Check Your State for Deadlines on New Hazardous Waste Pharmaceuticals Rule

By A.J. Plunkett

Let your pharmacists and anyone else in your organization who handles hazardous waste pharmaceuticals know that flushing those drugs down a drain or toilet will be specifically prohibited as of August 2019. That is provided the EPA’s new final rule on the management of hazardous waste pharmaceuticals is published as planned on February 22 in the Federal Register.

The ban on sewering hazardous waste pharmaceuticals is “long overdue,” said Kristin Fitzgerald, with the EPA Office of Resource Conservation and Recovery on February 14 during the first of what could be several informational webinars the agency plans on the long-awaited rule.

Sewering “is a common practice in many healthcare facilities and it needs to stop,” said Fitzgerald, noting that the while the new prohibition applies only to hazardous waste drugs and only to those organizations covered under the new rule, the EPA strongly discourages the flushing of any pharmaceuticals by anyone anywhere.

While the final rule creating a new Subpart P to the federal Resource Conservation and Recovery Act (RCRA) does exempt controlled substances that are under the Drug Enforcement Administration’s jurisdiction from the new hazardous waste regulations, even those controlled drugs still are banned under the no-flushing rule.

While the rule as a whole is not effective until six months after it is published in the Federal Register, there are some limitations. For instance, states that have their own RCRA programs will be allowed time to update their regulations to meet the new standards.

However, the no-sewering rule is being declared under the authority of the federal Hazardous and Solid Waste Amendments, so it goes into effective as soon as the rule does.

“That’s the one exception everybody has to get ready for sooner than later,” Fitzgerald stated.

The final rule, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” was signed in mid-December and prepublished on the EPA’s website. However, with the partial government shutdown it was never formally posted in the Federal Register, which by regulation is what kicks off any stated deadlines.

During the webinar, Fitzgerald and other EPA officials said they anticipated publication on February 22, barring another government shutdown. The next day a bipartisan bill was signed to avert that second shutdown and the publication appears to be on track.

Overall, the final rule creates more stringent requirements for handling the drugs covered under Subpart P as well as the sewering ban, but eases rules on the disposal of certain nicotine-replacement products, such packaging for nicotine gums or patches.

While everyone is looking forward to the less stringent rules on nicotine-replacement products, don’t act yet, warns Fitzgerald.

Because the rules are less stringent, states are not required to adopt the exemption, she said. “We do expect most states will pick it up, but they are not required to.”

But the more stringent rules of Subpart P must be adopted, she noted. To that end, all states except the two states without authorized RCRA programs — Iowa and Alaska — will be allowed time to incorporate the new rule into their programs. (Iowa and Alaska along with along with U.S. and Indian territories must comply by August 2019, or six months after publication in the Federal Register.)

For states and territories with authorized RCRA programs that do not need to have legislative action to adopt the more stringent rules, they have until July 1, 2021, to do so.

In states and territories that require legislative action for a statutory amendment, the deadline is July 1, 2022.

Be aware of what’s happening in your locality, though. States are allowed to adopt the programs ahead of deadline.

“We do expect some states to adopt earlier,” says Fitzgerald. For instance, Mississippi and Pennsylvania always adopt earlier than required, she noted. And the states of Washington and Connecticut have indicated they might as well.