How to Dispose of RCRA-Hazardous Pharmaceutical Waste
How to identify and dispose of P-listed, U-listed, and characteristic hazardous pharmaceutical waste under federal RCRA rules.
What counts as rcra-hazardous pharmaceutical waste
A pharmaceutical is RCRA hazardous waste, when discarded, in one of two ways. First, it can be a listed waste under 40 CFR 261.33: the P-list at paragraph (e) covers acutely hazardous discarded commercial chemical products (off-spec product, container residues, and spill residues count), and the U-list at paragraph (f) covers other listed commercial chemical products identified as toxic. A listing applies only when the named chemical is the sole active ingredient. P-listed pharmaceutical examples include warfarin and salts when present at concentrations greater than 0.3 percent (P001), nicotine and salts (P075), physostigmine (P204), and physostigmine salicylate (P188). Note two current carve-outs: the P075 listing no longer includes FDA-approved over-the-counter nicotine patches, gums, and lozenges (2019 rule), and EPA has long interpreted the P042 epinephrine listing to cover only epinephrine base (CAS 51-43-4), not the epinephrine salts (such as epinephrine HCl and epinephrine bitartrate) used in most products, including EpiPens (EPA interpretive memorandum, October 15, 2007). Second, a drug can be a characteristic waste under 40 CFR Part 261 Subpart C even if not listed: ignitable (D001, 40 CFR 261.21, for example many alcohol-based solutions and aerosol inhalers), corrosive (D002), reactive (D003), or toxic (40 CFR 261.24, for example D009 mercury from thimerosal preservatives, D007 chromium, D004 arsenic, D006 cadmium, D011 silver). Some chemotherapy agents are listed (for example U-listed) and others are evaluated by characteristic.
Step by step: containment, segregation, transport
- Make a hazardous waste determination on each drug.
For every unused, expired, or unsaleable pharmaceutical, determine whether it is RCRA hazardous waste before discarding. Check the P-list and U-list at 40 CFR 261.33(e) and (f) by the sole active ingredient, then evaluate the characteristics under 40 CFR Part 261 Subpart C (ignitability, corrosivity, reactivity, toxicity). This determination is required by 40 CFR 262.11.
- Segregate hazardous from non-hazardous pharmaceutical waste.
Keep RCRA-hazardous pharmaceutical waste separate from non-hazardous pharmaceutical waste and from regulated medical (red bag) waste. Non-creditable hazardous waste pharmaceuticals are accumulated for shipment to a designated receiving facility; do not commingle them with materials that change their regulatory status.
- Use Subpart P containers and labeling, including black containers.
Healthcare facilities operating under 40 CFR Part 266 Subpart P collect non-creditable hazardous waste pharmaceuticals in containers that are structurally sound, compatible with the contents, and labeled or marked clearly with the words Hazardous Waste Pharmaceuticals. Many facilities use a black container as the industry-standard color to signal RCRA-hazardous pharmaceutical waste and keep it distinct from other waste streams.
- Never pour hazardous waste pharmaceuticals down the drain.
Do not sewer any hazardous waste pharmaceutical. Under 40 CFR 266.505, all healthcare facilities (including very small quantity generators) and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works, regardless of any pretreatment permit. This ban has been in effect nationwide since August 21, 2019.
- Ship to a permitted facility for incineration.
Accumulate within Subpart P time limits, ship on a hazardous waste manifest to a designated receiving facility (a permitted or interim-status RCRA treatment, storage, and disposal facility), and have the waste destroyed at a RCRA-permitted hazardous waste incinerator. Use a properly permitted hauler and keep manifests and records.
Container, color code, and labeling
Black is the de facto industry color for RCRA-hazardous pharmaceutical waste containers; facilities use black bins or liners to keep listed and characteristic hazardous drugs separate from non-hazardous pharmaceuticals and from red-bag medical waste. Healthcare facilities and reverse distributors that manage these wastes do so under 40 CFR Part 266 Subpart P (Management Standards for Hazardous Waste Pharmaceuticals), which became effective August 21, 2019. Two Subpart P provisions matter most for disposal. The sewer ban at 40 CFR 266.505 prohibits discharging any hazardous waste pharmaceutical to a sewer that passes to a publicly owned treatment works. The empty-container relief at 40 CFR 266.507 lets a healthcare facility treat stock, dispensing, and unit-dose containers (not over 1 liter or 10,000 pills), syringes emptied by fully depressing the plunger, and fully administered IV bags as RCRA-empty using normal removal practices, which removes the harsh triple-rinse requirement that the general empty-container rule at 40 CFR 261.7(b)(3) otherwise imposes on residues of P-listed (acutely hazardous) materials. Final disposal of the collected hazardous waste pharmaceuticals is by destruction at a RCRA-permitted hazardous waste incinerator after shipment on a manifest to a designated receiving facility.
Frequently asked questions
Is warfarin always a P-listed hazardous waste?
No. Warfarin and salts are P001 only when present at concentrations greater than 0.3 percent (40 CFR 261.33(e)). Below that concentration the P001 listing does not apply, though you must still evaluate the waste for any hazardous characteristic.
Are used EpiPens (epinephrine) RCRA hazardous waste?
Generally no, when epinephrine salt is the sole active ingredient. EPA's longstanding interpretation (October 15, 2007 memorandum) is that the P042 listing covers only epinephrine base (CAS 51-43-4), not the salts such as epinephrine HCl or bitartrate used in most products including EpiPens, so their residues are not P042-listed. Always confirm the specific formulation and check for any characteristic before disposal.
Can a healthcare facility pour expired hazardous drugs down the sink?
No. 40 CFR 266.505 prohibits all healthcare facilities and reverse distributors from sewering any hazardous waste pharmaceutical to a system that reaches a publicly owned treatment works. This applies even to very small quantity generators and regardless of any pretreatment permit.
Do I still have to triple-rinse P-listed drug containers?
Not for the container types covered by 40 CFR 266.507. Under Subpart P, healthcare facilities can treat qualifying stock, dispensing, and unit-dose containers (not over 1 liter or 10,000 pills), emptied syringes, and administered IV bags as empty using normal removal practices, instead of the triple-rinse standard the general rule at 40 CFR 261.7(b)(3) imposes on P-listed residues.