ARC 1307C
PHARMACY BOARD[657]
Adopted and Filed
Pursuant to the authority of Iowa Code section 147.76, the Board of Pharmacy hereby amends Chapter 11, “Drugs in Emergency Medical Service Programs,” Iowa Administrative Code.
The amendment permits a pharmacy that utilizes a decentralized automated medication distribution system (AMDS) to authorize specific members of an emergency medical service program to replenish the service program’s drug supplies from the AMDS. The amendment requires that a pharmacist verify the drugs to be stocked in the AMDS before the drugs are removed from the pharmacy and requires that authorized service program personnel be assigned unique identification and access codes limiting access to specific drugs authorized for use by the service program. The amendment also requires a pharmacist to verify and document verification of the access and removal of drugs by service program personnel within 72 hours of such access.
Requests for waiver or variance of the discretionary provisions of these rules will be considered pursuant to 657—Chapter 34.
Notice of Intended Action was published in the October 2, 2013, Iowa Administrative Bulletin as ARC 1039C. The Board received no written comments regarding the proposed amendment. The adopted amendment is identical to that published under Notice.
The amendment was approved during the January 14, 2014, meeting of the Board of Pharmacy.
After analysis and review of this rule making, no impact on jobs has been found.
This amendment is intended to implement Iowa Code chapter 147 and Iowa Code sections 124.301 and 155A.13.
This amendment will become effective on March 12, 2014.
The following amendment is adopted.
	Amend subrule 11.20(1) as follows:
	11.20(1) Pharmacy-based. The pharmacist in charge, the medical director, and the service director shall jointly develop a list of drugs to be maintained for administration by the service program. The pharmacy shall maintain an accurate list of all prescription drugs including controlled substances that the pharmacy maintains at the primary program site and at any program substation.
	a. 	No change.
	b. 	Replenishment using automated medication distribution system (AMDS). A pharmacy utilizing a decentralized automated medication distribution system (AMDS) pursuant to 657—Chapter 9 may authorize replenishment of the service program’s drug supplies from the AMDS provided that a pharmacist verifies the drugs stocked in the AMDS component before the drugs are removed from the pharmacy. Service program personnel authorized to remove drugs from the AMDS for restocking the service program’s supplies shall be assigned a unique identification and access code for the purpose of accessing the AMDS. Access by authorized service program personnel shall be restricted to specific drug products authorized for use by the service program. A pharmacist shall, within 72 hours, verify the access of and removal of drugs from the AMDS by service program personnel and shall maintain documentation of that verification within the pharmacy records.
	b.  c.	Inspections. The pharmacist in charge shall ensure the completion of a monthly inspection of all prescription drugs maintained by the pharmacy at the primary program site and any program substation. Inspection shall include the removal of outdated or adulterated drugs. All drugs removed from administration stock shall be returned to the pharmacy. Records of inspection shall be maintained for two years at the pharmacy. The pharmacist in charge may delegate the conduct of the monthly inspection to another pharmacist, a pharmacist-intern, a certified pharmacy technician, or the service director.
[Filed 1/16/14, effective 3/12/14]
[Published 2/5/14]
Editor’s Note: For replacement pages for IAC, see IAC Supplement 2/5/14.