Iowa Admin. Code r. 657-21.2

Current through Register Vol. 47, No. 6, September 18, 2024
Rule 657-21.2 - Definitions

For the purpose of this chapter, the following definitions shall apply:

"Automated data processing system " means an application that is used for prescription, patient, drug, and prescriber information; installed on a pharmacy's computer or server; and controlled by the pharmacy.

"Automated medication distribution system" or "AMDS" includes, but is not limited to, an automated device or series of devices operated by an electronic interface with one or more computers that is used to prepare, package, or dispense specified dosage units of drugs for administration or dispensing. "AMDS" does not include electronic storage devices that do not have an electronic interface with one or more computers of the pharmacy.

"CSA " means the Iowa uniform controlled substances Act.

"CSA registration " means the registration issued by the board pursuant to the CSA that signifies the registrant's authorization to engage in registered activities with controlled substances.

"DEA " means the U.S. Department of Justice, Drug Enforcement Administration.

"Electronically prepared prescription " means a prescription that is generated utilizing an electronic prescription application.

"Electronic device" means an electronic, mechanical, or other device which is used to intercept communications and includes but is not limited to network, file and print servers; desktop workstations; laptop computers; tablets; mini-computers; smart phones; and similar devices.

"Electronic prescription" means an electronically prepared prescription that is authorized and transmitted from the prescriber to the pharmacy by means of electronic transmission.

"Electronic prescription application " means software that is used to create electronic prescriptions and that is intended to be installed on a prescriber's computers and servers where access and records are controlled by the prescriber.

"Electronic signature" means a confidential personalized digital key, code, number, or other method used for secure electronic data transmissions which identifies a particular person as the source of the message, authenticates the signatory of the message, and indicates the person's approval of the information contained in the transmission.

"Electronic transmission " means the transmission of an electronic prescription, formatted as an electronic data file, from a prescriber's electronic prescription application to a pharmacy's computer, where the data file is imported into the pharmacy prescription application.

"Facsimile transmission " or "fax transmission " means the transmission of a digital image of a prescription from the prescriber or the prescriber's agent to the pharmacy. "Facsimile transmission" includes but is not limited to transmission of a written prescription between the prescriber's fax machine and the pharmacy's fax machine; transmission of an electronically prepared prescription from the prescriber's electronic prescription application to the pharmacy's fax machine or printer; or transmission of an electronically prepared prescription from the prescriber's fax machine to the pharmacy's fax machine, computer, or printer.

"Intermediary " means any technology system that receives and transmits an electronic prescription between the prescriber and the pharmacy.

"Pharmacist verification " or "verified by a pharmacist" means the accuracy of a prescription drug is verified by a pharmacist, pharmacist-intern, or technician in an approved technician product verification program.

"Prescription drug order" or "prescription " means a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacy, regardless of whether the communication is oral, electronic, via facsimile, or in printed form.

"Readily retrievable " means that hard-copy or electronic records can be separated out from all other records within 72 hours of a request from the board or other authorized agent.

"Written prescription" means a prescription that is created on paper, a prescription that is electronically prepared and printed, or a prescription that is electronically prepared and transmitted from the prescriber's electronic device to a pharmacy via facsimile. A written prescription for a controlled substance shall be manually signed by the prescriber in compliance with federal and state laws, rules, and regulations.

Iowa Admin. Code r. 657-21.2

ARC 9912B, IAB 12/14/11, effective 1/18/12
Amended by IAB February 14, 2018/Volume XL, Number 17, effective 3/21/2018
Amended by IAB July 31, 2019/Volume XLII, Number 3, effective 9/4/2019
Amended by IAB March 25, 2020/Volume XLII, Number 20, effective 4/29/2020