Proposed EPA Regulation of Pharmaceutical Waste

In 2008, EPA proposed adding pharmaceutical wastes to the Universal waste rule to provide a better way to ensure adequate collection and disposal of these wastes. Currently pharmaceutical wastes are unregulated at the federal level. The proposed rule would apply to pharmacies, hospitals, physician and dental offices, other home-based medical care facilities, and veterinarians. Other materials that are considered universal wastes are mercury containing devices and batteries.

A pharmaceutical waste is defined under the rule as any chemical product, vaccine or allergenic that is used to diagnose, cure, mitigate, treat or prevent disease. The rule excludes radioactive wastes, which are regulated separately. The rule includes other items that are used to delivers pharmaceutical products, such as bottles and IV bags, but does not include sharps or other potentially infectious wastes.

EPA proposed regulating pharmaceutical waste as a universal waste, as opposed to a hazardous waste because it believes that there is less danger in accumulation and transport of pharmaceutical waste than industrial hazardous waste. Universal waste regulations are generally simpler than the standard RCRA hazardous waste regulatory waste scheme.

Household pharmaceutical wastes are often disposed of by pouring them down the drain.  Many larger healthcare facilities follow this practice as well.  EPA discourages this policy because of the potential adverse effects that disposal of pharmaceutical waste may have on the water system.

EPA does not have a firm timeline for finalizing the regulation. It received many comments about the lack of notification and record keeping. At this time, EPA is unsure of the way forward, and is exploring other potential options.

If you have any questions regarding EPA pharmaceutical rulemaking or the Universal Waste Rule, contact us at 773-467-7134 or info@thornenvironmentallaw.com, or through our web contact form.

Disclaimer: This article cannot, and does not, create any attorney/client or consultant/client relationship.