Skip to site content
U.S. Department of Health and Human Services
Indian Health Manual

Part 3, Chapter 27: Manual Exhibit 3-27-B

EXHIBIT 3-27-B – HAZARDOUS DRUG WASTE MANAGEMENT

Sec.
1. Types of Hazardous Drug Wastes
2. Trace Hazardous Drug Waste Disposal
3. Bulk Hazardous Drug Waste Disposal
4. Excreta
5. Unused Pharmaceuticals
6. Waste Transportation
  1. TYPES OF HAZARDOUS DRUG WASTES
    1. Acutely toxic hazardous drug waste.

      If disposing of a waste that the Environmental Protection Agency (EPA) considers “acutely toxic,” then the waste container may also be considered hazardous (the 3 percent by weight rule discussed below does not apply). The EPA designates acutely toxic waste with a “P” designation. There are a few National Institute for Occupational Safety and Health (NIOSH) hazardous drugs that the EPA designates as acutely toxic. These are:
      1. Arsenic trioxide P012; and
      2. Warfarin >0.3% P001.
      If a P-listed chemical is added to a waste container, then the entire container may be considered acutely toxic. This practice can change the hazardous waste generator status of a facility. A guide to generator status and impact may be found in EPA document 910-R-08-002 - A Guide to Hazardous Waste Management at Tribal Health Care Clinics. It should be noted that some non NIOSH hazardous drugs may be considered acutely toxic when disposed.

      If a facility will be disposing of any acutely toxic drugs, it is suggested they calculate the expected residual of acutely toxic waste in the empty containers. A 2011 EPA memorandum entitled “Containers that Once Held P-listed Pharmaceuticals” describes this approach. All acutely toxic hazardous drug waste and their containers should be disposed with the “bulk hazardous drug waste” as described below.
    2. Trace hazardous drug waste.

      For hazardous waste that is not acutely toxic, trace hazardous wastes are waste items that contain less than 3 percent (by weight) of the original quantity of hazardous drugs. Trace hazardous drug waste includes empty vials and syringes, gloves, gowns, linen, and tubing.
    3. Bulk hazardous drug waste. Bulk hazardous drug wastes are waste items that contain more than 3 percent (by weight) of the original quantity of hazardous drugs or any amount of acutely toxic hazardous waste. Bulk hazardous drug waste includes spill clean-up materials; saturated Personal Protective Equipment (PPE); partially or fully filled vials; expired or unused vials; ampoules; syringes; bags and bottles of hazardous drugs; or solutions with more than trace contamination.
    4. Excreta. Patients excrete the majority of drug metabolites in their urine and stool within 48 hours after administration. However, some drug metabolites are excreted in urine and stool for 7-days after administration. See package insert of the medication. During these time periods, patient excreta should be handled with care using the appropriate PPE.
    5. Unused Pharmaceuticals.
  2. TRACE HAZARDOUS DRUG WASTE DISPOSAL.  Collect trace hazardous drug waste in approved yellow waste containers
    1. Seal containers when three fourths full.
    2. Locate waste containers for trace hazardous drug waste in areas where drugs are prepared or administered.
    3. Keep waste containers closed.
    4. Trace hazardous drug waste must be incinerated at a regulated medical waste facility or a municipal incinerator permitted to accept non-hazardous pharmaceutical waste or a Resource Conservation and Recovery Act (RCRA) permitted incinerator.

      Microwaving or autoclaving trace hazardous drug waste does not inactivate the hazardous drugs. Do not use these methods for final destruction of trace hazardous drug waste.
  3. BULK HAZARDOUS DRUG WASTE DISPOSAL.  Bulk hazardous drug waste includes spill clean-up materials; saturated PPE; partially or fully filled vials; expired or unused vials; ampoules; syringes; bags and bottles of hazardous drugs; or solutions with more than trace contamination.
    1. Seal containers when three fourths full.
    2. A location for collecting bulk hazardous drug waste should be centrally located in a secure area.
    3. Hazardous drug waste storage areas shall meet applicable EPA requirements. All hazardous waste storage areas must be well ventilated.
    4. Bulk hazardous drug waste must be incinerated at a RCRA permitted hazardous waste incinerator. Microwaving or autoclaving bulk hazardous drug waste does not inactivate the hazardous drugs. Do not use these methods for final destruction of bulk hazardous drug waste.
    5. RCRA Hazardous Drug Waste.
      1. The RCRA hazardous drug list was last updated in 1976. There are antineoplastic medications that are not included on RCRA list, but best practice is to dispose of these as hazardous drug waste.
      2. The following NIOSH hazardous drugs are considered RCRA hazardous waste when disposed as bulk hazardous drug waste:
        1. Arsenic Trioxide (012P012);
        2. Chlorambucil (035U035);
        3. Cyclophosphamide (058U058);
        4. Daunomycin (059U059);
        5. Diethylstilbestrol (U089);
        6. Etoposide (when waste has more the 24% alcohol);
        7. Melphalan (U-listed waste);
        8. Mitomycin C (U-listed waste);
        9. Paclitaxel (when waste has more the 24% alcohol);
        10. Streptozotocin (U-listed waste);
        11. Toposar (when waste has more the 24% alcohol);
        12. Torisel (when waste has more the 24% alcohol);
        13. Uracil Mustard (U-listed waste);
        14. Warfarin >0.3% (P001;); and
        15. Warfarin <0.3% (U248;).
      3. All RCRA hazardous drug waste must be packaged, labeled, listed on the manifest, and then incinerated at a RCRA permitted hazardous waste incinerator (this is different than a medical waste incinerator).
      4. Facilities must maintain records of names, amounts, weights, types of bulk hazardous drug wastes generated, manifests, and records of destruction in order to verify records of the waste transporter and comply with RCRA requirements.
  4. EXCRETA.
    1. Patient excreta can usually be disposed in the sanitary sewer. Confirm this with your facility safety officer or environmental health officer as some localities may require notification of disposal of contaminated excreta.
    2. Encourage male patients to sit on toilet seats rather than standing during urination to reduce the risk of aerosolization and droplet transfer.
    3. When feasible, encourage the use of toilets rather than urinals and bedpans so that excreta can be disposed of immediately.
    4. When applicable, collect drainage of pleural fluids, ascites, and other body fluids in a closed system that can be disposed of intact.
    5. If possible, use disposable ostomy pouches rather than rinsing and reusing them.
    6. Protect the skin of incontinent patients from their own excreta. The metabolites of drugs found in the urine or stool may be damaging to the skin. Following each urination or stool, cleanse the skin with soap and water and apply a moisture barrier to the perineal and perirectal areas. Apply a clean disposable diaper.
    7. Educate patients receiving hazardous drugs in home care regarding the hazards of their excreta.
    8. Close the lid on the toilet, if available; prior to flushing in order to reduce the risk of aerosolization and droplet transfer.
    9. Diapers and other absorbable material contaminated with patient excreta from patients receiving hazardous drugs should be treated as trace hazardous drug wastes.
  5. UNUSED PHARMACEUTICALS.

    Many reverse distribution companies (RDC) offer product return processing, professional waste disposal and customized reporting services. These companies will pick up unused hazardous drugs, controlled substances, and other pharmaceuticals and return them to the manufacturer, usually for a percentage of the value of the returned pharmaceuticals. Drugs that cannot be returned to the manufacturer should be handled as hazardous waste and disposed.
    1. It is strongly recommended that facilities ensure the RDC inspects their hazardous waste disposal facility. Documentation of this audit from the RDC should be required as an element of the RDC contract.
    2. The RDC must not designate any hazardous drug products being returned as "waste" onsite. This designation will make your facility the generator of hazardous waste. This designation must be made offsite so that the RDC will be the generator of the hazardous waste.
    3. The RDC must provide a certificate of destruction for all hazardous drugs that are incinerated, deposited in a hazardous waste landfill, or otherwise disposed.
  6. WASTE TRANSPORTATION.  Transportation of hazardous waste is regulated by the EPA, the Federal Department of Transportation (DOT), and State regulators.
    1. Trace hazardous drugs waste must be sealed and transported in the same manner as regulated medical waste as defined by State and Federal regulations. Minimally, the waste should be double bagged and labeled. Other State requirements may apply.
    2. Resource Conservation and Recovery Act hazardous waste (includes U listed, P listed characteristic bulk hazardous drug waste).
      1. At a minimum, hazardous drug waste leaving the facility must be listed on a manifest, labeled appropriately, and shipped to a regulated treatment storage disposal facility.

        To make manifesting easier when it is unknown which of the facility’s hazardous pharmaceuticals may be in a specific shipment, the facility should work with a vendor who will help create a waste profile.
      2. Since the generator of the hazardous drug waste (the facility) is ultimately responsible for the disposition of the waste, the waste hauler must be reputable, competent, and certified to haul hazardous waste.
      3. Any staff who prepare RCRA waste for shipping and/or who sign the manifest as the generator must have DOT hazmat training.
      4. It is strongly recommended that the institutional environmental health officer(s) or facility safety officer(s) inspect the hazardous waste hauler's policies and procedures on an annual basis to ensure that hazardous drugs are properly transported. Depending on the findings, this survey may need to be conducted more frequently. This inspection should be outlined in the contract with the hazardous waste hauler.