BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1229|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
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THIRD READING
Bill No: SB 1229
Author: Jackson (D) and Stone (R)
Amended: 4/19/16
Vote: 21
SENATE JUDICIARY COMMITTEE: 6-0, 4/12/16
AYES: Jackson, Moorlach, Hertzberg, Leno, Monning, Wieckowski
NO VOTE RECORDED: Anderson
SUBJECT: Home-generated pharmaceutical waste: secure drug
take-back bins
SOURCE: California Product Stewardship Council
DIGEST: This bill provides specified collectors that are
authorized under federal law to engage in drug take-back
collection with limited protection from civil and criminal
liability (or "qualified immunity") for maintaining secure drug
take-back bins. Specifically, this bill provides that a
collector shall not be liable in a civil action, or subject to
criminal prosecution, for maintaining a secure drug take-back
bin on its premises if the collector, in good faith and not for
compensation, takes specified steps to ensure the health and
safety of consumers and employees and the proper disposal of the
home-generated pharmaceutical waste contained in the secure drug
take-back bin. This qualified immunity shall not apply in the
case of personal injury or wrongful death which results from the
collector's gross negligence or willful or wanton misconduct in
maintaining a secure drug take-back bin.
ANALYSIS:
SB 1229
Page 2
Existing law:
1)Provides that everyone is responsible, not only for the result
of his or her willful acts, but also for an injury occasioned
to another by his or her want of ordinary care or skill in the
management of his or her property or person, except so far as
the latter has, willfully or by want of ordinary care, brought
the injury upon himself or herself.
2)Provides that a person or entity that acquires an automatic
external defibrillator (AED) for emergency use is not liable
for any civil damages resulting from any acts or omissions
when the AED is used to render emergency care, provided that
the person or entity has complied with certain notice,
maintenance, and other reasonable care requirements under the
Health and Safety Code, as specified. These requirements
include that the person or entity must:
comply with all regulations governing the placement of
an AED;
notify an agent of the local EMS agency of the
existence, location, and type of AED acquired;
ensure that the AED is maintained and tested according
to the operation and maintenance guidelines set forth by
the manufacturer;
ensure that the AED is tested at least biannually and
after each use;
ensure that an inspection is made of all AEDs on the
premises at least every 90 days for potential issues
related to operability of the device, as specified; and
ensure, when an AED is placed in a building, that at
least once a year a demonstration is made to at least one
person associated with the building so that the person can
be walked through how to use an AED properly in an
emergency, and that instructions are posted next to the
AED, as specified, on how to use the AED.
1)Provides that the qualified immunities described above do not
apply in the case of personal injury or wrongful death which
results from the gross negligence or willful or wanton
misconduct of the person who uses the AED to render emergency
care.
2)Provides that a licensed health care provider who acts with
SB 1229
Page 3
reasonable care and issues a prescription for, or an order for
the administration of, an opioid antagonist to a person
experiencing or suspected of experiencing an opioid overdose
is not subject to professional review, liable in a civil
action, or subject to criminal prosecution for issuing the
prescription or order. Provides, further, that a person who
is not otherwise licensed to administer an opioid antagonist,
but who meets certain other conditions, is not subject to
professional review, liable in a civil action, or subject to
criminal prosecution for administering an opioid antagonist.
3)Provides that any prehospital emergency medical care person or
lay rescuer, as specified, who administers an epinephrine
auto-injector, in good faith and not for compensation, to
another person who appears to be experiencing anaphylaxis at
the scene of an emergency situation is not liable for any
civil damages resulting from his or her acts or omissions in
administering the epinephrine auto-injector, if that person
has complied with specified requirements of the Health and
Safety Code. Provides that this protection does not apply in a
case of personal injury or wrongful death that results from
the gross negligence or willful or wanton misconduct of the
person who renders emergency care treatment by the use of an
epinephrine auto-injector.
4)Provides that an authorizing physician and surgeon shall not
be subject to professional review, be liable in a civil
action, or be subject to criminal prosecution for the issuance
of a prescription or order to a qualified supervisor of health
or administrator at a school district, county office of
education, or charter school for epinephrine auto-injectors,
as specified, unless the physician and surgeon's issuance of
the prescription or order constitutes gross negligence or
willful or malicious conduct.
This bill:
1)Provides that any collector, as defined, that maintains a
secure drug take-back bin shall not be liable in a civil
action, or be subject to criminal prosecution, for maintaining
a secure drug take-back bin on its premises if the collector,
in good faith and not for compensation, takes specified steps
to ensure the health and safety of consumers and employees and
the proper disposal in the waste stream of the home-generated
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pharmaceutical waste contained in a secure drug take-back bin.
This immunity does not apply in a case of personal injury or
wrongful death which results from the collector's gross
negligence or willful or wanton misconduct in maintaining a
secure drug take-back bin.
2)Provides that a collector must do all of the following in
order to be subject to the qualified civil or criminal
immunity protections, above:
comply with all applicable state and federal laws and
regulations relating to the collection of home-generated
pharmaceutical waste for disposal in secure drug take-back
bins, including, but not limited to, the federal Secure and
Responsible Drug Disposal Act of 2010;
notify local law enforcement and any local environmental
health department as to the existence and location of any
secure drug take-back bin on the collector's premises and
the status of the collector's registration as a collector
with the federal Drug Enforcement Administration (DEA);
ensure that the secure drug take-back bin is placed in a
location that is regularly monitored by employees of the
registered collector;
ensure that conspicuous signage is posted on the secure
drug take-back bin that clearly notifies customers as to
what controlled and non-controlled substances are and are
not acceptable for deposit into the bin, as well as the
hours during which collection is allowed;
ensure that public access to the secure drug take-back
bin is limited to hours wherein employees of the registered
collector are present and able to monitor the operation of
the secure drug take-back bin;
regularly inspect the area surrounding the secure drug
take-back bin for potential tampering or diversion and
maintain certain records and logs, as specified;
notify local law enforcement authorities of any
suspected or known tampering, theft, or significant loss of
controlled substances within one business day of discovery,
unless the collector maintains daily business hours, in
which case the notification must be within one calendar
day; and
notify local law enforcement as to any decision to
discontinue its voluntary collection of controlled
substances, as specified.
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1)Provides that nothing in the above shall be construed to
require entities that may qualify as a collector to acquire,
maintain, or make available to the public a secure drug
take-back bin on its premise.
2)Defines various terms for these purposes. Specifically, among
other things:
"Collector" includes only those entities authorized by
and registered with the DEA to receive a controlled
substance for the purpose of destruction, if the entity is
in good standing with any applicable licensing authority.
"Compensation" means reimbursement or funds received
from a customer to compensate for the cost incurred in
obtaining, installing, or maintaining a secure drug
take-back bin. Compensation does not include reimbursement
or funds received from any other person or entity, other
than a customer, to compensate for the costs incurred in
obtaining, installing, or maintaining a secure drug
take-back bin.
"Home-generated pharmaceutical waste" means a
pharmaceutical that is no longer wanted or needed by the
consumer and includes any delivery system, such as pills,
liquids, and inhalers.
"Secure drug take-back bin" means a collection
receptacle as described in Section 1317.75 of Title 21 of
the Code of Federal Regulations.
1)Includes various findings and statements of legislative
intent.
Background
Prior to 2010, as a matter of federal law, individuals who
wanted to dispose of unused, unwanted, or expired pharmaceutical
controlled substances only had limited disposal options because
the federal Controlled Substances Act (21 U.S.C. Sec. 801 et
seq.) only permitted individuals to either destroy those
substances themselves (such as by flushing or discarding),
surrender them to law enforcement, or otherwise seek assistance
from the federal Drug Enforcement Administration (DEA).
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According to the DEA, these restrictions resulted in the
accumulation of pharmaceutical controlled substances in
household medicine cabinets that were available for abuse,
misuse, diversion, and accidental ingestion. (DEA, Final Rule,
Disposal of Controlled Substances (Sept. 9, 2014)
Page 7
leads-fight-against-prescription-drug-abuse-with-new-programs-to-
help-curb-misuse-of-medications-and-the-rise-in-overdose-deaths.h
tm (as of Apr. 3, 2016).)
Additionally, at least one state has already sought to
incentivize pharmacies to engage in similar activities.
Specifically, the state of Virginia recently enacted a law that
provides that no person that participates in a drug disposal
program shall be liable for any theft, robbery, or other
criminal act related to participation in the pharmacy drug
disposal program or for any acts of simple negligence in the
collection, storage, or destruction of prescription drugs
collected through such pharmacy drug disposal program, provided
that the pharmacy practice site is acting in good faith and in
accordance with applicable state and federal law and
regulations. (See Virginia's HB 629,
Page 8
over-the-counter human or veterinary drugs that are "left
over" from treatment or have expired), has become an
increasing problem nationwide and in California. With the rise
of prescription drug abuse, these excess drugs-often stored in
medicine cabinets or under sinks for years-have found their
way into recreational use by teens or are otherwise misused by
seniors or others. People taking un-prescribed or expired
drugs are creating a growing public health and safety risk.
Without a safe means of disposal, many people with excess
drugs are turning to throwing them in the trash or flushing
them in a toilet. This creates serious problems with soil and
water quality, especially since our water treatment plants are
not capable of removing pharmaceuticals from wastewater.
Law enforcement and pioneering pharmacies concerned with
public safety and environmental health have been hosting drug
take-back programs and bins voluntarily. These early efforts
are laudable, but the scope of these drug take-back options
has remained relatively small in relation to the demand for
convenient and safe disposal. Many pharmacies have raised
concerns regarding potential liability as the reason behind
their reluctance to host a drug take-back bin. [ . . . ]
In order to help protect the public from prescription drug
abuse and to protect water quality from home-generated
pharmaceutical waste, SB 1229 would encourage [other]
pharmacies to host secure drug take-back bins by:
1. Establishing a duty of care for the proper oversight of
secure drug take-back bins.
2. Providing limited civil and criminal liability immunity
for pharmacies hosting drug take-back bins if they meet
that duty of care.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
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SUPPORT: (Verified4/20/16)
Californians Against Waste
California Alliance for Retired Americans
California Association for Environmental Health Administrators
California State Association of Counties
California State PTA
City of Palo Alto
City of Torrance
Clean Water Action
County Health Executives Association of California
County of Riverside
League of California Cities
Los Angeles County Solid Waste Management Committee/Integrated
Waste Management Task Force
Medication Education and Disposal Safety Coalition
Napa Sanitation District
San Luis Obispo County Integrated Waste Management Authority
Santa Barbara County Board of Supervisors
Santa Clara County Board of Supervisors
Sierra Club California
StopWaste
Solid Waste Association of North America
Summerland Sanitary District Board of Directors
OPPOSITION: (Verified4/20/16)
None received
ARGUMENTS IN SUPPORT: Clean Water Action writes in support
of the bill:
[ . . . ] Pharmaceuticals provide a wealth of benefits to
public health. However, the reality is that both prescription
and over the counter drugs are often not used completely and
become out of date or unwanted. Advanced wastewater treatment
is not financially accessible to most California communities,
and even where it exists, it is not adequate to remove all of
the complex chemicals in medications. Consequently, when
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drugs are flushed down the toilet or thrown in the trash
(where they end up in groundwater or effluent that is later
put through the wastewater system), they enter our waterways
and drinking water supplies. The effects on wildlife are well
documented, including reproductive harm, negative behavioral
changes, and endocrine disruption.
While improper disposal has sobering environmental impacts,
Clean Water Action's members also recognize that without
convenient options, medications are often stockpiled in the
home, posing a growing threat to youth and the elderly who may
mistakenly misuse them. For this reason, pharmacies that
choose to host bins provide an important public service.
Again, SB 1229 ensures that such bins meet minimum standards
while providing these responsible retailers the assurance that
they too are protected from unreasonable liability. This is a
win-win for the public and for pharmacies.
Prepared by:Ronak Daylami / JUD. / (916) 651-4113
4/20/16 15:39:03
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