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Impacted Facilities

PharmWaste - EPA Subpart P Regulations Impacted Facilities
Impacted Facilities
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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.  

 

NAICS Facility Type # 
4242 Drug Wholesalers  12,962
44511 Supermarkets & Other Grocery (not convenience) Stores  94,915
44611 Pharmacies and Drug Stores  53,256
452311 Warehouse Clubs and Supercenters  1,790
54194 Veterinary Services  43,681
6211 Physicians' Offices  445,363
6212 Dentists' Offices  193,685
6213 Other Health Practitioners (e.g., chiropractors)  264,274
6214 Outpatient Care Centers  64,236
6219 Other Ambulatory Health Care Services  140,505
6221 General Medical and Surgical Hospitals  24,973
6222 Psychiatric and Substance Abuse Hospitals  4,078
6223 Specialty Hospitals  2,728
6231 Nursing Care Facilities  32,548
Various Reverse Distributors  55
   Total  1,379,044
 

Copyright Warning

All information found on this website is copyright protected by PharmWaste Technologies, Inc.  Do not copy or redistribute without written permission from PTI or note any reproduction or derivative as copyrighted by PharmWaste Technologies, Inc.

 

* #'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.        
  

 


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Contact PharmWaste

PharmWaste Technologies, Inc.
4164 NW Urbandale Dr, Ste A
Urbandale, IA 50322

Phone: 515-276-5302
Hours: 8-5 M-F, CST

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