United States: EPA Proposes New Management Standards For Hazardous Waste Pharmaceuticals Rule

Last Updated: September 20 2015
Article by David G. Dickman, Bernice I. Corman and John B. Mavretich

On August 31, the Environmental Protection Agency (EPA) released its proposed rule for Management Standards for Hazardous Waste Pharmaceuticals (Proposed Rule) prior to its publication in the Federal Register. The proposal would create a new Subpart P under existing Resource Conservation and Recovery Act (RCRA) regulations exclusively for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. Currently, there are no RCRA regulations that focus specifically on the management of hazardous wastes from hospitals, pharmacies, reverse distributors and other healthcare-related facilities; such facilities are currently required to comply with the same RCRA hazardous waste regulations as many other types of industries that generate wastes.

By issuing this proposed rule, EPA has tentatively decided not to add hazardous waste pharmaceuticals to the existing federal universal waste program, as EPA had initially proposed in 2008. This means that hazardous waste pharmaceuticals may no longer be added as a category of hazardous waste for management under the Universal Waste program, as had previously been done in Michigan and Florida. Because the proposed rule requirements are more stringent than the standards for the Universal Waste program, if the rule is finalized, both states will be required to amend their programs to adopt standards at least as stringent as those in the new Subpart P.

What the Proposed Rule Covers

EPA is proposing an expansive definition of "Pharmaceutical" as:

any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal. This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act (FD&C Act), prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with residues of pharmaceuticals, and clean-up material from the spills of pharmaceuticals.

The Rule would govern the management of "Hazardous Waste Pharmaceuticals," which include any pharmaceuticals that are currently listed as a hazardous waste under 40 C.F.R. Part 261, Subpart D, or that have any of the characteristics of hazardous waste listed in in 40 C.F.R. Part 261, Subpart C (ignitability, corrosivity, reactivity, toxicity).

Who It Covers

The Rule as proposed would apply to "healthcare facilities," which include:

hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.

Of note, the definition includes locations that sell pharmaceuticals over the internet, through the mail, or through other types of distribution mechanisms, and also includes entities that engage in drug compounding. It does not include pharmaceutical manufactures and their representative, wholesalers, or any other entity involved in the manufacturing, processing, or wholesale distribution of over-the-counter or prescription pharmaceuticals, unless they meet the definition of a pharmaceutical reverse distributor. These are entities that receive and accumulate potentially hazardous waste pharmaceuticals "for the purpose of facilitating or verifying manufacturer's credit" upon the return of unused and/or expired pharmaceuticals. The EPA's definition of a pharmaceutical reverse distributor is different than and broader in scope than the definition of that term as used by the Drug Enforcement Administration.

EPA is proposing that a healthcare facility that is currently considered either a traditional large quantity generator (LGQ) or a small quantity generator (SQG) be subject to Subpart P if it generates (or accumulates) more than 100 kg of hazardous waste per month or more than one (1) kg of acute hazardous waste per month. An acute hazardous waste is generally, but not necessarily solely, any P-listed hazardous waste. A healthcare facility that is currently considered to be a conditionally exempt small-quantity generator (CESQG) (generates less than or equal to 100 kg of hazardous waste, and less than or equal to 1 kg of acutely hazardous waste) will be able to maintain its conditional exemption under 40 C.F.R. § 261.5 and will not be subject to most aspects of the proposed rule. However, EPA is proposing a ban on sewer disposal of hazardous waste pharmaceuticals by all healthcare facilities, including CESQG facilities. Additionally, currently, CESQG facilities are limited in where they may send their hazardous wastes for treatment and disposal; the rule proposes to allow CESQG healthcare facilities to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor.

Requirements under the Proposed Rule

The applicable handling and disposal requirements would depend upon whether the hazardous waste pharmaceutical is eligible for a manufacturer's credit. If it is not eligible, it "must be transported as hazardous waste, including the use of the hazardous waste manifest, and sent to a RCRA interim status or permitted facility." However, the Rule as proposed would allow creditable hazardous waste pharmaceuticals to be shipped to pharmaceutical reverse distributors for processing of the manufacturer's credit.

New Subpart P would contain separate requirements for healthcare facilities and reverse distribution facilities. Healthcare facilities would be responsible for, among other requirements:

  • Training employees to be "thoroughly familiar with proper waste handling and emergency procedures";
  • Maintaining inventories of non-creditable hazardous waste pharmaceuticals;
  • Disposing of hazardous waste pharmaceuticals within one year; and
  • Preventing disposal of hazardous waste pharmaceuticals into a sewer system.

Reverse distribution facilities would be allowed to accept and accumulate potentially creditable hazardous waste pharmaceuticals without a permit, provided that they comply with the requirements of new Subpart P. These requirements include, but are not limited to:

  • Complying with specific packaging, labeling, and marking requirements;
  • Maintaining an inventory of all potentially creditable hazardous waste pharmaceuticals;
  • Creating and enforcing minimum security requirements; and
  • Properly disposing of the potentially creditable hazardous waste pharmaceuticals within 90 days.

EPA will accept comments on the Proposed Rule for 60 days following its publication in the Federal Register.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.