Rulemaking Published

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

Adopted 

ARC 6416C has been adopted and amends Chapter 3, “Pharmacy Technicians”, and Chapter 6, “General Pharmacy Practice”.

• The rulemaking provides for  pharmacist delegation of technical functions relating to prescription processing activities under specific conditions (e.g., data entry or insurance processing) to an Iowa-registered certified pharmacy technician who is performing the delegated functions at a location other than where the pharmacist is physically located, seeking to continue the practice initiated under the pandemic’s public health emergency, which require: 
• Adequate security and supervision at all times to prevent unauthorized access to, and unauthorized storage/transfer of, confidential patient information or patient records,
• The supervising pharmacist having real-time access to the prescription processing system the technician is using or patient records which the technician is processing,
• The technician having access to the supervising pharmacist via a real-time communication mechanism, and 
• The prescription processing system documentation of the functions performed by the technician.
• The rulemaking becomes effective August 31, 2022.

ARC 6417C has been adopted and amends Chapter 8, “Universal Practice Standards”, and Chapter 19, “Nonresident Pharmacy Practice”.

• The rulemaking provides:
• Modification of the handling of ownership changes for resident and nonresident pharmacies, 
• A requirement that nonresident pharmacies that directly dispense to Iowa patients provide evidence of a toll-free telephone number with access to a pharmacist who has access to the patient’s records during the pharmacy’s regular business hours, and
• The process by which a pharmacy can temporarily relocate pharmacy operations in response to an exceptional circumstance or disaster rendering the pharmacy unsafe.
• The rulemaking becomes effective August 31, 2022.

ARC 6418C has been adopted and amends Chapter 12, “Precursor Substances”.

• The amendment adds one chemical as a precursor substance in response to similar action taken by the federal Drug Enforcement Administration.
• The rulemaking becomes effective August 31, 2022.

Notice of Intended Action

ARC 6421C has been published as a Notice of Intended Action to amend Chapter 23, “Care Facility Pharmacy Practice.” 

• The proposed amendment (a result of an overall 5-year review and subsequent recommendation from a care facility pharmacy stakeholder) provides a time frame for a care facility to submit documentation to the provider pharmacy relating to the administration of vaccines provided by the pharmacy for an immunization or screening program.

• Comments may be submitted until 4:30pm on August 16, 2022.

ARC 6422C has been published as a Notice of Intended Action to amend Chapter 41, “Outsourcing Facilities”.

• The proposed amendments (a result of an overall 5-year review) provides:
• More detailed information for applicants relating to the inspection requirement provided in Iowa law,
• Clarification on when a change of ownership is determined to have occurred which necessitates a license change,
• Late penalty fees to be assessed when an outsourcing facility is not timely in submitting an application for license changes, and
• A fee to be assessed to a licensee for written verification of a license when the Board’s online verification system is available at no charge.
• Comments may be submitted until 4:30pm on August 16, 2022.

ARC 6423C has been published for Notice of Intended Action to amend Chapter 14, “Public Information and Inspection of Records”.

• The proposed amendments (a result of an overall 5-year review) update the manner in which records are maintained by the Board and correct Iowa Code references.
• Comments may be submitted until 4:30pm on August 16, 2022.

ARC 6424C has been published for Notice of Intended Action to amend Chapter 12, “Precursor Substances”.

• The proposed amendment (a result of an overall 5-year review) provides updated application processes and corrects a cross-reference.
• Comments may be submitted until 4:30pm on August 16, 2022.

ARC 6425C has been published for Notice of Intended Action to amend Chapter 10, “Controlled Substances”.

• The proposed amendment temporarily places one substance (a new FDA-approved medication to treat seizures) into Schedule V of the Iowa CSA in response to similar action taken by the federal DEA.
• Comments may be submitted until 4:30pm on August 16, 2022.