Pharmaceutical waste management: Compliance with environmental regulations

April 21, 2012

Compliance with environmental laws and regulations pertaining to pharmaceutical waste disposal is an essential part of pharmacy management. Here are some tips to make the process less daunting.

The information provided here is intended as general guidance to assist the healthcare-system pharmacy manager, and in some cases, it may also apply to the community pharmacist.

This article specifically addresses those environmental regulations currently administered by the U.S. Environmental Protection Agency (EPA) and state environmental regulatory agencies concerned with the current requirements for the proper disposal of all wastes, including pharmaceutical waste. There are several categories of waste defined in the law, and certainly all pharmaceutical waste meets one or more of those definitions.

Other agencies that may need to be consulted in connection with pharmaceutical waste disposal are the U.S. Drug Enforcement Administration (DEA), the federal and state departments of transportation, the Occupational Safety and Health Administration (OSHA) and its counterparts at the state level, publicly owned treatment works (POTWs), and state pharmacy boards.

Background information

There is no current federal or state law that is directed specifically toward the disposal activities of healthcare pharmacy managers or pharmacists. However, in regard to medications intended for discard, they are expected to comply with a federal law, the Resource Conservation and Recovery Act (RCRA), as well as Title 40, Parts 239-259 (solid waste) and Parts 260-279 (hazardous waste), the Code of Federal Regulations (40 CFR 239-279) , and state counterpart regulations enacted to implement RCRA, that do exist - and have done so for decades - to regulate the disposal of solid wastes, both hazardous and non-hazardous.

RCRA, the first federal law to address the hazardous waste issue was enacted in 1976. (See further mention of RCRA below, “Pertinent waste regulations.”) It gives EPA authority to control hazardous waste from any source, from the “cradle-to-grave,” including the generation, transportation, treatment, storage, and disposal of hazardous waste.

It is a misconception to believe that hazardous waste regulations and promulgated rules apply only to manufacturers. These laws are written broadly and apply to all sectors of business, including, but not limited to, service providers, for-profits, non-profits, municipalities, and healthcare facilities. (Examples of healthcare facilities include hospitals, clinics, ambulatory surgery centers, veterinarian clinics, nursing homes, dental clinics, etc).

Only hazardous wastes from households are exempt from federal and state disposal laws, and can, without any review, be disposed of in a regular landfill. (Regulatory agencies are, however, ramping up efforts to educate the general public, including in recommendations for best disposal practices for domestically generated hazardous waste of all types, with growing emphasis on waste pharmaceuticals found in households).

Passed in 1984, amendments to RCRA (the Hazardous and Solid Waste Amendments), addressed several mandates, including waste minimization, corrective action for releases, increased enforcement authority for EPA, and more stringent hazardous waste management standards.

Reasons for concern

Several recent U.S. studies have revealed the presence of pharmaceutical compounds in both surface and ground waters. Some of these drugs are toxic (e.g., chemotherapy agents), while others cause more limited physiological changes to aquatic organisms and/or other organisms higher in the food chain.

Most unused pharmaceuticals dissolve easily; however, they do not all readily breakdown into common elements once they are released into the environment, and therefore, they generally remain intact. This allows these drugs to be absorbed by plants, animals, and human beings.

Ultimately, the goal of the environmental protection agencies is to protect our water supply. Therefore, the environmentally preferred disposal option for unused pharmaceuticals from all sources is incineration (because of its high burn temperatures and effective emission-control systems) at authorized (permitted) incinerators, which prevents unused medications from entering our valuable water supply.

While not all the risks to human beings are currently known and more study is required, it is important to understand why we should be concerned with the safe disposal of unused pharmaceuticals.

Experts believe that there may be subtle long-term human effects from drugs ingested from contaminated drinking-water sources. Even though the concentrations of drugs found in samples that have been tested are lower than those levels known to affect human beings, because pof the expected bioconcentration, EPA is working with the National Academy of Sciences to determine the potential risk to human health posed by low-level residues in drinking water.

Many scientists have expressed concerns about fetal exposure. In addition, their concerns include the increase of antibiotics in water, which eventually leads to antibiotic resistance in pathogenic organisms, as well as impact to naturally occurring beneficial bacteria.

It is not known how much of the pharmaceutical contamination found in water samples is caused by drugs that are metabolized versus drugs that are unmetabolized, because analytical results are largely dependent on ambient water chemistry. It is known that most medications enter the waterways from agricultural sources. However, human pharmaceutical sources have also been defined, such as excretion, drugs dumped into toilets and sinks, effluents discharging from waste-water treatment plants that are not capable of removing the medications, landfill leachate (medications discarded in trash), and septic systems.

As a result of all concerns, for the first time, EPA is now considering a drinking-water standard for medicinal drugs.

Getting started with compliance

For the community pharmacist or healthcare-system pharmacy manager, the first order of business connected with compliance with environmental regulations - which includes the correct level of waste management that will be required for the facility - is to secure the necessary support from senior management, as well as to address budgetary needs for the development and implementation of a pharmaceutical waste management program.

The next step will be to decide whether there is in-house staff available (pharmacists, pharmacy technicians, or environmental health and safety personnel) who understand waste disposal, who can make determinations regarding waste streams, and who will be able to meet all waste management requirements. If staff members with adequate expertise are not available, either locally or at the corporate level, then a consultant who is well-versed in hazardous waste management or a waste management company should be contracted.

It is important to understand that waste disposal regulations clearly define the generator of the waste as the responsible party for all waste generated at the site (e.g., hospitals, clinics, local pharmacies, etc.). This is not a matter of “out of sight, out of mind” - it is a strict situation of “cradle to grave” responsibility. Generators of pharmaceutical waste must be certain that their waste is properly stored, transported, and ultimately disposed of according to all legal requirements. If any questions or concerns arise regarding the waste management program, it is best to contact the local office of the appropriate regulatory agency or the contracted vendor, and ask for assistance.

Determining the level of waste management

Both federal and state regulations dictate the level of pharmaceutical waste management. This is determined first through a thorough audit of all waste streams generated by the facility. A waste characterization must be made for every waste type -including each drug at each dose - either through analysis of the waste, review of Material Safety Data Sheets (MSDSs), or checking with suppliers and/or manufacturers of products. (Also see correspondence from Region 5, EPA: http://www.epa.gov/region1/healthcare/pdfs/AcadiaHospResponse12-30-08.pdf).

The completed characterization will document the waste determination and specifically identify which wastes are hazardous waste (listed or characteristic), non-hazardous solid waste, or liquid industrial waste (regulated only in some states). Facilities may also have mixed medical waste and/or controlled substances requiring disposal, both of which may contain hazardous waste.

Once all waste streams have been defined, it is only the hazardous waste that must be managed at one of three levels, known as “hazardous waste generator status.” The three levels are Large Quantity Generator (LQG), Small Quantity Generator (SQG), and Conditionally Exempt Small Quantity Generator (CESQG).

The generator status is established by determining the total amount (in pounds) of all nonacute and acute hazardous waste generated at the facility in one month, as follows:

  • LQG: 2,200 lbs. or more of nonacute hazardous waste and/or 2.2 lbs. or more of acute hazardous waste
  • SQG: Greater than or equal to 220 lbs. and less than 2,200 lbs. of nonacute hazardous waste, with accumulation never exceeding 13,200 lbs.
  • CESQG: Less than 220 lbs., with accumulation never exceeding 2,200 lbs.

All three of the generator status levels have storage time limits and specific requirements for handling and disposal. To verify the level of management required for hazardous waste, a monthly waste inventory must be developed, maintained, and made available for inspection for at least three years.

The pharmaceutical waste stream includes (1) products that are off-spec or have expired, (2) dispensed drugs that are unwanted, no longer needed, or refused, and (3) contaminated medications.

Although chemotherapy medications are toxic, few are included in the federal and state hazardous waste lists because most didn’t exist at the time the regulations were enacted. The EPA is currently reviewing a means to update the regulations to address the disposal of these hazardous pharmaceuticals. The best management practice promoted by the regulatory agencies is to manage chemotherapy drugs consistent with the current hazardous waste regulations.

At this point, the significance of proper waste characterization and the separation of unwanted medications - especially from medical waste, sharps, and nonhazardous solid waste - cannot be overstated. This step, when performed accurately, may reduce the level of regulation involved and lead to lower disposal costs. For example, medical waste is regulated differently from hazardous waste. If medical waste becomes contaminated with hazardous pharmaceutical waste, the entire mixture must be managed as hazardous waste and disposed of accordingly, which will add to costs.

Pertinent waste regulations

Once the pharmaceutical waste categories generated at the facility have been determined, it will be necessary for the responsible individual(s) handling waste disposal to become knowledgeable about the requirements of both the federal and state environmental laws governing the on-site handling and disposal of waste medications. If further guidance or clarification is required concerning compliance with the pertinent environmental laws and regulations, the responsible staff should consult with corporate counsel or another qualified attorney.

As mentioned earlier, the original RCRA regulations provided the guidelines for the management of both hazardous waste and solid wastes. Pharmaceuticals that can no longer be used or are unwanted may meet the definition of a hazardous waste.

At this point, it is important to understand the definition of the term “solid waste.” Any material becomes a solid waste when it is discarded or intended for discard (40 CFR 261.2). This includes solids, liquids, semi-solids, and contained gaseous materials from any source other than domestic households. A material is a hazardous waste if it first meets the definition of a solid waste. Since waste pharmaceuticals are intended for discard, they are solid wastes by definition.

Materials become hazardous wastes if they are “listed” in 40 CFR, Part 261, Subpart D (P- and U-listed wastes), or “characteristic” if they exhibit one or more of the hazardous waste characteristics (ignitable, corrosive, reactive, or toxic), 40 CFR 261.20 - 261.24.

At present, under authorization from the EPA, the base RCRA program is implemented in 50 states and territories. These state and territorial RCRA programs must be at least as stringent as the federal requirements; however, each individual jurisdiction may adopt more stringent requirements as well. Therefore, it should be noted that both federal and state regulations may apply regarding the correct management of pharmaceutical hazardous wastes and non-hazardous solid wastes. If a state or territory has not received authority from EPA to implement the base RCRA program, then the federal agency is responsible for the enforcement of RCRA rules in that state or territory.

Some unused liquid medications may be considered nonhazardous liquid industrial waste, and while they are regulated by RCRA as solid waste, they may also be regulated by some states under industrial liquid-waste rules.

If unused medications become mixed with medical waste, the entire waste is then treated as mixed medical waste, also known as dual waste. Medical waste, alone (not contaminated with pharmaceutical waste), is primarily regulated at the state level. Mixed medical waste is subject to both federal and state hazardous waste regulations as well as state medical waste regulations, and must meet all the requirements under each of the regulations that apply to the waste stream, unless the statute and/or rules specifically exempt or exclude the waste from being subject to the other regulation. The most effective management practice is not to mix any pharmaceutical waste with medical waste, which will avoid the additional regulatory burden.

Two states, Michigan and Florida, currently allow hazardous pharmaceutical waste to be managed using their streamlined universal waste regulations. Although federal universal waste regulations do not include pharmaceuticals at this time, they are being considered by EPA, which expects to publish proposed rulemaking on the issue again in spring of 2013. (See http://www.epa.gov/wastes/hazard/wastetypes/universal/pharm-rule.htm; site last updated in March 2012).

The EPA and the two states recognize that compliance with the RCRA hazardous waste regulations is complex and can be difficult for healthcare systems and pharmacies, as opposed to businesses that operate in an industrial setting. Pharmacists should consider managing their hazardous waste using these regulations when and where possible.

All controlled substances are regulated by the federal Controlled Substances Act (CSA) Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and its promulgated rules. These regulations are administered by DEA. Options for disposal within these regulations are very limited. Because some of the chemicals regulated by CSA can also be hazardous waste, these pharmaceuticals must be specifically managed not only for safety and security, but also for environmental purposes.

Some situations of noncompliance with environmental regulations of any nature stem from a lack of knowledge of the laws and promulgated rules that apply.

Less waste, less regulation, less cost

The current and enforceable federal waste regulations contained in RCRA were written as they were to encourage generators of hazardous waste, in particular, to practice waste minimization and recycling where possible. These two practices can result in less total hazardous waste generated per month at the facility/pharmacy (as discussed earlier, the monthly total for the facility includes the pharmaceutical waste), meaning less regulation will apply, and usually less disposal expense will be involved.

For example, a facilities waste characterization that results in a determination of LQG may be lowered to the next-lower status, SQG, or even the lowest status, CESQG, through reduction or elimination of pharmaceutical waste streams. Many businesses of all types have greatly lowered their hazardous waste disposal costs simply by working to lower their generator status.

However, waste reduction must be performed in accordance with all pertinent regulations. While some practices can reduce the volume of pharmaceutical waste that a facility or pharmacist must manage (e.g., burning drugs or flushing them down toilets and sinks), these practices are not environmentally friendly and in most cases are illegal.

Proper incineration of waste drugs requires special permits from the regulatory agencies, especially for both hazardous waste and controlled substances. Flushing drugs may be in violation of the local POTW ordinance, and if drugs are flushed to septic systems, state and local groundwater regulations may be violated. These methods of disposal must be authorized through permission obtained from sanitary sewer authority or state environmental regulatory agencies with regulations intended to protect groundwater.

To achieve the lowest possible hazardous waste generator status and lower disposal costs, pharmacy managers and pharmacists seeking to minimize or perhaps even eliminate the pharmaceutical waste stream should take note of the following tips.

Precautions for minimizing waste

1. Do not mix waste pharmaceuticals with medical waste, sharps, or any other form of waste. If the waste drugs are hazardous, then the entire mixture must be disposed of as hazardous waste and infectious medical waste (dual or mixed waste), which is more costly than the disposal of segregated medical waste and sharps.

While one best management practice recommended by some regulatory agencies is to treat all pharmaceutical waste as hazardous waste, regulations do allow the segregation of wastes, resulting in less disposal cost; however, there will be additional overhead cost for training, containers, etc.).

The facility should keep accurate documentation and records demonstrating that all the hazardous waste has been characterized, managed, and disposed of within all requirements).

2. Use reverse distributors whenever possible, or return unwanted medications directly to the pharmaceutical manufacturer. The facility should request documentation verifying that all requirements have been met when it disposes of unwanted drugs by this method.

3. If possible, return unused samples to drug sales representatives or use sample vouchers, so that the medication is not dispensed until the patient fills the voucher at the pharmacy. If the number of free samples is limited, disposal costs are likely to be lower. If vouchers are used, disposal costs are eliminated.

4. Consider treating all hazardous wastes as universal wastes in states where this is allowed. Universal waste has less restrictive management requirements (e.g., the volume of hazardous waste is not included in the monthly calculation of the hazardous waste generator status; universal waste can be accumulated far longer than allowed for a LQG or SQG; and less labeling of the waste is required).

“Prescription” for compliance

The lesson in all this is relatively simple. Federal and state environmental laws regulating the management and proper disposal of hazardous and nonhazardous waste have been around for a long time. Historically, heavy industry rather than generators of pharmaceutical waste was the focus of agency compliance efforts. Now, in light of the fact that medicinal drugs are being found by studies of the U.S. surface and ground waters and aquatic organisms, the healthcare industry is coming into the spotlight, and regulatory agencies are beginning to look more closely at these facilities. This trend is expected to continue.

The U.S. EPA and many state environmental regulatory agencies, with compliance assistance staff, are currently trying to get the message out to the healthcare community about the hazardous waste laws that apply to pharmaceutical waste management, so that they can get ahead of the curve; those in the industry who do not take advantage of resources available to them now are likely to see an impact on their practice of pharmacy, such as real liabilities and sanctions later, as provided under the regulations.

The road to compliance with the environmental laws and regulations that pertain to pharmaceutical waste can seem daunting, but there are several things healthcare pharmacy managers and pharmacists can do now that will enable their achievement of compliance.

What you can do

1.Be aware of this issue. Proper management and disposal of waste pharmaceuticals that meet the definition of hazardous waste are not voluntary - they are required by law.

2. Review environmental regulatory agency websites to learn more about the regulations and requirements involved, or discuss them with appropriate corporate staff.

3.Attend conferences, seminars, workshops, and webinars to learn more about this topic. While you’re there, speak with regulatory compliance assistance staff, if they are available. (At an all-day session sponsored by the Michigan Health & Hospital Association and the Michigan Department of Environmental Quality in Lansing, Michigan, in January 2012, entitled “MHA Healthcare Pharmaceutical Waste Management Workshop,” the room was filled with pharmacists and nurses).

4. Review the websites provided below.

5.Keeping in mind that waste minimization is key to both compliance and lower disposal costs, learn what your waste streams are, and begin to take action to reduce them.

By following these suggestions, both healthcare pharmacy managers and local pharmacists can “do no harm,” join other responsible professionals in making a substantial contribution to sustainability, and play a vital role in preserving and protecting the environment for future generations.

For more information:

EPA website on RCRA

http://www.epa.gov/epawaste/inforesources/online/index.htm/

EPA website listing state/territory regulatory agencies authorized to implement RCRA programs

http://www.epa.gov/epawaste/wyl/stateprograms.htm

EPA regional offices

http://www.epa.gov/aboutepa/index.html#regional

A directory of state environmental compliance assistance programs provided by the Small Business Environmental Homepage

http://www.smallbiz-enviroweb.org (Select SBO/SBEAP List)

Healthcare Environmental Resource Center

http://www.hercenter.org/

Practice Greenhealth website: Pharmaceutical Waste

http://practicegreenhealth.org/topics/waste/waste-categories-types/pharmaceutical-waste