BILL ANALYSIS                                                                                                                                                                                                    






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          |SENATE RULES COMMITTEE            |                       SB 1229|
          |Office of Senate Floor Analyses   |                              |
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                                   THIRD READING 


          Bill No:  SB 1229
          Author:   Jackson (D) and Stone (R)
          Amended:  4/19/16  
          Vote:     21 

           SENATE JUDICIARY COMMITTEE:  6-0, 4/12/16
           AYES:  Jackson, Moorlach, Hertzberg, Leno, Monning, Wieckowski
           NO VOTE RECORDED:  Anderson

           SUBJECT:   Home-generated pharmaceutical waste:  secure drug  
                     take-back bins


          SOURCE:    California Product Stewardship Council

          DIGEST:  This bill provides specified collectors that are  
          authorized under federal law to engage in drug take-back  
          collection with limited protection from civil and criminal  
          liability (or "qualified immunity") for maintaining secure drug  
          take-back bins. Specifically, this bill provides that a  
          collector shall not be liable in a civil action, 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 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. This qualified immunity shall not apply in the  
          case of personal injury or wrongful death which results from the  
          collector's gross negligence or willful or wanton misconduct in  
          maintaining a secure drug take-back bin.  

          ANALYSIS:  
          








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          Existing law:

          1)Provides that everyone is 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.  

          2)Provides that a person or entity that acquires an automatic  
            external defibrillator (AED) for emergency use is not liable  
            for any civil damages resulting from any acts or omissions  
            when the AED is used to render emergency care, provided that  
            the person or entity has complied with certain notice,  
            maintenance, and other reasonable care requirements under the  
            Health and Safety Code, as specified. These requirements  
            include that the person or entity must: 

                 comply with all regulations governing the placement of  
               an AED;
                 notify an agent of the local EMS agency of the  
               existence, location, and type of AED acquired;
                 ensure that the AED is maintained and tested according  
               to the operation and maintenance guidelines set forth by  
               the manufacturer;
                 ensure that the AED is tested at least biannually and  
               after each use;
                 ensure that an inspection is made of all AEDs on the  
               premises at least every 90 days for potential issues  
               related to operability of the device, as specified; and
                 ensure, when an AED is placed in a building, that at  
               least once a year a demonstration is made to at least one  
               person associated with the building so that the person can  
               be walked through how to use an AED properly in an  
               emergency, and that instructions are posted next to the  
               AED, as specified, on how to use the AED.  

          1)Provides that the qualified immunities described above do not  
            apply in the case of personal injury or wrongful death which  
            results from the gross negligence or willful or wanton  
            misconduct of the person who uses the AED to render emergency  
            care. 

          2)Provides that a licensed health care provider who acts with  







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            reasonable care and issues a prescription for, or an order for  
            the administration of, an opioid antagonist to a person  
            experiencing or suspected of experiencing an opioid overdose  
            is not subject to professional review, liable in a civil  
            action, or subject to criminal prosecution for issuing the  
            prescription or order.  Provides, further, that a person who  
            is not otherwise licensed to administer an opioid antagonist,  
            but who meets certain other conditions, is not subject to  
            professional review, liable in a civil action, or subject to  
            criminal prosecution for administering an opioid antagonist.  

          3)Provides that any prehospital emergency medical care person or  
            lay rescuer, as specified, who administers an epinephrine  
            auto-injector, in good faith and not for compensation, to  
            another person who appears to be experiencing anaphylaxis at  
            the scene of an emergency situation is not liable for any  
            civil damages resulting from his or her acts or omissions in  
            administering the epinephrine auto-injector, if that person  
            has complied with specified requirements of the Health and  
            Safety Code. Provides that this protection does not apply in a  
            case of personal injury or wrongful death that results from  
            the gross negligence or willful or wanton misconduct of the  
            person who renders emergency care treatment by the use of an  
            epinephrine auto-injector. 

          4)Provides that an authorizing physician and surgeon shall not  
            be subject to professional review, be liable in a civil  
            action, or be subject to criminal prosecution for the issuance  
            of a prescription or order to a qualified supervisor of health  
            or administrator at a school district, county office of  
            education, or charter school for epinephrine auto-injectors,  
            as specified, unless the physician and surgeon's issuance of  
            the prescription or order constitutes gross negligence or  
            willful or malicious conduct.    

          This bill:

          1)Provides that any collector, as defined, that maintains a  
            secure drug take-back bin shall not be liable in a civil  
            action, or be 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  
            to ensure the health and safety of consumers and employees and  
            the proper disposal in the waste stream of the home-generated  







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            pharmaceutical waste contained in a secure drug take-back bin.  
             This immunity does not apply in a case of personal injury or  
            wrongful death which results from the collector's gross  
            negligence or willful or wanton misconduct in maintaining a  
            secure drug take-back bin.

          2)Provides that a collector must do all of the following in  
            order to be subject to the qualified civil or criminal  
            immunity protections, above: 

                 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; 
                 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 Drug Enforcement Administration (DEA);
                 ensure that the secure drug take-back bin is placed in a  
               location that is regularly monitored by employees of the  
               registered collector;
                 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; 
                 ensure that public access to the secure drug take-back  
               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;
                 regularly inspect the area surrounding the secure drug  
               take-back bin for potential tampering or diversion and  
               maintain certain records and logs, as specified;
                 notify local law enforcement authorities of any  
               suspected or known tampering, theft, or significant loss of  
               controlled substances within one business day of discovery,  
               unless the collector maintains daily business hours, in  
               which case the notification must be within one calendar  
               day; and 
                 notify local law enforcement as to any decision to  
               discontinue its voluntary collection of controlled  
               substances, as specified.







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          1)Provides that nothing in the above 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 premise. 

          2)Defines various terms for these purposes.  Specifically, among  
            other things: 

                 "Collector" includes only those entities authorized by  
               and registered with the DEA to receive a controlled  
               substance for the purpose of destruction, if the entity is  
               in good standing with any applicable licensing authority.
                 "Compensation" means reimbursement or funds received  
               from a customer to compensate for the cost incurred in  
               obtaining, installing, or maintaining a secure drug  
               take-back bin. Compensation does not include reimbursement  
               or funds received from any other person or entity, other  
               than a customer, to compensate for the costs incurred in  
               obtaining, installing, or maintaining a secure drug  
               take-back bin.
                 "Home-generated pharmaceutical waste" means a  
               pharmaceutical that is no longer wanted or needed by the  
               consumer and includes any delivery system, such as pills,  
               liquids, and inhalers.
                 "Secure drug take-back bin" means a collection  
               receptacle as described in Section 1317.75 of Title 21 of  
               the Code of Federal Regulations.

          1)Includes various findings and statements of legislative  
            intent.


          Background


          Prior to 2010, as a matter of federal law, individuals who  
          wanted to dispose of unused, unwanted, or expired pharmaceutical  
          controlled substances only had limited disposal options because  
          the federal Controlled Substances Act (21 U.S.C. Sec. 801 et  
          seq.) only permitted individuals to either destroy those  
          substances themselves (such as by flushing or discarding),  
          surrender them to law enforcement, or otherwise seek assistance  
          from the federal Drug Enforcement Administration (DEA).  







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          According to the DEA, these restrictions resulted in the  
          accumulation of pharmaceutical controlled substances in  
          household medicine cabinets that were available for abuse,  
          misuse, diversion, and accidental ingestion. (DEA, Final Rule,  
          Disposal of Controlled Substances (Sept. 9, 2014)  
           
                                                                    Page  7


          leads-fight-against-prescription-drug-abuse-with-new-programs-to- 
          help-curb-misuse-of-medications-and-the-rise-in-overdose-deaths.h 
          tm  (as of Apr. 3, 2016).)  


          Additionally, at least one state has already sought to  
          incentivize pharmacies to engage in similar activities.   
          Specifically, the state of Virginia recently enacted a law that  
          provides that no person that participates in a drug disposal  
          program shall be liable for any theft, robbery, or other  
          criminal act related to participation in the pharmacy drug  
          disposal program or for any acts of simple negligence in the  
          collection, storage, or destruction of prescription drugs  
          collected through such pharmacy drug disposal program, provided  
          that the pharmacy practice site is acting in good faith and in  
          accordance with applicable state and federal law and  
          regulations.  (See Virginia's HB 629,  
           
                                                                    Page  8


            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 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 [other]  
            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.


             2.   Providing limited civil and criminal liability immunity  
               for pharmacies hosting drug take-back bins if they meet  
               that duty of care.


          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:NoLocal:    No









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          SUPPORT:   (Verified4/20/16)


          Californians Against Waste
          California Alliance for Retired Americans
          California Association for Environmental Health Administrators
          California State Association of Counties
          California State PTA
          City of Palo Alto
          City of Torrance
          Clean Water Action
          County Health Executives Association of California
          County of Riverside
          League of California Cities
          Los Angeles County Solid Waste Management Committee/Integrated  
          Waste Management Task Force
          Medication Education and Disposal Safety Coalition
          Napa Sanitation District
          San Luis Obispo County Integrated Waste Management Authority
          Santa Barbara County Board of Supervisors
          Santa Clara County Board of Supervisors
          Sierra Club California
          StopWaste
          Solid Waste Association of North America 
          Summerland Sanitary District Board of Directors


          OPPOSITION:   (Verified4/20/16)


          None received


          ARGUMENTS IN SUPPORT:     Clean Water Action writes in support  
          of the bill: 


            [ . . . ] Pharmaceuticals provide a wealth of benefits to  
            public health.  However, the reality is that both prescription  
            and over the counter drugs are often not used completely and  
            become out of date or unwanted.  Advanced wastewater treatment  
            is not financially accessible to most California communities,  
            and even where it exists, it is not adequate to remove all of  
            the complex chemicals in medications.  Consequently, when  







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            drugs are flushed down the toilet or thrown in the trash  
            (where they end up in groundwater or effluent that is later  
            put through the wastewater system), they enter our waterways  
            and drinking water supplies.  The effects on wildlife are well  
            documented, including reproductive harm, negative behavioral  
            changes, and endocrine disruption.  


            While improper disposal has sobering environmental impacts,  
            Clean Water Action's members also recognize that without  
            convenient options, medications are often stockpiled in the  
            home, posing a growing threat to youth and the elderly who may  
            mistakenly misuse them.  For this reason, pharmacies that  
            choose to host bins provide an important public service.   
            Again, SB 1229 ensures that such bins meet minimum standards  
            while providing these responsible retailers the assurance that  
            they too are protected from unreasonable liability.  This is a  
            win-win for the public and for pharmacies.


          Prepared by:Ronak Daylami / JUD. / (916) 651-4113
          4/20/16 15:39:03


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