News, Skilled Nursing Facility

EPA’s final rule on pharmaceutical waste material effective August 21

The EPA published its final rule, Management Standards for Hazardous Pharmaceuticals, earlier this year—giving healthcare facilities, including long-term care facilities, just a handful of months to comply with the rule, which goes into effect August 21, 2019.

In the final rule, the EPA has revised its definition of a long-term care facility (LTCF) to be more consistent with how the DEA and CMS define the term. The final rule defines an LTCF as a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. It does not include assisted living facilities.

The final rule also states LTCFs may no longer use the house-hold hazardous waste exclusion. Instead, LTCFs will need to manage their hazardous waste pharmaceuticals in accordance with the healthcare facility specific management standards.

At first glance, compliance by August 21 may seem like a daunting task for LTCFs. Several states (Alaska, Iowa, Kentucky, New Jersey, Pennsylvania, and Puerto Rico) have already adopted the rule.

“While states are required to adopt the rule, they have the abil-ity to make changes as far as waste disposal,” says Karen Stratoti, president and CEO of Excellence in Caring, LLC. Other states may have until 2021 or 2022 to adopt it, as those states already have their own version of the EPA or rules in place.

If states choose not to adopt the final rule due to having their own rules, they must add a rule that bans the disposal of pharmaceuticals down the drain, Stratoti explains.

In addition to improving compliance, the EPA has three goals for the final rule:

  • Reduce the amount of pharmaceuticals disposed of down the drain as discussed above
  • Address the overlap between EPA’s RCRA hazardous waste regulations and the DEA regulations for controlled sub-stances
  • Clarify the regulatory status of reverse distribution, a major practice used by healthcare facilities for the management of unused and/or expired pharmaceuticals