Pharmaceuticals Rule

This page is designed to provide hazardous waste generators that are healthcare facilities (HFs) or reverse distributors (RDs) a general understanding of the regulatory requirements governing the management of hazardous waste pharmacueticals (HWPs) and is not intended to replace, limit or expand upon the complete regulatory requirements. To navigate through the generalized generator requirements, please use the hyperlinks provided throughout the narrative that will provide more detail of the topic or provide the regulatory citation. The sections below follow the life-cycle of hazardous waste pharmaceuticals from generation, hazardous determination, and management for all healthcare facilities and reverse distributors. Other DEQ generator web pages are designed to provide more detail for other subject areas and regulatory requirements.

EPA’s Hazardous Waste (HW) Pharmaceuticals Rule was published in the Federal Register on February 22, 2019. A portion of this rule will mandate that all healthcare facilities and reverse distributors must stop flushing down the drain or placing into any sewer system all hazardous waste pharmaceuticals and will become effective August 21, 2019. The management requirements for Hazardous Waste Pharmaceuticals become effective in Virginia on August 23, 2019.

What are Hazardous Waste Pharmaceuticals?

Hazardous waste pharmaceuticals (HWPs) are pharmaceuticals that when expired or discarded can potentially cause harm to human health and the environment if not managed properly. Pharmaceuticals become a solid waste when expired, damaged, or partially administered and some pharmaceuticals are Controlled Substances regulated under the Drug Enforcement Administration (DEA.) Hazardous Waste Pharmaceuticals meet the definition of hazardous waste because they are either listed, or because they exhibit a characteristic of hazardous waste; see Generator Regulations page for more information.

Pharmaceuticals Rule Applicability - Determination

Healthcare facilities (HFs) and Reverse Distributors (RDs) are required to determine what solid wastes are generate or otherwise manage at the facility. Healthcare Facilities that are Small Quantity Generators (SQG) or Large Quantity Generators (LQG) for their monthly combined totals (pre-rule) of hazardous waste (HW) and hazardous waste pharmaceuticals (HWPs) (combined total) and Reverse Distributors are required to comply with 40 CFR Subpart P. For HFs that are Very Small Quantity Generators (VSQG), compliance with Subpart P is optional. All healthcare facilities are regulated the same for their hazardous waste pharmaceuticals (HWPs) regardless of the generation rate per month (generator category) under to 40 CFR Subpart P. For information regarding hazardous waste counting, generator categories, and healthcare facilities regulations please see the applicable web pages.

Definitions:

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 (OTC) pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals.

Reverse Distributor (RD): Any person that receives and accumulates prescription pharmaceuticals that are potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit.

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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Determination of Hazardous Waste Pharmaceuticals

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Notification Requirements

Subpart P NotificationA Healthcare Facilities (HFs) and Reverse Distributors (RDs) must notify DEQ using the EPA Site Identification Form 8700-12 that it is a HF operating under Subpart P. HFs that already have an EPA identification number must update the existing notification to include Subpart P. HFs (not including RDs) that are required to submit a biennial report (BR) can submit this notification as part of its next BR. Otherwise, all facilities subject to Subpart P must notify within 60 days of the effective date of this Subpart, or within 60 days of becoming subject to this Subpart. HFs and RDs that do not already have an EPA ID number will be assigned one when it submits its notification of Subpart P activity. A facility must keep a copy of its notification on file for as long as the healthcare facility is subject to this Subpart.

Withdrawal Notification: Healthcare Facilities (HFs) that operated under this Subpart, but are no longer subject to this Subpart (e.g., Very Small Quantity Generators (VSQG) that elects to withdraw from this Subpart) must notify DEQ using EPA Site Identification Form 8700-12 that it is no longer operating under this Subpart prior to operating under the conditional exemption of 40 CFR § 262.14 in lieu of Subpart P. A copy of its withdrawal must be kept on file for three (3) years from the date of signature on the notification of its withdrawal.

All notifications should be made using MyRCRAID.

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Frequently Asked Questions to EPA - Pharmaceutical Rule

EPA's Frequent Questions About the Implementing the Hazardous Waste Pharmaceuticals Final Rule; this window is managed by EPA's Website.

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


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