Is Your Pharmaceutical Waste also Hazardous Waste - PUB2128

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 that is considered hazardous waste. This information should not be used in place of state or federal laws.

Note: Missouri adopted EPA’s Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (Subpart P). This rule adoption modifies regulations and management practices for hazardous waste pharmaceuticals at Healthcare Facilities and Reverse Distributors, as defined in Code of Federal Regulations 40 C.F.R. § 266.500.

How Do I Know if I am Subject to the Requirements of Subpart P?

To be subject to Subpart P, a facility must first be considered either a Healthcare Facility or Reverse Distributor as defined by 40 C.F.R. § 266.500:

• Healthcare Facility - Any person that is lawfully authorized to:
  • Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
  • Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This definition includes, but is not limited to, wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. This definition does not include pharmaceutical manufacturers, reverse distributors, or reverse logistics centers.
• Reverse Distributor - Any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit. Any person, including forward distributors, third-party logistics providers, and pharmaceutical manufacturers, that processes prescription pharmaceuticals for the facilitation or verification of manufacturer credit is considered a reverse distributor.   

A healthcare facility that is a very small quantity generators when counting generation of both hazardous waste pharmaceuticals and non-pharmaceutical hazardous wastes is not subject to the requirements of Subpart P, except the prohibition on sewering of hazardous waste pharmaceuticals described at 40 C.F.R. § 266.505. A healthcare facility that is a very small quantity generator as described above, who elects to not notify and operate under Subpart P, remains subject to the revised RCRA-empty standards of hazardous waste pharmaceuticals found at 40 C.F.R. § 266.507.

Healthcare facilities that are small or large quantity generators when counting generation of both hazardous waste pharmaceuticals and non-pharmaceutical hazardous wastes are subject to the requirement of Subpart P, and must notify the department of their participation. If a healthcare facility would be a lower hazardous waste generator category if counting only non-pharmaceutical hazardous waste, it may notify as such when it provides notification of compliance with Subpart P.  A healthcare facility that is a small or large quantity generator when counting both hazardous waste pharmaceuticals and non-pharmaceutical hazardous wastes is still subject to Subpart P, even if the non-pharmaceutical hazardous waste total would results in a generator status change to very small quantity generator. 

What is Pharmaceutical Waste?

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

• Pharmaceutical products
• 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 C.F.R. § 261.3
• 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 C.F.R. Part 261 Subpart C
  • Ignitability (D001)
  • Toxicity (D number specific to the chemical)
  • Corrosivity (D002)
  • Reactivity (D003)
• Specifically identified as a P-listed hazardous waste in 40 C.F.R. Part 261 Subpart D
• Specifically identified as a U-listed hazardous waste in 40 C.F.R. Part 261 Subpart D

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 C.F.R. § 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:

Note: Medicinal nitroglycerin is not considered a P081 listed hazardous waste because it is not reactive.

Waste code changes for healthcare facilities and reverse distributors of hazardous waste pharmaceuticals operating under Subpart P.

Healthcare facilities, as defined in 40 C.F.R. § 266.500, operating and notifying under the requirements of Subpart P must use code “PHRM” or “PHRMS” in box 13 of the Uniform Hazardous Waste Manifest. Healthcare facilities may elect to include applicable waste codes alongside these codes.

When is the Container that Held the Pharmaceutical Hazardous Waste Considered “RCRA Empty” and Not a Hazardous Waste?

According to 40 C.F.R. § 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- 5401.
• The inner liner that prevented contact between the acute hazardous waste and the container is removed. 

According to 40 C.F.R. § 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.

What changes were made to the RCRA-empty standards under Subpart P?

RCRA-empty standards were modified for certain container types common to the healthcare industry. These changes are described at 40 C.F.R. § 266.507.

What about Pressurized Containers such as Aerosol Inhalers?

Aerosol inhalers could be considered delivery devices and other containers, as defined in 40 C.F.R. § 266.507(d). Healthcare facilities that generate these types of wastes, which remain unused, partially administered, or fully administered, must manage them as non-creditable hazardous waste pharmaceuticals unless the container held a non-acute hazardous waste and is empty as defined in 40 C.F.R. § 261.7(b)(1) or (2).

What about Intravenous Pharmaceuticals or Syringes?

Intravenous (IV) bags that contain hazardous waste pharmaceuticals are considered empty when the bag has been fully administered to a patient, or if the IV bag held a non-acute hazardous waste pharmaceuticals and is empty as defined in 40 C.F.R. § 261.7(b)(1). Applicable infectious waste regulations still apply.

Syringes are considered empty when the contents have been removed by fully depressing the plunger of the syringe. If the syringe is not empty it must be managed as a non-creditable hazardous waste pharmaceutical. Applicable infectious waste regulations still apply.

What about Stock Bottles, Dispensing Bottles or Unit-dose Containers?

A stock bottle, dispensing bottle, vial, ampule or unit-dose container that does not exceed 1 liter or 10,000 pills is considered empty provided that the pharmaceuticals have been removed from the container using the practices commonly employed to remove materials from those types of containers.

Additional Information

• Containers that Once Held P-listed Pharmaceuticals - EPA
• Missouri Code of State Regulations - Title 10
• Missouri Revised Statutes