Rulemaking Published

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Rulemaking Published

Date: June 1, 2022

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

Adopted 

ARC 6330C has been adopted and amends Chapter 6, “General Pharmacy Practice,” Chapter 8, “Universal Practice Standards,” and Chapter 10, “Controlled Substances.” 

  • The rulemaking:
    • Provides minimum security and monitoring system requirements to be utilized by Iowa pharmacies to prevent and detect unauthorized access to prescription drugs and records;
    • Requires an exact measure or count of all controlled substances for a controlled substance inventory count (with the exception of liquids in non incremented containers which can be estimated to the nearest one-quarter container);
    • Requires a program to be established to monitor and ensure controlled substance accountability, including reconciliation of schedule II substances following each transaction and one or more measures to ensure accountability of schedule III-V substances; 
    • Requires development and implementation of a corrective action plan following the report of a theft or loss of controlled substances, including by robbery; and
    • Requires a controlled substance inventory be taken with each change in pharmacist in charge (PIC), including when the PIC is interim or temporary.
  • The rulemaking will be effective July 6, 2022, with the requirements for a basic alarm system and video surveillance system required no later than July 6, 2023.

ARC 6331C has been adopted and amends Chapter 20, “Compounding Practices.”

  • The rulemaking allows veterinarians who have obtained compounded preparations for office stock use to dispense the compounded preparations to the owner of a veterinary patient to treat an immediate medical need when:
    • Timely access to a patient-specific supply of compounded medication is not available,
    • No commercially available product can meet the patient’s need,
    • Lack of treatment will likely result in patient harm; and 
    • The supply does not exceed 14 days.
  • The rulemaking will be effective July 6, 2022.

Noticed

ARC 6333C has been filed for Notice of Intended Action and proposes to amend Chapter 20, “Compounding Practices.”

  • The proposed amendment requires documentation of ingredient source, lot and expiration date and the steps involved in the compounding process for all nonsterile and sterile compounded preparations as well as separates the rule into subrules for clarity.
  • Public comment may be submitted until 4:30pm on June 21, 2022 via the link above.
  • A public hearing will be held at the Board office on June 23, 2022 at 10am.

ARC 6334C has been filed for Notice of Intended Action and proposes to amend Chapter 10, “Controlled Substances.”

  • The rulemaking temporarily places seven substances (synthetic opioid-related substances) into schedule I and one (an FDA-approved medication to treat insomnia)  into schedule IV of the Iowa CSA in response to similar action taken by the DEA.
  • Public comment may be submitted until 4:30pm on June 21, 2022 via the link above.