Notice2026-04479
Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments
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Published
March 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to solicit public comment on what specifications for in-home disposal systems, if application holders are required to make them available under the Opioid Analgesic Risk Evaluation and Mitigation Strategy, would be necessary to show that these systems may mitigate the serious risks of abuse or overdose involving these medications.
Full Text
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[Federal Register Volume 91, Number 44 (Friday, March 6, 2026)]
[Notices]
[Pages 11077-11081]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04479]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1001]
Developing Specifications for In-Home Disposal Systems for Opioid
Analgesics Dispensed in an Outpatient Setting; Establishment of a
Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the establishment of a docket to solicit public comment on
what specifications for in-home disposal systems, if application
holders are required to make them available under the Opioid Analgesic
Risk Evaluation and Mitigation Strategy, would be necessary to show
that these systems may mitigate the serious risks of abuse or overdose
involving these medications.
DATES: Submit either electronic or written comments by April 6, 2026.
ADDRESSES: FDA is establishing a docket for public comment on this
notice. The docket number is FDA-2026-N-1001. The docket will close on
April 6, 2026. Submit either electronic or written comments by April 6,
2026. Please note that late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before April 6,
2026. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of April 6,
2026. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the 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'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://
[[Page 11078]]
www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#c982a0a4abacbba5b0e785aca1bbafaca5ad89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="480321252a2d3a243166042d203a2e2d242c082e2c296620203b662f273e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Purpose of Notice
The Agency is currently considering exercising its authority to
require, through a Risk Evaluation and Mitigation Strategy (REMS), that
a drug be dispensed to certain patients with safe disposal packaging or
a safe disposal system (21 U.S.C. 355-1(e)(4)). Specifically, the
Agency is considering whether to further modify the Opioid Analgesic
(OA) REMS to require application holders of opioid analgesics dispensed
in outpatient settings to make in-home disposal systems available to
pharmacies and other outpatient dispensers. The purpose of this notice
is to seek public comment on what specifications would be necessary to
show that in-home disposal systems may mitigate the serious risks of
abuse or overdose involving these medications.
II. Background
A. Public Health Need
Despite latest trends indicating decreased prescribing of opioid
analgesics, abuse, misuse, accidental exposure, and overdose associated
with prescription opioid analgesics remain serious problems in the
United States. In 2024, prescription pain relievers, such as opioid
analgesics, remained the most common class of prescription drugs
misused (i.e., used in any way not directed by a doctor) in the United
States, with approximately 8.0 million people aged 12 years and older
reporting past-year misuse (Ref. 1). Patients commonly report having
unused opioid analgesics after treatment of acute pain, such as pain
following surgical procedures (Refs. 2, 3, 4 and 5). Patients who are
prescribed opioid analgesics to treat chronic pain may also have unused
opioids when changing opioid therapy (new opioid ingredient or tablet
strength), upon discontinuation of opioid therapy, or upon death.
Accordingly, removing unused opioids from a home is an important public
health intervention, and FDA's efforts to address the opioid crisis
include a focus on encouraging appropriate disposal of unused opioid
analgesics.
B. SUPPORT Act and REMS Authority
The Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L.
115-271), signed into law on October 24, 2018, provided FDA several new
authorities to address the opioid crisis. As enacted in 2018, section
505-1(e)(4)(B) of the Food, Drug, and Cosmetic Act (FD&C Act)
authorized FDA to require through a REMS that safe disposal packaging
or a safe disposal system for the purposes of rendering the drug non-
retrievable \1\ be dispensed to certain patients with opioids or other
drugs that pose a serious risk of abuse or overdose if, among other
conditions, FDA determines that such safe disposal packaging or system
may mitigate such risks and is sufficiently available (21 U.S.C. 355-
1(e)(4) (referencing 355-1(b)(1)(B) and (C))).\2\ In December 2022,
Congress removed the ``nonretrievable'' requirement, thereby expanding
the scope of potential disposal options available for FDA to require
through a REMS (Consolidated Appropriations Act, 2023, Pub. L. 117-
328). Subsequently, in late 2025, Congress reauthorized the SUPPORT Act
(the 2025 SUPPORT Act Reauthorization), which directs the Secretary of
Health and Human Services, in consultation with the Drug Enforcement
Administration, to publish guidance to facilitate the use of in-home
safe disposal systems for applicable drugs (SUPPORT for Patients and
Communities Reauthorization Act, 2025, Pub. L. 119-44).
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\1\ Under the SUPPORT Act, nonretrievable was defined with an
explicit cross-reference to a Drug Enforcement Agency (DEA)
regulation, 21 CFR 1300.05. (Pub. L. 115-271). That regulation
defines non-retrievable, in pertinent part, as: ``. . . the
condition or state to which a controlled substance shall be rendered
following a process that permanently alters that controlled
substance's physical or chemical condition or state through
irreversible means and thereby renders the controlled substance
unavailable and unusable for all practical purposes.'' 21 CFR
1300.05(b).
\2\ The Agency interprets the term abuse as the intentional,
non-therapeutic use of a drug, even once, for its desirable
psychological or physiological effects. We interpret the term
overdose to include fatal or non-fatal poisoning resulting from
accidental (e.g., in young children) or intentional exposure (e.g.,
in settings of abuse or therapeutic misuse) to opioid analgesics.
Though we recognize that certain language may perpetuate stigma and
negative bias toward individuals who use substances or who have
substance use disorders, we use abuse and overdose throughout this
notice to align with language in the FD&C Act.
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C. FDA Previously Exercised SUPPORT Act Authority
FDA previously exercised its SUPPORT Act authority to expand
disposal options through the OA REMS. When deciding whether to take
this action, FDA considered the opioid disposal options available at
the time and the impact and benefits of FDA requiring application
holders, through the OA REMS, to provide a safe disposal option when
those drugs are dispensed. The Agency solicited input from stakeholders
at multiple points during its evaluation, including through an April
21, 2022, Federal Register notice entitled ``Providing Mail-Back
Envelopes and Education on Safe Disposal With Opioid Analgesics
Dispensed in an Outpatient Setting; Establishment of a Public Docket;
Request for Comments'' (87 FR 23869) in which FDA solicited public
comment on a potential modification to the OA REMS to require
application holders of opioid analgesics dispensed in outpatient
settings to make available prepaid mail-back envelopes.
In April 2023, the FDA notified application holders of opioid
analgesics dispensed in outpatient settings that the OA REMS would
require them to make available prepaid mail-back envelopes to
outpatient pharmacies and other dispensers as an additional disposal
option for patients. FDA approved that REMS modification in October
2024. Beginning March 31, 2025, outpatient pharmacies and dispensers
could order prepaid mail-back envelopes from opioid analgesic
application holders, free of charge, which they then could provide to
patients prescribed opioid analgesics.
In choosing to require prepaid mail-back envelopes, the Agency
recognized that mail-back envelopes, in particular, are one disposal
option that has ``multiple favorable characteristics'' (87 FR 23872,
Apr. 21, 2022): First, mail-back envelopes are relatively simple to
use; their use involves fewer steps than in-home disposal systems, and,
unlike collection kiosks, many people can use them without leaving the
home. Second, mail-back envelopes are subject to longstanding, existing
federal regulation and oversight, administered by the U.S. Drug
Enforcement Administration (DEA) and United States Postal Service
(USPS), which requires that mail-back envelopes be nondescript, fit for
purpose, and be able to safely and
[[Page 11079]]
securely transport unused medicines from the patient's home to the
location where they will be destroyed (87 FR 23872 at 23872, Apr. 21,
2022); 21 CFR 1300.05(b), 1317.70, 1317.90. Last, ``unlike other
alternatives,'' the mail-back envelopes could meet the
nonretrievability requirement that was in place at the time because DEA
regulations require mail-back envelopes to be disposed of in a manner
that renders them ``non-retrievable'' (87 FR 23872. 87 FR at 23872,
Apr. 21, 2022). At the time of the modification, FDA expected (and
still expects) that the mail-back envelope modification to the OA REMS
provides patients with an added and underutilized safe disposal option
that complements and does not displace disposal options already
available outside of the REMS (87 FR 23872 at 23872 and 23870, Apr. 21,
2022).
The REMS modification also required OA REMS application holders to
create a new written educational document for patients about the risks
of unused opioid analgesics and the importance of their safe disposal
that is provided to the patient with each mail-back envelope. FDA
expects that any future modifications to the OA REMS to include
additional safe disposal systems would be operationalized the same way:
outpatient dispensers would have the ability to order mail-back
envelopes and/or in-home disposal systems, and an educational document
would accompany all disposal options.
III. Potential Further Modification to the OA REMS To Require In-Home
Disposal Systems
FDA is now considering whether to further modify the OA REMS, using
the same SUPPORT Act authority, to require that application holders
also make commercially available in-home disposal systems available to
outpatient pharmacies and other dispensers as an additional opioid
analgesic disposal option for patients. That analysis, currently
underway, includes consideration of the public health need for
additional opioid disposal options in the context of the ongoing opioid
crisis and any new data regarding the impact that provision of in-home
disposal options has on patients' opioid analgesic disposal behaviors.
Should FDA decide to require that commercially available in-home
disposal systems, in addition to mail-back envelopes, be made available
under the OA REMS, the Agency plans to set out certain specifications
for systems to meet REMS requirements. The opioid analgesic application
holders would then be required, pursuant to the REMS, to identify a
system or more than one system that meet those specifications and make
them available to patients in outpatient settings. For mail-back
envelopes, the OA REMS was modified to require application holders to
make available mail-back envelopes that meet specifications set out in
USPS and DEA regulations (as described above). In contrast, no federal
agency currently regulates in-home disposal systems for purposes of
disposing of opioid analgesics. Thus, FDA plans to identify appropriate
specifications for these systems.
The purpose of this notice is to seek input from the public on what
specifications of in-home disposal systems under the OA REMS would be
appropriate to show that these systems may mitigate the serious risk of
opioid analgesic abuse and/or overdose, considering all the relevant
factors that may affect these risks.\3\ These inputs will also inform
our implementation of the 2025 SUPPORT Act Reauthorization requirement
that the Secretary publish guidance to facilitate the use of in-home
safe disposal systems for applicable drugs.
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\3\ This notice is not soliciting input on how commercially
available in-home disposal systems should be regulated beyond FDA's
REMS authority.
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A. FDA's Current Recommendations for Opioid Analgesic Disposal
FDA primarily recommends disposing of opioids using a take-back
option (i.e., kiosks in pharmacies, take-back events, or mail-back
envelopes) (Ref. 6). If a take-back option is not readily available,
FDA currently recommends that most opioids be flushed down the toilet.
This recommendation differs from most other prescription drugs, which
FDA recommends disposing by mixing them with an unpalatable substance
and disposing of them in trash if a take-back option is not readily
available. There are 11 opioids on FDA's ``Flush List,'' which lists
those products that should be disposed of by flushing down the toilet.
(Ref. 6). FDA does not recommend that opioid analgesics on the Flush
List be disposed of in household trash because of their serious risk of
abuse and fatal overdose. Given that in-home disposal systems are
intended to be put in household trash, FDA's determination that these
systems may mitigate the serious risks of abuse and/or overdose would
therefore constitute a substantial change in FDA's recommendations for
disposal of opioid analgesics.
B. Information About These Systems Obtained Thus Far
FDA has undertaken multiple efforts to obtain information about in-
home disposal systems' capabilities and usability to inform a potential
further modification to the OA REMS.
First, in June 2021, FDA requested information from nine
commercially available in-home disposal system manufacturers to gain a
better understanding of how their systems work and what testing,
including validation studies, they had undertaken. In response to these
requests, FDA received some information from six of the manufacturers,
and a subset of the information was evaluated by an independent lab. It
remains challenging to validate data on in-home disposal systems
because there are no industry-wide agreed upon tests to evaluate in-
home disposal systems for their intended purpose of disposing of opioid
analgesics. Further, these systems use varying mechanisms to render the
opioid unavailable, adding another layer of complexity in evaluating
the submitted data.
Second, on April 4, 2023 (88 FR 19959), FDA issued a request for
public comment about in-home disposal systems and announced the June
2023 National Academies of Sciences, Engineering, and Medicines'
(NASEM) Forum on Drug Discovery, Development, and Translation public
workshop entitled ``Defining and Evaluating In-Home Disposal Systems
for Opioid Analgesics'' (``In-Home Disposal Systems for Opioid
Analgesics; Request for Information'') (Docket No. FDA-2023-N-0917).
The workshop featured invited experts to discuss the types of in-home
drug disposal options that could be used to remove unused opioid
analgesics from the home. The workshop included, among other things,
presentations about and a discussion of the scientific, behavioral, and
policy considerations for assessing the safety, use, and effectiveness
of in-home drug disposal systems (see <a href="https://www.nationalacademies.org/our-work/advancing-regulatory-science-for-defining-and-evaluating-in-home-safe-disposal-systems-a-workshop">https://www.nationalacademies.org/our-work/advancing-regulatory-science-for-defining-and-evaluating-in-home-safe-disposal-systems-a-workshop</a>).
Comments submitted to the docket and made at the NASEM meeting
identified some recommended assessments of these systems, including
evaluating whether they are capable of rendering opioid analgesics
sufficiently unavailable for abuse (assuming the in-home disposal
system is used according to instructions) or overdose. Comments
suggested that relevant specifications could include whether the system
[[Page 11080]]
changes the physical integrity of the drug formulation, renders the
active ingredient unusable, is non-toxic and non-hazardous, timely
deactivates the drug, and has an acceptable ease-of-use. Additionally,
some manufacturers of in-home disposal systems submitted data about
their in-home disposal systems to the docket.
Third, FDA reviewed the limited information available on real-world
use experiences with commercially available in-home disposal systems.
As discussed above, neither FDA nor any other federal agency regulates
these systems for purposes of disposing of opioid analgesics, and thus,
there are no requirements that in-home disposal system manufacturers or
any other party report adverse events or other problems associated with
use of these systems to FDA or any other agency. Nonetheless, available
information from U.S. poison center cases and social media posts
reflects some instances of accidental pediatric exposure to in-home
disposal systems (without mention of exposure to opioids or other
medications), as well as other exposures associated with unclear or
misunderstood directions or inadequate patient counseling (e.g.,
reports of patients who thought the disposal system was a separate
medication that should be ingested, it should be used as a vehicle to
administer a medication, or it could be ingested as an antidote to
counteract adverse effects associated with opioid medications) and
apparent system malfunction (e.g., bags not sealing appropriately and
foaming out before the bag could be resealed). When outcomes of such
instances were shared, they were generally minor in severity.
Finally, FDA has commissioned a study by the University of
Maryland-Baltimore (UMB) through the Center of Excellence in Regulatory
Science and Innovation (CERSI) to assess commercially available in-home
drug disposal products (``The Assessment of Commercially Available In-
Home Drug Disposal Products,'' available at <a href="https://www.fda.gov/science-research/advancing-regulatory-science/assessment-commercially-available-home-drug-disposal-products">https://www.fda.gov/science-research/advancing-regulatory-science/assessment-commercially-available-home-drug-disposal-products</a>). The overall goal of the project
is to gain an understanding of the mechanisms of action, ingredients,
safety, usability, and range of capabilities of commercially available
in-home drug disposal systems. The CERSI project will evaluate various
commercially available in-home disposal systems by testing them with
multiple opioid analgesics, including immediate-release and extended-
release formulations. Depending on each system's mechanism of action,
the system will be analyzed for its ability to inactivate, sequester,
and/or adsorb the opioid analgesic at various time intervals after the
drug is placed into the in-home disposal system, following the
manufacturer's instructions. The in-home disposal systems will also be
tested to determine if the opioid analgesic can be recovered from the
used disposal systems with commonly available household solvents such
as lemon juice or alcohol. Additionally, a human factors study will be
conducted to evaluate how users interact with a sample of commercially
available in-home disposal systems and assess if they can correctly and
safely use these systems. The results of the CERSI study will inform
the appropriate specifications for these systems.
C. Additional Information Needed To Support a Modification To Require
Safe In-Home Disposal Systems
Commercially available in-home disposal systems have differing
characteristics that may impact their ability to mitigate the serious
risks of opioid analgesic abuse and overdose. Although all in-home
disposal systems are intended to render opioids or other medications
safe for disposal in household trash, they vary in their mechanism of
action (e.g., carbon binding, chemical deactivation, sequestration),
formulation (powder in envelopes, liquids in bottles), instructions for
use, and the types and formulations of medications for which they can
be used. Thus, the Agency intends to consider the specific
characteristics of the disposal system to determine whether requiring
application holders make it available through the OA REMS may mitigate
a serious risk of abuse and/or overdose. Foremost, an in-home disposal
system's ability to mitigate those risks depends on the extent to which
it makes the opioid unavailable and the speed with which this occurs.
The risk of accidental pediatric exposure may also be impacted by a
disposal system's use of child-resistant packaging (recognizing that
most in-home disposal systems require removing the opioid medication
from its original, child-resistant packaging). In addition, if the used
disposal system package is readily identifiable or if the opioid
analgesic product can be readily identified within the used system
(e.g., because a prescription vial label identifies the contents or
because tablet or capsule imprint codes remain readable), there may be
a greater risk of attempted opioid retrieval from the system. These
factors take on further importance considering that a modification to
the OA REMS that promotes the use of in-home disposal systems would
likely result in an increased number of used systems with potentially
available opioid analgesics in household trash. Finally, in-home
disposal systems vary in the complexity of use (e.g., requiring the
addition of water to a certain level or of a certain temperature,
shaking for a specified period); if patients have difficulty using an
in-home disposal system correctly, the capability of the systems to
achieve their intended purpose may be adversely impacted or patients
may be harmed. All these factors may be relevant for the Agency to
consider when deciding whether to modify the OA REMS to require that
in-home disposal systems be made available as an additional safe
disposal option and, if so decided, what specifications should apply to
those systems.
IV. Questions for Comment
The Agency is seeking public input on the specifications in-home
disposal systems would need to meet in order for FDA to require OA
application holders to make these systems available under the REMS.
Please explain your rationale for your input.
1. What amount of an opioid product's active ingredient would an
in-home disposal system need to render unavailable, when used according
to the system's instructions? For example, should we require that the
system render at least 95% of the opioid unavailable? If not, would a
lower threshold, such as 80%, be acceptable?
<bullet> How does the variation in opioid product dosage strength,
dosage form, and potency affect this consideration?
2. What should be the maximum time for an in-home disposal system
to make the specified percentage of opioid product's active ingredient
unavailable? For example, would the threshold percentage contemplated
in Question 1 need to be achieved within 2 hours in order to minimize
the time the opioid is available for abuse and/or overdose? 8 hours? 24
hours?
3. Should FDA consider the in-home disposal system's susceptibility
to manipulation after it is used? If so, how should this be assessed?
For example, should FDA require that the opioid product's active
ingredient remain unavailable after manipulating the used in-home
disposal system with commonly available household solvents (e.g.,
alcohol, lemon juice)? If so, to what extent? For example, would 75% of
the opioid product's active ingredient need to remain unavailable?
Should it be higher, or would a lower threshold, such as 50%, be
acceptable?
[[Page 11081]]
<bullet> How does the variation in opioid product dosage strength,
dosage form, and potency affect this consideration?
4. How should we consider the following characteristics in
determining the specifications for any in-home disposal system?
<bullet> Whether, or the extent to which, it is apparent that the
used disposal system may contain opioids.
<bullet> The potential risks associated with accidental exposure to
the in-home disposal system (e.g., ingestion, skin/eye exposure,
inhalation). Consider difference in risk for adults, children, and
pets.
<bullet> Use of child-resistant packaging.
<bullet> User interface of an in-home disposal system: i.e., does
its design support safe and correct use of the system.
<bullet> Robustness in light of expected use error: i.e., does the
system still work sufficiently well in real world use scenarios, which
may include some reasonably anticipated use errors (e.g., overfilling,
incorrect water temperature, insufficient shaking).
5. Are there any other specifications FDA should require or
characteristics that FDA should consider? Discuss other actions FDA
could take in addition to, or in support of, an in-home disposal system
REMS requirement to increase safe disposal of unused opioid analgesics.
V. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some references may be available at the website address,
if listed. References without asterisks are available for viewing only
at the Dockets Management Staff. FDA has verified the web addresses, as
of the date this document publishes in the Federal Register, but
websites are subject to change over time.
1. * Substance Abuse and Mental Health Services Administration,
``Key Substance Use and Mental Health Indicators in the United
States: Results from the 2024 National Survey on Drug Use and
Health'' (HHS Publication No. PEP25-07-007, NSDUH Series H-60),
Center for Behavioral Health Statistics and Quality, Substance Abuse
and Mental Health Services Administration (2025), available at
<a href="https://www.samhsa.gov/data/sites/default/files/reports/rpt56287/2024-nsduh-annual-national/2024-nsduh-annual-national-html-071425-edited/2024-nsduh-annual-national.htm">https://www.samhsa.gov/data/sites/default/files/reports/rpt56287/2024-nsduh-annual-national/2024-nsduh-annual-national-html-071425-edited/2024-nsduh-annual-national.htm</a>.
2. Mallama, C.A., C. Greene, A.A. Alexandridis, et al., ``Patient-
Reported Opioid Analgesic Use After Discharge From Surgical
Procedures: A Systematic Review,'' Pain Medicine, vol. 23(1), pp.
22-29, 2022, <a href="https://doi.org/10.1093/pm/pnab244">https://doi.org/10.1093/pm/pnab244</a>.
3. Bicket, M.C., J.J. Long, P.J. Pronovost, et al., ``Prescription
Opioid Analgesics Commonly Unused After Surgery: A Systematic
Review,'' JAMA Surgery, vol. 152(11), pp. 1066-1071, 2017, <a href="https://doi.org/10.1001/jamasurg.2017.0831">https://doi.org/10.1001/jamasurg.2017.0831</a>.
4. Collins, C.L., K. England, SW Conrad, et al., ``Patient-Reported
Duration of Opioid Analgesic Use After Discharge from Surgical
Procedures or Other Types of Acute Pain: A Scoping Review,'' Pain
Medicine, vol. 26(9), pp. 503-514, 2025, <a href="https://doi.org/10.1093/pm/pnaf029">https://doi.org/10.1093/pm/pnaf029</a>.
5. Atwood, K., T. Shackleford, W. Lemons, et al., ``Post Discharge
Opioid Use After Total Hip and Total Knee Arthroplasty,''
Arthroplasty Today, vol. 7, 2021, pp. 126-129, <a href="https://doi.org/10.1016/j.artd.2020.12.021">https://doi.org/10.1016/j.artd.2020.12.021</a>.
6. * FDA, ``Disposal of Unused Medicines: What You Should Know--
Learn How to Dispose of Unused or Expired Drugs,'' accessed October
31, 2021, available at <a href="https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know">https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04479 Filed 3-5-26; 8:45 am]
BILLING CODE 4164-01-P
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