Hazardous Waste Pharmaceuticals Program Under EPA Subpart P

A hazardous waste pharmaceuticals program under 40 CFR Part 266 Subpart P is the written procedures, labels, training, records and shipping steps a healthcare facility uses to manage pharmaceutical waste that is hazardous waste, starting with the ban on sewering it, which applies at every healthcare facility. Integral Healthcare Solutions (IHS) drafts those documents for your team to adopt; the facility makes the waste determinations and regulatory submissions. IHS is a consulting firm, not a law firm, and this page is not legal advice.

Last updated: November 2026

What does 40 CFR Part 266 Subpart P require?

Subpart P prohibits sewering hazardous waste pharmaceuticals at every healthcare facility. For healthcare facilities above very small quantity generator limits or opting in, where effective, §266.501(d)(1) covers non-creditable hazardous waste pharmaceuticals and potentially creditable ones not destined for a reverse distributor; (d)(2) covers potentially creditable prescription hazardous waste pharmaceuticals destined for a reverse distributor. This summary uses eCFR text rebuilt November 4, 2026; page opened November 5, 2026.

Sewer prohibition and empty-container standards

• Sewer ban (266.505). All healthcare facilities, including very small quantity generators operating under 262.14 in place of the subpart, and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. They also remain subject to the prohibitions in 40 CFR 403.5(b).
• Empty containers where Subpart P is effective (266.507). A syringe is empty if its contents were removed by fully depressing its plunger. An IV bag is empty if its pharmaceuticals were fully administered to a patient, or if it held non-acute hazardous waste pharmaceuticals and is empty under 261.7(b)(1). At facilities operating under Subpart P, a nonempty syringe or IV bag and its remaining hazardous waste pharmaceuticals must go into a container managed and disposed of as non-creditable hazardous waste pharmaceuticals; syringes also require compliance with applicable federal, state and local sharps-container and medical-waste requirements.

Selected standards for non-creditable hazardous waste pharmaceuticals

• Notification (266.502(a)). Form 8700-12, one per site or EPA identification number: as part of the next Biennial Report if the facility must submit one, otherwise within 60 days of the subpart's effective date or of becoming subject to it.
• Training and determination (266.502(b), (c)). All personnel managing non-creditable hazardous waste pharmaceuticals must be thoroughly familiar with proper handling and emergency procedures relevant to their responsibilities during normal operations and emergencies. A facility that generates a solid waste that is a non-creditable pharmaceutical must determine whether it is a hazardous waste pharmaceutical.
• Containers (266.502(d)). Containers must be structurally sound, compatible with their contents, without evidence of leakage, spillage or damage that could cause leakage under reasonably foreseeable conditions, and closed and secured against unauthorized access. Non-hazardous non-creditable pharmaceuticals may share containers, except non-creditable hazardous waste pharmaceuticals prohibited from combustion by the dilution prohibition in 268.3(c) (unless an exception in 268.3(c)(1) to (6) is met) or from lab packing under 268.42(c); those require separate containers labeled with all applicable EPA hazardous waste numbers.
• Shipping (266.508(a)(2)). For non-creditable hazardous waste pharmaceuticals, enter “PHRM” or “PHARMS” in manifest Item 13; no Biennial Report is required for these wastes managed under Subpart P (266.502(i)(1)). For a direct shipment without the designated facility owner or operator’s signed manifest within 60 calendar days after initial-transporter acceptance, submit a legible original-manifest copy to the facility’s EPA Regional Administrator indicating missing delivery confirmation, with a written note on the manifest or an attached sheet stating nonreceipt, search efforts and results (266.502(i)(2)(i)).
• Spills (266.502(k)). Immediately contain all spills of non-creditable hazardous waste pharmaceuticals and manage cleanup materials as that waste under Subpart P.

This overview is not a complete compliance checklist; state rules require separate review.

Is Subpart P in effect in my state?

The sewer ban is in effect in every state; the rest depends on where the facility is. EPA states that the sewering prohibition is effective in all states, territories and Indian Country on August 21, 2019, and that new rules go into effect in a state when it adopts them into state law (EPA table, last updated October 8, 2026, opened November 5, 2026).

• Adopted and authorized: 15 states. Adopted, not yet authorized: 25, including the District of Columbia.
• Neither adopted nor authorized: Arkansas, California, Connecticut, Guam, Kansas, Massachusetts, Minnesota, Nebraska, Nevada, New York and Rhode Island.
• Federal regulations administered by EPA: Iowa, American Samoa, the Northern Mariana Islands, Puerto Rico, the U.S. Virgin Islands and federal tribes.

The reason, per the 2019 Federal Register notice: most of Subpart P was issued under non-HSWA authority and applied on the effective date only in states without final authorization of their base RCRA program, while the sewer ban applied in all states (84 FR 5816, February 22, 2019; page opened November 5, 2026). Confirm requirements with the responsible state or territory agency.

Who needs it and what triggers it?

The sewer ban applies to every healthcare facility. Other Subpart P duties depend on jurisdiction, generator status and waste stream. For Subpart P applicability, count both pharmaceutical and non-pharmaceutical hazardous waste (266.501(a)). The monthly very-small-quantity limits are no more than 1 kilogram of acute waste, 100 kilograms of non-acute waste and 100 kilograms of acute cleanup residues; the separate Part 262 category determination applies the exclusions in 262.13(c) and (d) (262.13).

• A healthcare facility becomes subject to Subpart P; it must notify for each site or EPA identification number (266.502(a)(1)).
• A long-term care facility with 20 beds or fewer is presumed to be a very small quantity generator; one with more than 20 beds operating as one must demonstrate it is within the limits (266.504(d)).

How does IHS help?

IHS assesses gaps, maps documents and evidence, drafts content for your pharmacy and compliance leaders to approve, and supports mock review and readiness against applicable rules. Thomas G. Goddard, JD, PhD, IHS founder and former URAC Chief Operating Officer and General Counsel, leads it. See Compliance Services.

• IHS drafts waste-determination, empty-container, labeling, accumulation, sewer-ban and spill procedures; training materials; notification checklists; and record-retention schedules.
• You supply: generator-status facts, EPA identification number, state adoption check, vendor contracts and manifests, and drug-by-drug determinations. The duty is the facility's; IHS recommends that your pharmacist make the determinations.
• The real limit: IHS does not make determinations, notify or file with EPA or a state, hold your manifests, or communicate with EPA or a state agency.

What should we have ready?

Checklist references: 40 CFR Part 266 Subpart P as opened November 5, 2026.

1. Your Subpart P applicability count, separate Part 262 generator-category determination, and EPA identification number (266.501(a); 262.13).
2. Your state's adoption status for Subpart P, from EPA's table and your state agency.
3. Your current practice for drain disposal of pharmaceuticals (266.505).
4. A drug inventory with the waste streams it produces, and any determinations made, with who made them (266.502(c)).
5. Every Form 8700-12 you filed, one per site or EPA identification number (266.502(a)(1)).
6. Training records for each person who manages the waste (266.502(b)).
7. Container labels, closure practices and accumulation start dates, with the method that shows them (266.502(d) to (f)).
8. Your waste vendor contract, three years of manifests, signed return copies and any exception report (266.502(i), (j)).
9. Decisions on empty containers, controlled substances and potentially creditable returns (266.503, 266.506, 266.507).

Bring this checklist to the free introductory call.

How does it compare?

What does it cost?

• Authority fees. The sections IHS opened list no government fee for notifying or operating under Subpart P.
• Exposure. Under 42 U.S.C. 6928(a)(3), a compliance order may assess up to 25,000 dollars per day of noncompliance for each violation, weighing seriousness and good faith efforts to comply (statute, 2024 edition; page opened November 5, 2026). For violations after November 2, 2015 with penalties assessed on or after January 8, 2025, 40 CFR 19.4 lists 124,426 dollars for that provision.
• Consulting. IHS scopes each engagement after a free introductory call. Drivers are sites, generator status, state status and waste streams.

What this is not

• It is not legal advice. IHS is a consulting firm, not a law firm.
• It is not a drug-by-drug determination or a guarantee of any regulatory outcome.

Frequently asked questions

What is Subpart P?

Subpart P is 40 CFR Part 266, sections 266.500 to 266.510, EPA's management standards for hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Where effective, it replaces Parts 262 through 265 for hazardous waste pharmaceuticals at healthcare facilities above very small quantity generator limits, using the waste-stream routes in 266.501(d).

Does the sewer ban apply to small facilities, and in every state?

Yes to both. Section 266.505 covers all healthcare facilities, including very small quantity generators operating under 262.14, and reverse distributors, and EPA states it is effective in all states, territories and Indian Country on August 21, 2019.

Is the rest of Subpart P in effect in my state?

In authorized states, adoption determines when the non-HSWA provisions take effect; federal regulations apply directly in jurisdictions without final base-program authorization. Check EPA's adoption table and the responsible state or territory agency.

Which healthcare facilities follow Subpart P?

Where effective, the applicable standards cover healthcare facilities above very small quantity generator limits, counting pharmaceutical and non-pharmaceutical hazardous waste (266.501(a), (d)). A very small quantity generator stays under 262.14, outside the subpart except 266.505, 266.507 and the optional provisions of 266.504, unless it opts in (266.501(b)). Non-pharmaceutical hazardous waste stays under the other rules (266.501(c)).

Do pharmaceuticals still count toward our generator category?

Section 262.13(c)(9) excludes hazardous waste pharmaceuticals subject to or managed in accordance with Subpart P, and those that are DEA controlled substances conditionally exempt under 266.506. The Subpart P applicability test counts both pharmaceutical and non-pharmaceutical hazardous waste (266.501(a)).

What must the label say, and how long can waste stay on site?

Label or clearly mark each container of non-creditable hazardous waste pharmaceuticals “Hazardous Waste Pharmaceuticals” (266.502(e)). These pharmaceuticals may accumulate on site for one year or less without a permit or interim status; demonstrate the time from when they first became waste (266.502(f)).

What training is required?

Personnel who manage non-creditable hazardous waste pharmaceuticals must be thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal operations and emergencies (266.502(b)). A very small quantity generator that has not opted in is outside this section.

How long do we keep manifests and other records?

Under 266.502(j), keep each manifest signed under 262.23(a) for three years or until the designated facility’s signed copy arrives; retain that copy at least three years from initial-transporter acceptance. Retain exception reports at least three years from their dates, and tests, analyses and other determination-support records consistent with 262.11(f) at least three years from the date the waste was last sent to on-site or off-site treatment, storage or disposal. Determination documentation is not required if all non-creditable non-hazardous waste pharmaceuticals are managed as non-creditable hazardous waste pharmaceuticals. Retention extends automatically during unresolved enforcement regarding the regulated activity, or as the EPA Regional Administrator requests.

Who decides whether a drug is hazardous waste, and does IHS notify EPA?

The facility decides (266.502(c)). In IHS's process your pharmacist makes the drug-by-drug call and IHS drafts the procedure. If operating under Subpart P, your facility files Form 8700-12 (266.502(a)(1)); IHS does not notify or communicate with EPA or a state agency.