BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 1442
                                                                  Page 1

          CONCURRENCE IN SENATE AMENDMENTS
          AB 1442 (Wieckowski)
          As Amended  August 21, 2012
          Majority vote
           
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          |ASSEMBLY:  |78-0 |(May 30, 2012)  |SENATE: |37-0 |(August 27,    |
          |           |     |                |        |     |2012)          |
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           Original Committee Reference:    E.S. & T.M.  

           SUMMARY  :  Authorizes the transportation of pharmaceutical waste, 
          as defined, by a common carrier.  
           
          The Senate amendments:

           1)Clarified that pharmaceutical waste sent to out of the state 
            must be sent to facilities licensed by the California the 
            Board of Pharmacy (BOP), but they are not required to be 
            licensed as a transfer facility by the Department of Public 
            Health.

          2)Required pharmaceutical waste generators to notify the 
            enforcement agencies in the event that there is a discrepancy 
            in tracking document for the shipment of pharmaceutical waste.

          3)Required that the pharmaceutical waste that is separated from 
            medical waste by the generator be maintained in a manner to 
            secure the pharmaceutical waste contents from unauthorized 
            individuals.

           EXISTING LAW:
           
          1)Regulates, under the federal Resource Conservation and 
            Recovery Act (RCRA), the management of solid and hazardous 
            wastes. 

          2)Regulates, under the Radiation Control Law (Health and Safety 
            Code Section 114960 et seq.) and controls sources of ionizing 
            radiation. 

          3)Specifies, under the Medical Waste Management Act (MWMA) 
            (Section 117600 et seq.):









                                                                  AB 1442
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             a)   Defines "pharmaceuticals" as a prescription or 
               over-the-counter human or veterinary drug including, but 
               not limited to, a drug as defined in the Sherman Food, Drug 
               and Cosmetic Law or the Federal Food, Drug, and Cosmetic 
               Act.  "Pharmaceutical" does not include any pharmaceutical 
               that is regulated pursuant to either RCRA or the Radiation 
               Control Law.

             b)   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.  

             c)   Requires medical waste generators to maintain on file, 
               or file with the enforcement agency, specified documents 
               relating to the maintenance, treatment and transport of 
               medical waste.

             d)   Requires all medical waste be transported to an offsite 
               medical waste treatment facility to be transported by a 
               registered hazardous waste transporter.

             e)   Requires that medical waste treatment facilities 
               maintain specified records for three years, including 
               copies of the tracking documents for all medical waste it 
               receives for treatment from offsite generators or hazardous 
               waste haulers.

           AS PASSED BY THE ASSEMBLY  , this bill was substantially similar 
          to the version passed by the Senate.

           FISCAL EFFECT  :  According to the Senate Appropriations 
          Committee, enactment of this act would result in a cost of 
          $280,000 from the Medical Waste Management Fund in 2013-14 and 
          2014-15 for two full time and one limited term Department of 
          Public Health staff to coordinate with stakeholders statewide, 
          oversee rulemaking process and develop regulations.  The bill 
          will result in $160,000 annually thereafter to review exemption 
          requests and ensure compliance with documentation requirements.

           COMMENTS  :

           Need for the bill  :  According to the author, "Under existing 
          law, pharmaceutical drugs can be sent to health care facilities 
          through standard common carriers, or standard shipping means.  
          Unused drugs can sometimes be returned to the manufacturer for 








                                                                  AB 1442
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          credit, via a common carrier.  Expired and non-dispensable drugs 
          must be shipped as "Medical Waste," requiring expensive 
          hazardous waste shipping, instead of common carrier.  This is 
          unnecessarily expensive for pharmacies, hospitals, and other 
          health care facilities, who are simply returning the exact same 
          drug that was shipped to them by common carrier."
           
          Regulation of pharmaceutical waste under the Medical Waste 
          Management Act (MWMA)  :  Pharmaceutical wastes that must be 
          managed according to the MWMA are those that are classified as 
          "California only hazardous waste" by Chapter 11, Title 22, 
          California Code of Regulations.  If a pharmaceutical waste meets 
          the criteria of a California hazardous waste, it must be 
          segregated in an appropriate container, properly labeled, 
          stored, manifested, transported and incinerated at a regulated 
          medical waste incinerator or destroyed through another method 
          approved by the CDPH.  The MWMA prohibits a person from hauling 
          medical waste unless the person is either a registered hazardous 
          waste hauler or has an approved limited-quantity exemption.

           Reverse distribution and transporting pharmaceutical waste  :  It 
          is common practice for pharmacies and other health care 
          facilities to return unused pharmaceuticals to the manufacturer 
          for credit or disposal.  Health care facilities have the option 
          of hiring reverse distributors to manage their unused and/or 
          expired medication that could be returned to the manufacturer or 
          wholesaler for credit.  The reverse distributor determines which 
          medications may be returned to the manufacturer or wholesaler 
          for credit and arranges for disposal of unused medications that 
          are waste.  Once the unused pharmaceutical is determined to be 
          ineligible for credit, it becomes waste and must be managed as 
          such.

          In California, reverse distributors are regulated by both the 
          Board of Pharmacy (BOP) and the California Department of Public 
          Health (CDPH).  The BOP regulates activities involving 
          "dangerous drugs," as defined in Business and Professions Code 
          (BPC) Section 4022, which includes prescription medications.  
          Reverse distributors that intend to receive "outdated or 
          nonsalable dangerous drugs," which could include potentially 
          creditable drugs, must register with the BOP as "drug 
          wholesalers" (BPC Sections 4040.5, 4043 and 4160).  However, 
          once a pharmaceutical is designated as "medical waste" pursuant 
          to the MWMA, it is regulated by the CDPH (Health and Safety Code 
          (HSC) Section 117690).  For purposes of the MWMA, the term 








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          "pharmaceutical" isn't restricted to "dangerous drugs" as set 
          forth in the BPC, but rather is intended to cover all 
          pharmaceuticals, including both prescription and 
          over-the-counter drugs (HSC Section 117747).

          The MWMA requires that medical waste pharmaceuticals be sent to 
          reverse distributors via a licensed hazardous waste hauler (HSC 
          Section 118000).  However, according to DPH's Self-Assessment 
          Manual for Proper Management of Medical Waste, pharmaceuticals 
          that have "intrinsic value" (such as outdated or otherwise 
          unsalable pharmaceuticals that are returned for credit) are not 
          considered "waste" and, thus, may be shipped to a reverse 
          distributor via a common carrier.  Therefore, under current law, 
          whether or not a pharmaceutical is creditable determines whether 
          it must be transported via a registered waste hauler or is 
          authorized to be transported via common carrier.  As is 
          authorized under current law for outdated or otherwise unsalable 
          creditable pharmaceuticals, this bill authorizes the 
          transportation of outdated or otherwise unsalable non-creditable 
          pharmaceuticals, which are designated as medical waste, via a 
          common carrier.


           Analysis Prepared by  :    Bob Fredenburg / E.S. & T.M. / (916) 
          319-3965 


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