Medication Return, Donation, and Disposal
PDF Version of DQA 07-008
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Medication Return, Donation, and Disposal
This memo provides guidance with medication removal in assisted
living facilities, including Community Based Residential Facilities (CBRFs),
Adult Family Homes (AFHs), and Residential Care Apartment Complexes (RCACs).
In addition, this memo waives a portion of section HFS 83.33(3)(j), Wis.
Admin. Code, related to medication destruction.
Circumstances may arise in assisted living facilities that require
medications to be removed from the premises, e.g., medication order
changes, expired medications, adulterated or contaminated medications,
resident discharge, resident death, or other situations. The amount and
number of medications, the available options for removing these
medications, and concerns for the environment have led assisted living
facilities to seek guidance on how medications should be removed.
assisted living facilities have asked about outside sources picking up
medications for removal and how that should be handled. Although not
intended to be comprehensive, this memo provides some information and
options relating to removal of medications from assisted living
Rule and Compliance Guideline
Section HFS 83.33(3)(j), Wis. Admin. Code, addresses medication
destruction in CBRFs. It states:
HFS 83.33(3)(j) Destruction of medications.
- A resident's prescription medication shall be destroyed within 72
hours of a practitioner's order discontinuing its use, the resident's
discharge (unless the resident needs the medication at a new
location), the resident's death, loss of medication dosage form
integrity, removal of the medication from the medication package, or
the medication's expiration date.
- Records shall be kept of all medication returned to the pharmacy for
credit or destruction. Any medication not returned for credit or
destruction shall be destroyed in the facility and a record of the
destruction shall be witnessed, signed and dated by at least 2 of the
following: the administrator or designee, a registered nurse or a
pharmacist and one other employee.
Community Based Residential Facilities (CBRFs) that contract with
pharmacies or other companies to remove medications for the purpose of
credit, donation, or destruction may establish compliance with the HFS
83.33(3)(j) 72-hour requirement by either 1) removal of the medications
within 72 hours by the pharmacy or other company; OR 2) pending removal,
assuring that within 72 hours the medications are: a) physically separated
from other medications in current use in the facility; b) locked with
access limited the administrator or their designee; and c) readily subject
to reconciliation, auditing, or other monitoring to prevent diversion.
Medications requiring removal fall into three categories: 1)
Medications that can potentially be re-used or returned; 2) Medications
that cannot be re-used or returned; and 3) Controlled substances.
1. Medications that can be re-used or returned
Physician orders may be utilized to hold resident
medications that are temporarily
stopped and will potentially be
restarted for the same resident. This
process can eliminate some
medication destruction or returns.
Facilities can hold these
medications in facility storage as provided
by OQA Memo 05-003.
Return to pharmacy: Wisconsin pharmacy regulations under
Wis. Admin. Code, § Phar 7.04, allows medications to be returned from a
CBRF to a pharmacy for use by others where:
- The medication was never in the possession and control of the
- The medication was sold, distributed, or dispensed in a
tamper-resistant package, including the beyond-use date and
manufacturer's lot number;
- The health item is not commingled with a different health item; and
- The health item is in its original container, and the pharmacist
determines the contents are not adulterated or misbranded. (See
attachment section A for the complete text of Phar 7.04). This return
process may eliminate some medication waste.
Cancer/Chronic Disease Drug Repository: Newly promulgated
Wisconsin Administrative Code, Chapter HFS 148, created a mechanism for
usable medications to be donated to participating pharmacies. These
medications can potentially be used for individuals who do not have the
means to pay for medications. Information on the repository, including
participating providers, can be accessed at http://www.dhs.wisconsin.gov/bqaconsumer/cancerdrugreposy.htm.
An assisted living facility that has medications in a tamper-evident,
unit-dose package, e.g., blister or bubble pack, can contact one of the
participating pharmacies to determine if it will accept the medication. If
a participating pharmacy will accept the medication, the assisted living
facility can fill out a donation form and send the medication to that
Note: Many private insurance companies (and now Medicare Part D) do not
have a mechanism for pharmacies to credit the insurance plan for
medications that have been returned and will be used for other residents.
(Medicaid - other than Part D - continues to have a mechanism to accept
returns and credit.)
2. Medications that cannot be re-used or returned
- Generally, controlled substances cannot be returned to a pharmacy to
be used for other residents, per Federal Drug Enforcement
Administration (DEA) regulations. See controlled substance discussion
- Other medications that cannot be returned include expired
medications, adulterated or contaminated medications, and medications
which legally cannot be accepted for return or donated for further
use. See Wis. Admin. Code § Phar 7.04.
3. Controlled Substances
- Controlled substances can only be in the possession of Drug
Enforcement Administration (DEA) Registrants, law enforcement, and
consumers (assisted living residents) who have a prescription for the
controlled substance or the facility where the residents are residing.
Typically, physicians, pharmacies, and hospital are DEA registrants.
- Federal law currently prohibits controlled substances to be returned
from a non-DEA registrant, such as a resident in an assisted living
facility, to a DEA registrant, such as a pharmacy. Therefore, all
controlled substances need to be destroyed. (See Section D Appendix).
Disposal of Medication Waste
Medication waste generally falls into one of three regulatory
categories: hazardous waste, infectious waste (commonly called
biohazardous waste), and solid waste. All waste generators that are
businesses and institutions, including assisted living facilities, are
responsible for separating their wastes into the correct regulatory
categories and ensuring proper disposal.
- You may return medications to the resident or his/her family for
disposal. Residents or family may then take the medications to a
pharmaceutical collection under the household hazardous waste
exemption. (See Section B Appendix).
- If the assisted living facility assumes responsibility for disposing
of medications, solid and hazardous waste regulations DO apply to the
- DO NOT flush medications. Destroying medications by placing them in
the sink or toilet and flushing them into the waste water is highly
discouraged, because waste water treatment plants do not remove
medications. Drug components can harm plants and animals that live
downstream. Furthermore, it may be illegal to flush certain hazardous
- DO NOT put medications in infectious waste containers. It is not
appropriate (nor is it cost-effective) to put medications, empty
medication bottles, or empty insulin or vaccine vials in sharps
containers or biohazard waste bags. Mixing non-infectious waste with
infectious waste is prohibited in Wisconsin. (See Section C Appendix).
It is no longer true that most infectious waste is incinerated;
typically these wastes are disinfected and put in a landfill instead.
While medications that are hazardous waste are regulated both by state
and federal regulations, Wisconsin has authority to run the federal
program in Wisconsin. (See Section B Appendix). Hazardous waste includes
items that are listed by name in the regulations, or exhibit
characteristics of hazardous waste. Common hazardous waste medications
include Epinephrine, Coumadin, vaccines preserved with Thimerosal, and
even certain shampoos and vitamins/minerals.
An estimated 5-15 percent of
medication waste may be hazardous waste. A reputable hazardous waste
hauler can help you separate these wastes. Please refer to Section B in
the Attachments to assist you in handling hazardous waste.
Health care products that are infectious waste are regulated by the
Wisconsin Department of Natural Resources. (See Section C Appendix). This
category includes sharps such as syringes and intravenous delivery devices
that can cut or puncture the skin.
If the needle can be detached from an
IV delivery device in accordance with worker safety regulations, only the
needle needs to be managed as infectious waste. In most cases, syringes
are empty after use. Please refer to Section C in the Attachments to
assist you in handling infectious waste.
Medications that are neither infectious nor hazardous are classified as
solid waste. Medications that are considered solid waste can generally be
handled like other garbage. A potential problem with disposal via general
garbage is that medications can pose safety risks to individuals who
inappropriately access the garbage and expose themselves to the
In addition, medications that go to a landfill may leach to
the groundwater system or be extracted and taken through a wastewater
treatment plant. Therefore, DNR recommends that solid waste medications be
routed to a licensed municipal solid waste incinerator or hazardous waste
The preferred practice is to have a waste hauler take medications to a
medical waste or hazardous waste incinerator. The solid waste hauler may
have appropriate containers and specific procedures for disposing of
medications. If that method of disposal isn't available, place the
medications in a container that can be sealed. Add a small amount of water
to the medication to make a slurry. Add cat litter, plaster of paris, or
some other absorbent material to the slurry. Finally, seal the container
and place the container in the garbage. Remove or obliterate any labels
identifying the container as containing medications. See Section D for
links to federal guidance on this process.
It is very likely that medication containers contain personal health
information (PHI). It is the responsibility of a CBRF to assess risks of
privacy disclosures associated with medication disposal, and the facility
should implement security policies and procedures that will provide a
reasonable level of safeguards to protect the privacy of their residents.
If there are any questions related to medication removal, please
contact Doug Englebert at 608-266-5388.
Section A - Pharmacy Returns
Section B - Hazardous Waste
Section C - Infectious Waste and Trace Chemotherapy Waste
Section D - Drug Enforcement Adminstration
Section A-Pharmacy Returns
Phar 7.04 Return or exchange of health items.
(1) In this section:
(a) " Health item" means drugs, devices,
syringes, needles or other
objects for injecting a drug,
medicines, or items of
(b) " Inpatient health care facility" means any hospital,
nursing home, county home, county
tuberculosis sanitarium or similar
facility, but does not
include community-based residential
facilities, jails or
(c) " Original container" means the container in which a
health item was sold, distributed or dispensed.
(d) Resident health care patient" means a patient
a community-based residential
facility that controls a
resident's prescribed and
as specified by s. HFS 83.33 (3)
(e) Secured institutional health care patient" means any of
1. A jail inmate patient whose dispensed health
maintained under the custody and
control of the jail
pursuant to an approved policy and
under s. DOC 350.17, containing
procedures for the control and
medications complying with s. DOC
2. A juvenile patient who resides in a secured
facility, as defined in s. 938.02 (15m),
Stats.; a secured
child caring institution, as defined in s.
Stats.; a secured group home, as defined in s.
(15p), Stats.; a secured detention facility, as
defined in s.
938.02 (16), Stats.; or a juvenile portion of a
whose dispensed health items are maintained
custody and control of the health services staff as
in s. DOC 316.02 (6) and provided to a juvenile
under the provisions of s. DOC 316.03.
Note: Section 938.02 (15m), Stats., was renumbered
938.02 (10p), Stats., by 2005 Wis. Act 344 and the term
"secured correctional facility" was changed to
correctional facility". Section 938.02 (15p), Stats.,
repealed by 2005 Wis. Act 344. Section 938.02 (16),
Stats., was renumbered to s. 938.02 (10r), Stats., and
"secure detention facility" was changed to
detention facility" by 2005 Wis. Act 344.
(f) "Tamper - resistant package" means a container bearing a
beyond-use date that is sealed so that the contents cannot be
obvious destruction of the seal.
(2) No health items, after being taken from a pharmacy where sold,
distributed or dispensed, may be returned
to that pharmacy, except
for any of the following:
(a) From an inpatient health care facility, provided they
in their original containers,
and the pharmacist
determines the contents are
not adulterated or
(b) Where the health items were dispensed in error, were
defective, adulterated, misbranded,
beyond their beyond-use date.
(c) When in the professional judgment of the pharmacist,
substantial harm could result to
the public or a patient if
they were to remain in the
possession of the patient,
patient's family or agent, or other
(d) For a secured institutional health care patient or resident
health care patient where all of the
1. The health item was never in the possession and control of
2. The health item was sold, distributed or dispensed in a
tamper - resistant package and, for a drug,
beyond use date and manufacturer's lot number;
3. The health item is not commingled with a different health
item unless the health item will be repackaged
redispensed to the same patient; and
4. The health item is in its original container and the
pharmacist determines the contents are not
(e) A health item that is prepackaged for consumer use and
labeled in compliance with all applicable
state and federal
laws where all of the following apply:
1. The pharmacist determines that the original package is
sealed and intact and that package labeling is
2. The pharmacist determines the contents are not
(3) Health items returned to a pharmacy, pursuant to sub. (2) (b) and
may not be sold, resold, or repackaged and
sold or resold, given
away, or otherwise distributed or
dispensed. Returned health items
shall either be destroyed at the pharmacy
or delivered for destruction
or other disposal by an authorized person
(3m) Health items returned from a secured
institutional health care
patient to a pharmacy, pursuant to sub. (2) (d),
must be segregated in
the pharmacy and may not be sold, resold, or
repackaged and sold or
resold, given away, or otherwise sold,
distributed or re-dispensed
other than to a secured institutional health care
(4) It is not a ''return" for a patient or agent of a patient to
previously dispensed drug or device to a
pharmacy for the purpose of
repackaging and relabeling of that
previously dispensed drug or
device, and subsequent return of the drug or
device for the same
Note: The DEA does not permit the return of
controlled substances to
a pharmacy from a non?DEA registrant under any
(5) It is not a "return" for a patient or agent of a patient
to deliver a
previously dispensed drug or device to a pharmacy
for the purpose of
destruction at the pharmacy or other disposal by
an authorized person
Note: A prescription drug that is returned to
a pharmacy that primarily
serves patients confined in a state prison is not
addressed in this rule.
Such a drug may be redispensed to a patient in a
provided the requirements of s. 450.09 (7m),
Stats., are satisfied.
History: Cr. Register, January, 1983, No. 325,
eff. 2?1?83; am.
Register, August, 1991, No. 428, eff. 9?1?91; r.
and recr., Register,
December, 1998, No. 516, eff. 1?1?99; CR 05?029:
cr. (1) (c) to (f),
(2) (d) and (e), (3m) and (5), am. (2) (intro.)
and (b) Register
December 2005 No, 600, eff. 1?1?06.
Section B-Hazardous Waste
Hazardous Waste contacts and rules can be accessed at http://dnr.wi.gov/org/aw/wm/hazard/.
A publication regarding disposal of vaccines includes information about
how to use the state contractor to dispose of hazardous wastes. There are
also publications regarding household pharmaceutical waste.
General information about hazardous waste in healthcare, based on the
federal regulations, is offered by Hospitals for a Healthy Environment
(H2E), an environmental resource highly recommended for all healthcare
H2E's information about pharmaceutical disposal is at http://cms.h2e-online.org/ee/hazmat/
Some other hazardous waste websites that may be helpful include:
Section C-Infectious Waste and Trace Chemotherapy Waste
Infectious waste information can be accessed at: http://dnr.wi.gov/org/aw/wm/medinf/.
One DNR publication that includes basic information is entitled: "For
Generators of Small Amounts." Larger facilities should review
"Medical Waste Reduction and the Annual Report."
Infectious waste regulations are mostly found in Wis. Admin. Code ch.
Trace chemotherapy waste is regulated under Wis. Admin. Code § NR
Section D-Drug Enforcement Administration
Office of National Drug Control Policy on destruction of medication:
Drug Enforcement Administration Frequently Asked Questions: http://www.deadiversion.usdoj.gov/faq/general.htm
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