EPA announces final rule to set new standards on hazardous waste pharmaceuticals

By A.J. Plunkett

Get the word out to everyone in your organization who handles hazardous waste pharmaceuticals that soon, flushing or rinsing those drugs down a drain into the sewers will be specifically prohibited by the EPA.

That’s harder. On the easier end, you can tell your nurses that the packaging for a patient’s nicotine patch, gum, or lozenge might soon go straight into the regular trash—as long as it is FDA-approved as an over-the-counter nicotine replacement therapy and your state signs off on the exemption of the packaging as hazardous waste under the federal Resource Conservation and Recovery Act (RCRA).

Those are just some of the changes you can expect in handling hazardous waste pharmaceuticals at your facility or business now that the Environmental Protection Agency has finalized its long-awaited “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.”

The rule creates a new subpart P under RCRA that manages hazardous waste pharmaceuticals across a wide array of industries, including hospitals, physician offices, ambulatory care, and other providers who “distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals,” according to the EPA.

Under the provision, in general, the EPA says hospitals
 

• will no longer have to count hazardous waste pharmaceuticals in calculating generator status (those drugs often sent facilities into large-quantity generator, or LQG, status);
• can collect and manage hazardous waste pharmaceuticals from satellite facilities as long as they are under the same business umbrella;
• can accumulate the drugs on site without a RCRA permit for up to 365 days, an increase of 275 days over current regulations;
• but will have specific basic training requirements associated with those managing hazardous waste pharmaceuticals.

Experts in hazardous waste management in healthcare hailed the ruling as a breakthrough in finally putting a regulatory focus on the need to better control the amount of pharmaceuticals going into the environment while easing up on confusing and often unnecessary restrictions that cost both money and cause aggravation in the healthcare sector.

Another big plus for hospitals in the final rule is that drugs considered controlled substances are no longer considered hazardous waste, erasing concerns about competing regulations between the EPA and the Drug Enforcement Agency.

The rule’s provisions will become effective within six months of its publication in the Federal Register. While the rule has been signed and is expected to be published in the Federal Register before the end of December, there is still the question of when states with their own RCRA-authorized programs will adopt the new regulations.