reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 18 - Centralized Prescription Filling and Processing › Rule 657-18.10 - Policy and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to rule
				657-8.3
				(155A), 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 its authorized agent. The
				manual shall:
1. Outline the
			 responsibilities of each of the pharmacies;
2. 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; and
3. Include, but not necessarily be limited
			 to, policies and procedures for:
* Protecting the confidentiality and integrity of patient
				information;
* Protecting each patient's freedom of choice of pharmacy
				services;
* 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; and
* 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.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 18 - Centralized Prescription Filling and Processing › Rule 657-18.15 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
Central fill or central processing pharmacies shall maintain
				appropriate records that identify, by prescription drug order, the 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 initials or unique
				identification code of the pharmacist who performed drug use review. 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.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.1 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
"Board"
means the Iowa board of
				pharmacy.
"FDA"
means the United States Food and Drug
				Administration.
"Home state"
means the state in which a
				pharmacy is located.
"Nonresident pharmacy"
means a pharmacy
				located outside the state of Iowa that delivers, dispenses, or distributes, by
				any method, prescription drugs, devices, or pharmacy services to or intended
				for an ultimate user physically located in this state, including a pharmacy
				which engages in central fill or central processing functions as described in
				657-Chapter 18 on behalf of a pharmacy located in Iowa.
"Nonresident pharmacy license"
means a
				pharmacy license issued to a nonresident pharmacy.
"Pharmacy services"
includes, but is not
				limited to, nonproduct services provided by an Iowa-licensed pharmacist or a
				pharmacist practicing at an Iowa-licensed nonresident pharmacy, such as patient
				counseling and drug information, pharmaceutical care, and assessment of health
				risks.
"Registered pharmacist in charge"
means the
				pharmacist in charge at the nonresident pharmacy who is registered with the
				board and is legally responsible for the operation of the nonresident pharmacy
				with respect to the provision of prescription drugs, devices, or pharmacy
				services to patients located in Iowa.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.2 - Nonresident Pharmacy License

Current through Register Vol. 47, No. 3, July 24, 2024
A nonresident pharmacy shall apply for and obtain, pursuant to
				provisions of rule 657-8.35 (155A), a nonresident
				pharmacy license from the board prior to providing prescription drugs, devices,
				or pharmacy services to an ultimate user in this state. All requirements of
				rule 657-8.35 (155A) regarding
				licensure are applicable to nonresident pharmacies unless otherwise provided in
				this rule. Any pharmacy that dispenses controlled substances to Iowa residents
				shall also register pursuant to 657-Chapter 10.
(1)
Inspection requirements.
In lieu of the inspection requirement identified in 657-subrule 8.35(4), a
			 nonresident pharmacy submitting any application for licensure, except when
			 related to a change in location, shall submit with its application and fee an
			 inspection report that satisfies the following requirements:
a. Less than two years have passed since the
			 date of the inspection and the inspection report is the most recent inspection
			 report available that satisfies the requirements of these rules.
b. The inspection occurred while the pharmacy
			 was in operation. An inspection prior to the initial opening of the pharmacy
			 shall not satisfy this requirement.
c. The inspection report addresses all
			 aspects of the pharmacy's business that will be utilized in Iowa.
d. The inspection was performed by or on
			 behalf of the home state licensing authority, if available.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.3 - Registered Pharmacist in Charge

Current through Register Vol. 47, No. 3, July 24, 2024
The permanent pharmacist in charge of the nonresident pharmacy
				shall be designated as such on the nonresident pharmacy license application.
				Unless currently licensed in Iowa, the pharmacist in charge shall be registered
				with the board. The pharmacist in charge shall submit a completed application
				and a registration fee of $75. The registration shall expire on December 31
				following the date of issuance of the registration. An initial registration
				issued between November 1 and December 31 shall not require renewal until the
				following calendar year.
(1)
Registered pharmacist in charge application.
The pharmacist in
			 charge of an Iowa-licensed nonresident pharmacy who is not currently actively
			 licensed to practice pharmacy in Iowa shall be registered with the board. The
			 pharmacist in charge shall submit to the board an application that includes the
			 following information:
a. The pharmacist's
			 name and contact information.
b.
			 The pharmacist's license or registration number in the state in which the
			 nonresident pharmacy is located.
c.
			 The pharmacist's current place of employment.
d. Verification that the pharmacist's license
			 in the state in which the nonresident pharmacy is located is current and in
			 good standing.
e. Documentation
			 that the applicant has successfully completed the most current educational
			 training module approved by the board regarding the board's rules as they
			 relate to nonresident pharmacy practice.
f. Criminal and disciplinary history
			 information.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.4 - Applicability of Board Rules

Current through Register Vol. 47, No. 3, July 24, 2024
A nonresident pharmacy shall comply with all requirements of
				this chapter, 657-Chapter 8, and any other board rules relating to the services
				that are provided by the pharmacy to patients in Iowa.
(1)
Type of pharmacy
			 practice.
A nonresident pharmacy, based on the principal type of
			 pharmacy practice, shall comply with board rules as follows:
a. A "general pharmacy" as described in rule
			 657-6.1(155A) shall comply with all requirements of 657-Chapter 6.
b. A "hospital pharmacy" as described in rule
			 657-7.1(155A), excepting licensure pursuant to Iowa Code chapter 135B, shall
			 comply with all requirements of 657-Chapter 7.
c. A "limited use pharmacy" as described in
			 657-subrule 8.35(1) shall comply with all requirements of the limited use
			 pharmacy practice.
d. An
			 "outsourcing facility" as described in rule
			 657-41.2 (155A) shall
			 comply with all requirements of 657-Chapters 41 and 20.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.7 - Confidential Data

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to rule
				657-8.3
				(155A), each nonresident pharmacy shall have policies and procedures to ensure
				patient confidentiality and to protect patient identity and patient-specific
				information from inappropriate or nonessential access, use, or distribution
				pursuant to the requirements of rule 657-8.16(124,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.8 - Storage and Shipment of Drugs and Devices

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to rule
				657-8.3
				(155A), each nonresident pharmacy shall have policies and procedures to ensure
				compliance with rules
				657-8.7
				(155A) and 657-8.15(155A). Policies and procedures shall provide for the
				shipment of controlled substances via a secure and traceable method, and all
				records of such shipment and delivery to Iowa patients shall be maintained for
				a minimum of two years from the date of delivery.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.9 - Patient Record System, Prospective Drug Use Review, and Patient Counseling

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Patient
			 record system.
A patient record system shall be maintained pursuant to
			 rule
			 657-6.13
			 (155A) for Iowa patients for whom prescription drug orders are
			 dispensed.
(2)
Prospective
			 drug use review.
A pharmacist shall, pursuant to the requirements of
			 rule
			 657-8.21
			 (155A), review the patient record and each prescription drug order before
			 dispensing.
(3)
Patient
			 counseling.
Pursuant to rule
			 657-8.3
			 (155A), each nonresident pharmacy shall have policies and procedures to ensure
			 that Iowa patients receive appropriate counseling pursuant to the requirements
			 of rule
			 657-6.14
			 (155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.10 - Reporting Discipline and Criminal Convictions

Current through Register Vol. 47, No. 3, July 24, 2024
A nonresident pharmacy or registered pharmacist in charge shall
				provide notice to the board of any discipline imposed by any licensing
				authority on any license or registration held by the pharmacy or pharmacist in
				charge no later than 30 days after the final action. Discipline may include,
				but is not limited to, fine or civil penalty, citation or reprimand,
				probationary period, suspension, revocation, and voluntary surrender. A
				nonresident pharmacy or pharmacist in charge shall provide written notice to
				the board of any criminal conviction of the pharmacy, of any pharmacy owner, or
				of the pharmacist in charge that is related to prescription drugs or related to
				the operation of the pharmacy no later than 30 days after the conviction. The
				term "criminal conviction" includes instances when the judgment of conviction
				or sentence is deferred.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 19 - Nonresident Pharmacy Practice › Rule 657-19.11 - Discipline

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to 657-Chapter 36, the board may fine, suspend,
				revoke, or impose other disciplinary sanctions on a nonresident pharmacy
				license or pharmacist in charge registration for any of the following:
1. Any violation of the Federal Food, Drug,
			 and Cosmetic Act or federal regulations promulgated under the Act. A warning
			 letter issued by the FDA shall be conclusive evidence of a violation.
2. Any conviction of a crime related to
			 prescription drugs or the practice of pharmacy committed by the nonresident
			 pharmacy, pharmacist in charge, or individual owner, or if the pharmacy is an
			 association, joint stock company, partnership, or corporation, by any managing
			 officer.
3. Refusal of access to
			 the pharmacy or pharmacy records to an agent of the board for the purpose of
			 conducting an inspection or investigation.
4. Employing or continuing to employ a
			 pharmacist in charge without a current and active registration pursuant to rule
			 657-19.3(155A).
5. Any violation of
			 Iowa Code chapter 124, 124B, 126, 155A, or 205 or any rule of the
			 board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The requirements of this chapter apply to compounded
				preparations that are dispensed, distributed, or administered to an ultimate
				user in the state of Iowa, regardless of the location of the pharmacy or
				outsourcing facility where the preparation was compounded. This chapter applies
				to compounded preparations intended for humans and animals. In addition to the
				requirements in this chapter, all pharmacies and outsourcing facilities engaged
				in compounding shall comply with all applicable federal laws and regulations
				governing compounding and all applicable state laws, rules and regulations
				governing the practice of pharmacy. In the event the requirements in this
				chapter directly conflict with any federal law or regulation, the federal law
				or regulation shall supersede the requirements in this chapter. The
				requirements of 657-Chapter 16 apply to the compounding of
				radiopharmaceuticals. The requirements of 657-Chapter 41 apply to outsourcing
				facilities.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.3 - Nonsterile Compounding

Current through Register Vol. 47, No. 3, July 24, 2024
Iowa-licensed pharmacies that compound nonsterile preparations
				for ultimate users in the state of Iowa shall follow the current revision of
				USP Chapter 795 standards. Additional USP chapters incorporated by reference
				into USP Chapter 795 shall also be followed.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.4 - Sterile Compounding

Current through Register Vol. 47, No. 3, July 24, 2024
Iowa-licensed pharmacies that compound sterile preparations for
				ultimate users in the state of Iowa shall follow the current revision of USP
				Chapter 797 standards. Additional USP chapters incorporated by reference into
				USP Chapter 797 shall also be followed.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.5 - Delayed Compliance

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy that cannot meet the requirements for full
				compliance with applicable USP chapters by the enforcement date established by
				USP shall not engage in compounding until the pharmacy is in full compliance
				with all requirements or the board has approved delayed compliance for the
				specific requirement or requirements requested. The board may establish a
				committee to grant or deny requests for delayed compliance. The board or
				committee may grant a request for delayed compliance only if the pharmacy can
				demonstrate progress toward full compliance and adequate protection of the
				public health, safety, and welfare during the period of delayed compliance. The
				board or committee may only grant a request for delayed compliance of specific
				requirements in applicable USP chapters for a maximum of 18
				months.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.6 - Compounding Standards for Outsourcing Facilities

Current through Register Vol. 47, No. 3, July 24, 2024
An FDA-registered outsourcing facility shall be properly
				licensed in Iowa pursuant to 657-Chapter 41 and shall follow the FDA's current
				good manufacturing practices (cGMPs) for outsourcing facilities when
				compounding preparations for use in Iowa.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.9 - Prescriber/patient/pharmacist Relationship

Current through Register Vol. 47, No. 3, July 24, 2024
All compounded preparations shall be dispensed pursuant to a
				patient-specific prescription unless the compounded preparation is distributed
				pursuant to rule 657-20.15 (124,126,155A) or 657-20.16 (124,126,155A). A
				prescription for a compounded preparation shall be authorized by the prescriber
				for a specific patient. Prescriptions for all compounded preparations shall be
				maintained on file at the dispensing pharmacy.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.10 - Anticipatory Compounding

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Outsourcing facilities.
Outsourcing facilities are authorized
			 to engage in anticipatory compounding. Outsourcing facilities are not required
			 to obtain patient-specific prescriptions in order to distribute compounded
			 preparations.
(2)
Pharmacies.
Pharmacies may engage in anticipatory compounding
			 only if the anticipatory compounding is based on a history of receiving valid
			 prescriptions generated solely within an established
			 prescriber/patient/pharmacist relationship, so long as each compounded
			 preparation is dispensed pursuant to a patient-specific prescription.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.11 - Prohibition on Resale of Compounded Preparations

Current through Register Vol. 47, No. 3, July 24, 2024
The sale of compounded preparations to other pharmacies,
				prescribers, or entities, except as explicitly authorized by this chapter, is
				considered manufacturing.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.12 - Compounding Copies of an Approved Drug

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy or outsourcing facility may only compound
				preparations that are essentially copies of approved drugs if the compounded
				preparation is changed to produce for an individual patient a clinically
				significant difference to meet a medical need as determined and authorized by
				the prescriber. A pharmacy or outsourcing facility may compound a preparation
				that is essentially a copy of an approved drug if the approved drug is
				identified as currently in shortage on the FDA drug shortages database
				published on the FDA Web site,
				http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.
(1)
Essentially a copy.
The
			 board may consider the existence of the following factors as an indication that
			 a compounded preparation is essentially a copy of an approved drug:
a. The compounded preparation has the same
			 active pharmaceutical ingredient(s) as the commercially available drug
			 product;
b. The active
			 pharmaceutical ingredient(s) has the same, similar, or an easily substitutable
			 dosage strength; and
c. The
			 commercially available drug product can be used by the same route of
			 administration as prescribed for the compounded preparation.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.13 - Use of Flavoring Agents

Current through Register Vol. 47, No. 3, July 24, 2024
A flavoring agent may be added to a drug at the discretion of
				the pharmacist or upon the request of the prescriber, the patient, or the
				patient's agent. The pharmacist may add flavoring agents not to exceed 5
				percent of the total volume of the drug to which the flavoring agents are
				added. The pharmacist shall label the flavored drug with a beyond-use date no
				greater than 14 days past the date the flavoring agent is added if the drug is
				required to be stored in a refrigerator. A different beyond-use date or
				alternate storage conditions may be indicated if such variation is supported by
				peer-reviewed medical literature. The pharmacist shall electronically or
				manually document that a flavoring agent was added to a drug, and such
				documentation shall be made available for inspection and copying upon the
				request of the board or an agent of the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.15 - Compounding for Office Use

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Human compounded preparations.
Only an FDA-registered
			 outsourcing facility properly licensed in Iowa pursuant to 657-Chapter 41 may
			 distribute to a practitioner for office use human compounded preparations
			 without a patient-specific prescription.
(2)
Veterinary compounded
			 preparations.
Veterinary compounded preparations may be sold to a
			 practitioner for office use if the preparations are compounded by an
			 Iowa-licensed pharmacy or outsourcing facility and sold directly to the
			 practitioner by the pharmacy or outsourcing facility. Veterinary compounded
			 preparations sold to a practitioner for office use may be dispensed to the
			 owner of a veterinary patient to treat an immediate medical need when timely
			 access to a patient-specific supply of compounded medication is not available,
			 no commercially available product can meet the need of the patient, lack of
			 treatment will likely result in patient harm, and the supply does not exceed 14
			 days.
(3)
Office
			 use.
Compounded preparations distributed for office use pursuant to
			 subrule 20.15(1) or 20.15(2) and in accordance with the labeling requirements
			 of subrule 20.15(4) do not require a patient-specific prescription but do
			 require that the compounded preparation be administered to a patient in the
			 course of the practitioner's professional practice. Compounded preparations
			 distributed for office use pursuant to this rule shall not be further
			 distributed to other practitioners or dispensed to a patient for
			 self-administration, except as provided in subrule 20.15(2).
(4)
Labeling.
Compounded
			 preparations for office use, in addition to the labeling requirements specified
			 in rule 657-20.19 (124,126,155A), shall
			 include on the prescription label the practitioner's name in place of the
			 patient's name. The label shall state "For Office Use Only-Not for Resale." If
			 the sterility or integrity of the compounded preparation cannot be maintained
			 after the initial opening of the container, the label shall state "Single-Dose
			 Only."
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.16 - Compounding for Hospital Use

Current through Register Vol. 47, No. 3, July 24, 2024
Compounded preparations distributed or dispensed to a hospital
				or hospital pharmacy pursuant to this rule shall be administered to an
				individual patient in the hospital.
(1)
By an FDA-registered outsourcing
			 facility.
Only an FDA-registered outsourcing facility properly
			 licensed in Iowa pursuant to 657-Chapter 41 may distribute human compounded
			 preparations to a hospital or hospital pharmacy in the absence of a
			 patient-specific prescription. The compounded preparation shall be labeled in
			 compliance with subrule 20.19(3).
(2)
By a pharmacy that is not an
			 FDA-registered outsourcing facility.
Human compounded preparations
			 that are not compounded at an FDA-registered outsourcing facility may be
			 dispensed to a hospital or hospital pharmacy by an Iowa-licensed pharmacy
			 pursuant to a prescriber's authorization for administration to a specific
			 patient. The compounded preparation shall be labeled in compliance with subrule
			 20.19(2).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.19 - Labeling

Current through Register Vol. 47, No. 3, July 24, 2024
The label, or attached auxiliary labeling if necessary, affixed
				to the container of any compounded preparation dispensed or distributed into or
				within Iowa shall contain at least the information identified in one of the
				following subrules, as applicable.
(1)
General pharmacy or outpatient dispensing.
The label shall
			 meet the labeling requirements of 657-subrule 6.10(1) and shall include the
			 following additional information:
a. The name
			 and concentration of each active ingredient.
b. The date that the preparation was
			 compounded.
c. The beyond-use date
			 of the compounded preparation.
d.
			 Special storage and handling instructions, if applicable.
e. The statement "COMPOUNDED PREPARATION" or
			 a reasonable comparable alternative statement that prominently identifies the
			 drug as a compounded preparation.
f
			 If the compounded preparation is sterile, the word "STERILE."
g. If the compounded preparation was prepared
			 from batch preparation compounding, the batch identification or control number.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.20 - Labeling for Batch Preparation Compounding

Current through Register Vol. 47, No. 3, July 24, 2024
Compounded preparations resulting from batch preparation
				compounding shall be labeled with the following information until such time as
				the preparations are labeled pursuant to rule 657-20.19 (124,126,155A) for
				distribution to hospitals or practitioners or for dispensing or administration
				to patients:
1. The date that the
			 preparation was compounded.
2.
			 Compounded preparation name or formula.
3. Dosage form.
4. Strength.
5. Quantity per container.
6. Unique internal batch identification or
			 control number.
7. Beyond-use
			 date.
8. Special storage and
			 handling instructions, if applicable.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.23 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Retention.
All records required by this chapter shall be
			 retained as original records of the pharmacy or outsourcing facility and shall
			 be readily available for inspection and photocopying by agents of the board or
			 other authorized authorities for at least two years following the date of the
			 record.
(2)
Required
			 elements.
Records shall allow for the identification of the following:
a. All ingredients used in compounding,
			 including manufacturer or National Drug Code (NDC), lot number, and expiration
			 date.
b. The compounding steps
			 involved in the preparation.
c. All
			 personnel involved in compounding.
d. All personnel involved in reviewing
			 compounded preparations.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 20 - Compounding Practices › Rule 657-20.24 - Annual Reporting of Interstate Distribution of Compounded Preparations

Current through Register Vol. 47, No. 3, July 24, 2024
(1) No later than
			 April 1, 2022, and annually thereafter, each licensed pharmacy located in Iowa
			 that distributed compounded preparations for human use interstate in the
			 previous calendar year shall report compounding data to the NABP information
			 sharing network.
(2) Compounding
			 data may include, but not be limited to:
a.
			 Whether the pharmacy engaged in the following activities during the identified
			 calendar year:
(1) Sterile human drug
			 compounding;
(2) Nonsterile human
			 drug compounding;
(3)
			 Patient-specific compounding; and
(4) Non-patient-specific
			 compounding.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to provide the minimum standards
				for the utilization of electronic data and automated systems in the practice of
				pharmacy and shall apply to all pharmacies located in Iowa.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.3 - System Security and Safeguards

Current through Register Vol. 47, No. 3, July 24, 2024
To maintain the integrity and confidentiality of patient
				records and prescription drug orders, any system, computer, or electronic
				device utilized shall have adequate security including system safeguards
				designed to prevent and detect unauthorized access, modification, or
				manipulation of patient records and prescription drug orders. Authentication
				credentials shall be securely maintained by the individual to whom the
				credentials are issued and shall not be shared with or disclosed to any other
				individual. Once a drug or device has been dispensed, any alterations in either
				the prescription drug order data or the patient record shall be documented and
				shall include the identification of all pharmacy personnel who were involved in
				making the alteration as well as the responsible pharmacist. An automated data
				processing system used for the receipt and processing of electronic
				transmissions from a prescriber's electronic prescription application shall
				comply with DEA requirements relating to electronic prescriptions and shall be
				certified compliant with DEA regulations.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.5 - Automated Data Processing Systems

Current through Register Vol. 47, No. 3, July 24, 2024
An automated data processing system may be used, subject to
				the requirements contained in this rule, for the storage and retrieval of
				prescription, patient, prescriber and drug data as well as data relating to the
				pharmacy staff utilization of the system.
(1)
Electronic storage of hard-copy
			 prescriptions.
A pharmacy that maintains an electronic copy of an
			 original hard-copy prescription for a noncontrolled substance shall retain, in
			 a readily retrievable format, the original hard-copy prescription as required
			 in rule
			 657-6.8
			 (155A) but shall be exempt from the requirement to record on the original
			 hard-copy prescription the date and unique identification number of the
			 prescription.
(2)
Data
			 retrievable and printable.
Any automated data processing system shall
			 be capable of immediate retrieval (via computer monitor or hard-copy printout)
			 of, at a minimum, any prescription, patient, prescriber, and drug data as well
			 as data relating to pharmacy staff utilization of the system.
(3)
Auxiliary procedure for system
			 downtime.
A pharmacy utilizing an automated data processing system
			 shall have a procedure that will maintain security and confidentiality of all
			 data as well as ensure the legal dispensing of any prescription drug order in
			 the event the system experiences downtime.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.7 - Facsimile Transmission of a Prescription

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacist may dispense noncontrolled and controlled drugs,
				including Schedule II controlled substances only as provided in this rule,
				pursuant to a prescription faxed to the pharmacy by the prescribing
				practitioner or the practitioner's agent. The means of transmission via
				facsimile shall ensure that prescription information is not obscured or
				rendered illegible due to security features of the paper utilized by the
				prescriber to prepare a written prescription. The faxed prescription shall
				serve as the original record, except as provided in subrule 21.7(1), shall be
				maintained for a minimum of two years from the date of the last activity on the
				prescription, and shall contain all information required by Iowa Code section
				155A.27, including the prescriber's signature. If the prescription is
				transmitted by an agent of the prescriber, the facsimile transmission shall
				include the first and last names and title of the agent responsible for the
				transmission. The pharmacist shall be responsible for verifying the
				authenticity of the prescription as to the source of the facsimile
				transmission.
(1)
Schedule II
			 controlled substances-emergency situations.
A pharmacist may, in an
			 emergency situation as defined in 657-subrule 10.26(1), dispense a Schedule II
			 controlled substance pursuant to a facsimile transmission to the pharmacy of a
			 written, signed prescription from the prescriber or the prescriber's agent
			 pursuant to the requirements of rule
			 657-10.26 (124). The facsimile
			 shall serve as the temporary written record required by 657-subrule
			 10.26(2).
(2)
Schedule II
			 controlled substances-compounded injectable.
A prescription for a
			 Schedule II narcotic substance to be compounded for the direct administration
			 to a patient by parenteral, intravenous, intramuscular, subcutaneous, or
			 intraspinal infusion may be transmitted by a prescriber or the prescriber's
			 agent to a pharmacy via facsimile.
(3)
Schedule II controlled
			 substances-care facility patients.
A prescription for any Schedule II
			 controlled substance for a resident of a care facility, as defined in rule
			 657-23.2 (155A), may be
			 transmitted by the prescriber or the prescriber's agent to a pharmacy via
			 facsimile. The prescription shall identify that the patient is a resident of a
			 care facility.
(4)
Schedule
			 II controlled substances-hospice patients.
A prescription for any
			 Schedule II controlled substance for a patient in a hospice program licensed
			 pursuant to Iowa Code chapter 135J or a program certified or paid for by
			 Medicare under Title XVIII may be transmitted via facsimile by the prescriber
			 or the prescriber's agent to the pharmacy. The prescription shall identify that
			 the patient is a hospice patient.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.8 - Electronic Prescription Mandate and Exemptions

Current through Register Vol. 47, No. 3, July 24, 2024
All prescriptions shall be transmitted electronically to a
				pharmacy except as provided in this rule.
(1)
Prescriptions exempt.
Prescriptions which shall be exempt from electronic transmission include:
a. A prescription for a patient residing in a
			 nursing home, long-term care facility, correctional facility, or
			 jail.
b. A prescription authorized
			 by a licensed veterinarian.
c. A
			 prescription for a device.
d. A
			 prescription dispensed by a department of veterans affairs pharmacy.
e. A prescription requiring information that
			 makes electronic transmission impractical, such as complicated or lengthy
			 directions for use or attachments.
f. A prescription for a compounded
			 preparation containing two or more components.
g. A prescription issued in response to a
			 public health emergency in a situation where a non-patient-specific
			 prescription would be permitted.
h.
			 A prescription issued for an opioid antagonist pursuant to Iowa Code section
			 135.190, a prescription issued
			 for epinephrine pursuant to Iowa Code section
			 135.185, or a prescription
			 issued for a bronchodilator canister or bronchodilator canister and spacer
			 pursuant to Iowa Code section
			 280.16A.
i. A prescription issued during a temporary
			 technical or electronic failure at the location of the prescriber or pharmacy,
			 provided that a prescription issued pursuant to this paragraph shall indicate
			 on the prescription that the prescriber or pharmacy is experiencing a temporary
			 technical or electronic failure.
j.
			 A prescription issued pursuant to an established and valid collaborative
			 practice agreement, standing order, or drug research protocol.
k. A prescription issued in an emergency
			 situation pursuant to federal law and regulation and rules of the board. An
			 emergency situation may include, but is not limited to, the issuance of a
			 prescription to meet the immediate care need of a patient after hours when a
			 prescriber is unable to access electronic prescribing capabilities. Such
			 prescription shall be limited to a quantity sufficient to meet the acute need
			 of the patient with no authorized refills.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.9 - Exemption From Electronic Prescription Mandate-petition

Current through Register Vol. 47, No. 3, July 24, 2024
A prescriber, medical group, institution, or pharmacy that is
				unable to comply with the electronic prescription mandate in rule
				657-21.8(124,155A) may petition the board, on forms provided by the board, for
				an exemption from the requirements based upon economic hardship; technical
				limitations that the prescriber, medical group, institution, or pharmacy cannot
				control; or other exceptional circumstances. A timely petition for renewal of a
				previously approved exemption shall be submitted at least 60 days in advance of
				the expiration of the previously approved exemption.
(1)
Petition information.
A
			 petition for exemption from the electronic prescription mandate shall include,
			 but not be limited to, all of the following:
a. The name and address of the prescriber,
			 medical group, institution, or pharmacy seeking the exemption. For medical
			 groups and institutions, a list of the names, professional license numbers, and
			 CSA registration numbers of all prescribers who would be covered by the
			 exemption shall be maintained by the petitioner for the duration of any
			 approved exemption and shall not be required to be submitted with the
			 petition.
b. Whether the petitioner
			 is seeking an exemption for controlled substance prescriptions, non-controlled
			 substance prescriptions, or both.
c. The petitioner's current electronic
			 prescribing capabilities.
d. The
			 reason, such as economic hardship, technological limitations, or other
			 exceptional circumstances, the petitioner is seeking exemption, including any
			 supporting documentation to justify the reason.
e. Anticipated date of compliance with the
			 electronic prescription mandate.
f.
			 If the petition seeks renewal of a previously approved exemption, information
			 relating to the petitioner's actions during the previous exemption period to
			 work toward compliance with the electronic prescription mandate or an
			 explanation as to why no progress has been made.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.10 - Automated Medication Distribution System (AMDS)

Current through Register Vol. 47, No. 3, July 24, 2024
Any pharmacy that utilizes an AMDS shall comply with these
				rules in addition to all applicable federal and state laws, rules, and
				regulations.
(1)
Policies and
			 procedures.
Pursuant to the requirements regarding policies and
			 procedures in 657-subrule 8.3(5), each pharmacy utilizing an AMDS shall have
			 policies and procedures that address all aspects of the operation of the AMDS
			 to include, at a minimum:
a. Access to drugs
			 and patient information,
b.
			 Pharmacy personnel training in the proper operation of the AMDS,
c. Methods to ensure accurate stocking of the
			 AMDS pursuant to subrule 21.10(2),
d. Confidentiality of patient
			 information,
e. Routine and
			 preventative maintenance of the AMDS according to manufacturer recommendations,
f. Packaging and labeling of
			 prescription drugs loaded into or dispensed from the AMDS that is in compliance
			 with federal and state laws, rules, and regulations, and
g. Security and control of the prescription
			 drugs maintained and utilized in the AMDS to include:
(1) Drug loading, storage, and
			 records.
(2) Drugs removed from
			 system components but not used.
(3)
			 Inventory.
(4) Cross
			 contamination.
(5) Lot number
			 control.
(6) Wasted or discarded
			 drugs.
(7) Controlled
			 substances.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.11 - Pharmacist Verification of Controlled Substance Fills-daily Printout or Logbook

Current through Register Vol. 47, No. 3, July 24, 2024
The individual pharmacist who makes use of the pharmacy
				prescription application shall provide documentation of the fact that the fill
				information entered into the pharmacy prescription application each time the
				pharmacist fills a prescription order for a controlled substance is correct. If
				the pharmacy prescription application provides a hard-copy printout of each
				day's controlled substance prescription order fill data, that printout shall be
				verified, dated, and signed by each individual pharmacist who filled a
				controlled substance prescription order. Each individual pharmacist must verify
				that the data indicated is correct and sign this document in the same manner as
				the pharmacist would sign a check or legal document (e.g., J. H. Smith or John
				H. Smith). This document shall be maintained in a separate file at that
				pharmacy for a period of two years from the dispensing date. This printout of
				the day's controlled substance prescription order fill data shall be generated
				by and available at each pharmacy using a computerized pharmacy prescription
				application within 48 hours of the date on which the prescription was
				dispensed. The printout shall be verified and signed by each pharmacist
				involved with such dispensing. In lieu of preparing and maintaining printouts
				as provided above, the pharmacy may maintain a bound logbook or separate file.
				The logbook or file shall include a statement signed each day by each
				individual pharmacist involved in each day's dispensing that attests to the
				fact that the prescription information entered into the pharmacy prescription
				application that day has been reviewed by the pharmacist and is correct as
				shown. Pharmacist statements shall be signed in the manner previously
				described. The logbook or file shall be maintained at the pharmacy for a period
				of two years after the date of dispensing.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.12 - Prescription Drug Orders for Schedule Ii Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacist may dispense Schedule II controlled substances
				pursuant to an electronic transmission to the pharmacy of an electronically
				prepared prescription if both the prescriber's electronic prescription
				application and the pharmacy prescription application have been certified to
				comply with DEA requirements for electronic prescribing of controlled
				substances. Records of electronically prepared and transmitted prescriptions
				shall be maintained electronically. A pharmacist may dispense Schedule II
				controlled substances pursuant to facsimile transmission to the pharmacy of a
				written, signed prescription from the prescribing practitioner or the
				practitioner's agent provided that the original written, signed prescription is
				received by the pharmacist prior to the actual dispensing of the controlled
				substance. An emergency authorization transmitted to the pharmacy by the
				practitioner's agent shall include the first and last names and title of the
				individual who transmitted the prescription. The means of transmission shall
				ensure that prescription information is not obscured or rendered illegible due
				to security features of the paper utilized by the prescriber to prepare a
				written prescription. The original prescription shall be verified against the
				transmission at the time the substance is actually dispensed, shall be properly
				annotated, and shall be retained with the electronic transmission for
				filing.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.13 - Facsimile Transmission of a Prescription for Schedule Ii Controlled Substances-emergency Situations

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacist may in an emergency situation as defined in rule
				657-10.26
				(124) dispense Schedule II controlled substances pursuant to a facsimile
				transmission to the pharmacy of a written, signed prescription from the
				prescribing practitioner or the practitioner's agent pursuant to the
				requirements of rule
				657-10.26
				(124). The facsimile or a print of the facsimile transmission shall serve as
				the temporary written record required by rule 657-10.26(124).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.14 - Facsimile Transmission of a Prescription for Schedule Ii Narcotic Substances-parenteral

Current through Register Vol. 47, No. 3, July 24, 2024
A prescription for a nonoral dosage unit of a Schedule II
				narcotic substance to be compounded for the direct administration to a patient
				by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal
				infusion may be transmitted by a practitioner or the practitioner's agent to
				the pharmacy via facsimile. If the prescription is transmitted by the
				practitioner's agent, the transmission shall include the first and last names
				and title of the individual who transmitted the prescription. The means of
				transmission shall ensure that prescription information is not obscured or
				rendered illegible due to security features of the paper utilized by the
				prescriber to prepare a written prescription. The facsimile serves as the
				original written prescription.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.15 - Facsimile Transmission of Schedule Ii Controlled Substances-long-term Care Facility Patients

Current through Register Vol. 47, No. 3, July 24, 2024
A prescription for any Schedule II controlled substance for a
				resident of a long-term care facility may be transmitted by the practitioner or
				the practitioner's agent to the dispensing pharmacy via facsimile. If the
				prescription is transmitted by the practitioner's agent, the transmission shall
				include the first and last names and title of the individual who transmitted
				the prescription. The means of transmission shall ensure that prescription
				information is not obscured or rendered illegible due to security features of
				the paper utilized by the prescriber to prepare a written prescription.
(1)
Original prescription.
The facsimile serves as the original written prescription.
(2)
Information required.
The patient's address on the prescription shall indicate that the address
			 location is a long-term care facility.