Healthcare Facilities Subpart P Generator Requirements 

A Healthcare Facility (HF), under Subpart P, is 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, 

Table: Determining Generator Status as a Healthcare Facility

HAZARDOUS WASTE GENERATOR STATUS

FACILITY-WIDE GENERATION OF ACUTE HAZARDOUS WASTE PER MONTH

FACILITY-WIDE GENERATION OF NON-ACUTE HAZARDOUS WASTE PER MONTH

Very Small Quantity Generator (VSQG)*

< 1kg (2.2 lbs)*

< 100 kg (220 lbs)*

Small Quantity Generator (SQG)

< 1 kg (2.2 lbs)

between 100 kg and 1000 kg (220 - 2200 lbs)

Large Quantity Generator (LQG)

> 1 kg (2.2 lbs)

>1,000 kg (2200 lbs)

*If the total of acute is less than 1kg and your non-acute total is less than 100 kg/month (220 lb), you are a VSQG.

  1. To determine your status as a Subpart P facility, first determine your status as a generator of hazardous waste prior to applying the Subpart P requirements using the table above. Count all waste, both non-pharmaceutical hazardous waste, and pharmaceutical hazardous waste. Be sure to count acute and non-acute separately.
  2. If you are an LQG or an SQG based on the table, and you meet the definition of Healthcare Facility and you generate Hazardous Waste pharmaceuticals, you are required to comply with the Subpart S standards below and in 40 CFR Part 266 Subpart P.
  3. If you are a VSQG that meets the definition of Healthcare Facility and you generate Hazardous Waste pharmaceuticals, you have the option to comply with the Subpart P requirements, or to continue to manage your HW pharmaceuticals as regular hazardous waste.
  4. Facilities required to manage their HW pharmaceuticals under Subpart P must notify DEQ that they are subject to Subpart P. Once a facility notifies, they can re-count their hazardous waste status without including HW Pharmaceuticals. That is your new generator status, but you still must comply with Subpart P for HW Pharmaceuticals.

Healthcare Facilities Management Standards 

There are two types of requirements for Hazardous Waste Pharmaceuticals (HWP) managed by Healthcare Facilities (HF) subject to Subpart P: those for Non-Creditable Hazardous Waste pharmaceuticals and those for Potentially Creditable Hazardous Waste Pharmaceuticals.

Healthcare Facilities generating non-creditable hazardous waste, including Hazardous Waste Pharmaceuticals (HWPs), that are Small Quantity Generators (SQG) or Large Quantity Generators (LQG) or a Very Small Quantity Generator (VSQG) that has opted in, must comply with more stringent management requirements than for potentially creditable HWPs. The non-creditable HWPs must be treated and disposed of under the hazardous waste requirements; whereas potentially creditable HWPs may receive a manufacturer’s credit. 

Definitions

All specific definitions related to the Pharmaceuticals Rule requirements are provided in the Definitions web page.

 Table: Management Requirements for Potentially Creditable and Non-Creditable HWPs

This table is a summary and comparison of the management requirements for Potentially Creditable and Non-Creditable Hazardous Waste Pharmaceuticals for Healthcare.

 

Facilities which includes Very Small Quantity Generators (VSQGs) that have chosen to opt in. Please use the hyperlinks within the table below to navigate to other DEQ web pages for further information regarding the topic.

 

MANAGEMENT REQUIREMENTS

POTENTIALLYCREDITABLE HW PHARMACEUTICALS

NON-CREDITABLE HW PHARMACEUTICALS

Hazardous Waste Determinations

Yes

Yes

Generator Status Determination

Yes

Yes

Subpart P Notification

Yes

Yes

Withdrawal of Notification

Yes

Yes

Training of Personnel

Yes

Yes

Container Standards

No

Yes

Labeling of Containers

No

Yes

Maximum Accumulation Time

No

Yes

Land Disposal Restrictions

No

Yes

Procedures for Healthcare Facilities for Managing Rejected Shipments

No

Yes

Reporting/Biennial Reporting

Yes

Yes

Recordkeeping

Yes

Yes

Response to Spills

Yes

Yes

Accepting Non-Creditable HWPs from an Off-Site HF that is a VSQG

Yes

Yes

Sewer Prohibition

Yes

Yes