SSB 3012 (LSB 5260DP (3) 85)

SENATE/HOUSE FILE _____

BY  (PROPOSED BOARD OF PHARMACY BILL)

A BILL FOR

An Act relating to in-state special or limited-use pharmacy licensure and nonresident pharmacy practices, licensure, and discipline.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  Section 155A.13, subsections 3 and 5, Code 2014, are amended to read as follows:
   3.  The board may issue a special or limited-use pharmacy license or a telepharmacy license based upon special conditions of use imposed pursuant to rules adopted by the board for cases in which the board determines that certain requirements may be waived.
   5.  A hospital which elects to operate a pharmacy for other than its own use is subject to the requirements for a general pharmacy license. If the hospital’s pharmacy services for other than its own use are special or limited, the board may issue a special or limited-use pharmacy license or a telepharmacy license pursuant to subsection 3.
    Sec. 2.  Section 155A.13A, subsection 2, Code 2014, is amended to read as follows:
   2.  License renewal.  A nonresident pharmacy shall renew its license on or before January 1 annually. In order to renew a nonresident pharmacy license, a nonresident pharmacy shall submit a renewal application and fee as determined by the board, and shall fulfill all of the requirements of subsection 1, paragraphs “b” through “e”. A nonresident pharmacy shall pay an additional fee for late renewal as determined by the board.
    Sec. 3.  Section 155A.13A, Code 2014, is amended by adding the following new subsections:
   NEW SUBSECTION.  2A.  Pharmacist licensure requirement. At least one pharmacist employed by the nonresident pharmacy, who shall be designated the pharmacist in charge of the nonresident pharmacy, shall maintain a current license to practice pharmacy in Iowa during any period that the nonresident pharmacy is licensed by the board.
   NEW SUBSECTION.  2B.  Sterile compounding practice. A nonresident pharmacy that engages in the preparation of any sterile compounded product for dispensing to or for a patient located in Iowa shall comply with rules relating to sterile compounding practices adopted by the board. A nonresident pharmacy engaging in sterile compounding shall pay an amount necessary to cover the board’s costs of conducting periodic inspections of the pharmacy’s operations. Costs recovered pursuant to this subsection shall be considered repayment receipts as defined in section 8.2.
   NEW SUBSECTION.  2C.  Inspections. The board may inspect the premises and practices of any applicant for a new nonresident pharmacy license or for renewal of a nonresident pharmacy license.
    Sec. 4.  Section 155A.13A, subsection 3, Code 2014, is amended to read as follows:
   3.  Discipline.  The board may deny an application for a new or renewal of a nonresident pharmacy license if an agent of the board is refused access to the pharmacy or pharmacy records for the purpose of conducting a periodic inspection or investigation.  The board may deny, suspend, or revoke a nonresident pharmacy license for any violation of this section, section 155A.15, subsection 2, paragraph “a”, “b”, “d”, “e”, “f”, “g”, “h”, or “i”, chapter 124, 124A, 124B, 126, or 205, or a rule of the board.
    Sec. 5.  Section 155A.15, subsection 1, Code 2014, is amended to read as follows:
   1.  a.  A pharmacy subject to section 155A.13 shall not be operated until a license or renewal certificate has been issued to the pharmacy by the board.
   b.  A pharmacy subject to section 155A.13A shall not offer or provide pharmaceutical services to patients located in Iowa until a license or renewal certificate has been issued to the pharmacy by the board.
EXPLANATION
The inclusion of this explanation does not constitute agreement with

the explanation’s substance by the members of the general assembly.
   This bill relates to in-state special or limited-use pharmacy licensure and nonresident pharmacy practices, licensure, and discipline. The bill eliminates references to special pharmacy licenses. The bill allows the board of pharmacy to issue telepharmacy licenses pursuant to the rules of the board.
   The bill amends the requirements and practices for licensure of a nonresident pharmacy. A licensed nonresident pharmacy must submit an application for renewal of its license. The bill also requires the pharmacist in charge of a nonresident pharmacy to have a license to practice pharmacy in Iowa. The bill prohibits a nonresident pharmacy from providing pharmaceutical services to a patient in Iowa until the pharmacy is licensed by the board.
   The bill requires pharmacies to comply with the rules of the board for the preparation of sterile compounding products when engaging in the sterile compounding of any product for dispensing to or for a patient located in Iowa and also requires these pharmacies to pay the board’s costs in conducting inspections of the nonresident pharmacy’s sterile compounding operations. The bill authorizes the board to inspect the premises and practices of applicants for a new nonresident pharmacy license or for renewal of a nonresident pharmacy license.
   The bill states that the board may deny an application for a new or renewal of a nonresident pharmacy license if the pharmacy refuses the board access to the pharmacy or pharmacy records.
   The bill adds to the list of violations that could lead to a denial, suspension, or revocation of a nonresident pharmacy’s license. These additional violations include operating a nonresident pharmacy without a license and a violation by the pharmacy or a pharmacist of any provision in the pharmacy chapter or rule adopted pursuant to the chapter.