reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 7 - Hospital Pharmacy Practice › Rule 657-7.8 - Drug Distribution and Control

Current through Register Vol. 47, No. 3, July 24, 2024
Policies and procedures governing drug distribution and control
				shall be established pursuant to rule
				657-8.3 (155A) with input from
				other involved hospital staff such as physicians and nurses, from committees
				such as the pharmacy and therapeutics committee or its equivalent, and from any
				related patient care committee. It is essential that the pharmacist in charge
				or designee routinely be available to or on all patient care areas to establish
				rapport with the personnel and to become familiar with and contribute to
				medical and nursing procedures relating to drugs.
(1)
Drug preparation.
Control and adequate quality assurance procedures needed to ensure that
			 patients receive the correct drugs at the proper times shall be established
			 pursuant to rule 657-8.3 (155A).
a. Hospitals shall utilize a unit dose
			 dispensing system pursuant to rule
			 657-22.1 (155A). All drugs
			 dispensed by the pharmacy for administration to patients shall be in single
			 unit or unit dose packages if practicable unless the dosage form or drug
			 delivery device makes it impracticable to package the drug in a unit dose or
			 single unit package.
(1) Established policies
			 and procedures shall identify situations when drugs may be dispensed in other
			 than unit dose or single unit packages outside the unit dose dispensing
			 system.
(2) The need for nurses to
			 manipulate drugs prior to their administration shall be minimized.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 7 - Hospital Pharmacy Practice › Rule 657-7.9 - Drug Information

Current through Register Vol. 47, No. 3, July 24, 2024
Established policies and procedures shall include the provision
				to the facility's staff and patients of accurate, comprehensive information
				about drugs and their use. The pharmacy shall serve as the facility's center
				for drug information.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 7 - Hospital Pharmacy Practice › Rule 657-7.10 - Ensuring Rational Drug Therapy

Current through Register Vol. 47, No. 3, July 24, 2024
An important aspect of pharmaceutical services is that of
				maximizing rational drug use. Policies and procedures for ensuring the quality
				of drug therapy shall be established pursuant to rule
				657-8.3 (155A). For the purpose
				of this rule, "professional pharmacy staff means the professional employees of
				the pharmacy, including pharmacists, pharmacy technicians, and
				pharmacist-interns.
(1)
Patient profile.
The pharmacy shall maintain for each patient
			 receiving care at the hospital a patient profile, to include but not be limited
			 to drug history. Sufficient patient information to ensure meaningful and
			 effective patient care shall be collected, maintained, and reviewed by
			 professional pharmacy staff pursuant to policies and procedures. Appropriate
			 clinical information about patients shall be available and accessible to the
			 pharmacist for use in daily practice. Upon review of a patient's current
			 clinical profile, the pharmacist shall directly communicate any suggested
			 changes to the patient's health care team.
(2)
Adverse drug events.
Established policies and procedures shall include a mechanism for the reporting
			 of adverse drug events that occur in the facility which events are reviewed by
			 the facility's established quality control committee. The pharmacist shall be
			 informed of all reported adverse drug events occurring in the facility. Adverse
			 drug events include but are not limited to adverse drug reactions and
			 medication errors.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 7 - Hospital Pharmacy Practice › Rule 657-7.13 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
Every record required to be kept under this chapter or other
				board rules or under Iowa Code chapters 124 and 15 5 A shall be kept by the
				pharmacy and be available for inspection and copying by the board or its
				authorized agent for at least two years from the date of such record unless a
				longer retention period is specified for the particular record.
(1)
Medication order
			 information.
Each original medication order contained in inpatient
			 records shall include the following information:
a. Patient name and identification
			 number;
b. Drug name, strength, and
			 dosage form;
c. Directions for
			 use;
d. Date ordered;
e. Prescriber's signature or electronic
			 signature or that of the prescriber's authorized agent.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to establish the minimum
				standards of pharmacy practice for the activities identified in this chapter.
				The requirements of these rules shall apply to all Iowa-licensed pharmacists,
				other registered pharmacy personnel, and all pharmacies, including owners,
				providing the services addressed in this chapter to patients in Iowa. These
				rules are in addition to rules of the board relating to specific types of
				pharmacy licenses issued by the board unless otherwise indicated by
				rule.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purpose of this chapter, the following definitions
				shall apply:
"Board"
means the Iowa board of
				pharmacy.
"Confidential information"
means information
				accessed or maintained by the pharmacy in the patient's or the pharmacy's
				records which contains personally identifiable information that could be used
				to identify the patient. "Confidential information" includes but is not limited
				to patient name, address, telephone number, and social security number;
				prescriber name and address; and prescription and drug or device information
				such as therapeutic effect, diagnosis, allergies, disease state, pharmaceutical
				services rendered, medical information, and drug interactions.
"DEA "
means the United States Department of
				Justice, Drug Enforcement Administration.
"Pharmacy support person"
or
"PSP
				"
means a person, other than a member of the professional pharmacy
				staff, registered with the board who may perform nontechnical duties assigned
				by a supervising pharmacist under the pharmacist's responsibility and
				supervision.
"Professional pharmacy staff"
shall mean the
				professional employees of the pharmacy, including pharmacists, pharmacy
				technicians, and pharmacist-interns.
This rule is intended to implement Iowa Code chapter
				155A.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.3 - Responsible Parties

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Pharmacist in charge.
One professionally competent, legally
			 qualified pharmacist in charge in each pharmacy shall work cooperatively with
			 the pharmacy, by and through its owner or license holder, and with all staff
			 pharmacists to ensure the legal operation of the pharmacy, including meeting
			 all inspection and other requirements of state and federal laws, rules, and
			 regulations governing the practice of pharmacy. A part-time pharmacist in
			 charge has the same obligations and responsibilities as a full-time pharmacist
			 in charge.
(2)
Pharmacy.
Each pharmacy, by and through its owner or license
			 holder, shall work cooperatively with the pharmacist in charge and with all
			 staff pharmacists to ensure the legal operation of the pharmacy, including
			 meeting all inspection and other requirements of state and federal laws, rules,
			 and regulations governing the practice of pharmacy. The pharmacy, by and
			 through its owner or license holder, shall be responsible for employing a
			 professionally competent, legally qualified pharmacist in charge. The pharmacy,
			 by and through its owner or license holder, may be held responsible for
			 unethical conduct or practices of any of the pharmacy staff.
(3)
Pharmacy and pharmacist in
			 charge.
The pharmacist in charge and the pharmacy, by and through its
			 owner or license holder, shall share responsibility for, at a minimum, the
			 following:
a. Ensuring that the pharmacy
			 employs an adequate number of qualified personnel commensurate with the size
			 and scope of services provided by the pharmacy.
b. Ensuring the availability of any equipment
			 and references necessary for the particular practice of pharmacy.
c. Ensuring that there is adequate space
			 within the prescription department or a locked room not accessible to the
			 public for the storage of prescription drugs, including controlled substances,
			 devices, and pharmacy records, and to support the operations of the
			 pharmacy.
d. Ensuring that the
			 license, registration, or certification of each professional pharmacy staff
			 member and the registration of each pharmacy support person are maintained in
			 current and active status.
e.
			 Ensuring that the pharmacy provides adequate security to prevent unauthorized
			 access and diversion.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.4 - Pharmacist Identification and Staff Logs

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Display of pharmacist
			 license.
During any period a pharmacist is working in a pharmacy, each
			 pharmacist shall display, in a position visible to the public, an original
			 license to practice pharmacy in Iowa. A current license renewal certificate,
			 which may be a photocopy of an original renewal certificate, shall be displayed
			 with the original license.
(2)
Registration maintained of pharmacy personnel.
Each
			 pharmacist-intern, pharmacy technician, and pharmacy support person shall
			 maintain current registration with the board. The registration certificate or a
			 copy of the registration certificate shall be readily retrievable upon request
			 of the board or its authorized agent.
(3)
Identification codes.
A
			 permanent log of the initials or identification code identifying by name each
			 pharmacist, pharmacist-intern, pharmacy technician, and pharmacy support person
			 shall be maintained for a minimum of two years and shall be available for
			 inspection and copying by the board or its representative. The initials or
			 identification code shall be unique to the individual to ensure that each
			 pharmacist, pharmacist-intern, pharmacy technician, and pharmacy support person
			 can be identified.
(4)
Temporary or intermittent pharmacy staff.
The pharmacy shall
			 maintain a log of all pharmacists, pharmacist-interns, pharmacy technicians,
			 and pharmacy support persons who have worked at that pharmacy and who are not
			 regularly staffed at that pharmacy. Such log shall include the dates and shifts
			 worked by each pharmacist, pharmacist-intern, pharmacy technician, and pharmacy
			 support person and shall be available for inspection and copying by the board
			 or its representative for a minimum of two years following the date of the
			 entry.
(5)
Identification.
While on duty, pharmacy personnel shall wear
			 visible identification that clearly identifies the person by licensed or
			 registered title and includes at least the person's first name.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.7 - Procurement, Storage, and Recall of Drugs and Devices

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Source.
Procurement of
			 prescription drugs and devices shall be from an Iowa-licensed distributor or,
			 on a limited basis, from another licensed pharmacy or licensed practitioner
			 located in the United States.
(2)
Manner of storage.
Drugs and devices shall be stored in a
			 manner to protect their identity and integrity.
(3)
Storage temperatures.
All drugs and devices shall be stored at the proper temperature as provided in
			 manufacturer labeling. In the absence of a specific temperature range, the
			 pharmacy shall defer to storage conditions identified in United States
			 Pharmacopeia chapter 659.
(4)
Product recall.
There shall be a system for removing from use,
			 including unit dose, any drugs and devices subjected to a product
			 recall.
(5)
Outdated drugs
			 or devices.
Any drug or device bearing an expiration date shall not be
			 dispensed for use beyond the expiration date of the drug or device. Outdated
			 drugs or devices shall be removed from dispensing stock and shall be
			 quarantined until such drugs or devices are properly disposed of.
(6)
Records.
All pharmacies
			 shall maintain supplier invoices of prescription drugs and controlled
			 substances upon which the actual date of receipt of the drugs by the pharmacist
			 or other responsible individual is clearly recorded. All pharmacies shall
			 maintain supplier credit memos. Pharmacy records of invoices and credit memos
			 shall be maintained for at least two years from the date of the record. If the
			 original supplier invoice or credit memo is received electronically, hard-copy
			 record is not required.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.9 - Records Storage

Current through Register Vol. 47, No. 3, July 24, 2024
Every record required to be maintained by a pharmacy pursuant
				to board rules or Iowa Code chapters 124 and 155A shall be maintained and be
				available for inspection and copying by the board or its representative for at
				least two years from the date of such record or the date of last activity on
				the record unless a longer retention period is specified for the particular
				record.
(1)
Records less than
			 12 months old.
Records shall be maintained within the licensed
			 pharmacy department for a minimum of 12 months, except as provided herein.
			 Pharmacy records less than 12 months old may be stored in a secure storage area
			 outside the licensed pharmacy department, including at a remote location, if
			 the pharmacy has retained electronic copies of the records in the pharmacy that
			 are immediately available and if the original records are available within 72
			 hours of a request by the board or its authorized agent, unless such remote
			 storage is prohibited under federal law.
(2)
Records more than 12 months
			 old.
Records more than 12 months old may be maintained in a secure
			 storage area outside the licensed pharmacy department, including at a remote
			 location, if the records are retrievable within 72 hours of a request by the
			 board or its authorized agent, unless such remote storage is prohibited under
			 federal law.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.11 - Unethical Conduct or Practice

Current through Register Vol. 47, No. 3, July 24, 2024
The provisions of this rule apply to licensed pharmacies,
				licensed pharmacists, registered pharmacy technicians, registered pharmacy
				support persons, and registered pharmacist-interns.
(1)
Misrepresentative deeds.
A pharmacy, pharmacist, technician, support person, or pharmacist-intern shall
			 not make any statement intended to deceive, misrepresent or mislead anyone, or
			 be a party to or an accessory to any fraudulent or deceitful practice or
			 transaction in pharmacy or in the operation or conduct of a pharmacy.
(2)
Unethical conduct.
a. A pharmacy, pharmacist, pharmacist-intern,
			 technician, or support person shall not participate in any of the following
			 types of unethical conduct:
(1) Any activity
			 that negates a patient's freedom of choice of pharmacy services.
(2) Providing prescription blanks or forms
			 bearing the pharmacy's name or other means of identification to any person
			 authorized to prescribe, except that a hospital may make prescription blanks or
			 forms bearing the hospital pharmacy's name or other means of identification
			 available to hospital staff prescribers, emergency department prescribers, and
			 prescribers granted hospital privileges for the preservers' use during practice
			 at or in the hospital.
(3) Any
			 financial arrangement or transaction that would violate federal healthcare
			 fraud, waste, and abuse laws, including but not limited to the Stark Law, the
			 False Claims Act, and the Anti-Kickback Statute.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.12 - Advertising

Current through Register Vol. 47, No. 3, July 24, 2024
Prescription drug information, including price, may be provided
				to the public by a pharmacy so long as the information is not false or
				misleading and is not in violation of any federal or state laws applicable to
				the advertisement of such articles generally and if all of the following
				conditions are met:
1. All charges for
			 services to the consumer shall be stated.
2. The effective dates for the prices listed
			 shall be stated.
3. No reference
			 shall be made to controlled substances listed in Schedules II through V of the
			 latest revision of the Iowa uniform controlled substances Act and the rules of
			 the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.13 - Personnel Histories

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to the requirements of Iowa Code section
				135C.33,
				the provisions of this rule shall apply to any pharmacy employing any person to
				provide patient care services in a patient's home. For the purposes of this
				rule, "employed by the pharmacy" shall include any individual who is paid to
				provide treatment or services to any patient in the patient's home, whether the
				individual is paid by the pharmacy or by any other entity such as a
				corporation, a temporary staffing agency, or an independent contractor.
				Specifically excluded from the requirements of this rule are individuals such
				as delivery persons or couriers who do not enter the patient's home for the
				purpose of instructing the patient or the patient's caregiver in the use or
				maintenance of the equipment, device, or drug being delivered, or who do not
				enter the patient's home for the purpose of setting up or servicing the
				equipment, device, or drug used to treat the patient in the patient's
				home.
(1)
Applicant
			 acknowledgment.
The pharmacy shall ask the following question of each
			 person seeking employment in a position that will provide in-home services: "Do
			 you have a record of founded child or dependent adult abuse or have you ever
			 been convicted of a crime, in this state or any other state?" The applicant
			 shall also be informed that a criminal history and child and dependent adult
			 abuse record checks will be conducted. The applicant shall indicate, by signed
			 acknowledgment, that the applicant has been informed that such record checks
			 will be conducted.
(2)
Criminal history check.
Prior to the employment of any person
			 to provide in-home services as described by this rule, the pharmacy shall
			 request that the department of public safety perform a criminal history
			 check.
(3)
Abuse history
			 checks.
Prior to the employment of any person to provide in-home
			 services as described by this rule, the pharmacy shall request that the
			 department of human services perform a child and dependent adult abuse record
			 check.
a. A person who has a criminal record,
			 founded dependent adult abuse report, or founded child abuse report shall not
			 be employed by a pharmacy to provide in-home services unless the department of
			 human services has evaluated the crime or founded abuse report, has concluded
			 that the crime or founded abuse does not merit prohibition from such
			 employment, and has notified the pharmacy that the person may be employed to
			 provide in-home services.
b. The
			 pharmacy shall keep copies of all record checks and evaluations for a minimum
			 of two years following receipt of the record or for a minimum of two years
			 after the individual is no longer employed by the pharmacy, whichever is
			 greater.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.14 - Training and Utilization of Registered Pharmacy Staff

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to rule
				657-8.3
				(155A), all Iowa-licensed pharmacies utilizing pharmacist-interns, pharmacy
				technicians, or pharmacy support persons shall have written policies and
				procedures for the training and utilization of pharmacist-interns, pharmacy
				technicians, and pharmacy support persons appropriate to the practice of
				pharmacy at that licensed location. Training shall be documented and maintained
				by the pharmacy for at least two years from the last date of employment or
				internship and shall be available for inspection by the board or its authorized
				agent.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.15 - Delivery of Prescription Drugs and Devices

Current through Register Vol. 47, No. 3, July 24, 2024
A prescription order may be delivered to a patient at any
				location licensed as a pharmacy. Alternatively, a pharmacy may use the mail, a
				common carrier, or personal delivery to deliver a prescription order to any
				location requested by the patient. A pharmacy that delivers prescription orders
				by one or more alternate methods shall have policies and procedures to ensure
				patient confidentiality, prescription order accountability, and proper storage
				of prescription orders during delivery. When counseling is required pursuant to
				rule 657-6.14 (155A), oral counseling
				shall be provided before the prescription order is delivered to the patient.
				Documentation of the delivery of prescription orders shall be maintained by the
				pharmacy for at least two years from the date of delivery. The term "patient"
				includes the patient and the patient's authorized
				representatives.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.16 - Confidential Information

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Release of confidential information.
Confidential information
			 may be released only as follows:
a. Pursuant
			 to the express written authorization of the patient or the order or direction
			 of a court.
b. To the patient or
			 the patient's authorized representative.
c. To the prescriber or other licensed
			 practitioner then caring for the patient.
d. To another licensed pharmacist when the
			 best interests of the patient require such release.
e. To the board or its representative or to
			 such other persons or governmental agencies duly authorized by law to receive
			 such information.
A pharmacist shall utilize the resources available to
				determine, in the professional judgment of the pharmacist, that any persons
				requesting confidential patient information pursuant to this rule are entitled
				to receive that information.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.18 - Electronic Prescription Mandate

Current through Register Vol. 47, No. 3, July 24, 2024
Beginning January 1, 2020, all prescriptions shall be
				transmitted electronically to a pharmacy pursuant to rule
				657-21.6 (124,155A), except as
				provided in rule 657-21.8 (124,155A). A
				pharmacist who receives a written, oral, or facsimile prescription shall not be
				required to verify that the prescription is subject to an exception provided in
				rule 657-21.8 (124,155A) and may
				dispense a prescription drug pursuant to an otherwise valid written, oral, or
				facsimile prescription pursuant to rule
				657-8.19(124,126,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.19 - Manner of Issuance of a Prescription Drug or Medication Order

Current through Register Vol. 47, No. 3, July 24, 2024
A prescription drug order or medication order that is issued
				prior to January 1, 2020, or that is exempt from the electronic prescription
				mandate pursuant to rule
				657-21.8 (124,155A) may be
				transmitted from a prescriber or a prescriber's agent to a pharmacy in written
				form, orally including telephone voice communication, by facsimile transmission
				as provided in rule 657-21.7 (124,155A), or by
				electronic transmission in accordance with applicable federal and state laws,
				rules, and regulations. Any prescription drug order or medication order
				provided to a patient in written or printed form shall include the original,
				handwritten signature of the prescriber except as provided in rule
				657-21.6 (124,155A).
(1)
Requirements for a
			 prescription.
A valid prescription drug order shall be based on a
			 valid patient-prescriber relationship except as provided in subrule 8.19(7) for
			 epinephrine auto-injectors, subrule 8.19(8) for opioid antagonists, or subrule
			 8.19(10) for bronchodilator canisters or bronchodilator canisters and spacers.
a.
Written, electronic, or facsimile
			 prescription.
In addition to the electronic prescription application
			 and pharmacy prescription application requirements of this rule, a written,
			 electronic, or facsimile prescription shall include:
(1) The date issued.
(2) The name and address of the patient
			 except as provided in subrule 8.19(7) for epinephrine auto-injectors, subrule
			 8.19(8) for opioid antagonists, subrule 8.19(9) for expedited partner therapy,
			 or subrule 8.19(10) for bronchodilator canisters or bronchodilator canisters
			 and spacers.
(3) The name,
			 strength, and quantity of the drug or device prescribed.
(4) The name and address of the prescriber
			 and, if the prescription is for a controlled substance, the prescriber's DEA
			 registration number.
(5) The
			 written or electronic signature of the prescriber.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.20 - Valid Prescriber/patient Relationship

Current through Register Vol. 47, No. 3, July 24, 2024
Prescription drug orders and medication orders shall be valid
				as long as a prescriber/patient relationship exists. Once the
				prescriber/patient relationship is broken and the prescriber is no longer
				available to treat the patient or oversee the patient's use of a prescription
				drug, any remaining prescription refills may be dispensed at the discretion of
				the pharmacist for a suitable amount of time so that the patient can establish
				care with a new provider and a new order can be issued. In determining the
				duration of which prescriptions may be dispensed, the pharmacist shall consider
				the patient's health care status and access to health care
				services.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.21 - Prospective Drug Use Review

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
			 For purposes of promoting therapeutic appropriateness and ensuring rational
			 drug therapy, a pharmacist shall review the patient record, information
			 obtained from the patient, and each prescription drug or medication order to
			 identify:
a. Overutilization or
			 underutilization;
b. Therapeutic
			 duplication;
c. Drug-disease
			 contraindications;
d. Drug-drug
			 interactions;
e. Incorrect drug
			 dosage or duration of drug treatment;
f. Drug-allergy interactions;
g. Clinical abuse/misuse;
h. Drug-prescriber contraindications.
Upon recognizing any of the above, the pharmacist shall take
				appropriate steps to avoid or resolve the problem and shall, if necessary,
				include consultation with the prescriber. The review and assessment of patient
				records shall not be delegated to pharmacy technicians or pharmacy support
				persons but may be delegated to registered pharmacist-interns under the direct
				supervision of the pharmacist.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.22 - Notification of Interchangeable Biological Product Selection

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to Iowa Code section
				155A.32,
				when a pharmacist substitutes a biological product that is an interchangeable
				biological product for the biological product prescribed, the pharmacist or
				pharmacist's designee shall, within five business days of dispensing the
				biological product, communicate to the prescriber the name and manufacturer of
				the biological product dispensed unless the prescription information has been
				entered into an electronic record system, such as an electronic medical record,
				electronic prescribing system, pharmacy benefit management system, or a
				pharmacy record to which the prescriber has access. The manner of communication
				to the prescriber may be via telephone, facsimile, electronic transmission, or
				other prevailing means.
This rule is intended to implement Iowa Code section
				155A.32.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.24 - Documented Verification

Current through Register Vol. 47, No. 3, July 24, 2024
The pharmacist shall provide, document, and retain a record of
				the final verification for the accuracy, validity, completeness, and
				appropriateness of the patient's prescription or medication order prior to the
				delivery of the medication to the patient or the patient's representative. In
				an approved technician product verification program, the checking technician
				shall provide, document, and retain a record of the final verification for the
				accuracy of the patient's prescription or medication order prior to the
				delivery of the medication to the patient or the patient's
				representative.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.26 - Continuous Quality Improvement Program

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to rule
				657-8.3
				(155A), each pharmacy licensed to provide pharmaceutical services to patients
				in Iowa shall implement or participate in a continuous quality improvement
				program (CQI program). The CQI program is intended to be an ongoing, systematic
				program of standards and procedures to detect, identify, evaluate, and prevent
				medication errors, thereby improving medication therapy and the quality of
				patient care. A pharmacy that participates as an active member of a hospital or
				corporate CQI program that meets the objectives of this rule shall not be
				required to implement a new program pursuant to this rule.
(1)
Reportable program
			 events.
For purposes of this rule, a reportable program event or
			 program event means a preventable medication error resulting in the incorrect
			 dispensing of a prescribed drug received by or administered to the patient and
			 includes but is not necessarily limited to:
a. An incorrect drug;
b. An incorrect drug strength;
c. An incorrect dosage form;
d. A drug received by the wrong
			 patient;
e. Inadequate or incorrect
			 packaging, labeling, or directions; or
f. Any incident related to a prescription
			 dispensed to a patient that results in or has the potential to result in
			 serious harm to the patient.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 8 - Universal Practice Standards › Rule 657-8.35 - Pharmacy License

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy license issued by the board is required for all
				sites where prescription drugs are offered for sale or dispensed under the
				supervision of a pharmacist. The current pharmacy license certificate shall be
				displayed in a position visible to the public. The board may issue any of the
				following types of pharmacy licenses: a general pharmacy license, a hospital
				pharmacy license, a limited use pharmacy license, or a nonresident pharmacy
				license. Nonresident pharmacy license applicants shall comply with board rules
				regarding nonresident pharmacy practice except when a waiver has been granted.
				Applicants for general or hospital pharmacy practice shall comply with board
				rules regarding general or hospital pharmacy practice except when a waiver has
				been granted. Any pharmacy that dispenses controlled substances to Iowa
				residents must also register pursuant to 657-Chapter 10.
(1)
Limited use pharmacy
			 license.
A limited use pharmacy license may be issued for nuclear
			 pharmacy practice, correctional facility pharmacy practice, veterinary pharmacy
			 practice, telepharmacy practice, and other limited use practice settings.
			 Applications for a limited use pharmacy license shall be considered on a
			 case-by-case basis.
(2)
Application.
Applicants for initial licensure, license
			 renewal, license reactivation, or license changes pursuant to subrule 8.35(6)
			 shall complete the relevant pharmacy license application and shall include all
			 required information and attachments. All pharmacy license applications require
			 submission of a nonrefundable $135 license fee plus applicable penalty fees.
			 The application shall include the signature of the pharmacy owner's authorized
			 representative and shall require at a minimum the following:
a. Disclosure of pharmacy ownership
			 information, including information about the pharmacy's registered
			 agent;
b. Identification and
			 signature of the pharmacist in charge;
c. The identification of and average number
			 of hours worked by all pharmacists, pharmacist-interns, pharmacy technicians,
			 and pharmacy support persons working in the pharmacy;
d. Criminal and disciplinary history
			 information;
e. Description of the
			 scope of services provided by the pharmacy; and
f. If the pharmacy is located outside of
			 Iowa, identification of a registered agent located in Iowa.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
This chapter establishes the minimum standards for any activity
				that involves controlled substances. Any person or business that manufactures;
				distributes; dispenses; prescribes; conducts instructional activities,
				research, or chemical analysis with; or imports or exports controlled
				substances listed in Schedules I through V of Iowa Code chapter 124 in or into
				the state of Iowa, or that proposes to engage in such activities, shall obtain
				and maintain a registration issued by the board unless exempt from registration
				pursuant to rule
				657-10.8
				(124). A person or business required to be registered shall not engage in any
				activity for which registration is required until the application for
				registration is granted and the board has issued a certificate of registration
				to such person or business. A registration is not transferable to any person or
				business.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purposes of this chapter, the following definitions
				shall apply:
"Authorized collection program "
means a
				program administered by a registrant that has modified its registration with
				DEA to collect controlled substances for the purpose of disposal. Federal
				regulations for such programs can be found at
www.deadiversion.usdoj.gov/drug_disposal/
.
				Modification to the registrant's Iowa controlled substances Act registration
				shall not be required.
"Board"
means the Iowa board of
				pharmacy.
"CSA "
means the Iowa uniform controlled
				substances Act.
"CSA registration "
or
"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 United States Department of
				Justice, Drug Enforcement Administration.
"Individual practitioner"
means a physician or
				surgeon (M.D.), osteopathic physician or surgeon (D.O.), dentist (D.D.S. or
				D.M.D.), doctor of veterinary medicine (D.V.M.), podiatric physician (D.P.M.),
				optometrist (O.D.), physician assistant (P.A.), resident physician, advanced
				registered nurse practitioner (A.R.N.P.), or prescribing psychologist.
"Prescription monitoring program, " "PMP, "
or
"program "
means the program established pursuant to
				657-Chapter 3 7 for the collection and maintenance of PMP information and for
				the provision of PMP information to authorized individuals.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.3 - Who Shall Register

Current through Register Vol. 47, No. 3, July 24, 2024
The following persons or businesses shall register on forms
				provided by the board:
1.
			 Manufacturers, distributors, importers, and exporters located in Iowa.
			 Effective January 1, 2018, nonresident manufacturers, distributors, importers,
			 and exporters distributing controlled substances into Iowa.
2. Reverse distributors located in Iowa.
			 Effective January 1,2018, nonresident reverse distributors engaging in the
			 transfer of controlled substances with registrants located in Iowa.
3. Individual practitioners located in Iowa
			 who are administering, dispensing, or prescribing controlled substances and
			 individual practitioners located outside of Iowa who are dispensing or
			 prescribing controlled substances via telehealth services to patients located
			 in Iowa.
4. Pharmacies located in
			 Iowa that are dispensing controlled substances. Effective January 1, 2018,
			 pharmacies located outside of Iowa that are delivering controlled substances to
			 patients located in Iowa.
5.
			 Hospitals located in Iowa that are administering or dispensing controlled
			 substances. Effective January 1, 2018, hospitals located outside of Iowa that
			 are administering or dispensing controlled substances to patients located in
			 Iowa.
6. Emergency medical service
			 programs that are administering controlled substances to patients located in
			 Iowa.
7. Care facilities that are
			 located in Iowa.
8. Researchers,
			 analytical laboratories, and teaching institutions that are located in
			 Iowa.
9. Animal shelters and dog
			 training facilities that are located in Iowa.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.4 - Who May Register

Current through Register Vol. 47, No. 3, July 24, 2024
On a case-by-case basis, the board may issue a registration to
				a business location not listed in rule
				657-10.3 (124) if it would be
				impractical to require each individual practitioner who administers or
				dispenses controlled substances to separately register at the business
				location. Examples of business locations that may be eligible for a
				registration pursuant to this rule include, but are not limited to, ambulatory
				surgical centers as defined in Iowa Code section
				147.163, dialysis centers,
				federally qualified health centers, and standalone clinics associated with a
				hospital system.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.5 - Application

Current through Register Vol. 47, No. 3, July 24, 2024
Applicants for initial registration, registration renewal
				pursuant to rule 657-10.6 (124), or modifications
				pursuant to rule 657-10.9 (124) shall complete
				the appropriate application and shall include all required information and
				attachments.
(1)
Signature
			 requirements.
Each application, attachment, or other document filed as
			 part of an application shall be signed by the applicant as follows:
a. If the applicant is an individual
			 practitioner, the practitioner shall sign the application and supporting
			 documents.
b. If the applicant is a
			 business, the application and supporting documents shall be signed by the
			 person ultimately responsible for the security and maintenance of controlled
			 substances at the registered location. If the applicant is a pharmacy, the
			 responsible individual shall be the pharmacist in charge, unless the applicant
			 petitions the board for an alternate responsible individual.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.6 - Registration Renewal

Current through Register Vol. 47, No. 3, July 24, 2024
Each registration shall be renewed prior to its expiration. A
				registrant may renew its registration up to 60 days prior to the registration
				expiration. The nonrefundable fee for registration renewal shall be $90 per
				biennium and may include a nonrefundable surcharge of not more than 25 percent
				of the registration fee for deposit into the program fund.
(1)
Delinquent registration grace
			 period.
A registration renewal application that is submitted after
			 expiration but within 30 days following expiration shall be considered
			 delinquent and shall require the nonrefundable payment of the application fee
			 plus a nonrefundable late penalty fee of $90 and may require payment of a
			 surcharge of not more than 25 percent of the applicable fees for deposit into
			 the program fund. A registrant that submits a completed registration renewal
			 application, nonrefundable late application fee, and nonrefundable late penalty
			 fee within 30 days following expiration shall not be subject to disciplinary
			 action for continuing to operate in the 30 days following expiration.
(2)
Delinquent registration
			 reactivation beyond grace period.
If a registration renewal
			 application is not postmarked or hand-delivered to the board office within 30
			 days following the registration's expiration date, the registrant may not
			 conduct operations that involve controlled substances until the registrant
			 reactivates the registration. A registrant may apply for reactivation by
			 submitting a registration application for reactivation. The nonrefundable fee
			 for reactivation shall be $360 and may include a nonrefundable surcharge of not
			 more than 25 percent of the applicable fee for deposit into the program fund.
			 As part of the reactivation application, the registrant shall disclose the
			 activities conducted with respect to controlled substances while the
			 registration was expired. A registrant that continues to conduct activities
			 with respect to controlled substances without an active registration may be
			 subject to disciplinary sanctions.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.8 - Separate Registrations for Separate Locations; Exemption From Registration

Current through Register Vol. 47, No. 3, July 24, 2024
A separate registration is required for each principal place
				of business or professional practice location where controlled substances are
				manufactured, distributed, imported, exported, dispensed, stored, or collected
				for the purpose of disposal unless the person or business is exempt from
				registration pursuant to Iowa Code section
				124.302(3),
				this rule, or federal regulations.
(1)
Warehouse.
A warehouse where controlled substances are stored
			 by or on behalf of a registered person or business shall be exempt from
			 registration except as follows:
a.
			 Registration of the warehouse shall be required if such controlled substances
			 are distributed directly from that warehouse to registered locations other than
			 the registered location from which the substances were delivered to the
			 warehouse.
b. Registration of the
			 warehouse shall be required if such controlled substances are distributed
			 directly from that warehouse to persons exempt from registration pursuant to
			 Iowa Code section
			 124.302(3).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.10 - Denial of Application or Discipline of Registration

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Grounds for denial or
			 discipline.
The board may deny any application or discipline any
			 registration upon a finding that the applicant or registrant:
a. Has furnished false or fraudulent material
			 information.
b. Has had the
			 applicant's or registrant's federal registration to manufacture, distribute, or
			 dispense controlled substances suspended, revoked, or otherwise
			 sanctioned.
c. Has been convicted
			 of a public offense under any state or federal law relating to any controlled
			 substance. For the purpose of this rule only, a conviction shall include a plea
			 of guilty, a forfeiture of bail or collateral deposited to secure a defendant's
			 appearance in court which forfeiture has not been vacated, or a finding of
			 guilt in a criminal action even if entry of the judgment or sentence has been
			 withheld and the applicant or registrant has been placed on
			 probation.
d. Has committed such
			 acts as would render the applicant's or registrant's registration under Iowa
			 Code section
			 124.303 inconsistent
			 with the public interest as determined by that section.
e. Has been subject to discipline by the
			 applicant's or registrant's respective professional licensing board and the
			 discipline revokes or suspends the applicant's or registrant's professional
			 license or otherwise disciplines the applicant's or registrant's professional
			 license in a way that restricts the applicant's or registrant's authority to
			 handle or prescribe controlled substances. A copy of the record of licensee
			 discipline or a copy of the licensee's surrender of the professional license
			 shall be conclusive evidence.
f.
			 Has failed to obtain or maintain active registration while engaged in
			 activities which require registration.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.12 - Inspection

Current through Register Vol. 47, No. 3, July 24, 2024
The board may inspect, or cause to be inspected, the
				establishment of an applicant or registrant. The board shall review the
				application for registration and other information regarding an applicant or
				registrant in order to determine whether the applicant or registrant has met
				the applicable standards of Iowa Code chapter 124 and these
				rules.