Waste Management Program
Address
Division of Environmental Quality
P.O. Box 176
Jefferson City, MO 65102-0176
United States
Email
The Missouri Department of Natural Resources’ Waste Management Program prepared this fact sheet for Missouri businesses and institutions to help identify and manage pharmaceutical waste considered hazardous waste. This information should not be used in place of state or federal laws.
Note: Missouri has not yet adopted the EPA’s Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine. As of the date on this fact sheet a rulemaking to adopt this rule is underway. The department hopes to have the rule formally adopted in 2021. Until the rule is formally adopted by the department, the information in this factsheet is the department's formal guidance.
What is Pharmaceutical Waste?
Pharmaceutical waste can be any of the following discarded or confiscated items:
- Pharmaceutical products
- Illegal drugs
- Pharmaceutical precursors or ingredients
- Veterinary pharmaceutical products
What is Hazardous Waste?
Hazardous waste is any waste that:
- Has been or is intended to be discarded, as described in Code of Federal Regulations 40 CFR 261.2
- Has not been excluded by federal or state law
- Is listed (identified) as a hazardous waste in state or federal law
- Contains materials that shows at least one of the following characteristics:
- Ignitable
- Corrosive
- Reactive
- Toxic
Why is it Important to Know if a Pharmaceutical Waste is Hazardous Waste?
Although seemingly harmless in small amounts, pharmaceutical waste can create a serious hazard to human health and the environment if disposed of incorrectly. State and federal laws require wastes identified as hazardous to be handled, stored, treated and disposed of according to the Missouri Hazardous Waste Management law. All non-exempt hazardous waste must be sent to an authorized facility.
How Do I Know Which Pharmaceutical Waste is Hazardous Waste?
There are three main ways pharmaceutical waste can be identified as a hazardous waste:
- Exhibits one or more characteristics of a hazardous waste, as described in 40 CFR 261.24
- Ignitability (D001)
- Toxicity (D number specific to the chemical)
- Corrosivity (D002)
- Reactivity (D003)
- Specifically identified as a P-listed hazardous waste in 40 CFR 261.33
- Specifically identified as a U-listed hazardous waste in 40 CFR 261.33
Pharmaceuticals that exhibit characteristics of hazardous wastes may contain arsenic, barium, cadmium, chloroform, chromium, lindane, selenium, silver, mercury or m-cresol. Mercury is used as a preservative in some vaccines and in phenyl mercuric acetate. M-cresol is used as a preservative in some insulin and vaccines. In addition, ignitable pharmaceuticals, or solutions containing more than 24% alcohol (such as compounding chemicals) or chemicals that are highly corrosive, can be hazardous waste.
If you are unsure if a pharmaceutical waste is a hazardous waste, contact the manufacturer. The manufacturer will be able to tell you the active ingredients in the pharmaceutical. The manufacturer should also be able to provide a Safety Data Sheet, which explains the potential hazards of the chemicals used in a product. It may also be necessary to analyze the pharmaceutical waste to determine if it is hazardous. More guidance about determining if waste is hazardous can be found through the Environmental Protection Agency’s website.
P-listed hazardous wastes include acutely hazardous commercial chemical products that have been or intend to be discarded. P-listed hazardous wastes have extremely hazardous properties that make them harmful in very small quantities. U-listed hazardous wastes include commercial chemical products that have been or intend to be discarded.
In order to qualify as a U- or P-listed hazardous waste, the waste must meet these two criteria:
- The waste must be a commercial chemical product. Commercial chemical products are unused chemicals, manufacturing intermediates of a chemical, off-specification variations of a chemical, residues in containers that are not “Resource Conservation and Recovery Act, or RCRA, empty” or cleanup residue or debris of any chemical named on the U or P list. More discussion about RCRA empty is available below.
- The commercial chemical product’s sole active ingredient must be specifically listed on the U or P list. Sole active ingredient is interpreted as the ingredient that performs the main function of the product. Fillers, colorants, carriers or the like are not considered active ingredients. The commercial chemical product is not a U- or P-listed hazardous waste if it has two or more active ingredients, even if all the ingredients are listed on the U or P list.
The active chemical ingredients listed in paragraphs (e) and (f) of 40 CFR 261.33 are listed by chemical name, not necessarily by their common or commercial name. Most chemicals can be identified by more than one name. Cross-referencing chemical synonyms and verifying by Chemical Abstract Number must be done to confirm the chemical does not have another name on the P or U list. See the U.S. Environmental Protection Agency’s publication, Consolidated List of Chemicals Subject to EPCRA and Section 112(r) of the Clean Air Act, EPA550-B-01-003.
A list of common pharmaceutical precursors and ingredients that are U- or P-listed hazardous wastes is given in the following tables:
| Acute Hazardous Waste |
Substance |
| P001 | Warfarin >0.3% |
| P012 | Arsenic trioxide |
| P042 | Epinephrine (not epinephrine salts) |
| P046 | Phentermine (not phentermine salts) |
| P075 | Nicotine and Salts |
| P188 | Physostigmine salicylate |
| P204 | Physostigmine |
Note: Medicinal nitroglycerin is not considered a P081 listed hazardous waste because it is not reactive.
| Hazardous Waste |
Substance |
| U010 | Mitomycin C |
| U034 | Chloral Hydrate |
| U035 | Chlorambucil |
| U044 | Chloroform |
| U058 | Cyclophosphamide |
| U059 | Daunomycin |
| U075 | Dichlorodifluromethane |
| U089 | Diethylstilbestrol |
| U117 | Ethyl Ether |
| U121 | Trichloromonofluromethane |
| U122 | Formaldehyde |
| U129 | Lindane (also can fail for toxicity) |
| U132 | Hexachlorophene |
| U141 | Isosafrole |
| U150 | Melphalan |
| U182 | Paraldehyde |
| U187 | Phenacetin |
| U188 | Phenol |
| U200 | Reserpine |
| U201 | Resorcinol |
| U203 | Safrole |
| U205 | Selenium Sulfide |
| U206 | Streptozotocin |
| U220 | Toluene |
When is the Container that Held the Pharmaceutical Hazardous Waste Considered “RCRA Empty” and Not a Hazardous Waste?
According to 40 CFR 261.7(b)(3), a container or inner liner removed from a container that held an acute hazardous waste is empty if one of the three following procedures is followed:
- The container is triple rinsed with a solvent capable of removing the acute hazardous waste. The rinsate resulting from this process is considered an acute hazardous waste. The solvent may also exhibit a hazardous waste characteristic, such as ignitability.
- The container has been cleaned by another method shown in scientific literature, or by tests conducted by the generator, to achieve equivalent removal. If you decide to use an alternative cleaning method, you must document the equivalency of the method. It is a good idea to discuss the use of an equivalent removal method with the Missouri Department of Natural Resources’ Waste Management Program at 573-751- 3176.
- The inner liner that prevented contact between the acute hazardous waste and the container is removed.
According to 40 CFR 261.7(b)(1), a container or inner liner removed from a container that held a non-acute hazardous waste is empty if all wastes have been removed that can be removed using “commonly employed practices” for that type of container and one of the three following criteria are met:
- No more than 2.5 centimeters (1 inch) of residue remains on the bottom of the container or liner.
- No more than 3% by weight of the total capacity of the container remains if the container is less than or equal to 119 gallons in size.
- No more than 0.3% by weight of the total capacity of the container remains if the container is more than 119 gallons in size.
Commonly employed practices of removing wastes from a container include pouring, pumping and aspirating. The method chosen must be appropriate for the type of container you are emptying. For example, if turning a vial upside-down and pouring out the pharmaceutical hazardous waste removes more of the waste than aspirating, or sucking out the waste, then the pharmaceutical hazardous waste should be poured out. The RCRA empty container can now be discarded as a regular solid waste so long as the container itself is not hazardous waste. Packaging that once contained pharmaceutical hazardous waste, such as those surrounding pills, gum or patches, may be discarded as regular solid waste unless visibly soiled or overtly contaminated with the pharmaceutical hazardous waste.
The department has accepted the EPA “Containers that Once Held P-listed Pharmaceuticals” guidance released in November 2011 with one caveat—the facility will need to provide documentation to show their calculations for their pharmaceutical waste based on their own testing or test results provided by their pharmaceutical suppliers.
What about Pressurized Containers, Such as Aerosol Inhalers?
Empty aerosol inhalers can be either disposed as a solid waste or recycled. If the aerosol inhaler still contains a pharmaceutical or propellant, you must make a hazardous waste determination for the inhaler. Most propellants in aerosol inhalers are ignitable, making the inhaler a characteristic hazardous waste if it is still pressurized.
What about Intravenous Pharmaceuticals?
A hazardous waste determination must be made on waste intravenous pharmaceuticals; however, the type of determination depends on the circumstances. Intravenous (IV) pharmaceuticals may not be completely given to a patient, due to allergic reaction or change in pharmaceutical choice while dosing. The part of the IV infusion not given to the patient qualifies as a commercial chemical product since it was not used for its intended purpose. A determination for both listed and characteristic hazardous waste must be made for the remaining IV pharmaceuticals.
Intravenous pharmaceuticals completely administered to the patient according to normal IV practices do not qualify as a commercial chemical products since they were used for their intended purpose nor do they qualify as a listed hazardous waste; however, you still need to determine if it is a characteristic hazardous waste. If you determine the IV pharmaceuticals are a pharmaceutical hazardous waste, the IV bag and tubing that contained the pharmaceutical hazardous waste must meet the RCRA empty criteria or be disposed of as hazardous waste.
What if My Business Produces One of These Wastes?
Your business or institution may be considered a hazardous waste generator if you produce any of the hazardous wastes listed in the previous tables. If you produce or accumulate more than 1 kilogram or 2.2 pounds of a P-listed waste per month or at any one time, your business is considered a large quantity hazardous waste generator. Please refer to the appropriate state and federal laws and regulations for guidance. See the fact sheet, Hazardous Waste Generator Status Guidance - PUB2224.