Amended in Assembly June 14, 2016

Amended in Senate April 19, 2016

Amended in Senate March 28, 2016

Senate BillNo. 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 maintaining a secure drug take-back bin on its premises if the collector,begin delete in good faith andend delete not for compensation,begin delete takesend deletebegin insert acts in good faith to takeend insert 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:

P2    1

SECTION 1.  

(a) The Legislature finds and declares the
2following:

3(1) On October 12, 2010, the federal Secure and Responsible
4Drug Disposal Act of 2010 (Public Law 111-273; hereafter referred
5to as the Disposal Act) was enacted. Before the Disposal Act,
6individuals who wanted to dispose of unused, unwanted, or expired
7pharmaceutical controlled substances had limited disposal options.
8The federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.;
9hereafter referred to as the CSA) only permitted individuals to
10destroy those substances themselves (e.g., by flushing or
11discarding), surrender them to law enforcement, or seek assistance
12from the federal Drug Enforcement Administration (DEA). These
13restrictions resulted in the accumulation of pharmaceutical
14controlled substances in household medicine cabinets that were
15available for abuse, misuse, diversion, and accidental ingestion.
16The Disposal Act amended the CSA to authorize specified
17individuals, referred to as “ultimate users,” to deliver their
18pharmaceutical controlled substances to another person for the
19purpose of disposal in accordance with regulations promulgated
20by the United States Attorney General.

21(2) On September 9, 2014, the DEA issued its final rule
22governing the secure disposal of controlled substances by
23registrants and ultimate users. Those regulations implement the
24Disposal Act by expanding the options available to collect
25controlled substances from ultimate users for the purpose of
26disposal, including take-back events, mail-back programs, and
27collection receptacle locations. Those regulations, among other
28things, allow authorized manufacturers, distributors, reverse
29distributors, narcotic treatment programs, hospitals/clinics with
30anbegin delete on-siteend deletebegin insert onsiteend insert pharmacy, and retail pharmacies to voluntarily
31administer mail-back programs and maintain collection receptacles.

P3    1(b) It is the intent of the Legislature, with the enactment of this
2act, to do both of the following:

3(1) Encourage the good faith participation of federally authorized
4entities to maintain secure drug take-back bins on their premises
5for the convenience and public health and safety of prescription
6drug consumers and the proper disposal in the waste stream of the
7pharmaceutical waste contained in the bins.

8(2) Limit the civil and criminal liability of participating entities
9that meet certain minimum standards and take reasonable care to
10ensure the health and safety of consumers and employees when
11maintaining secure drug take-back bins on their premises.

begin insert

12
(c) The terms and conditions provided by subdivision (b) of
13Section 1714.24 of the Civil Code, as added by this act, shall be
14construed in a manner consistent with the requirements imposed
15by the DEA’s final rule governing the secure disposal of controlled
16substances (79 Fed. Reg. 53519-70 (September 9, 2014)) and any
17regulations promulgated by the state.

end insert
18

SEC. 2.  

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

19

1714.24.  

(a) For purposes of this section, the following
20definitions shall apply:

21(1) “Collector” includes only those entities authorized by and
22registered with the federal Drug Enforcement Administration to
23receive a controlled substance for the purpose of destruction, if
24the entity is in good standing with any applicable licensing
25authority.

26(2) “Compensation” means reimbursement or funds received
27from a customer to compensate for the cost incurred in obtaining,
28installing, or maintaining a secure drug take-back bin.
29“Compensation” does not include reimbursement or funds received
30from any other person or entity, other than a customer, to
31compensate for the costs incurred in obtaining, installing, or
32maintaining a secure drug take-back bin.

33(3) “Home-generated pharmaceutical waste” means a
34pharmaceutical that is no longer wanted or needed by the consumer
35and includes any delivery system, such as pills, liquids, and
36inhalers.

37(4) “Maintains” includes owning, leasing, operating, or
38otherwise hosting a secure drug take-back bin on the collector’s
39premises.

P4    1(5) “Pharmaceutical” means a prescription or over-the-counter
2human or veterinary drug, including, but not limited to, a drug as
3defined in Section 109925 of the Health and Safety Code and
4Section 321(g)(1) of Title 21 of the United States Code.
5“Pharmaceutical” includes controlled substances included in
6Schedule II, III, IV, or V of thebegin insert Californiaend insert Uniform Controlled
7Substances Act (Division 10 (commencing with Section 11000)
8of the Health and Safety Code), but does not include a controlled
9substance included in Schedule I.

10(6) “Secure drug take-back bin” means a collection receptacle
11as described in Section 1317.75 of Title 21 of the Code of Federal
12Regulations.

13(b) Any collector that maintains a secure drug take-back bin
14shall not be liable in a civil action, or be subject to criminal
15prosecution, for maintaining a secure drug take-back bin on its
16premises if the collector,begin insert not for compensation, actsend insert in good faith
17begin delete and not for compensation, takesend deletebegin insert to takeend insert all of the following steps
18to ensure the health and safety of consumers and employees and
19the proper disposal in the waste stream of the home-generated
20pharmaceutical waste contained in a secure drug take-back bin:

21(1) Complies with all applicable state and federal laws and
22regulations relating to the collection of home-generated
23pharmaceutical waste for disposal in secure drug take-back bins,
24including, but not limited to, the federal Secure and Responsible
25Drug Disposal Act of 2010 (Public Law 111-273).

26(2) Notifies local law enforcement and any local environmental
27health department as to the existence and location of any secure
28drug take-back bin on the collector’s premises and the status of
29the collector’s registration as a collector with the federal Drug
30Enforcement Administration.

31(3) Ensures that the secure drug take-back bin is placed in a
32location that is regularly monitored by employees of the registered
33collector.

34(4) Ensures that conspicuous signage is posted on the secure
35drug take-back bin that clearly notifies customers as to what
36controlled and noncontrolled substances are and are not acceptable
37for deposit into the bin, as well as the hours during which collection
38is allowed.

39(5) Ensures that public access to the secure drug take-back bin
40is limited to hours in which employees of the registered collector
P5    1are present and able to monitor the operation of the secure drug
2take-back bin.

3(6) Regularly inspects the area surrounding the secure drug
4 take-back bin for potential tampering or diversion. Record logs of
5those inspections shall be maintained and retained for two years,
6reflecting the date and time of the inspection, and the initials of
7the employee inspecting the area.begin insert The logs shall be maintained in
8writing or electronically and may be combined with logs required
9by state or federal regulations. The logs may be used to
10demonstrate regular inspection of the area.end insert
Other records or reports
11mandated by federal or state regulations shall also be retained for
12a minimum of two years unless regulations mandate a longer
13period.

14(7) Notifies local law enforcement authorities of any suspected
15or known tampering, theft, or significant loss of controlled
16substances, within one business day of discovery. If the collector
17maintains daily business hours, this notification shall be made
18within one calendar day.

19(8) Notify local law enforcement as to any decision to
20discontinue its voluntary collection of controlled substances and
21provide documentation of its written notification to the federal
22Drug Enforcement Administration’s Registration Unit as otherwise
23required under federal laws and regulations.

24(c) The protection specified in subdivision (b) shall not apply
25in a case of personal injury or wrongful death that results from the
26collector’s gross negligence or willful or wanton misconduct in
27maintaining a secure drug take-back bin.

28(d) Nothing in this section shall be construed to require entities
29that may qualify as a collector to acquire, maintain, or make
30available to the public a secure drug take-back bin on its premises.



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