BILL ANALYSIS Ó SB 1229 Page 1 SENATE THIRD READING SB 1229 (Jackson and Stone) As Amended June 27, 2016 Majority vote SENATE VOTE: 39-0 ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Judiciary |9-0 |Mark Stone, Wagner, | | | | |Alejo, Chau, Chiu, | | | | |Gallagher, | | | | | | | | | | | | | | |Cristina Garcia, | | | | |Holden, Maienschein | | | | | | | | | | | | ------------------------------------------------------------------ SUMMARY: Provides qualified immunity from civil and criminal liability of participating entities that take reasonable care to ensure the health and safety of consumers and employees when maintaining secure drug take-back bins on their premises. Specifically, this bill: SB 1229 Page 2 1)Defines the term "collector" to include only those entities authorized by and registered with the federal Drug Enforcement Administration (DEA) to receive a controlled substance for the purpose of destruction, if the entity is in good standing with any applicable licensing authority. 2)Provides that a collector must do all of the following in order to receive qualified civil or criminal immunity from liability: a) Comply 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. b) Notify 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 DEA. c) Ensure that the secure drug take-back bin is placed in a location that is regularly monitored by employees of the registered collector. d) Ensure that conspicuous signage is posted on the secure drug take-back bin that clearly notifies customers as to what controlled and non-controlled substances are and are not acceptable for deposit into the bin, as well as the hours during which collection is allowed. e) Ensure that public access to the secure drug take-back SB 1229 Page 3 bin is limited to hours wherein employees of the registered collector are present and able to monitor the operation of the secure drug take-back bin. f) Regularly inspect the area surrounding the secure drug take-back bin for potential tampering or diversion, and maintain certain records and logs for at least two years, in writing or electronic form, that may be used to demonstrate regular inspection of the area. g) Notify local law enforcement authorities of any suspected or known tampering, theft, or significant loss of controlled substances within one business day of discovery. h) Notify local law enforcement as to any decision to discontinue its voluntary collection of controlled substances, as specified. 3)Provides that a collector that maintains a secure drug take-back bin, in good faith and not for compensation, 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 steps specified in 2) above. This does not apply if the injury or harm results from the collector's gross negligence or willful and wanton misconduct 4)Clarifies that the terms and conditions specified in 2) shall be construed in a manner consistent with the requirements imposed by the DEA's final rule governing the secure disposal of controlled substances pursuant to 79 Federal Regulation 53519-70 and any regulations promulgated by the state of SB 1229 Page 4 California. 5)Provides that nothing in this bill 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. FISCAL EFFECT: None. COMMENTS: This bill, sponsored by the California Product Stewardship Council (CPSC), seeks to encourage pharmacies and other authorized entities to voluntarily maintain secure drug take-back receptacles on their premises where their customers and others can come to safely dispose of unused or expired medications. To incentivize more of these take-back receptacles to be introduced in California, this bill attempts to alleviate the civil liability concerns that are reportedly an obstacle to greater voluntary participation in this growing movement to reduce improper disposal of prescription drugs. Specifically, the bill provides qualified immunity to entities that meet certain eligibility conditions and that act to comply with specified requirements, reflected in recent federal DEA regulations, that seek to ensure public health and safety as well as the proper disposal of the pharmaceutical waste collected. In explaining the compelling need for this bill, the author states: Home-generated pharmaceutical waste (i.e., prescription or over-the-counter human or veterinary drugs that are "left over" from treatment or have expired), has become an increasing problem nationwide and in California. With the rise of prescription drug abuse, these excess SB 1229 Page 5 drugs-often stored in medicine cabinets or under sinks for years-have found their way into recreational use by teens or are otherwise misused by seniors or others. People taking un-prescribed or expired drugs are creating a growing public health and safety risk. Without a safe means of disposal, many people with excess drugs are turning to throwing them in the trash or flushing them in a toilet. This creates serious problems with soil and water quality, especially since our water treatment plants are not capable of removing pharmaceuticals from wastewater. Law enforcement and pioneering pharmacies concerned with public safety and environmental health have been hosting drug take-back programs and bins voluntarily. These early efforts are laudable, but the scope of these drug take-back options has remained relatively small in relation to the demand for convenient and safe disposal. Many pharmacies have raised concerns regarding potential liability as the reason behind their reluctance to host a drug take-back bin. In order to help protect the public from prescription drug abuse and to protect water quality from home-generated pharmaceutical waste, SB 1229 would encourage pharmacies to host secure drug take-back bins by 1) establishing a duty of care for the proper oversight of secure drug take-back bins; and 2) providing limited civil and criminal liability immunity for pharmacies hosting drug take-back bins if they meet that duty of care. By offering qualified immunity from liability for maintaining a secure collection bin, this bill seeks to encourage more pharmacies and other authorized entities to voluntarily participate in secure drug-take back programs. Generally SB 1229 Page 6 speaking, current law holds every person 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. (Civil Code Section 1714 (a).) However, the Legislature has authorized qualified immunity from civil liability in order to promote good public policy and actions that benefit the public generally. The public policy goal of qualified immunity is to encourage a person or entity to undertake an activity or responsibility that the person or entity would otherwise not be compensated, required or willing to do (as a duty of employment or a professional standard of conduct, for example) because the act would be beneficial to the public interest. For instance, in order to encourage persons to render potentially lifesaving care in medical emergencies, California law provides qualified immunities to lay persons who use an automated external defibrillator (AED) device in emergency situations (Civil Code Section 1714.21) and to those laypersons who administer opioid antagonist medication to persons experiencing an opioid overdose (Civil Code Section 1714.23). As previously discussed, this bill is intended to further the laudable public policy of reducing prescription drug abuse and protecting water quality from home-generated pharmaceutical waste by encouraging pharmacies to voluntarily set up and maintain a drug take-back receptacle for their patients, something they are otherwise not required to do. According to the author, to further these policy goals it is necessary to establish new qualified immunities because the threat of civil liability (whether real or imagined) discourages pharmacies and other entities from voluntarily maintaining secure drug take-back receptacles. According to the California Pharmacists Association: [O]ne barrier discouraging independent pharmacies from SB 1229 Page 7 hosting collection receptacles continues to be the fear of the civil liability associated with doing so. A pharmacy that tries to help patients by hosting a collection receptacle and takes all the right steps to ensure the safe and secure operation of that receptacle should be confident that they will not be held civilly liable for events outside of their control. In order to incentivize more pharmacies to voluntarily set up and maintain a drug take-back receptacle for their patients, this bill would provide pharmacies and other authorized entities with qualified liability protections, as specified, as long as they comply with certain requirements for maintaining a secure drug take-back receptacle. Characteristics of the qualified immunity provisions and their relationship to federal rules. The qualified immunity provisions of this bill are limited with respect to who they apply to and the conditions under which immunity becomes available-in both cases respecting the need to observe federal regulations governing the collection of controlled substances. First, the immunity provisions only extend to pharmacies and entities that qualify as authorized "collectors" under federal DEA regulations. As defined by this bill, a collector must be an entity authorized by and registered with the DEA to receive a controlled substance for the purpose of destruction. Under federal regulations, this can include registered manufacturers, distributors, reverse distributors, narcotic treatment programs, hospital or clinics with an on-site pharmacy, or retail pharmacies that are so authorized and registered with the DEA. In addition, because an entity would also have to be licensed in California under state law whether or not it voluntarily maintains a drug take-back bin, this bill also requires that a collector be in good standing with any applicable state licensing authority in order to qualify for these immunity protections. SB 1229 Page 8 Second, the bill's qualified immunity provisions only protect the collector from liability if the collector, not for compensation and acting in good faith, complies with a number of specified requirements that operate to ensure the health and safety of consumers and employees and the proper disposal of the home-generated pharmaceutical waste contained in the secure drug take-back bin. To qualify for immunity from liability, the collector must, among other things: 1) comply 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; 2) ensure that the secure drug take-back bin is placed in a location that is regularly monitored by employees of the registered collector; 3) ensure 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; and 4) ensure 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. In addition to the above conditions, there are several notification requirements that must also be followed in order to obtain immunity. The collector must: 1) notify 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 DEA; 2) notify local law enforcement of any suspected or known tampering, theft, or significant loss of controlled substances, within one business day of discovery, or, if the collector maintains daily business hours, within one calendar day; and 3) 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 DEA's Registration Unit as otherwise required under federal laws and regulations. SB 1229 Page 9 Recent amendments to the bill clarify that the qualified immunity provisions do not apply to gross negligence or willful or wanton misconduct in either civil or criminal cases, and that in such cases the collector shall not enjoy immunity from liability for any injury or harm that results from the collector maintaining the secure drug take-back bin. Special requirement for collectors to maintain logs of inspections. The bill requires that a collector regularly inspect the area surrounding the secure drug take-back receptacle for potential tampering or diversion-a safety requirement that is also reflected in the DEA 2014 regulations. Specific to this bill, according to the author, is a further requirement that record logs of those inspections, reflecting the date and time of the inspection, be maintained and retained by the take-back program for two years. The bill also requires retention of other records or reports mandated by federal or state regulations for a minimum of two years, unless regulations mandate a longer period. The bill provides that these logs shall be maintained in writing or electronic form, may be combined with logs required by state or federal regulations, and may be used to demonstrate regular inspection of the area surrounding the take-back receptacle. This last requirement may be particularly useful to a collector seeking to claim immunity in court pursuant to these provisions, because the logs could help the collector prove it has complied with the minimum requirements necessary to establish the qualified immunity protections. Analysis Prepared by: Anthony Lew / JUD. / (916) 319-2334 FN: 0003546 SB 1229 Page 10