The USP does not enforce regulations. However, USP’s drug standards do influence and can be adopted by regulatory bodies including the Food and Drug Administration (FDA), state pharmacy boards and accrediting agencies such as Joint Commission.
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Stericycle’s EPA Knowledge Center
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Last updated September 09, 2021
Disposal of Hazardous Drugs Waste
The term hazardous drug (HD), refers to drugs found on the NIOSH list of Hazardous drugs. These drugs are listed due to being carcinogenic and/or for causing other toxic effects on humans. The list is further divided into 3 groups. Group 1 includes all antineoplastic, Group 2 includes non-antineoplastic drugs that are a reproductive hazard and meet other criteria from NIOSH to be considered an HD, and Group 3 includes non-antineoplastic drugs that are only reproductive hazards.
A drug that possesses any one of the following six characteristics is considered a hazardous drug, even if it does not appear on the NIOSH list:
• Genotoxicity
• Carcinogenicity
• Teratogenicity
• Fertility impairment or reproductive toxicity
• Serious organ toxicity at low doses
• Drugs with a chemical structure and profile that resemble other drugs known to be hazardous
The Environmental Protection Agency (EPA) regulates hazardous waste pharmaceutical disposal through the Resource Conservation and Recovery Act (RCRA). The law requires companies that use hazardous chemicals, including hazardous waste pharmaceuticals, to classify and dispose of them following prescribed criteria and procedures.
About 5% to 10% of pharmaceutical products can be classified as RCRA hazardous waste. EPA regulations do not require organizations to treat non-RCRA pharmaceutical waste as hazardous waste, though some States may have requirements. It is considered best practice to properly dispose of all pharmaceutical waste, whether RCRA or non-RCRA. Other agencies that regulate medicine waste disposal include the U.S. Department of Transportation (DOT), which covers how drug waste should be transported to waste management facilities, and the U.S. Drug Enforcement Administration (DEA), which oversees controlled substance waste management.
Trace Chemotherapy Waste
Drugs used in chemotherapy, including antineoplastics and cytotoxics, are potent and toxic agents that can cause serious health problems for employees if the drugs and drug waste are improperly handled and disposed of. To protect staff, healthcare organizations should have clear waste disposal processes that mitigate exposure risk. See these resources to help keep your healthcare facility safe and compliant:
How to dispose of Hazardous Drugs under USP 800?
The U.S. Pharmacopeia Convention (USP) is a scientific nonprofit organization with a mission “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” On December 1, 2019, General Chapter 800 of the USP published guidelines on handling hazardous drugs in healthcare settings. The standards set under the USP 800 should not be confused with and is unrelated to the regulations under the EPA Final Rule on Hazardous Waste Pharmaceuticals.
The USP 800 is a chapter of the USP that identifies best practices, setting industry standards for handling hazardous drugs (HDs) “to protect patients, healthcare personnel, and the environment.”
Stericycle monitors all federal and state regulations affecting your regulated waste management. If Stericycle is servicing your facilities’ pharmaceutical waste and you are following the Stericycle Waste Acceptance Policy, you are compliant with waste management regulations and current USP 800
standards concerning disposal. Be aware:
- USP 800 is not a new set of regulations concerning pharmaceutical waste but rather new protocols for safe handling of pharmaceuticals in the clinical or pharmaceutical workplace.
- Pharmaceutical waste will continue to be handled in accordance with EPA requirements, NIOSH guidelines, and individual state regulations.
- Stericycle strives to ensure our customers stay OSHA compliant, including with OSHA’s Hazard Communication Standard
For the safety of your employees and to stay compliant with the OSHA Hazard Communication Standard, you must keep an updated Hazard Communication Program (HCP). The USP 800 recommends only two additions: A written plan that describes how the USP 800 standard will be implemented and a provision that personnel of reproductive capability must confirm in writing that they understand the risks of handling hazardous drugs. Among other rules of the Hazard
Communication Standard, your HCP still needs to include:
- All containers of hazardous chemicals must be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings
- Entities must have an safety data sheet (SDS) for each hazardous chemical they use (29 CFR 1910.1200)
- Entities must ensure that the SDSs for each hazardous chemical used are readily accessible to personnel during each work shift and when they are in their work areas
- Personnel who may be exposed to hazardous chemicals when working must be provided information and training before the initial assignment to work with a hazardous chemical, and also whenever the hazard changes.
USP 800 states that “handling hazardous drugs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal.” USP 800 refers primarily to transport and disposal within the healthcare facility but the standard does reflect Stericycle’s long-standing recommendations as well as our Waste Acceptance Policy regarding hazardous drug wastage generated from chemotherapy.
Transport <800>, 11.3
“Hazardous drugs that need to be transported must be labeled, stored, and handled in accordance with applicable federal, state, and local regulations. HDs must be transported in containers that minimize the risk of breakage or leakage. Pneumatic tubes must not be used to transport any liquid hazardous drugs or any antineoplastic hazardous drugs because of the potential for breakage and contamination. When shipping hazardous drugs to locations outside the entity, the entity must consult the Transport Information on the SDS. The entity must ensure that labels and accessory labeling for the hazardous drugs include storage instructions, disposal instructions, and HD category information in a format that is consistent with the carrier’s policies.”
Disposal <800>, 11.4
“All personnel who perform routine custodial waste removal and cleaning activities in HD handling areas must be trained in appropriate procedures to protect themselves and the environment to prevent hazardous drug contamination. disposal of all hazardous drug waste, including, but not limited to, unused HDs and trace-contaminated PPE and other materials, must comply with all applicable federal, state, and local regulations.” Note: Disposal of all HD waste (including unused and unusable HDs) must comply with all applicable federal, state, and local regulations. Because USP 800 is not a regulation, and USP does not have jurisdiction over waste disposal, the standard defers to federal, state, and local regulations for waste disposal. This means that EPA regulations need to be followed for hazardous drug disposal that are also hazardous wastes. Some states also regulate waste that previously contained HDs or was used to administer HDs, in those states’ regulated medical waste regulations; this waste is often referred to as “trace chemotherapy” waste.
