Healthcare Facilities Pharmaceuticals Rule Regulations

Healthcare Facility (HF): 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, 40 CFR 266.501.

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.

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Healthcare Facility Subject To Part 266 Subpart P

Healthcare Facilities Management Standards

There are two types of requirements for Hazardous Waste Pharmaceuticals (HWP) managed by Healthcare Facilities (HF) subject to 40 CFR Part 266 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.

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Definitions

Hazardous Waste Pharmaceutical (HWP): A pharmaceutical that is a solid waste, as defined in 40 CFR § 261.2, and exhibits one or more characteristics identified in Part 261 Subpart C or is listed in Part 261 Subpart D.

Non-Creditable Hazardous Waste Pharmaceuticals: A prescription Hazardous Waste Pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a nonprescription Hazardous Waste Pharmaceutical that does not have a reasonable expectation to be legitimately used, reused or reclaimed. This includes but is not limited to, investigational drugs, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings, and cleanup material from the spills of pharmaceuticals.

Potentially Creditable Hazardous Waste Pharmaceuticals: A prescription Hazardous Waste Pharmaceutical that has a reasonable expectation to receive manufacturer credit and is (1) in original manufacturer's packaging (except pharmaceuticals that were subject to recall); (2) undispensed; and (3) unexpired or less than one year past expiration date. The term does not include HWPs or nonprescription pharmaceuticals including, but not limited to, over-the-counter (OTC) drugs, homeopathic drugs, and dietary supplements.

All specific definitions related to the Pharmaceuticals Rule requirements are provided on the Definitions ;web page and 40 CFR § 266.500.

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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 that are Small Quantity Generators (SQGs), Large Quantity Generators (LGQs) or 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 Creditable 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


















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Virginia Department of
Environmental Quality
P.O. Box 1105
Richmond, VA 23218
(804) 698-4000


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