Iowa Admin. Code r. 657-18.3

Current through Register Vol. 47, No. 8, October 30, 2024

Rule 657-18.3 - General requirements

(1)Essential qualifications. An originating pharmacy may outsource prescription drug filling to a central fill pharmacy or prescription drug order processing to a central processing pharmacy provided the pharmacies:

a. Have the same owner or have entered into a written contract or agreement, which is available for inspection and copying by the board or its authorized agent, that outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws, rules, and regulations; and

b. Share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to perform the contracted functions.

(2)Legal compliance. An originating pharmacy, a central fill pharmacy, and a central processing pharmacy shall comply with all provisions applicable to the pharmacy contained in federal and state laws, rules, and regulations to the extent applicable for the specific filling or processing activity and these rules, including but not limited to the following:

a. Each pharmacy located within Iowa shall maintain Iowa pharmacy licensure and, if the pharmacy dispenses controlled substances, the pharmacy shall maintain DEA and Iowa controlled substances registrations.

b. Each pharmacy located outside Iowa shall maintain Iowa nonresident pharmacy licensure in addition to the licensure requirements of the pharmacy's home state.

c. Each pharmacist providing centralized prescription drug order processing or filling functions as an employee or agent of a central processing or central fill pharmacy located within Iowa shall maintain active licensure to practice pharmacy in Iowa.

d. Pharmacies shall comply with Iowa board rules relating to the duties that must be performed by a pharmacist.

e. Pharmacies shall comply with Iowa requirements for supervision of pharmacy technicians and pharmacy support persons.

(3)Originating pharmacy responsibility. Except as specifically provided by this subrule, the originating pharmacy shall be responsible for all dispensing functions as the term "dispense" is defined in rule 657-18.2 (155A). An originating pharmacy contracting only for centralized filling shall retain responsibility for all processing functions, and an originating pharmacy contracting only for centralized processing shall retain responsibility for all filling functions.

a. A mail order pharmacy engaged in the centralized filling of prescription drug orders may deliver a filled prescription directly to the patient and shall not be required to return the filled prescription to the originating pharmacy.

b. A central fill or a central processing pharmacy that shares a common central processing unit with the originating pharmacy may perform prospective drug use review (DUR) pursuant to rule 657-8.21 (155A). Only a pharmacist shall perform the DUR, and such review shall not be delegated. The pharmacist performing the DUR shall document in the shared patient record all concerns, recommendations, observations, and comments resulting from that review. The pharmacist at the originating pharmacy shall utilize the DUR notes in counseling the patient pursuant to rule 657-6.14 (155A).

(4)Central fill label requirements. The label affixed to the prescription container filled by a central fill pharmacy on behalf of an originating pharmacy shall include the following:

a. A unique identifier indicating that the prescription was filled at the central fill pharmacy;

b. Serial number (a unique identification number of the prescription) as assigned by the originating pharmacy;

c. The name, address, and telephone number of the originating pharmacy;

d. The name of the patient or, if such drug is prescribed for an animal, the species of the animal and the name of its owner, except as provided in 657-subrule 8.19(7) for epinephrine auto-injectors, 657-subrule 8.19(8) for opioid antagonists, 657-subrule 8.19(9) for expedited partner therapy, or 657-subrule 8.19(10) for bronchodilator canisters or bronchodilator canisters and spacers.

e. The name of the prescribing practitioner;

f. The date the prescription is filled by the central fill pharmacy;

g. The directions or instructions for use, including precautions to be observed;

h. Unless otherwise directed by the prescriber, the name, strength, and quantity of the drug dispensed.

(1) If a pharmacist selects an equivalent drug product for a brand name drug product prescribed by a practitioner, the prescription container label shall identify the generic drug and may identify the brand name drug for which the selection is made, such as "(generic name) Generic for (brand name product)";

(2) If a pharmacist selects a brand name drug product for a generic drug product prescribed by a practitioner, the prescription container label shall identify the brand name drug product dispensed and may identify the generic drug product ordered by the prescriber, such as "(brand name product) for (generic name)";

(3) If a pharmacist selects an interchangeable biological product for the biological product prescribed by a practitioner, the prescription container label shall identify the interchangeable biological product dispensed and may identify the biological product prescribed by the practitioner, such as "(interchangeable biological product) for (biological product)";

i. The initials or other unique identification of the pharmacist who performed drug use review, unless the identification of the pharmacist involved in each step of the prescription filling process is electronically documented and retrievable.

Iowa Admin. Code r. 657-18.3

ARC 8673B, IAB 4/7/10, effective 6/1/10

Amended by IAB June 20, 2018/Volume XL, Number 26, effective 7/25/2018

Amended by IAB August 29, 2018/Volume XLI, Number 5, effective 10/3/2018

Amended by IAB February 12, 2020/Volume XLII, Number 17, effective 3/18/2020

Amended by IAB March 22, 2023/Volume XLV, Number 19, effective 4/26/2023