Handling and Disposal of Non-hazardous, Hazardous, and Pharmaceutical Substances and Waste
Table of Contents
Non-Hazardous Drugs
Non-hazardous drugs are pharmaceuticals that do not meet the criteria for hazardous waste under the Resource Conservation and Recovery Act (RCRA).
These drugs are generally safe for standard disposal methods, such as reverse distribution, take-back programs, incineration, or municipal solid waste disposal.
These drugs are generally safe for standard disposal methods, such as reverse distribution, take-back programs, incineration, or municipal solid waste disposal.
Characteristics of Non-Hazardous Drugs
A drug is considered non-hazardous if:- It is not flammable, reactive, corrosive, or highly toxic.
- It does not contain heavy metals (e.g., mercury, lead).
- It is not a chemotherapy agent classified as hazardous.
- It is not regulated under the DEA as a hazardous controlled substance.
Examples of Non-Hazardous Drugs
OTC Medications- Acetaminophen (Tylenol)
- Ibuprofen (Advil, Motrin)
- Metformin (for diabetes)
- Lisinopril (for hypertension)
- Atorvastatin (Lipitor, for cholesterol)
- Amoxicillin
- Azithromycin (Z-Pak)
- Cephalexin (Keflex)
- Alprazolam (Xanax) – C-IV
- Tramadol – C-IV
- Codeine-containing cough syrups – C-V
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Federal Regulations for Handling & Disposal of Non-hazardous Drugs
A. Environmental Protection Agency (EPA)
- Resource Conservation and Recovery Act (RCRA), Subtitle D
- Governs the management of solid (non-hazardous) waste, including most pharmaceutical waste that is not classified as hazardous.
- Prohibits healthcare facilities and pharmacies from flushing or pouring pharmaceuticals down the drain into public wastewater systems.
- Encourages healthcare facilities to use incineration or permitted municipal solid waste landfills for non-hazardous pharmaceuticals.
B. Drug Enforcement Administration (DEA) – Controlled Substances
- If a non-hazardous drug is a controlled substance (Schedule II-V), it must follow DEA disposal rules under the Controlled Substances Act (CSA):
- Disposal must occur through DEA-registered reverse distributors or authorized drug take-back programs.
C. Food and Drug Administration (FDA)
- FDA Flush List: Some high-risk medications (e.g., opioids like fentanyl patches) are recommended for flushing if no other disposal options are available, though this is discouraged unless necessary. Click Here
- FDA Non-Flush List: Follow simple steps before trashing medicines at home that are not on the flush list. Click here
- FDA’s Drug Take-Back Program: The best and safest way to throw away unused or expired medicines is by using drug take-back programs. Click Here
Reverse Distribution
Pharmacies and healthcare facilities can send expired, unused, or unwanted non-hazardous pharmaceuticals to a reverse distributor for credit and proper disposal.Incineration & Waste Disposal Services
Non-hazardous drugs can be disposed of through licensed medical waste disposal companies via high-temperature incineration or in permitted municipal solid waste landfills.Household Disposal (for Consumers)
- If no take-back option is available:
- Mix medications with an undesirable substance (e.g., coffee grounds, cat litter).
- Place the mixture in a sealed container before disposal in household trash.
- Do not crush pills or capsules to prevent potential exposure.
Hazardous drugs
Hazardous drugs (HDs) are pharmaceuticals that pose a risk to human health or the environment due to their toxicity, carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity, or genotoxicity.
These drugs are regulated under the Resource Conservation and Recovery Act (RCRA) by the Environmental Protection Agency (EPA) and by the National Institute for Occupational Safety and Health (NIOSH), which maintains a list of hazardous drugs used in healthcare settings.
These drugs are regulated under the Resource Conservation and Recovery Act (RCRA) by the Environmental Protection Agency (EPA) and by the National Institute for Occupational Safety and Health (NIOSH), which maintains a list of hazardous drugs used in healthcare settings.
Characteristics of Hazardous Drugs
A drug is considered hazardous if it exhibits any of the following properties:- Carcinogenicity (cancer-causing)
- Teratogenicity or Reproductive Toxicity (harmful to unborn babies or reproductive health)
- Genotoxicity (damages genetic material)
- Organ Toxicity at Low Doses (damages organs over time)
- Similar Structure or Toxicity to Other Hazardous Drugs
Examples of Hazardous Drugs
The NIOSH List of Hazardous Drugs classifies them into three groups:A. Antineoplastic (Chemotherapy) Drugs
These drugs are primarily used to treat cancer and pose the highest risk.- Methotrexate
- Cyclophosphamide
- Doxorubicin
- Cisplatin
- Fluorouracil (5-FU)
- Vincristine
- Paclitaxel
Non-Antineoplastic Hazardous Drugs
These medications are not used for cancer treatment but still have hazardous properties (organ toxicity, reproductive harm, etc.).- Phenytoin (Dilantin) – Seizure medication
- Carbamazepine (Tegretol) – Seizure & bipolar disorder medication
- Mycophenolate mofetil – Immunosuppressant for organ transplants
- Tacrolimus – Immunosuppressant
- Spironolactone – Diuretic
Drugs with Reproductive Risk
These medications pose risks to pregnant women, those trying to conceive, or breastfeeding mothers due to teratogenic (birth defect-causing) effects.- Finasteride (Propecia, Proscar) – Used for hair loss & prostate issues
- Testosterone – Hormone therapy
- Estrogens (e.g., Estradiol, Premarin) – Used in hormone replacement therapy
- Valproic Acid (Depakote) – Seizure & mood stabilizer medication
- Methimazole – Thyroid medication
Federal Regulations for Handling & Disposal of Non-hazardous Drugs
A. Storage & Handling
USP <800> Guidelines require pharmacies and healthcare workers to:- Use separate storage areas for hazardous drugs.
- Wear PPE (gloves, gowns, masks, eye protection) when handling.
- Use ventilated cabinets for drug preparation (for antineoplastic drugs).
B. Disposal Methods
- Hazardous drugs CANNOT be disposed of in regular trash or down the drain. They must be:
- Collected in black hazardous waste bins (for RCRA hazardous drugs).
- Disposed of through licensed hazardous waste disposal services.
- Properly labeled and documented according to EPA and OSHA regulations.
Chemotherapy Waste
Chemotherapy waste is regulated under EPA (RCRA), OSHA, USP <800>, and DOT guidelines to ensure safe handling, storage, and disposal in healthcare settings.
These regulations help protect healthcare workers, patients, and the environment from exposure to hazardous chemotherapy agents.
These regulations help protect healthcare workers, patients, and the environment from exposure to hazardous chemotherapy agents.
Chemotherapy Waste Classification
Chemotherapy waste is regulated under EPA (RCRA), OSHA, USP <800>, and DOT guidelines to ensure safe handling, storage, and disposal in healthcare settings.These regulations help protect healthcare workers, patients, and the environment from exposure to hazardous chemotherapy agents.
Chemotherapy waste is divided into two main categories based on toxicity and contamination levels:
1. Trace Chemotherapy Waste (Non-Hazardous) – “Yellow Bin”
Includes materials contaminated with small amounts of chemotherapy drugs (less than 3% of the total volume).Examples:
- Empty chemotherapy vials, IV bags, and tubing
- PPE (gloves, gowns, masks) used in chemotherapy preparation
- Used wipes, pads, and other non-sharp materials
- Placed in yellow chemotherapy waste bins
- Sent for incineration at regulated medical waste facilities
2. Bulk Chemotherapy Waste (Hazardous) – “B
Includes highly concentrated or unused chemotherapy drugs that meet EPA’s hazardous waste criteria.Examples:
- Unused chemotherapy drugs (cyclophosphamide, methotrexate, etc.)
- Partially used vials, IV bags, syringes containing chemotherapy drugs
- Spills or cleanup materials containing significant chemotherapy residue
- Collected in black hazardous waste containers
- Managed as RCRA hazardous waste
- Must be disposed of via EPA-permitted hazardous waste incinerators
Federal Regulations for Chemotherapy Waste
A. EPA (Environmental Protection Agency) – RCRA Regulations
Chemotherapy drugs classified as hazardous waste must comply with Resource Conservation and Recovery Act (RCRA) rules.- U-Listed Waste (Toxic chemotherapy drugs) – Examples:
- Cyclophosphamide
- Mitomycin C
- Melphalan
- P-Listed Waste (Acutely hazardous drugs) – Examples:
- Arsenic Trioxide (requires strict disposal)
B. OSHA (Occupational Safety and Health Administration) – Worker Protection
OSHA regulates the handling and exposure prevention of chemotherapy waste under USP <800> and hazardous drug handling guidelines. Requirements:- Employers must provide PPE (gloves, gowns, masks, and eye protection)
- Use of closed-system drug transfer devices (CSTDs) when preparing chemotherapy drugs
- Proper ventilation and storage for hazardous drugs
- Spill kits and emergency procedures for chemotherapy spills
C. USP <800> (United States Pharmacopeia) – Safe Handling Standards
USP <800> sets best practices for handling and disposing of hazardous drugs, including chemotherapy agents. Requirements:- Separate hazardous drug compounding areas
- Proper labeling and storage of chemotherapy waste
- Use of negative pressure rooms for handling volatile hazardous drugs
- Regular staff training on handling hazardous drug waste
D. DOT (Department of Transportation) – Waste Transport Rules
Since chemotherapy waste is classified as hazardous medical waste, it must be transported following DOT hazardous material regulations. Requirements:- Black-bin chemotherapy waste must be labeled as “Hazardous Waste – RCRA Regulated”
- Must be transported by a licensed hazardous waste disposal company
- Containers must have proper hazard symbols and safety documentation
Sharps Containers
Sharps waste, including needles, syringes, lancets, and other contaminated sharp objects, must be handled and disposed of according to regulations from OSHA, EPA, DOT, and FDA. These rules ensure safety for healthcare workers, patients, and the environment.
Sharps Container Requirements
Must be FDA-approved (puncture-resistant, leak-proof, labeled) Color-coded:- Red containers – Regular medical sharps (e.g., needles, syringes)
- Yellow containers – Chemotherapy sharps (e.g., used chemo syringes)
- Black containers – Hazardous sharps waste (e.g., P-listed chemo drugs)
Disposal of Sharps Waste
| Type of Sharps Waste | Examples | Container Type | Disposal Method |
| General Medical Sharps | Used needles, syringes, lancets | Red Sharps Container | Medical waste incineration or autoclaving |
| Chemotherapy Contaminated Sharps | Needles, syringes used for chemo | Yellow Sharps Container | Medical waste incineration |
| Hazardous Drug Sharps (P-Listed) | Arsenic trioxide-contaminated syringes | Black Sharps Container | EPA-permitted hazardous waste incineration |
Storage & Transport of Sharps Container
- Full sharps containers must be properly sealed and labeled
- Must be transported by a licensed medical waste disposal company
- DOT requires secure packaging for transport
Prohibited Practices
❌ Do NOT recap, bend, or break needles before disposal❌ Do NOT dispose of sharps in regular trash
❌ Do NOT flush needles down toilets or sinks
