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, 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.
Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.
The people of the State of California do enact as follows:
(a) The Legislature finds and declares the
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 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
begin delete Agencyend delete (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
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
30an on-site pharmacy, and retail pharmacies to voluntarily
31administer mail-back programs and maintain collection receptacles.
32(b) It is the intent of the Legislature, with the enactment of this
33act, to do both of the following:
begin deleteTo encourage end deletethe good faith participation of
begin delete federally-authorizedend delete entities to maintain secure
3drug take-back bins on their premises for the convenience and
4public health and safety of prescription drug consumers and the
5proper disposal in the waste stream of the pharmaceutical waste
6contained in the bins.
begin deleteTo limit end deletethe civil and criminal liability of participating
8entities that meet certain minimum standards and take reasonable
9care to ensure the health and safety of consumers and employees
10when maintaining secure drug take-back bins on their premises.
Section 1714.24 is added to the Civil Code, to read:
(a) For purposes of this section, the following
13definitions shall apply:
14(1) “Collector” includes only those entities authorized by and
15registered with the federal Drug Enforcement
begin delete Agencyend delete
16 to receive a controlled substance for the purpose
17of destruction, if the entity is in good standing with any applicable
19(2) “Compensation” means reimbursement or funds received
20from a customer to compensate for the cost incurred in obtaining,
21installing, or maintaining a secure drug take-back bin.
begin delete Compensationend delete does not include reimbursement
23or funds received from any other person or entity, other than a
24customer, to compensate for the costs incurred in obtaining,
25installing, or maintaining a secure drug take-back bin.
26(3) “Home-generated pharmaceutical waste” means a
27pharmaceutical that is no longer wanted or needed by the consumer
28and includes any delivery system, such as pills, liquids, and
30(4) “Maintains” includes owning, leasing, operating, or
31otherwise hosting a secure drug take-back bin on the collector’s
33(5) “Pharmaceutical” means a prescription or over-the-counter
34human or veterinary drug, including, but not limited to, a drug as
35defined in Section 109925 of the Health and Safety Code and
36Section 321(g)(1) of Title 21 of the United States Code.
37“Pharmaceutical” includes controlled substances included in
38Schedule II, III, IV, or V of the Uniform Controlled Substances
39Act (Division 10 (commencing with Section 11000) of the Health
P4 1and Safety Code), but does not include a controlled substance
2included in Schedule I.
3(6) “Secure drug take-back bin” means a collection receptacle
4as described in Section 1317.75 of Title 21 of the Code of Federal
6(b) Any collector that maintains a secure drug take-back
begin delete bin, in shall not be liable in a
7good faith and not for compensation,end delete
8civil action, or be subject to criminal prosecution, for maintaining
9a secure drug take-back bin on its premises if the
begin delete collectorend delete
10 takes all of the
11following steps to ensure the health and safety of consumers and
12employees and the proper disposal in the waste stream of the
13home-generated pharmaceutical waste contained in a secure drug
15(1) Complies with all applicable state and federal laws and
16regulations relating to the collection of home-generated
17pharmaceutical waste for disposal in secure drug take-back bins,
18including, but not limited
begin delete toend delete the federal Secure and Responsible
19Drug Disposal Act of 2010 (Public Law 111-273).
20(2) Notifies local law enforcement and any local environmental
21health department as to the existence and location of any secure
22 drug take-back bin on the collector’s premises and the status of
23the collector’s registration as a collector with the federal Drug
begin delete Agency.end delete
25(3) Ensures that the secure drug take-back bin is placed in a
26location that is regularly monitored by employees of the registered
28(4) Ensures that conspicuous signage is posted on the secure
29drug take-back bin that clearly notifies customers as to what
begin delete non-controlledend delete substances are and
31are not acceptable for deposit into the bin, as well as the hours
32during which collection is allowed.
33(5) Ensures that public access to the secure drug take-back bin
34is limited to hours
begin delete whereinend delete employees of the registered
35collector are present and able to monitor the operation of the secure
36drug take-back bin.
37(6) Regularly inspects the area surrounding the secure drug
38 take-back bin for potential tampering or diversion. Record logs of
39those inspections shall be maintained and retained for
begin delete fourend delete
40 years, reflecting the date and time of the inspection, and the initials
P5 1of the employee inspecting the area. Other records or reports
2mandated by federal or state regulations shall also be retained for
3a minimum of
begin delete fourend delete years unless regulations mandate a longer
5(7) Notifies local law enforcement authorities of any suspected
6or known tampering, theft, or significant loss of controlled
7substances, within one business day of discovery. If the collector
8maintains daily business hours, this notification shall be made
9within one calendar day.
10(8) Notify local law enforcement as to any decision to
11discontinue its voluntary collection of controlled substances and
12provide documentation of its written notification to the federal
begin delete Agency’send delete Registration Unit
14as otherwise required under federal laws and regulations.
15(c) The protection specified in subdivision (b) shall not apply
16in a case of personal injury or wrongful death that results from the
17collector’s gross negligence or willful or wanton misconduct in
18maintaining a secure drug take-back bin.
19(d) Nothing in this section shall be construed to require entities
20that may qualify as a collector to acquire, maintain, or make
21available to the public a secure drug take-back bin on its premises.