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 Civilbegin delete Code, and to add Sections 117670.5, 117748, and 118312 to the Health and Safetyend delete Code, relating to pharmaceutical waste.

LEGISLATIVE COUNSEL’S DIGEST

SB 1229, as amended, Jackson. begin deletePharmacies: end deletebegin insertHome-generated pharmaceutical waste: end insertsecure 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.begin delete aend deletebegin insert Aend insert violation of that provision is a crime.

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This bill would require a pharmacy that owns or operates a secure drug take-back bin, as defined, in a publicly accessible location to take reasonable steps to ensure the proper disposal of the pharmaceutical waste contained in the bins. The bill would provide that the owner or operator is not liable for civil damages arising from the use of the secure drug take-back bin if the owner or operator takes reasonable steps, as specified, to ensure the health and safety of consumers and employees and the proper disposal in the waste stream of the pharmaceutical waste contained in the bins. By expanding the application of a crime, the bill would impose a state-mandated local program.

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The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

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This bill would provide that no reimbursement is required by this act for a specified reason.

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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.

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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, in good faith and not for compensation, takes 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.

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Vote: majority. Appropriation: no. Fiscal committee: begin deleteyes end deletebegin insertnoend insert. State-mandated local program: begin deleteyes end deletebegin insertnoend insert.

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

P2    1begin insert

begin insertSECTION 1.end insert  

end insert

begin insert(a)end insertbegin insertend insertbegin insertThe Legislature finds and declares the
2following:end insert

begin insert

3
(1) On October 12, 2010, the federal Secure and Responsible
4Drug Disposal Act of 2010 (Public Law 111-273; hereafter
5referred to as the Disposal Act) was enacted. Before the Disposal
6Act, individuals who wanted to dispose of unused, unwanted, or
7expired pharmaceutical controlled substances had limited disposal
8options. The federal Controlled Substances Act (21 U.S.C. Sec.
9801 et seq.; hereafter referred to as CSA) only permitted
10individuals to destroy those substances themselves (e.g., by flushing
11or discarding), surrender them to law enforcement, or seek
12assistance from the federal Drug Enforcement Agency (DEA).
13These restrictions 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
P3    1individuals, referred to as “ultimate users,” to deliver their
2pharmaceutical controlled substances to another person for the
3purpose of disposal in accordance with regulations promulgated
4by the United States Attorney General.

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begin insert

5
(2) On September 9, 2014, the DEA issued its final rule
6governing the secure disposal of controlled substances by
7 registrants and ultimate users. Those regulations implement the
8Disposal Act by expanding the options available to collect
9controlled substances from ultimate users for the purpose of
10disposal, including take-back events, mail-back programs, and
11collection receptacle locations. Those regulations, among other
12things, allow authorized manufacturers, distributors, reverse
13distributors, narcotic treatment programs, hospitals/clinics with
14an on-site pharmacy, and retail pharmacies to voluntarily
15administer mail-back programs and maintain collection
16receptacles.

end insert
begin insert

17
(b) It is the intent of the Legislature, with the enactment of this
18act, to do both of the following:

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19
(1) To encourage the good faith participation of
20federally-authorized entities to maintain secure drug take-back
21bins on their premises for the convenience and public health and
22safety of prescription drug consumers and the proper disposal in
23the waste stream of the pharmaceutical waste contained in the
24bins.

end insert
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25
(2) To limit the civil and criminal liability of participating
26entities that meet certain minimum standards and take reasonable
27care to ensure the health and safety of consumers and employees
28when maintaining secure drug take-back bins on their premises.

end insert
29begin insert

begin insertSEC. 2.end insert  

end insert

begin insertSection 1714.24 is added to the end insertbegin insertCivil Codeend insertbegin insert, to read:end insert

begin insert
30

begin insert1714.24.end insert  

(a) For purposes of this section, the following
31definitions shall apply:

32
(1) “Collector” includes only those entities authorized by and
33registered with the federal Drug Enforcement Agency to receive
34a controlled substance for the purpose of destruction, if the entity
35is in good standing with any applicable licensing authority.

36
(2) “Compensation” means reimbursement or funds received
37from a customer to compensate for the cost incurred in obtaining,
38installing, or maintaining a secure drug take-back bin.
39Compensation does not include reimbursement or funds received
40from any other person or entity, other than a customer, to
P4    1compensate for the costs incurred in obtaining, installing, or
2maintaining a secure drug take-back bin.

3
(3) “Home-generated pharmaceutical waste” means a
4pharmaceutical that is no longer wanted or needed by the consumer
5and includes any delivery system, such as pills, liquids, and
6inhalers.

7
(4) “Maintains” includes owning, leasing, operating, or
8otherwise hosting a secure drug-take back bin on the collector’s
9premises.

10
(5) “Pharmaceutical” means a prescription or over-the-counter
11human or veterinary drug, including, but not limited to, a drug as
12defined in Section 109925 of the Health and Safety Code and
13Section 321(g)(1) of Title 21 of the United States Code.
14“Pharmaceutical” includes controlled substances included in
15Schedule II, III, IV, or V of the Uniform Controlled Substances
16Act (Division 10 (commencing with Section 11000) of the Health
17and Safety Code), but does not include a controlled substance
18included in Schedule I.

19
(6) “Secure drug take-back bin” means a collection receptacle
20as described in Section 1317.75 of Title 21 of the Code of Federal
21Regulations.

22
(b) Any collector that maintains a secure drug take-back bin,
23in good faith and not for compensation, shall not be liable in a
24civil action, or be subject to criminal prosecution, for maintaining
25a secure drug take-back bin on its premises if the collector takes
26all of the following steps to ensure the health and safety of
27consumers and employees and the proper disposal in the waste
28stream of the home-generated pharmaceutical waste contained in
29a secure drug take-back bin:

30
(1) Complies with all applicable state and federal laws and
31regulations relating to the collection of home-generated
32pharmaceutical waste for disposal in secure drug take-back bins,
33including, but not limited to the federal Secure and Responsible
34Drug Disposal Act of 2010 (Public Law 111-273).

35
(2) Notifies local law enforcement and any local environmental
36health department as to the existence and location of any secure
37drug-take back bin on the collector’s premises and the status of
38the collector’s registration as a collector with the federal Drug
39Enforcement Agency.

P5    1
(3) Ensures that the secure drug take-back bin is placed in a
2location that is regularly monitored by employees of the registered
3collector.

4
(4) Ensures that conspicuous signage is posted on the secure
5drug take-back bin that clearly notifies customers as to what
6controlled and non-controlled substances are and are not
7acceptable for deposit into the bin, as well as the hours during
8which collection is allowed.

9
(5) Ensures that public access to the secure drug take-back bin
10is limited to hours wherein employees of the registered collector
11are present and able to monitor the operation of the secure drug
12take-back bin.

13
(6) Regularly inspects the area surrounding the secure drug
14take-back bin for potential tampering or diversion. Record logs
15of those inspections shall be maintained and retained for four
16years, reflecting the date and time of the inspection, and the initials
17of the employee inspecting the area. Other records or reports
18mandated by federal or state regulations shall also be retained
19for a minimum of four years unless regulations mandate a longer
20period.

21
(7) Notifies local law enforcement authorities of any suspected
22or known tampering, theft, or significant loss of controlled
23substances, within one business day of discovery. If the collector
24maintains daily business hours, this notification shall be made
25within one calendar day.

26
(8) Notify local law enforcement as to any decision to
27discontinue its voluntary collection of controlled substances and
28provide documentation of its written notification to the federal
29Drug Enforcement Agency’s Registration Unit as otherwise
30required under federal laws and regulations.

31
(c) The protection specified in subdivision (b) shall not apply
32in a case of personal injury or wrongful death that results from
33the collector’s gross negligence or willful or wanton misconduct
34in maintaining a secure drug take-back bin.

35
(d) Nothing in this section shall be construed to require entities
36that may qualify as a collector to acquire, maintain, or make
37available to the public a secure drug take-back bin on its premises.

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38

SECTION 1.  

(a) It is the intent of the Legislature to encourage
39the good faith participation of pharmacies in hosting secure drug
40take-back bins on their premises for the convenience and public
P6    1health and safety of prescription drug consumers and the proper
2disposal in the waste stream of the pharmaceutical waste contained
3in the bins.

4(b) It is the intent of the Legislature to prescribe the standards
5of reasonable care necessary for pharmacies that host secure drug
6take-back bins on their premises.

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SEC. 2.  

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

8

1714.24.  

Any pharmacy that owns or operates a secure drug
9take-back bin in a publicly accessible location shall not be liable
10for civil damages arising from the use of the secure drug take-back
11bin if the owner or operator takes reasonable steps pursuant to
12Section 118312 of the Health and Safety Code to ensure the health
13and safety of consumers and employees and the proper disposal
14in the waste stream of the pharmaceutical waste contained in the
15bins.

end delete
begin delete16

SEC. 3.  

Section 117670.5 is added to the Health and Safety
17Code
, to read:

18

117670.5.  

“Home-generated pharmaceutical waste” means a
19pharmaceutical that is a waste generated by a household or
20households.

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begin delete21

SEC. 4.  

Section 117748 is added to the Health and Safety Code,
22to read:

23

117748.  

“Secure drug take-back bin” means a receptacle that
24can receive home-generated pharmaceutical waste, that employs
25a locking mechanism that requires the hazardous waste hauler and
26the bin owner or operator to use two, nonidentical keys
27simultaneously to access the contents of the bin, and that is secured
28to a wall or the ground.

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begin delete29

SEC. 5.  

Section 118312 is added to the Health and Safety Code,
30to read:

31

118312.  

Any pharmacy that owns or operates a secure drug
32take-back bin in a publicly accessible location shall take reasonable
33steps to ensure the proper disposal in the waste stream of the
34pharmaceutical waste contained in the bins.

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35

SEC. 6.  

No reimbursement is required by this act pursuant to
36Section 6 of Article XIII B of the California Constitution because
37the only costs that may be incurred by a local agency or school
38district will be incurred because this act creates a new crime or
39infraction, eliminates a crime or infraction, or changes the penalty
40for a crime or infraction, within the meaning of Section 17556 of
P7    1the Government Code, or changes the definition of a crime within
2the meaning of Section 6 of Article XIII B of the California
3Constitution.

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