BILL ANALYSIS                                                                                                                                                                                                    �



                                                                  SB 431
                                                                  Page  1

          Date of Hearing:   August 17, 2011

                        ASSEMBLY COMMITTEE ON APPROPRIATIONS
                                Felipe Fuentes, Chair

                    SB 431 (Emmerson) - As Amended:  May 10, 2011 

          Policy Committee:                             HealthVote:11-2
                       Business and Professions         Vote: 9-0

          Urgency:     No                   State Mandated Local Program: 
          Yes    Reimbursable:              No

           SUMMARY  

          This bill modifies existing reporting requirements to the Board 
          of Pharmacy (Board) regarding employee theft of drugs, prohibits 
          a pharmacist whose license has been revoked from dispensing 
          medication via mail, and prohibits reverse distributors (who 
          dispose of unusable drugs) from accepting prescription drugs 
          that have been dispensed to a patient and later returned to the 
          pharmacy, unless certain conditions are met.

           FISCAL EFFECT  

          Minor and absorbable costs to the state Board of Pharmacy for 
          enforcement of this measure.

           COMMENTS  

           1)Rationale  . According to the author, this bill contains 
            consumer protection measures that improve the Board's 
            oversight and enforcement activities. This bill attempts to 
            address three separate problems: prescription drug theft, 
            pharmacists with revoked licenses who are providing 
            prescription drugs through the mail, and improper disposal of 
            prescription drugs. First, the provision that requires more 
            rapid and complete reporting of cases of drug theft will allow 
            the Board to respond more quickly and effectively to such 
            cases.  The provision that prohibits a pharmacist whose 
            license has been revoked in the state to distribute 
            prescription drugs via mail closes a loophole that undermines 
            the Board's public protection efforts. 
             
             Finally, the Board contends that the provision relating to 








                                                                  SB 431
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            reverse distributors clarifies that reverse distributors are 
            able to continue removing drugs from the drug supply chain 
            under certain circumstances. 

           2)Disposal of Pharmaceutical Waste  .  According to the US Food 
            and Drug Administration, proper disposal of home-generated 
            pharmaceutical waste (HGPW) is important to address the 
            potential for misuse, as well as contamination of water that 
            occurs when drugs are improperly flushed down the toilet.  
            Some other states have established drug take-back programs at 
            pharmacies for consumers to dispose of their unused drugs.

            A report by the California Department of Resources Recycling 
            (CalRecyle) submitted to the Legislature this March pursuant 
            to SB 966 (Simitian), Chapter 542, Statutes of 2007 lays out 
            several policy options related to improving disposal of HGPW, 
            including establishing pharmacy take-back programs. In 
            addition, this report indicates that recent federal 
            legislation, the Secure and Responsible Drug Disposal Act of 
            2010, gives the federal government more flexibility in 
            developing regulations that would allow public and private 
            entities to operate a variety of effective and safe collection 
            and disposal methods for controlled substances. 

            Reverse distributors accept expired or otherwise unusable 
            drugs from pharmacies and properly dispose of them, including 
            sending the drugs back to manufacturers for credit or 
            incinerating them. This bill prohibits a reverse distributor 
            from accepting the return of drugs that have been dispensed to 
            patients and returned to the pharmacy unless there is no 
            evidence that the package was opened damaged, or tampered 
            with.  In this way, the bill limits the ability of reverse 
            distributors to accept HGPW, and essentially limits the 
            ability of reverse distributors to participate in 
            pharmaceutical take-back programs for HGPW that are 
            contemplated by the DRRR report and by pending federal 
            regulations.

           3)Opposition Concerns  . Concerns about the provision related to 
            the ability of reverse distributors to accept HGPW have been 
            raised by the Bay Area Pollution Prevention Group, a pollution 
            watchdog, as well as by EXP Pharmaceutical Services Corp., one 
            of California's few reverse distributors. EXP indicates that 
            this bill's provisions may conflict with federal regulations, 
            among other concerns.  EXP also points out that reverse 








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            distributors have expertise in handling pharmaceutical waste 
            and can do so cheaply and effectively, and with stricter 
            oversight and control than hazardous waste haulers, which is 
            the alternative disposal route.


           Analysis Prepared by  :    Lisa Murawski / APPR. / (916) 319-2081