The Environmental Protection Agency (EPA) recently revisited its hazardous pharmaceutical regulations. This was done in part due to hearing about the difficulty of organizations in implementing the Resource Conservation and Recovery Act (RCRA). Additionally, the EPA became increasingly concerned after receiving reports of various studies showing the presence of pharmaceuticals in United States’ water supply. After months of studies and public comments, on February 22, 2019, the EPA published a Final Rule entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine”.

The Final Rule will go into effect August 21, 2019. The first part of these new regulations is to revise and tailor current hazardous waste regulations. The Final Rule is intended to address the current restrictive standards making it easier and safer for health care facilities to implement the current hazardous waste generator regulations. Additionally, the Final Rule aims to protect the environment as well as the health of humans.

All states will be required to adopt the Final Rule but will have the ability to make changes. As part of the Final Rule, affected parties will be required to implement training, complete reporting, and maintain records when dealing with their pharmaceuticals. Non-compliance can result in potential fines and penalties. In order to maintain compliance, businesses should assess their compliance plan to ensure they are meeting the new Final Rule prior to its implementation. The business should also ensure they follow any changes made on their state level.

A major component of the Final Rule is a ban on flushing hazardous pharmaceuticals. The EPA was compelled to address this issue as most pharmaceuticals enter the water stream through flushing or other similar means. Once these pharmaceuticals are in the water supply, they have negative effects on aquatic ecosystems, fish, and animal populations. Since flushing has been prevalent, the EPA addressed this issue once and for all by banning the flushing of hazardous pharmaceuticals in all states. It is important to note this ban does not affect non-hazardous pharmaceuticals or controlled substances, which fall under the oversight of the Drug Enforcement Agency (DEA).

Although the Final Rule was published in February, the current rules will remain in effect until the effective date in the federal register and as adopted by the states. To view the Final Rule and for additional information, please follow the link below to the EPA website. Finally, the information contained in this article is not considered legal or regulatory advice but rather material to inform you of regulations which may impact your business.



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Article Written by Melissa Myers