reglab/statecodes huggingface dataset:
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.1 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
As used in this chapter:
"Board"
means the Iowa board of
				pharmacy.
"Confidential record"
means a record which is
				not available as a matter of right for examination and copying by members of
				the public under applicable provisions of law. Confidential records include
				records or information contained in records that the board is prohibited by law
				from making available for examination by members of the public, and records or
				information contained in records that are specified as confidential by Iowa
				Code section
				22.7 or other
				provision of law, but that may be disclosed upon order of a court, order of the
				lawful custodian of the record, or order of another person duly authorized to
				release the record. Mere inclusion in a record of information declared
				confidential by an applicable provision of law does not necessarily make that
				entire record a confidential record.
"Custodian"
means the executive director of
				the board.
"Open record"
means a record other than a
				confidential record.
"Personally identifiable information"
means
				information about or pertaining to an individual or business entity in a record
				which identifies the individual or entity and which is contained in a record
				system.
"Record"
means the whole or a part of a
				"public record," as defined in Iowa Code section
				22.1, that is owned
				by or in the physical possession of the board.
"Record system"
means any group of records
				under the control of the board from which a record may be retrieved by a
				personal identifier such as the name of an individual or business entity,
				number, symbol, or other unique retriever assigned to an individual or business
				entity.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.2 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to facilitate broad public
				access to open records. It seeks to facilitate rational board determinations
				with respect to the handling of confidential records and the implementation of
				the fair information practices Act. Board staff shall cooperate with members of
				the public in implementing the provisions of this chapter. This chapter does
				not:
1. Require the board to index or
			 retrieve records that contain information about individuals by that person's
			 name or other personal identifier.
2. Make available to the general public
			 records that would otherwise not be available under Iowa Code chapter
			 22.
3. Govern the maintenance or
			 disclosure of, notification of or access to records in the possession of the
			 board that are governed by rules of another board or agency.
4. Apply to grantees, including local
			 governments or subdivisions, administering state-funded programs, unless
			 otherwise provided by law or agreement.
5. Make available records compiled by the
			 board in reasonable anticipation of court litigation or formal administrative
			 proceedings. Applicable legal and constitutional principles, statutes, rules of
			 discovery, evidentiary privileges, and rules of the board shall govern the
			 availability of the records to the general public or to any subject individual
			 or party to litigation or proceedings.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.3 - Requests for Access to Records

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Location of record.
A request for access to a record should be
			 directed to Executive Director, Iowa Board of Pharmacy, 400 S.W. Eighth Street,
			 Suite E, Des Moines, Iowa 50309-4688.
(2)
Office hours.
Open
			 records shall be made available during all customary office hours, which are 8
			 a.m. to 4:30 p.m. daily, excluding Saturdays, Sundays, and official state
			 holidays.
(3)
Request for
			 access.
Requests for access to open records shall be made in writing.
			 Requests shall identify the particular records sought, by name or description,
			 in order to facilitate determining the location of the record. All requests
			 shall include the name, address, and telephone number of the person requesting
			 the information.
(4)
Response to requests.
a.
			 Access to an open record shall be provided in a timely manner upon request. If
			 the size or nature of the request for access to an open record requires time
			 for processing, the custodian shall comply with the request as soon as
			 feasible. Access to an open record may be delayed for one of the purposes
			 authorized by Iowa Code section 22.8(4) or
			 22.10(4).
			 The custodian shall promptly give notice to the requester of the reason for any
			 delay in access to an open record and an estimate of the length of that delay
			 and, upon request, shall promptly provide that notice to the requester in
			 writing.
b. The custodian of a
			 record may deny access to the record by members of the public only on the
			 grounds that such a denial is warranted under Iowa Code section
			 22.8(4)
			  or
			 22.10(4),
			 or that it is a confidential record, or that its disclosure is prohibited by a
			 court order. Access by members of the public to a confidential record is
			 limited by law and, therefore, may generally be provided only in accordance
			 with the provisions of rule
			 657-14.4
			 (22,124,155A) and other applicable provisions of law.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.6 - Procedure by Which Additions, Dissents, or Objections May Be Entered Into Certain Records

Current through Register Vol. 47, No. 3, July 24, 2024
Except as otherwise provided by law, a person may file a
				request with the custodian to review, and to have a written statement of
				additions, dissents, or objections entered into, a record containing personally
				identifiable information pertaining to that person. This does not authorize a
				person who is a subject of such a record to alter the original copy of that
				record or to expand the official record of any board proceeding. A requester
				shall send the request to review such a record or the written statement of
				additions, dissents, or objections to Executive Director, Iowa Board of
				Pharmacy, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688. A
				request to review such a record or the written statement of additions,
				dissents, or objections to the record shall be dated and signed by the
				requester and shall include the current address and telephone number of the
				requester or the requester's representative.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.7 - Consent to Disclosure by the Subject of a Confidential Record

Current through Register Vol. 47, No. 3, July 24, 2024
To the extent permitted by any applicable provision of law, a
				person who is the subject of a confidential record may have a copy of the
				portion of that record concerning the subject disclosed to a third party. A
				request for such a disclosure shall be in writing and shall identify the
				particular record or records that may be disclosed, the particular person or
				class of persons to whom the record may be disclosed, and any applicable time
				period during which the record may be disclosed. The person who is the subject
				of the record and, where applicable, the person to whom the record is to be
				disclosed shall be required to provide proof of identity. Appearance of counsel
				before the board on behalf of a person who is the subject of a confidential
				record is deemed to constitute consent for the board to disclose records about
				that person to the person's attorney. This rule does not authorize the subject
				of a record that is confidential under Iowa Code section
				272C.6(4)
				 to consent to the release of the
				record.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.8 - Notice to Suppliers of Information

Current through Register Vol. 47, No. 3, July 24, 2024
When the board requests that a person supply information about
				that person, the board shall notify the person of the use that will be made of
				the information, which persons outside the board may routinely be provided this
				information, which parts of the requested information are required and which
				are optional, and the consequences of failure to provide the requested
				information. This notice may be given in these rules, on the written form used
				to collect the information, on a separate fact sheet or letter, in brochures,
				in formal agreements, in contracts, in handbooks, in manuals, verbally, or by
				other appropriate means.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.9 - Disclosures Without the Consent of the Subject

Current through Register Vol. 47, No. 3, July 24, 2024
(1) Open records are routinely disclosed
			 without the consent of the subject.
(2) To the extent allowed by law, disclosure
			 of confidential records may occur without the consent of the subject. Following
			 are instances when disclosure, if lawful, will generally occur without notice
			 to the subject:
a. For a routine use as
			 defined in rule
			 657-14.10
			 (22,124,155A) or in the notice for a particular record system.
b. To a recipient who has provided the board
			 with advance written assurance that the record will be used solely as a
			 statistical research or reporting record, provided that the record is
			 transferred in a form that does not identify the subject.
c. To another government agency or to an
			 instrumentality of any governmental jurisdiction within or under the control of
			 the United States for a civil or criminal law enforcement activity if the
			 activity is authorized by law. An authorized representative of the government
			 agency or instrumentality shall have submitted a written request to the board
			 specifying the record desired and the law enforcement activity for which the
			 record is sought.
d. To an
			 individual pursuant to a showing of compelling circumstances affecting the
			 health or safety of any individual, provided a notice of the disclosure is
			 transmitted to the last-known address of the subject.
e. To the legislative services agency as
			 provided in Iowa Code section
			 2A.3.
f. In the course of employee disciplinary
			 proceedings.
g. In response to a
			 court order or subpoena.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.10 - Routine Use

Current through Register Vol. 47, No. 3, July 24, 2024
"Routine use" means the disclosure of a record without the
				consent of the subject or subjects, for a purpose that is compatible with the
				purpose for which the record was collected, and includes disclosures required
				to be made by statute other than the public records law, Iowa Code chapter
				22.
To the extent allowed by law, the following uses are considered
				routine uses of all board records:
1.
			 Disclosure to those officers, employees, investigators, members, and agents of
			 the board who have a need for the record in the performance of their duties.
			 The custodian of the record may, upon request of any officer, employee,
			 investigator, member, or agent of the board or on the custodian's own
			 initiative, determine what constitutes legitimate need to use confidential
			 records.
2. Disclosure of
			 information that indicates an apparent violation of law to appropriate law
			 enforcement authorities for investigation and possible criminal prosecution,
			 civil court action, or regulatory order.
3. Disclosure to the attorney general's
			 office for use in performing its official function.
4. Transfers of information among board staff
			 and members; to other state agencies, boards, and departments; to federal
			 agencies; to agencies in other states; to the National Association of Boards of
			 Pharmacy; or to local units of government as appropriate to carry out the
			 board's statutory authority.
5.
			 Information released to the staff of federal or state entities for audit
			 purposes or for purposes of determining whether the board is lawfully operating
			 a program.
6. Any disclosure
			 specifically authorized by the statute under which the record was collected or
			 maintained.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.11 - Consensual Disclosure of Confidential Records

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Consent to disclosure by a
			 subject individual.
To the extent permitted by law, the subject may
			 consent in writing to board disclosure of confidential records as provided in
			 rule
			 657-14.7
			 (22,124,155A).
(2)
Complaints to public officials. A
letter from a subject of a
			 confidential record to a public official that seeks the official's intervention
			 on behalf of the subject in a matter involving the board may, to the extent
			 permitted by law, be treated as an authorization to release to the official
			 sufficient information about the subject to resolve the matter.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.12 - Release to Subject

Current through Register Vol. 47, No. 3, July 24, 2024
(1) The
			 subject of a confidential record may file a written request to review
			 confidential records about that person as provided in rule
			 657-14.6
			 (22,124,155A). However, the board need not release the following records to the
			 subject:
a. The identity of a person
			 providing information to the board need not be disclosed directly or indirectly
			 to the subject of the information when the information is authorized to be held
			 confidential pursuant to Iowa Code section
			 22.7(18)
			  or other provision of law.
b. Records need not be disclosed to the
			 subject when they are the work product of an attorney or are otherwise
			 privileged.
c. Peace officers'
			 investigative reports may be withheld from the subject, except as required by
			 the Iowa Code. See Iowa Code section
			 22.7(5).
d. All information in licensee complaint and
			 investigation files maintained by the board for the purposes of licensee
			 discipline are required to be withheld from the subject prior to the filing of
			 formal charges and the notice of hearing in a licensee disciplinary
			 action.
e. As otherwise authorized
			 by law.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.15 - Other Groups of Records

Current through Register Vol. 47, No. 3, July 24, 2024
This rule describes groups of records maintained by the board
				other than record systems as defined in rule
				657-14.1
				(22,124,155A). These records are routinely available to the public and may be
				accessible via the Internet. The board's files of these records do not contain
				confidential information except where indicated. These records may contain
				information about individuals and include:
(1)
Board calendars, agenda, news
			 releases, statistical reports and compilations, newsletters, publications,
			 correspondence, and other information intended for the public.
These
			 records may contain information about individuals, including board members and
			 staff, and are stored on paper, electronically, and in computer.
(2)
Minutes of open meetings of the
			 board.
These records contain information about people who participate
			 in board meetings. This information is collected pursuant to Iowa Code section
			 21.3
			 and is stored electronically, in computer, and on paper, and may be accessed
			 via the Internet.
(3)
Records of board rule-making proceedings.
These records may
			 contain information about individuals making written or oral comments on rules
			 proposed by the board. This information is collected pursuant to Iowa Code
			 section
			 17A.4
			 and is stored electronically, in computer, and on paper. Information may be
			 accessible via the Internet.
(4)
Board decisions, findings of fact, final orders, advisory opinions,
			 declaratory orders, and other statements of law or policy issued by the board
			 in the performance of its function.
These records are open to the
			 public pursuant to Iowa Code section
			 272C.6(4),
			 except for information that is confidential, and are stored on paper,
			 electronically, and in computer.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 14 - Public Information and Inspection of Records › Rule 657-14.16 - Computer

Current through Register Vol. 47, No. 3, July 24, 2024
The board uses an in-house network of file and print servers
				and personal computers. This network system permits the comparison of
				personally identifiable information in one computerized record system with
				personally identifiable information in another computerized record
				system.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
It is the intent of these rules to authorize the department of
				corrections to distribute prescription drugs to patients in correctional
				facilities from one or more correctional pharmacies. Each correctional pharmacy
				shall be responsible for the provision of pharmacy services for a specific
				number of correctional facilities. The correctional pharmacies may be located
				on the grounds of a correctional facility or may be located off site from all
				facilities. The correctional pharmacies shall be licensed by the board with
				limited-use pharmacy licenses designated as correctional pharmacy licenses.
				Pharmacists shall be responsible for any delegated act performed by supportive
				personnel under the pharmacists' supervision. The requirements of these rules
				for correctional pharmacy practice are in addition to the requirements of
				657-Chapter 8 and other rules of the board relating to the services provided by
				the pharmacies.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For purposes of this chapter, the following definitions shall
				apply:
"Board"
means the Iowa board of
				pharmacy.
"Department"
means the Iowa department of
				corrections.
"Emergency/first dose drug supply"
means a
				limited inventory of drugs stored outside the correctional pharmacy and
				accessible to designated health care staff for the purpose of initiating
				emergency or first dose prescription drug orders issued during periods when the
				pharmacist is unavailable.
"Medication administration record"
means the
				record of the administration of drugs to patients.
"Med-pak"
means 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.
"Prescription drug order "
means an order that
				is for a drug or device for a patient in custody status in a correctional
				facility, that is originated by a practitioner authorized to prescribe, and
				that meets the information requirements for a prescription drug order but is
				recorded, distributed, and administered as though it were a medication
				order.
"Qualified individual"
means a pharmacist, a
				person who has successfully completed a medication administration course, or a
				person specifically authorized under pertinent sections of the Iowa Code to
				administer prescription drugs.
"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 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.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.3 - Responsibilities

Current through Register Vol. 47, No. 3, July 24, 2024
In any correctional pharmacy, the following responsibilities,
				which are in addition to the responsibilities required by all applicable
				federal and state laws, rules and regulations and the responsibilities as
				described in rule
				657-8.3
				(155A), shall be assigned as follows:
1. The pharmacist in charge or designee shall
			 ensure that a quarterly inspection of all pharmaceuticals located at the
			 correctional facility, including any emergency/first dose drug supply located
			 outside the confines of the pharmacy, is completed and documented.
2. The pharmacist in charge or a pharmacist
			 shall provide drug information to other health professionals, to other
			 caregivers, and to patients as required or requested.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.4 - Reference Library

Current through Register Vol. 47, No. 3, July 24, 2024
Each correctional pharmacy shall maintain a reference library,
				which is either printed or computer-accessed and which adequately meets the
				needs of the services provided and patients served. Examples of references
				include:
1. A reference including all
			 pertinent Iowa laws, rules, and regulations that impact the pharmacy's
			 practice.
2. A patient information
			 reference that includes or provides patient information in compliance with rule
			 657-6.14
			 (155A).
3. A reference on drug
			 interactions.
4. A drug information
			 reference.
5. A drug equivalency
			 reference.
6. A reference on
			 natural or herbal medicines.
7. The
			 readily accessible telephone number of a poison control center that serves the
			 area.
8. Additional references
			 relating to specific patient populations served.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.5 - Security

Current through Register Vol. 47, No. 3, July 24, 2024
The pharmacy shall be located in an area or areas that provide
				for effective control against theft of, diversion of, and unauthorized access
				to prescription drugs and pharmacy records. The following conditions shall be
				met to ensure appropriate control over drugs and chemicals in the
				pharmacy:
(1)
Locked
			 areas.
All areas occupied by the correctional pharmacy or where drugs
			 or devices are maintained or stored shall be lockable by a key, combination, or
			 electronic device so as to prevent access by unauthorized personnel and shall
			 be locked when unoccupied or unattended.
(2)
Access when pharmacist
			 absent.
Pursuant to rule
			 657-8.3
			 (155A), the pharmacy shall have policies and procedures for the security of the
			 correctional pharmacy. Policies and procedures shall identify who will have
			 access to the pharmacy, what areas may be accessed, and the procedures to be
			 followed for obtaining drugs and chemicals when the pharmacist is absent from
			 the pharmacy.
(3)
Pharmacist responsibility.
Each pharmacist, while on duty,
			 shall be responsible for the security of the correctional pharmacy. This
			 responsibility includes provisions for effective control against theft of,
			 diversion of, or unauthorized access to prescription drugs or devices,
			 controlled substances, records for such drugs and devices, and patient records
			 as provided in 657-Chapter 21 and rule
			 657-8.16
			 (124,155A). A pharmacist shall be on site during all times that the pharmacy is
			 open.
(4)
Drugs in the
			 correctional facility.
All drugs distributed from the pharmacy to
			 areas of the correctional facility for subsequent administration to patients
			 shall be kept in locked storage when not in use. Policies and procedures shall
			 identify the qualified individuals who are authorized to access these drugs and
			 the process to be followed for their removal.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.7 - Training and Utilization of Pharmacy Technicians or Pharmacy Support Persons

Current through Register Vol. 47, No. 3, July 24, 2024
Pharmacy technician and pharmacy support person training shall
				be documented and maintained by the pharmacy for at least two years from the
				last date of employment. Policies and procedures and documentation of pharmacy
				technician and pharmacy support person training shall be available for
				inspection by the board or an agent of the board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.8 - Drug Distribution and Dispensing Controls

Current through Register Vol. 47, No. 3, July 24, 2024
Prescription drugs shall be distributed or dispensed only from
				the original or a properly verified prescription drug order. There shall be no
				transcribing of prescription drug orders by nursing staff or clerical staff
				except for their own records.
(1)
Required information.
Prescription drug orders written in
			 patient health records shall include the following information:
a. Patient name, identification number, and
			 correctional facility location;
b.
			 Drug name, strength, dosage form, and quantity or duration;
c. Directions for use of the drug;
d. Date the prescription drug order is
			 authorized;
e. Prescriber's name,
			 signature or electronic signature, and office address;
f. Prescriber's DEA number for controlled
			 substances.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 15 - Correctional Pharmacy Practice › Rule 657-15.10 - Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
Pharmacy policies and procedures, established, implemented, and
				complied with pursuant to rule
				657-8.3
				(155A), shall address, but not be limited to, the following:
1. Controlled substances;
2. Formulary or drug list;
3. Stop orders;
4. Drug sample use and
			 distribution;
5. Drug
			 recalls;
6. Outdated
			 drugs;
7. Patient
			 records;
8. Inspection of drug
			 inventories;
9. Adverse reaction
			 reports;
10. Leave and release
			 drugs;
11. Emergency/first dose
			 drug supply;
12. Drugs brought into
			 the facility;
13. Medication
			 administration and records;
14.
			 Drug compounding;
15. Sterile
			 products;
16. Access to the
			 pharmacy in the absence of the pharmacist;
17. Transfers of drugs between facilities and
			 correctional pharmacies;
18.
			 Transfers of prescription drug orders between correctional
			 pharmacies;
19. Delivery of
			 drugs;
20. Notification when a drug
			 or device is not available;
21.
			 Drug destruction within the pharmacy;
22. Return of unused drugs.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
This chapter establishes the minimum standard for the practice
				of pharmacy relating to radioactive drugs. These rules apply to individuals
				authorized to receive, handle, transfer, dispense, or dispose of radioactive
				drugs pursuant to Iowa Code chapters 136C, 155A, and 455B, and rules of the
				board, the environmental protection commission, or the public health
				department. For pharmacies, these rules are in addition to other applicable
				chapters of rules of the board including, but not limited to, 657-Chapters 8
				and 20.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.2 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
"Authentication of product history"
means, but
				is not limited to, identifying the purchasing source, the ultimate fate, and
				any intermediate handling of any component of a radiopharmaceutical.
"Authorized nuclear pharmacist"
means a person
				currently licensed to practice pharmacy in Iowa who meets the qualifications
				established by rule
				657-16.3
				(155A).
"Board"
means the Iowa board of
				pharmacy.
"Internal test assessment"
means, but is not
				limited to, conducting those tests of quality assurance necessary to ensure the
				integrity of the test.
"Nuclearpharmacy"
means a pharmacy providing
				radiopharmaceutical services.
"Radioactive drug"
or
"radiopharmaceutical"
means a drug or device that contains a
				radioactive substance and is used to diagnose or treat disease.
"Radiopharmaceutical quality assurance"
means,
				but is not limited to, the performance of appropriate chemical, biological and
				physical tests on potential radiopharmaceuticals and the interpretation of the
				resulting data to determine the radiopharmaceuticals' suitability for use in
				humans and animals, including internal test assessment authentication of
				product history and the keeping of proper records.
"Radiopharmaceutical service"
means, but is
				not limited to, the preparation, dispensing, labeling and delivery of
				radiopharmaceuticals; the compounding of radiopharmaceuticals; the
				participation in radiopharmaceutical selection and radiopharmaceutical
				utilization reviews; the proper and safe storage and distribution of
				radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance;
				the responsibility for advising, as necessary or required, of the therapeutic
				values, hazards and use of radiopharmaceuticals; and the offering or performing
				of those acts, services, operations, or transactions necessary in the conduct,
				operation, management and control of a nuclear pharmacy.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.5 - Library

Current through Register Vol. 47, No. 3, July 24, 2024
Each nuclear pharmacy shall have access to the following
				references. References may be printed or computer-accessed and shall be current
				editions or revisions.
1. United
			 States Pharmacopoeia/National Formulary, with supplements;
2. A reference including all pertinent Iowa
			 laws, rules, and regulations that impact the pharmacy's practice;
3. State rules and federal regulations
			 governing the use of applicable radioactive materials;
4. Additional references as may be necessary
			 for the pharmacist to adequately meet the needs of the patients
			 served.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.6 - Minimum Equipment Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
Each nuclear pharmacy shall maintain the following equipment
				for use in the provision of radiopharmaceutical services:
1. Appropriate primary engineering control
			 device to comply with rule 657-16.8 (155A);
2. Dose calibrator;
3. Single-channel scintillation
			 counter;
4. Microscope;
5. Incubator, or access to one;
6. Radiation survey meter;
7. Other equipment necessary for the
			 radiopharmaceutical services provided as required by the board.
A pharmacy may request waiver or variance from a provision of
				this rule pursuant to the procedures and requirements of 657-Chapter
				34.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.7 - Training and Utilization of Pharmacy Support Persons

Current through Register Vol. 47, No. 3, July 24, 2024
Nuclear pharmacies utilizing pharmacy support persons shall
				develop, implement, and periodically review written policies and procedures for
				the training and utilization of pharmacy support persons. Pharmacy policies
				shall specify the frequency of review. Pharmacy support person training shall
				be documented and maintained by the pharmacy for the duration of employment.
				Such policies and procedures and documentation of pharmacy support person
				training shall be available for inspection by the board or an agent of the
				board.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 16 - Nuclear Pharmacy Practice › Rule 657-16.8 - Sterile Radiopharmaceutical Preparations and Compounding

Current through Register Vol. 47, No. 3, July 24, 2024
Sterile radiopharmaceutical preparations shall comply with
				federal laws and regulations for radiopharmaceuticals, including enforceable
				chapters of the United States Pharmacopeia (USP) and final guidance documents
				regarding sections of the Federal Food, Drug, and Cosmetic
				Act.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
This chapter establishes the licensing requirements and
				standards applicable to a wholesale distributor of human prescription drugs as
				defined by Iowa Code section 155 A.3 and the Drug Supply Chain Security Act. In
				the event the requirements in this chapter directly conflict with any federal
				law or regulation, the federal law or regulation shall supersede the
				requirements in this chapter.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.2 - 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:
"Drug Supply Chain Security Act"
or
"DSCSA "
means the law enacted by Congress in November 2013
				which establishes the minimum standards for ensuring a legitimate drug supply
				chain.
"Facility manager"
means the individual
				responsible for managing the daily operations of the wholesale distribution
				facility.
"FDA "
means the United States Food and Drug
				Administration.
"Returns processor"
means a person who owns or
				operates an establishment that dispositions or otherwise processes saleable or
				nonsaleable product received from a purchaser, manufacturer, or seller who
				purchased or received such product at wholesale, such that the product may be
				processed for credit to the purchaser, manufacturer, or seller, or disposed of
				for no further distribution.
"Wholesale distribution"
means the
				distribution of a drug to a person other than a consumer or patient, or the
				receipt of a drug by a person other than a consumer or patient, but does not
				include transactions identified in Iowa Code section
				155A.3 and
				DSCSA.
"Wholesale distributor"
means a person, other
				than a manufacturer, a manufacturer's co-licensed partner, a third-party
				logistics provider, or a repackager, engaged in the wholesale distribution of a
				prescription drug.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.4 - Grounds for Denial

Current through Register Vol. 47, No. 3, July 24, 2024
The board may deny a wholesale distributor license application,
				or refuse to renew a wholesale distributor license, for any of the
				following:
1. Any criminal convictions
			 of the applicant or facility manager related to wholesale
			 distribution;
2. Any felony
			 convictions of the applicant;
3.
			 Insufficient experience in the wholesale distribution business, 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 by wholesale distributors;
8. Conducting transactions with a person that
			 is not properly licensed or registered; 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 17 - Wholesale Distributor Licenses › Rule 657-17.7 - Compliance With Federal and State Laws

Current through Register Vol. 47, No. 3, July 24, 2024
A wholesale distributor is responsible for complying with all
				applicable federal and state laws, including those not specifically identified
				in this chapter.
(1) A licensed
			 wholesale distributor shall meet the requirements set forth in the Drug Supply
			 Chain Security Act, including but not limited to:
a.
									21
			 U.S.C. §
										360ee e-1, relating to product
			 tracing, product identifiers, authorized trading partners, suspect products,
			 and illegitimate products;
b.
									21
			 U.S.C. §
										360ee e-2, relating to national
			 standards for drug wholesale distributors; and
c. Any regulations promulgated
			 thereunder.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.8 - Written Policies and Procedures

Current through Register Vol. 47, No. 3, July 24, 2024
Wholesale distributors shall establish, maintain, and adhere to
				written policies and procedures that are in compliance with federal law for the
				receipt, security, storage, inventory, and distribution of prescription drugs,
				including policies and procedures for identifying, recording, and reporting
				losses or thefts and for correcting all errors and inaccuracies in inventories.
				Wholesale distributors shall also include in their written policies and
				procedures the following:
(1)
Recalls and market withdrawals.
A procedure to be followed for
			 handling recalls and withdrawals of prescription drugs.
a. The procedure shall be adequate to deal
			 with recalls and withdrawals due to:
(1) Any
			 action initiated at the request of the Food and Drug Administration or other
			 federal, state, or local law enforcement agency or other government agency,
			 including the board;
(2) Any
			 voluntary action by the manufacturer to remove defective or potentially
			 defective drugs from the market; or
(3) Any action undertaken to promote public
			 health and safety by replacing existing merchandise with an improved product or
			 new package design.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.9 - Facilities

Current through Register Vol. 47, No. 3, July 24, 2024
All wholesale distribution facilities shall:
1. Be of suitable size and construction to
			 facilitate cleaning, maintenance, and proper operations;
2. Have storage areas designed to provide
			 adequate lighting, ventilation, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
3. Except for returns processors, have a
			 quarantine area for storage of outdated, damaged, unsafe, deteriorated,
			 misbranded, or adulterated prescription drugs; for drugs that are in immediate
			 or sealed outer or sealed secondary containers that have been opened; for drugs
			 that have been identified as being defective or are believed to be defective;
			 and for drugs that do not meet the FDA-approved criteria for the
			 product;
4. Be maintained in a
			 clean and orderly condition;
5. Be
			 free from infestation by insects, rodents, birds, or vermin of any
			 kind.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.10 - Security

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Secure
			 from unauthorized entry.
All wholesale distribution facilities shall
			 be secure from unauthorized entry.
a. Access
			 from outside the premises shall be kept to a minimum and be well
			 controlled.
b. The outside
			 perimeter of the premises shall be well lighted.
c. Entry into areas where prescription drugs
			 are held shall be limited to authorized personnel.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.11 - Storage and Handling

Current through Register Vol. 47, No. 3, July 24, 2024
All prescription drugs shall be stored and shipped at
				appropriate temperatures and under appropriate conditions in accordance with
				requirements, if any, in the labeling of such drugs or with requirements in the
				current edition of the United States Pharmacopeia. Manual, electromechanical,
				or electronic temperature and humidity monitoring and recording equipment,
				devices, or logs shall be utilized to document proper storage of prescription
				drugs to prevent and detect excursions. Shipment of prescription drugs
				requiring refrigeration shall maintain temperature requirements in accordance
				with the manufacturer requirements or as described in the current edition of
				the United States Pharmacopeia. All excursions shall be evaluated to determine
				any adverse impact on the integrity of the drug. The requirements of this rule
				do not apply to nonsaleable returns handled by returns
				processors.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.17 - 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 wholesale
				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 wholesale 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 conviction, a
				wholesale 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 wholesale distributor, any owner of the wholesale
				distributor, or facility manager, if the conviction is related to prescription
				drug distribution. The term "criminal conviction" includes instances when the
				judgment of conviction or sentence is deferred.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 17 - Wholesale Distributor Licenses › Rule 657-17.18 - 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 wholesale 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.
2. Any
			 conviction of a crime related to the distribution of prescription drugs
			 committed by the wholesale distributor, its owners, or the facility
			 manager.
3. Refusing access to the
			 wholesale 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 wholesale
			 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 18 - Centralized Prescription Filling and Processing › Rule 657-18.1 - Purpose and Scope

Current through Register Vol. 47, No. 3, July 24, 2024
The purpose of this chapter is to provide standards for
				centralized prescription drug order filling or centralized prescription
				processing by a pharmacy. Any facility established for the purpose of filling
				or processing prescription drug orders on behalf of other pharmacies shall be
				licensed as a pharmacy and shall hold all necessary registrations. A hospital
				pharmacy may participate in centralized prescription filling only of
				prescription drug orders for noncontrolled substances pursuant to these rules.
				A hospital pharmacy may engage in centralized prescription processing pursuant
				to the requirements of rule
				657-7.7
				(155A). Except as specifically identified in the rules, the requirements of
				these rules for centralized prescription filling or centralized prescription
				processing are in addition to the requirements of 657-Chapters 6, 7, and 8, and
				other rules of the board relating to services provided by
				pharmacies.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 18 - Centralized Prescription Filling and Processing › Rule 657-18.3 - General Requirements

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Essential qualifications.
An originating pharmacy may
			 outsource prescription drug filling to a central fill pharmacy or prescription
			 drug order processing to a central processing pharmacy provided the pharmacies:
a. Have the same owner or have entered into a
			 written contract or agreement, which is available for inspection and copying by
			 the board or its authorized agent, that outlines the services to be provided
			 and the responsibilities and accountabilities of each pharmacy in compliance
			 with federal and state laws, rules, and regulations; and
b. Share a common electronic file or have
			 appropriate technology to allow access to sufficient information necessary or
			 required to perform the contracted functions.
Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 18 - Centralized Prescription Filling and Processing › Rule 657-18.5 - Patient Notification and Authorization

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Prior notification and
			 authorization.
A pharmacy that outsources prescription drug order
			 filling or prescription drug order processing to another pharmacy shall, prior
			 to outsourcing a patient's prescription:
a.
			 Notify the patient or the patient's agent that prescription filling or
			 processing may be outsourced to another pharmacy.
b. Provide the name of the pharmacy that will
			 be filling or processing the prescription or, if the pharmacy is part of a
			 network of pharmacies under common ownership and any of the network pharmacies
			 may fill or process the prescription, the patient shall be notified of this
			 fact. Notification shall be provided through a notice to the patient or the
			 patient's agent by means of a sign prominently displayed in the originating
			 pharmacy and through written notice provided to the patient or the patient's
			 agent prior to implementation of the program or upon commencement of services
			 to a new patient, as applicable.
c.
			 If a patient provides the originating pharmacy with notification that the
			 patient no longer authorizes the originating pharmacy to outsource the
			 patient's prescription drug orders, the originating pharmacy shall discontinue
			 outsourcing the filling or processing of the patient's prescription drug
			 orders.