BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



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          |SENATE RULES COMMITTEE            |                   SB 431|
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                                 THIRD READING


          Bill No:  SB 431
          Author:   Emmerson (R)
          Amended:  5/10/11
          Vote:     21

           
           SENATE BUS., PROF. & ECON. DEVEL. COMMITTEE  :  9-0, 4/25/11
          AYES:  Price, Emmerson, Corbett, Correa, Hernandez, Negrete 
            McLeod, Vargas, Walters, Wyland

           SENATE ENVIRONMENTAL QUALITY COMMITTEE  : 7-0, 05/04/11
          AYES: Simitian, Strickland, Blakeslee, Hancock, Kehoe, 
            Lowenthal, Pavley

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8


           SUBJECT  :    Pharmacies:  regulation

           SOURCE  :     Board of Pharmacy


           DIGEST  :    This bill expands existing reporting 
          requirements to the Board of Pharmacy when a pharmacy 
          discovers that an employee has been stealing drugs, 
          prohibits a pharmacist whose California license has been 
          revoked from dispensing medication to Californians via 
          mail, and requires a pharmacy to use a licensed hazardous 
          waste hauler to dispose of previously dispensed 
          prescription drugs.

           ANALYSIS  :    

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           Existing law  :

          1. Provides for the licensure and regulation of pharmacies, 
             pharmacists and wholesalers of dangerous drugs or 
             devices by the Board of Pharmacy (Board) within the 
             Department of Consumer Affairs (DCA).  

          2. Defines the following terms:

             A.    "Authorized officers of the law" as inspectors 
                of the Board, inspectors of the Food and Drug 
                Branch of the State Department of Public Health, 
                and investigators of DCA's Division of 
                Investigation or peace officers engaged in 
                official investigations.

             B.    "Designated representative" as an individual to 
                whom a license has been granted to provide 
                sufficient and qualified supervision in a 
                wholesaler or veterinary food-animal drug 
                retailer.  Specifies that the designated 
                representative shall protect the public health and 
                safety in the handling, storage, and shipment of 
                dangerous drugs and dangerous devices.  
                "Designated representative-in-charge" means a 
                designated representative or a pharmacist proposed 
                by a wholesaler or veterinary food-animal drug 
                retailer and approved by the Board as the 
                supervisor or manager responsible for ensuring 
                compliance with all state and federal laws.

             C.    "Pharmacist-in-charge" as a pharmacist proposed 
                by a pharmacy and approved by the Board as the 
                supervisor or manager responsible for ensuring the 
                pharmacy's compliance with all state and federal 
                laws and regulations pertaining to the practice of 
                pharmacy.

             D.    "Reverse distributor" as every person who acts 
                as an agent for pharmacies, drug wholesalers, 
                manufacturers, and other entities by receiving, 
                inventorying, and managing the disposition of 
                outdated or nonsalable dangerous drugs.


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          3. Requires pharmacies to keep records of manufacture, 
             sale, acquisition or disposition of dangerous drugs or 
             dangerous devices for three years, and requires these 
             records to be available for inspection by authorized 
             officers of the law.  Requires that an inventory be kept 
             by every manufacturer, wholesaler, pharmacy, veterinary 
             food-animal drug retailer, physician, dentist, 
             podiatrist, veterinarian, laboratory, clinic, hospital, 
             institution, or establishment holding a currently valid 
             and unrevoked certificate, license, permit, registration 
             who maintains a stock of dangerous drugs or devices.  
             Makes the owner, officer, partner and 
             pharmacist-in-charge or designated 
             representative-in-charge responsible for maintaining 
             records and keeping inventory.  Clarifies that the 
             pharmacist-in-charge or designated 
             representative-in-charge are not criminally responsible 
             for the acts of an owner, officer, partner or employee 
             if the pharmacist-in-charge or designated 
             representative-in-charge had no knowledge of the acts.

          4. Requires pharmacies to have procedures in place to take 
             action when a licensed individual employed by or with 
             the pharmacy is chemically, mentally, or physically 
             impaired to the extent it affects his or her ability to 
             practice the profession or occupation he or she is 
             licensed to practice, or when a licensed individual has 
             engaged in the theft, diversion, or self-use of 
             dangerous drugs.  Requires pharmacies to have written 
             policies and procedures for addressing chemical, mental, 
             or physical impairment, as well as theft, diversion, or 
             self-use of dangerous drugs, among licensed individuals 
             employed by or with the pharmacy. States that anyone 
             making a report has immunity from any civil or criminal 
             liability that might otherwise arise from making of the 
             report.  Requires pharmacies to report the following to 
             the Board within 30 days: 

             A.    Any admission by a licensed individual of 
                chemical, mental, or physical impairment affecting 
                his or her ability to practice.

             B.    Any admission by a licensed individual of 
                theft, diversion, or self-use of dangerous drugs.

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             C.    Any video or documentary evidence demonstrating 
                chemical, mental, or physical impairment of a 
                licensed individual to the extent it affects 
                his/her ability to practice.

             D.    Any video or documentary evidence demonstrating 
                theft, diversion, or self-use of dangerous drugs 
                by a licensed individual.

             E.    Any termination based on chemical, mental, or 
                physical impairment of a licensed individual to 
                the extent it affects his/her ability to practice.

             F.    Any termination of a licensed individual based 
                on theft, diversion, or self-use of dangerous 
                drugs.

          5. Requires all records or other documentation of the 
             acquisition and disposition of dangerous drugs and 
             dangerous devices by any entity licensed by the Board to 
             be retained on the licensed premises in readily 
             retrievable form.

          6. Specifies that a nonresident pharmacy is any pharmacy 
             located outside of California that ships, mails or 
             delivers controlled substances, dangerous drugs, or 
             dangerous devices into California and establishes 
             certain licensing, disclosure and record keeping 
             requirements for these entities. 

          This bill:

          1.Clarifies that any record pertaining to the return of 
            dangerous drugs to a wholesaler, or provided to a reverse 
            distributor, must document the quantity or weight of the 
            drugs returned, the date the drugs were returned and the 
            name of the reverse distributor or wholesaler to whom the 
            drugs were provided.  Specifies that a reverse 
            distributor must not accept the return of dangerous drugs 
            that have been dispensed to a patient and later returned 
            by a patient or patient's agent. 

          2.Clarifies that any record pertaining to the return of 

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            dangerous drugs to a hazardous waste hauler must list the 
            volume in weight or measurement of the pharmaceutical 
            waste returned, the date the waste was returned and the 
            name of the hazardous waste hauler to whom waste was 
            provided.  Specifies that a pharmacy may furnish 
            dangerous drugs to a hazardous waste hauler for the sole 
            purpose of waste disposal of pharmaceutical waste 
            returned to the pharmacy by a patient or patient's agent. 
             Specifies that only a hazardous waste hauler can pick up 
            or handle dangerous drugs returned by a patient or 
            patient's agent to a pharmacy.   

          3.Requires a pharmacy, within 14 days, report certain 
            information and evidence about licensees related to 
            chemical, mental, or physical impairment to the extent it 
            affects his or her ability to practice and theft, 
            diversion or self-use of dangerous drugs to the Board.  

          4.Requires the report required above include sufficient 
            detail to inform the Board of the facts on which the 
            report is based, including an estimate of the type and 
            quantity of all dangerous drugs involved, the timeframe 
            over which the losses are suspected, and the date of the 
            last controlled substances inventory.  Requires a 
            pharmacy, upon request of the Board, prepare and submit 
            an audit involving the suspected missing dangerous drugs.

          5.Requires the owner, corporate officer, or manager of an 
            entity licensed by the Board, when requested by an 
            authorized officer of the law or by an authorized 
            representative of the Board, to provide the requested 
            records within three business days of the time the 
            request was made.  Specifies that the entity may request 
            an extension in writing for up to 14 calendar days, 
            subject to Board approval.  Deems an extension approved 
            if the Board fails to deny the request within two 
            business days of the time the extension request was made 
            directly to the Board.

          6.Clarifies that a nonresident pharmacy shall not permit a 
            pharmacist whose license has been revoked by the Board to 
            manufacture, compound, furnish, sell, dispense, or 
            initiate the prescription of a dangerous drug or 
            dangerous device, or to provide any pharmacy-related 

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            service, to a person residing in California.

          7.Prohibits a reverse distributor from accepting dangerous 
            drugs that have been dispensed to a patient and later 
            returned to the pharmacy unless the dangerous drugs were 
            dispensed in a sealed or tamper-evident package and there 
            is no evidence that the package was opened, damaged or 
            otherwise tampered with.  Requires the pharmacy keep 
            records of returned dangerous drugs.

           Background
           
          There are growing concerns about the impact of drugs and 
          pharmaceutical waste based on improper disposal, which in 
          turn leads to contamination of water systems and improper 
          access by potential abusers.  The U.S. Geological Survey 
          conducted a study in 2002, sampling 139 streams across 30 
          states and found that 80 percent had measurable 
          concentrations of prescription and nonprescription drugs, 
          steroids, and reproductive hormones.  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.  Proper disposal is 
          believed to decrease the threat of these substances to the 
          environment and waterways.

          According to recent studies, and data collected by the 
          federal government, prescription drug abuse is the 
          fastest-growing drug problem in the U.S.  As prescription 
          drugs are legal, they are easily accessible, often from a 
          home medicine cabinet.  Studies show that some individuals 
          who misuse prescription drugs, particularly teens, believe 
          these substances are safer than illicit drugs because they 
          are prescribed by a health care professional and sold 
          behind the counter.  Proper disposal is believed to 
          decrease the availability of expired and unused 
          prescription drugs to abusers.

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes   
          Local:  Yes

           SUPPORT  :   (Verified  5/23/11)

          Board of Pharmacy (source)

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           OPPOSITION  :    (Verified  5/23/11)

          Bay Area Pollution Prevention Group
          EXP Pharmaceutical Services Corp.

           ARGUMENTS IN SUPPORT  :    According to the author's office, 
          this bill will increase consumer protection as well as 
          better ensure the proper disposal of prescription drugs.  
          Without a safe and effective method for disposal, 
          prescription drugs may be left in medicine cabinets where 
          they pose a threat of potential drug misuse or abuse.  The 
          author's office asserts that this bill also makes certain 
          that when drugs are received by a pharmacy that it has 
          established a take-back program, they are properly disposed 
          of, and not re-introduced into the pharmaceutical supply.  
          The author's office believes that this bill contains 
          consumer protection measures that provide the Board with 
          information it needs to quickly discipline errant licensees 
          by requiring additional reporting on drug loss.  
          Additionally, the author's office notes that ensuring that 
          an individual whose pharmacist license has been revoked in 
          California is not able to dispense medication to 
          Californians via mail supports the Board's public 
          protection efforts.  

           ARGUMENTS IN OPPOSITION  :    The Bay Area Pollution 
          Prevention Group represents 43 wastewater treatment 
          facilities around the San Francisco Bay and beyond, that 
          work to prevent pollution in San Francisco Bay.  They raise 
          several concerns with the bill.  They state that the bill 
          could be in conflict with the pending federal regulation 
          and could make it even more difficult and costly for 
          agencies, retailers, and drug manufacturers in California 
          to provide programs for the public to properly dispose of 
          pharmaceuticals.  They point to reverse distributors, as 
          well as common carriers, as options that the DEA is looking 
          at as pick-up and transportation services.  They claim that 
          reverse distribution is possibly one of the best and most 
          cost-effective tools for residential disposal programs.  
          Reverse distributors already work in pharmacies to dispose 
          of medication that was not sold either due to overstocking, 
          recalls, or expiration.  A pharmacy-based residential 
          collection program could utilize their reverse distribution 

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          network to remove unwanted residential medication at the 
          same time as these unsold drugs.  Also, they point to 
          another option that many public agencies, hospitals, and 
          long-term care facilities would like to consider for 
          disposal of residential unwanted medication; the use of 
          common carriers to transport pharmaceutical waste to an 
          incineration facility.  Currently, United States Postal 
          Service, FedEx, and United Parcel Service deliver 
          medication to end users.  They claim that leftover 
          medication could safely be sent by common carrier to a 
          regulated facility for incineration at a significantly 
          lower cost than medical or hazardous waste hauling.  
          

          JJA:do  5/23/11   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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