Pharmaceutical Waste Regulations

31 states have not adopted the EPA regulations, 17 states have adopted the regulations and two states are administered by EPA. The new regulation recommends that hazardous waste pharmaceuticals with metals that also contain greater than 1% total organic carbon be incinerated.

Overview Of The Pharmaceutical Waste Regulations

  • The Management Standards for Hazardous Waste Pharmaceuticals was first proposed by the EPA in 2008 but due to concerns over the lack of notification requirements for facilities that generate, handle or transport pharmaceutical wastes and the lack of tracking requirements for the shipment of these wastes, the proposed rule was not finalized but instead enhanced to meet the growing concerns.
  • EPA issued a new proposal for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors in 2015 and the final rule was signed by the EPA in 2018 and became effective in August 21, 2019.
  • The final rule sets cost-saving, standardized requirements for the processing of hazardous waste pharmaceuticals to best suit the healthcare sector’s operations while protecting public health and environmental security.
  • By decreasing the amount of toxic waste pharmaceuticals entering the waters by 1,644 to 2,300 tons annually, the final regulation would make drinking and surface water cleaner and healthier by banning all facilities subject to the rule from sewering them. It will also help resolve the problem illustrated by an increasing number of publicly accessible research documenting the prevalence of pharmaceuticals in drinking and surface waters and their harmful effects on aquatic and riparian habitats.
  • Under the final rule, over-the-counter nicotine replacement therapies approved by the FDA would no longer be deemed toxic waste when discarded, resulting in substantial cost savings and a decrease in the burden of handling these forms of nicotine waste.
  • The new regulations also states that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed will not be considered solid waste.
  • Hazardous waste pharmaceuticals with metals that also contain greater than 1% total organic carbon may be incinerated. It is also recommended that household waste pharmaceuticals be incinerated preferably at an approved hazardous waste incinerator, but at a large or small municipal waste combustion plant when this is not feasible.

Status Of The EPA Pharmaceutical Waste Regulations

  • Iowa and Alaska are the only states administered by EPA.
  • Utah, Colorado, Oklahoma, Alabama, Georgia, Florida, North Carolina, Virginia, West Virginia, Kentucky, Illinois, Ohio, Pennsylvania, New Jersey, Wisconsin, South Dakota, and Washington are states that have adopted the management standards for hazardous waste pharmaceuticals.
  • Oregon, California, Nevada, Arizona, Idaho, Montana, Wyoming, North Dakota, Minnesota, Nebraska, Kansas, New Mexico, Texas, Missouri, Arkansas, Louisiana, Mississippi, Tennessee, South Carolina, Indiana, Michigan, Maryland, Delaware, District of Columbia, Connecticut, Rhode Island, Massachusetts, New Hampshire, New York, Hawaii, Vermont, and Maine are states that have not adopted the EPA regulations.
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