NCHR Written Comment to FDA on In-Home Disposal Systems for Opioid Analgesics

April 6, 2026

Re: Docket No. FDA-2026-N-1001 for “Developing Specifications for In-Home Disposal Systems That May Be Made Available Through the Opioid Analgesic Risk Evaluation and Mitigation Strategy For Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments”

The National Center for Health Research (NCHR) appreciates the opportunity to comment on the FDA’s request for information regarding in-home disposal systems for opioid analgesics.

NCHR is a nonprofit, nonpartisan group that reviews health policies and regulations to make sure they are based on strong science and protect public health. For over 27 years, our experts have studied how federal laws and policies affect patients and communities across the U.S. We regularly submit comments to federal agencies, testify at advisory meetings, and share clear, evidence-based insights to help improve patient safety and health outcomes.

Unused opioid medications in the home remain a significant and preventable source of misuse, diversion, and accidental exposure. Many prescribed opioids go unused, and many patients retain these medications in case they need to use them in the future or because it is not convenient to safely dispose of them. Importantly, most individuals who misuse prescription opioids obtain them from friends or relatives, making leftover medications a primary source of misuse (Substance Abuse and Mental Health Services Administration (SAMHSA), 2017).

A randomized clinical trial found that providing drug disposal bags significantly increased proper disposal rates, but a large proportion of patients still retained unused opioids at home (Lawrence et al., 2019). These findings underscore the need for thorough, evidence-based performance standards and system-level support to ensure that disposal interventions meaningfully reduce risk without imposing unnecessary burden.

1. Amount of opioid that must be rendered unavailable: The key issue is not a fixed percentage, but the amount of active drug remaining that could still cause harm or be misused. Even small residual amounts can be clinically significant, especially for high-potency opioids or large initial doses.

FDA should require that disposal systems reduce the remaining active drug to a level that is not usable, retrievable, or clinically meaningful, across all formulations (e.g., tablets, liquids, patches, extended-release). A fixed threshold like 80% or 95% is not sufficient on its own, because it does not account for differences in dose strength and potency. Performance standards should instead be based on product-specific data, ensuring minimal to no active drug remains accessible after use.

2. Time required for inactivation: Inactivation should occur as quickly as feasible based on product performance, but current evidence does not support very short timelines like 2 hours. Available data suggest that substantial inactivation can occur within several hours, with further reduction over time (~28 days) (National Academies, 2024; Gao et al., 2018). However, longer timeframes increase the window during which opioids may still be accessible.

  • Require evidence-based time-to-inactivation standards, based on actual product performance
  • Require clear labeling so users understand how long the drug remains active and how to handle the system during that time.

3. Susceptibility to manipulation after use: Disposal systems must ensure that the drug cannot be recovered or reused after disposal, even under realistic household conditions. FDA should require testing against:

  • Common household solvents (e.g., water, alcohol)
  • Physical disruption (e.g., opening, crushing, dilution)

Again, fixed percentage thresholds (e.g., 50% or 75%) are less meaningful than ensuring that no clinically usable amount can be recovered, especially given variation in potency and dosage form.

4. Product design, safety, and usability: FDA should prioritize real-world safety and usability, not just lab performance.

  • Visibility of contents: There is currently no FDA requirement that disposal systems hide their contents, but this is an important safety gap. FDA has taken a related step by requiring manufacturers to provide prepaid mail-back envelopes, which are designed to be unmarked and opaque and allow patients to securely return unused opioids for destruction. However, in-home disposal systems do not have similar design standards. FDA should require use of opaque, fiber-based materials (e.g., coated paper or cardboard) that block visibility, along with plant-based or mineral-based binding agents (e.g., activated carbon or cellulose-based powders) that form a dark gel or solid mass when activated, making pills unrecognizable. These approaches can ensure that remaining opioids are not visible, recognizable, or retrievable while supporting more sustainable design.
  • Prevent accidental harm: Systems should reduce the drug to non-harmful, non-retrievable levels and include clear, standardized warnings (e.g., “Do not open after use”). Designs should seal permanently once activated to prevent exposure. While such deactivation systems already exist (e.g., activated carbon or chemical binding products), they are not currently required by FDA. The FDA should set minimum performance, labeling, and safety standards to ensure these products are consistently effective and safe for real-world use.
  • Practical safeguards to reduce unintended access: Standard child-resistant packaging does not prevent access by older children, adolescents, or others in the household, which is a common source of opioid diversion. Determined individuals can still access medications, particularly if they intend to remove only a few pills in a bottle. FDA should therefore prioritize feasible, incremental safeguards, such as improved tamper-evident packaging (e.g., breakable seals or shrink bands that visibly indicate access), enhanced child-resistant caps requiring two-step alignment or added force, and optional low-cost locking mechanisms like slide-lock or twist-lock sleeves that add an additional barrier to opening. These measures do not eliminate access but can increase effort, introduce visibility of prior access, and therefore reduce misuse, particularly in shared household settings. These are likely to be most useful when the patient and caregiver are provided with clear information about the need for safe storage, rather than relying on packaging alone to prevent misuse.
  • Ease of use: Instructions should be simple, clear, and plain language. Current guidance often includes multiple decision steps and relies on terms like “DEA website” and “FDA flush list,” which can be difficult for patients and families to understand and follow in real-world settings. FDA should require streamlined, step-by-step instructions with minimal decision points, supported by clear visuals and icons, and available in multiple languages to ensure accessibility for all users.
  • Robustness to user error: Systems should still work if used imperfectly since real-world use is inconsistent. FDA should require standardized performance testing under common misuse scenarios (e.g., overfilling, incorrect water use, incomplete activation) showing that the drug is still rendered non-retrievable under these conditions.

5. Additional considerations and supporting actions: Disposal systems alone will not solve the problem. While in-home disposal systems may reduce diversion of unused opioids, their impact will depend on prescribing patterns and how the disposal system is used in the real-world. FDA should prioritize practical, risk-based strategies:

  • Prioritize reducing excess prescribing and dispensing, as smaller quantities of unused opioids will directly reduce the need for disposal
  • Adopt a quantity- and risk-based approach to disposal requirements, prioritizing in-home disposal systems for higher pill counts or higher-risk formulations, while allowing simpler guidance (i.e.,  FDA-recommended flushing for select high-risk opioids) for small quantities where appropriate. Linking disposal requirements to quantity may also create an incentive for prescribers to issue smaller initial prescriptions, which is safer for patients and also reduces the amount of unused medication available for diversion or accidental exposure.
  • Support clear, simple, and consistent patient instructions (including when not to flush), rather than relying on complex or multi-step disposal systems and instructions.
  • Encourage pharmacy-based or community take-back programs, which are more established and do not depend on correct in-home use
  • Require basic usability and reliability standards for disposal systems, rather than extensive performance requirements that may increase cost without improving real-world effectiveness.
  • Expand take-back and mail-back programs, especially in underserved areas.
  • Require post-market evaluation to assess real-world effectiveness.

Evidence shows that even when disposal tools are provided, many patients still retain unused opioids (Lawrence et al., 2019). This highlights the need for system-level approaches, not just product requirements.

Respectfully,
National Center for Health Research
Washington, D.C. 

References:

  1. Bicket, M. C., Long, J. J., Pronovost, P. J., Alexander, G. C., & Wu, C. L. (2017). Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA surgery, 152(11), 1066–1071. https://doi.org/10.1001/jamasurg.2017.0831
  2. Stubbings, J., Crawford, S. Y., & Menighan, T. E. (2022). A safe in-home disposal system with every opioid prescription? Food and Drug Administration is considering a potential new Risk Evaluation and Mitigation Strategy that could impact pharmacists. Journal of the American Pharmacists Association, 62(2), 413-418.
  3. Substance Abuse and Mental Health Services Administration. (2017). How people obtain the prescription pain relievers they misuse. https://www.samhsa.gov/data/sites/default/files/report_2686/ShortReport-2686.html
  4. Lawrence, A. E., Carsel, A. J., Leonhart, K. L., Richards, H. W., Harbaugh, C. M., Waljee, J. F., … & Cooper, J. N. (2019). Effect of drug disposal bag provision on proper disposal of unused opioids by families of pediatric surgical patients: a randomized clinical trial. JAMA pediatrics, 173(8), e191695.
  5. National Academies of Sciences, Engineering, and Medicine. 2024. Defining and Evaluating In-Home Drug Disposal Systems For Opioid Analgesics: Proceedings of a Workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/894.
  6. Gao, X., Bakshi, P., Sunkara Ganti, S., Manian, M., Korey, A., Fowler, W., & Banga, A. K. (2018). Evaluation of an activated carbon-based deactivation system for the disposal of highly abused opioid medications. Drug development and industrial pharmacy, 44(1), 125–134. https://doi.org/10.1080/03639045.2017.1386199
  7. FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. (2023). https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-use
  8. U.S. Food and Drug Administration. 2024. Disposal of unused medicines: What you should know. https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know
  9. https://store.sharpsinc.com/Rx-DESTROYER-1-Gallon-Starter-Kit-Lockbox
  10. Leishman, E., Wang, Y., Channu, R. et al. Development and implementation of SafeMedWaste, a chemical denaturant for non-hazardous disposal of controlled medications. Sci Rep 11, 1129 (2021). https://doi.org/10.1038/s41598-020-80388-w
  11. U.S. Food and Drug Administration. 2023. FDA moves forward with mail-back envelopes for opioid analgesics dispensed in outpatient settings . https://www.fda.gov/news-events/press-announcements/fda-moves-forward-mail-back-envelopes-opioid-analgesics-dispensed-outpatient-settings