EPA offers definitions for new management of hazardous waste drugs

by A.J. Plunkett (aplunkett@decisionhealth.com)

In February, the EPA published a long-awaited final rule on the management of hazardous waste pharmaceuticals that creates a new section, Subpart P, under the federal Resource Conservation and Recovery Act (RCRA).

The first deadline, the ban on sewering of all hazardous waste pharmaceuticals, was effective as of August 21 (see Ensure compliance with EPA rule: Ban all sewering of hazardous waste drugs). Other sections of the rule will go into effect as states adopt and revise their own EPA-approved RCRA programs.

All hospitals fall under the EPA rule. But what about physicians’ offices or other off-campus facilities that may be part of a health system, but not the hospital itself?

Here’s how federal officials define a healthcare facility for the purposes of enforcing RCRA’s new Subpart P, according to an EPA-sponsored webinar in April:

“Healthcare Facility means any person that is lawfully authorized to

(1) Provide preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or

(2) Distribute, sell, or dispense pharmaceuticals, including over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals”

“Healthcare Facility includes, but is not limited to:

• Wholesale distributors
• Third-party logistics providers (3PLs) that serve as forward distributors
• Military medical logistics facilities
• Hospitals
• Psychiatric hospitals
• Ambulatory surgical centers
• Health clinics
• Physicians’ offices
• Optical and dental providers
• Chiropractors
• Long-term care facilities
• Ambulance services
• Pharmacies
• Long-term care pharmacies
• Mail-order pharmacies
• Retailers of pharmaceuticals
• Veterinary clinics & hospitals.”

And what, you ask, constitutes a long-term care facility? According to the EPA:

“Long-term Care Facility means

• A licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility

“Long-term Care Facility includes, but is not limited to:

• Hospice facilities
• Nursing facilities
• Skilled nursing facilities
• Nursing and skilled nursing care portions of continuing care retirement communities

“A Long-Term Care Facility does NOT include:

• Group homes
• Independent living communities
• Assisted living facilities
• Independent and assisted living portions of continuing care retirement communities.”