reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 21 - Electronic Data and Automated Systems in Pharmacy Practice › Rule 657-21.16 - Facsimile Transmission of Schedule Ii Controlled Substances-hospice Patients

Current through Register Vol. 47, No. 3, July 24, 2024
A prescription for a Schedule II controlled substance for a
				patient enrolled in a hospice care program licensed pursuant to Iowa Code
				chapter 135J or a program certified or paid for by Medicare under Title XVIII
				may be transmitted via facsimile by the practitioner or the practitioner's
				agent to the dispensing pharmacy. If the prescription is transmitted by the
				practitioner's agent, the transmission shall include the first and last names
				and title of the individual who transmitted the prescription. The means of
				transmission shall ensure that prescription information is not obscured or
				rendered illegible due to security features of the paper utilized by the
				prescriber to prepare a written prescription.
(1)
Original prescription.
The facsimile serves as the original written prescription.
(2)
Information required.
The practitioner or the practitioner's agent shall note on the prescription
			 that the patient is a hospice patient.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 22 - Unit Dose, Alternative Packaging, and Emergency Boxes › Rule 657-22.1 - Unit Dose Dispensing Systems

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Definitions.
For the
			 purpose of this rule, the following definitions shall apply:
"Single unit package "
means a package that
				contains one discrete pharmaceutical dosage form.
"Unit dose dispensing system "
means a drug
				distribution system utilizing single unit, unit dose, or unit of issue
				packaging in a manner that helps reduce or remove traditional drug stocks from
				resident care areas and enables the selection and distribution of drugs to be
				pharmacy-based and controlled.
"Unit dose package "
means a package that
				contains that particular dose of a drug ordered for the patient for one
				administration time. A unit dose package is not always a single unit package.
				"Unit dose package" does not include a strip pack prepared utilizing an
				automated medication distribution system (AMDS). A strip pack is a patient med
				pak subject to the requirements of rule
				657-22.5
				(126,155A).
"Unit of issue package "
means a package that
				provides multiple units or doses attached to each other but separated in a card
				or specifically designed container.
(2)
General procedures.
The
			 following will apply when a unit dose dispensing system is employed:
a. The pharmacist shall be responsible for
			 determining the classification for containers, as set by USP General Chapter
			 671, used by the pharmacy to repackage nonsterile drugs into single unit, unit
			 dose, or unit of issue packaging. This classification shall be used to
			 determine maximum expiration dating for repackaging set forth in subrule
			 22.1(4).
b. Established written
			 policies and procedures shall be available in the pharmacy for inspection by
			 the board or its agents which specify the drug categories, specific drugs, or
			 dosage forms which will not be dispensed under the particular unit dose
			 dispensing system employed.
c.
			 Those drugs not dispensed under a unit dose dispensing system shall be
			 dispensed in accordance with the packaging requirements of the federal Food and
			 Drug Administration (FDA).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 22 - Unit Dose, Alternative Packaging, and Emergency Boxes › Rule 657-22.3 - Prepackaging

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Control
			 record.
Pharmacies may prepackage and label drugs in convenient
			 quantities for subsequent labeling and dispensing. Such drugs shall be
			 prepackaged by or under the direct supervision of a pharmacist. The supervising
			 pharmacist shall be responsible for the preparation and maintenance of a
			 packaging control record containing the following information:
a. Date.
b. Identification of drug.
(1) Name of drug.
(2) Dosage form.
(3) Manufacturer.
(4) Manufacturer's lot number.
(5) Strength.
(6) Expiration date.
c. Container specification.
d. Copy of a sample label.
e. Initials or unique identification of the
			 packager.
f. Initials or unique
			 identification of the supervising pharmacist.
g. Quantity per container.
h. Internal control number or date.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 22 - Unit Dose, Alternative Packaging, and Emergency Boxes › Rule 657-22.5 - Patient Med Paks

Current through Register Vol. 47, No. 3, July 24, 2024
In lieu of dispensing prescribed drug products in conventional
				prescription containers, a pharmacist may, with the consent of the patient, the
				patient's caregiver, or the prescriber, provide a customized patient medication
				package (patient med pak) pursuant to the requirements of this rule.
(1)
Definition.
A patient
			 med pak is a customized patient medication package prepared for a specific
			 patient which comprises a series of immediate containers containing prescribed
			 solid oral dosage forms, each container being labeled with the time or the
			 appropriate period for the patient to take its contents. A patient med pak
			 includes but is not limited to a strip pack prepared utilizing an automated
			 medication distribution system (AMDS).
(2)
General procedures.
The
			 following shall apply when patient med paks are employed:
a. The pharmacist shall be responsible for
			 determining the classification, as directed by USP General Chapter 671, for
			 containers used by the pharmacy to repackage nonsterile drugs into patient med
			 paks.
b. Packaging for all
			 nonsterile solid oral dosage forms stored and dispensed in patient med paks
			 shall:
(1) Preserve and protect the identity
			 and integrity of the drug from the point of packaging to the point of
			 administration, and
(2) Be clean
			 and free of extraneous matter when the drugs are placed into the
			 package.
c. Drugs
			 dispensed in patient med paks to patients may not be returned to the pharmacy
			 stock and reissued except to the same patient as provided in subrule
			 22.5(4).
d. There is no special
			 exemption for patient med paks from the requirements of the Poison Prevention
			 Packaging Act. Thus, the patient med pak, if it does not meet child-resistant
			 standards, shall be placed in an outer package that does comply, or the
			 necessary consent of the purchaser or physician to dispense in a container not
			 intended to be child-resistant shall be obtained.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 22 - Unit Dose, Alternative Packaging, and Emergency Boxes › Rule 657-22.9 - Home Health Agency/hospice Emergency Drugs

Current through Register Vol. 47, No. 3, July 24, 2024
Recognizing the emergency and unanticipated need for drugs to
				be available to qualified individuals authorized to administer drugs and
				employed by a home health agency or hospice, an Iowa-licensed pharmacy may
				provide an emergency drug supply pursuant to this rule. Such qualified
				individuals may carry the emergency drug supply. An inpatient hospice facility
				may have an emergency drug supply provided by an Iowa-licensed pharmacy
				pursuant to rule
				657-22.7
				(124,155A), which supply may be maintained within the facility.
(1)
Contract.
A written
			 contract shall exist between the home health agency or hospice and the
			 pharmacist in charge of the Iowa-licensed pharmacy. This contract shall be
			 available for review by the board or its authorized agent upon
			 request.
(2)
Ownership
			 retained.
The drugs included in this emergency supply shall remain the
			 property of and under the responsibility of the Iowa-licensed provider
			 pharmacy.
a. The pharmacist shall ensure that
			 each portable container of emergency drugs is sealed in such a manner that a
			 tamperproof seal must be broken to gain access to the drugs.
b. Each portable container of emergency drugs
			 shall be labeled on the outside of the container with a list of the contents
			 and the earliest expiration date.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.2 - 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.
"Care facility"
or
"facility"
means:
1. A facility licensed by the Iowa department of inspections
				and appeals under Iowa Code chapter 135C or 135H;
2. A hospital-based long-term care unit certified under 42 CFR,
				Part 483, Subpart B;
3. An inpatient hospice certified under 42 CFR, Part
				418;
4. A group living facility wherein health care-related services
				are provided by the facility; or
5. A health care facility registered with the board under Iowa
				Code chapter 124.
"Care facility pharmacy"
or
"provider
				pharmacy"
means a pharmacy that provides pharmacy services to a care
				facility.
"Consultant pharmacist"
in a care facility
				means an Iowa-licensed pharmacist who is responsible for developing,
				coordinating, and supervising pharmaceutical services in a care facility on a
				regularly scheduled basis.
"DEA "
means the United States Department of
				Justice, Drug Enforcement Administration.
"Medication order, "
as used in these rules,
				means an order from a practitioner or the practitioner's authorized agent for
				administration of a drug or device. For purposes of this chapter, "medication
				order" includes a prescription.
"Provider pharmacist"
means a pharmacist
				licensed to engage in the practice of pharmacy who is employed by or contracted
				to a care facility pharmacy or a provider pharmacy and who is responsible for
				supervising the accurate dispensing and proper delivery of drugs and devices to
				a care facility located within this state. These services shall include, at a
				minimum, proper medication labeling, storage, transport, record keeping, and
				prospective drug utilization review in compliance with all federal and state
				laws and regulations.
"Unit dose dispensing system "
means a drug
				distribution system utilizing unit dose packaging.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.3 - Freedom of Choice

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to 657-subrule 8.11(2), no pharmacist or pharmacy
				shall participate in any agreement or plan that infringes on any resident's
				right to freedom of choice as described in rules of the department of
				inspections and appeals.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.4 - Responsibilities

Current through Register Vol. 47, No. 3, July 24, 2024
The pharmacist in charge and staff pharmacists in any pharmacy
				providing pharmaceutical services to care facility patients shall share
				responsibility for:
1. Dispensing
			 drugs pursuant to a medication order for an individual resident that are
			 properly labeled and packaged in a manner consistent with the facility's
			 established drug delivery system and in compliance with applicable board rules
			 for the drug delivery system.
2.
			 Affixing labels to each container of drugs for residents in care facilities, in
			 compliance with 657-Chapter 22 or rule
			 657-6.10
			 (126,155A),
			 657-23.13
			 (124,155A), or
			 657-23.14
			 (124,155A).
3. Maintaining records
			 as required by law and maintaining accurate control over and accountability for
			 all drugs and prescription devices.
4. Complying with a drug recall procedure,
			 established pursuant to rule
			 657-8.3
			 (155A), that protects the health and safety of residents.
5. Providing 24-hour emergency service either
			 directly or by contract with another pharmacy.
6. Conducting prospective drug use review
			 pursuant to rule
			 657-8.21
			 (155A) and subrule 23.5(1).
7.
			 Providing sufficient and accurate information to facility staff regarding the
			 appropriate administration and use of all dispensed drugs and
			 devices.
8. Communicating with the
			 consultant pharmacist and the facility staff regarding concerns and resolution
			 thereof.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.5 - Emergency Drugs

Current through Register Vol. 47, No. 3, July 24, 2024
A supply of emergency drugs may be provided by one or more
				pharmacies to the facility pursuant to rule
				657-22.7
				(124,155A).
(1)
Emergency
			 medication order-pharmacist review.
When an emergency drug is provided
			 pursuant to rule
			 657-22.7
			 (124,155A), the medication order shall be reviewed by the resident's dispensing
			 pharmacist prior to the administration of a second dose.
(2)
Other emergency drugs and
			 devices.
In addition to emergency drug supplies, a care facility may
			 maintain a stock of intravenous fluids, irrigation fluids, heparin flush kits,
			 medicinal gases, sterile water and saline, and prescription devices. Such stock
			 shall be limited to a listing to be determined by the provider pharmacist in
			 consultation with the consultant pharmacist and the medical director and
			 director of nursing of the facility.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.7 - Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
Pursuant to rule
				657-8.3
				(155A), each pharmacy shall have policies and procedures related to all aspects
				of the pharmacy's packaging and dispensing responsibilities to the residents of
				a care facility. The policies and procedures shall be maintained at the
				provider pharmacy and shall be available to the facility and the consultant
				pharmacist. Policies and procedures shall include, at a minimum:
1. Methods used to dispense and deliver drugs
			 and devices to the facility in a timely fashion.
2. Proper notification to the facility when a
			 drug or device is not readily available.
3. Proper labeling requirements to meet the
			 needs of the facility and which are consistent with state and federal laws and
			 regulations.
4. Appropriate drug
			 destruction or return of unused drugs, or both, consistent with state and
			 federal laws and regulations.
5. An
			 automatic stop order policy to ensure that drug orders are not continued
			 inappropriately.
6. Methods to
			 ensure that all discontinued, outdated, deteriorated, or improperly labeled
			 drugs and all containers with worn, illegible or missing labels are disposed of
			 so as to render them unusable and protected from unauthorized possession or
			 use.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.9 - Medication Orders

Current through Register Vol. 47, No. 3, July 24, 2024
Drugs and prescription devices may be dispensed only upon
				orders of an authorized prescriber or authorized pharmacist as part of a
				collaborative drug therapy management protocol pursuant to rule
				657-39.13(155A).
(1)
Requirements for noncontrolled substances.
New medication
			 orders transmitted to the pharmacy for noncontrolled substances shall, at a
			 minimum, contain resident name, drug name and strength, directions for use,
			 date of order, and name of prescriber.
(2)
Requirements for controlled
			 substances.
New medication orders transmitted to the pharmacy for
			 controlled substances, including Schedule II controlled substances, shall be in
			 compliance with 657-Chapter 10, 657-Chapter 21, and federal
			 regulations.
(3)
Who may
			 transmit medication orders.
An authorized prescriber or prescriber's
			 agent may transmit to the pharmacy a medication order lawfully ordered by an
			 authorized prescriber. An order transmitted by the prescriber's agent shall
			 include the agent's first and last names and title. Specifically for the
			 transmission of a controlled substance prescription, a member of the care
			 facility staff is an agent of the prescriber only if the prescriber maintains
			 an office in the facility or there exists an agent agreement between the
			 prescriber and the care facility staff member.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.11 - Drugs Dispensed-general Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Labeling.
All
			 prescription containers, other than those dispensed pursuant to 657-Chapter 22,
			 rule
			 657-23.13
			 (124,155A), or rule
			 657-23.14
			 (124,155A), shall be properly labeled in accordance with 657-subrule 6.10(1).
a. If a label change is required to reflect a
			 change in directions, the pharmacist shall be responsible for affixing the
			 correct label to the container. Care facility personnel shall not be directed
			 by the pharmacy to affix such a label to the drug container.
b. Direction change labels that notify care
			 facility personnel that a change in directions for the drug has taken place may
			 be used and affixed to the container by facility personnel so as not to deface
			 the original label.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.13 - Labeling Drugs Under Special Circumstances

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Drug products of insufficient
			 size to accommodate pharmacy labeling.
Drug products, such as insulin,
			 ophthalmics, otic preparations, and injectables, that are of insufficient size
			 to accommodate a full pharmacy label shall be dispensed with a label affixed to
			 the immediate container showing at least the resident's name and
			 location.
(2)
Legend
			 solutions
-
irrigation and infusion.
Legend
			 irrigation solutions and infusion solutions supplied by a pharmacy may be
			 stored in the locked medication area of a care facility provided that:
a. The facility uses the solution only within
			 the confines of the facility and under the orders of an authorized
			 prescriber;
b. Upon use, the
			 container is identified by resident name and is used exclusively for that
			 resident;
c. The container is dated
			 and initialed upon opening.
d. The
			 solution is stored appropriately after opening according to facility policy and
			 manufacturer labeling.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.14 - Provision of Drugs to a Facility for Immunization or Screening Programs

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy may provide drugs to be used in the care facility
				for a health immunization or ongoing screening program, such as influenza
				vaccine, tuberculin skin test, or hepatitis-B.
(1)
Labeling.
The pharmacy
			 label shall be affixed so as not to obscure the manufacturer's label and shall
			 include the following information.
a.
			 Identification of pharmacy;
b. Name
			 of facility;
c. Name of biological
			 or drug;
d. Route of administration
			 when necessary for clarification;
e. Strength of biological or drug;
f. Auxiliary labels as needed;
g. Date dispensed.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.15 - Return and Reuse of Drugs and Devices

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy shall not accept from a patient or facility for
				reuse or resale any drug or device unless, in the professional judgment of the
				pharmacist, the integrity of the drug or device has not in any way been
				compromised. Under no circumstances shall a pharmacist accept from a patient or
				facility any controlled substances except for reuse by the same patient.
				Prescription drugs, excluding controlled substances, dispensed in a unit dose
				dispensing system pursuant to 657-Chapter 22 may, however, be returned and
				reused as authorized in 657-subrule 22.1(6). No items of a personal contact
				nature which have been removed from the original package or container after
				dispensing shall be accepted for return, exchanged, or resold by any
				pharmacist.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.17 - Accountability of Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
Use of Schedule II controlled substances shall be documented. A
				committee or representative of the facility may also require that Schedule III,
				IV, or V controlled substances or any other drugs be accounted for on
				proof-of-use forms. Documentation shall include at a minimum:
1. Name of drug;
2. Dose;
3. Name of ordering prescriber;
4. Name of resident;
5. Date and time of administration to
			 resident;
6. Identification of
			 individual administering;
7.
			 Documentation of destruction, return to the pharmacy, or other disposition of
			 all unused portions of single doses including the signatures of two
			 individuals, at least one of whom is a licensed health care
			 professional.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.19 - Dispensing Schedule Ii Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy that dispenses Schedule II controlled substances
				shall advise facility personnel that federal and state laws and regulations
				governing such drugs require that accurate records be kept of their
				administration or their ultimate disposition in compliance with rule
				657-23.17
				(124,155A). The pharmacy shall further advise facilities that stored Schedule
				II substances shall be double-locked in accordance with rules of the Iowa
				department of inspections and appeals. The requirement for double-locking
				Schedule II controlled substances shall not apply to periods during which drugs
				are being administered to residents; however, these substances shall be secured
				during such administration periods.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.20 - Partial Filling of Schedule Ii Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
A medication order for a Schedule II controlled substance for a
				resident in a long-term care facility (LTCF) may be filled in partial
				quantities to include individual dosage units. The pharmacist shall record on
				the written or electronic medication order that the patient is an "LTCF
				patient." A medication order that is partially filled and does not contain the
				notation "LTCF patient" shall be deemed to have been filled in violation of the
				controlled substances Act.
(1)
Partial filling record.
For each partial filling, the
			 dispensing pharmacist shall record on the back of the medication order (or on
			 another appropriate record, uniformly maintained, and readily retrievable) the
			 date of the partial filling, quantity dispensed, remaining quantity authorized
			 to be dispensed, and the identification of the dispensing pharmacist.
(2)
Total dispensed.
The
			 total quantity of Schedule II controlled substances dispensed in all partial
			 fillings shall not exceed the total quantity prescribed.
(3)
Duration.
Schedule II
			 medication orders for residents in a long-term care facility shall be valid for
			 a period not to exceed 60 days from the issue date unless sooner terminated by
			 the discontinuance of the drug.
(4)
Requirements of computerized system.
Information pertaining to
			 current Schedule II medication orders for residents in a long-term care
			 facility may be maintained in a computerized system if this system has the
			 capability to permit:
a. Output (display and
			 printout) of the original prescription number, date of issue, identification of
			 prescribing individual practitioner, identification of resident, address of the
			 long-term care facility, identification of the drug authorized (to include
			 dosage form, strength and quantity), listing of the partial fillings that have
			 been dispensed under each medication order, and the information required in
			 this rule.
b. Immediate (real-time)
			 updating of the medication order record each time a partial filling of the
			 medication order is conducted.
c.
			 Retrieval of partially filled Schedule II medication order information as
			 required in rule
			 657-21.4
			 (124,155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 23 - Care Facility Pharmacy Practice › Rule 657-23.21 - Disposal of Previously Dispensed Controlled Substances

Current through Register Vol. 47, No. 3, July 24, 2024
Controlled substances dispensed to a resident in a care
				facility and subsequently requiring disposal due to discontinuance of the drug,
				death of the resident, or other reasons necessitating disposal shall be
				disposed of by one of the following methods. Controlled substances shall not be
				returned to a pharmacy for disposal.
(1)
Disposal in the
			 facility.
A licensed health care professional (pharmacist, registered
			 nurse, licensed practical nurse) may dispose of controlled substances in
			 witness of one other responsible adult. The professional disposing of the drug
			 shall prepare and maintain a readily retrievable record of the disposition
			 which shall be clearly marked to indicate the disposition of resident drugs.
			 The record shall include, at a minimum, the following:
a. Resident name and unique identification or
			 number assigned by the dispensing pharmacy to the prescription;
b. The name, strength, and dosage form of the
			 substance;
c. The quantity disposed
			 of;
d. The date the substance is
			 disposed of;
e. The signature or
			 uniquely identifying initials or other unique identification of the
			 professional and the witness;
f The
			 name and address of the dispensing pharmacy or the dispensing
			 practitioner.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
In the interests of public information, health, and safety,
				and pursuant to the provisions of Iowa Code section 155A. 13B, this chapter
				establishes requirements for the Internet sale of prescription drugs by
				pharmacies and for VIPPS accreditation. This chapter identifies specific
				information that must be displayed on a pharmacy Internet site and establishes
				requirements for site registration. The requirements of this chapter apply to
				any Internet pharmacy and pharmacy Internet site as defined in rule
				657-24.2
				(155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.3 - General Requirements for Internet Pharmacy

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy operating within or outside Iowa shall not provide
				any prescription product to any patient within Iowa through an Internet site or
				e-mail unless the pharmacy is in compliance with the provisions of this
				chapter.
(1)
Pharmacy
			 license.
A pharmacy, prior to providing any prescription drug,
			 including any controlled substance, to any patient within Iowa, shall apply
			 for, obtain, and maintain a pharmacy license pursuant to the provisions of rule
			 657-8.35 (155A).
(2)
Pharmacist
			 license.
A pharmacist practicing in a pharmacy that provides any
			 prescription drug, including any controlled substance, to any patient within
			 Iowa shall be licensed by the pharmacist licensing authority in the state
			 wherein the pharmacist practices.
(3)
Iowa PMP.
A pharmacy,
			 wherever located, that provides any controlled substance included in Schedules
			 II through IV of Iowa Code chapter 124 to any patient within Iowa, unless the
			 pharmacy is exempt from reporting pursuant to 657-subrule 37.3(1), shall report
			 those dispensed prescriptions to the Iowa PMP as provided in rule
			 657-37.3
			 (124).
(4)
VIPPS
			 accreditation.
An Internet pharmacy that provides any prescription
			 drugs, including controlled substances, to any patient within Iowa shall obtain
			 and maintain VIPPS accreditation and shall include evidence of such VIPPS
			 accreditation on any Internet site identifying the pharmacy as provided in rule
			 657-24.7
			 (155A).
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.6 - Prescription Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
A prescription drug order issued by an authorized prescriber
				shall comply with the requirements for a prescription identified in Iowa Code
				section
				155A.27.
				No prescription product may be delivered, distributed, or dispensed by means
				of, through, or on behalf of an Internet site or by means of an e-mail
				communication without a valid prescription drug order.
(1)
Prescriber licensed.
A
			 prescriber who authorizes a prescription drug order through an Internet site or
			 e-mail for a patient located in Iowa shall:
a.
			 Be licensed by the licensing authority of the state in which the prescriber
			 practices,
b. Be in compliance with
			 all applicable federal and state laws, rules and regulations relating to the
			 prescriber's practice, and
c. If
			 the prescription drug order authorizes the dispensing of a controlled
			 substance, be registered to prescribe controlled substances by the DEA and, if
			 required, by the appropriate state agency or board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.7 - Internet Site Registration

Current through Register Vol. 47, No. 3, July 24, 2024
An Internet site that intends to display, advertise, or solicit
				the Internet sale of prescription products to patients in Iowa shall apply for,
				obtain, and maintain a pharmacy Internet site registration through the board. A
				pharmacy Internet site registration shall be issued to the Internet site by the
				domain name and the owner of the Internet site.
(1)
Application for
			 registration.
Application for registration and registration renewal
			 shall be on forms provided by the board. The application form shall include the
			 following information:
a. The common or
			 searchable name, if such name exists, of the Internet site.
b. The domain name including "dot" extension
			 of the Internet site.
c. The
			 Internet protocol number of the Internet site.
d. The name and address of the owner or
			 owners of the Internet site. If the owner is a corporation, the names and
			 addresses of the officers and directors of the corporation shall be included.
			 If the owner is a partnership or limited partnership, the names and addresses
			 of all partners shall be included.
e. The name, address, and Iowa pharmacy
			 license number of each Internet pharmacy that will be identified on the
			 Internet site.
f. The signature of
			 the owner of the Internet site or the signature of the owner's, partnership's
			 or corporation's authorized representative and the date the application is
			 signed.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.8 - Internet Site Information

Current through Register Vol. 47, No. 3, July 24, 2024
A pharmacy Internet site shall display on the home page of the
				Internet site or on a page directly linked to the home page the information
				identified in this rule. If the information is displayed on a page directly
				linked to the home page, the link on the home page shall be visible and clearly
				and conspicuously identified.
(1)
Registration number.
The
			 Internet site registration number shall be displayed. Display shall consist of
			 the following statement or a statement substantially equivalent to the
			 following statement: "In compliance with Iowa Code section
			 155A.13B and 657 IAC
			 Chapter 24, this internet site is registered with the Iowa Board of Pharmacy,
			 registration number___."
(2)
Pharmacy identification.
The following information shall be
			 displayed for each pharmacy that delivers, distributes, or dispenses
			 prescription drugs pursuant to orders made on, through, or on behalf of the
			 Internet site:
a. The name of the
			 pharmacy.
b. The address of the
			 licensed physical location of the pharmacy.
c. The telephone number of the
			 pharmacy.
d. The pharmacy license
			 number issued to the pharmacy by the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.11 - Records

Current through Register Vol. 47, No. 3, July 24, 2024
Records regarding the operation of a pharmacy and the
				dispensing of prescription products to patients within Iowa shall be maintained
				by each Internet pharmacy pursuant to the requirements of federal and state
				laws, rules and regulations. Required pharmacy and inventory records shall be
				available for inspection and copying by the board or its representative for at
				least two years from the date of the record or inventory unless a longer
				retention period is specified for a particular record or
				inventory.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.12 - Pharmacy Liability

Current through Register Vol. 47, No. 3, July 24, 2024
An Internet pharmacy shall not disclaim, limit, or waive any
				liability to which the pharmacy otherwise is subject under law for the act or
				practice of selling, dispensing, distributing, or delivering prescription
				products to any patient in Iowa based on the patient's submission of the
				purchase order or refill request for the prescription product through an
				Internet site or by e-mail.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.13 - Application Denial

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The
			 executive director or designee may deny an application for registration or
			 renewal of a registration as a pharmacy Internet site for any violation of the
			 laws of this state, another state, or the United States relating to
			 prescription products, Internet pharmacy practices, or the distribution of
			 prescription products utilizing the Internet or e-mail or for any violation of
			 Iowa Code chapter 124, 124A, 124B, 126, 147, 155A, or 205 or any rule of the
			 board.
(2) An applicant whose
			 application has been denied pursuant to this rule may, within 30 days after
			 issuance of the notice of denial, appeal to the board for reconsideration of
			 the application.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 24 - Pharmacy Internet Sites › Rule 657-24.14 - Discipline

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Internet site.
The board may impose discipline for any
			 violation of the laws of this state, another state, or the United States
			 relating to prescription products, Internet pharmacy practices, or the
			 distribution of prescription products utilizing the Internet or e-mail or for
			 any violation of Iowa Code chapter 124, 124A, 124B, 126, 147, 155A, or 205 or
			 any rule of the board. The board may impose on the pharmacy Internet site
			 registrant any disciplinary sanctions allowed by law as may be appropriate
			 including, but not limited to, revocation of the registration, suspension of
			 the registration for a specified period or until further order of the board,
			 nonrenewal of a registration, the imposition of civil penalties not to exceed
			 $25,000, or issuance of a citation and warning.
(2)
Pharmacy, pharmacist, and other
			 pharmacy staff.
The board may impose discipline for any violation of
			 the laws of this state, another state, or the United States relating to
			 prescription products, Internet pharmacy practices, or the distribution of
			 prescription products utilizing the Internet or e-mail or for any violation of
			 Iowa Code chapter 124,124A, 124B, 126,147,155A, or 205 or any rule of the
			 board. The board may impose on the pharmacy, pharmacist, or other registered
			 pharmacy staff any disciplinary sanctions allowed by law as may be appropriate
			 or as may be identified in Iowa law or rules of the board regarding sanctions
			 that may be imposed on the specific license or registration.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 25 - Child Support Noncompliance › Rule 657-25.1 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purpose of this chapter the following definitions shall
				apply:
"Act"
means Iowa Code chapter
				252J.
"Board"
means the Iowa board of pharmacy
				examiners.
"Certificate "
means a document known as a
				certificate of noncompliance which is provided by the child support unit
				certifying that the named licensee is not in compliance with a support order or
				with a written agreement for payment of support entered into by the child
				support unit and the licensee.
"Child support unit"
means the child support
				recovery unit of the Iowa department of human services.
"Denial notice"
means a board notification
				denying an application for the issuance or renewal of a license as required by
				the Act.
"License "
means a license to practice
				pharmacy, a registration to practice as a pharmacist-intern, a registration to
				practice as a pharmacy technician, a registration to practice as a pharmacy
				support person, or a registration to possess, prescribe, dispense, administer,
				distribute, or otherwise handle controlled substances under Iowa Code chapter
				124.
"Licensee "
means an individual to whom a
				license has been issued or who is seeking the issuance of a license.
"Revocation or suspension notice"
means a
				board notification suspending a license for an indefinite or specified period
				of time or a notification revoking a license as required by the Act.
"
Withdrawal certificate "
means a document
				known as a withdrawal of a certificate of noncompliance provided by the child
				support unit certifying that the certificate is withdrawn and that the board
				may proceed with issuance, reinstatement, or renewal of a
				license.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 25 - Child Support Noncompliance › Rule 657-25.2 - Issuance or Renewal of License-denial

Current through Register Vol. 47, No. 3, July 24, 2024
The board shall deny the issuance or renewal of a license upon
				the receipt of a certificate from the child support unit. This rule shall apply
				in addition to the procedures set forth in the Act.
(1)
Service of denial
			 notice.
Notice shall be served upon the licensee by certified mail,
			 return receipt requested; by personal service; or through authorized
			 counsel.
(2)
Effective date
			 of denial.
The effective date of the denial of issuance or renewal of
			 a license, as specified in the notice, shall be 60 days following service of
			 the notice upon the licensee.
(3)
Preparation and service of denial notice.
The executive
			 director of the board is authorized to prepare and serve the notice upon the
			 licensee.
(4)
Licensee
			 responsible to inform board.
Licensees shall keep the board informed
			 of all court actions and all child support unit actions taken under or in
			 connection with the Act and shall provide the board with copies, within seven
			 days of filing or issuance, of all applications filed with the district court
			 pursuant to the Act, all court orders entered in such actions, and any
			 withdrawal certificates issued by the child support unit.
(5)
Reinstatement following license
			 denial.
All board fees required for application, license renewal, or
			 license reinstatement shall be paid by licensees before a license will be
			 issued, renewed, or reinstated after the board has denied the issuance or
			 renewal of a license pursuant to the Act.
(6)
Effect of filing in district
			 court.
In the event a licensee files a timely district court action
			 following service of a notice, the board shall continue with the intended
			 action described in the notice upon the receipt of a court order lifting the
			 stay, dismissing the action, or otherwise directing the board to proceed. For
			 purposes of determining the effective date of the denial of the issuance or
			 renewal of a license, the board shall count the number of days before the
			 action was filed and the number of days after the action was disposed of by the
			 court.
(7)
Final
			 notification.
The board shall notify the licensee in writing through
			 regular first-class mail, or such other means as the board determines
			 appropriate in the circumstances, within ten days of the effective date of the
			 denial of the issuance or renewal of a license and shall similarly notify the
			 licensee if the license is issued or renewed following the board's receipt of a
			 withdrawal certificate.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 25 - Child Support Noncompliance › Rule 657-25.4 - Share Information

Current through Register Vol. 47, No. 3, July 24, 2024
Notwithstanding any statutory confidentiality provision, the
				board may share information with the child support unit through manual or
				automated means for the sole purpose of identifying applicants or licensees
				subject to enforcement under the Act.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 26 - Petitions for Rule Making › Rule 657-26.1 - Petition for Rule Making

Current through Register Vol. 47, No. 3, July 24, 2024
Any person, association, agency, or political subdivision may
				file a petition for rule making with the board of pharmacy at 400 S.W. Eighth
				Street, Suite E, Des Moines, Iowa 50309-4688. A petition is deemed filed when
				received by that office. The board shall provide the petitioner with a
				file-stamped copy of the petition if the petitioner provides the board an extra
				copy for this purpose. The petition must be typewritten, machine printed, or
				legibly handwritten in ink and must substantially conform to the following
				form:
IOWA BOARD OF PHARMACY
Click here to
				view Image
The petition shall include the following information:
1. A statement of the specific rule-making
			 action sought by the petitioner including the text or a summary of the contents
			 of the proposed rule or amendment to a rule and, if it is a petition to amend
			 or repeal a rule, a citation and the relevant language to the particular
			 portion or portions of the rule proposed to be amended or repealed.
2. A citation to any law deemed relevant to
			 the board's authority to take the action urged or to the desirability of that
			 action.
3. A brief summary of
			 petitioner's arguments in support of the action urged in the
			 petition.
4. A brief summary of any
			 data supporting the action urged in the petition.
5. The names and addresses of other persons,
			 or a description of any class of persons, known by petitioner to be affected by
			 or interested in, the proposed action which is the subject of the
			 petition.
6. Any request by
			 petitioner for a meeting provided for by rule
			 657-26.4
			 (17A).
7. Original signature of
			 petitioner and date signed.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 26 - Petitions for Rule Making › Rule 657-26.2 - Briefs

Current through Register Vol. 47, No. 3, July 24, 2024
The petitioner may attach a brief to the petition in support of
				the action urged in the petition. The board may request a brief from the
				petitioner or from any other person concerning the substance of the
				petition.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 26 - Petitions for Rule Making › Rule 657-26.3 - Inquiries

Current through Register Vol. 47, No. 3, July 24, 2024
Inquiries concerning the status of a petition for rule making
				may be made to Executive Director, Iowa Board of Pharmacy, 400 S.W. Eighth
				Street, Suite E, Des Moines, Iowa 50309-4688, or via electronic mail to
				andrew.funk(5)iowa.gov.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 26 - Petitions for Rule Making › Rule 657-26.4 - Board Consideration

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Initial activities.
Within 14 days after the filing of a
			 petition, the board shall submit a copy of the petition and any accompanying
			 brief to the administrative rules coordinator and to the administrative rules
			 review committee. Upon request by petitioner in the petition, the board shall
			 schedule a brief and informal meeting between the petitioner and the board, a
			 member of the board, or a member of the staff of the board to discuss the
			 petition. The board may request that the petitioner submit additional
			 information or argument concerning the petition. The board may also solicit
			 comments from any person on the substance of the petition. Any person may
			 submit to the board comments on the substance of the petition.
(2)
Decision issued.
Within
			 60 days after the filing of the petition, or within any longer period agreed to
			 by the petitioner, the board shall, in writing, deny the petition, and notify
			 petitioner of its action and the specific grounds for the denial, or grant the
			 petition and notify petitioner that it has instituted rule-making proceedings
			 on the subject of the petition. Petitioner shall be deemed notified of the
			 denial or grant of the petition on the date when the board mails or delivers
			 the required notification to petitioner.
(3)
Denial for
			 nonconformity.
Denial of a petition because it does not substantially
			 conform to the required form does not preclude the filing of a new petition on
			 the same subject that seeks to eliminate the grounds for the board's rejection
			 of the original petition.