Understanding New EPA Regulations for Pharmaceutical Waste

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By Jeff Hollar

The Environmental Protection Agency (EPA) has passed new regulations surrounding the handling and disposal of pharmaceutical waste at healthcare facilities (HCF) and reverse distributors (RD). Often simply referred to as EPA’s Subpart P, it has had a substantial impact on the way pharmaceutical waste is handled and disposed of in the industry.

Unless you’ve been living under a rock this last year, you have likely been exposed to numerous articles, webinars and workshops that try to tackle the extensive regulations of Subpart P. None of these formats can do the new regulations justice in explaining all aspects to the degree that is deserved. This article will focus on one critical component of the new regulations… Hazardous waste pharmaceuticals a healthcare facility generates and where to send them.

So, you think you know what a healthcare facility is? Think again. In short, EPA defines a healthcare facility as any person that is lawfully authorized to provide patient care to humans or animals. Or, a facility that sells or dispenses prescription or OTC drugs, which can also include nutritional supplements. Because of EPA’s broad definition of a healthcare facility, this effects more than just what one would consider a traditional healthcare facility. Limited examples may even include: airport and hotel gift shops, gas stations, convenience or dollar stores, physician’s offices, veterinary facilities, optometry facilities, chiropractors drug wholesalers and dentist offices just to name a few.

So, what does this mean for all of the healthcare facilities? EPA has determined that healthcare facilities are the actual generators of solid wastes, which may also include hazardous waste and those need to be managed in compliance with the new Subpart P regulations. Gone are the days of the pharmacy simply throwing pharmaceuticals in a box without closely examining what is being sent where.

PCHWH - EPA specifies two possible hazardous waste pharmaceuticals that a healthcare facility can generate. Those pharmaceuticals that have the potential for manufacturer credit are referred to as potentially creditable hazardous waste pharmaceuticals (PCHWP). In order for a hazardous waste pharmaceutical to qualify as potentially creditable must first have a reasonable expectation for credit. In order to get a good idea of reasonable expectation for credit, we must first look at some examples of pharmaceuticals that do not having a reasonable expectation for credit such as samples, compounding chemicals, compounded drugs, investigational drugs, drug floor sweepings and damaged pharmaceuticals, just to name a few. Additionally, EPA sets the following specific PCHWP criterial each of which needs to be met for each hazardous waste pharmaceutical: 1) Undispensed, 2) In original container, 3) Less than one-year past expiration. Fortunately, PCHWP’s that a healthcare facility generates can be shipped back to a reverse distributor via a common carrier without a uniform hazardous waste manifest. There are some mandatory regulatory requirements for the management of PCHWP at a facility, but these are relatively not cumbersome due to the nature of the waste involved. Regulatory management standards under Subpart P for PCHWP include but are not limited to: EPA site identification notification, recordkeeping, delivery confirmation receipt from the RD, shipping and spill response requirements.

NCHWP - On the flipside, hazardous waste pharmaceuticals that do not have the potential for credit are referred to as non-creditable hazardous waste pharmaceuticals (NCHWP). This means any pharmaceutical that does not have a reasonable expectation for credit, or it fails any one of the PCHWP criteria. Any NCHWP generated need to ultimately be disposed of through a TSDF (Treatment Storage and Disposal Facility – a.k.a. hazardous waste incinerator), accompanied by a Uniform Hazardous Waste Manifest and transported by a hazardous waste vendor. Regulatory requirements for management under Subpart P for NCHWP include, but are not limited to: EPA site identification notification, training, container standards, storage, labeling, accumulation, exception reporting, recordkeeping, shipping, land disposal restrictions, manifesting, spill response, rejected shipments, commingling, unsuitable for incineration container/labeling and disposal confirmation requirements. As you can see, NCHWP requirements are more extensive due to the nature of the waste involved.

Here are some common scenarios of noncreditable hazardous waste pharmaceuticals. Any hazardous drug that has been repackaged or not in its original container. Any hazardous drug past one-year expiration. Any hazardous drug that has been dispensed. Any hazardous drug that does not have a reasonable expectation for credit.

So, not only does a healthcare facility need to identify which HWP’s it generates, but carefully examine each one to determine if it is potentially or non-creditable to make sure it gets sent to the right destination. And what happens if a non-creditable hazardous waste pharmaceutical inadvertently gets shipped to a reverse distributor? No big deal, right? Wrong! The reverse distributor is then required to fill out an Unauthorized Waste Report detailing the NCHWP waste received. This report not only goes back to the healthcare facility, but to the EPA as well. One could logically conclude that multiple Unauthorized Waste Reports from a single facility may attract the attention of inspectors. Therefore, it is essential for the healthcare facility to have a strict procedure in place for the proper identification of hazardous waste pharmaceuticals and whether or not they are potentially or non-creditable. Secondly, it is imperative that these wastes are properly managed at the healthcare facility and get transported to their proper destination for ultimate disposal.

We’ve just explored in detail one critical aspect of EPA’s Subpart P which can be found in 40 CFR Part 266, Subpart P. There are many more facets to the regulations which need to be explored by all healthcare facilities as defined by the EPA.

It is important to note that all states are required to adopt Subpart P and several states already have. State adoption progress along with extensive Subpart P information can be found at www.epa-subpart-p.com. There, you can also register for our free monthly webinar that digs into these new regulations in greater detail. As more and more states adopt Subpart P, there will be an increased demand for proper hazardous pharmaceutical waste identification and compliant disposal solutions.

Jeff Hollar is President of PharmWaste Technologies, Inc. – Providing healthcare facilities with solutions in the area of pharmaceutical waste management since 2007. He can be reached at jhollar@pwaste.com.

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