BILL ANALYSIS                                                                                                                                                                                                    Ó




           ----------------------------------------------------------------- 
          |SENATE RULES COMMITTEE            |                       SB 1229|
          |Office of Senate Floor Analyses   |                              |
          |(916) 651-1520    Fax: (916)      |                              |
          |327-4478                          |                              |
           ----------------------------------------------------------------- 


                                UNFINISHED BUSINESS 


          Bill No:  SB 1229
          Author:   Jackson (D) and Stone (R)
          Amended:  6/27/16  
          Vote:     21 

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

           SENATE FLOOR:  39-0, 4/21/16
           AYES:  Allen, Anderson, Bates, Beall, Berryhill, Block,  
            Cannella, De León, Fuller, Gaines, Galgiani, Glazer, Hall,  
            Hancock, Hernandez, Hertzberg, Hill, Hueso, Huff, Jackson,  
            Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning,  
            Moorlach, Morrell, Nguyen, Nielsen, Pan, Pavley, Roth, Stone,  
            Vidak, Wieckowski, Wolk
           NO VOTE RECORDED:  Runner

           ASSEMBLY FLOOR:  76-0, 8/4/16 - See last page for vote

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


          SOURCE:    California Product Stewardship Council


          DIGEST:  This bill provides certain 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 any injury or harm that  
          results from a collector maintaining a secure drug take-back bin  
          on its premises, provided that the collector, not for  
          compensation, acts in good faith to take specified steps to  
          ensure the health and safety of consumers and employees and the  








                                                                    SB 1229  
                                                                    Page  2



          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.  


          Assembly Amendments (1) clarify the gross negligence or willful  
          or wanton misconduct exception to the qualified immunity granted  
          to collectors who maintain a secure drug take-back bin; (2) add  
          to the findings and declarations that specified provision of the  
          bill shall be construed in a manner consistent with the  
          requirements imposed by state and federal regulations, as  
          specified; (3) clarify that the mandated record logs, for  
          purposes of the qualified immunity, shall be maintained in  
          writing or electronically, may be combined with logs required by  
          state or federal regulations, and may be used to demonstrate  
          regular inspection of the area; and (4) make other technical and  
          clarifying changes. 
          
          ANALYSIS:   




          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,  








                                                                    SB 1229  
                                                                    Page  3



            maintenance, and other reasonable care requirements under the  
            Health and Safety Code, as specified. These requirements  
            include, for example, that the person or entity: 

                 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; and

                 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.

          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  
            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  








                                                                    SB 1229  
                                                                    Page  4



            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 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  
            specified steps to ensure the health and safety of consumers  
            and employees and the proper disposal in the waste stream of  
            the home-generated 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: 








                                                                    SB 1229  
                                                                    Page  5




                 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.








                                                                    SB 1229  
                                                                    Page  6






          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.

                  "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.



          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 Drug Enforcement Administration (DEA). 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  








                                                                    SB 1229  
                                                                    Page  7



          accidental ingestion. (DEA, Final Rule, Disposal of Controlled  
          Substances (Sept. 9, 2014).)  In 2010, the federal Secure and  
          Responsible Drug Disposal Act of 2010 (Disposal Act) was  
          enacted, amending the Controlled Substances Act to authorize  
          certain individuals ( "ultimate users" ) to deliver their  
          pharmaceutical controlled substances to another person for the  
          purpose of disposal in accordance with regulations promulgated  
          by the U.S. Attorney General.


          Accordingly, in September of 2014, the DEA issued its final rule  
          implementing the Disposal Act and governing the secure disposal  
          of controlled substances by registrants and ultimate users.   
          Those regulations have expanded the options available to collect  
          controlled substances from ultimate users for the purpose of  
          disposal, including take-back events, mail-back programs, and  
          collection receptacle locations and, among other things, allow  
          authorized manufacturers, distributors, reverse distributors,  
          narcotic treatment programs, hospitals/clinics with an on-site  
          pharmacy, and retail pharmacies to voluntarily administer  
          mail-back programs and maintain collection receptacles (what  
          this bill refers to as "secure drug take-back bins").  (See id.)  



          While the changes to federal law are rather recent, there has  
          already been a significant push to increase the use and  
          availability of secure drug take-back programs both across the  
          nation and in this state.  For example, one major retailer,  
          Walgreens, announced earlier this year that it has begun to  
          install safe medication disposal kiosks in more than 500  
          drugstores in 39 states and Washington, D.C. to make the  
          disposal of medications - including opioids and other controlled  
          substances - easier and more convenient while also helping to  
          reduce the misuse of medications and the rise in overdose  
          deaths.  (Walgreens Press Release, Walgreens Leads Fight Against  
          Prescription Drug Abuse with New Programs to Help Curb Misuse of  
          Medications and the Rise in Overdose Deaths (Feb. 9, 2016)  
           
                                                                    Page  8





          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  9



            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.  [ . . .] 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 limiting the  
            civil and criminal liability of pharmacies that maintain  
            secure drug take-back bins if they meet certain minimum  
            standards specified in the bill.
          
          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:NoLocal:    No


          SUPPORT:   (Verified8/4/16)


          California Product Stewardship Council (source)
          AAA Advisory Council
          Applied Pharmacy Solutions
          California Alliance for Retired Americans
          California Association of Environmental Health Administrators
          California Association of Sanitation Agencies
          California Medical Association
          California Pharmacists Association








                                                                    SB 1229  
                                                                    Page  10



          California Special Districts Association
          California State Association of Counties
          California State Board of Pharmacy
          California State PTA
          Californians Against Waste
          City of Palo Alto
          City of Santa Barbara
          City of Torrance
          Clean Water Action
          County Health Executives Association of California
          County of Los Angeles Board of Supervisors
          County of Los Angeles Department of Public Health
          County of Riverside
          County of Santa Barbara
          League of California Cities
          Los Angeles County Board of Supervisors
          Los Angeles County Solid Waste Management Committee/Integrated  
          Waste Management Task Force
          Medication Education and Disposal Safety Coalition
          Napa Sanitation District
          Research in Social Administrative Pharmacy
          Sacramento State Student Health and Counseling Services Pharmacy
          San Luis Obispo County Integrated Waste Management Authority
          Sanitation Districts of Los Angeles County
          Santa Clara County Board of Supervisors
          Sierra Club California
          Solid Waste Association of North America
          Sonoma County Waste Management Authority
          South Bay Cities Council of Governments
          StopWaste
          Summerland Sanitary District


          OPPOSITION:   (Verified8/4/16)


          None received


          ASSEMBLY FLOOR:  76-0, 8/4/16
          AYES:  Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,  
            Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,  








                                                                    SB 1229 
                                                                    Page  11



            Calderon, Campos, Chau, Chiu, Chu, Cooper, Dababneh, Dahle,  
            Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina  
            Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,  
            Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones,  
            Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,  
            Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,  
            Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk,  
            Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark  
            Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams,  
            Wood, Rendon
          NO VOTE RECORDED:  Chang, Chávez, Cooley, Roger Hernández


          Prepared by:Ronak Daylami / JUD. / (916) 651-4113
          8/5/16 10:17:51


                                   ****  END  ****