The New EPA Subpart P Regulations

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The New EPA Subpart P Regulations

On 12/11/2018 The Environmental Protection Agency (EPA) Administer signed the MANAGEMENT STANDARDS FOR HAZARDOUS WASTE PHARMACEUTICALS AND AMENDMENT TO THE P075 LISTING FOR NICOTINE. Pre-Publication Version

Beware of these Changes

These new EPA/RCRA regulations change the way hazardous waste drugs are handled in the healthcare industry. In particular, what pharmaceuticals that can be sent back to National Pharmaceuticals Returns for credit processing and disposal.

Under this rule, the EPA is adding a new subpart P under 40 CFR part 266. It is important to point out that only the hazardous waste drugs are affected by EPA Subpart P. Generally, we have found this be around 4-6% of the pharmacy's total inventory.

One significant change is that prescription pharmaceuticals moving through a Reverse Distributor, such as National Pharmaceutical Returns, are solid wastes at the healthcare facility. Therefore, the healthcare facility is considered the generator of these wastes. Previously, waste determination, other than obvious waste, was typically made by the reverse distributor. Subpart P addresses the management of the solid waste pharmaceuticals that are hazardous from the impacted healthcare facilities.

Another significant change is that hazardous waste pharmaceuticals are no longer able to be sewered or drain disposed by healthcare facilities. This will help keep hazardous waste pharmaceuticals out of our nation’s water supply.

Subpart P is mandatory for healthcare facilities that are: SQG (Small Quantity Generators), LQG (Large Quantity Generators) and all RD (Reverse Distributors). It is optional for VSQGs (Very Small Quantity Generators), except where noted (e.g., hazardous waste sewer ban). Due to EPA's Hazardous Waste Generator Improvements Rules, some states may still refer to VSQG's as CESQG's (Very Small Quantity Generator's) or state equivalent.

Those Affected

Facilities affected include:

  • Retail Pharmacies
  • Hospital Pharmacies
  • Wholesaler Drug Distributors
  • Drug Compounding Facilities
  • Nursing Care Facilities
  • Long Term Care Facilities
  • 3rd Party Logistics Providers that serve as forward distributors
  • Psychiatric Hospitals
  • Ambulatory Surgical Centers
  • Health Clinics
  • Optical Providers
  • Dental Providers
  • Chiropractors
  • Mail Order Pharmacies
  • LTC Pharmacies
  • Retailers Of Pharmaceuticals
  • Veterinary Clinics
  • Veterinary Hospitals
  • Veterinary Pharmacies
  • Locations that sell pharmaceuticals over the internet
  • Mail or other distribution systems

New 40 CFR Sections

A summary of the new sections to be published are as follows:

Section Description
266.500 Definitions
266.501 Applicability
266.502 Standards - Non-creditable
266.503 Standards - Potentially creditable
266.504 VSQG's
266.505 Sewer ban
266.506 DEA/HWP exemption
266.507 Empty container exemption
266.508 Shipping - Non-creditable
266.509 Shipping - Potentially creditable
266.510 Standards - Reverse distributors

The final rule for Management Standards for Hazardous Waste Pharmaceuticals and Amendment To The P075 Listing For Nicotine goes into effect 6 (six) months after publication in the Federal Register for the states of Iowa and Alaska. It will go into effect for the remainder of the states when approved by the state. Note, non-approval is not an option and states can be more stringent in some regulations when it adopts Subpart P. Also, it is important to point out that the sewer ban does not have to be approved by the states and goes into effect at the six month mark from being published in the federal register.

How We Can Help

NPR has partnered with PTI (PharmWaste Technologies, Inc.) in EPA Subpart P compliance. PTI has an extensive analysis of these new regulations that can be accessed here.

NPR will be modifying their processes accordingly to be in compliance with EPA’s Subpart P. We look forward to assisting our customers so they too can be in compliance.

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