40 CFR 266 Subpart P: EPA Hazardous Waste Pharmaceuticals

Regulatory citation: 40 CFR Part 266, Subpart P, Hazardous Waste Pharmaceuticals

What Is EPA's Hazardous Waste Pharmaceuticals Rule?

Subpart P of 40 CFR Part 266 sets tailored management standards for hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Healthcare facilities include hospitals, clinics, pharmacies, long-term care facilities and others authorized to provide care or dispense pharmaceuticals. Facilities covered by Subpart P manage their hazardous waste pharmaceuticals under it instead of the standard generator rules in Parts 262 to 265.

A healthcare facility that is a very small quantity generator when counting all of its hazardous waste may stay under the very small quantity generator rules, but must still follow the sewer ban and empty container rules.

Why Pharmaceutical Waste Management Matters

Flushing or draining pharmaceuticals sends active ingredients into waterways that treatment plants are not designed to remove. Subpart P creates rules that fit how healthcare facilities actually handle drugs, while keeping hazardous pharmaceuticals out of sewers and regular trash.

Core Requirements

1. Notify EPA (266.502(a))

A healthcare facility operating under Subpart P must notify the EPA Regional Administrator using Form 8700-12. Facilities with an EPA identification number can notify with their next Biennial Report if they file one; otherwise notification is due within 60 days of becoming subject. A copy must be kept on file.

2. Train Staff and Make Waste Determinations (266.502(b)–(c))

Personnel who handle non-creditable hazardous waste pharmaceuticals must be thoroughly familiar with proper handling and emergency procedures. The facility must determine whether each pharmaceutical waste is hazardous, and may choose to manage non-hazardous pharmaceuticals under Subpart P as well.

3. Use Proper Containers and Labels (266.502(d)–(e))

Containers must be structurally sound, compatible with the contents, free of leaks and kept closed and secured against unauthorized access. Incompatible wastes must not be mixed in a way that could cause fire, explosion or toxic gases. They must be labeled with the words "Hazardous Waste Pharmaceuticals."

4. Accumulate for One Year or Less (266.502(f))

Non-creditable hazardous waste pharmaceuticals may be accumulated on site for one year or less. The facility must be able to show how long the waste has been accumulating, for example by marking the start date.

5. Never Sewer Hazardous Waste Pharmaceuticals (266.505)

All healthcare facilities, including very small quantity generators, and all reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer that leads to a publicly owned treatment works. EPA states that this sewer prohibition took effect in all states, territories and Indian Country on August 21, 2019.

6. Ship Correctly (266.508–266.509)

Non-creditable waste is shipped on a hazardous waste manifest. The facility writes "PHRM" or "PHARMS" in Item 13, and listing waste codes there is optional. Potentially creditable pharmaceuticals going to a reverse distributor do not need a manifest, but the shipper must follow up if delivery is not confirmed within 35 calendar days.

7. Apply the Empty Container Rules (266.507)

Stock bottles, dispensing bottles, vials and ampules holding up to 1 liter or 10,000 pills, and unit-dose containers, are empty once the contents are removed by customary practices. Syringes are empty when the plunger is fully depressed. IV bags are empty when fully administered, or in some cases under the general empty container rule. Other containers, such as inhalers, aerosol cans and nebulizers, are managed as non-creditable waste unless they meet an empty standard.

8. Keep Records and File Exception Reports (266.502(i)–(j))

Biennial reporting is not required for these wastes. If a signed return copy of the manifest does not arrive within 60 calendar days of the initial transporter accepting the waste, the facility must file an exception report. Manifests, exception reports and waste determination records must be kept for three years.

Common Compliance Approaches

Point-of-Use Collection

Place labeled, closed containers on units and in pharmacies so staff can discard hazardous pharmaceuticals where they work.

Formulary Review

Flag hazardous drugs in the formulary or pharmacy system so staff know which containers to use.

Reverse Distribution Program

Separate unexpired, potentially creditable items for return through a reverse distributor, and keep delivery confirmations.

Example: Pharmaceutical Waste Management in Practice

A community hospital notifies EPA that it is operating under Subpart P. Each nursing unit has a closed container labeled "Hazardous Waste Pharmaceuticals" for partially used vials and non-empty syringes. Environmental services moves full containers to a central area and dates each one. A vendor picks up the waste every few months on a manifest marked "PHARMS." Staff are trained that no pharmaceutical waste goes down a sink or toilet.

Related regulations: EPA Hazardous Waste Generators, EPA Hazardous Waste Identification, EPA Universal Waste Rule.

Note: Subpart P applies in a state once that state adopts it, except for the sewer prohibition, which EPA states applies nationwide. Many states run RCRA programs under EPA authorization and may have additional or more stringent requirements. Always check the current regulation text and any state rules that apply to you.

Frequently Asked Questions

Can a hospital pour hazardous waste pharmaceuticals down the drain?

No. Section 266.505 prohibits all healthcare facilities and reverse distributors from discharging hazardous waste pharmaceuticals to a sewer that passes through to a publicly owned treatment works.

How long can non-creditable hazardous waste pharmaceuticals be stored?

Up to one year on site. The facility must be able to show the accumulation start date.

Are nicotine patches and gum hazardous waste?

Under the same 2019 rule, EPA amended the P075 nicotine listing so that FDA-approved over-the-counter nicotine replacement therapies, such as patches, gums and lozenges, are no longer hazardous waste when discarded. States may choose whether to adopt this change.