reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.7 - Pmp Reporting-exemptions

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Exempted dispensing or
			 administration.
The dispensing or administration of a controlled
			 substance as described in this subrule shall not be considered a reportable
			 prescription. A pharmacy engaged in the distribution of controlled substances
			 solely pursuant to one or more of the practices identified in this subrule
			 shall notify the PMP administrator of the exempted practice, and the pharmacy
			 shall not be required to report to the PMP.
a. The dispensing by a licensed hospital
			 pharmacy for the purposes of inpatient hospital care.
b. The dispensing by a licensed pharmacy for
			 a patient residing in a health care facility or inpatient hospice
			 facility.
c. The administration by
			 a prescriber of a controlled substance for the purposes of outpatient
			 procedures and treatment.
d. The
			 sale by a licensed pharmacy of a Schedule V controlled substance without a
			 prescription which sale is subject to the reporting requirements of 657-Chapter
			 100.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.8 - Pmp Reporting-dispensing Prescribers

Current through Register Vol. 47, No. 3, July 24, 2024
Each dispensing prescriber, unless exempt pursuant to rule
				657"37.7(124), shall submit to the PMP a record of each reportable prescription
				dispensed during a reporting period pursuant to subrule 37.12(2). For purposes
				of prescriber dispensing, the prescriber shall also be identified as the
				dispenser or pharmacy. A veterinarian may, but shall not be required to, submit
				to the PMP a record of reportable prescriptions dispensed by the
				veterinarian.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.9 - Pmp Reporting-pharmacies

Current through Register Vol. 47, No. 3, July 24, 2024
Each pharmacy, unless exempt pursuant to rule
				657-37.7 (124), shall submit to
				the PMP either a record of each reportable prescription dispensed or
				administered during a reporting period pursuant to subrule 37.12(2) or a zero
				report pursuant to subrule 37.12(4), as appropriate.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.12 - Reporting Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Data elements.
The information submitted to the PMP for each
			 reportable prescription shall be accurate and shall include, at a minimum, the
			 following data elements:
a. Dispenser DEA
			 number.
b. Date the prescription is
			 dispensed or administered.
c.
			 Prescription number or unique identification number.
d. NDC number of the drug dispensed or
			 administered.
e. Quantity of the
			 drug dispensed or administered.
f.
			 Number of days of drug therapy provided by the drug dispensed or
			 administered.
g. Patient legal
			 first and last names.
h. Patient
			 address including street address, city, state, and ZIP code.
i. Patient phone number.
j. Patient date of birth.
k. Patient gender.
l. Prescriber name and DEA number.
m. Date the prescription was issued by the
			 prescriber.
n. Method of
			 payment.
o. Form of transmission of
			 prescription origin.
p. Refill
			 number.
q. Number of refills
			 authorized.
r. Indication as to
			 whether the prescription is new or a refill.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.13 - Opioid Antagonist Administration by First Responders

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The administration of an opioid
			 antagonist by a first responder shall be reported to the PMP, unless such
			 administration was reported to the Iowa department of public health bureau of
			 emergency and trauma services.
(2)
			 The reporting of the administration of an opioid antagonist by a first
			 responder shall include the following data elements:
a. Patient first and last names.
b. First and last names of the individual who
			 administered the opioid antagonist.
c. Date of administration.
d. Quantity of the opioid antagonist
			 administered.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.16 - Access to Pmp Information

Current through Register Vol. 47, No. 3, July 24, 2024
All information contained in the PMP is confidential and shall
				only be accessed as provided in this rule. All requests for PMP information
				must comply with the format specified by the board for the particular type of
				request. Once information is accessed, further dissemination or use of that
				information is governed by applicable federal and state laws governing the
				person who accessed the information. The board may charge a fee to recover the
				actual costs associated with responding to any request by a person other than a
				practitioner or a practitioner's delegate. Any fees or costs assessed by the
				board shall be considered repayment receipts as defined in Iowa Code section
				8.2.
(1)
Prescribers.
A prescriber may access a patient's prescription history report; the
			 prescriber's activity report; proactive alerts or system user notes, such as
			 peer-to-peer communication; and NarxCare reports. A veterinarian with authority
			 to prescribe controlled substances may access a current patient's or client's
			 prescription history report if the veterinarian has a reasonable basis to
			 suspect the client may be abusing drugs or mistreating an animal.
(2)
Pharmacists.
a. A pharmacist may access a patient's or
			 client's prescription history report; proactive alerts or system user notes,
			 such as peer-to-peer communication; and NarxCare reports.
b. A pharmacist shall review a patient's or
			 client's prescription history report prior to dispensing a Schedule V
			 controlled substance without a prescription pursuant to rule
			 657-10.33 (124, 155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.17 - Integrated Systems

Current through Register Vol. 47, No. 3, July 24, 2024
A practitioner or a health care system may integrate its
				electronic health record system or a pharmacy may integrate its automated data
				processing system with the PMP using an application programming interface. Use
				of an integrated system shall comply with all of the following:
(1) The integrated system shall log each
			 user's access to PMP information. Access logs shall be retained by the
			 practitioner, health care system, or pharmacy for a minimum of four years from
			 the date of access and shall be provided to the board upon request.
(2) If the user identified in access logs is
			 not the practitioner, the integrated system shall clearly identify on which
			 practitioner's behalf the user was accessing PMP information. A practitioner's
			 delegate using an integrated system is required to maintain active PMP
			 registration.
(3) The integrated
			 system shall maintain appropriate administrative, technical, and physical
			 security measures to safeguard against unauthorized access, disclosure, or
			 theft of PMP information and shall meet all HIPAA requirements for safeguarding
			 protected health information.
(4)
			 The practitioner, health care system, or pharmacy shall notify the PMP
			 administrator of any breach in the electronic health record system that may
			 have included PMP information within 72 hours of making the determination that
			 a breach occurred.
(5) An
			 integrated system shall comply with all requirements in subchapter VI of Iowa
			 Code chapter 124 and all requirements of this chapter.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.18 - Pmp Administrator Access

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
PMP staff.
The board may
			 designate PMP administrators who may access any PMP information needed to
			 perform the functions of the job.
(2)
Statistical data.
The
			 PMP administrator or designee may provide summary, statistical, or aggregate
			 data to public or private entities for statistical, public research, public
			 policy, or educational purposes. The board may charge a fee to recover the
			 actual costs associated with responding to a request for PMP data pursuant to
			 this subrule. Any fees or costs assessed by the board shall be considered
			 repayment receipts as defined in Iowa Code section
			 8.2.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.19 - Prescriber Activity Reports

Current through Register Vol. 47, No. 3, July 24, 2024
The PMP administrator shall, at least annually, electronically
				issue to each prescriber who prescribed a controlled substance that was
				reported to the program as dispensed in or into this state during the preceding
				reporting period an activity report which shall include, at a minimum, the
				following:
1. A summary of the
			 prescriber's history of prescribing controlled substances,
2. A comparison of the prescriber's history
			 of prescribing controlled substances with the history of other prescribers of
			 the same profession or specialty,
3. The prescriber's history of program
			 use,
4. General patient risk
			 factors, and
5. Educational
			 updates.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.20 - Proactive Notifications

Current through Register Vol. 47, No. 3, July 24, 2024
The PMP administrator shall provide notification to a
				practitioner when a patient may be practitioner shopping or at risk of abusing
				or misusing a controlled substance based on criteria and thresholds determined
				by the board and the advisory council. A proactive notification pursuant to
				this rule will be initiated when a patient obtains prescriptions for controlled
				substances from a minimum number of prescribing practitioners and from a
				minimum number of pharmacies within a maximum number of days which exceed the
				thresholds established by the board and advisory council. The notification will
				suggest review of the patient's prescription history.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.21 - Record Retention

Current through Register Vol. 47, No. 3, July 24, 2024
The PMP shall retain all reported prescriptions, all records of
				access to or query of PMP information, and all information distributed to
				practitioners in proactive notifications for a minimum of four years from the
				date of the record.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 37 - Iowa Prescription Monitoring Program › Rule 657-37.22 - Information Errors

Current through Register Vol. 47, No. 3, July 24, 2024
Any person who believes that PMP information is erroneous shall
				notify the pharmacy or dispensing practitioner. Upon notification of a
				potential error in PMP information, the pharmacy or dispensing practitioner
				shall promptly correct erroneous information in the record.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 39 - Expanded Practice Standards › Rule 657-39.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to establish the minimum
				standards for the programs and activities identified in this chapter. These
				rules shall apply to all licensed pharmacists, other registered pharmacy
				personnel, and all pharmacies, including owners, engaged in the state of Iowa
				in the programs and activities identified in this chapter. These rules are in
				addition to rules of the board relating to the practice of pharmacy unless
				otherwise indicated by rule.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 39 - Expanded Practice Standards › Rule 657-39.4 - Pharmaceutical Care

Current through Register Vol. 47, No. 3, July 24, 2024
Pharmaceutical care is a comprehensive, patient-centered,
				outcomes-oriented pharmacy practice in which the pharmacist accepts
				responsibility for assisting the prescriber and the patient in optimizing the
				patient's drug therapy plan and works to promote health, to prevent disease,
				and to optimize drug therapy. Pharmaceutical care does not include the
				prescribing of drugs without the consent of the prescriber.
(1)
Drug therapy problems.
In providing pharmaceutical care, the pharmacist shall strive to identify,
			 resolve, and prevent drug therapy problems.
(2)
Drug therapy plan.
In
			 providing pharmaceutical care, the pharmacist shall access and evaluate
			 patient-specific information, identify drug therapy problems, and utilize that
			 information in a documented plan of therapy that assists the patient or the
			 patient's caregiver in achieving optimal drug therapy. In concert with the
			 patient, the patient's prescribing practitioner, and the patient's other health
			 care providers, the pharmacist shall assess, monitor, and suggest modifications
			 of the drug therapy plan as appropriate.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 39 - Expanded Practice Standards › Rule 657-39.6 - Statewide Protocols

Current through Register Vol. 47, No. 3, July 24, 2024
To the extent authorized in Iowa Code section
				155A.46, a
				pharmacist may, pursuant to statewide protocols developed by the board in
				consultation with the department of public health and available on the board's
				website at pharmacy.iowa.gov, order and dispense medications pursuant to the
				requirements identified in the statewide protocols. For the purpose of this
				rule, the order shall constitute a prescription.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 39 - Expanded Practice Standards › Rule 657-39.8 - Medications Administered via Prescription

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Vaccine administration.
A pharmacist who is authorized to administer vaccines pursuant to the statewide
			 protocol may administer, including via delegation to authorized pharmacy
			 personnel, any vaccine pursuant to a prescription or medication order for an
			 individual patient. In case of a serious complication, the pharmacist shall
			 notify the prescriber who authorized the prescription within 24 hours and shall
			 submit a report to the Vaccine Adverse Event Reporting System
			 (VAERS).
(2)
Medication
			 administration.
A pharmacist may administer, including via delegation
			 to authorized pharmacy personnel if so delegated or authorized by the
			 prescriber, any medication pursuant to a prescription or medication order for
			 an individual patient. In case of a serious complication, the pharmacist shall
			 notify the prescriber who issued the prescription within 24 hours and shall
			 submit a report to the United States Food and Drug Administration Adverse Event
			 Reporting System (FAERS).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 40 - Technology-assisted Technician Product Verification Programs › Rule 657-40.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy located in Iowa which provides clinical pharmacy
				services may, but shall not be required to, develop and implement a technician
				product verification (TPV) program in accordance with these rules. For the
				purpose of this chapter, clinical pharmacy services shall mean services that
				exceed the minimum requirements of the practice of pharmacy. Clinical pharmacy
				services include, but are not limited to, medication therapy management,
				collaborative practice, statewide protocols, and immunizations. In a TPV
				program, certified pharmacy technicians provide technology-assisted final drug
				product verification during the prescription-filling or medication distribution
				process. The pharmacist shall still be responsible for verification of the
				accuracy of data entry, drug utilization review, ensuring rational drug
				therapy, and counseling. The onsite practice hours for a pharmacist shall not
				be reduced but shall be redistributed directly to clinical pharmacy services to
				improve patient care and health outcomes.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 40 - Technology-assisted Technician Product Verification Programs › Rule 657-40.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purposes of this chapter, the following definitions
				shall apply:
"Board"
means the board of pharmacy.
"Certifiedpharmacy technician "
means an
				individual who holds a valid current national certification and who has
				registered with the board as a certified pharmacy technician pursuant to
				657-Chapter 3.
"Checking technician "
means a certified
				pharmacy technician who has been authorized pursuant to rule
				657-40.4 (155A) by the
				responsible pharmacist to provide drug product verification in a TPV
				program.
"Representative sample "
means a subset of
				prescriptions that must be verified by a pharmacist for each checking
				technician involved in a TPV program. A subset consists of a minimum of 1
				percent of prescriptions verified by each checking technician or 25
				prescriptions per checking technician, whichever is greater.
"Responsiblepharmacist"
means the pharmacist
				who is designated by the pharmacy or pharmacist in charge to oversee a TPV
				program and who is responsible for ensuring the TPV program complies with these
				rules.
"Technician product verification program"
or
"TPV"
means a program formally established and implemented
				pursuant to these rules which permits a checking technician to provide
				technology-assisted drug product verification during the prescription-filling
				or medication distribution process. "TPV" includes programs previously approved
				by the board as "tech-check-tech" or "TCT" programs.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 40 - Technology-assisted Technician Product Verification Programs › Rule 657-40.4 - Checking Technician Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
A certified pharmacy technician shall comply with the
				requirements of this rule prior to being authorized to engage in checking
				technician activities in a TPV program. Prior to authorizing the technician to
				engage in TPV activities, the responsible pharmacist shall ensure the
				technician is proficient in all aspects of the TPV program and the
				responsibilities of a checking technician.
(1)
Minimum qualifications.
a.
National certification.
The certified pharmacy technician's national certification as required pursuant
			 to rule 657-3.5 (155A) shall be
			 current.
b.
Iowa
			 registration.
The certified pharmacy technician's registration with
			 the board as required pursuant to rule
			 657-3.3 (155A) shall be current
			 and not currently subject to disciplinary charges or sanctions.
c.
Prior experience.
The
			 certified pharmacy technician shall have completed a minimum of 2,000 hours as
			 a technician and be trained pursuant to subrule 40.4(2).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 40 - Technology-assisted Technician Product Verification Programs › Rule 657-40.7 - Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
Policies and procedures shall be developed and adhered to in a
				TPV program. Policies and procedures for a TPV program shall include, at a
				minimum, the following:
1. A program
			 to train certified pharmacy technicians to be checking technicians pursuant to
			 subrule 40.4(2), including but not limited to training in the scanning
			 technology to be utilized in the TPV program, limitations of the scanning
			 technology, and strategies to compensate for these limitations.
2. A procedure to identify a representative
			 sample to complete a quarterly quality assurance double check of prescriptions
			 verified by each checking technician.
3. Redirection of pharmacist hours to
			 clinical pharmacy services.
4.
			 Identification of drug products for which authorized checking technicians will
			 be prohibited from performing final drug product verification during the
			 prescription-filling or medication distribution process.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 40 - Technology-assisted Technician Product Verification Programs › Rule 657-40.8 - Tpv Program Quality Assurance

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Quality assurance
			 program
-
quarterly verification.
The responsible
			 pharmacist shall establish and implement a quality assurance program to
			 evaluate TPV program activities. Each quarter, a pharmacist shall verify a
			 representative sample of prescriptions verified by each checking technician.
			 The quarterly verification shall be documented, and such documentation shall be
			 maintained pursuant to subrule 40.11(2).
(2)
Review of errors.
Any
			 error resulting from TPV shall be documented and evaluated via the pharmacy's
			 continuous quality improvement program (CQI) pursuant to rule
			 657-8.26 (155A) and shall
			 require the technician responsible for the error to be retrained through the
			 pharmacy's established training program.
(3)
Quarterly reports.
The
			 responsible pharmacist shall ensure the completion of a quarterly report on
			 forms provided by the board. The quarterly report shall be maintained in the
			 pharmacy pursuant to subrule 40.11(3).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 40 - Technology-assisted Technician Product Verification Programs › Rule 657-40.11 - Tpv Program Records

Current through Register Vol. 47, No. 3, July 24, 2024
The records required in this rule, in addition to any other
				required records of the pharmacy, shall be available for inspection and copying
				by the board, its authorized agent, or another authorized agency for a minimum
				of two years following the date of the record.
(1)
Checking technician training and
			 authorization.
TPV program records shall include all records
			 documenting the successful completion of the pharmacy's training program for
			 each checking technician in the TPV program. The record for each checking
			 technician shall include the following:
a. The
			 name of the technician.
b. The date
			 on which the technician completed the system-specific training for
			 participation in the TPV program.
c. The date on which the technician was
			 authorized to participate in the TPV program.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 41 - Outsourcing Facilities › Rule 657-41.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to establish the minimum
				standard of practice for outsourcing facilities that intend to provide
				compounding services in or into Iowa. The requirements of these rules, in
				addition to any other board rules applicable to the facility's operation, apply
				to all Iowa-licensed outsourcing facilities that provide compounded medications
				in or into Iowa whether pursuant to a patient-specific prescription or
				not.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 41 - Outsourcing Facilities › Rule 657-41.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purposes of this chapter, the following definitions
				shall apply:
"Board"
means the Iowa board of
				pharmacy.
"FDA"
means the United States Food and Drug
				Administration.
"Home state"
means the state in which an
				outsourcing facility is located.
"Outsourcing facility"
or
"facility"
means any compounding facility that is registered
				as an outsourcing facility, as defined in
				21 U.S.C. Section
				353b, that distributes sterile compounded
				human drug products without a patient-specific prescription to an authorized
				agent or practitioner in this state.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 41 - Outsourcing Facilities › Rule 657-41.3 - Outsourcing Facility License

Current through Register Vol. 47, No. 3, July 24, 2024
An outsourcing facility shall apply for and obtain an
				outsourcing facility license from the board prior to providing
				non-patient-specific compounded human drug products in this state. The
				applicant shall submit a completed application along with an application fee of
				$400. An outsourcing facility that intends to distribute controlled substances
				in or into Iowa shall also, prior to distributing such substances in or into
				Iowa, apply for and obtain an Iowa controlled substances Act registration
				pursuant to 657-Chapter 10.
(1)
Application requirements.
The application shall require
			 demographic information about the facility; ownership information; the name,
			 signature and home state license number for the supervising pharmacist; an
			 attestation that the supervising pharmacist has read and understands the laws
			 and rules relating to sterile compounding in Iowa; information about the
			 entity's registered agent; criminal and disciplinary history information; and a
			 description of the scope of services to be provided in Iowa. As part of the
			 application process, the applicant shall also:
a. Submit evidence of possession of a valid
			 registration with the FDA as an outsourcing facility.
b. If one or more inspections have been
			 conducted by the FDA in the five-year period immediately preceding the
			 application, submit a copy of any correspondence from the FDA as a result of
			 the inspection, including but not limited to any form 483s, warning letters, or
			 formal responses, and all correspondence from the applicant to the FDA related
			 to such inspections, including but not limited to formal responses and
			 corrective action plans. In addition, the applicant shall submit evidence of
			 correction of all deficiencies discovered in such inspections and evidence of
			 compliance with all directives from the FDA.
c. Submit evidence that the supervising
			 pharmacist, as described in
			 21 U.S.C. Section
			 353b(a), holds a valid
			 pharmacist license in the state in which the facility is located and that such
			 license is in good standing.
d.
			 Submit information to facilitate a national criminal history record
			 check.
e. Submit evidence of a
			 satisfactory inspection conducted by the home state regulatory authority or an
			 entity approved by the board in accordance with subrule 41.3(6) along with
			 evidence of corrective action taken to satisfy any deficiency identified in the
			 inspection report and of compliance with all legal directives of the home state
			 licensing authority.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 41 - Outsourcing Facilities › Rule 657-41.4 - Applicability of Board Rules

Current through Register Vol. 47, No. 3, July 24, 2024
An outsourcing facility shall comply with all requirements of
				this chapter, 657-Chapter 20, and any other board rules relating to the
				services that are provided to Iowa customers.
(1)
Controlled substances.
An outsourcing facility providing prescription drugs identified as controlled
			 substances under Iowa Code chapter 124 to Iowa customers or patients shall
			 comply with all requirements of 657-Chapter 10.
(2)
Electronic data.
An
			 outsourcing facility utilizing any electronic data processing or transmission
			 devices or services shall comply with all requirements of 657-Chapter
			 21.
(3)
Patient-specific
			 prescriptions.
An outsourcing facility that also provides
			 patient-specific compounded medications pursuant to a prescription shall comply
			 with all requirements of 65 7-Chapters 8, 19, and 20.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 41 - Outsourcing Facilities › Rule 657-41.5 - Reporting Discipline and Criminal Convictions

Current through Register Vol. 47, No. 3, July 24, 2024
An outsourcing facility shall provide written notice to the
				board of any disciplinary or enforcement action imposed by any licensing or
				regulatory authority on any license or registration held by the facility.
				Written notice shall be received 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. An outsourcing facility shall provide written notice to the board of
				any criminal conviction of the facility or of any owner that is related to the
				operation of the facility no later than 3 0 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 41 - Outsourcing Facilities › Rule 657-41.6 - 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 an outsourcing facility
				license 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 outsourcing
			 facility, supervising pharmacist, or individual owner, or if the outsourcing
			 facility is an association, joint stock company, partnership, or corporation,
			 by any managing officer.
3.
			 Refusing access to the outsourcing facility or facility records to an agent of
			 the board for the purpose of conducting an inspection or
			 investigation.
4. Failure to
			 maintain licensure pursuant to 657-Chapter 8 or 657-Chapter 19 when dispensing
			 compounded drugs pursuant to patient-specific prescriptions into the
			 state.
5. Any violation of Iowa
			 Code chapter 155A, 124, 124B, 126, or 205 or any rule of the board, including
			 the disciplinary grounds set forth in 657-Chapter 36.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to establish the minimum
				standard of practice for limited drug and device distribution in the state of
				Iowa. This chapter applies to a person who is involved in the distribution of
				drugs and devices but who does not meet the definition of a wholesale
				distributor under federal or state law. In addition to the rules of the board,
				any distribution of prescription drugs and devices shall be in compliance with
				all applicable federal and state laws and regulations.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
In addition to the definitions found in Iowa Code section
				155A.3, which are
				adopted for the purposes of this chapter, the following definitions shall
				apply:
"Board"
means the Iowa board of
				pharmacy.
"Distribute "
means the delivery or transfer
				of a prescription drug or device from one person to another.
"Facility manager"
means the individual
				responsible for managing the daily operations of the limited distributor
				facility.
"Limited distributor"
means a person operating
				or maintaining a location, regardless of the location, where prescription drugs
				or devices are manufactured, repackaged, distributed at wholesale, or
				distributed to a patient pursuant to a prescription drug order, who is not
				eligible for a wholesale distributor license or a pharmacy license. Included in
				the definition of "limited distributor" are the activities identified in
				subrule 42.3(1).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.3 - Limited Distributor License

Current through Register Vol. 47, No. 3, July 24, 2024
Beginning January 1, 2019, no person other than a licensed
				wholesale distributor, licensed pharmacy, or practitioner shall engage in any
				of the activities found herein in this state without a limited distributor
				license. Where operations are conducted at more than one location by a single
				distributor, each location shall be separately licensed. The applicant shall
				submit a completed application along with a nonrefundable fee of $175. A
				limited distributor that engages in distribution of controlled substances into,
				out of, or within this state shall also obtain a controlled substances Act
				registration pursuant to 657-Chapter 10.
(1)
License required.
A
			 person engaged in the following activities shall obtain a limited distributor
			 license prior to distribution in or into Iowa:
a. Distribution of a medical gas or device at
			 wholesale or to a patient pursuant to a prescription drug order.
b. Wholesale distribution of a prescription
			 animal drug.
c. Wholesale
			 distribution of a prescription drug, or brokering the distribution of a
			 prescription drug at wholesale, by a manufacturer, a manufacturer's co-licensed
			 partner, or a repackager.
d.
			 Intracompany distribution of a prescription drug, including pharmacy chain
			 distribution centers.
e.
			 Distribution at wholesale of a combination product as defined by the United
			 States Food and Drug Administration, medical convenience kit, intravenous fluid
			 or electrolyte, dialysis solution, radioactive drug, or irrigation or sterile
			 water solution to be dispensed by prescription only.
f. Distribution of a dialysis solution by the
			 manufacturer or the manufacturer's agent to a patient pursuant to a
			 prescription drug order, provided that a licensed pharmacy processes the
			 prescription drug order.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.6 - Grounds for Denial

Current through Register Vol. 47, No. 3, July 24, 2024
The board may deny a limited distributor license application,
				or refuse to renew a license, for any of the following:
1. Any criminal convictions of the applicant
			 related to the distribution of drugs or devices;
2. Any felony convictions of the
			 applicant;
3. Insufficient
			 experience in the distribution of prescription drugs or devices, including a
			 lack of knowledge regarding the requirements of applicable federal and state
			 laws or regulations;
4. The
			 furnishing of false or fraudulent material;
5. Suspension, revocation, or other
			 disciplinary action taken by the licensing authority of another state or
			 federal agency against any license or registration currently or previously held
			 by the applicant;
6. Noncompliance
			 with licensing requirements under previously granted licenses, if
			 any;
7. Noncompliance with the
			 requirements to maintain or make available to the board, its agents, or to
			 federal, state, or local law enforcement officials those records required to be
			 maintained;
8. Conducting
			 transactions with a person that is not properly licensed, registered, or
			 authorized; and
9. Any other
			 factors or qualifications the board considers relevant to and consistent with
			 public health and safety.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.7 - Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
			 Distributors shall have for all aspects of the distributor's operation policies
			 and procedures that, at a minimum, address the rules in this chapter and any
			 other applicable federal, state, and local laws, rules, and
			 regulations.
(2) The policies shall
			 address, at a minimum:
a. Security of the
			 facility and of patient information;
b. Storage of products, including proper
			 storage conditions and handling of outdated, recalled, and returned
			 products;
c. Records, including the
			 retention period for all required records;
d. Security, storage and records for products
			 in the possession of a distributor's authorized representative; and
e. Employment of personnel with education and
			 experience appropriate to the responsibilities of the position held.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.10 - Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Physical requirements.
A distributor's location shall:
a. Be of suitable size and construction to
			 facilitate cleaning, maintenance, and proper operations;
b. Have storage areas designed to provide
			 adequate lighting, ventilation, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
c. Have a quarantine area for storage of
			 outdated, damaged, unsafe, deteriorated, misbranded, or adulterated products
			 and for any suspect products;
d. Be
			 maintained in a clean and orderly condition;
e. Be free from infestation by insects,
			 rodents, birds, or vermin of any kind.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.12 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
Distributors shall establish and maintain records of all
				transactions regarding the receipt and distribution or other disposition of
				products, including outdated, damaged, deteriorated, misbranded, or adulterated
				products.
(1)
Transaction
			 records.
Records for receipt and distribution transactions for all
			 products shall include the following information:
a. The source of the products, including the
			 name and principal address of the seller or transferor and the address of the
			 location from which the products were shipped;
b. The identity and quantity of the products
			 received or distributed;
c. The
			 date of receipt or distribution of the products; and
d. The identity of the purchaser of the
			 products, including the name and principal address of the purchaser or
			 transferee and the address to which the products were shipped or
			 distributed.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.14 - Reporting Discipline and Criminal Convictions

Current through Register Vol. 47, No. 3, July 24, 2024
No later than 30 days after the final action, a limited
				distributor shall provide to the board written notice, including an unredacted
				copy of the action or order, of any disciplinary or enforcement action imposed
				by any licensing or regulatory authority on any license or registration held by
				the distributor. Discipline may include, but is not limited to, fine or civil
				penalty, citation or reprimand, probationary period, suspension, revocation,
				and voluntary surrender. No later than 30 days after the conviction, a limited
				distributor shall provide to the board written notice, including an unredacted
				copy of the judgment of conviction or sentence, of any criminal conviction of
				the distributor, any owner of the distributor, or any individual responsible
				for managing the daily operations of the distribution facility, if the
				conviction is related to prescription drug or device distribution. The term
				"criminal conviction" includes instances when the judgment of conviction or the
				sentence is deferred.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 42 - Limited Distributor Licenses › Rule 657-42.15 - 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 limited distributor license
				for any of the following:
1. Any
			 violation of the federal Food, Drug, and Cosmetic Act or federal regulation
			 promulgated under the Act. A warning letter issued by the United States Food
			 and Drug Administration shall be conclusive evidence of a violation.
2. Any conviction of a crime related to the
			 distribution of prescription drugs or devices committed by the distributor, its
			 owners, or the facility manager.
3.
			 Refusing access to the distribution facility or records to an agent of the
			 board for the purpose of conducting an inspection or investigation.
4. Failure to maintain registration pursuant
			 to 657-Chapter 10 when distributing controlled substances into, out of, or
			 within this state.
5. Any act of
			 unethical or unprofessional conduct by an employee of the
			 distributor.
6. Any violation of
			 Iowa Code chapter 124, 126, 155A, or 205, or rule of the board, including the
			 disciplinary grounds set forth in 657-Chapter 36.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to establish the minimum
				standards required of third-party logistics providers as defined in Iowa Code
				section
				155A.3 in this state
				pursuant to national standards as established by federal law. This chapter
				applies to logistics providers operating in or into this state. A 3PL does not
				include an entity that solely engages in shipping activities. Applicable
				activities of a 3PL include, but are not limited to, picking, packing, and
				shipping; inventory management; and warehousing or distribution management. In
				the event the requirements of this chapter directly conflict with any federal
				law or regulation, the federal law or regulation shall supersede the
				requirements in this chapter.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purposes of this chapter, the definitions found in Iowa
				Code section
				155A.3 and the
				following definitions apply.
"Board"
means the Iowa board of
				pharmacy.
"Facility manager "
means the individual who
				is responsible for the daily operation of a third-party logistics licensed
				location.
"FDA "
means the United States Food and Drug
				Administration.
"Home state "
means the state in which a
				third-party logistics provider is located.
"Third-party logistics provider "
or
"3PL "
means an entity that provides or coordinates
				warehousing or other logistics services of a product in interstate commerce on
				behalf of a manufacturer, wholesale distributor, or dispenser of a product, but
				does not take ownership of the product nor have responsibility to direct the
				sale or other disposition of the product.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.5 - Compliance With Federal and State Laws

Current through Register Vol. 47, No. 3, July 24, 2024
A 3PL is responsible for complying with all applicable federal
				and state laws, including those not specifically identified in this
				chapter.
1. A licensed 3PL shall meet
			 the requirements set forth in the Drug Supply Chain Security Act,
			 21
			 U.S.C. §
									360ee e-3, relating to
			 third-party logistics and regulations promulgated thereunder.
2. A licensed 3PL shall permit agents of the
			 board to enter and inspect the facility for compliance with federal and state
			 laws. A licensed 3PL shall cooperate with other regulatory or law enforcement
			 officials with jurisdiction over the facility.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.6 - Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
A licensed 3PL shall establish, maintain, and adhere to written
				policies and procedures that are in compliance with standards established
				pursuant to federal and Iowa law and which address, at a minimum, the
				following:
1. Storage
			 practices;
2. Maintaining adequate
			 security;
3. Receipt, inventory,
			 shipment, and distribution of product;
4. Theft or loss;
5. Inventory errors and
			 inaccuracies;
6. Manufacturer
			 recalls and withdrawals;
7.
			 Emergency and disaster plan;
8.
			 Records, including the retention period for all required records;
9. Drug diversion detection and prevention;
			 and
10. Outdated, adulterated, or
			 suspect products.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.9 - Reporting Discipline and Criminal Conviction

Current through Register Vol. 47, No. 3, July 24, 2024
No later than 30 days after the final action, a 3PL shall
				provide to the board written notice, including an unredacted copy of the action
				or order, of any disciplinary sanction imposed on any license or registration
				held by the 3PL or its owner or owners. Discipline may include, but is not
				limited to, fine or civil penalty, citation or reprimand, probationary period,
				suspension, revocation, and voluntary surrender. No later than 3 0 days after
				the conviction, a 3PL shall provide to the board written notice, including an
				unredacted copy of the judgment of conviction or sentence, of any criminal
				convictions related to product distribution, including convictions of any of
				its owners, or its facility manager. The term "criminal conviction" includes
				instances when the judgment of conviction or the sentence is
				deferred.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 43 - Third-party Logistics Provider Licenses › Rule 657-43.10 - 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 3PL license for any of the
				following:
1. Any violation of the
			 federal Food, Drug, and Cosmetic Act or federal regulation promulgated under
			 the Act related to third-party logistics and drug or device
			 distribution.
2. Any conviction of
			 a crime related to the distribution of prescription drugs or devices committed
			 by the 3PL, its owners, or the facility manager.
3. Refusing access to the 3PL facility or
			 records to an agent of the board or other authorized regulatory authority for
			 the purpose of conducting an inspection or investigation.
4. Failure to maintain registration pursuant
			 to 657-Chapter 10 when distributing controlled substances into, out of, or
			 within this state.
5. Any act of
			 unethical or unprofessional conduct by an employee of the 3PL.
6. Any violation of Iowa Code chapter 124,
			 126, 155A, or 205, or rule of the board, including the disciplinary grounds set
			 forth in 657-Chapter 36.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 100 - Iowa Real-time Electronic Pseudoephedrine Tracking System › Rule 657-100.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
Iowa Code section
				124.212B
				directs the governor's office of drug control policy to establish a real-time
				electronic repository to monitor and control the sale of Schedule V products
				that are not listed in another controlled substance schedule and that contain
				any detectible amount of pseudoephedrine, its salts, or optical isomers, or
				salts of optical isomers; ephedrine; or phenylpropanolamine. All pharmacies
				dispensing such products without a prescription shall electronically report all
				such sales to the repository. The real-time electronic repository shall be
				under the control of and administered by the governor's office of drug control
				policy. Both the governor's office of drug control policy and the board of
				pharmacy are directed to adopt rules relating to the real-time electronic
				repository and have jointly adopted these rules. These rules establish the
				pseudoephedrine tracking system (PTS).