BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1229|
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UNFINISHED BUSINESS
Bill No: SB 1229
Author: Jackson (D) and Stone (R)
Amended: 6/27/16
Vote: 21
SENATE JUDICIARY COMMITTEE: 6-0, 4/12/16
AYES: Jackson, Moorlach, Hertzberg, Leno, Monning, Wieckowski
NO VOTE RECORDED: Anderson
SENATE FLOOR: 39-0, 4/21/16
AYES: Allen, Anderson, Bates, Beall, Berryhill, Block,
Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hall,
Hancock, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson,
Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning,
Moorlach, Morrell, Nguyen, Nielsen, Pan, Pavley, Roth, Stone,
Vidak, Wieckowski, Wolk
NO VOTE RECORDED: Runner
ASSEMBLY FLOOR: 76-0, 8/4/16 - See last page for vote
SUBJECT: Home-generated pharmaceutical waste: secure drug
take-back bins
SOURCE: California Product Stewardship Council
DIGEST: This bill provides certain 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 any injury or harm that
results from a collector maintaining a secure drug take-back bin
on its premises, provided that the collector, not for
compensation, acts in good faith to take specified steps to
ensure the health and safety of consumers and employees and the
SB 1229
Page 2
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.
Assembly Amendments (1) clarify the gross negligence or willful
or wanton misconduct exception to the qualified immunity granted
to collectors who maintain a secure drug take-back bin; (2) add
to the findings and declarations that specified provision of the
bill shall be construed in a manner consistent with the
requirements imposed by state and federal regulations, as
specified; (3) clarify that the mandated record logs, for
purposes of the qualified immunity, shall be maintained in
writing or electronically, may be combined with logs required by
state or federal regulations, and may be used to demonstrate
regular inspection of the area; and (4) make other technical and
clarifying changes.
ANALYSIS:
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,
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maintenance, and other reasonable care requirements under the
Health and Safety Code, as specified. These requirements
include, for example, that the person or entity:
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; and
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.
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
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
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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 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
specified steps to ensure the health and safety of consumers
and employees and the proper disposal in the waste stream of
the home-generated 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:
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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.
"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.
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 Drug Enforcement Administration (DEA). 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
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accidental ingestion. (DEA, Final Rule, Disposal of Controlled
Substances (Sept. 9, 2014).) In 2010, the federal Secure and
Responsible Drug Disposal Act of 2010 (Disposal Act) was
enacted, amending the Controlled Substances Act to authorize
certain individuals ( "ultimate users" ) to deliver their
pharmaceutical controlled substances to another person for the
purpose of disposal in accordance with regulations promulgated
by the U.S. Attorney General.
Accordingly, in September of 2014, the DEA issued its final rule
implementing the Disposal Act and governing the secure disposal
of controlled substances by registrants and ultimate users.
Those regulations have expanded the options available to collect
controlled substances from ultimate users for the purpose of
disposal, including take-back events, mail-back programs, and
collection receptacle locations and, among other things, allow
authorized manufacturers, distributors, reverse distributors,
narcotic treatment programs, hospitals/clinics with an on-site
pharmacy, and retail pharmacies to voluntarily administer
mail-back programs and maintain collection receptacles (what
this bill refers to as "secure drug take-back bins"). (See id.)
While the changes to federal law are rather recent, there has
already been a significant push to increase the use and
availability of secure drug take-back programs both across the
nation and in this state. For example, one major retailer,
Walgreens, announced earlier this year that it has begun to
install safe medication disposal kiosks in more than 500
drugstores in 39 states and Washington, D.C. to make the
disposal of medications - including opioids and other controlled
substances - easier and more convenient while also helping to
reduce the misuse of medications and the rise in overdose
deaths. (Walgreens Press Release, Walgreens Leads Fight Against
Prescription Drug Abuse with New Programs to Help Curb Misuse of
Medications and the Rise in Overdose Deaths (Feb. 9, 2016)
Page 8
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 9
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. [ . . .] 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 limiting the
civil and criminal liability of pharmacies that maintain
secure drug take-back bins if they meet certain minimum
standards specified in the bill.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
SUPPORT: (Verified8/4/16)
California Product Stewardship Council (source)
AAA Advisory Council
Applied Pharmacy Solutions
California Alliance for Retired Americans
California Association of Environmental Health Administrators
California Association of Sanitation Agencies
California Medical Association
California Pharmacists Association
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California Special Districts Association
California State Association of Counties
California State Board of Pharmacy
California State PTA
Californians Against Waste
City of Palo Alto
City of Santa Barbara
City of Torrance
Clean Water Action
County Health Executives Association of California
County of Los Angeles Board of Supervisors
County of Los Angeles Department of Public Health
County of Riverside
County of Santa Barbara
League of California Cities
Los Angeles County Board of Supervisors
Los Angeles County Solid Waste Management Committee/Integrated
Waste Management Task Force
Medication Education and Disposal Safety Coalition
Napa Sanitation District
Research in Social Administrative Pharmacy
Sacramento State Student Health and Counseling Services Pharmacy
San Luis Obispo County Integrated Waste Management Authority
Sanitation Districts of Los Angeles County
Santa Clara County Board of Supervisors
Sierra Club California
Solid Waste Association of North America
Sonoma County Waste Management Authority
South Bay Cities Council of Governments
StopWaste
Summerland Sanitary District
OPPOSITION: (Verified8/4/16)
None received
ASSEMBLY FLOOR: 76-0, 8/4/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,
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Page 11
Calderon, Campos, Chau, Chiu, Chu, Cooper, Dababneh, Dahle,
Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina
Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,
Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,
Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk,
Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark
Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams,
Wood, Rendon
NO VOTE RECORDED: Chang, Chávez, Cooley, Roger Hernández
Prepared by:Ronak Daylami / JUD. / (916) 651-4113
8/5/16 10:17:51
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