The Environmental Protection Agency, EPA, recently revisited its hazardous pharmaceutical waste regulations. This occurred in part due to hearing about the difficulty of organizations in implementing the Resource Conservation and Recovery Act, or RCRA. Additionally, the EPA became increasingly concerned after receiving reports of various studies showing the presence of pharmaceutical waste in the 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”.
When will this go into effect?
The Final Rule goes into effect on August 21, 2019.
Why was this created?
Firstly, these regulations revise and tailor the current hazardous waste regulations. The Final Rule intends to address the current restrictive standards. By doing this, it makes it easier and safer for health care facilities to implement the right hazardous-waste generator regulations. Additionally, the Final Rule aims to protect the environment as well as the health of humans.
Placing a ban on flushing hazardous pharmaceuticals in all states is a major component of the Final Rule. Most pharmaceuticals enter the water stream through flushing or other similar means. This compelled the EPA to address this issue. Once these pharmaceuticals infiltrate the water supply, they negatively affect the aquatic ecosystems, fish, and animal populations.
Note this ban does not affect non-hazardous pharmaceuticals or controlled substances, which fall under the oversight of the Drug Enforcement Agency (DEA).
Who does this effect and what does it mean?
All states will be required to adopt the Final Rule but can make changes to it. As part of the Final Rule, requires affected parties to implement training, complete reporting, and maintain records when dealing with their pharmaceuticals. Non-compliance can result in potential fines and penalties. To maintain compliance, assess your compliance plan to ensure you meet the new Final Rule before its implementation. You, the business, should also ensure to follow any changes made on state levels.
What you need to do.
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.
Now is the time to prepare your facilities and train your staff properly. By partnering, with a knowledge company, such as SLM Facility Solutions Nationwide, they can cultivate a plan specific to you and your locations. Also, they can assist with the training of your staff. Fill out our free facilities assessment today to find out more.
Finally, the information contained in this article is not considered legal or regulatory advice. This material informs you of regulations that may impact your business. For more information in regards to the new regulation please visit EPA.gov.
Article Written by Melissa Myers, SLM Facility Solutions Nationwide Company Trainer.
