SF 240 (LSB 2466XS (3) 91)

SENATE FILE 240

BY  CAMPBELL

A BILL FOR

An Act relating to the inspection of compounding pharmacies, and making penalties applicable.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  Section 22.7, Code 2025, is amended by adding the following new subsection:
   NEW SUBSECTION.  76.  Records relating to the investigation and remediation of an infraction at a compounding facility engaging in the compounding of nonsterile preparations as provided in section 155A.15A.
    Sec. 2.  NEW SECTION.  155A.15A  Compounding facilities —— inspections —— penalties.
   1.  a.  If an inspector employed by the board discovers during the course of an inspection that a compounding facility engaging in the compounding of nonsterile preparations is out of compliance with the requirements of United States pharmacopeia general chapter 795, the inspector shall notify the pharmacist in charge of the compounding facility of the infraction that the pharmacist in charge must correct.
   b.  If an inspector employed by the board discovers during the course of an inspection conducted not less than thirty days, or more than ninety days, after the date of an inspection described in paragraph “a” that the infraction identified pursuant to paragraph “a” has not been corrected, the inspector shall provide comprehensive instruction regarding the infraction and the correction of the infraction to the pharmacist in charge.
   c.  If an inspector employed by the board discovers during the course of an inspection conducted not less than thirty days, or more than ninety days, after an inspection described in paragraph “b” that the infraction identified pursuant to paragraph “a” has not been corrected, the inspector shall prescribe mandatory education for the pharmacist in charge for the correction of the infraction.
   2.  If a compounding facility engaging in the compounding of nonsterile preparations does not correct an infraction as provided in subsection 1, the board may impose a single fine not to exceed five hundred dollars, which shall be adjusted for inflation, as defined in section 668.15A, by the board by rule on January 1 of each even-numbered year. The board shall not impose any other fine or remedy for a violation of this section. This subsection shall not affect damages available in tort, contract, or otherwise for a violation of this section.
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 the investigation and remediation of infractions at compounding facilities (facility) engaging in the compounding of nonsterile preparations. The bill requires an inspector employed by the board of pharmacy (board) who discovers during the course of an inspection that a facility engaging in the compounding of nonsterile preparations is out of compliance with the United States pharmacopeia general chapter 795 to notify the pharmacist in charge of the infraction. If an inspector discovers at a subsequent inspection that the infraction has not been corrected, the bill requires the inspector to provide comprehensive instruction regarding the infraction and the correction of the infraction to the pharmacist in charge. If an inspector discovers at a third inspection that an infraction has not been corrected, the bill requires the inspector to prescribe mandatory education for the correction of the infraction to the pharmacist in charge.
   The bill allows the board to impose a single fee of not more than $500, adjusted for inflation, on a facility that fails to correct an infraction as provided in the bill. The bill makes records relating to the investigation and remediation of infractions pursuant to the bill confidential records that are not subject to examination by the public.