BILL ANALYSIS                                                                                                                                                                                                    



                                                                    SB 1229


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          Date of Hearing:   June 21, 2016


                           ASSEMBLY COMMITTEE ON JUDICIARY


                                  Mark Stone, Chair


          SB  
          1229 (Jackson) - As Amended June 14, 2016


                              As Proposed to be Amended


          SENATE VOTE:  39-0


          SUBJECT:  HOME-GENERATED PHARMACEUTICAL WASTE:  SECURE DRUG  
          TAKE-BACK BINS


          KEY ISSUE:  SHOULD A pharmacy or other entity that meets certain  
          minimum health and safety standards BE GIVEN QUALIFIED IMMUNITY  
          FROM CIVIL AND CRIMINAL LIABILITY FOR NEGLIGENCE, BUT NOT GROSS  
          NEGLIGENCE OR WILLFUL OR MALICIOUS MISCONDUCT, IN CONNECTION  
          WITH any injury or harm that results from the collector  
          maintaining a secure drug-take back bin on its premises?


                                      SYNOPSIS


          Empirical data indicates that the volume of pharmaceutical drugs  
          prescribed in the U.S. is at a record level and still growing.  
          More drugs prescribed also means more drugs that expire or, for  
          various reasons, are never used.  Unused prescription drugs then  
          accumulates in drawers and medicine cabinets across the nation.   








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          Until recently, disposal options for unused or leftover drugs,  
          because of their status as controlled substances, were limited  
          and largely dictated by law enforcement policy concerns.  People  
          were specifically told that one of their disposal options-easily  
          the most convenient one-was the undesirable practice of dumping  
          these medications in the household trash or flushing them down  
          the toilet, where they end up chemically polluting our  
          landfills, rivers, and drinking water supply.  In addition, a  
          glut of unused and easily misappropriated medications has helped  
          feed a growing epidemic of prescription drug abuse, particularly  
          of narcotic painkillers and opioids, as well-documented in many  
          recent national press accounts.


          This non-controversial 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 into use in California, this bill attempts to  
          alleviate 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 who act responsibly  
          to comply with specified requirements reflected in recent  
          federal Drug Enforcement Agency (DEA) regulations, that seek to  
          ensure public health and safety as well as the proper,  
          environmentally safe disposal of the unused medications  
          collected.  To qualify for immunity from liability, the  
          collector must, among many other things, do the following: (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; and (3) ensure that public access to the  
          secure drug take-back bin is limited to hours in which employees  








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          of the registered collector are present and able to monitor its  
          operation.  Proposed 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 collectors remain liable for any injury or harm  
          that results from the collector maintaining the secure take-back  
          bin under the health and safety conditions specified in the  
          bill, when the injury or harm results from the collector's gross  
          negligence or willful and wanton misconduct.


          This bill enjoys a broad range of support, including the  
          California Pharmacists Association; environmental groups like  
          the Sierra Club and Californians Against Waste, who want to  
          prevent contamination of watersheds and drinking water supplies;  
          and many local governments, who see the potential for cost  
          savings since they currently spend millions of dollars managing  
          the waste stream and regulating intake at county landfills.   
          This bill was approved in the Senate without receiving a single  
          "No" vote, and there is no known opposition.


          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:   


          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:










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             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  
               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.










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             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 maintaining a secure drug take-back bin on  
            its premises if the collector takes all of the steps specified  
            in # 2), above.


          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 Fed.  
            Reg. 53519-70 and any regulations promulgated by the state of  
            California.


          5)Clarifies that a collector remains liable for any injury or  
            harm that results from the collector maintaining the secure  
            take-back bin under the health and safety conditions specified  
            in the bill, unless the injury or harm results from the  
            collector's gross negligence or willful and wanton misconduct.


          6)Clarifies that the immunity in # 3) would 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.










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          7)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.


          EXISTING LAW:   


          1)Pursuant to the Medical Waste Management Act, requires the  
            Department of Public Health to regulate the management and  
            handling of medical waste, including pharmaceutical waste, as  
            defined.  (Part 14 of Division 104 of the Health and Safety  
            Code, commencing with Section 117600.)


          2)Defines "pharmaceutical waste" as any pharmaceutical that for  
            any reason may no longer be sold or dispensed for use as a  
            drug and excludes from this definition those pharmaceuticals  
            that still have potential value to the generator because they  
            are being returned to a reverse distributor for possible  
            manufacturer credit.





          3)Specifies that waste comprised only of pharmaceuticals is  
            hazardous, and is considered "medical waste," although it is  
            not subject to hazardous waste laws, as specified.


          4)Provides that no person who in good faith, and not for  
            compensation, renders emergency medical or nonmedical care at  
            the scene of an emergency shall be liable for any civil  
            damages resulting from any act or omission other than an act  
            or omission constituting gross negligence or willful or wanton  
            misconduct.  (Health and Safety Code Section 1799.102.)









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          5)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.  (Civil Code Section 1714  
            (a).)


          6)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; except that these  
            qualified immunities 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.  (Civil Code Section  
            1714.21, subd. (d) and (e).)


          7)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.  Further 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.  (Civil Code  
            Section 1714.23, subd. (b) and (c).)  









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          FISCAL EFFECT:  As currently on print this bill is keyed  
          non-fiscal.


          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  
               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  








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               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.





          High volume of unused pharmaceuticals and the social and  
          environmental problems associated with improper disposal.  The  








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          volume of pharmaceutical drugs that are prescribed in the U.S.  
          is estimated to be at unprecedented levels, and is projected to  
          continue growing even further in coming years.  According to  
          predicted figures by the U.S. Centers for Medicare & Medicaid  
          Services (CMS), which publishes the National Health Expenditure  
          (NHE) Projections, approximately $305.1 billion of prescription  
          drugs were predicted to be prescribed in the U.S. in 2014, with  
          that total increasing to $328.4 billion in 2015, and $343.2  
          billion in 2016.  (NHE Projections 2014-2024, available at  
           https://www.cms.gov/Research-Statistics-Data-and-Systems/Statisti 
          cs-Trends-and-Reports/NationalHealthExpendData/   
          NationalHealthAccounts Projected.html.)  The proportion of  
          prescribed drugs that are not consumed by the patient, and thus  
          potentially disposable, has been the subject of many studies in  
          the U.S. and in Europe, but is difficult to precisely estimate  
          because of differing methodologies.  In 2009, researchers in  
          Washington reviewed many of these studies and found that perhaps  
          between 10% and 33% of prescribed drugs go unused.  In one study  
          conducted in Northern California and cited by these researchers,  
          examination of containers containing unused medicine revealed an  
          average of 52% of the original medicine still inside, unused.   
          (Grasso, Cheri, et al., (2009) Secure Medicine Return in  
          Washington State, The PH:ARM Pilot.  See:  
           http://www.takebackyourmeds.org/pdf-files/  pharm-final-report.)   
          These figures don't even include over-the-counter medications,  
          which pose similar problems of pollution and drug abuse if  
          unused and not properly disposed.





          According to the sponsor, unused drugs that accumulate in homes  
          increase the risk of preventable poisonings, drug abuse, and  
          overdoses.  Recent data show that drug overdoses are now the  
          leading cause of injury death in the United States, even  
          surpassing motor vehicle crash deaths.  According to the Centers  
          for Disease Control and Prevention (CDC), nearly half a million  
          people died from drug overdoses from 2000 to 2014, and the  








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          majority of drug overdose deaths involve an opioid, including  
          prescription pain relievers and heroin.  Overdose is a growing  
          problem even among school-age youth.  The 2014 National Survey  
          on Drug Use and Health reported an estimated 0.7 percent of  
          adolescents aged 12 to 17 (approximately 168,000 adolescents)  
          had a pain reliever use disorder in 2014, while 18,000  
          adolescents, representing 0.1 percent of those in the same age  
          group, had a heroin use disorder in 2014.  (Available at:  
           https://nsduhweb.rti.org/respweb/homepage.cfm  .)





          Apparently lacking knowledge of better disposal options, many  
          people simply throw their unused medications into the household  
          trash, or flush them down the toilet.  Flushing medication into  
          sewage systems, however, harms the environment, including  
          wildlife, and contaminates drinking water sources, such as  
          aquifers and rivers.  According to a 2002 study by the U.S.  
          Geological Survey, researchers sampling 139 streams across 30  
          states found that 80 percent had measurable concentrations of  
          prescription and nonprescription drugs, steroids, and  
          reproductive hormones.  ("Water-Quality Data for  
          Pharmaceuticals, Hormones, and Other Organic Wastewater  
          Contaminants in U.S. Streams, 1999-2000" (2002) USGS; available  
          at:  http://toxics.usgs.gov/pubs/OFR-02-94/index.html  .) Exposure,  
          even to low levels of pharmaceuticals, has been shown to have  
          negative effects on fish and other aquatic species and may have  
          negative effects on human health.   A 2010 Associated Press  
          investigation found medications in watersheds near Los Angeles,  
          Riverside and Long Beach, raising strong public health concerns  
          about bacterial resistance to antibiotics and endocrine  
          disruption in aquatic organisms.  ("AP investigation details  
          pharmaceuticals found in watersheds of 28 major metro areas."  
          (2010) Associated Press; available at:  http://hosted.ap.org/   
          specials/interactives/pharmawater_site/day1_07.html.)










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          Federal actions to encourage drug collection programs and reduce  
          improper disposal of unused drugs.  In 2010, Congress enacted  
          the Secure and Responsible Drug Disposal Act of 2010 (Public Law  
          111-273; hereafter "Disposal Act.")  Before the Disposal Act,  
          individuals who wanted to dispose of unused, unwanted, or  
          expired pharmaceutical controlled substances had limited options  
          because the federal Controlled Substances Act (21 U.S.C. Sec.  
          801 et seq.; hereafter "CSA") only permitted individuals were  
          allowed to destroy those substances (e.g., by flushing or  
          discarding), surrender them to law enforcement, or seek  
          assistance from the federal Drug Enforcement Agency  
          Administration (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.  The Disposal Act  
          amended the CSA to authorize specified individuals, referred to  
          as "ultimate users," to deliver their pharmaceutical controlled  
          substances to another person for the purpose of disposal in  
          accordance with regulations promulgated by the United States  
          Attorney General.





          On September 9, 2014, the DEA issued its final rule (79 Fed.  
          Reg. 53519-70) governing the secure disposal of controlled  
          substances by ultimate users.  Those regulations implement the  
          Disposal Act by expanding 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.  Those regulations, 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  








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          receptacles.


          According to CPSC, medication collection programs are  
          recommended by the White House Office of National Drug Control  
          Policy (ONDCP), Drug Enforcement Administration (DEA), Food and  
          Drug Administration (FDA), and the Environmental Protection  
          Administration (EPA) as a more secure and environmentally safe  
          method of disposal than throwing medicines in the trash.   
          ("Report on Options for Managing Home Generated Medications in  
          San Joaquin County" (2016) California Product Stewardship  
          Council.)  Since passage of the Disposal Act, the DEA has  
          coordinated National Prescription Drug Take-Back Day events at  
          sites across the country to collect unused drugs and educate the  
          public about responsible means of disposal and the potential for  
          abuse of these medications.  Furthermore, the ONDCP's 2015  
          National Drug Control Strategy calls for increased use of  
          prescription medication return/take-back programs as one of four  
          pillars in combating prescription medication misuse, along with  
          the education of health care providers, patients, and families;  
          enhancing and encouraging the establishment of prescription drug  
          monitoring programs statewide; and increased enforcement to  
          address doctor shopping and pill mills.





          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  
          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  








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          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  
               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. 








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          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.


          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  








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          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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          According to the author, the intent of the bill is to ensure  
          that individuals are not provided immunity from either civil or  
          criminal liability for injuries or harm resulting from gross  
          negligence or willful or wanton misconduct-and this application  
          of the rule is not limited just to civil cases of personal  
          injury or wrongful death in the civil context, as may arguably  
          be implied by the current language of proposed Section 1712.24,  
          subdivision (c).  Therefore, the author proposes the following  
          amendments to clarify the qualified immunity provisions do not  
          apply to gross negligence or willful or wanton misconduct in  
          either civil or criminal cases:


          On page 4, lines 13 to 20, make the following changes:


            (b) Any collector 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  if   provided that  the collector, not for compensation,  
            acts in good faith to take all of the following 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  ,  
            unless the injury or harm results from the collector's gross  
            negligence or willful and wanton misconduct  :


            [. . . ]


          On page 5, delete lines 24 to 27, and on line 28, replace "(d)"  
          with "(c)"









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          Special requirement for collectors to maintain logs of  
          inspections.  As noted above, 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.  Recent amendments to the bill clarify  
          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.  


          Previous Related Legislation.  SB 738 (Huff), Ch. 132, Stats.  
          2015, 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 epi-pens pursuant to specified  
          law, unless the physician and surgeon's issuance constitutes  
          gross negligence or willful or malicious conduct.





          AB 635 (Ammiano), Ch. 707, Stats. 2013, provides that a licensed  








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          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. The bill also  
          provide, that a person who is not otherwise licensed to  
          administer an opioid antagonist, but who meets other specified  
          conditions, is not subject to professional review, liable in a  
          civil action, or subject to criminal prosecution for  
          administering an opioid antagonist.




          REGISTERED SUPPORT / OPPOSITION:


          Support


          California Product Stewardship Council (sponsor)


          American Federation of State, County, and Municipal Employees  
          (AFSCME)


          Applied Pharmacy Solutions 


          Area Agency on Aging 


          Californians Against Waste


          California Alliance for Retired Americans









                                                                    SB 1229


                                                                    Page  20






          California Association of Sanitation Agencies


          California Pharmacists Association


          California Special Districts Association


          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 Los Angeles 


          County of Santa Barbara 


          County of Riverside 


          County Sanitation Districts of Los Angeles County









                                                                    SB 1229


                                                                    Page  21






          David Cortese, Santa Clara County Supervisor


          League of California Cities


          Los Angeles County Solid Waste Management Cmte./ Integrated  
          Waste Management Task Force


          Medication Education and Disposal Safety Coalition


          Napa Sanitation District


          Nate Miley, Alameda County Supervisor


          Sacramento State Student Health and Counseling Services Pharmacy  



          San Luis Obispo County Integrated Waste Management Authority


          Santa Clara County Board of Supervisors


          Sierra Club California 


          Solid Waste Association of North America


          South Bay Cities Council of Governments










                                                                    SB 1229


                                                                    Page  22





          StopWaste


          Summerland Sanitary District


          Research in Social and Administrative Pharmacy




          Opposition


          None on file




          Analysis Prepared by:Anthony Lew / JUD. / (916)  
          319-2334