Hazardous Waste Pharmaceuticals
Timing/State Adoption of Subpart P
Special VSQG Provisions
In February 2019, EPA published a final rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P-75 Listing for Nicotine. It is codified at 40 CFR 266 Subpart P and is referred to as the Pharmaceuticals Rule or Subpart P. This regulation applies to all healthcare facilities that generate hazardous waste pharmaceuticals (e.g., waste chemotherapy drugs and associated materials).
This new rule allows healthcare facilities to manage hazardous pharmaceutical waste in a manner that is better tailored to the healthcare industry and the common practices associated with the management of waste pharmaceuticals. In addition, this rule eliminates the dual regulation of hazardous waste pharmaceuticals that are also controlled substances regulated by the Drug Enforcement Agency (DEA).
Timing/State Adoption of Subpart P
Subpart P must be adopted by your state before your facility can "opt in" to the streamlined standards. The adoption of Subpart P by all states is expected to occur by the end of 2023, or soon thereafter. Until your state adopts subpart P, your facility must operate under the general hazardous waste regulations and/or state rules.
EPA maintains a map that shows which states have adopted subpart P. However, you should double check by contacting your state environmental agency.
This new rule applies to hazardous waste pharmaceuticals generated and managed at all healthcare facilities that are categorized as small quantity generators (SQGs) or large quantity generators (LQGs) of hazardous waste, as well as at all reverse distributers. These facilities are required to manage all hazardous waste pharmaceuticals under the new Subpart P and in compliance with these new regulations.
Very small quantity generators (VSQGs) are not required to manage their hazardous waste pharmaceuticals under the Subpart P regulations. However, VSQGs may in lieu of complying with 40 CFR 262.14 opt into the Subpart P rules for hazardous waste pharmaceuticals by submitting a notification (see below).
It is important to note that this rule applies only to hazardous waste pharmaceuticals, all other hazardous wastes generated at a facility remain subject to the applicable hazardous waste regulations, 40 CFR 260 through 40 CFR 273.
Subpart P has several new definitions that are important in determining whether your facility is subject to the new rule as well as identification of the hazardous waste pharmaceuticals that must be managed pursuant to the rule. Of note are the definitions of "hazardous waste pharmaceutical", "healthcare facility", "potentially creditable hazardous waste pharmaceutical", and "non-creditable hazardous waste pharmaceutical". See 40 CFR 266.500.
To regulate the over 800,000 hazardous waste generators in the United States, EPA established three types of generators:
Very Small Quantity Generators (VSQG) who generate less than or equal to 100 kg of non-acute hazardous waste a month, less than or equal to 1 kg of acute hazardous waste a month (e.g. p-listed wastes such as arsenic trioxide) and less than or equal to 100 kg of residues or contaminated soil, waste, and other debris from the spill cleanup of acute hazardous waste;
Small Quantity Generators (SQG) who generate greater than 100 kg and less than 1,000 kg of non-acute hazardous waste a month, less than or equal to 1 kg of acute hazardous waste a month, and less than or equal to 100 kg of spill residue from acute hazardous waste; and
Large Quantity Generators (LQG) who generate 1,000 kg or more of non-acute hazardous waste a month, greater than 1 kg of acute hazardous waste a month, and greater than 100 kg of spill residue from acute hazardous waste.
For healthcare facilities, generator status is determined by counting all hazardous waste pharmaceuticals and nonpharmaceutical hazardous waste generated per month at a facility. Once generator status has been determined and proper notification has been submitted pursuant to that determination, you no longer need to count hazardous waste pharmaceuticals in your category determination.
This is effectively a two-step generator category determination process, the first to assess whether you must comply with the new pharmaceutical rule and the second to assess under what category you must manage your non-pharmaceutical hazardous waste.
It is possible that your generator status for non-pharmaceutical hazardous waste drops and you are subject to less stringent requirements for those wastes. Additionally, once you are managing hazardous waste pharmaceuticals under the new Subpart P rule, the amount of hazardous waste pharmaceuticals that you generate does not matter. Once you are managing your hazardous waste pharmaceuticals pursuant to the P-rule, there are no generator categories for these wastes and all requirements are the same. Therefore, you may mix your non-hazardous waste pharmaceuticals with your hazardous waste pharmaceuticals and manage all these wastes together pursuant to the Subpart P requirements without affecting your generator status. This management approach is recommended by EPA.
Important note: Not all states recognize the VSQG category. Check with your state regarding VSQG requirements.
All healthcare facilities that are SQGs or LQGs must operate under Subpart P and notify their state or EPA Region. Notification is required even if it previously received a RCRA ID number.
Healthcare facilities that are very small quantity generators (VSQGs) of hazardous waste are not federally required to operate under Subpart P but may opt in, in which case, they must notify. [Important note: Not all states recognize the VSQG category. Check with your state regarding VSQG requirements.]
Whom do I notify? If the healthcare facility is in Iowa, Alaska, Indian country, or U.S. territories (other than Guam), then it must notify the EPA Regional Office. In all other cases, the healthcare facility must notify the state environmental agency.
When do I have to notify under Subpart P? If the healthcare facility is required to submit a Biennial Report (or state annual report), it can notify as part of that report. Otherwise, the healthcare facility must notify within 60 days of Subpart P becoming effective in that state, or within 60 days of becoming subject to Subpart P (e.g., moving up in generator category from VSQG to SQG).
How do I notify under Subpart P? A healthcare facility can notify by submitting the EPA Site Identification Form (Form 8700-12) or equivalent state notification form to your authorized state or EPA Region. Some states also allow users to notify electronically via the myRCRAid online tool of U.S. EPA's RCRAInfo hazardous waste data system. To notify using myRCRAid, you must first register as an industry user with RCRAInfo. After you have access, you must complete and submit the required information and indicate that you are operating under Subpart P. EPA encourages healthcare facilities to notify electronically wherever possible. Please check with your state environmental agency to see if the electronic myRCRAid tool is available to you. If you are in Iowa, Alaska, Indian country, or a U.S. Territory, EPA encourages you to use myRCRAid. The instructions are available here. [For additional guidance on completing Form 8700-12, see: A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities, 2022 Edition, Appendix F.]
Following are some highlights of the new management requirements. This is not an exhaustive list, and you must review the regulations in their entirety to ensure you are operating in compliance.
Management requirements differ for storing "potentially creditable hazardous waste pharmaceuticals" (pharmaceuticals sent to a reverse distributer for manufacturer credit) and "non-creditable hazardous waste pharmaceuticals" (pharmaceuticals that are sent directly off-site for disposal).
Non-creditable hazardous waste pharmaceuticals requirements:
Hazardous waste determinations must be made on all solid waste pharmaceuticals.
Staff must be appropriately trained.
Containers must be structurally sound, compatible with the contents, not leaking and free from damage that could cause leakage.
There are special requirements for ignitable or reactive drug wastes.
Containers must be kept closed.
Containers must be labeled with the words "Hazardous Waste Pharmaceuticals."
Land disposal restrictions must be met, see 40 CFR 268.7(a) (hazardous waste codes are not required on LDR paperwork for hazardous waste pharmaceuticals for an LQG or SQG).
Shipments must be on a hazardous waste manifest and manifests must be retained for 3 years. Hazardous waste codes do not need to be listed, instead write "PHARMS" in Item 13 of the hazardous waste manifest (EPA form 8700-22).
Spills must be immediately contained and cleaned-up.
Facilities may accumulate hazardous waste pharmaceuticals for up to one year and be able to demonstrate the length of time hazardous waste pharmaceuticals have been accumulated (accumulation start date on container, inventory system, etc.)
Shipments of hazardous waste pharmaceuticals to a disposal facility must be on a hazardous waste manifest, but the individual hazardous waste numbers (codes) do not need to be entered in item 13 of the manifest, instead write the word "PHARMS".
Pre-transport requirements: there are some packaging, labeling, marking and placarding requirements for shipping hazardous waste pharmaceuticals off site for disposal. See 40 CFR 267.508 for specifics.
Potentially creditable hazardous waste pharmaceuticals requirements:
Hazardous waste determinations must be made on all solid waste pharmaceuticals. • Spills must be immediately contained and cleaned-up.
Records of shipments to a reverse distributer must be maintained for 3 years, these shipments do not need to be on a hazardous waste manifest.
Pre-transport requirements (see 40 CFR 267.509) – you must follow applicable U.S. Department of Transportation (DOT) requirements when shipping potentially creditable hazardous waste pharmaceuticals off site. Potentially creditable hazardous waste pharmaceuticals will not be considered hazardous waste under DOT requirements because they are not required to be shipped on a hazardous waste manifest, but they may meet the definition of hazardous materials pursuant to 49 CFR section 171.8 for purposes of shipping. See 49 CFR Parts 171 through 180 for DOT shipping requirements.
Other aspects of the new rule
Sewer Ban. The sewer ban is in effect for all VSQGs, SQGs, and LQGs in all states, territories, and in Indian Country. Regardless of your Subpart P decision or your state's adoption status of Subpart P. As of August 21, 2019, no hazardous waste pharmaceuticals can be disposed of down the drain at any healthcare facility in any state or territory or in Indian country (40 CFR 266.505). The prohibition on sewering hazardous waste pharmaceuticals is expected to help address the issue of the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.
Conditional exemption for DEA-controlled substances: The new rule has a conditional exemption from hazardous waste regulation for hazardous waste pharmaceuticals that are also on a schedule of controlled substances by the DEA if these wastes are managed in accordance with DEA requirements. See 40 CFR 267.506 for specific requirements.
Containers that held acute (p-listed) hazardous waste pharmaceuticals (such as warfarin) are no longer considered hazardous waste and may be disposed of in the solid waste trash. If the pharmaceuticals have been removed using practices commonly employed to remove materials from the type of container (stock bottle, dispensing bottle, vial, ampule or unit dose container), the residues and therefore the container will no longer be regulated as hazardous waste. There are some limits on the size of the container (1 liter or 10,000 pills) over which this exemption will not apply and there are some specific conditions for other types of containers, such as syringes and IV bags, to be considered empty and not subject to regulation. See 40 CFR 267.507 for specifics.
Revision to the P075 nicotine hazardous waste listing: As part of this rulemaking, the P075 nicotine hazardous waste listing was revised to no longer include over-the-counter nicotine replacement therapies such as gums, lozenges, and patches, therefore these items are no longer considered hazardous wastes (40 CFR 261.33(e)). The listing still includes prescription nicotine replacement therapies and e-cigarettes and e-liquids, these wastes must still be managed as acute hazardous wastes.
Special VSQG Provisions
Very small quantity generators (VSQGs) are not required to manage their hazardous waste pharmaceuticals under the Subpart P regulations but may opt into this regulation for hazardous waste pharmaceuticals in lieu of complying with 40 CFR 262.14, by filing a Site Identification Form (EPA form 8700-12). The best and easiest option to accomplish this is by using "MyRCRAid," an on-line tool.
If a VSQG chooses to opt into Subpart P regulations, it is important to note that this rule applies only to hazardous waste pharmaceuticals, all other hazardous wastes generated at a facility remain subject to the applicable hazardous waste regulations found at 40 CFR Parts 262 through 279.
Even if a VSQG healthcare facility chooses not to opt into managing their hazardous waste pharmaceuticals under the new Subpart P regulations, these facilities are still subject to the Sewer Ban (40 CFR 266.505).
US EPA resources:
State agency information:
Many states have posted regulatory, policy or guidance information on their websites concerning Subpart P rules. Please email us if you are aware of applicable information for your state not listed here and we will update the list accordingly.
States with additional resources: CA and WA.
Links to code of regulations (40 CFR) for Subpart P:
266.500 - Definitions
266.501 - Applicability
266.502 - Standards - Non-creditable
266.503 - Standards - Potentially creditable
266.504 - VSQG's
266.505 - Sewer ban
266.506 - DEA/HWP exemption
266.507 - Empty container exemption
266.508 - Shipping - Non-creditable
266.509 - Shipping - Potentially creditable
266.510 - Standards - Reverse distributors