BILL ANALYSIS �
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|Hearing Date:April 21, 2014 |Bill No:SB |
| |1014 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: SB 1014Author:Jackson
As Amended:April 21, 2014 Fiscal: Yes
SUBJECT: Pharmaceutical waste: home-generated.
SUMMARY: Establishes the Home-Generated Pharmaceutical Waste
Collection and Disposal Act to be administered by the Department of
Recycling and Recovery (CalRecycle) according to certain guidelines.
Authorizes a pharmacy to accept the return of home-generated
pharmaceutical waste (HGPW) from a consumer. Provides that HGPW under
a collection and disposal program is not medical waste.
NOTE: This bill was heard by the Senate Committee on Environmental
Quality on March 26, 2014 and passed 5-1. The bill has been
substantially amended since that hearing but still deals with the same
general subject matter of disposal of prescription drugs.
Existing law, the Business and Professions Code (BPC):
1) Establishes the Pharmacy Law which provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of dangerous
drugs or devices by the Board of Pharmacy (Board) within the DCA.
2) Defines reverse distributor as every person who acts as an agent
for pharmacies, drug wholesalers, manufacturers and other entities
by receiving, inventorying and managing the disposition of outdated
or nonsalable dangerous drugs. (BPC � 4040.5)
3) Establishes a licensure category under the authority of the Board
for a "surplus medication collection and distribution intermediary"
operating for the purpose of facilitating the donation of
medications to, or transfer of, medications between participating
entities under a county's unused medication repository and
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distribution program. (BPC � 4046)
4) Authorizes a pharmacy to accept the return of needles and syringes
from the public if contained in a sharps container (BPC � 4146)
Existing law, the Health and Safety Code (HSC):
1) Establishes the California Uniform Controlled Substances Act which
regulates controlled substances. (HSC � 11000 et seq.)
2) Defines drug as: (HSC � 11014)
a) Substances recognized as drugs in the official United States
Pharmacopoeia, official Homeopathic Pharmacopoeia of the United
States, or official National Formulary, or any supplement to any
of them.
b) Substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
animals.
c) Substances (other than food) intended to affect the structure
or any function of the body of man or animals.
3) Establishes the Medical Waste Management Act (MWMA) which regulates
the generation, handling, storage, transport, treatment, and
disposal of medical waste, as defined, overseen by the Department
of Public Health (DPH) and designated local agencies. (HSC �117600
et seq.)
4) Defines "household waste" as any material, including garbage,
trash, and sanitary wastes in septic tanks and medical waste that
is derived from households, farms, or ranches and does not include
trauma scene waste. (HSC � 117670)
5) Defines "home-generated sharps waste" as hypodermic needles, pen
needles, intravenous needles, lancets, and other devices that are
used to penetrate the skin for the delivery of medications derived
from a household, including a multifamily residence or household.
(HSC � 117671)
6) Defines "pharmaceuticals" as a prescription or over-the-counter
human or veterinary drug including, but not limited to, a drug as
defined in the Sherman Food, Drug and Cosmetic Law or the Federal
Food, Drug, and Cosmetic Act. "Pharmaceutical" does not include
any pharmaceutical that is regulated pursuant to the federal
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Resource Conservation and Recovery Act (RCRA) of 1976 (which
governs the management of solid and hazardous wastes) or the
Radiation Control Law. (HSC � 117747)
7) Defines "pharmaceutical waste" as any pharmaceutical that for any
reason may no longer be sold or dispensed for use as a drug and
excludes from this definition those pharmaceuticals that still have
potential value to the generator because they are being returned to
a reverse distributor for possible manufacturer credit. (HSC �
117748)
8) Specifies that waste comprised only of pharmaceuticals is
biohazardous, and is considered "medical waste." (HSC � 117635)
9) Requires all medical waste be transported to an offsite medical
waste treatment facility to be transported by a registered
hazardous waste transporter. (HSC �118000)
10)Establishes a voluntary drug repository and distribution program
(Program) for the purpose of distributing surplus medications to
persons in need of financial assistance to ensure access to
necessary pharmaceutical therapies. (HSC � 150200 et seq.)
Existing Law, the Public Resources Code (PRC):
1) Establishes the California Integrated Waste Management Act. (PRC �
40000 et seq.)
2) Requires pharmaceutical manufacturers that sell or distribute a
medication in California that is self-injected at home through the
use of a hypodermic needle, pen needle, intravenous needle, or any
other similar device to submit to CalRecycle a plan that describes
what actions, if any, the manufacturer supports for the safe
management of sharps waste.
(PRC � 47115)
This bill:
1) Establishes the Home-Generated Pharmaceutical Waste Collection and
Disposal Act.
2) Authorizes a pharmacy to accept the return of home-generated
pharmaceutical waste from a consumer.
3) Defines "Home-generated pharmaceutical waste" (HGPW) for the
purposes of the MWMA as a prescription or over-the-counter human or
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veterinary home-generated pharmaceutical, including, but not
limited to, a home-generated pharmaceutical as defined under
federal law that is waste derived from a household, including, but
not limited to, a multifamily residence or household.
4) Provides that medical waste does not include HGPW, including but
not limited to, consolidated HGPW, that is handled by a collection
and disposal program operating in accordance with regulations
adopted by the Department of Recycling and Recovery (CalRecycle).
5) Makes the following definitions in the Public Resources Code
related to HGPW collection and disposal:
a) "Consumer" is an individual purchaser or owner of a
pharmaceutical and does not include a business, corporation,
limited partnership or entity involved in a wholesale transaction
between a distributor and a retailer.
b) "Entity" is a state or local public agency, pharmacy
veterinarian clinic or other office or facility that provides
medical services.
c) "HGPW" means the same as above and includes all of the
following:
i) Articles recognized in the official United States
Pharmacopoeia, the official National Formulary, the official
Homeopathic Pharmacopeia of the United States or any
supplement of the formulary or those pharmacopoeias.
ii) Articles intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in humans or
other animals.
iii) Articles, excluding food, intended to affect the
structure or function of the body of humans or other
animals.
iv) Articles intended for use as a component of an
article specified above.
a) "Participant" is an entity that CalRecycle deems appropriate
for implementing and evaluating a program in accordance with
regulations and that chooses to participate.
b) "Sale" is, but is not limited to, transactions conducted
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through sales outlets, catalogs or the Internet, or any other
similar electronic means, but does not include a sale that is a
wholesale transaction with a distributor or retailer.
6)Requires CalRecycle to adopt regulations authorizing a Participant
to establish a program to collect and properly dispose of HGPW.
Specifies that the regulations be based upon the model guidelines
already developed by CalRecycle and require a Participant to do all
of the following:
a) Provide, at no additional cost to the consumer, for the safe
take back and proper disposal of the type or brand of
pharmaceuticals that the participant sells or previously sold.
b) Ensure the protection of the public health and safety, the
environment and the health and safety of consumers and employees.
c) Report to CalRecycle, for the purposes of evaluation, the
safety, efficiency, effectiveness and funding sustainability of
the implemented program.
d) Protect against the potential for the diversion of
pharmaceutical waste for unlawful use or sale.
e) Provide notices and materials to consumers that provide
information about the potential impacts of improper disposal of
HGPW and return opportunities for the proper disposal of HGPW
that include Internet Web site links, telephone numbers on an
invoice, information about opportunities and locations for
no-cost HGPW disposal, prominently displayed and easily visible
signage, written material provided to consumers at the time of
purchase or delivery, reference to the HPW take back
7)Requires the regulations to also do the following and authorizes
CalRecycle to revise the regulations if changes will ensure public
health and safety:
a) Specify the types of Participants authorized to maintain
permanent collection locations.
b) Establish requirements for obtaining local or state permits or
approvals.
c) Require Participants to enter into arrangements with medical
or hazardous waste haulers to ensure that all HGPW is
appropriately picked up and transported by registered waste
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haulers.
d) Specify which HGPW may be included in a program, including the
requirements for the collection of a controlled substance.
e) Specify methods for handling wastes commingled in containers
with other household or hazardous waste.
f) Provide methods for collecting and storing HGPW, including the
use of secured containers and ensure that collected HGPW is not
resold, reused, sold, donated or provided to anyone other than a
registered medical or hazardous waste hauler.
g) Provide that a facility that collects HGPW becomes the
generator of the waste and is responsible for ensuring that the
storage, removal and transportation of containers and the waste
are in compliance with state laws and regulations.
h) Require the collection and retention of detailed information
and invoices for each collection site.
i) Impose requirements for one-time or periodic collection
events.
j) Impose requirements for mail-back collection and disposal
programs.
aa) Include provisions for the appropriate management of HGPW to
ensure public health and safety.
8)Requires an Entity that participates in a HGPW program to comply
with the regulations, and provides that a Participant operating a
program in accordance with the regulations is in compliance with all
state laws and regulations related to the handling, management and
disposal of HGPW.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is co-sponsored by Alameda County , City and
County of San Francisco , California Alliance of Retired Americans ,
California Product Stewardship Council and Clean Water Action .
According to the Author, in response to the growing problem of
prescription drug abuse, accidental poisonings, and the detection
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of pharmaceutical products in California waters, local governments
throughout the state have struggled to establish safe and
convenient medication take-back programs. The Author states that
the public demand and need for such programs has been tremendous -
even limited programs have collected hundreds of pounds of drugs.
Law enforcement, federal agencies, public health and environmental
professionals agree that take-back programs are the safest way to
dispose of unused medicines. The Author notes that establishing
these disposal programs on a city by city basis is haphazard,
inefficient and expensive for local ratepayers. The Author states
that this approach means that not all consumers have access to
take-back locations, perpetuating a lack of harmonized messaging to
the public about safe drug disposal.
2. Pharmaceutical Waste Management and the Need for Take-Back. Laws
regulating the collection and disposal of pharmaceuticals are
present at the federal, state, and local levels. As reported by
CalRecycle in its 2010 report to the Legislature Recommendations
for Home-Generated Pharmaceutical Collection Programs in
California, there is no single federal or state agency that has
sole or ultimate authority for home-generated pharmaceutical waste
collection, consolidation, management, and disposal. Instead, the
federal Drug Enforcement Administration (DEA) and several
California state agencies (Department of Public Health (DPH), Board
of Pharmacy, and Department of Toxic Substances Control (DTSC)) all
have responsibility, sometimes overlapping, making it challenging
for local jurisdictions to develop and maintain effective
collection and management programs they know conform to legal
requirements.
Two federal laws currently control the regulation of
pharmaceuticals and their waste. Under the federal Food, Drug, and
Cosmetic Act, the Food and Drug Administration (FDA) is authorized
to oversee the safety of food, drugs, and cosmetics. Additionally,
under the Resource Conservation and Recovery Act (RCRA) of 1976,
the management of solid and hazardous wastes is regulated. This
results in strict protocols for the collection of controlled
substances to prevent their illegal diversion and abuse such that
only law enforcement officials can handle certain pharmaceutical
wastes. The federal Secure and Responsible Drug Act of 2010
outlined take-back disposal options for pharmaceutical waste,
including a requirement for DEA to promulgate regulations related
to the take-back of controlled substances. The draft regulations
would allow pharmacies to accept controlled substances for disposal
in particular circumstances and under particular conditions. In
early 2013, the DEA released these proposed regulation requirements
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for the take-back and destruction of controlled substances with
comments due by the end of February 2013; however, the DEA has not
yet released final regulation requirements.
There are growing concerns about the impact of drugs and
pharmaceutical waste based on improper disposal, which in turn
leads to contamination of water systems and inappropriate access by
potential abusers. The U.S. Geological Survey conducted a study in
2002, sampling 139 streams across 30 states and found that 80
percent had measurable concentrations of prescription and
nonprescription drugs, steroids, and reproductive hormones.
Exposure, even to low levels of pharmaceuticals, has been shown to
have negative effects on fish and other aquatic species and may
have negative effects on human health. Proper disposal is believed
to decrease the threat of these substances to the environment and
waterways. Proper disposal is also believed to decrease the
availability of expired and unused prescription drugs to abusers.
The guidelines for proper disposal of prescription drugs can be
confusing, lack uniformity throughout the state and nation, and are
cumbersome to the consumer. A February 2007 statement from the
Office of National Drug Control Policy states that unused, unneeded
or expired prescription drugs should be taken out of their original
containers and thrown in the trash or brought to take-back programs
that allow the public to bring unused drugs to a central location
for proper disposal. For example, the federal FDA highlights
certain drugs that should be flushed down a toilet, but the
organization also recommends a lengthy process for proper disposal
of the majority of prescriptions drugs, including mixing whole
tablets or capsules with an unpalatable substance such as kitty
litter or used coffee grounds then placing that mixture in a sealed
container before throwing it in household trash. The Board's
recommended process for disposal is similarly extensive and
requires even additional steps. Controlled substances can
currently only be returned to law enforcement agencies.
Take-back programs for medication disposal have risen in popularity
due to problems surrounding safe, accessible, easy disposal
options. These programs are seen as a good way to remove expired,
unwanted, or unused medicines from the home and reduce the chance
that others may accidentally take the medicine or it ends up being
flushed. In California, though, the MWMA currently requires
home-generated pharmaceutical waste to be managed as "medical
waste" which includes such material as infectious and biohazardous
waste and other types of waste that pose a potential harm to public
health and safety and the environment if not managed properly. The
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MWMA establishes rigorous management and tracking requirements for
medical waste; including requiring the use of hazardous or medical
waste haulers and strict manifesting requirements.
Many pharmacies and other retail establishments have expressed an
interest in providing collection opportunities for their customers
and while they are willing and able to provide safe and appropriate
collection, they do not want to become licensed medical waste
collectors. Concerns have been raised regarding the issue of theft
of HPW at collection points, including pharmacies. As pharmacies
have the responsibility of keeping the drug supply safe, it is
important that assurances are in place for drugs taken back at a
pharmacy to remain secure and not diverted to unauthorized users.
Similarly, expired or unused medications that have been dispensed
to a consumer must not re-enter the drug supply, to ensure quality
of products.
3. California's Model Guidelines for Take-Back. In 2007, the
Legislature passed SB 966 (Simitian, Chapter 542, Statutes of 2007)
which required CalRecycle's predecessor, the California Integrated
Waste Management Board (CIWMB), to develop, in consultation with
appropriate state, local, and federal agencies, model programs for
the collection and proper disposal of pharmaceutical drug waste.
Those guidelines were developed in consultation with a
pharmaceutical working group which included CIWMB staff, Board
staff and representatives from the Department of Public Health,
Department of Toxic Substances Control and State Water Resources
Board. The model programs include parameters for both permanent
and occasional take-back event collection sites and also include a
mail back component as an alternative to onsite collection. The
guidelines, "Criteria and Procedures for Model Home-Generated
Pharmaceutical Waste Collection and Disposal Programs" were adopted
by CIWMB in 2009 to provide consumers the ability to dispose of
unwanted prescription and over-the-counter drugs without flushing
them down the toilet or throwing them in the garbage (the
guidelines did not include controlled substances which must be
returned only to law enforcement). These guidelines are only
guidelines and not currently enforceable as standards.
According to the Board, any pharmacy that participates in a
voluntary take-back program is expected to use the guidelines when
offering the public the opportunity to return drugs. The Board
believes that the following should be particularly observed:
Drugs should not be reviewed personally by staff at a
collection site before being deposited into a secure collection
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bin and the patient or their agent should personally deposit
drugs into the bin as a means of preventing staff from knowing
what is being returned.
Drugs that are collected should be separated from their
containers by patients or their agents before being placed in
the collection bin, reducing the disposal costs because the
containers will not be part of the pharmaceutical waste weight.
There should be two separate locks on the secured
collection bins: one key should be in the possession of the
pharmacy and the other in the possession of the licensed waste
hauler who will pick up the waste. This permits each to serve
as a control for the other to help establish no one has entered
the collection container to retrieve drugs.
1. Take-Back in California. Absent a statewide program, many
consumers utilize dedicated, one-day take-back opportunities to
safely dispose of medications. These one-time events allow
individuals to dispose of prescription or non-prescription
medications which are taken to a safe disposal site after
collection. The DEA's seventh National Take-Back Day in October
2013 collected 324 tons of expired and unwanted medications
across all 50 states. Since the inception of the National
Take-Back Day in 2010, the DEA has collected over 3.4 million
pounds of medicine from circulation.
Between 2009 and 2010, CalRecycle identified 177 continuous
collection programs at pharmacies and law enforcement offices in
California. In that time, these programs collected more than
200,000 pounds of pharmaceuticals. San Francisco established a
Safe Medicine Disposal Pilot Program in 2012, allowing residents to
return pharmaceuticals (not including controlled substance) to 13
pharmacies via secured collection bins or any pharmaceuticals to
San Francisco police stations during business hours. As of October
2013, over 25,800 pounds of pharmaceuticals had been collected, 93%
of which was at the pharmacy locations. The Los Angeles County
Sheriff's Department launched their Safe Drug Drop-Off program in
September 2009 where drug disposal boxes are available 24 hours a
day, 365 days a year outside of sheriff's stations. A total of 21
drop-off locations have collected over 53,000 pounds of
prescription medication as of September 2013. Santa Clara County
currently has two county agencies that collect and safely dispose
of pharmaceuticals - the county Household Hazardous Waste Program,
which spends roughly $21,600 annually on the collection and
disposal of 7.2 tons of medication a year (1,200 pounds a month)
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and a program run by the county sheriff's office at 10 locations.
Annually, the program costs the county $41,600 for 10.8 tons of
collected and disposed medication. Alameda County passed a Safe
Drug Disposal Ordinance in 2012 that requires producers of covered
drugs (including both brand name and generic drugs) to operate
take-back programs after submitting a plan to the county's
Department of Environmental Health. Programs include the creation,
administration, promotion, and payment of the program (including
the payment of Alameda County's costs to administer and enforce the
Ordinance). CalRecycle reports that the average cost of current
take-back programs in California vary from $3-$7 a pound
2. Barriers to Broader Implementation of Take-Back. In
implementing take-back programs on a more broad scale throughout
the state, concerns still remain and there are only a small
number of pharmacies currently accepting drugs back from
consumers. Drugs are very heavily regulated throughout each step
of the supply chain and there are even a limited number of
options (all of which are also tightly regulated) for pharmacies
to remove drugs that have not been dispensed. For example, a
pharmacy can return unwanted drugs to the wholesaler the pharmacy
bought the drugs from provided the drug has not expired or been
recalled; wholesalers are Board licensees. Pharmacies can also
return outdated, nonsalable drugs that have not been dispensed to
a reverse distributor, also a Board licensee, for possible
manufacturer credit and destruction. Or pharmacies can provide
outdated, nonsalable drugs to licensed hazardous waste haulers.
With regards to mandatory take-back collection sites within
pharmacies, issues have been raised about the potential for
pharmacies to become recycling centers when they are a location
where health care is being provided. Pharmacies have also
expressed concerns over the past number of years that there may
not be the appropriate space needed for proper collection and
cite the costs associated with the appropriate handling of drug
waste.
The 2010 CalRecycle Report found that only about one-third of
existing programs in California meet the model guidelines and
highlighted a number of barriers. According to CalRecycle, law
enforcement programs can readily meet requirements for collecting
controlled substances, but the public may not be willing to bring
pharmaceutical wastes to police stations. Further, law enforcement
agencies themselves have higher resource allocation priorities.
Pharmacies are widespread and accessible, but they typically do not
meet all of the safety protocols (e.g., regarding collection bins
and security) delineated in guidelines. Household Hazardous Waste
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facilities also face similar issues as pharmacies, particularly
relative to safety, and are dependent on local government funding
support. Periodic collection events are somewhat easier to
implement for local governments and can accommodate large amounts of
materials in a short time, but are not as cost-effective as
continuous collection programs, often do not have safety protocols,
and are subject to local government budgetary constraints.
Mail-back programs can be convenient and safety is not a major
concern, but there are only three such programs in the state and a
high return rate is necessary for the method to be cost-effective.
Cal Recycle also noted the following as factors which make the model
guidelines difficult to meet:
The federal Controlled Substances Act requires
strict protocols for the collection of controlled substances
to prevent their illegal diversion and abuse and although
controlled substances represent only about 10 percent of
HGPW, the requirements for their safe management (e.g.,
requiring only law enforcement officials to handle them)
means most collection programs are costly.
The pending DEA regulations appear to address this barrier
highlighted by CalRecycle, as they would allow controlled
substances to be handled differently and not only by law
enforcement which is an integral component to the successful
development of drug take-back programs.
There is no clear statutory definition of HGPW, nor
is there an identified agency or department that has sole or
ultimate authority for HGPW collection, consolidation,
management, and disposal.
This bill appears to begin to address this barrier
highlighted by CalRecycle by defining HGPW and clarifying
that it is not medical waste.
There is a lack of funding, as local governments
currently fund more than 80 percent of collection programs
and pharmacies fund another 15 percent.
A number of different funding models have been proposed
through legislation and also imposed by other jurisdictions
to address the lack of funding for take-back programs. In
Alameda County, producers of drugs are required to operate
take-back programs, including the creation, administration,
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promotion, and payment for the program. In British
Columbia, manufacturers are required to pay for the cost of
a take-back program, not including agency oversight. Kings
County, Washington established an industry-funded product
stewardship model in 2013 to collect and safely dispose of
unwanted household medicines from residents of the county.
While there is no agreement on any single best practice for
funding continuous drug take-back programs, there appears to
be a continuously echoed sentiment that any successful
program should include a role for all players in the drug
supply chain who have a part in providing prescription drugs
to consumers. Assessing whether the specific role for
specific players is related to monetary contributions
through a regulatory fee or other forms of participation
shapes the core of current debates on this particular aspect
of implementing take-back programs.
1. Extended Producer Responsibility and Product Stewardship.
According to CalRecycle, Extended Producer Responsibility (EPR),
also known as Product Stewardship, is a strategy to place a
shared responsibility for end-of-life product management on the
producers, and all entities involved in the product chain,
instead of the general public, while encouraging product design
changes that minimize a negative impact on human health and the
environment at every stage of the product's lifecycle.
CalRecycle states that this allows the costs of treatment and
disposal to be incorporated into the total cost of a product and
places primary responsibility on the producer, or brand owner,
who makes design and marketing decisions. According to
CalRecycle, EPR also creates a setting for markets to emerge that
truly reflect the environmental impacts of a product, and to
which producers and consumers respond. Cal Recycle states that
EPR is a waste reduction strategy and that by shifting costs and
responsibilities of product discards to producers and others who
directly benefit, EPR provides an incentive to eliminate waste
and pollution through product design changes. Products in
California that are currently subject to an EPR-like framework
include mercury thermostats, paint, carpet and mattresses. There
have also been proposals related to batteries, fluorescent
lights, home-generated medical sharps and other consumer
products.
When introduced, this bill would have required a producer of a
pharmaceutical sold in this state, individually or through a
stewardship organization, to submit a stewardship plan to
CalRecycle by July 1, 2015, to provide for the development of a
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program to collect, transport, and dispose of home-generated
pharmaceutical waste that includes information on tracking,
education, placement in retail stores, and cost allocation. As
amended, the bill no longer requires the creation of a stewardship
plan and instead codifies the model guidelines adopted by
CalRecycle with input from various other entities.
2. Related Legislation This Session. SB 727 (Jackson) of 2013
would have created the Drug Abuse Prevention and Safe Disposal
Program stewardship program and required a producer of a
pharmaceutical sold in this state, individually or through a
stewardship organization, to submit a plan to CalRecycle by
January 1, 2015, to provide for the development of a program to
collect, transport, and process home-generated pharmaceutical
drugs. ( Status: The bill was not heard in a policy committee.)
AB 333 (Wieckowski) of 2013 would make various changes to the MWMA.
( Status: The bill is currently pending in the Senate
Environmental Quality Committee.)
AB 403 (Stone) of 2013 would have required businesses that sell
medical sharps to establish a product stewardship plan for the end
of life management of home-generated medial sharps. ( Status: The
bill was held under submission by the Assembly Committee on
Appropriations.)
AB 467 (Stone, Chapter 10, Statutes of 2014) created a licensure
category for a surplus medication collection and distribution
intermediary.
AB 1727 (Rodriguez) of 2014 would restrict certain pharmaceuticals
from county operated prescription drug collection and
redistribution programs. ( Status: This bill is currently pending
in the Assembly Committee on Health.)
AB 1893 (Stone and Eggman) of 2014 would require all sharps sold to
the general public in California to be sold with a sharps waste
container approved by DPH. ( Status: This bill is currently
pending in the Assembly Committee on Health.)
3. Prior Related Legislation. AB 1442 (Wieckowski, Chapter 689,
Statutes of 2012) defined pharmaceutical waste as any
pharmaceutical that may no longer be sold or dispensed, excluding
pharmaceuticals that could be returned to a reverse distributor
for possible manufacturer credit.
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SB 419 (Simitian) of 2011 required pharmaceutical manufacturers to
provide their annual reports on disposal of sharps waste to
CalRecycle electronically and make them readily available on their
websites. ( Status: The bill was vetoed by the Governor.)
SB 26 (Simitian) of 2009 would have defined HGPW and exempt it from
existing regulatory requirements for the handling of medical waste
and would have authorized pharmacies and other facilities to
collect HGPW, under specified conditions. ( Status: The bill was
amended to deal with a different topic and was not heard in a
policy committee.)
SB 486 (Simitian, Chapter 591, Statutes of 2009) required a
pharmaceutical manufacturer that sells or distributes a medication
that is self-injected at home through the use of a hypodermic
needle, pen needle, intravenous needle, or any other similar
devices to submit to the CIWMB, or its successor agency, a plan
that describes how the manufacturer supports the safe collection
and destruction of home-generated sharps waste.
SB 966 (Simitian, Chapter 542, Statutes of 2007) required CIWMB to
develop, in consultation with appropriate state, local, and federal
agencies, model programs for the collection and proper disposal of
pharmaceutical drug waste.
AB 501 (Swanson and Hancock) of 2007 would have required a
pharmaceutical manufacturer whose product is administered through a
syringe to provide a postage prepaid mail-back sharps container for
safe disposal of the used device, or storage and transport to a
sharps consolidation location. ( Status: The bill was vetoed by the
Governor.)
SB 1305 (Figueroa, Chapter 64, Statutes of 2006) prohibited a person
from knowingly placing home-generated sharps waste in commercial and
residential solid waste collection containers after September 1,
2008.
4. Arguments in Support. According to the California Alliance for
Retired Americans (CARA), many seniors fear that highly potent
and addictive drugs around the house could get into the wrong
hands and cite the lack of safe and convenient disposal options
for consumers that lead to less than desirable options like home
storage, flushing medications down the toilet or throwing them in
the garbage. CARA supports this bill along with a statewide,
long-term solution to providing a safe, convenient and secure
method of disposal for unwanted drugs in medicine cabinets.
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Californians for a Healthy and Green Economy and the Center for
Environmental Health note that the safe disposal of pharmaceutical
chemicals is crucial to protect the health of all Californians.
The California Product Stewardship Council (CPSC) believes that by
establishing standards on how to safely manage medication
collection in pharmacies through the model guidelines, we are
ensuring the safety of the return to system for medications at
pharmacies to prevent the illegal diversion of drugs and providing
protection for entities operating under these standards. CPSC
believes that with no consistent or convenient take-back option for
unwanted pharmaceuticals, the household medicine cabinet continues
to be a source that fuels the nation's prescription drug abuse
epidemic.
Clean Water Action and the Alameda County Board of Supervisors
support this bill, noting that model guidelines were developed
through a series of meetings with state agencies and stakeholders
and will help ensure that those who decide to conduct a voluntary
take-back program has good standards to follow to ensure the
protection of public health, safety and the environment while also
protecting against the potential for diversion of pharmaceutical
waste for unlawful use or sale.
SUPPORT AND OPPOSITION:
Support:
Alameda County Board of Supervisors
California Alliance for Retired Americans
California Product Stewardship Council
Californians for a Healthy and Green Economy
Center for Environmental Health
Clean Water Action
Support: (Received for prior version of the bill)
7th Generation Advisors
Alameda County Health Care Services
Alameda County Sheriff's Office
Ashland Cherryland Together
Association of Bay Area Governments
Breast Cancer Action
Butte County Office Of The Sheriff
Californians Against Waste
SB 1014
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California Alliance for Retired Americans
California Association of Environmental Health Administrators
California Association of Sanitation Agencies
California Nurses Association
California Police Chiefs Association Inc.
California Product Stewardship Council
California Resource Recovery Association
California Rural Legal Assistance Foundation
California School Employees Association
California State Association of Counties
California State Sheriff's Association
California Teamsters Public Affairs Council
California Water Environment Association
Center for Biological Diversity
Central California Alliance For Health
Central Contra Costa Sanitary District
Central Contra Costa Solid Waste Authority
City of Chula Vista Police Department
City of Chula Vista Office of the Mayor
City of Cotati
City of Covina
City of El Cerrito
City of Fortuna
City of Livermore
City of Los Altos
City of Menlo Park
City of Palo Alto
The City of Pleasanton
City of Porterville
City of Roseville
City of Sacramento
City of San Diego Environmental Services Department
City and County of San Francisco
City and County of San Francisco Police Department
City of San Jose
City of San Rafael
City of San Mateo
City of Millbrae
City of Santa Monica
City of Santa Rosa
City of Sunnyvale
City of Torrance
City of Ukiah
Clean Water Action
Clover Flat
Coalition for Safe Medication Disposal of Tompkins County, NY
SB 1014
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CommPre
Community Prevention Partners of Santa Cruz County
Community Water Center
Consumer Federation of California
Contra Costa County Board of Supervisors
County of Alameda
County of Los Angeles Public Health
County of Los Angeles
County of Marin Board of Supervisors
County of San Mateo Board of Supervisors
County of Santa Barbara
County of Santa Clara
County of Santa Cruz
Defenders of Wildlife
Delta Diablo
District Attorney Alameda County
Ecology Action
Ecology Center
East Bay Municipal Utility District
Eastern Municipal Water District
El Dorado Irrigation District
Environment California
Environmental Working Group
Goleta Sanitary District
Goleta West Sanitary District
Gray Panthers of San Francisco
Green Science Policy Institute
Heal the Bay
Health Officers Association of California
The Hope2gether Foundation
Hospice of Santa Cruz County
Las Gallinas Valley Sanitary District
Las Virgenes Municipal Water District
League of California Cities
League of Women Voters of California
Leucadia Wastewater District
Mammoth Community Water District
Marin County Hazardous and Solid Waste Management Joint Powers
Authority
Marin Sanitary Services
Mendocino Solid Waste Management Authority
The Metropolitan Water District of Southern California
Midway City Sanitary District
Mt. View Sanitary District
Monterey Regional Waste Management District
The National Association of Clean Water Agencies
SB 1014
Page 19
The North American Hazardous Materials Management Association
The National Coalition Against Prescription Drug Abuse
Napa County Board of Supervisors
National Resources Defense Council
Napa Sanitation District
Older Women's League
Pajaro Valley Community Health Trust
Pajaro Valley Water Management Agency
Palo Alto Medical Foundation
Pharmacists Planning Service, Inc.
Prescription Drug Abuse Prevention Coalition
Product Stewardship Institute
Physicians for Social Responsibility
Rural County Representatives of California
Regionalsan
Russian River Watershed Association
Sacramento State Student Health Services Pharmacy
Santa Cruz Desal Alternatives
San Francisco Water Power Sewer
Scotts Valley Police Department
Sierra Club of California
Sierra Club Foundation
Silicon Valley Clean Water
Shasta County Sheriff
Solid Waste Association
Sonoma County Waste Management Agency
Sonoma County Water Agency
Stege Sanitary District
Stopwaste
Tehama County
Teleosis Foundation
Town of Fairfax
Town of Windsor
United Long Term Care Workers
Upper Valley
UPSTREAM
Union Sanitary District
Vallejo Sanitation and Flood
Victor Valley Wastewater Reclamation Authority
Watsonville Pharmacy
West County Wastewater District
Western Placer Waste Management Authority
Women's Recovery Services
Multiple individuals
Opposition: (Received for prior version of the bill)
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Page 20
BayBio
BIOCOM
California Chamber of Commerce
California Healthcare Institute
California Manufacturers and Technology Association
California Medical Association
Civil Justice Association of California
Consumer Healthcare Products Association
Generic Pharmaceutical Association
Healthcare Distribution Management Association
Pharmaceutical Researchers and Manufacturers of America
TechNet
Consultant:Sarah Mason