Veterinary Compliance Assistance

For compliance assistance, see:
A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities, 2022 Edition.

Hazardous Waste Pharmaceuticals

Introduction
Background
Overview of the Pharmaceuticals Rule
Subpart P Notification
More Resources

Introduction

In February 2019, EPA published a final rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P-75 Listing for Nicotine (referred to as the Pharmaceuticals Rule). This regulation applies to all animal and human healthcare facilities that generate hazardous waste pharmaceuticals (e.g., waste chemotherapy drugs and associated materials). However, some aspects of the Pharmaceuticals Rule are less applicable to veterinary hospitals and clinics than to human hospitals. An obvious example is the deregulation of waste material associated with over-the counter (OTC) nicotine patches, gum and lozenges. Further, the bearing of the Pharmaceuticals Rule varies depending on the quantity of hazardous waste generated by a facility. Most human hospitals generate a moderate to large quantity of hazardous waste; resulting in a need to comply with most aspects of the Pharmaceuticals Rule. Alternatively, nearly all veterinary hospitals and clinics, which tend to generate small quantities of hazardous waste, have a choice of operating under the Pharmaceuticals Rule or continuing to operate under the general hazardous waste regulations.

As with many decisions, there are pros and cons that must be evaluated by each veterinary facility. This section of VETCA is intended to help veterinary hospitals and clinics understand and navigate the Pharmaceuticals Rule and operate in a manner that assures protection of human health and the environment. If you do decide to operate under the Pharmaceuticals Rule, instructions are provided here on when and how to notify the appropriate agencies.

Background

Although some basic regulatory information is provided here, before undertaking this section any further, readers may want to familiarize themselves with the Resource Conservation and Recovery Act (RCRA) hazardous waste rules by visiting other sections of VETCA. Most particularly, these include:

Hazardous Waste Determinations - This page will help you determine if a given waste material (including waste pharmaceuticals) is classified as hazardous waste.
Managing Hazardous Waste – This page provides an overview of the procedures that facilities must follow if they generate hazardous waste.

Under the Resource Conservation and Recovery Act (RCRA) regulations, generators of hazardous waste fall into one of three categories:

VSQGs are not required to operate under Subpart P, however, VETCA recommends this approach. It reduces your workload/cost and is good for the environment.

Very Small Quantity Generators (VSQGs) generate 100 kilograms or less per month of hazardous waste or one kilogram or less per month of acutely hazardous waste.
Small Quantity Generators (SQGs) generate more than 100 kilograms, but less than 1,000 kilograms of hazardous waste per month.
Large Quantity Generators (LQGs) generate 1,000 kilograms per month or more of hazardous waste or more than one kilogram per month of acutely hazardous waste.

Important notes: Not all states recognize the VSQG category. Nine of the fifty states have generator categories that are different than the federal categories. Please check this MAP to see if your state uses the federal generator categories. If your state does not recognize the VSQG category, then the VSQG benefits described below may not be available for your business. Also, check with your state agency.

Your generator status is very important in determining your specific compliance requirements for both the general hazardous waste regulations and hazardous waste pharmaceutical regulations. As one would expect, the rules are more comprehensive for facilities that generate larger quantities of hazardous waste. To avoid significant penalties, be certain that you correctly identify your category.

The guidance presented in this section is primarily applicable to veterinary hospitals and clinics that fall into the VSQG category. Veterinary facilities associated with universities or research facilities that combined generate greater quantities of hazardous waste may be classified as SQGs or LQGs and will find more suitable compliance information at the Healthcare Environmental Resource Center.

Overview of the Pharmaceuticals Rule

General. Veterinary facilities generate small amounts of waste pharmaceuticals that are considered hazardous waste because they exhibit a hazardous characteristic or are a listed hazardous waste. The hazardous waste pharmaceutical rules were developed to simplify the handling and disposal of these wastes, while keeping them out of solid waste landfills and sanitary sewers where they can cause harm to the public and environment.

The Pharmaceuticals Rule is comprised of two different components.

40 CFR Part 266 subpart P, which includes two subcomponents:

Streamlined standards for handling hazardous waste pharmaceuticals.
Sewering prohibition (sewer ban) of hazardous waste pharmaceuticals.

Hazardous waste exemption for OTC nicotine patches, gums and lozenges.

Only the first component (often referred to as subpart P) is of concern to the veterinary industry. The exemption for tobacco-use cessation products will not be discussed here.

In addition to EPA rules, both National Institute for Occupational Safety and Health (NIOSH) and US Drug Enforcement Agency (DEA) regulations can affect handling and disposal of waste pharmaceuticals. The overlap of these rules is also discussed below.

Special Provision for VSQGs. Except for the mandatory sewer ban (40 CFR 266.505) and empty container standards (40 CFR 266.507), veterinary hospitals and clinics that are VSQGs will have the choice of

(1) opting into the subpart P streamlined standards (40 CFR 266 Subpart P) or,

(2) continuing to operate under the general hazardous waste rules (40 CFR 262.14).

The subpart P standards include various provisions that can reduce the regulatory workload and costs associated with management and disposal of hazardous waste pharmaceuticals.

EPA encourages VSQG facilities to opt into subpart P. That way, they can take advantage of all the benefits of the rule while managing their pharmaceutical waste in a more environmentally protective manner. The information below will help facilities make that decision. Also, for veterinary hospitals and clinics that do decide to opt in, there is a section below that explains how, where, and when to submit a notification (see subpart P Notification).

Components of Subpart P. This section contains a short overview of the EPA regulations governing the management of hazardous waste pharmaceuticals at healthcare facilities, including veterinary offices and hospitals. For a complete discussion of subpart P components, see: A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities (2022 version).

Applicability. Initially when determining if you qualify as a VSQG, you must count all hazardous waste generated, including hazardous waste pharmaceuticals. If you meet the VSQG criteria and choose to opt into subpart P, then going forward, the hazardous waste pharmaceuticals no longer count towards generator status.

As an aside, veterinary facilities that are small quantity generators (SQGs) managing their hazardous waste pharmaceuticals under subpart P (and therefore, no longer counting hazardous waste pharmaceuticals towards generator status) could become a VSQG with respect to its non-pharmaceutical hazardous waste. In this case, they would be subject to the less rigorous VSQG regulations in 40 CFR 262.14 for their non-pharmaceutical hazardous waste.

Timing/State Adoption of Subpart P. Subpart P must be adopted by your state before your facility can "opt in" to the streamlined standards. The adoption of subpart P by all states is expected to occur before 2023, or soon thereafter. Until your state adopts subpart P, your facility must operate under the general hazardous waste regulations.

EPA maintains a map that shows which states have adopted subpart P. However, you should double check by contacting your state environmental agency.

Sewer Ban. The sewer ban is in effect for all VSQGs, SQGs, and LQGs in all states, territories, and in Indian Country. Regardless of your subpart P decision or your state's adoption status of subpart P. As of August 21, 2019, no hazardous waste pharmaceuticals can be disposed of down the drain at any healthcare facility in any state or territory or in Indian country (40 CFR 266.505). The prohibition on sewering hazardous waste pharmaceuticals is expected to help address the issue of the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.

Streamlined Standards. If your veterinary facility is operating under subpart P, then you no longer need to count the amount of hazardous waste pharmaceuticals generated or make individual hazardous waste determinations for each pharmaceutical waste, as is necessary under the general hazardous waste regulations. If you do decide to opt into subpart P, you must comply with all parts, including notifying your state (discussed below). Before a veterinary facility can opt into subpart P, their state must first adopt subpart P.

Aside from the above, when operating under subpart P, incompatible hazardous waste pharmaceuticals, such as aerosols and oxidizers, must still be segregated and managed separately, as must a drug that is prohibited from being incinerated, such as discarded arsenic trioxide.

Empty Container Standards. The following is a summary of empty container standards (40 CFR 266.507) under subpart P:

Containers that once held pharmaceutical waste are considered RCRA empty, and are therefore, not regulated as hazardous waste if emptied by commonly employed practices. This applies to containers of up to 10,000 pills, and bottles/vials up to 1 liter.

Warfarin empty containers, including stock bottles up to 10,000 pills and unit dose containers are no longer P-listed hazardous waste and can be disposed in the trash.

Empty arsenic trioxide vials and empty IV bags can be discarded as trace chemotherapy waste instead of hazardous waste.

Arsenic trioxide waste itself must be segregated and separately packaged and labeled as such by your hazardous waste vendor.

Triple rinsing of containers that held P-listed hazardous waste pharmaceuticals is no longer allowed.

Note that the empty container standards apply to all VSQGs, regardless of whether they opt into subpart P or not.

Outdated/Expired Hazardous Waste Pharmaceuticals. Expired hazardous waste pharmaceuticals become a waste the day of expiration, or sooner, if a decision has been made to discard them. If they are in the original manufacturer's packaging, have not been dispensed to a patient, are within one year of expiration, and have a reasonable expectation of receiving manufacturer credit, they are "potentially creditable" and can be accumulated in your returns area and sent to a reverse distributor. If they do not meet these criteria, they must be placed into a hazardous waste pharmaceutical container immediately and managed as non-creditable hazardous waste pharmaceuticals.

Controlled Substances. Hazardous waste controlled substances are exempted from hazardous waste status IF they are incinerated at one of five types of permitted incinerators listed in 40 CFR 266.506(b)(3). In addition, if in the future, DEA deems in writing that another method of destruction meets the non-retrievable standard, then that method may be used to destroy the hazardous waste controlled substances under this exemption. As of September 2022, DEA has not identified any additional methods of destruction that meet their non-retrievable standard.

Training. All personnel managing hazardous waste pharmaceuticals must be thoroughly familiar with proper waste handling and emergency procedures (40 CFR 266.502(b)). This is another performance-based standard, which means it is up to the healthcare facility to determine the appropriate training material, methods, etc.

Subpart P Notification

Keep in mind that VSQGs have the choice of opting into the subpart P streamlined standards or continuing to operate under the general hazardous waste rules. If you chose to opt-in, then you must notify your state by submitting Form 8700-12 or corresponding state form (40 CFR 266.502(a)(1)). For Alaska, Iowa, and most territories notify your EPA region. Some states also allow electronic notification via myRCRAid. The notification requirement applies even if the healthcare facility has already notified previously and has an EPA ID number. If the healthcare facility does not have an ID number, they will be assigned one by EPA upon notification.

If a VSQG healthcare facility chooses not to opt into subpart P, it does not have to submit a notification.

This Step-by-Step Guide to Notifying Under Subpart P explains the notification procedures in greater detail and is applicable to VSQGs as well as SQGs and LQGs.

Additional state information is presented below under More Resources.

Overlap of EPA, DEA and NIOSH Pharmaceutical Waste Regulations

The US Environmental Protection Agency (EPA) is a federal regulatory agency. The National Institute for Occupational Safety and Health (NIOSH) is a federal institution that establishes the list of hazardous drugs but is not a regulatory body. The Occupational Safety and Health Administration (OSHA) is a federal regulatory agency within the Department of Labor that establishes regulations for worker protection that handle hazardous drugs. OSHA enforces the Hazard Communication Standard in general, including the employee right-to-know requirement if exposed to hazardous chemicals. Added to that is the non-governmental, non-regulatory standard-setting body, the United States Pharmacopeia (USP). The USP has developed standards of practice, one of which, USP 800, refers to hazardous drug handling. While NIOSH establishes the list of hazardous drugs, other governmental and non-governmental organizations may choose to use that list to regulate or accredit healthcare facilities.

Due to the similarity in naming, the terms RCRA hazardous waste pharmaceuticals and NIOSH hazardous drugs are often confused. The fact that some drugs meet both EPA and NIOSH definitions should be kept in mind when operationalizing compliance strategies for these two related but distinctly different categories of drugs. The policies and procedures developed to ensure compliance with both should be kept separate and distinct within the organization. The focus of this webpage is RCRA hazardous waste pharmaceuticals. The topic of NIOSH hazardous drugs is mentioned here primarily to accurately distinguish them from hazardous waste to assist facilities in applying the steps that follow. (For more information on NIOSH hazardous drugs please see: A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities, 2022 version, Appendix E.)

More Resources

US EPA Resources:

State Agency Information:

Many states have posted regulatory, policy or guidance information on their websites concerning subpart P rules. Please email us if you are aware of applicable information for your state not listed here and we will update the list accordingly.