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Rulemaking Published

Date

Rulemaking action by the Iowa Board of Pharmacy has been published in the Iowa Administrative Bulletin as follows: 

Adopted 

ARC 6174C has been adopted and amends Chapter 39, “Expanded Practice Standards.” 

  • The rulemaking updates the board’s rule relating to collaborative pharmacy practice agreements with practitioners who have independent prescribing authority. The rule recognizes a health system’s P&T committee in establishing CPAs with pharmacists and requires documentation of a pharmacist’s review of the CPA which documentation is not required to be maintained in the pharmacy.
  • The rulemaking becomes effective March 16, 2022.

Notice of Intended Action

ARC 6178C has been published as a Notice of Intended Action to amend Chapter Chapter 20, “Compounding Practices.” 

  • The proposed amendments:
    • Would allow a veterinarian who has obtained compounded preparations for office stock to further dispense the compounded preparation to an owner of a veterinary patient to treat an immediate medical need when the following conditions are met:
      • Timely access to a patient-specific supply of compounded medication is not accessible,
      • No commercially available product can meet the need of the patient,
      • Lack of treatment will likely result in patient harm, and
      • When the supply does not exceed 14 days.
  • Comments may be submitted until 4:30pm on March 1, 2022.

ARC 6179C has been published as an Amended Notice of Intended Action to amend Chapter 6, “General Pharmacy,” Chapter 8, “Universal Practice Standards,” and Chapter 10, “Controlled Substances.” 

  • The proposed amendments:
    • Provide minimum security and monitoring system requirements; 
    • Require an exact count or measure of all schedules of controlled substances for a controlled substance inventory count;
    • Require a system be established to monitor controlled substance accountability;
    • Require development and execution of a corrective action plan following the report of the theft or loss of controlled substances; and 
    • Require a controlled substance inventory to be taken with each change in pharmacist in charge.
  • The rulemaking had been originally published as a Notice of Intended Action on August 11, 2021 and the board received a number of comments in response. After review of the public comments, the board made significant changes to the proposed amendments to revise, or remove entirely, some of the proposed requirements. The changes include:
    • Removal of the provision allowing a pharmacist to delegate the dispensing of a prescription which requires patient counseling while the pharmacist is on a break;
    • Modification of the requirement to maintain a basic alarm and video surveillance system by allowing each pharmacy to determine utilization commensurate with the pharmacy operation; 
    • Modification of the requirement to maintain accountability of schedules III-V controlled substances by providing a range of options for the registrant to utilize; 
    • Addition of a requirement to develop and implement a corrective action plan in response to a report of theft or loss which addresses the conditions which contributed to the theft or loss; and 
    • Modification of the requirement to conduct a controlled substance inventory count at each change of pharmacist in charge, including when the incoming pharmacist in charge is interim or temporary. 
  • Comments may be submitted until 4:30pm on March 1, 2022.
  • A public hearing will be held at the Board offices as well as via Zoom at 10:00am on March 3, 2022.