Amended in Assembly June 27, 2016

Amended in Assembly June 14, 2016

Amended in Senate April 19, 2016

Amended in Senate March 28, 2016

Senate Bill No. 1229

Introduced by Senators Jackson and Stone

February 18, 2016

An act to add Section 1714.24 to the Civil Code, relating to pharmaceutical waste.

LEGISLATIVE COUNSEL’S DIGEST

SB 1229, as amended, Jackson. Home-generated pharmaceutical waste: secure drug take-back bins.

Under existing law, the Medical Waste Management Act, the State Department of Public Health regulates the management and handling of medical waste, including pharmaceutical waste, as defined. The act generally prohibits a person from transporting, storing, treating, disposing, or causing the treatment of medical waste in a manner not authorized by the act. A violation of that provision is a crime.

Under existing law, everyone is generally 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.

This bill would provide that a collector, as defined, is not liable for civil damages, or subject to criminal prosecution, for begin insert any injury or harm that results from the collector end insert maintaining a secure drug take-back bin on its premises begin delete if end delete begin insert provided that end insert the collector, not for compensation, acts in good faith to take specified steps, including that the collector regularly inspects the area surrounding the secure drug take-back bin for potential tampering or diversion, to ensure the health and safety of consumers and employees and the proper disposal in the waste stream of home-generated pharmaceutical waste, as defined, contained in the bins.

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

(a) The Legislature finds and declares the
following:

(1) On October 12, 2010, the federal Secure and Responsible
Drug Disposal Act of 2010 (Public Law 111-273; hereafter referred
to as the Disposal Act) was enacted. Before the Disposal Act,
individuals who wanted to dispose of unused, unwanted, or expired
pharmaceutical controlled substances had limited disposal options.
The federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.;
hereafter referred to as the CSA) only permitted individuals to
destroy those substances themselves (e.g., by flushing or
discarding), surrender them to law enforcement, or seek assistance
from the federal Drug Enforcement Administration (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.
The Disposal Act amended the CSA to authorize specified
individuals, referred to as “ultimate users,” to deliver their
pharmaceutical controlled substances to another person for the
purpose of disposal in accordance with regulations promulgated
by the United States Attorney General.

(2) On September 9, 2014, the DEA issued its final rule
governing the secure disposal of controlled substances by
registrants and ultimate users. Those regulations implement the
Disposal Act by expanding 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. Those regulations, among other
things, allow authorized manufacturers, distributors, reverse
distributors, narcotic treatment programs, hospitals/clinics with
an onsite pharmacy, and retail pharmacies to voluntarily administer
mail-back programs and maintain collection receptacles.

(b) It is the intent of the Legislature, with the enactment of this
act, to do both of the following:

(1) Encourage the good faith participation of federally authorized
entities to maintain secure drug take-back bins on their premises
for the convenience and public health and safety of prescription
drug consumers and the proper disposal in the waste stream of the
pharmaceutical waste contained in the bins.

(2) Limit the civil and criminal liability of participating entities
that meet certain minimum standards and take reasonable care to
ensure the health and safety of consumers and employees when
maintaining secure drug take-back bins on their premises.

(c) The terms and conditions provided by subdivision (b) of
Section 1714.24 of the Civil Code, as added by this act, shall be
construed in a manner consistent with the requirements imposed
by the DEA’s final rule governing the secure disposal of controlled
substances (79 Fed. Reg. 53519-70 (September 9, 2014)) and any
regulations promulgated by the state.

SEC. 2.  

Section 1714.24 is added to the Civil Code, to read:

1714.24.  

(a) For purposes of this section, the following
definitions shall apply:

(1) “Collector” includes only those entities authorized by and
registered with the federal Drug Enforcement Administration to
receive a controlled substance for the purpose of destruction, if
the entity is in good standing with any applicable licensing
authority.

(2) “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.

(3) “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.

(4) “Maintains” includes owning, leasing, operating, or
otherwise hosting a secure drug take-back bin on the collector’s
premises.

(5) “Pharmaceutical” means a prescription or over-the-counter
human or veterinary drug, including, but not limited to, a drug as
defined in Section 109925 of the Health and Safety Code and
Section 321(g)(1) of Title 21 of the United States Code.
“Pharmaceutical” includes controlled substances included in
Schedule II, III, IV, or V of the California Uniform Controlled
Substances Act (Division 10 (commencing with Section 11000)
of the Health and Safety Code), but does not include a controlled
substance included in Schedule I.

(6) “Secure drug take-back bin” means a collection receptacle
as described in Section 1317.75 of Title 21 of the Code of Federal
Regulations.

(b) Any collector that maintains a secure drug take-back bin
shall not be liable in a civil action, or be subject to criminal
prosecution, for begin insert any injury or harm that results from the collector end insert
maintaining a secure drug take-back bin on its premises begin delete if end delete begin insert provided
that end insert the collector, not for compensation, acts in good faith to take
all of the following 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 begin delete bin: end delete begin insert bin, unless the injury or harm results
from the collector’s gross negligence or willful and wanton
misconduct: end insert

(1) Complies 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 (Public Law 111-273).

(2) Notifies 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.

(3) Ensures that the secure drug take-back bin is placed in a
location that is regularly monitored by employees of the registered
collector.

(4) Ensures 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.

(5) Ensures 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.

(6) Regularly inspects the area surrounding the secure drug
take-back bin for potential tampering or diversion. Record logs of
those inspections shall be maintained and retained for two years,
reflecting the date and time of the inspection, and the initials of
the employee inspecting the area. The logs shall be maintained in
writing or electronically and may be combined with logs required
by state or federal regulations. The logs may be used to demonstrate
regular inspection of the area. Other records or reports mandated
by federal or state regulations shall also be retained for a minimum
of two years unless regulations mandate a longer period.

(7) Notifies local law enforcement authorities of any suspected
or known tampering, theft, or significant loss of controlled
substances, within one business day of discovery. If the collector
maintains daily business hours, this notification shall be made
within one calendar day.

(8) 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
Drug Enforcement Administration’s Registration Unit as otherwise
required under federal laws and regulations.

begin delete

(c) The protection specified in subdivision (b) shall not apply
in a case of personal injury or wrongful death that results from the
collector’s gross negligence or willful or wanton misconduct in
maintaining a secure drug take-back bin.

end delete begin delete

(d)

end delete

begin insert ( end insert begin insert c) end insert  Nothing in this section 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.