazardous waste pharmaceuticals on site for up to one year. During that accumulation, the vape shop must comply with container management and labeling standards in § 266.502(d) and (e). The vape shop must use a hazardous waste transporter and hazardous waste manifest and send the non-creditable hazardous waste pharmaceuticals to a hazardous waste treatment, storage, and disposal facility (§ 266.508). In addition, the vape shop must not dispose of any of its hazardous waste pharmaceuticals down the drain (§ 266.505) and must use the new provisions for determining when containers of hazardous waste pharmaceuticals are considered “RCRA empty” (§ 266.507).

If a vape shop generates other hazardous waste, then other applicable RCRA regulations apply to the management and disposal of that hazardous waste (e.g. 40 CFR part 273 for universal waste or 40 CFR part 262 for most other hazardous waste).

Sequestration Devices

  1. If a healthcare facility puts leftover, partially administered pharmaceuticals into an on-site drug “sequestration unit,” can that unit be placed in the trash?
  2. Some healthcare facilities use specialized containers to accumulate waste pharmaceuticals, particularly those that are DEA controlled substances. These sequestration devices typically have some material inside such as activated carbon.  Are these sequestration devices considered allowable generator treatment?

1. If a healthcare facility puts leftover, partially administered pharmaceuticals into an on-site drug “sequestration unit,” can that unit be placed in the trash?

Not in most cases. If a sequestration unit contains any hazardous waste pharmaceuticals, it cannot be disposed of in the trash.

Drug sequestration units are often marketed to hospitals for the collection of leftover, partially administered pharmaceuticals (what DEA refers to as “pharmaceutical wastage”). According to DEA’s policy, pharmaceutical wastage of DEA controlled substances does not have to be destroyed to meet the DEA’s non-retrievable standard; therefore, pharmaceutical wastage of controlled substances may be placed in sequestration units.

EPA recommends that healthcare facilities take a conservative approach by assuming the likely scenario that healthcare workers will use the sequestration units to collect a combination of pharmaceutical wastage, including:

  1. Regulated RCRA hazardous wastes
  2. Conditionally exempt RCRA hazardous wastes that are also DEA controlled substances (refer to 40 CFR section 266.506), and
  3. DEA controlled substances.

In this case, the sequestration unit may not be put in trash. Nor would the unit would be eligible for the conditional exemption in 40 CFR section 266.506. In this case, the unit would be subject to the 40 CFR part 266 subpart P container standards during accumulation and pre-transportation. Furthermore, because the treatment standard under the land disposal restrictions is combustion for most hazardous waste pharmaceuticals, the unit must go to a hazardous waste combustor for treatment, and then to a hazardous waste landfill for disposal. For additional detail, refer to page 5901 of the preamble to the Hazardous Waste Pharmaceuticals Final Rule (84 FR 5816; February 22, 2019).

If a healthcare facility uses the sequestration unit only for collecting pharmaceutical wastage of DEA controlled substances that are not RCRA hazardous wastes, the unit may go in the trash. However, we expect that this is an unlikely scenario.

2. Some healthcare facilities use specialized containers to accumulate waste pharmaceuticals, particularly those that are DEA controlled substances. These sequestration devices typically have some material inside such as activated carbon.  Are these sequestration devices considered allowable generator treatment?

Drug sequestration units are often marketed to hospitals for the collection of leftover, partially administered pharmaceuticals (what DEA refers to as “pharmaceutical wastage”). According to DEA’s policy, pharmaceutical wastage of DEA controlled substances does not have to be destroyed to meet the DEA’s non-retrievable standard; therefore, pharmaceutical wastage of controlled substances may be placed in sequestration units.

As we stated in our Response to Comments document that accompanies the Hazardous Waste Pharmaceuticals Final Rule (refer to pages 92 and 570):

EPA’s understanding is that these containers are designed to accumulate hazardous waste pharmaceuticals and that these systems are designed to deter access. If the containers meet the standards under subpart P, healthcare facilities can use these containers to accumulate non-creditable hazardous waste pharmaceuticals. It is not necessary to determine whether treatment is occurring in these types of units because EPA would allow them to be used as accumulation units.

Episodic Generation

1. Can a healthcare facility or reverse distributor that is operating under part 266 subpart P use the episodic generation provisions in part 262 subpart L?

One of the key provisions of the 2016 Generator Improvements Rule was to add regulatory flexibility to allow a hazardous waste generator to avoid the increased burden of a higher generator category when generating episodic waste, provided the episodic waste is properly managed in accordance with part 262 subpart L.

Under some circumstances (read below), healthcare facilities and reverse distributors operating under part 266 subpart P can take advantage of this added regulatory flexibility (assuming their state has adopted the episodic generator provision).

  1. VSQG healthcare facilities not operating under part 266 subpart P can use the episodic generator provisions for pharmaceutical and non-pharmaceutical hazardous waste. A healthcare facility that is a VSQG for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste can use the episodic generation provision of part 262 subpart L for all of its hazardous waste, including its hazardous waste pharmaceuticals. If a healthcare facility is generally operating under § 262.14 as a VSQG, but has an episodic event, it would be far less burdensome to comply with part 262 subpart L than to come into compliance with all the provisions of part 266 subpart P for the short duration of the episodic event. For example, if a VSQG healthcare facility is directed to dispose of recalled pharmaceuticals, it could use the episodic generator provisions of part 262 subpart L to avoid an increase in hazardous waste generator category. However, if a healthcare facility that is a VSQG generates hazardous waste in excess of the allowable amounts as a VSQG, and it chooses not to use the episodic generator provisions in part 262 subpart L, it would become subject to part 266 subpart P for its hazardous waste pharmaceuticals.
  2. Healthcare facilities and reverse distributors operating under part 266 subpart P can use the episodic generator provisions for non-pharmaceutical hazardous waste. Healthcare facilities and reverse distributors that are subject to part 266 subpart P for their hazardous waste pharmaceuticals may still be subject to part 262 for the management of their non-pharmaceutical hazardous waste. A healthcare facility or reverse distributor operating under part 266 subpart P for its hazardous waste pharmaceuticals may not use the episodic generator standards of part 262 subpart L with respect to its hazardous waste pharmaceuticals. Under part 266 subpart P, all healthcare facilities are regulated the same regardless of amounts of hazardous waste pharmaceuticals generated and all reverse distributors are regulated the same, regardless of amounts of hazardous waste pharmaceuticals managed, making the need for episodic generation provisions unnecessary. On the other hand, if a healthcare facility or reverse distributor is generally operating as a VSQG or SQG for its non-pharmaceutical hazardous waste, but has an episodic event, the healthcare facility or reverse distributor may use the provisions in part 262 subpart L for its non-pharmaceutical hazardous waste.

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Last updated on February 25, 2024