Is Your Pharmaceutical Waste also Hazardous Waste?

Environmental Remediation Program fact sheet
06/2020
Division of Environmental Quality Director: Ed Galbraith
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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 Departments formal guidance.

What is Pharmaceutical Waste?

Pharmaceutical waste can be any of the following discarded or confiscated items:

What is Hazardous Waste?

Hazardous waste is any waste that:

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:

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 percent alcohol (such as compounding chemicals) or chemicals which 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 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:

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:

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, Fact Sheet--PUB2224
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For More Information

Learn the Basics of Hazardous Waste
EPA guidance
Code of Federal Regulations

Missouri Code of State Regulations for Department of Natural Resources

Missouri Revised Statutes

Missouri Department of Natural Resources
Waste Management Program
Compliance and Enforcement Unit
P.O. Box 176
Jefferson City, MO 65102-0176
800-361-4827 or 573-751-7560