BILL NUMBER: SB 1229	ENROLLED
	BILL TEXT

	PASSED THE SENATE  AUGUST 11, 2016
	PASSED THE ASSEMBLY  AUGUST 4, 2016
	AMENDED IN ASSEMBLY  JUNE 27, 2016
	AMENDED IN ASSEMBLY  JUNE 14, 2016
	AMENDED IN SENATE  APRIL 19, 2016
	AMENDED IN SENATE  MARCH 28, 2016

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, 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 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,
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.


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 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 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 bin, unless the injury or harm results from the collector's
gross negligence or willful and wanton misconduct:
   (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.
   (c) 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.