BILL ANALYSIS                                                                                                                                                                                                    



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          SENATE THIRD READING


          SB  
          1229 (Jackson and Stone)


          As Amended  June 27, 2016


          Majority vote


          SENATE VOTE:  39-0


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          |Committee       |Votes|Ayes                  |Noes                |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |----------------+-----+----------------------+--------------------|
          |Judiciary       |9-0  |Mark Stone, Wagner,   |                    |
          |                |     |Alejo, Chau, Chiu,    |                    |
          |                |     |Gallagher,            |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
          |                |     |Cristina Garcia,      |                    |
          |                |     |Holden, Maienschein   |                    |
          |                |     |                      |                    |
          |                |     |                      |                    |
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          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:   








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          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  








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               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  








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            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  








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               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  








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          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  








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               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.









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          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.








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          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










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