Pharmaceutical Waste Practice Resource Center

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Prescription medications are critical to maintaining health and improving the quality of life for millions of Americans. However, not all medications dispensed to patients are consumed. Prescribed medications may go unused for a variety of reasons, including: a patient’s medical condition has been resolved before the medication is totally consumed; the patient’s medication supply is not completely used prior to the expiration date; the patient has an adverse effect from the medication and must stop therapy; the medication is not effective and the physician changes the patient to a different medication; the patient fails to adhere to the prescribed therapy; or the person dies and leaves behind a supply of medications.

In recent years, the topic of pharmaceutical waste has become a public health issue of increasing urgency. The Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Centers for Medicare and Medicaid Services (CMS), and Food and Drug Administration (FDA) have all taken steps to address pharmaceutical waste in both the community and institutional settings. However, these efforts have not been coordinated and have in some cases conflicted with one another.

Disposal Resources

DEA was authorized by the Safe and Secure Drug Disposal Act of 2010 (PDF) to develop regulations to allow non-DEA registrants, including long-term care facilities, to dispose of unused controlled medications. DEA announced in a December 21 Federal Register notice a long-awaited proposed rule for controlled substance disposal. The proposed rule provides guidance for DEA registrants, law enforcement agencies, ultimate users of medication and long-term care facilities. It is intended to ensure the secure disposal of controlled medications through mail-back programs, take-back events, and secured on-site receptacles. The proposed rule recommends that long-term care facilities dispose of accumulated controlled medications through on-site receptacles provided and managed voluntarily by a retail pharmacy. If implemented as proposed, long-term care facilities would not be allowed to use reverse distributors or other third parties for the disposal of controlled substances. The rule, if finalized, is voluntary and does not provide a regulatory framework for disposal of controlled medications accumulated in long-term care facilities if a retail pharmacy does not provide an on-site receptacle. ASCP plans to analyze this proposed rule and submit comments to the docket by the February 19 deadline.

For further information, visit DEA's Office of Diversion Control site.

White House Office of National Drug Control Policy (ONDCP)

The White House Office of National Drug Control Policy with input of the Food and Drug Administration (FDA) provided guidelines on drug disposal. The following is a summary of the White House Office of National Drug Control Policy (ONDCP) Federal Guidelines for the Proper Disposal of Prescription Drugs:

  • Do not flush prescription drugs down the toilet or drain unless the label or accompanying patient information specifically instructs you to do so. For information on drugs that should be flushed, visit the FDA’s website.
  • To dispose of prescription drugs not labeled to be flushed,  you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events,  that collect drugs at a central location for proper disposal.  Call your city or county government’s household trash and recycling service and ask if a drug take-back program is available in your community.
  • If a drug take-back or collection program is not available:
    • Take your prescription drugs out of their original containers
    • Mix drugs with an undesirable substance, such as cat litter or used coffee grounds
    • Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag
    • Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off.
    • Place the sealed container with the mixture, and the empty drug containers, in the trash.

Environmental Protection Agency (EPA)

EPA oversees implementation of the Resource Conservation and Recovery Act (RCRA), which is a federal law controlling the management and disposal of solid and hazardous wastes. EPA proposed in 2008 to add pharmaceuticals to the Universal Waste Program governing waste disposal, but has since declined to finalize that proposal. EPA plans to publish a new proposed regulation in summer 2013 intended to govern the disposal of pharmaceutical waste generated by health care facilities.

Food and Drug Administration (FDA)

FDA provides guidance on safe disposal of medications that is primarily directed towards consumers, but may apply to drug supplies in long-term care facilities. FDA’s page, “Disposal of Unused Medicines: What You Need to Know,” provides guidance on which medications should be disposed of by flushing, rather than in municipal waste or other means.

In particular, FDA recommends that used fentanyl patches be disposed of by folding the adhesive side of the patch together and then flushing the patch down the toilet to reduce the risk of accidental exposure, ingestion, or overdose, particularly by children. Fentanyl patches are a focus of FDA’s “Safe Use Initiative,” an ongoing effort to educate consumers and health professionals and reduce preventable medication harm.

Centers for Medicare and Medicaid Services (CMS)

The CMS State Operations Manual F-Tag 425 (PDF) requires nursing facilities and skilled nursing facilities to have policies and procedures for disposal of medications. More specifically:

  • “Timely identification and removal (from current medication supply) of medications for disposition;
  • Identification of storage method for medications awaiting final disposition;
  • Control and accountability of medications awaiting final disposition consistent with standards of practice;
  • Documentation of actual disposition of medications to include: resident name, medication name, strength, prescription number (as applicable), quantity, date of disposition, and involved facility staff, consultant(s) or other applicable individuals; and
  • Method of disposition consistent with applicable state and federal requirements, local ordinances, and standards of practice.”

In November 2012, CMS included guidance for disposal of used fentanyl patches (PDF) in a memo to state survey agencies.

Facilities may also be required to comply with regulations for 14-days-or-less dispensing of certain brand name medications. Visit ASCP’s practice resource center for more information.

Occupational Safety and Health Administration (OSHA)

The Occupational Safety and Health Administration (OSHA) may play a role in disposal, especially when sharps containers are involved (e.g., Duragesic patches placed in sharps containers).  In verbal discussions with OSHA, ASCP was told that OSHA has no guidance about medication disposal other than to say medications should not be put into sharps containers.  OSHA also maintains a list of medications that are considered “hazardous,” which dictates certain disposal methods and also requires Material Safety Data Sheets (MSDS).  State government agencies may maintain their own list of hazardous pharmaceuticals.

Pharmacy Return and Waste Companies/Reverse Distributors

State and local governments may also maintain laws and regulations pertinent to medication disposal under the purview of the Board of Pharmacy, Department of Health, and environmental agencies. In addition, drug manufacturers may recommend disposal methods for specific medications or products in the package insert or product labeling.

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News

FDA Releases New Resources, Guidance on Fentanyl Patch Disposal

The Food and Drug Administration (FDA) has updated its guidance on fentanyl patch disposal and created new online resources as part of its “Safe Use Initiative.” FDA’s guidance recommends that for all used fentanyl patches, upon removal from the skin, “the adhesive side of the patch should be folded together and then the patch should be flushed down the toilet.”

This advice is consistent with that from the Centers for Medicare and Medicaid Services (CMS), which raised concerns about used fentanyl patch disposal in a November 2012 memo to state survey agencies. Both agencies have highlighted concerns about the potential for accidental exposure and overdose from used fentanyl patches, particularly for young children. A full list of medications FDA recommends be disposed of by flushing is available online.

NIOSH Proposes Additions to Hazardous Drugs List

The National Institute for Occupational Safety and Health (NIOSH) has proposed adding 28 drugs to a list of potentially hazardous drugs in health care settings. NIOSH regularly updates this list to help avoid “occupational exposures to antineoplastic and other hazardous drugs” for health care workers. The proposed additions to the list are: abacavir; abiraterone acetate; apomorphine; bevacizumab; crizotinib; deferiprone; dexmedetomidine; eribulin mesylate; erlotinib; ezogabine; fingolimod; fluconazole; icatibant; liraglutide recombinant; misoprostol; nevirapine; propylthiouracil; spironolactone; tesamorelin acetate; topiramate; ulipristal acetate; vemurafenib; voriconazole; and warfarin.

NIOSH has also added four medications based on manufacturers’ safe-handling guidelines: brentuximab vedotin; cabazitaxel; dexrazoxane; and vandetanib. The proposed additions will be subject to a 60-day public comment period. For guidance on preventing hazardous drug exposures in the workplace, visit the NIOSH Web site.

July 5, 2013
FDA Releases New Resources, Guidance on Fentanyl Patch Disposal

The Food and Drug Administration (FDA) has updated its guidance on fentanyl patch disposal and created new online resources as part of its “Safe Use Initiative.” FDA’s guidance recommends that for all used fentanyl patches, upon removal from the skin, “the adhesive side of the patch should be folded together and then the patch should be flushed down the toilet.” 

This advice is consistent with that from the Centers for Medicare and Medicaid Services (CMS), which raised concerns about used fentanyl patch disposal in a November 2012 memo to state survey agencies. Both agencies have highlighted concerns about the potential for accidental exposure and overdose from used fentanyl patches, particularly for young children. A full list of medications FDA recommends be disposed of by flushing is available online

June 19, 2013
NIOSH Proposes Additions to Hazardous Drugs List


The National Institute for Occupational Safety and Health (NIOSH) has proposed adding 28 drugs to a list of potentially hazardous drugs in health care settings. NIOSH regularly updates this list to help avoid “occupational exposures to antineoplastic and other hazardous drugs” for health care workers.

The proposed additions to the list are: abacavir; abiraterone acetate; apomorphine; bevacizumab; crizotinib; deferiprone; dexmedetomidine; eribulin mesylate; erlotinib; ezogabine; fingolimod; fluconazole; icatibant; liraglutide recombinant; misoprostol; nevirapine; propylthiouracil; spironolactone; tesamorelin acetate; topiramate; ulipristal acetate; vemurafenib; voriconazole; and warfarin.

NIOSH has also added four medications based on manufacturers’ safe-handling guidelines: brentuximab vedotin; cabazitaxel; dexrazoxane; and vandetanib.

The proposed additions will be subject to a 60-day public comment period. For guidance on preventing hazardous drug exposures in the workplace, visit the NIOSH Web site.

December 21, 2012
DEA Releases Controlled Drug Disposal Proposed Rule


The Drug Enforcement Administration (DEA) announced in a December 21 Federal Register notice a long-awaited proposed rule for controlled substance disposal. The proposed rule provides guidance for DEA registrants, law enforcement agencies, ultimate users of medication and long-term care facilities. It is intended to ensure the secure disposal of controlled medications through mail-back programs, take-back events, and secured on-site receptacles. The proposed rule recommends that long-term care facilities dispose of accumulated controlled medications through on-site receptacles provided and managed voluntarily by a retail pharmacy. If implemented as proposed, long-term care facilities would not be allowed to use reverse distributors or other third parties for the disposal of controlled substances. The rule, if finalized, is voluntary and does not provide a regulatory framework for disposal of controlled medications accumulated in long-term care facilities if a retail pharmacy does not provide an on-site receptacle. ASCP plans to analyze this proposed rule and submit comments to the docket by the February 19 deadline.

May 25, 2012
OIG Conducts an Evaluation on EPA

The Office of Inspector General (OIG) conducted an evaluation of EPA (PDF). OIG concluded that “EPA has not used its RCRA authority to determine whether pharmaceuticals may qualify as hazardous waste.” OIG made the following recommendations in their report:

  1. Identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous waste.
  2. Establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste.
  3. Develop a nationally consistent outreach and compliance assistance plan to help states address challenges that health care facilities, and others as needed, have in complying with RCRA regulations for managing HWPs.

January 13, 2012
CMS Requests for Comments on Long-Term Care Utilization and Waste and Medication Therapy Management

CMS released a memo addressed to Medicare Part D plans (PDF) which requested comments regarding proposed changes for CY2013 Part D reporting requirements. The proposal includes new data elements for the reporting of unused drugs in LTC and a request for improvements on requirements or identification of any additional situations or issues that need to be addressed as well as the timeframe for systems enhancements for all systems to collects and store discontinued dates. ASCP assisted and advised Medicare Part D plans in their submission of comments.

April 15, 2011
CMS Releases Short Cycle Final Rule

Section 3310 of the Affordable Care Act authorized by Section 3310 of the Affordable Care Act of 2010 requires certain drugs dispensed to Medicare Part D beneficiaries residing in nursing facilities or skilled nursing facilities to be dispensed in quantities, as finalized, of 14 days or less. In addition, pharmacies are required to report the quantity of unused drugs. Long-term care pharmacies that voluntarily dispense 7 days or less can be waived from the reporting requirement.

This requirement is effective starting January 1, 2013. The final rule (PDF) was published in the Federal Register on April 15, 2011.

This regulation is enforced by the Centers for Medicare & Medicaid Services (CMS) and is intended to achieve cost savings by reducing the quantity of medications dispensed but not consumed by Medicare Part D beneficiaries residing in nursing or skilled nursing facilities. The cost savings realized through this provision is expected to offset the cost of other provisions in the Affordable Care Act. CMS expects this requirement to reduce the amount of prescription drug waste associated with 30-day fill cycles because of adverse reactions, care transitions, death of a patient, or other reasons. ASCP has developed a Practice Resource Center with information on short cycle / 14-day-or-less requirements.

November 9, 2010
ASCP Submits Comments to EPA Regarding Best Management Practices for Unused Pharmaceuticals

The ASCP provided comments to the EPA (PDF) in response to a solicitation for public comments on the draft guidance document titled “Best Management Practices for Unused Pharmaceuticals at Health Care Facilities.” The comments address various sections of the draft where guidelines are not applicable to long-term care settings or additional guidance is needed.

September 8, 2010
EPA Requests Comments on Draft Document Availability for Best Management Practices at Health Care Facilities

EPA requested public comments on a draft guidance document (PDF) entitled, Best Management Practices for Unused Pharmaceuticals at Health Care Facilities on August 26, 2010. The guidance is targeted at hospitals, medical clinics, doctors' offices, long-term care facilities and veterinary facilities. EPA expects that this document will help reduce the amount of pharmaceuticals that are discharged to water bodies.

January 11, 2010
EPA Releases Interim Report

EPA released an interim report titled “Unused Pharmaceuticals in the Health Care Industry” (PDF). The report incorporated data from a detailed study by the EPA released on September 22, 2009 that focused on hospitals and long-term care facilities. The interim report found the following preliminary observations:

  1. Federal, state, and local laws and regulations often require special handling of pharmaceutical waste. These laws and regulations can influence the options hospitals and long-term care facilities have for disposing of unused pharmaceuticals.
  2. Organization size, ease and access of disposal, and cost are also factors influencing the disposal of unused pharmaceuticals.
  3. Fewer disposal opportunities exist for long-term care facilities because they are often not CSA registrants and cannot generally return pharmaceuticals to the manufacturer or use reverse distributors.
  4. Best management practices, if widely implemented, have the potential to reduce the amount of unused pharmaceuticals entering our nation’s waters from disposal.

In the report, EPA’s next steps were to conduct a nationwide study to estimate the amount of unused pharmaceuticals disposed of in our nation’s waterways, evaluate current disposal practices and their cost, examine the barriers to alternate disposal methods, and evaluate best management practices and their costs.

September 22, 2009
EPA Releases Report Titled “Health Care Industry Unused Pharmaceuticals Detailed Study 2007-2009 Data Collection and Outreach”

EPA released a report (PDF) on a study conducted on unused pharmaceuticals using data from 2007-2009 in hospitals and long-term care facilities. The study focused on in understanding the following research questions which were used for the Interim Report released January 11, 2010:

  • What are the current industry practices for disposing of unused pharmaceuticals?
  • Which pharmaceuticals are being disposed of and at what quantities?
  • What are the options for disposing of unused pharmaceuticals other than down the drain or toilet?
  • What factors influence disposal decisions?
  • Do disposal practices differ within industry sectors?
  • What best management practices (BMPs) could facilities implement to reduce the generation of unused pharmaceuticals?
  • What reductions in the quantities of pharmaceuticals discharged to POTWs would be achieved by implementing BMPs or alternative disposal methods?
  • What are the costs of current disposal practices compared to the costs of implementing BMPs or alternative disposal methods?

March 23, 2009
ASCP Files Comments on DEA's Disposal of Controlled Substances Information Solicitation

ASCP has filed comments to DEA (PDF) regarding their solicitation of information on the disposal of controlled substances dispensed to individual patients and long term care facilities. The ASCP submitted comments to DEA in response to an advanced notice of rule-making on disposal of controlled substances by persons not registered with the DEA issued January 21, 2009. The comments addressed questions that DEA had put forth to the public and made the following recommendations:

  • The Food and Drug Administration (FDA), CMS, EPA and DEA work together to develop a comprehensive, coordinated set of national guidelines for the disposal of all unused medications, both controlled and non-controlled.
  • Encouragement for outreach to and education of health care providers on the national disposal guidelines.
  • Strong encouragement to consider operational efficiency and both direct and indirect business costs for any disposal method that the Agency recommends or mandates.

March 4, 2009
ASCP Files Comments on EPA's Proposed Amendment to Universal Waste Rule

ASCP filed comments (PDF) on EPA's proposed rule entitled Amendment to the Universal Waste Rule: Addition of Pharmaceuticals. EPA’s proposal includes adding hazardous pharmaceutical wastes to the federal universal waste program.

November 10, 2008
ASCP Submits Comments to EPA on DRAFT Survey of Medical Facilities on Disposal of Unused Pharmaceuticals

The Environmental Protection Agency (EPA) released a DRAFT survey of medical facilities regarding their procedures for disposal of unused medications.  The survey will be primarily directed towards hospitals, nursing facilities, and hospices - although facilities are expected to rely upon multiple individuals to fill out the various survey questions (i.e., consultant pharmacist, dispensing pharmacy).  ASCP submitted formal comments to the EPA on their draft survey, specifically questioning the length and complexity of the survey and their request for voluminous, specific data.  ASCP also offered suggestions on the wording of questions to more accurately reflect medication management within the nursing facility setting.

March 10, 2008
Media Spotlights on Traces of Unused Medications Ending Up in the Water Supply

The following are press articles that had initially spotlighted the discovery of unused medications in water supplies:

May 2, 2005
DEA Releases Final Rule Which Establishes Reverse Distributors as Another DEA Registrant

DEA’s final rule entitled "Definition and Registration of Reverse Distributors" establishes reverse distributors as a new category of registration and regulates the “standards under which reverse distributors may handle unwanted, unusable, or outdated controlled substances acquired from another DEA registrant.”

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