Senate File 2156 - Introduced SENATE FILE 2156 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO SSB 3012) A BILL FOR An Act relating to in-state special or limited-use pharmacy 1 licensure and nonresident pharmacy practices, licensure, and 2 discipline. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 5260SV (2) 85 ad/nh

S.F. 2156 Section 1. Section 155A.13, subsections 3 and 5, Code 2014, 1 are amended to read as follows: 2 3. The board may issue a special or limited-use pharmacy 3 license or a telepharmacy license based upon special conditions 4 of use imposed pursuant to rules adopted by the board for cases 5 in which the board determines that certain requirements may be 6 waived. 7 5. A hospital which elects to operate a pharmacy for other 8 than its own use is subject to the requirements for a general 9 pharmacy license. If the hospital’s pharmacy services for 10 other than its own use are special or limited, the board 11 may issue a special or limited-use pharmacy license or a 12 telepharmacy license pursuant to subsection 3 . 13 Sec. 2. Section 155A.13A, subsection 2, Code 2014, is 14 amended to read as follows: 15 2. License renewal. A nonresident pharmacy shall renew its 16 license on or before January 1 annually. In order to renew 17 a nonresident pharmacy license, a nonresident pharmacy shall 18 submit a renewal application and fee as determined by the 19 board, and shall fulfill all of the requirements of subsection 20 1 , paragraphs “b” through “e” . A nonresident pharmacy shall pay 21 an additional fee for late renewal as determined by the board. 22 Sec. 3. Section 155A.13A, Code 2014, is amended by adding 23 the following new subsections: 24 NEW SUBSECTION . 2A. Sterile compounding practice. A 25 nonresident pharmacy that engages in the preparation of any 26 sterile compounded product for dispensing to or for a patient 27 located in Iowa shall comply with rules relating to sterile 28 compounding practices adopted by the board. A nonresident 29 pharmacy engaging in sterile compounding shall pay an amount 30 necessary to cover the board’s costs of conducting periodic 31 inspections of the pharmacy’s operations. Costs recovered 32 pursuant to this subsection shall be considered repayment 33 receipts as defined in section 8.2. 34 NEW SUBSECTION . 2B. Inspections. The board may inspect the 35 -1- LSB 5260SV (2) 85 ad/nh 1/ 3

S.F. 2156 premises and practices of any applicant for a new nonresident 1 pharmacy license or for renewal of a nonresident pharmacy 2 license. 3 Sec. 4. Section 155A.13A, subsection 3, Code 2014, is 4 amended to read as follows: 5 3. Discipline. The board may deny an application for a 6 new or renewal of a nonresident pharmacy license if an agent 7 of the board is refused access to the pharmacy or pharmacy 8 records for the purpose of conducting a periodic inspection 9 or investigation. The board may deny, suspend, or revoke a 10 nonresident pharmacy license for any violation of this section , 11 section 155A.15, subsection 2 , paragraph “a” , “b” , “d” , “e” , 12 “f” , “g” , “h” , or “i” , chapter 124 , 124A , 124B , 126 , or 205 , or 13 a rule of the board. 14 Sec. 5. Section 155A.15, subsection 1, Code 2014, is amended 15 to read as follows: 16 1. a. A pharmacy subject to section 155A.13 shall not be 17 operated until a license or renewal certificate has been issued 18 to the pharmacy by the board. 19 b. A pharmacy subject to section 155A.13A shall not offer 20 or provide pharmaceutical services to patients located in Iowa 21 until a license or renewal certificate has been issued to the 22 pharmacy by the board. 23 EXPLANATION 24 The inclusion of this explanation does not constitute agreement with 25 the explanation’s substance by the members of the general assembly. 26 This bill relates to in-state special or limited-use 27 pharmacy licensure and nonresident pharmacy practices, 28 licensure, and discipline. The bill eliminates references 29 to special pharmacy licenses. The bill allows the board of 30 pharmacy to issue telepharmacy licenses pursuant to the rules 31 of the board. 32 The bill amends the requirements and practices for licensure 33 of a nonresident pharmacy. A licensed nonresident pharmacy 34 must submit an application for renewal of its license. 35 -2- LSB 5260SV (2) 85 ad/nh 2/ 3

S.F. 2156 The bill prohibits a nonresident pharmacy from providing 1 pharmaceutical services to a patient in Iowa until the pharmacy 2 is licensed by the board. 3 The bill requires pharmacies to comply with the rules 4 of the board for the preparation of sterile compounding 5 products when engaging in the sterile compounding of any 6 product for dispensing to or for a patient located in Iowa and 7 also requires these pharmacies to pay the board’s costs in 8 conducting inspections of the nonresident pharmacy’s sterile 9 compounding operations. The bill authorizes the board to 10 inspect the premises and practices of applicants for a new 11 nonresident pharmacy license or for renewal of a nonresident 12 pharmacy license. 13 The bill states that the board may deny an application for 14 a new or renewal of a nonresident pharmacy license if the 15 pharmacy refuses the board access to the pharmacy or pharmacy 16 records. 17 The bill adds to the list of violations that could lead to a 18 denial, suspension, or revocation of a nonresident pharmacy’s 19 license. These additional violations include operating a 20 nonresident pharmacy without a license and a violation by the 21 pharmacy or a pharmacist of any provision in the pharmacy 22 chapter or rule adopted pursuant to the chapter. 23 -3- LSB 5260SV (2) 85 ad/nh 3/ 3