The City of Tacoma Pharmaceutical Waste

Businesses

If you are currently disposing of pharmaceuticals, including dietary supplements, into the dumpster or down the drain, you need to reconsider that practice. New regulations from the Environmental Protection Agency (EPA) under the Resource Conservation and Recovery Act (RCRA) impact how health care facilities must dispose of unused pharmaceuticals. The new regulations treat some dietary supplements as pharmaceuticals and therefore regulate them as hazardous waste. Additionally, as of August 21, 2019, health care facilities are prohibited from disposing of pharmaceuticals and dietary supplements into the sewer, etc. This is in addition to RCRA already prohibiting disposal into the garbage or in some instances by recycling. Noncompliance comes with hefty fines.

Does your company qualify as a health care facility?

The new RCRA regulations only apply to health care facilities, the definition of which might seem limited to locations like physicians’ offices, hospitals, and pharmacies. However, regulators approved an expansive definition of health care facility in the new rules, including any location authorized to distribute, sell, or dispense pharmaceuticals (including regulated dietary supplements).

Do your products qualify as pharmaceuticals?

In the new regulations, ‘‘pharmaceutical’’ means any drug or dietary supplement for use by humans or other animals. The regulation incorporates the definition for dietary supplement created by the Federal Food, Drug and Cosmetic Act as amended by the Dietary Supplement Health and Education Act of 1994 (21 U.S.C. 321(ff)). Under that definition, a product is a dietary supplement if it is intended to supplement a diet and contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clauses (A), (B), (C), (D), or (E).

Is your product a hazardous waste pharmaceutical?

Although most dietary supplements are considered pharmaceuticals under the above definition, only dietary supplements that meet the definition of “hazardous waste pharmaceutical” under RCRA are regulated. In this final rule, ‘‘hazardous waste pharmaceutical’’ means a pharmaceutical that (1) is a solid waste as defined in RCRA Section 261.2, and (2) exhibits certain characteristics such as toxicity (per part 261 subpart C) or is specifically listed by the EPA (per part 261 subpart D).

As to the first prong of the analysis, a pharmaceutical that is discarded (e.g., placed in the sewer, abandoned, trashed, or sometimes even recycled) may fit within the definition of solid waste in Section 261.2. 

As to the second prong, assuming the dietary supplement isn’t specifically listed under subpart D, the pertinent question is whether the dietary supplement exhibits toxicity characteristics under subpart C. The EPA has promulgated a table in subpart C setting forth concentration thresholds elements and chemicals such as cadmium, lead, mercury, arsenic, selenium, and chromium. When a product contains a listed element or chemical above the determined threshold, the product is considered to have a toxicity characteristic: cadmium’s threshold is 1.0 parts per million (ppm), lead’s threshold is 5.0 ppm, mercury’s threshold is .2 ppm, arsenic’s threshold is 5.0 ppm, selenium’s threshold is 1.0 ppm, and chromium’s threshold is 5.0 ppm. Accordingly, if you dispose of dietary supplements that may have concentrations exceeding any of these thresholds, those products are classified as hazardous waste pharmaceutical and subject to the new regulations.

Penalties and implementation

Violations of RCRA Subtitle C allow for maximum civil penalty of $74,552 per day, per violation. The sewer ban takes effect Aug. 21, 2019. If you are worried about your disposal practices given the new RCRA rules, it would be prudent to contact environmental legal counsel experienced in this area to ensure you do not run afoul of RCRA. 

Many pharmaceuticals can pollute the environment if not properly managed and disposed of. Most waste pharmaceuticals designate as either Resource Conservation and Recovery Act (RCRA) hazardous waste or Washington state-only dangerous waste.

For the full list of dangerous waste requirements, refer to the Rules, Policy, and Guides page for more details. We also have a list of definitions for commonly used terms and answers to your frequently asked questions.

 All healthcare facilities must: 

1. Send controlled substances and viable pharmaceuticals to a reverse distributor or manufacturer.
2. Choose a management option below for remaining pharmaceutical wastes.

Option 1

• Assume all pharmaceutical waste is RCRA hazardous waste.
• Send everything to a RCRA-permitted facility.

Option 2

• Determine what pharmaceutical waste is RCRA hazardous waste through designation and send to a RCRA-permitted facility.
• Assume the remainder is state-only dangerous waste and send to an incinerator under the Conditional Exclusion.

Option 3

• Determine what pharmaceutical waste is RCRA hazardous waste through designation and send to a RCRA-permitted facility.
• Designate remainder to determine if it is state-only dangerous waste.
  

Ecology plans to amend specific sections of the dangerous waste regulations to incorporate new federal hazardous waste rules. These changes will affect pharmaceutical waste.

Adopting new pharmaceutical waste rules will help healthcare facilities and waste management vendors:

• Better understand the regulations regarding pharmaceutical waste.
• Manage pharmaceutical waste streams properly.
• Reduce regulatory burden.

Pharmaceutical Waste: A Healthcare Facility Manager's Guide

Waste pharmaceuticals from hospitals, clinics, and other care facilities may be hazardous waste. Learn what facility managers can do to ensure staff put waste in the proper containers.

Pharmaceutical Waste: A Healthcare Worker's Guide

Waste pharmaceuticals are getting into waterways, wildlife, and, ultimately, people. Learn how healthcare workers can keep pharmaceutical waste out of the environment and dispose of it properly.