Changes to Hazardous Waste Pharmaceuticals Rules & Upcoming DEC Webinar

Jackie Pappalardi and Lisa Volk Allison Gold in Clinical & Quality

The Environmental Protection Agency (EPA) recently published the Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Rule for handling hazardous waste pharmaceuticals (HWPs) by health care facilities. The new rules are intended to standardize and manage HWP.

Prior to the new rules, health care facilities that generated HWPs followed a variety of regulations under the federal Resource Conservation and Recovery Act (RCRA) like other industries. The management of HWPs at long-term care facilities, however, was excluded from the RCRA and treated the same as HWPs at residential households.

EPA defines in this new rule that skilled nursing and hospice facilities are more akin to hospitals, therefore, the management of any hazardous waste, including HWPs, will be subject to similar RCRA requirements. Health care facilities and reverse distributors will now manage HWPs under this new set of standards, 40 C.F.R. Part 266, Subpart P (“Subpart P”).

Highlighted Changes

The new regulations prohibit the disposal of hazardous waste pharmaceuticals down the drain, this ban on “sewering” hazardous waste pharmaceuticals goes into effect nationwide on the effective date of the federal rule, regardless of adoption status of the rule by authorized states.

The new regulations exclude certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies (NRTs) (e.g., nicotine gums, patches, lozenges) from regulation as hazardous waste.

Definition of Affected Health Care Facilities

The new rules apply to most health care facilities and reverse distributors that generate hazardous-waste pharmaceuticals, including long-term care facilities. Long-term care facilities include hospice facilities, nursing facilities, skilled nursing facilities, and nursing and skilled nursing care portions of continuing care retirement communities.

Long-term care facilities not included are group homes, independent living communities, assisted living facilities, independent and assisted living portions of continuing care retirement communities.

Effective Date

Most of the provisions of this rule will not be in effect in New York until the State adopts them, however the prohibition on “sewering” HWPs takes effect August 21, 2019, regardless of adoption status of the rule by New York State.

Training: NYS Dept. of Environmental Conservation Hazardous Waste Pharmaceuticals Webinar

The webinar will be held on July 16, 2019 at 1:00 pm and will provide an in-depth discussion of the Hazardous Waste Pharmaceuticals Rule. Those wishing to participate must register here.

NYSHFA-NYSCAL is developing education for members to help prepare for the new rules and strongly encourages members to join the DEC Webinar on July 16, 2019.

NYSHFA/NYSCAL CONTACTS:

Allison Gold, Esq.
Director of Policy & Reimbursement
518-462-4800 x25

Jackie Pappalardi, RN, BSN
Director, Educational Development & Grant Mgmt.
518-462-4800 x16

Lisa Volk, RN, B.P.S., LNHA
Director, Clinical & Quality Services
518-462-4800 x15