40 CFR 266.501
Facilities impacted by Subpart P
EPA's definition of healthcare facility:
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.
EPA has indicated the following types of healthcare facilities that potentially will be affected. However, this list is indicated as not all inclusive.
||Supermarkets & Other Grocery (not convenience) Stores
||Pharmacies and Drug Stores
||Warehouse Clubs and Supercenters
||Other Health Practitioners (e.g., chiropractors)
||Outpatient Care Centers
||Other Ambulatory Health Care Services
||General Medical and Surgical Hospitals
||Psychiatric and Substance Abuse Hospitals
||Nursing Care Facilities
* #'s taken from www.naics.com at time of publication. Some agencies allow for more than one NAICS code per establishment. Example: Pharmacy (44611) located within a Grocery Store (44511).
Expanded examples include: Wholesaler Distributors, Drug Compounding Facilities, 3rd Party Logistics Providers that serve as forward distributors, Psychiatric Hospitals, Ambulatory Surgical Centers, Health Clinics, Optical Providers, Dental Providers, Chiropractors, Fire Stations, Mail Order Pharmacies, Nursing Facilities, Skilled Nursing Facilities, Hospice Facilities, LTC Pharmacies, Retailers Of Pharmaceuticals, Veterinary Clinics, Veterinary Hospitals, Veterinary Pharmacies and locations that sell pharmaceuticals over the internet, mail or other distribution systems.
Does not include: Households, Pharmaceutical Manufacturers (unless they physically accept pharmaceuticals for credit) or independently located coroners or medical examiners (unless located in a healthcare facility), farmers, ranchers, fisheries.
Long Term Care Facilities
EPA defines 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.
- LTCF's included in Subpart P (considered HCFs by EPA):
- Hospice facilities
- Nursing facilities
- Skilled nursing facilities
- Nursing/Skilled nursing parts of continuing care retirement communities
- Facilities excluded from Subpart P (not considered HCFs by EPA):
- Assisted living facilities
- Group homes
- Independent living communities
- Independent/assisted living portions of continuing care retirement facilities
- All hazardous waste, including non-pharmaceuticals generated by LTCF's included under Subpart P (above) are NOT considered exempt from RCRA as household hazardous waste. This means those particular LTCF'S may no longer use EPA's household hazardous waste exclusion.
- LTCF may be impacted by Subpart P if pharmaceuticals are located in a central pharmacy or in custody of the LTCF even if indicated as excluded from Subpart P (above).
- HW Pharmaceuticals that are collected from residents that self-administered are not managed under Subpart P.
- LTCF's with 20 beds or less are considered VSQG's and therefore are not required to document hazardous waste generation.
- LTCF's that are VSQG's can dispose of HW Pharmaceuticals (excluding PPE and cleanup residue) through the use of an onsite DEA authorized collection receptacle. However, this applies to "Ultimate Users" (as defined by the DEA) at the healthcare facility. A LTCF that is a DEA registrant, CANNOT put their HW Pharmaceuticals in the receptacle as this would be a violation of DEA regulations.