Senate Study Bill 3012 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) 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 5260DP (3) 85 ad/nh

S.F. _____ H.F. _____ 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. Pharmacist licensure requirement. At 25 least one pharmacist employed by the nonresident pharmacy, who 26 shall be designated the pharmacist in charge of the nonresident 27 pharmacy, shall maintain a current license to practice pharmacy 28 in Iowa during any period that the nonresident pharmacy is 29 licensed by the board. 30 NEW SUBSECTION . 2B. Sterile compounding practice. A 31 nonresident pharmacy that engages in the preparation of any 32 sterile compounded product for dispensing to or for a patient 33 located in Iowa shall comply with rules relating to sterile 34 compounding practices adopted by the board. A nonresident 35 -1- LSB 5260DP (3) 85 ad/nh 1/ 3

S.F. _____ H.F. _____ pharmacy engaging in sterile compounding shall pay an amount 1 necessary to cover the board’s costs of conducting periodic 2 inspections of the pharmacy’s operations. Costs recovered 3 pursuant to this subsection shall be considered repayment 4 receipts as defined in section 8.2. 5 NEW SUBSECTION . 2C. Inspections. The board may inspect the 6 premises and practices of any applicant for a new nonresident 7 pharmacy license or for renewal of a nonresident pharmacy 8 license. 9 Sec. 4. Section 155A.13A, subsection 3, Code 2014, is 10 amended to read as follows: 11 3. Discipline. The board may deny an application for a 12 new or renewal of a nonresident pharmacy license if an agent 13 of the board is refused access to the pharmacy or pharmacy 14 records for the purpose of conducting a periodic inspection 15 or investigation. The board may deny, suspend, or revoke a 16 nonresident pharmacy license for any violation of this section , 17 section 155A.15, subsection 2 , paragraph “a” , “b” , “d” , “e” , 18 “f” , “g” , “h” , or “i” , chapter 124 , 124A , 124B , 126 , or 205 , or 19 a rule of the board. 20 Sec. 5. Section 155A.15, subsection 1, Code 2014, is amended 21 to read as follows: 22 1. a. A pharmacy subject to section 155A.13 shall not be 23 operated until a license or renewal certificate has been issued 24 to the pharmacy by the board. 25 b. A pharmacy subject to section 155A.13A shall not offer 26 or provide pharmaceutical services to patients located in Iowa 27 until a license or renewal certificate has been issued to the 28 pharmacy by the board. 29 EXPLANATION 30 The inclusion of this explanation does not constitute agreement with 31 the explanation’s substance by the members of the general assembly. 32 This bill relates to in-state special or limited-use 33 pharmacy licensure and nonresident pharmacy practices, 34 licensure, and discipline. The bill eliminates references 35 -2- LSB 5260DP (3) 85 ad/nh 2/ 3

S.F. _____ H.F. _____ to special pharmacy licenses. The bill allows the board of 1 pharmacy to issue telepharmacy licenses pursuant to the rules 2 of the board. 3 The bill amends the requirements and practices for licensure 4 of a nonresident pharmacy. A licensed nonresident pharmacy 5 must submit an application for renewal of its license. The 6 bill also requires the pharmacist in charge of a nonresident 7 pharmacy to have a license to practice pharmacy in Iowa. 8 The bill prohibits a nonresident pharmacy from providing 9 pharmaceutical services to a patient in Iowa until the pharmacy 10 is licensed by the board. 11 The bill requires pharmacies to comply with the rules 12 of the board for the preparation of sterile compounding 13 products when engaging in the sterile compounding of any 14 product for dispensing to or for a patient located in Iowa and 15 also requires these pharmacies to pay the board’s costs in 16 conducting inspections of the nonresident pharmacy’s sterile 17 compounding operations. The bill authorizes the board to 18 inspect the premises and practices of applicants for a new 19 nonresident pharmacy license or for renewal of a nonresident 20 pharmacy license. 21 The bill states that the board may deny an application for 22 a new or renewal of a nonresident pharmacy license if the 23 pharmacy refuses the board access to the pharmacy or pharmacy 24 records. 25 The bill adds to the list of violations that could lead to a 26 denial, suspension, or revocation of a nonresident pharmacy’s 27 license. These additional violations include operating a 28 nonresident pharmacy without a license and a violation by the 29 pharmacy or a pharmacist of any provision in the pharmacy 30 chapter or rule adopted pursuant to the chapter. 31 -3- LSB 5260DP (3) 85 ad/nh 3/ 3