January 01, 2014

The War on Drugs: Pharmaceutical Waste Management Challenges and Emerging Issues

Lynn Kornfeld and Ann Prouty

The discovery of prescription drugs in water resources throughout the United States has heightened both public and agency scrutiny of pharmaceutical waste management practices. Healthcare facility practices have been reported as a contributor to this water-quality concern. Cornelia Dean, Drugs Are in the Water. Does It Matter? NY Times, Apr. 3, 2007. As a result, many healthcare facilities have been the focus of several large enforcement actions by both the U.S. Environmental Protection Agency (EPA) and state agencies related to the handling, storage, and disposal of pharmaceutical waste. Until recently, hazardous waste management regulatory programs have failed to consider the unique challenges healthcare facilities face in characterizing, handling, and disposing of pharmaceutical wastes. However, more recent agency focus on pharmaceutical waste issues has led to a number of federal and state regulatory and policy initiatives to try to streamline pharmaceutical waste management requirements and facilitate broader compliance.

This article explores recent developments related to pharmaceutical waste management, including enforcement activity under the Resource Conservation and Recovery Act (RCRA) and state implementing programs, in addition to emerging federal and state regulatory initiatives that affect hospitals, pharmacies, clinics, and all other facilities that manage pharmaceutical products and wastes. The article also provides recommendations for healthcare facilities to maintain compliance with this rapidly evolving area of regulation and actions those entities can take to ensure that future regulatory changes and guidance address the unique concerns and challenges faced by the healthcare industry.

Pharmaceutical waste management practices are regulated by a number of federal and state environmental laws and regulations, including RCRA, 42 U.S.C. § 6901 et seq., and the Clean Water Act, 33 U.S.C. § 1251 et seq., and their state implementing regulations. Many states also have specific regulatory programs for the management of infectious or nonhazardous medical waste. These requirements are not only applicable to pharmaceutical manufacturers but to all entities that manage pharmaceuticals, such as hospitals, pharmacies, ambulatory surgery centers, dialysis clinics, nursing homes, veterinarian clinics, as well as supermarkets and big box retailers that contain pharmacies.

 

Healthcare facilities face unique challenges in managing pharmaceutical waste. Healthcare facilities may manage thousands of pharmaceutical products or combinations of products, many of which are either listed or characteristic hazardous wastes under RCRA. Moreover, wastes from these products may be generated in many different ways and involve a number of different delivery devices. Practicing Greenhealth, Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States (rev. Aug. 2008). For example, unused or outdated products, intravenous preparations, and partially used intravenous lines, and vials or syringes all produce pharmaceutical wastes that must be managed and disposed of appropriately. Depending on the pharmaceutical product in question, there may also be options other than disposal, such as the reuse of unopened, usable products through state donation programs or the return of products to the manufacturer through available reverse distribution programs. The process of tracking, appropriately characterizing wastes for disposal, and understanding the array of potential disposal options can be daunting for facilities, especially at facilities where few personnel may be trained in waste management and disposal compliance.

In addition to environmental waste management concerns, healthcare facilities also have requirements related to the management of certain pharmaceutical wastes under other nonenvironmental laws. For example, the Controlled Substances Act (CSA), 21 U.S.C. § 801 et seq., prohibits the transfer of controlled substances between healthcare facilities unless both facilities are Drug Enforcement Agency (DEA) registrants. If a facility is not a DEA registrant, it must directly dispose of pharmaceutical wastes. These CSA requirements add additional obstacles and complexities to the management of pharmaceutical waste by healthcare facilities.

In light of these intricacies, many healthcare facilities have developed unique approaches to managing pharmaceutical waste, many of which may not be permissible under applicable federal or state regulations. For example, many healthcare facilities do not make waste determinations at their locations. Instead, their practice has been to send the pharmaceuticals to a centralized location where formal waste determinations and management or disposal options are more easily determined. The management and shipment of hazardous pharmaceutical waste to these centralized distribution or warehouse centers is often done in violation of hazardous waste manifesting and other requirements under RCRA. In addition, many healthcare facilities have historically disposed of hazardous pharmaceutical products down the drain in violation of state law or local wastewater pretreatment requirements.

These and other practices by healthcare facilities have recently become the focus of some significant EPA enforcement actions. Facilities that fail to comply with RCRA with regard to their unused pharmaceuticals face penalties up to $37,500 per violation per day; however, EPA has generally agreed to settle such complaints for significantly smaller penalties.

Recent Federal Enforcement Actions

EPA has demonstrated its increased focus on pharmaceutical waste by pursuing enforcement actions against healthcare facilities that fail to properly manage pharmaceutical hazardous waste under RCRA. For example, in 2012, EPA Region 4 settled an enforcement action against a Tennessee hospital for violations of Tennessee’s RCRA-authorized hazardous waste program. In the Matter of Baptist Hospital, RCRA-04-2012-4000(b), 2012 EPA RJO Lexis 95 (Feb. 16, 2012). According to EPA’s inspection report, numerous pharmaceutical products typically used at the facility should have been managed as hazardous waste but were not. Instead, the hospital typically included the hazardous pharmaceutical waste with medical wastes or nonhazardous solid wastes or discharged it into the sanitary sewer. EPA therefore alleged, among other claims, that the hospital violated Tennessee’s statute implementing RCRA by failing to make hazardous waste determinations on solid waste generated at the facility. The hospital ultimately settled this and other violations by paying an $18,620 civil penalty. Likewise, in 2008, EPA Region 7 entered into a settlement with a Missouri hospital that EPA alleged had failed to conduct a hazardous waste determination for waste pharmaceuticals in its pharmacy and had failed to properly dispose of the pharmaceuticals. In the Matter of Children’s Mercy Hospital, RCRA-07-2008-0005, 2008 EPA RJO Lexis 313 (Sept. 18, 2008). The facility was shipping its pharmaceutical hazardous wastes off-site without using a hazardous waste manifest and was shipping the waste to a facility that was not authorized to accept hazardous waste. The hospital agreed to pay a civil penalty of $86,043 to resolve these and other RCRA violations and committed to submit documentation to EPA demonstrating its compliance with RCRA requirements in the future.

EPA has also incorporated pharmaceutical waste management requirements into settlements with facilities charged with violating RCRA. In 2009, Region 7 entered into a Consent Agreement with the Department of Veterans Affairs Eastern Kansas Health Care System, settling claims under Kansas hazardous waste laws. In the Matter of Dep’t of Veterans Affairs, RCRA-07-2008-0013, 2009 EPA RJO Lexis 298 (Aug. 7, 2009). As part of the settlement, the Department of Veterans Affairs committed to complete a Supplemental Environmental Project for which it would spend at least $482,069 to develop and implement a program to properly identify, segregate, and manage pharmaceutical and chemical wastes at its facilities. It further agreed to pay a civil penalty of $51,501.

These enforcement actions are some limited examples of EPA’s focus on pharmaceutical wastes management compliance at healthcare facilities. This enforcement priority is likely to persist as EPA continues to develop its regulations and guidance for pharmaceutical waste disposal and may expand to include enforcement against other healthcare facilities, such as retail pharmacies. Following EPA’s lead, many state implementing agencies have begun directing their attention to healthcare industry inspections and enforcements as well.

Regulatory Response and Emerging Issues

Concerns about the mismanagement of pharmaceutical waste have also led to a number of recent federal and state initiatives to streamline or clarify requirements for the healthcare industry. Those agency initiatives range from the issuance of guidance on compliance and best-management practices for the industry to regulatory changes to help streamline pharmaceutical waste management requirements.

In 2008, EPA first attempted to comprehensively address some of the challenges inherent in managing hazardous pharmaceutical wastes by proposing regulatory changes to the management of hazardous pharmaceutical waste. 73 Fed. Reg. 73,520–44 (Dec. 2, 2008). That proposed rule would have allowed regulated entities to manage hazardous pharmaceutical waste under the more streamlined requirements for universal waste. It also proposed to reduce some of the regulatory obstacles in the collection of pharmaceutical wastes in order to facilitate pharmaceutical take-back programs—or programs that allow the public to return unused or outdated medications to a centralized location for proper disposal. The rule was never finalized in part due to concerns expressed during the public comment period that the management of hazardous pharmaceutical waste as a universal waste would not provide adequate waste tracking and notification.

Rather than finalize the proposed rule, EPA issued a draft guidance document to assist healthcare facilities with waste management issues. The document, entitled Best Management Practices for Unused Pharmaceuticals at Health Care Facilities, is the result of an extensive stakeholder process—including input from 700 stakeholders and visits to twelve healthcare facilities—to develop ways to better manage unused pharmaceuticals. EPA, Draft Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (EPA-821-R-1-006) (Aug. 26, 2010). The guidance outlines specific recommended steps to better manage pharmaceuticals, including those related to conducting pharmaceuticals inventories; reducing the volume of unused pharmaceuticals; properly segregating wastes for disposal; recommended destruction options other than disposal down the sewer drain; and employee training.

Earlier this year, EPA announced that it again plans to revise the standards related to the regulation of hazardous pharmaceutical waste. EPA has indicated that the new standards will both help streamline waste management requirements while also addressing prior concerns about maintaining adequate waste tracking and notification procedures.

Outside of a comprehensive approach to help streamline hazardous waste requirements for healthcare facilities, EPA has adopted certain other drug- or waste-specific policies or regulatory changes intended to address some of the unique challenges of waste management at healthcare facilities. For example, EPA exempted epinephrine salts from hazardous waste listing P042, thereby excluding that waste from having to be managed as a hazardous waste. Memorandum from EPA Office of Solid Waste to RCRA Division Directors, Scope of Hazardous Waste Listing P042 (Epinephrine), (Oct. 15, 2007). Through interpretive guidance, EPA has also stated its position that residues of P- and U-listed pharmaceuticals that may remain in a syringe after the dose has been administered to a patient are exempt from regulation under Subtitle C of RCRA. EPA Hotline Questions and Answers, Epinephrine Residue in Syringe Is Not P042, Dec. 1994 (RO 13718). Thus, healthcare facilities do not have to manage these as hazardous waste. This exemption has not been extended to any other dispensing devices other than syringes. Through a 2001 change to RCRA regulations, P- and U-listed wastes that are listed solely for their characteristic as an ignitable, corrosive, or reactive waste are not deemed hazardous once they no longer exhibit that characteristic. 66 Fed. Reg. 27,286. This regulatory change exempted certain weak, nonreactive medicinal nitroglycerin formulations from regulation as a P-listed waste.

In addition to the EPA’s efforts to ensure pharmaceutical waste is properly managed, a number of states have issued their own guidance on the proper handling of pharmaceutical waste within their borders. Most of the emerging issues deal with the management of hazardous pharmaceutical waste. While the states that have addressed management of hazardous waste pharmaceuticals have used different approaches, their focus on this issue demonstrates its importance for companies selling or distributing pharmaceuticals.

The majority of states that have considered the appropriate treatment of pharmaceutical wastes under the hazardous waste regulations have indicated that hazardous pharmaceutical wastes must be handled in the same way as other hazardous wastes. California, New York, North Dakota, and Washington, among many others, require all generators of pharmaceutical wastes—including pharmacies, hospitals, physician’s offices, school nurse’s offices, outpatient care centers, and other facilities—to make hazardous waste determinations for their pharmaceutical waste and comply with hazardous waste regulations where applicable. Many states, such as Colorado, have issued specific guidance to help notify and educate generators of hazardous pharmaceutical waste that they are subject to hazardous waste regulations.

In addition to complying with hazardous waste programs, some states have enacted more stringent requirements related to the disposal of pharmaceutical waste, including Illinois, which has banned the disposal of pharmaceutical waste through the sewer system. Other states, such as Maine, have also proposed or enacted bans on the disposal of pharmaceutical waste in landfills, instead requiring incineration. These states may change their approach if and when EPA’s proposed rule becomes final. However under current regulations pharmaceutical waste generators are required to comply with the onerous requirements or RCRA and state hazardous waste laws.

In the states that treat unused pharmaceuticals as hazardous waste, a key issue that arises is whether facilities such as hospitals and pharmacies may use “reverse distribution” to manage their hazardous pharmaceutical wastes. Reverse distribution refers to the practice of returning unused or expired pharmaceuticals to a manufacturer or centralized repository for disposal, reuse, or reclamation. The hospital or pharmacy that ships the unused pharmaceuticals does not make a hazardous waste determination or manifest the pharmaceuticals as hazardous waste prior to shipment; rather compliance with hazardous waste regulations is postponed until the pharmaceuticals arrive at the centralized facility and that facility determines they will be disposed.

The states that have considered this issue have taken differing positions on the acceptability of the practice. Colorado considers hazardous waste pharmaceuticals that are returned to a reverse distributor to be a waste, not a commodity. Therefore, pharmaceuticals that meet the definition of hazardous wastes must be managed as a hazardous waste and generally cannot be returned to a reverse distributor for management. See CDPHE, Compliance Bulletin: Medical Waste Treatment (Feb. 2012). Colorado makes an exception for waste pharmaceuticals that are controlled substances, which can be sent to a DEA registered reverse distributor.

By contrast, states such as North Dakota, Ohio, and Minnesota permit outdated or unused pharmaceuticals to be returned to a reverse distributor for management in certain circumstances. However, the reverse distribution programs in the states that authorize the practice vary significantly. For example, in North Dakota, facilities are permitted to use a reverse distributor to return unused pharmaceuticals because the facilities may receive a manufacturer credit; therefore, the pharmaceuticals still have potential value and are not considered wastes at the time of shipment. North Dakota Dep’t of Health, Envtl. Health Section, Div. of Waste Mgmt., North Dakota’s Pharmaceutical Waste Guidance (Jan. 2010). North Dakota does require facilities to monitor the end disposition of the pharmaceuticals sent off-site. If the reverse distributor always disposes of a particular pharmaceutical, then the facility must manage it as a hazardous waste on-site. Likewise, pharmaceuticals that are no longer usable—for example because they are expired—cannot be managed through reverse distribution.

Ohio takes a similar approach to that of North Dakota, authorizing reverse distribution if “there is a reasonable likelihood that [the hazardous pharmaceutical waste] will be recycled by being used, reused or reclaimed,” or if the generator is certain it will receive monetary credit for the pharmaceutical. Ohio Envtl. Protection Agency, The Disposal of Hazardous Pharmaceutical Wastes from Businesses (Nov. 2010). However, if the generator does not have a reasonable, documentable expectation that the pharmaceutical can be recycled or credited, the generator must manage the pharmaceutical on-site as hazardous waste.

Minnesota follows the unique approach of authorizing the use of a reverse distributor even when the pharmaceuticals are unusable and will be disposed of, provided certain criteria are met. Specifically, the facility must obtain a Hazardous Waste Identification Number document stating that the wastes will be properly disposed of as hazardous waste, comply with certain packaging and labeling requirements, and maintain records of the shipments. Further, Minnesota does not permit facilities to reverse distribute hazardous pharmaceutical waste that the facility accepted from households or from another generator. Minnesota justifies this approach to reverse distribution because reverse distribution “provides an environmentally protective method for handling waste pharmaceuticals.” Minnesota Pollution Control Agency, Reverse Distribution of Pharmaceuticals: Guidance for Minnesota Healthcare Providers (June 2011).

The permissibility of reverse distribution has important implications because of the costs and difficulty of RCRA compliance for small offices and retail facilities. A large number of facilities that generate hazardous pharmaceutical waste, such as retail pharmacies and doctors’ offices, do not generate other RCRA hazardous waste. Accordingly, if these facilities are allowed to reverse distribute unused or expired pharmaceuticals, they would not be required to obtain a RCRA generator identification number or comply with numerous RCRA regulations at each individual retail pharmacy location or office. The regulatory burden of requiring these small facilities, which typically lack on-site environmental or compliance professionals, to comply with RCRA solely on the grounds that they generate unused pharmaceutical waste is significant.

Although most states require pharmaceutical wastes that meet the definition of hazardous waste to be managed as such, a minority has taken the position that these wastes may be managed as “universal waste” instead to simplify the characterization process. For example, the Michigan Department of Environmental Quality provides facilities the option of characterizing all of their pharmaceuticals except controlled substances as universal waste. Mich. Dep’t of Envtl. Quality, Universal Waste (Sept. 2008). The receiving universal waste handler then makes a waste determination for the pharmaceuticals and ships the waste for disposal under the applicable regulations. Likewise, the Florida Department of Environmental Protection determined that “pharmaceutical waste that meets the definition of hazardous waste may be managed as ‘universal waste’ in Florida.” Florida Dep’t of Envtl. Protection, Pharmaceutical Waste Guidance (May 2009).

Universal waste requirements are somewhat less stringent than hazardous waste requirements, thus many Michigan and Florida facilities likely take advantage of this regulatory option. At this time, treatment of hazardous pharmaceutical waste as universal waste is not consistent with EPA guidance and regulations, thus facilities should consider the risk of EPA enforcement if they fail to manage their pharmaceutical waste as hazardous.

A final area of regulatory concern at the state level is the disposal of unused hazardous pharmaceuticals by households. Although household hazardous wastes are exempt from RCRA requirements, disposal by households has begun to raise regulatory concerns regarding the impact on the environment and drinking water when pharmaceuticals are disposed of in the sanitary system and landfills. In response, certain states have developed medication take-back programs, under which the states organize collection points for pharmaceutical wastes and encourage citizens to return their unused pharmaceuticals for proper management and disposal. Likewise, certain companies that manufacture or sell pharmaceuticals have voluntarily agreed to accept unused medications from consumers for disposal.

While pharmacies and medication distributors’ participation in various medication take-back programs has been voluntary to date, increased regulatory concern regarding the improper disposal of household pharmaceutical waste may lead various states agencies to require companies to provide take-back services in the future. Companies that sell pharmaceuticals to households should monitor applicable state programs to ensure they comply with any new programs.

Recommendations for Healthcare Facilities

Pharmaceutical waste management requirements are rapidly changing at both the federal and state levels. It is important for healthcare facilities to track both federal and state requirements related to the management of pharmaceutical waste and revise their current pharmaceutical waste management practices to address any potential compliance concerns. Particular emphasis should be placed on reuse or disposal practices, including understanding any state reverse distribution or universal waste programs and corresponding eligibility criteria. Healthcare facilities should also determine local wastewater requirements and whether there are any state bans on drain and/or landfill disposal. It may also be important to refer to applicable best management practices that have been developed by federal and state agencies for the industry, as those will guide agency scrutiny and enforcements.

For healthcare facilities that manage a multitude of different pharmaceutical products, the best approach to ensure ongoing compliance is to develop a comprehensive system to track the pharmaceutical wastes they manage, including the characterization of those wastes alone or in combination with other products, and the appropriate handling, labeling, storage, and disposal requirements. Facilities should also ensure that pharmaceuticals and waste containers are properly segregated and labeled. It is also important to ensure that personnel who are assigned to manage pharmaceutical wastes receive comprehensive training and that company compliance training and policies are frequently reviewed and updated as may be appropriate.

EPA’s proposed 2014 rulemaking will likely result in significant changes in how healthcare facilities manage pharmaceutical waste. The results of that rulemaking, in turn, will result in regulatory changes at the state level, both through regulatory changes as well as new or modified agency interpretations or guidance materials. Healthcare facilities should track EPA’s proposed rulemaking, as well as related state initiatives, and consider participating by joining stakeholder groups or submitting public comments. Broad industry participation is needed to ensure that federal and state pharmaceutical waste management programs adequately address the healthcare industry’s unique concerns and compliance challenges.

Lynn Kornfeld and Ann Prouty

Ms. Kornfeld and Ms. Prouty are attorneys in the Environmental Practice at Faegre Baker Daniels LLP in Denver, Colorado. Ms. Kornfeld is a partner specializing in environmental transactional and compliance matters. She has represented major multinational corporations in resolution of a broad range of issues under the Resource Conservation and Recovery Act (RCRA). Ms. Prouty is an environmental associate and primarily represents clients in litigation and compliance matters arising under state and federal environmental laws, including RCRA.