CHAPTER 18
CENTRALIZED PRESCRIPTION FILLING AND PROCESSING
657—18.1(155A) Purpose and scope. The purpose of this chapter is to provide standards for centralized prescription drug order filling or centralized prescription processing by a pharmacy. Any facility established for the purpose of filling or processing prescription drug orders on behalf of other pharmacies shall be licensed as a pharmacy and shall hold all necessary registrations. A hospital pharmacy may participate in centralized prescription filling only of prescription drug orders for noncontrolled substances pursuant to these rules. A hospital pharmacy may engage in centralized prescription processing pursuant to the requirements of rule 657—7.7(155A). Except as specifically identified in the rules, the requirements of these rules for centralized prescription filling or centralized prescription processing are in addition to the requirements of 657—Chapters 6, 7, and 8, and other rules of the board relating to services provided by pharmacies.
657—18.2(155A) Definitions. For the purposes of this chapter, the following definitions shall apply:
“Central fill pharmacy” means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating pharmacy, that provides centralized prescription drug order filling on behalf of the originating pharmacy pursuant to these rules.
“Centralized prescription drug order filling” or “centralized filling” means the filling of a prescription drug order by a pharmacy on behalf of another pharmacy. “Centralized filling” does not include the processing or dispensing of a prescription drug order but may include any of the following filling functions:
	1.	Receiving prescription drug orders from the originating pharmacy;
	2.	Interpreting or clarifying prescription drug orders;
	3.	Entering prescription drug order information into a pharmacy’s prescription record system;
	4.	Selecting, counting, and placing the prescribed drug into an appropriate prescription container;
	5.	Affixing the prescription label, including any auxiliary labels, to the prescription container;
	6.	Obtaining refill and substitution authorizations;
	7.	Verifying all filling processes performed by the central fill pharmacy.
“Centralized prescription drug order processing” or “centralized processing” means the processing of a prescription drug order by a pharmacy on behalf of another pharmacy. “Centralized processing” does not include the filling or dispensing of a prescription drug order but may include any of the following processing functions:
	1.	Interpreting or clarifying prescription drug orders;
	2.	Entering prescription drug order information into a pharmacy’s prescription record system;
	3.	Interpreting clinical data for prior authorization for dispensing;
	4.	Performing formulary-directed therapeutic interchange.
“Central processing pharmacy” means a pharmacy contracting with an originating pharmacy, or having the same owner as an originating pharmacy, that provides centralized prescription drug order processing on behalf of the originating pharmacy pursuant to these rules.
“DEA” means the U.S. Department of Justice, Drug Enforcement Administration.
“Dispense” means the delivery of a prescription drug or device to an ultimate user or the ultimate user’s agent by or pursuant to the lawful order of a practitioner. “Dispense” includes:
	1.	Receiving the prescription drug order from the patient, the patient’s agent, or the prescriber;
	2.	Delivering the filled prescription to the patient or the patient’s agent;
	3.	Providing drug information concerning a patient’s drug therapy;
	4.	Providing patient counseling;
	5.	Providing medication therapy management.
“Hospital” means a facility licensed pursuant to Iowa Code chapter 135B.
“Hospital pharmacy” means and includes a pharmacy licensed by the board and located within any hospital, health system, institution, or establishment which maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may or may not be admitted for overnight stay at the facility.
“Mail order pharmacy” means a pharmacy located within a United States jurisdiction whose primary business is to dispense a prescription drug or device pursuant to a valid prescription drug order and to deliver the drug or device to a patient, including a patient in this state, via the United States Postal Service, a common carrier, or a delivery service. “Mail order pharmacy” includes a pharmacy that does business via the Internet or other electronic media.
“Medication therapy management” means the review of drug therapy regimens of a patient by a pharmacist for the purpose of evaluating and rendering advice to a practitioner, or for the purpose of evaluating and modifying the drug regimen in accordance with a collaborative drug therapy management protocol pursuant to rule 657—8.34(155A).
“Originating pharmacy” means a pharmacy that receives a prescription drug order from a patient, the patient’s agent, or a prescriber, outsources prescription filling or processing functions to another pharmacy, and ultimately dispenses the prescription drug or device to the patient or the patient’s agent.
657—18.3(155A) General requirements.
	18.3(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 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.
	18.3(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.
	18.3(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 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; the review shall not be delegated to a pharmacy technician, registered nurse, or other pharmacy support person. 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).
	18.3(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;
	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)”;
	i. 	The initials or other unique identification of the pharmacist in the originating pharmacy who performed drug use review and transmitted the prescription drug order to the central fill pharmacy.
[ARC 8673B, IAB 4/7/10, effective 6/1/10]
657—18.4 Reserved.
657—18.5(155A) Patient notification and authorization.
	18.5(1) Prior notification and authorization. A pharmacy that outsources prescription drug order filling or prescription drug order processing to another pharmacy shall, prior to outsourcing a patient’s prescription:
	a. 	Notify the patient or the patient’s agent that prescription filling or processing may be outsourced to another pharmacy.
	b. 	Provide the name of the pharmacy that will be filling or processing the prescription or, if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may fill or process the prescription, the patient shall be notified of this fact. Notification shall be provided through a notice to the patient or the patient’s agent by means of a sign prominently displayed in the originating pharmacy and through written notice provided to the patient or the patient’s agent prior to implementation of the program or upon commencement of services to a new patient, as applicable.
	c. 	If a patient provides the originating pharmacy with notification that the patient no longer authorizes the originating pharmacy to outsource the patient’s prescription drug orders, the originating pharmacy shall discontinue outsourcing the filling or processing of the patient’s prescription drug orders.
	18.5(2) Exception. The provisions of this rule do not apply to a patient in a facility, such as a hospital or long-term care facility, where Iowa law requires that drugs be administered to the patient by a health care professional.
657—18.6 to 18.9 Reserved.
657—18.10(155A) Policy and procedures.
	18.10(1) Manual maintained. A policy and procedure manual relating to centralized filling or centralized processing activities shall be maintained at all pharmacies involved in centralized filling or centralized processing and shall be available for inspection and copying by the board or an agent of the board.
	18.10(2) Manual contents. The manual shall:
	a. 	Outline the responsibilities of each of the pharmacies;
	b. 	Include a list of the names, addresses, telephone numbers, and all license and registration numbers of the pharmacies involved in centralized filling or centralized processing;
	c. 	Include evidence that all licenses and registrations have been verified to be current and in good standing, identifying the individual verifying license and registration status and the method used to verify status; and
	d. 	Include, but not necessarily be limited to, policies and procedures for:
	(1)	Protecting the confidentiality and integrity of patient information;
	(2)	Protecting each patient’s freedom of choice of pharmacy services;
	(3)	Maintaining appropriate records to identify the name, the initials or unique identification code, and the specific activities of each pharmacist or pharmacy technician who performed any centralized filling or centralized processing function;
	(4)	Complying with federal and state laws, rules, and regulations;
	(5)	Operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
	(6)	Reviewing, at least annually, the written policies and procedures and documenting that review.
657—18.11 to 18.14 Reserved.
657—18.15(155A) Records. Central fill or central processing pharmacies shall maintain appropriate records that identify, by prescription drug order, the name and initials or unique identification code of each pharmacist or pharmacy technician who performs a centralized filling or centralized processing function for a prescription drug order. Originating pharmacies shall maintain appropriate records that identify, by prescription drug order, the name and initials or unique identification code of the pharmacist who performed drug use review and the pharmacist who transmitted the prescription drug order to the central fill or central processing pharmacy. These records may be maintained separately by each pharmacy or in a common electronic file as long as the data processing system is capable of producing a printout that lists the functions performed by each pharmacy and pharmacist or technician and identifies the pharmacist or technician who performed each function.
These rules are intended to implement Iowa Code sections 124.301, 124.306, 124.308, 155A.13, and 155A.28.
[Filed 6/2/05, Notice 1/19/05—published 6/22/05, effective 7/27/05]
[Filed 3/6/08, Notice 12/19/07—published 3/26/08, effective 4/30/081]
[Filed emergency 6/9/08—published 7/2/08, effective 7/9/08]
[Filed 11/24/08, Notice 10/8/08—published 12/17/08, effective 1/21/09]
[Filed ARC 8673B (Notice ARC 8380B, IAB 12/16/09), IAB 4/7/10, effective 6/1/10]
1	April 30, 2008, effective date of ARC 6671B delayed 70 days by the Administrative Rules Review Committee at its meeting held April 4, 2008.