BILL ANALYSIS                                                                                                                                                                                                    �



                                                                  SB 960
                                                                  Page  1

          Date of Hearing:   June 17, 2014

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                               Susan A. Bonilla, Chair
                     SB 960 (Morrell) - As Amended:  May 28, 2014

           SENATE VOTE  :   36-0
           
          SUBJECT  :   Pharmacy

           SUMMARY  :   Authorizes the Board of Pharmacy (BOP) to issue a  
          letter of admonishment (LOA) to an applicant who has committed a  
          violation that BOP deems worthy of caution, but does not merit a  
          license denial or probationary status.  Specifically,  this bill  :  
            

          1)Authorizes the BOP's executive officer (EO), or his or her  
            designee, to issue an LOA concurrently with a license to an  
            applicant who has committed any violation of law BOP deems, in  
            its discretion, does not merit the denial of a license or  
            require probationary status. 

          2)Requires the LOA to inform the applicant that within 30 days  
            of service of the order of admonishment, the applicant may do  
            either of the following:

             a)   Submit a written request for an office conference to the  
               executive officer of the board to contest the letter of  
               admonishment, according to the following procedures:

               i)     Upon a timely request, the EO, or his or her  
                 designee, shall hold an office conference with the  
                 applicant or his or her legal counsel or authorized  
                 representative. Unless so authorized by the EO, or his or  
                 her designee, no individual other than the applicant's  
                 legal counsel or authorized representative may accompany  
                 the applicant to the office conference;

               ii)    Prior to or at the office conference, the applicant  
                 may submit declarations and documents pertinent to the  
                 subject matter of the LOA to the EO;

               iii)   The office conference is intended to be an informal  
                 proceeding and shall not be subject to the Administrative  








                                                                  SB 960
                                                                  Page  2

                 Procedure Act or provisions regarding formal hearings;

               iv)    The EO, or his or her designee, may affirm, modify,  
                 or withdraw the LOA. Within 14 calendar days from the  
                 date of the office conference, the EO, or his or her  
                 designee, shall personally serve or send by certified  
                 mail BOP's written decision to the applicant's address of  
                 record. This decision shall be deemed the final  
                 administrative decision concerning the LOA; and,

               v)     Judicial review of the decision may be had by filing  
                 a petition for a writ of mandate within 30 days of the  
                 date the decision was personally served or sent by  
                 certified mail. The judicial review shall extend to the  
                 question of whether or not there was a prejudicial abuse  
                 of discretion in the issuance of the letter of  
                 admonishment; or,

             b)   Comply with the letter of admonishment and submit a  
               written corrective action plan to the EO documenting  
               compliance. If an office conference is not requested,  
               compliance with the LOA shall not constitute an admission  
               of the violation noted in the letter of admonishment.

          3)Requires the LOA to be served upon the applicant personally or  
            by certified mail at his or her address of record. If the  
            applicant is served by certified mail, service shall be  
            effective upon deposit in the United States mail.

          4)Requires the applicant to maintain and have readily available  
            a copy of the LOA and corrective action plan, if any, for at  
            least three years from the date of issuance.

          5)Prohibits the issuance of an LOA from being construed as a  
            disciplinary action or discipline for purposes of licensure or  
            the reporting of discipline for licensure.

           EXISTING LAW  :

          1) Establishes the Pharmacy Law which provides for the licensure  
             and regulation of pharmacies, pharmacists and wholesalers of  
             dangerous drugs or devices by BOP.  (Business and Professions  
             Code (BPC) Sections 4000 et seq.)  

          2) Requires BOP, upon receipt of an application for licensure  








                                                                  SB 960
                                                                  Page  3

             and appropriate fee, to investigate whether the applicant is  
             qualified for the license being sought, including all matters  
             directly related to the issuance of a license that may affect  
             the public welfare.  (BPC  4207 (a))

          3) Permits BOP to issue a probationary license to any applicant  
             for a license who is guilty of unprofessional conduct and who  
             has met all other requirements for licensure.  Permits BOP to  
             issue the license subject to any terms or conditions not  
             contrary to public policy.  (BPC 4300)

          4) Requires BOP, immediately upon the denial of any application  
             for a license, to notify the applicant in writing and  
             authorizes the applicant, within 10 days after the notice of  
             denial, to present a written petition for a license.  (BPC  
             4310) 

          5) Authorizes BOP to issue an LOA to a licensee for failing to  
             comply with provisions of the BPC, Pharmacy Law, and  
             regulations, directing the licensee to come into compliance.   
             Sets forth the requirements for issuance of an LOA by BOP and  
             options for a recipient related to an office conference with  
             BOP staff, including: 

             a)    A requirement that the letter be in writing and  
                describe in detail the nature and facts of the violation,  
                including a reference to the statutes or regulations  
                violated;  

             b)    A requirement that a letter to be served upon a  
                licensee personally or by certified mail at the  
                applicant's address of record with the Board; 

             c)    Provides that a letter inform the licensee that within  
                30 days of receipt of the letter, the licensee may either  
                submit a written request for an office conference to  
                contest the letter or may accept the letter without  
                challenge;

             d)    Outlines requirements for the office conference, if  
                requested by a licensee, to specify that: 

                    i)          Within 30 days of receipt of a request for  
                      an office conference, a representative of BOP must  
                      hold an office conference with the licensee and the  








                                                                  SB 960
                                                                  Page  4

                      licensee's legal counsel or authorized  
                      representative, if any.  Specifies that unless  
                      authorized by the EO, or his or her designee, any  
                      individual other than the legal counsel or  
                      authorized representative of the licensee may not  
                      accompanying the licensee to the office conference;

                    ii)         The licensee is authorized to submit  
                      declarations and documents pertinent to the subject  
                      matter of the LOA;

                    iii)        The office conference is intended to be an  
                      informal proceeding that is not subject to the  
                      Administrative Procedures Act;

                    iv)         The BOP representative may affirm, modify,  
                      or withdraw the LOA and, within 14 calendar days  
                      from the date of the office conference, the BOP  
                      representative shall personally serve or send by  
                      certified mail to the licensee's address of record a  
                      written decision which will be deemed the final  
                      administrative decision concerning the LOA;

                    v)          Judicial review of the decision may be had  
                      by filing a petition for a writ of mandate within 30  
                      days of the date the decision was personally served  
                      or sent by certified mail. The judicial review shall  
                      extend to the question of whether or not there was a  
                      prejudicial abuse of discretion in the issuance of  
                      the letter; and,

                    vi)         Requires the licensee to maintain and have  
                      available the letter and any corrective action plan  
                      for at least three years from the date of issuance  
                      of the letter. (BPC 4315)

          FISCAL EFFECT  :   Unknown 

           COMMENTS  :   

           1)Purpose of this bill  .  This bill allows BOP to issue an LOA to  
            an applicant who has committed a violation that BOP deems  
            worthy of caution, but does not merit a license denial or  
            probationary status, as specified.  By expanding the use of  
            LOAs to include applicants for licensure, this bill will  








                                                                  SB 960
                                                                  Page  5

            reduce the costs associated with the formal investigatory and  
            hearing process necessary for a probationary license, while  
            still preserving public safety and granting the applicant full  
            licensure.  This bill is sponsored by BOP.

           2)Author's statement  .  According to the author's office, "In  
            fiscal year 2012/2013, the [BOP] received more than 15,000  
            applications from individuals. Of these, an average of less  
            than one percent was denied licensure; however, the denial of  
            pharmacy technicians averaged 1.15%.  Each applicant's  
            individual circumstances are considered when making a  
            licensing decision. An individual denied licensure has the  
            right to appeal the board's decision through a formal appeal  
            process, which can be costly for the applicant as well as for  
            the [BOP].

            "Senate Bill 960 would allow the [BOP] to issue a license  
            concurrently with a Letter of Admonishment.  The [BOP]  
            believes that by issuing a Letter of Admonishment with a  
            license, the individual would receive the privilege of the  
            license, while the letter would serve to protect the public  
            and provide notice to an employer of facts and violations  
            about the new licensee.

            "Existing law authorizes the [BOP] to issue a Letter of  
            Admonishment to a licensee that fails to comply with the law  
            and outlines a process through which the licensee may object  
            to the letter.  This bill extends authority to the board to  
            use the Letter of Admonishment as a tool in issuing a  
            license."
                
            3)Probationary licenses  .  Current law affords a procedure for  
            BOP to award a probationary license with practice conditions  
            in lieu of a full license.  However, that process is  
            considered formal discipline and requires a full investigation  
            and formal hearing, which takes 12-18 months to complete and  
            costs approximately $4,000.  

          This bill creates an abridged process that would allow BOP to  
            grant a license to an applicant whose case may not be  
            significant enough to result in a probationary license or  
            license denial, but places a flag on the licensee's license  
            due to prior behavior.  Current law affords the Medical Board  
            of California a similar process for both the probationary  
            license and public letter of reprimand.   








                                                                  SB 960
                                                                  Page  6

           
             BOP estimates that if this bill passes, this option will  
            likely be used less than a dozen times per year.
             
          1)Existing LOA law  .  Existing law currently allows BOP to issue  
            an LOA to a licensee for failing to comply with provisions of  
            the BPC, Pharmacy Law, or regulations.  This bill adds the  
            ability to issue an LOA to an applicant, as well.  However,  
            this bill prohibits the issuance of an LOA to an applicant  
            from being construed as a disciplinary action or discipline  
            for purposes of licensure or the reporting of discipline for  
            licensure, as it is for licensees. 
             
          1)Office conference  . This bill states that the LOA is intended  
            to be an informal proceeding and is not subject to the APA or  
            formal hearing process.  The applicant is allowed to appeal  
            the letter, however, via an "office conference."  
                 
             An office conference allows the applicant and his or her legal  
            counsel or authorized representative to meet with BOP's EO, or  
            his or her designee, and dispute the issuance of the LOA.  The  
            applicant is allowed to present declarations and documents in  
            support of his or her case, and the EO, or his or her  
            representative, makes a decision within 14 calendar days of  
            the hearing.  

            If the applicant disputes the decision, he or she may file a  
            writ of mandate, which is a process by which a court without a  
            jury hears a final decision of an administrative body.  BOP  
            uses the office conference for other lesser violations, such  
            as a letter of admonishment (for minor violations of the  
            Pharmacy Law) and order of correction (a directive to change  
            practices), and as a tandem appeal for formal citations.  

           2)Arguments in support  .  The Board of Pharmacy writes, "This  
            bill would provide [BOP] with an additional tool to ensure  
            public protection.  Upon receipt of an application for a  
            license, [BOP] conducts a thorough investigation to determine  
            whether the individual is qualified for the license being  
            sought.  We investigate all matters related to the issuance of  
            the license that may affect the public welfare, to include a  
            review of an individual's criminal history record information  
            to determine prior arrests and convictions within and outside  
            of California.  [BOP] also requires information about prior  
            administrative actions taken by any regulatory agency against  








                                                                  SB 960
                                                                  Page  7

            an applicant.  Sometimes information gained from this  
            background review shows serious violations in the individual's  
            past.
             
             "When considering the appropriate action when making a  
            licensing decision, [BOP] recognizes that some violations -  
            while serious - may not be sufficient or are so old that [BOP]  
            may have difficulty sustaining a denial of the license.

            "[SB] 960 would authorize [BOP] to issue [an LOA], which would  
            describe the nature and facts of an individual's violations.   
            [SB 960] would provide the individual the right to contest the  
            [LOA] and specify the process and timeframe for the contesting  
            of the [LOA], and would require that a letter of admonishment  
            be purged three years from the date of issuance."

           3)Suggested technical amendments  .  The following suggested  
            amendments represent clarifying grammatical fixes.
             
               On page 2, line 29, after "the," add "licensee's or  
            applicant's" and delete "his or her"

              On page 3, line 8, delete "with" and add "'s" to board.

            According to BOP, a corrective action plan is not always  
            necessary or required.  The following amendment will clarify  
            this in the bill.

                 On page 3, line 19, after "plan" add ", if necessary,"

           4)Related legislation  . AB 2131 (Morrell) of 2014 was a very  
            similar measure sponsored by BOP, modeled after the Medical  
            Board of California's letter of reprimand.  However, the  
            bill's author moved to the Senate, and the language of AB 2131  
            was amended into SB 960 to use a LOA instead of a letter of  
            reprimand.  AB 2131 is currently in Senate Business,  
            Professions, and Consumer Protection Committee, with no plans  
            for a hearing.       

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          California Board of Pharmacy (sponsor)
          California Pharmacists Association








                                                                  SB 960
                                                                  Page  8

           
            Opposition 
           
          None on file.

           Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301