reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-1 - Approval of electronic data processing system

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 1.
(a) No
				electronic data processing system may be used by a pharmacist pursuant to a
				category I or category III pharmacy permit as an alternative to his or her
				recordation of prescription information unless that system has been approved by
				the board.
(b) No electronic data
				processing system may be used by a pharmacist as an alternative to his or her
				recordation of information directly on the original prescription under IC
				25-26-13-25 (e),
				without the approval of the board, and such an electronic data processing
				system does not qualify for approval unless it satisfies at a minimum the
				requirements found in this rule. Any such system must be approved by the board
				before initial installation in Indiana. Any pharmacy installing such a system
				must make a written request to the board for approval. Approval is subject to
				withdrawal for cause so that the pharmacist must in such a case discontinue use
				of the system as an alternative.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-2 - On-line retrieval and printout capabilities; data requirements; discontinuance of system

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 2.
(a) Any such
				proposed computerized system must provide on-line retrieval (via visual display
				device or hard-copy printout) of original prescription order information for
				those prescription orders which are currently authorized for refilling. This
				shall include:
(1) prescription
				number;
(2) date of issuance of the
				original prescription order by the prescriber;
(3) full name and address of the
				patient;
(4) name and address of
				prescriber;
(5) DEA number of
				prescriber when drug prescribed is controlled substance;
(6) the name, strength (if applicable),
				dosage form, and quantity of medication originally dispensed;
(7) total number of refills authorized by
				prescriber.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-3 - Hard copy of daily dispensing; verification and retention; back-up capability

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 3.
(a) A
				pharmacy using an electronic data processing system must provide a separate
				hard copy printout of prescription or drug order and refill data for each day's
				dispensing or other board approved uniformly maintained readily retrievable
				system. This hard copy printout or other board approved system shall include
				the following:
(1) Prescription
				number.
(2) Date of
				dispensing.
(3) Patient
				name.
(4) Drug and strength (if
				applicable).
(5) Quantity
				dispensed.
(6) Prescriber
				identification.
(7) Pharmacist
				identification.
(8) Refill
				status.
(9) Controlled drug
				schedule identification.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-4 - Auxiliary system

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 4.
In the event that a pharmacy which employs such an
				  electronic data processing system experiences system down time, the pharmacy
				  must have an auxiliary procedure which will be used for documentation of
				  refills of prescription orders. This auxiliary procedure must insure that
				  refills are authorized by the original prescription order, that the maximum
				  number of refills has not been exceeded, and that all of the appropriate data
				  is retained for on-line service. However, nothing in this section shall
				  preclude a pharmacist from using his professional judgment to benefit the
				  health of the patient.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-5 - Safeguards

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-15; IC
				  25-26-13-25
Sec. 5.
When utilizing electronic data processing systems,
				  pharmacists shall comply with IC
				  25-26-13-15.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-6 - Data entry; supervision

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 6.
When electronic data processing equipment is utilized in any
				  pharmacy, input of drug information shall be performed by a pharmacist or under
				  the immediate and personal supervision of a pharmacist. The pharmacist must
				  certify the accuracy of the information entered and verify the prescription or
				  drug order.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 29 - Electronic Data Processing of Prescriptions › Section 29-9 - Applicability of rule

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 9.
This rule applies to pharmacies with category I and category
				  III permits.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-1 - Purpose

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 1.
The purpose of this rule is to provide standards for the
				  preparation, labeling, and distribution of sterile pharmaceutical products by
				  licensed pharmacists, pursuant to a drug order or prescription.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-2 - "Biological safety cabinet" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 2.
As used in this rule, "biological safety cabinet" means a
				  containment unit suitable for the preparation of low to moderate risk agents
				  where there is a need for protection of the product, personnel, and
				  environment, according to National Sanitation Foundation (NSF) Standard 49.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-3 - "Class 100 environment" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 3.
As used in this rule, "Class 100 environment" means an ISO
				  class 5 atmospheric environment, which contains less than one hundred (100)
				  particles five-tenths (0.5) microns in diameter per cubic foot of air,
				  according to the ISO for clean rooms and associated controlled
				  environments.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4 - "Cytotoxic" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.
As used in this rule, "cytotoxic" means a pharmaceutical
				  that has the capability of killing living human cells.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4.1 - "Hazardous" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.1.
As used in this rule, "hazardous" means any drug or waste
				  that may:
(1) be:
(A) cytotoxic;
(B) genotoxic;
(C) oncogenic;
(D) mutagenic;
(E) teratogenic; or
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4.2 - "ISO" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.2.
(a) "ISO"
				means the International Organization for Standardization.
(b) That certain document being titled
				International Organization for Standardization, as published by the
				International Organization for Standardization 1, rue de Varembé, Case
				postale 56 CH-1211 Geneva 20, Switzerland, is hereby incorporated by reference
				as if fully set out in this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4.3 - "NSF" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.3.
(a) "NSF"
				means the National Sanitation Foundation.
(b) That certain document being titled The
				Standard for Performance (copyright 2004), as published by the National
				Sanitation Foundation, P.O. Box 130140, 789 North Dixboro Road, Ann Arbor,
				Michigan 48113-0140, is hereby incorporated by reference as if fully set out in
				this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4.4 - "Parenteral" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.4.
As used in this rule, "parenteral" means a sterile
				  preparation of drugs for injection through one (1) or more layers of the skin.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4.5 - "Positive patient outcome" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.5.
As used in this rule, "positive patient outcome" means
				  the:
(1) cure or prevention of
				disease;
(2) elimination or
				reduction of symptoms; or
(3)
				arresting or slowing of disease process;
so as to improve the patient's quality of life.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-4.6 - "Product quality and characteristics" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 4.6.
As used in this rule, "product quality and characteristics"
				  means the following:
(1)
				Sterility.
(2) Potency associated
				with environmental quality.
(3)
				Preparation activities.
(4) Checks
				and tests.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-5 - "Qualified pharmacist" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 5.
As used in this rule, "qualifying pharmacist" means a
				  licensed pharmacist, identified in the policy and procedure manual, required by
				  section 7 of this rule, as responsible for the preparation of the sterile
				  pharmaceuticals, in compliance with the policy and procedure manual and the
				  applicable laws governing the practice of pharmacy in Indiana.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-6 - "Sterile pharmaceutical" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 6.
As used in this rule, "sterile pharmaceutical" means any
				  dosage form of a drug, including, but not limited to, parenteral, injectable,
				  and ophthalmic dosage forms, which dose form is free from living microbes and
				  free from chemical or physical contamination.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-7 - Policy and procedure manual

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 7.
Each pharmacy preparing and dispensing, or holding itself
				  out to prepare or dispense, sterile pharmaceuticals shall maintain a policy and
				  procedure manual relating to the compounding, dispensing, delivery,
				  administration, storage, and use of sterile pharmaceutical products, pursuant
				  to prescriptions or drug orders, or both, as part of the pharmacy policy and
				  procedure manual or as a separate policy and procedure manual. This manual
				  shall be available at the pharmacy for inspection by the board or its
				  designated inspector. The manual shall be reviewed annually by the
				  pharmacist-in-charge or the qualifying pharmacist and revised if needed. The
				  manual shall include the name of the pharmacist-in-charge of the preparation of
				  sterile pharmaceuticals and policies and procedures for the following:
(1) Clinical services provided.
(2) The handling, storage, disposal, and
				cleanup of accidental spills of hazardous drugs, if they are
				prepared.
(3) Disposal of unused
				supplies and drugs.
(4) Drug
				destruction and returns.
(5) Drug
				dispensing.
(6) Drug labeling and
				relabeling.
(7) Drug
				storage.
(8) Duties and
				qualifications for professional and nonprofessional staff.
(9) Equipment.
(10) Handling of infectious wastes, if drug
				products or administration devices are returned to the pharmacy after
				administration in the case of home administration.
(11) Infusion devices and drug delivery
				systems, if utilized.
(12)
				Investigational drugs, if dispensed.
(13) Quality assurance procedures to include
				the following:
(A) Recall
				procedures.
(B) Storage and
				expiration dating.
(C) Educational
				procedures for professional staff, nonprofessional staff, and the patient, if
				needed, in the case of home administration.
(D) Sterile procedures to include monitoring
				the temperature of the refrigerator, routine maintenance, and report of hood
				certification.
(E) Sterility
				testing or monitoring, if employed, in the case of routine bulk compounding
				from nonsterile chemicals.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-8 - Physical requirements

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13-18
Sec. 8.
(a) A
				licensed pharmacy preparing sterile pharmaceuticals shall have a designated
				area for preparing compounded, sterile pharmaceuticals. The designated area
				shall be restricted to only those personnel authorized for the preparation of
				sterile pharmaceuticals. This area may be in a separate room or in a portion of
				a larger room. The area cannot be a warehouse or stockroom setting and must be
				free of dust and dirt.
(b) The
				designated preparation area shall be used only for the preparation of sterile
				pharmaceutical products and related functions.
(c) The licensed pharmacy preparing sterile
				pharmaceutical products shall have the following equipment:
(1) An environmental control device capable
				of maintaining at least an ISO Class 5 (Class 100) environment in the work
				space where critical objects are exposed and critical activities are performed.
				This device must be capable of maintaining ISO Class 5 (Class 100) conditions
				during normal activity. Examples of appropriate devices include the following:
(A) Laminar airflow hood.
(B) Zonal laminar flow of high efficiency
				particulate air (HEPA) filtered air.
(C) Barrier isolators.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-9 - Personnel

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 9.
(a) Each
				pharmacist, pharmacist intern, pharmacist extern, and pharmacy technician
				engaged in preparing sterile pharmaceuticals must be trained in the specialized
				functions of preparing and dispensing compounded, sterile pharmaceuticals,
				including the principles of aseptic technique and quality assurance.
				Documentation of such training or experience shall be made available for
				inspection by the board or its representatives.
(b) The qualifying pharmacist shall be
				responsible for the following:
(1)
				Purchasing, storage, compounding, repackaging, dispensing, and distribution of
				all sterile pharmaceuticals.
(2)
				Development and continuing review of all:
(A)
				policies and procedures;
(B)
				training manuals; and
(C) quality
				assurance programs.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-10 - Support personnel

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 10.
(a) The
				pharmacist may be assisted by support personnel in compliance with IC
				25-26-13-18
				(a)(4). Such personnel shall have specialized
				training in the preparation of sterile pharmaceuticals and shall work under the
				supervision of a licensed pharmacist. The training provided to these personnel
				shall be described in writing. The duties and responsibilities of supportive
				personnel must be consistent with their training and experience.
(b) This section is not to preclude other
				licensed health care professionals, as allowed by law, may also prepare sterile
				pharmaceuticals when there is an immediate need, or when the preparation in a
				pharmacy is not practical.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-11 - Staffing

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 11.
A pharmacist shall be accessible at all times to respond to
				  patients' and other health professionals' questions and needs.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-12 - Profile or medication record system

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13-18
Sec. 12.
A pharmacy-generated profile or medication record system for
				  sterile pharmaceuticals administered to patients, except for those inpatients
				  in an institutional facility, as defined in
				  856 IAC
				  1-28-1(a), holding a Type II pharmacy
				  permit, shall be maintained separately from the prescription file. The patient
				  profile or medication record system shall contain at a minimum the
				  following:
(1) Patient's name, date of
				birth or age, weight, and sex.
(2)
				Sterile pharmaceutical products dispensed.
(3) Drug content and quantity.
(4) Directions for the patient, if
				administered outside the facility.
(5) Identification of the dispensing
				pharmacist and other authorized personnel responsible for preparing the sterile
				pharmaceutical.
(6) Other drug
				therapy information, if applicable.
(7) Known or suspected drug sensitivities and
				allergies of the patient to drugs and foods, if applicable.
(8) Primary diagnosis and chronic conditions
				if the sterile pharmaceutical is administered outside the facility.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-13 - Labeling

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 13.
(a) Each
				sterile pharmaceutical product dispensed to a patient shall be labeled with the
				following:
(1) Date of preparation by the
				pharmacy.
(2) Patient name and bed
				number, if an institutionalized patient.
(3) Name of each drug in the preparation,
				strength, and amount.
(4)
				Expiration date of the preparation, including time, if applicable.
(5) Identity of the pharmacist compounding
				and dispensing the sterile pharmaceutical, and identity of other authorized
				personnel preparing the product, if applicable.
(6) Other information required by the
				dispensing pharmacy regarding storage requirements or special
				warnings.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-14 - Records and reports

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-15; IC
				  25-26-13-18
Sec. 14.
(a) The
				qualifying pharmacist shall be responsible for such records and reports as
				required to ensure the patient's health, safety, and welfare. Such records
				shall be readily available and maintained for two (2) years from the date of
				issuance of the prescription or drug order and be subject to inspection by the
				Indiana board of pharmacy or its designated inspector. These records shall
				include the following:
(1) Patient profile or
				medication record system.
(2)
				Policy and procedure manual.
(3)
				Training manuals.
(4) Policies and
				procedures for disposal of hazardous waste, when applicable.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-15 - Disposal of infectious waste

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 15.
The qualifying pharmacist is responsible for assuring that
				  there is a system for the disposal of infectious waste returned from outside
				  the facility in a manner consistent with the protection of the public's health
				  and safety and in compliance with applicable state and federal law.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-16 - Emergency kit

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 16.
When sterile pharmaceuticals are provided to home care
				  patients, the dispensing pharmacy may supply the nurse with emergency drugs, if
				  the treating physician has authorized the use of such drugs by a protocol, for
				  use in an emergency situation, e.g., anaphylactic shock.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-17 - Hazardous drugs

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 17.
In addition to the minimum requirements for a pharmacy
				  established by rules of the board, the following requirements are necessary to
				  ensure the protection of the personnel involved in those licensed pharmacies
				  that prepare hazardous drugs:
(1) All
				hazardous drugs shall be compounded in a Class II, biological safety cabinet.
				If this cabinet is not dedicated solely to the compounding of hazardous drugs,
				policies and procedures must be in place for the cleaning and decontaminating
				this biological safety cabinet.
(2)
				Protective apparel shall be worn by personnel compounding hazardous drugs. This
				shall include disposable gloves and gowns with tight cuffs.
(3) Appropriate safety and containment
				techniques for compounding hazardous drugs shall be used in conjunction with
				the aseptic techniques required for preparing sterile products.
(4) Procedures for disposal of hazardous
				waste shall be specified within the policy and procedure manual as required by
				section 7 of this rule and comply with all applicable local, state, and federal
				requirements.
(5) Written
				procedures for handling both major and minor spills of hazardous agents must be
				developed and included in the policy and procedure manual.
(6) Prepared doses of hazardous drugs shall
				be dispensed and labeled with proper precautions inside and outside and shipped
				in a manner designed to minimize the risk of accidental rupture of the primary
				container.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 30 - Sterile Pharmaceuticals; Preparation and Dispensing › Section 30-18 - Quality assurance

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-18
Sec. 18.
(a) The
				designated qualifying pharmacist shall conduct a documented, ongoing quality
				assurance program that monitors personnel performance, equipment, and
				facilities. Samples of finished products shall be examined, or other continuous
				monitoring methods shall be used to assure that the pharmacy is capable of
				consistently preparing sterile pharmaceuticals meeting specifications in
				accordance with good compounding practices and the current USP/NF Chapter on
				sterile preparation. Quality assurance procedures shall include the following:
(1) Recall procedures for compounded sterile
				pharmaceuticals.
(2) Storage and
				dating for compounded sterile pharmaceuticals.
(3) Sterile procedures, including the
				following:
(A) Monitoring the temperature of
				the refrigerator.
(B) Routine
				maintenance.
(C) Report of laminar
				flow hood certification.
(4) Written documentation of periodic hood
				cleaning.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 31 - Facsimile Machines › Section 31-1 - "Facsimile machine" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-2
Sec. 1.
As used in this rule, "facsimile machine" means a machine
				  that electronically transmits exact images through connection with a
				  telecommunications network.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 31 - Facsimile Machines › Section 31-2 - Use of a facsimile machine to electronically transmit a prescription or drug order

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-1-9; IC 25-26-13-15
Sec. 2.
Prescription or drug orders for legend drugs, including
				  schedules II through V substances, may be transmitted by facsimile machine from
				  an authorized prescribing practitioner or an authorized employee or agent of
				  the individual practitioner to a pharmacy under the following
				  restrictions:
(1) A prescription or
				drug order for a schedule II controlled substance may be transmitted to a
				pharmacy via facsimile equipment, provided the original written, signed
				prescription or drug order is presented to the pharmacist for review prior to
				the actual dispensing of the controlled substance, except as noted in
				subdivision (2) or (3).
(2) A
				prescription or drug order prepared in accordance with
				856 IAC 2-6-4 written for a
				schedule II narcotic substance to be compounded for the direct administration
				to a patient in a private residence, long-term care facility, or hospice
				setting by means of:
(A)
				parenteral;
(B)
				intravenous;
(C)
				intramuscular;
(D) subcutaneous;
				or
(E) intraspinal;
infusion may be transmitted by facsimile.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 31 - Facsimile Machines › Section 31-3 - Facsimile prescription or drug order maintenance

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-1-9; IC
				  25-26-13-25
Sec. 3.
The facsimile serves as the original written prescription or
				  drug order, and it shall be maintained in accordance with IC
				  25-26-13-25.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 32 - Transfer of Prescriptions Between Pharmacies › Section 32-1 - Applicability of rule

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 1.
This rule governs the transfer of prescription information,
				  either originally filled or previously refilled, by one (1) pharmacy to another
				  pharmacy for refills.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 32 - Transfer of Prescriptions Between Pharmacies › Section 32-2 - Noncontrolled and controlled substance prescription transfers

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 2.
(a)
				Prescription information for legend drugs that are not controlled substances
				may be transferred at any time during the lifetime of the prescription up to
				one (1) year after the date originally issued by the prescriber or when the
				original number of authorized refills expires, whichever comes first.
(b) Except as limited by the requirement of
				subsection (a), prescriptions for legend drugs that are not controlled
				substances may be transferred any number of times.
(c) If any authorized refills remain,
				prescriptions for schedule III, schedule IV, and schedule V controlled
				substances may be transferred only once within six (6) months from the date the
				prescription was issued. However, pharmacies electronically sharing a
				real-time, online database may transfer up to the maximum refills permitted by
				law and the prescriber's authorization.
(d) Prescriptions for schedule II controlled
				substances may not be transferred.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 32 - Transfer of Prescriptions Between Pharmacies › Section 32-3 - Patient's right to transfer prescriptions

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-16; IC
				  25-26-13-25
Sec. 3.
A pharmacist may not legally refuse to transfer a patient's
				  prescription or prescription information except when to do so would be against
				  the professional judgment of the pharmacist in the manner provided for under IC
				  25-26-13-16.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 32 - Transfer of Prescriptions Between Pharmacies › Section 32-4 - Pharmacists' responsibilities

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 4.
Transfer of prescription information must be communicated
				  between licensed pharmacists or licensed pharmacist interns in accordance with
				  this title and all applicable U.S. Drug Enforcement Administration regulations
				  and must meet the following requirements:
(1) The pharmacist or pharmacist intern
				transferring the prescription shall do the following:
(A) Indicate that the prescription is no
				longer active and has been transferred.
(B) Record the name, address, and U.S. Drug
				Enforcement Administration registration number of the pharmacy to which it was
				transferred and the name of the pharmacist receiving the
				prescription.
(C) Record the date
				of the transfer and the name of the pharmacist transferring the
				information.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 32 - Transfer of Prescriptions Between Pharmacies › Section 32-5 - Electronic transfers

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 5.
(a) Two (2)
				or more pharmacies may establish and use a common electronic file to maintain
				required information related to the practice of the profession of
				pharmacy.
(b) Pharmacies using such
				a common electronic file are not required to transfer prescriptions or
				information for dispensing purposes between or among pharmacies participating
				in the same common prescription file as described in section 4 of this rule
				provided the following:
(1) The pharmacies are
				under common ownership or a contractual agreement.
(2) Any such common file must contain
				complete and adequate records of such prescription or prescriptions and refill
				or refills dispensed according to IC
				25-26-13-25.
(3) All pharmacies and pharmacists involved
				in the transactions pursuant to the practice of the profession of pharmacy are
				properly licensed, permitted, or registered within the United States.
(4) A policy and procedures manual that
				governs all participating pharmacies and pharmacists:
(A) is available to the board upon request;
				and
(B) includes the procedure for
				maintaining appropriate records for regulatory oversight for tracking a
				prescription during each stage of the practice of the profession of
				pharmacy.
(5) The
				pharmacists involved in the practice of the profession of pharmacy are
				identified. A pharmacist shall be accountable for the specific tasks
				performed.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 33 - Counseling › Section 33-1 - Definitions

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-4
Sec. 1.
The following definitions apply throughout this rule:
(1) "Counseling" means appropriate
				communication, by a pharmacist, to a patient, as defined in subdivision (3), of
				information for the purpose of improving therapeutic outcomes by maximizing the
				proper use of drugs and devices dispensed pursuant to prescriptions.
(2) "Offer" means a statement that is verbal
				or, only if necessary for an individual patient, nonverbal, for example,
				printed or written, that clearly informs the patient that a pharmacist is
				available, at the time the offer is made, to counsel the patient, including,
				but not limited to, giving information to or answering questions, or both, from
				the patient.
(3) "Patient" means
				the following:
(A) The individual for whom a
				prescription was issued.
(B) The
				caregiver of the individual for whom a prescription was issued.
(C) The agent of the individual for whom a
				prescription was issued.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 33 - Counseling › Section 33-1.5 - Offer requirements

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13-10
Sec. 1.5.
(a) The
				following can satisfy an offer:
(1) A
				pharmacist counseling the patient.
(2) A pharmacist intern/extern registered
				under IC 25-26-13-10 if:
(A) permitted by the
				pharmacist; and
(B) the counseling
				by the pharmacist intern/extern is followed by a bona fide offer for the
				pharmacist to counsel the patient and if the patient or patient's
				representative desires such counseling.
(3) A written notice containing the
				pharmacy's phone number and a bona fide offer when:
(A) a patient is not present and has not
				authorized the giving of information to another; or
(B) the drug or device is delivered by the
				United States Postal Service, parcel delivery, or hand delivery.
(4) Any personnel in the
				prescription department, as defined in
				856 IAC
				1-13-3(b)(3), making an offer to
				counsel, as defined in section 1(2) of this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 33 - Counseling › Section 33-2 - Patient counseling requirements

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-16
Sec. 2.
(a) Upon the
				receipt of a prescription or upon the subsequent refilling of a prescription,
				and following a review of the patient's prescription medication profile, the
				pharmacist shall be responsible for the initiation of an offer, as set forth in
				section 1.5(a) of this rule, to counsel the patient on matters that, in the
				pharmacist's professional judgment, are significant to optimizing drug therapy.
				Depending upon the situation, these matters may include, but are not
				necessarily limited to, the following:
(1) The
				name and description of the medicine.
(2) The route, dosage form, dosage, route of
				administration, and duration of drug therapy.
(3) Special directions and
				precautions.
(4) Common adverse
				effects or interactions and therapeutic contraindications that may be
				encountered, including their avoidance and the action required if they
				occur.
(5) Techniques for
				self-monitoring drug therapy.
(6)
				Proper storage.
(7) Prescription
				refill information.
(8) Action to
				be taken in the event of a missed dose.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 33 - Counseling › Section 33-3 - Patient profile requirements

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-25
Sec. 3.
The pharmacist shall assure that prescription medication
				  profiles are maintained for all patients receiving pharmaceutical care at that
				  pharmacy. Within limits of reasonably available information, the pharmacy
				  medication profile shall include the following:
(1) Name, address, telephone number, age or
				date of birth, and gender.
(2)
				Known drug allergies and adverse reactions.
(3) A list of current medications and
				relevant devices, either of which may relate to the patient's drug
				therapy.
(4) Known disease
				states.
(5) Any other information
				that, in the pharmacist's professional judgment, the pharmacist deems
				appropriate.
(6) Pharmacist's
				comments relevant to the individual's drug therapy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 33 - Counseling › Section 33-4 - Institutional patient exception

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-26-13-4
Sec. 4.
The requirements for patient counseling, as described in
				  this rule, shall not apply to patients residing in institutional facilities in
				  Indiana as defined under
				  856 IAC
				  1-28.1-1(6).
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 33 - Counseling › Section 33-5 - Patient counseling violations

Current through July 10, 2024
Authority: IC 25-26-13-4
Affected: IC 25-1-9
Sec. 5.
Violation of this rule shall be grounds for discipline by
				  the board under either IC 25-1-9 or
				  856 IAC 1-20.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 34 - Security Features for Prescriptions › Section 34-1 - Applicability

Current through July 10, 2024
Authority: IC
				  25-26-24-22
Affected: IC
				  16-42-19-5; IC
				  25-26-24-17
Sec. 1.
This rule establishes minimum standards for security
				  features for prescriptions issued by practitioners as described in IC
				  16-42-19-5. Practitioners licensed
				  in Indiana must comply with this rule in order for their prescriptions to be
				  accepted for filling in licensed Indiana pharmacies.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 34 - Security Features for Prescriptions › Section 34-2 - Security feature requirements

Current through July 10, 2024
Authority: IC
				  25-26-24-22
Affected: IC
				  16-42-19-5; IC
				  25-26-24-17
Sec. 2.
(a) All
				controlled substance prescriptions written by licensed Indiana practitioners,
				as defined by IC
				16-42-19-5, must contain the
				following security features:
(1) A latent,
				repetitive "void" pattern screened at five percent (5%) in reflex blue must
				appear across the entire face of the document when the prescription is
				photocopied.
(2) There shall be a
				custom artificial watermark printed on the back side of the base paper so that
				it may only be seen at a forty-five (45) degree angle. The watermark shall
				consist of the words "Indiana Security Prescription", appearing horizontally in
				a step-and-repeated format in five (5) lines on the back of the document using
				12-point Helvetica bold type style.
(3) An opaque RX symbol must appear in the
				upper right-hand corner, one-eighth (1/8) of an inch from the top of the pad
				and five-sixteenths (5/16) of an inch from the right side of the pad. The
				symbol must:
(A) be three-fourths (3/4) inch
				in size; and
(B) disappear if the
				prescription copy is lightened.
(4) Six (6) quantity check-off boxes must be
				printed on the form and the following quantities must appear and the
				appropriate box be checked off for the prescription to be valid:
(A) 1-24.
(B) 25-49.
(C) 50-74.
(D) 75-100.
(E) 101-150.
(F) 151 and over.
(5) No advertisements may appear on the front
				or back of the prescription blank.
(6) Logos, defined as a symbol utilized by an
				individual, professional practice, professional association, or hospital, may
				appear on the prescription blank. The upper left one (1) inch square of the
				prescription blank is reserved for the purpose of logos. Only logos, as defined
				by this subdivision, may appear on the prescription blank.
(7) Only one (1) prescription may be written
				per prescription blank. The following statement must be printed on the bottom
				of the pad: "Prescription is void if more than one (1) prescription is written
				per blank.".
(8) Refill options
				that can be circled by the prescriber must appear below any logos and above the
				signature lines on the left side of the prescription blank in the following
				order:
Refill NR 1 2 3 4 5 Void after _____.
(9) Practitioner name and state issued
				professional license number must be preprinted, stamped, or manually printed on
				the prescription.
(10) All
				prescription blanks printed under this rule shall be four and one-fourth (4
				1/4) inches high and five and one-half (5 1/2) inches wide.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 34 - Security Features for Prescriptions › Section 34-3 - Preprinted controlled substance prohibition

Current through July 10, 2024
Authority: IC
				  25-26-24-22
Affected: IC
				  25-26-24-17; IC
				  35-48-2
Sec. 3.
The name of any controlled substance, as defined by IC
				  35-48-2, may not be preprinted on
				  any prescription forms at any time before the prescription is being prepared
				  and executed for presentation to the patient or the patient's agent. That
				  includes, but is not limited to, such activities as typing prescriptions in
				  anticipation of their need, and using a rubber stamp or other similar means
				  which would accomplish the same end. Commercially printed forms containing
				  names of controlled substances are also prohibited.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 34 - Security Features for Prescriptions › Section 34-4 - Exemption

Current through July 10, 2024
Authority: IC
				  25-26-24-22
Affected: IC
				  25-26-24
Sec. 4.
Prescriptions utilized by pharmacists to record call-in
				  prescriptions, transferred prescriptions, or facsimile prescriptions do not
				  need to comply with this rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 34 - Security Features for Prescriptions › Section 34-5 - Approval

Current through July 10, 2024
Authority: IC
				  25-26-24-22
Affected: IC
				  25-26-24
Sec. 5.
Printers wishing to supply prescription blanks to authorized
				  recipients must obtain a template design from the board to use as a layout
				  guide. Printers must also submit a preprint proof to the board for approval
				  prior to any production of prescription blanks governed by this
				  rule.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 1 - PHARMACIES AND PHARMACISTS › Rule 35 - Pharmacy Technicians › Section 35-1 - Purpose and scope

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 1.
(a) The board
				is responsible for establishing standards for the competent practice of
				pharmacy.
(b) The use of pharmacy
				technicians to assist the pharmacist with nondiscretionary functions associated
				with the practice of pharmacy enables the pharmacist to provide pharmaceutical
				care to the patient.
(c) Evolved
				pharmacy practice demands additional time for pharmacists to counsel individual
				patients regarding the proper use of drugs.
(d) Only pharmacists (licensed under IC
				25-26-13-11), pharmacy interns and
				externs (as defined in IC
				25-26-13-2 and registered under IC
				25-26-13-10), and pharmacy
				technicians as described in this section shall be permitted to participate in
				the activities associated with a drug order or prescription
				preparation.
(e) A pharmacist shall
				not permit a pharmacy technician to participate in the activities associated
				with a drug order or prescription preparation unless the pharmacy technician
				meets the qualifications of this section.
(f) The pharmacist is responsible for the
				work performed by the pharmacy technician under the pharmacist's
				supervision.