Medical Waste
Non-Hazardous Medical Waste
Medical wastes that are not hazardous waste are subject to regulation under Tennessee’s solid waste regulations, Rule Chapter 0400-11-01.
Within these regulations, information pertaining to medical waste can be found on pages 7, 8, 11 (under “special waste”) and 14, Rule Chapter 0400-11-01.
The Division has developed guidance for the disposal of non-hazardous medical waste in a class I landfill starting on page 133 of the Division’s Policy and Guidance Manual.
Hazardous Medical Wastes
Hazardous Medical Wastes are those medical wastes which contain chemicals (such as Nicotine, Epinephrine, Nitroglycerine, Warfarin, chemotherapy drugs, etc) that the EPA has determined must be managed under the strict criteria established by federal regulations. More information about hazardous medical waste is available below including some examples of possible listed hazardous waste that healthcare facilities may generate.
A small quantity -- one kilogram -- of a P-listed waste can cause a facility to be classified as a "large quantity generator," and to have to comply with more stringent rules as a consequence. If you are interested in reducing the hazardous waste generated in your facility, eliminating or finding substitutes for P-listed chemicals is a good place to start.
The P-list includes about 239 different "acutely toxic" substances, listed under about 135 different waste codes. (Some codes cover several substances.) HERC has identified 15 of these that you might expect to find in a healthcare facility. They are listed below, along with their waste codes and typical uses associated with each. The CAS numbers for these compounds can be found in the official list at 40 CFR 216.33. The equivalent Tennessee regulation is found in Tennessee Rule 0400-12-01-.02(4)(d).
Please note that this short list is not meant to be exhaustive.
| Material | Code | Use |
|---|---|---|
| 3-benzyl Chloride |
P028 |
pharmaceutical manufacturing |
| Arsenic |
P012 |
veterinary medicine, severe parasitic diseases |
| Arsenic Trioxide |
P012 |
chemotherapy |
| Chloropropionitrile |
P027 |
pharmaceutical synthesis |
| Cyanide Salts |
P030 |
laboratory |
| Epinephrine(1) |
P042 |
emergency allergy kits, certain types of glaucoma, eye surgery, cardiac arrest |
| Nicotine |
P075 |
smoking cessation, nicotine patches, etc. |
| Nitroglycerin |
P081 |
coronary vasodilator in angina treatment Individual doses, if not reactive, are not P081. |
| Phentermine(3) |
P046 |
appetite suppressant |
| Phenylmercuric acetate |
P092 |
bactericide, pharmaceutic aid in contact lens solutions and nasal sprays |
| Physotigmine |
P204 |
acholinergenics (liberates/acts like acetylcholine) |
| Physotigmine Salicylate |
P188 |
acholinergenics (liberates/acts like acetylcholine) |
| Potassium Silver Cyanide |
P099 |
bactericide |
| Sodium Azide(2) |
P105 |
chemical preservative in hospitals, laboratories |
| Strychnine |
P108 |
veterinary tonic and stimulant |
| 1 Does not include epinephrine salts. |
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| 2 Special note on sodium azide (P105): Sodium azide, found in Enterococcus agars, is also used in detonators and other explosives. An odorless white solid, it s a rapidly acting, potentially deadly chemical. It changes rapidly to a toxic gas with a pungent (sharp) odor when it is mixed with water or an acid, or when it comes into contact with certain metals (for example when it is poured into a drain pipe containing lead or copper). But the odor of the gas may not be sharp enough to give people sufficient warning of the danger. Serious accidents have occurred in laboratory settings. In one case, sodium azide exploded when it was poured into a drain and the toxic gas was inhaled. |
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| 3 See EPA 2/17/2012 memorandum that clarifies the scope of the hazardous waste listing. |
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The U-list includes about 472 distinct materials, listed under about 247 different waste codes. (As with the P-list, the same code can refer to several different materials.) HERC has identified 66 of them that you might expect to find in a healthcare setting. They are listed below along with their waste codes and typical uses. The CAS numbers for these compounds can be found in the official list at 40 CFR 216.33.
This list is not meant to be exhaustive.
| Material | Code | Use |
|---|---|---|
| Acetone |
U002 |
solvent in pharmaceutical formulations |
| Acetyl Chloride |
U006 |
cholesterol testing |
| Acrylonitrile |
U009 |
pharmaceutical manufacturing |
| Aniline |
U012 |
pharmaceutical manufacturing |
| Azaserine |
U015 |
antifungal, antineoplastic |
| Benzidine dichloride |
U243 |
pathology laboratory |
| Bromoform |
U225 |
sedative, hypnotic, antitussive |
| Cacodylic Acid |
U136 |
dermatologic |
| Carbon Tetrachloride |
U211 |
anthelmintic, pharmaceutical formulations |
| Chloral Hydrate |
U034 |
cough syrups, sleeping pills |
| Chlorambucil |
U035 |
chemotherapy |
| Chlornaphazin |
U026 |
antineoplastic |
| Chloroform |
U044 |
anesthetic |
| Creosote |
U051 |
antiseptic, expectorant |
| Cresols |
U052 |
antiseptics, disinfectants |
| Cyclophosphamide |
U058 |
chemotherapy |
| Daunomycin |
U059 |
chemotherapy |
| o-Dichlorobenzene |
U070 |
germicides, pharmaceutical manufacturing |
| m-Dichlorobenzene |
U071 |
germicides, pharmaceutical manufacturing |
| p-Dichlorobenzene |
U072 |
germicides, pharmaceutical manufacturing |
| Diethylstilbestrol |
U089 |
anticancer agent, contraceptive |
| Ethyl Acetate |
U112 |
drug flavoring agent, topical anesthetic |
| Ethyl Carbamate |
U238 |
antineoplastic |
| Ethyl Ether |
U117 |
disinfectant, anesthetic |
| Ethylene Oxide |
U115 |
high level sterilant for surgical instruments |
| Formaldehyde |
U122 |
antiseptic, disinfectant, preservative |
| Formic Acid |
U123 |
diuretic, heart and muscle treatment |
| Hexachloroethane |
U131 |
anthelmintic (anti-worm treatment) |
| Hexachlorophene |
U132 |
skin treatment (pHisoHex', Septisol') |
| Hexachloropropene |
U243 |
dialysis, pesticide |
| Lindane |
U129 |
scabicide |
| Melphalan |
U150 |
chemotherapy |
| Maleic Anyhydride |
U147 |
pharmaceutical manufacture |
| Mercury |
U151 |
preservatives (thimerosal), antiseptics (mercurochrome), devices (thermometers, sphygmomanometers, others) |
| Methanol |
U154 |
solvent in pharmaceutical manufacture |
| Methylpyrilene |
U155 |
antihistamine |
| Methylthiouracil |
U164 |
thyroid inhibitor |
| Mitomycin |
U010 |
chemotherapy |
| Naphthalene |
U165 |
antiseptic, anthelmintic |
| N-butyl alcohol |
U031 | bactericide, pharmaceutical manufacture, pain control, anti-hemorrhagic |
| P-Chloro-m-Cresol |
U039 |
antiseptic |
| Paraldehyde |
U182 |
sedative, hypnotic |
| Phenacetin |
U187 |
analgesic, antipyretic |
| Phenol |
U188 |
antiseptic, anesthetic, antipruritic (relieves itching) |
| Reserpine |
U200 |
hypertension, insanity, snakebite, cholera, horse tranquilizer |
| Resorcinol |
U201 |
acne, dandruff treatment, intermediate in pharmaceutical synthesis |
| Saccharin |
U202 |
sugar substitute, food preparation |
| Selenium sulfide |
U205 |
shampoos |
| Streptozotocin |
U206 |
chemotherapy |
| Tetrachloroethylene |
U210 |
anthelmintic |
| Uracil mustard |
U237 |
chemotherapy |
| Thiram |
U244 |
antiseptic |
| Trichloroethylene |
U228 |
inhalation anesthetic, pharmaceutical manufacture |
| Warfarin < 0.3% |
U248 |
anticoagulant |
| 2-Chloroethyl Vinyl Ether |
U042 |
anesthetics and sedatives manufacture |
| 3-Methylchloranthrene |
U157 |
cancer research |
Some chemicals used to treat cancer patients during chemotherapy fall on either the U or P lists. These are often referred to by their brand names rather than the chemical designations appearing on the lists. HERC has compiled a list of some common brand names, together with their chemical names and RCRA waste codes. Please note that since new products may be introduced at any time, the list may not include all brand names composed of RCRA listed chemicals.
Hazardous Waste Characteristics
Tennessee Rule 0400-12-01-.02(3) [40 CFR 261. 21-24]
If it is determined that the waste pharmaceutical is not a listed hazardous waste, then the healthcare facility must determine if that waste pharmaceutical meets one of the hazardous waste characteristics. The generator of the waste can either use a standardized test method or apply general knowledge of the waste’s properties in making this determination.
Examples of hazardous waste characteristics exhibited by pharmaceutical wastes, as well as other wastes, are provided below. Generators should consult the actual regulations to get the exact limits and regulatory language.
Ignitability (D001): the presence of a flammable solvent is the most common reason pharmaceuticals meet this characteristic. For alcohol, the regulations set a threshold limit of 24% (i.e., if the formulation contains more than 24% alcohol, then the waste is considered hazardous waste). Strong oxidizers, such as silver nitrate and potassium permanganate, in pharmaceutical formulations may also meet the definition.
Corrosivity (D002): applies to strong acids (pH≤2) or strong bases (pH≥12.5). In pharmaceutical compounding, glacial acetic acid and concentrated sodium hydroxide might be used. Their wastes are corrosive (see above pH limits) and thus considered hazardous.
Reactivity (D003): nitroglycerin, a P-listed hazardous waste, would fall into this category if used in bulk. However, dosage forms typically do not exhibit characteristics of reactivity.
Toxicity (D004 to D043): The toxicity characteristic (TC) identifies wastes that are likely to leach concentrations of any one of 40 different toxic chemicals in amounts above the specified regulatory levels. Examples of TC chemicals/heavy metals that have pharmaceutical uses and their toxicity threshold levels are:
- Arsenic (D004): 5.0 mg/L;
- Barium (D005): 100.0 mg/L; 11
- Cadmium (D006): 1.0 mg/L;
- Chloroform (D022): 6.0 mg/L;
- Chromium (D007): 5.0 mg/L;
- m-Cresol (D024): 200 mg/L;
- Lindane (D013): 0.4 mg/L;
- Mercury (D009): 0.2 mg/L;
- Selenium (D010): 1.0 mg/L;
- Silver (D011): 5.0 mg/L
Reverse Distribution for Unused and Unopened Pharmaceuticals
Tennessee follows EPA’s guidance on the reverse distribution process for unused pharmaceuticals that are in the original packaging, have not been sold or distributed, and are returned by the healthcare facility or retailer to the manufacturer under a legitimate reverse distribution system for evaluation, potential credits, and final disposition or resale or reuse.
New Management Standards for Hazardous Waste Pharmaceuticals
EPA finalized regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors in a rule published in the Federal Register on February 22, 2019.
The Final Rule applies to healthcare facilities that generate, accumulate, or otherwise handle hazardous waste pharmaceuticals and reverse distributors engaged in the management of prescription hazardous waste pharmaceuticals. However, the Final Rule does not apply to non-pharmaceutical hazardous waste or to hazardous waste pharmaceuticals by facilities other than healthcare facilities and reverse distributors.
The Final Rule will affect industries such as pharmacies and drug stores, veterinary clinics, physicians’ and dentists’ offices; health care practitioners such as chiropractors, outpatient care centers, ambulatory surgical centers, hospitals, nursing care facilities, continuing care retirement communities, some medical examiners and coroners’ offices, wholesale distributors, supermarkets, warehouse clubs and supercenters, retailers of pharmaceuticals, and reverse distributors that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals they no longer need.
Pharmaceuticals are defined as any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system; or any liquid nicotine packaged for retail sale for use in electronic nicotine delivery systems. The definition includes dietary supplements, prescription drugs, over-the-counter drugs, homeopathic drugs, compounded drugs, investigational new drugs, pharmaceuticals remaining in non-empty containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals. However, the Final Rule exempts FDA-approved over-the-counter nicotine replacement therapies such as patches, gums, and lozenges from regulation as a RCRA hazardous waste.
As with any other waste, a pharmaceutical waste is considered hazardous waste if it is a solid waste meeting a listing or exhibiting a characteristic described at Tennessee Rule 0400-12-01-.02 (40 C.F.R. Part 261).
Final Rule Implications
First, the Final Rule explicitly prohibits discharges of hazardous waste pharmaceuticals into public sewer systems. In addition, the Final Rule lays out a list of requirements that affected facilities must follow in order to qualify for relief, including:
- Training for employees who handle and accumulate these wastes
- Hazardous waste determinations
- New, unique accumulation rules and time limits
- Specific labeling requirements for certain hazardous waste pharmaceutical containers
- Reporting, recordkeeping, and release response standards
- Land disposal restrictions (LDR) for certain hazardous waste pharmaceuticals
- Manifests for certain off-site shipments
Non-prescription hazardous waste pharmaceuticals and other unsold retail items such as over-the-counter pharmaceuticals, dietary supplements, and homeopathic drugs sent through reverse logistics to a reverse logistics center will not be considered wastes at the healthcare or retail facility if they have a reasonable expectation of being lawfully used or reused for their intended purpose or reclaimed. If the reverse logistics center decides that these products cannot be reused or reclaimed, then they must be disposed of as solid waste. The rules applicable to reverse logistics are effective immediately at the federal level.
Prescription hazardous waste pharmaceuticals moving through the reverse distribution process, whereby reverse distributors receive shipments of unused or expired prescription pharmaceuticals from healthcare facilities and facilitate the process of crediting those healthcare facilities for the unused products, are considered solid wastes at the healthcare facility. These products, if potentially creditable, must be managed under the new Subpart P standards. The rules applicable to reverse distribution are effective in non-authorized states on August 21, 2019, and effective in authorized states when the state adopts Subpart P.
The Final Rule will not become effective in states authorized for the RCRA program until states have adopted the Final Rule, with one notable exception. The sewer prohibition is effective in all states on August 21, 2019, regardless of whether the state is authorized or has adopted Subpart P. Tennessee has adopted the Final Rule, and Subpart P became effective on April 11, 2022.
| Contact |
|---|
| Bassam Faleh Non-Hazardous Medical Waste Contact 615-878-2850 Bassam.Faleh@tn.gov |
| Beverly Philpot Hazardous Medical Waste Contact 615-795-1188 Beverly.Philpot@tn.gov |
This Page Last Updated: July 9, 2024 at 6:50 PM