BILL ANALYSIS Ó
SB 1229
Page 1
SENATE THIRD READING
SB
1229 (Jackson and Stone)
As Amended June 27, 2016
Majority vote
SENATE VOTE: 39-0
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|Committee |Votes|Ayes |Noes |
| | | | |
| | | | |
| | | | |
|----------------+-----+----------------------+--------------------|
|Judiciary |9-0 |Mark Stone, Wagner, | |
| | |Alejo, Chau, Chiu, | |
| | |Gallagher, | |
| | | | |
| | | | |
| | |Cristina Garcia, | |
| | |Holden, Maienschein | |
| | | | |
| | | | |
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SUMMARY: Provides qualified immunity from civil and criminal
liability of participating entities that take reasonable care to
ensure the health and safety of consumers and employees when
maintaining secure drug take-back bins on their premises.
Specifically, this bill:
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1)Defines the term "collector" to include only those entities
authorized by and registered with the federal Drug Enforcement
Administration (DEA) to receive a controlled substance for the
purpose of destruction, if the entity is in good standing with
any applicable licensing authority.
2)Provides that a collector must do all of the following in
order to receive qualified civil or criminal immunity from
liability:
a) 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.
b) 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 DEA.
c) Ensure that the secure drug take-back bin is placed in a
location that is regularly monitored by employees of the
registered collector.
d) 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.
e) Ensure that public access to the secure drug take-back
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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.
f) Regularly inspect the area surrounding the secure drug
take-back bin for potential tampering or diversion, and
maintain certain records and logs for at least two years,
in writing or electronic form, that may be used to
demonstrate regular inspection of the area.
g) Notify local law enforcement authorities of any
suspected or known tampering, theft, or significant loss of
controlled substances within one business day of discovery.
h) Notify local law enforcement as to any decision to
discontinue its voluntary collection of controlled
substances, as specified.
3)Provides that a collector that maintains a secure drug
take-back bin, in good faith and not for compensation, shall
not be liable in a civil action, or be subject to criminal
prosecution, for any injury or harm that results from the
collector maintaining a
secure drug take-back bin on its premises, provided that the
collector, not for compensation, acts in good faith to take
all of the steps specified in 2) above. This does not apply
if the injury or harm results from the collector's gross
negligence or willful and wanton misconduct
4)Clarifies that the terms and conditions specified in 2) shall
be construed in a manner consistent with the requirements
imposed by the DEA's final rule governing the secure disposal
of controlled substances pursuant to 79 Federal Regulation
53519-70 and any regulations promulgated by the state of
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California.
5)Provides that nothing in this bill 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 premises.
FISCAL EFFECT: None.
COMMENTS: This bill, sponsored by the California Product
Stewardship Council (CPSC), seeks to encourage pharmacies and
other authorized entities to voluntarily maintain secure drug
take-back receptacles on their premises where their customers
and others can come to safely dispose of unused or expired
medications. To incentivize more of these take-back receptacles
to be introduced in California, this bill attempts to alleviate
the civil liability concerns that are reportedly an obstacle to
greater voluntary participation in this growing movement to
reduce improper disposal of prescription drugs. Specifically,
the bill provides qualified immunity to entities that meet
certain eligibility conditions and that act to comply with
specified requirements, reflected in recent federal DEA
regulations, that seek to ensure public health and safety as
well as the proper disposal of the pharmaceutical waste
collected.
In explaining the compelling need for this bill, the author
states:
Home-generated pharmaceutical waste (i.e., prescription
or 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
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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 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; and 2)
providing limited civil and criminal liability immunity
for pharmacies hosting drug take-back bins if they meet
that duty of care.
By offering qualified immunity from liability for maintaining a
secure collection bin, this bill seeks to encourage more
pharmacies and other authorized entities to voluntarily
participate in secure drug-take back programs. Generally
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speaking, current law holds every person 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. (Civil Code
Section 1714 (a).) However, the Legislature has authorized
qualified immunity from civil liability in order to promote good
public policy and actions that benefit the public generally.
The public policy goal of qualified immunity is to encourage a
person or entity to undertake an activity or responsibility that
the person or entity would otherwise not be compensated,
required or willing to do (as a duty of employment or a
professional standard of conduct, for example) because the act
would be beneficial to the public interest. For instance, in
order to encourage persons to render potentially lifesaving care
in medical emergencies, California law provides qualified
immunities to lay persons who use an automated external
defibrillator (AED) device in emergency situations (Civil Code
Section 1714.21) and to those laypersons who administer opioid
antagonist medication to persons experiencing an opioid overdose
(Civil Code Section 1714.23).
As previously discussed, this bill is intended to further the
laudable public policy of reducing prescription drug abuse and
protecting water quality from home-generated pharmaceutical
waste by encouraging pharmacies to voluntarily set up and
maintain a drug take-back receptacle for their patients,
something they are otherwise not required to do. According to
the author, to further these policy goals it is necessary to
establish new qualified immunities because the threat of civil
liability (whether real or imagined) discourages pharmacies and
other entities from voluntarily maintaining secure drug
take-back receptacles. According to the California Pharmacists
Association:
[O]ne barrier discouraging independent pharmacies from
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hosting collection receptacles continues to be the fear
of the civil liability associated with doing so. A
pharmacy that tries to help patients by hosting a
collection receptacle and takes all the right steps to
ensure the safe and secure operation of that receptacle
should be confident that they will not be held civilly
liable for events outside of their control.
In order to incentivize more pharmacies to voluntarily set up
and maintain a drug take-back receptacle for their patients,
this bill would provide pharmacies and other authorized entities
with qualified liability protections, as specified, as long as
they comply with certain requirements for maintaining a secure
drug take-back receptacle.
Characteristics of the qualified immunity provisions and their
relationship to federal rules. The qualified immunity
provisions of this bill are limited with respect to who they
apply to and the conditions under which immunity becomes
available-in both cases respecting the need to observe federal
regulations governing the collection of controlled substances.
First, the immunity provisions only extend to pharmacies and
entities that qualify as authorized "collectors" under federal
DEA regulations. As defined by this bill, a collector must be
an entity authorized by and registered with the DEA to receive a
controlled substance for the purpose of destruction. Under
federal regulations, this can include registered manufacturers,
distributors, reverse distributors, narcotic treatment programs,
hospital or clinics with an on-site pharmacy, or retail
pharmacies that are so authorized and registered with the DEA.
In addition, because an entity would also have to be licensed in
California under state law whether or not it voluntarily
maintains a drug take-back bin, this bill also requires that a
collector be in good standing with any applicable state
licensing authority in order to qualify for these immunity
protections.
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Second, the bill's qualified immunity provisions only protect
the collector from liability if the collector, not for
compensation and acting in good faith, complies with a number of
specified requirements that operate 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. To qualify for immunity from liability, the
collector must, among other things: 1) 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; 2) ensure that the
secure drug take-back bin is placed in a location that is
regularly monitored by employees of the registered collector; 3)
ensure that public access to the secure drug take-back bin is
limited to hours in which employees of the registered collector
are present and able to monitor the operation of the secure drug
take-back bin; and 4) ensure that conspicuous signage is posted
on the secure drug take-back bin that clearly notifies customers
as to what controlled and noncontrolled substances are and are
not acceptable for deposit into the bin, as well as the hours
during which collection is allowed.
In addition to the above conditions, there are several
notification requirements that must also be followed in order to
obtain immunity. The collector must: 1) 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 DEA; 2) notify
local law enforcement of any suspected or known tampering,
theft, or significant loss of controlled substances, within one
business day of discovery, or, if the collector maintains daily
business hours, within one calendar day; and 3) notify local law
enforcement as to any decision to discontinue its voluntary
collection of controlled substances and provide documentation of
its written notification to the federal DEA's Registration Unit
as otherwise required under federal laws and regulations.
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Recent amendments to the bill clarify that the qualified
immunity provisions do not apply to gross negligence or willful
or wanton misconduct in either civil or criminal cases, and that
in such cases the collector shall not enjoy immunity from
liability for any injury or harm that results from the collector
maintaining the secure drug take-back bin.
Special requirement for collectors to maintain logs of
inspections. The bill requires that a collector regularly
inspect the area surrounding the secure drug take-back
receptacle for potential tampering or diversion-a safety
requirement that is also reflected in the DEA 2014 regulations.
Specific to this bill, according to the author, is a further
requirement that record logs of those inspections, reflecting
the date and time of the inspection, be maintained and retained
by the take-back program for two years. The bill also requires
retention of other records or reports mandated by federal or
state regulations for a minimum of two years, unless regulations
mandate a longer period. The bill provides that these logs
shall be maintained in writing or electronic form, may be
combined with logs required by state or federal regulations, and
may be used to demonstrate regular inspection of the area
surrounding the take-back receptacle. This last requirement may
be particularly useful to a collector seeking to claim immunity
in court pursuant to these provisions, because the logs could
help the collector prove it has complied with the minimum
requirements necessary to establish the qualified immunity
protections.
Analysis Prepared by:
Anthony Lew / JUD. / (916) 319-2334 FN: 0003546
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