reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 2 - Licensing and Operational Requirements › Section 2-6 - Termination of licensure; transfer of license

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14-14; IC
				  25-26-14-15
Sec. 6.
(a) The
				license of any person shall terminate if and when such person dies or ceases
				legal existence. Any licensee who ceases legal existence or discontinues
				business shall notify the board within ten (10) days of such fact in
				writing.
(b) No license or any
				authority conferred thereby shall be assigned or otherwise transferred except
				to the extent allowed by IC
				25-26-14-15, and then only
				pursuant to the written consent of the board.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 3 - Accreditation › Section 3-1 - Board-approved accreditation body

Current through July 10, 2024
Authority: IC
				  25-26-14-13; IC
				  25-26-14-14
Affected: IC
				  25-26-14-14
Sec. 1.
The National Association of Boards of Pharmacy's
				  Verified-Accredited Wholesale Distributors (VAWD) program shall do the
				  following:
(1) Evaluate a wholesale
				drug distributor's operations to determine compliance with the following:
(A) Industry standards.
(B) IC
				25-26-14.
(C) This title.
(D) Any other applicable
				law.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 3 - Accreditation › Section 3-2 - Accreditation for new applicants

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14-14
Sec. 2.
For licenses issued after December 31, 2005, applicants for
				  licensure as wholesale drug distributors shall obtain the accreditation from
				  the National Association of Boards of Pharmacy's Verified-Accredited Wholesale
				  Distributors (VAWD) program before issuance of licensure.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 3 - Accreditation › Section 3-3 - Accreditation for existing license holders

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14-14
Sec. 3.
For licenses issued before January 1, 2006, license holders
				  shall obtain the accreditation from the National Association of Boards of
				  Pharmacy's Verified-Accredited Wholesale Distributors (VAWD) program before
				  renewal of licensure on September 30, 2006.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 4 - Pedigrees › Section 4-1 - Pedigrees; contents

Current through July 10, 2024
Authority: IC 25-26-14-8.7; IC 25-26-14-13
Affected: IC 25-26-14
Sec. 1.
A pedigree for each legend drug shall contain the following
				  information:
(1) The legend drug
				proprietary and established name.
(2) The container size of the legend
				drug.
(3) The number of
				containers.
(4) The dosage
				form.
(5) The dosage
				strength.
(6) Lot/control numbers
				with expiration dates.
(7) The name
				of the manufacturer and repackager, if applicable, of the finished legend drug
				product.
(8) The name, address, and
				telephone number of each entity involved in the chain of the legend drug's
				custody.
(9) The name and address
				of each person certifying delivery or receipt of the legend drug.
(10) The sales invoice number or other
				number, unique to the shipping document.
(11) The dates of each transaction, including
				manufacturer, delivery, and receipt.
(12) A certification that each recipient has
				authenticated the pedigree, back to the manufacturer.
(13) A certification from the licensed entity
				that the information contained on the pedigree is true.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 4 - Pedigrees › Section 4-2 - Pedigrees; approved formats

Current through July 10, 2024
Authority: IC 25-26-14-8.7; IC 25-26-14-13
Affected: IC 25-26-14
Sec. 2.
The pedigree format:
(1) shall include the contents described in
				section 1 of this rule; and
(2) may
				be subject to the approval of the board.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 5 - Normal Distribution Chain of Custody › Section 5-1 - Authorized distributor to authorized distributor transaction; pedigree requirement

Current through July 10, 2024
Authority: IC 25-26-14-8.5; IC 25-26-14-13
Affected: IC 25-26-14-17
Sec. 1.
For purposes of IC 25-26-14 and this article, within the
				  normal distribution chain of custody, an authorized distributor that receives a
				  legend drug directly from the manufacturer, or from the manufacturer's third
				  party logistics provider, may sell the legend drug to a pharmacy, chain drug
				  warehouse, or practitioner or one (1) other authorized distributor of the
				  manufacturer that sells the legend drug directly to a pharmacy, chain drug
				  warehouse, or practitioner without passing a pedigree if the invoice or
				  accompanying document for the transaction includes a statement that the product
				  was purchased directly from:
(1) the
				manufacturer; or
(2) an authorized
				distributor of the manufacturer who purchased the product direct from the
				manufacturer.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 5 - Normal Distribution Chain of Custody › Section 5-2 - Chain drug warehouses in the normal distribution chain of custody

Current through July 10, 2024
Authority: IC 25-26-14-8.5; IC 25-26-14-13
Affected: IC 25-26-14-1.8; IC 25-26-14-17
Sec. 2.
As used in IC 25-26-14 and in this article, chain drug
				  warehouses that are distributing to their affiliated pharmacies or warehouses
				  are not required to:
(1) be recognized
				as an authorized distributor, as defined in IC 25-26-14-1.8, for the normal
				distribution chain of custody to apply; or
(2) within the normal distribution chain of
				custody, pass a pedigree to or between their affiliated pharmacies or
				warehouses.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 5 - Normal Distribution Chain of Custody › Section 5-3 - Entities within the normal distribution chain custody

Current through July 10, 2024
Authority: IC
				  25-26-14-8.5; IC
				  25-26-14-13
Affected: IC
				  25-26-14-17
Sec. 3.
All entities, other than manufacturers approved by the Food
				  and Drug Administration, within the normal distribution chain of custody shall
				  be located and licensed within the United States or its
				  territories.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 5 - Normal Distribution Chain of Custody › Section 5-4 - Applicability of normal distribution chain of custody

Current through July 10, 2024
Authority: IC 25-26-14-8.5; IC 25-26-14-13
Affected: IC 25-26-14-17
Sec. 4.
Normal distribution chain of custody applies to the
				  following:
(1) Physical movement of the
				legend drug.
(2) Its passage of
				title.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 6 - Drug Returns › Section 6-1 - Drug returns; pedigree requirement

Current through July 10, 2024
Authority: IC 25-26-14-11; IC 25-26-14-13
Affected: IC 25-26-14-17
Sec. 1.
The returns or exchanges of saleable legend drugs, received
				  by the wholesale distributor as provided by this article, are not subject to
				  the pedigree requirements under IC 25-26-14 and 856 IAC 3-4. Wholesale
				  distributors are responsible for the following:
(1) Policing the returns process.
(2) Maintaining operations that are designed
				against the entry of an adulterated or counterfeit product into
				distribution.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 3 - WHOLESALE LEGEND DRUGS › Rule 7 - Authentications › Section 7-1 - Authentication

Current through July 10, 2024
Authority: IC
				  25-26-14-13
Affected: IC
				  25-26-14
Sec. 1.
Manufacturers shall cooperate in the process of
				  authentication, as defined in IC
				  25-26-14.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-1 - Education and training

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  25-26-13-10
Sec. 1.
(a) For
				purposes of this article, "pharmacist student" has the same meaning as a
				"pharmacist intern" registered under IC
				25-26-13-10.
(b) In order to qualify to administer
				immunizations, a pharmacist or pharmacist intern must successfully complete a
				course of training in immunization that is provided by an Accreditation Council
				for Pharmacy Education accredited provider and meets the standards set forth
				by:
(1) the Centers for Disease Control and
				Prevention;
(2) a similar health
				authority; or
(3) a professional
				body approved by the Indiana board of pharmacy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-2 - Required components of immunization protocol for administering vaccinations

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  25-26-13
Sec. 2.
(a) The
				protocol for the administration of immunizations must include the following:
(1) For each immunization to be administered
				by a pharmacist, or pharmacist intern, the following:
(A) The name and strength of the
				vaccine.
(B) Precautions and
				contraindications.
(C) The intended
				audience or patient population.
(D)
				The appropriate dosage.
(E)
				Administration schedules in accordance with the Centers for Disease Control and
				Prevention guidelines.
(F)
				Appropriate routes of administration.
(G) Appropriate injection
				sites.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-3 - Delegation of protocol authority

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  25-26-13
Sec. 3.
The pharmacist or pharmacist intern is prohibited from
				  delegating the administration of the immunization to another
				  person.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-4 - Reporting of adverse events

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  16-38-5-2; IC
				  25-26-13
Sec. 4.
(a) A
				pharmacist or pharmacist intern's supervising pharmacist shall report adverse
				events to the patient's primary care physician and the physician who approved
				the immunization protocol within seventy-two (72) hours of the pharmacist's
				knowledge of the adverse event.
(b)
				A pharmacist or pharmacist intern's supervising pharmacist shall report to the
				Vaccine Adverse Events Reporting Systems, the cooperative program for vaccine
				safety of the Centers for Disease Control and Prevention and the Food and Drug
				Administration.
(c) A pharmacist or
				designee shall report the immunization of each individual to the immunization
				data registry maintained by the state department of health under IC
				16-38-5, unless a written
				immunization data exception form has been completed and filed in accordance
				with IC 16-38-5-2.
(d) The qualifying pharmacist is responsible
				for ensuring that records of the reporting of adverse events is maintained by
				the pharmacy.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-5 - Immunization practice voluntary

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  25-26-13
Sec. 5.
(a) A
				pharmacist or pharmacist intern may not be required to:
(1) administer an immunization; or
(2) complete the accredited training program;
if the pharmacist or pharmacist intern chooses not to
				  administer any immunization.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-6 - Pharmacist personnel training requirements

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  25-26-13
Sec. 6.
The qualifying pharmacist is responsible for ensuring that
				  all pharmacist personnel engaging in immunization practice are trained:
(1) as required by this rule; and
(2) in the pharmacy's written policies and
				procedures of operation;
prior to performing any immunizations.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 4 - PHARMACIST VACCINATIONS ADMINISTERED VIA PROTOCOL AUTHORITY › Rule 1 - Pharmacist Vaccinations Administered via Protocol Authority › Section 1-7 - Consent required for pharmacist intern or pharmacist student to administer immunizations

Current through July 10, 2024
Authority: IC
				  25-26-13-4; IC
				  25-26-13-31.5
Affected: IC
				  25-26-13
Sec. 7.
In order for a pharmacist intern or pharmacist student to
				  administer an immunization, the pharmacist intern or pharmacist student must
				  identify themselves to the patient as a pharmacist intern or pharmacist student
				  and receive consent from the patient.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-1 - Purpose and scope

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 1.
This article establishes standards applicable to any:
(1) pharmacy holding a permit issued by the
				board; and
(2) facility subject to
				inspection by the board;
that utilizes automation technology to store, package,
				  dispense, and distribute prescriptions or medication orders.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-2 - ''Automated medication system'' defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 2.
(a) As used
				in this article, ''automated medication system'' means any technology assisted
				operation approved by the board that:
(1)
				relies on bar code or other automated technology to dispense and distribute
				medications; and
(2) records all
				transactions related to its operation.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-3 - "Board" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13-3
Sec. 3.
As used in this rule, "board" means the Indiana board of
				  pharmacy established under IC
				  25-26-13-3.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-4 - "Operation" defined

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 4.
As used in this article, "operation" means the storing,
				  assembly, packing, dispensing, and distributing of drugs including the:
(1) operability;
(2) integrity;
(3) maintenance;
(4) safety;
(5) security;
(6) confidentiality; and
(7) accuracy;
of the automated process.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-5 - Authority to use automated medication system

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  16-42-19-5; IC
				  25-26-13; IC 35-48
Sec. 5.
(a) A
				pharmacy or facility may use an automated medication system to fill
				prescriptions or medication orders provided that:
(1) the qualifying pharmacist of the pharmacy
				or a practitioner as defined by IC
				16-42-19-5 is responsible for the
				operation of the automated medication system;
(2) the board:
(A) conducts an inspection of the pharmacy or
				facility including an inspection of the automated medication system;
				and
(B) approves the system;
				and
(3) the automated
				medication system is tested by the pharmacy or facility and found to dispense
				accurately. The pharmacy or facility shall make the results of such testing
				available to the board upon request.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-6 - Written policies and procedures of operation

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 6.
(a) An
				automated medication system used to fill prescriptions or medication orders
				shall be operated according to the pharmacy's or facility's written policies
				and procedures of operation. The policies and procedures of operation shall:
(1) include a:
(A) table of contents; and
(B) description of all procedures of
				operation;
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-7 - Personnel training requirements

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 7.
The qualifying pharmacist or practitioner shall be
				  responsible for ensuring that all personnel with access to the automated
				  medication system are trained in the pharmacy's or facility's written policies
				  and procedures of operation prior to performing any automated medication system
				  operations.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-8 - Written program for quality assurance

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 8.
A pharmacy or facility that uses an automated medication
				  system to fill prescriptions or medication orders shall operate according to a
				  written program for quality assurance of the automated medication system
				  that:
(1) requires continuous
				monitoring of the automated medication system;
(2) establishes mechanisms and procedures to
				test the accuracy of the automated medication system biannually and upon any
				modification to the system including medications used within that
				system;
(3) establishes a protocol
				for measuring the effectiveness of the automated medication system;
				and
(4) requires the pharmacy or
				facility to:
(A) report to the board each
				recurring error of the automated medication system; and
(B) maintain all documentation relating to
				the written program for quality assurance for at least two (2)
				years.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-9 - Written plan for recovery

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 9.
A pharmacy or facility that uses an automated medication
				  system to fill prescriptions or medication orders shall maintain a written plan
				  for recovery from an emergency that interrupts the ability of the pharmacy or
				  facility to provide services. The written plan for recovery shall include the
				  following:
(1) Planning and
				preparation for an emergency.
(2)
				Procedures for response to an emergency.
(3) Procedures for the maintenance and
				testing of the written plan for recovery.
(4) A procedure to notify:
(A) the board;
(B) each organization that has contracted
				with the pharmacy or facility;
(C)
				each patient of the pharmacy or facility; and
(D) other appropriate agencies;
of an emergency and the date on which the pharmacy or
				  facility expects to recommence the provision of
				  service.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 5 - AUTOMATED MEDICATION SYSTEMS › Rule 1 - Automated Medication Systems › Section 1-10 - Written program for preventative maintenance of automated medication system

Current through July 10, 2024
Authority: IC
				  25-26-13-4
Affected: IC
				  25-26-13
Sec. 10.
A pharmacy or facility that uses an automated medication
				  system to fill prescriptions or medication orders shall maintain a written
				  program for preventative maintenance of the system.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 6 - CONTROLLED SUBSTANCE MONITORING › Rule 1 - Electronic Prescription Monitoring Program › Section 1-1 - Definitions

Current through July 10, 2024
Authority: IC 35-48-7-12
Affected: IC 35-48-2
Sec. 1.
(a) As used
				in this article, "department" refers to the Indiana state police
				department.
(b) As used in this
				article, "dispense" means the actual or constructive transfer from one (1)
				person to another whether or not there is an agency relationship.
(c) As used in this article, "dispenser" has
				the meaning set forth in IC 35-48-7-3
[IC 35-48-7-3 was repealed by P.L.
				105-2008, SECTION 66, effective January 1, 2009.]
.
(d) As used in this article, "Schedule II
				controlled substance" means a controlled substance classified in Schedule II:
(1) under IC 35-48-2-6; or
(2) by rule adopted under IC
				35-48-2-14.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 6 - CONTROLLED SUBSTANCE MONITORING › Rule 1 - Electronic Prescription Monitoring Program › Section 1-2 - Applicability

Current through July 10, 2024
Authority: IC 35-48-7-12
Affected: IC 35-48-7-8
Sec. 2.
This article shall apply to Schedule II, III, IV, and V
				  controlled substances and shall not apply to any other drug.
Transferred from the Controlled Substances Advisory
					 Committee ( 858 IAC 2-1-2 ) to the Indiana Board of Pharmacy ( 856 IAC 6-1-2 )
					 by P.L. 84-2010, SECTION 70, effective July 1,
					 2010.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 6 - CONTROLLED SUBSTANCE MONITORING › Rule 1 - Electronic Prescription Monitoring Program › Section 1-3 - Prescription monitoring program

Current through July 10, 2024
Authority: IC 35-48-7-12
Affected: IC 35-48-7-8
Sec. 3.
(a) Each time
				a Schedule II, III, IV, or V controlled substance is dispensed, the dispenser
				shall transmit to the central repository information outlined in IC
				35-48-7-8.
(b) Dispensers reporting
				more than twenty (20) Schedule II, III, IV, or V prescriptions in any given
				month must transmit to the central repository information outlined in IC
				35-48-7-8 utilizing one (1) of the following:
(1) An electronic device compatible with the
				receiving device of the central repository.
(2) A computer diskette.
(3) A magnetic tape.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 6 - CONTROLLED SUBSTANCE MONITORING › Rule 1 - Electronic Prescription Monitoring Program › Section 1-4 - Application for payment of pharmacy costs

Current through July 10, 2024
Authority: IC 35-48-7-12
Affected: IC 35-48-7-9
Sec. 4.
(a) Before
				the department will pay for the purchase of hardware to comply with the
				program, an applicant must file an application provided by the department and
				provide the following information:
(1) The
				dispenser's name, address, and Indiana license number.
(2) A detailed description of the dispenser's
				current computer hardware, including the name and manufacturer of all
				components.
(3) A detailed
				description of the hardware the dispenser intends to purchase and two (2) price
				quotes from computer hardware vendors.
(4) The reason why the dispenser believes the
				computer hardware will be necessary to comply with the program.
(5) The number of Schedule II, III, IV, and V
				prescriptions the pharmacy dispenses in any given month.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 1 - Purpose and Scope › Section 1-1 - Purpose and scope

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 1.
(a) This
				article establishes standards applicable to any:
(1) prescription drug take back
				program;
(2) entities that may
				participate in prescription drug take back programs; and
(3) guidelines and standards for prescription
				drug take back programs.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-1 - Definitions

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  16-42-19; IC
				  16-42-20; IC
				  25-26-13-2; IC
				  25-26-23
Sec. 1.
All terms which are defined in IC
				  25-26-13-2, IC
				  16-42-19, and IC
				  16-42-20 shall have the same
				  meanings as they are so defined when used in the rules of the Indiana board of
				  pharmacy found in article 7 of title 856 of the Indiana Administrative Code
[this article]
.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-2 - "Board" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-13-3
Sec. 2.
"Board" or "board" means the Indiana board of pharmacy
				  established under IC
				  25-26-13-3.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-3 - "Take back program" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 3.
"Take back program" refers to a program or service intended
				  to collect unused or unwanted medication from consumers or patients, and
				  established and run under the guidelines and standards as laid out in this
				  article.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-4 - "Return of unused medication" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 4.
"Return of unused medication" refers to medications that are
				  collected under the auspices of an eligible take back program as established
				  under this article. This does not include medication that is returned for
				  credit, resale, and redistribution. This also does not include drugs that are
				  listed in Schedule 1 controlled substances under Indiana law.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-5 - "Entities" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC 16-28; IC 25-26
Sec. 5.
"Entities" shall mean those licensed facilities that are
				  eligible to run a legal take back program under Indiana law. Licensed
				  facilities included in this definition are all pharmacies licensed under IC
				  25-26 listed as active and in good standing and healthcare facilities licensed
				  under IC 16-28 listed as active and in good standing.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-6 - "Vendor" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-13-3
Sec. 6.
"Vendor" means a contracted party that is providing services
				  to the entity that is running a take back program established under this
				  article. A vendor can perform any of the services that are part of the program
				  so long as those services are defined in the contract established between that
				  vendor and the entity. The vendor assumes the liabilities and responsibilities
				  as established in the contract and policies and procedures that apply in each
				  relationship.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-7 - "Unused or unwanted medication" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  16-42-19
Sec. 7.
"Unused or unwanted medication" could mean all drugs that
				  fall under the definition of drug as defined in IC
				  16-42-19. Entities that run take
				  back programs may further define or limit what drugs they are capable or
				  willing to accept for destruction purposes. They are not required or mandated
				  to take all drugs in order to maintain eligibility as a take back
				  program.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-8 - "Drug storage device" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-13-3
Sec. 8.
"Drug storage device" means the device in which the returned
				  prescription drugs are stored after return by the consumer and before
				  disposal.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 2 - Definitions › Section 2-9 - "Drug return receptacle" defined

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-13-3
Sec. 9.
"Drug return receptacle" means the receptacle into which the
				  consumer places the returned prescription drugs, whether or not it is the drug
				  storage device.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 3 - Responsibilities of Entities Who Accept Unused or Unwanted Medications › Section 3-1 - Personnel

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 1.
Entities that run a take back program must have licensed
				  personnel that directly manage and have oversight for implementation and the
				  day-to-day activities of the program and services. The individual responsible
				  for managing the program or services must have an active and in good standing
				  license issued by the Indiana professional licensing agency under IC
				  25.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 3 - Responsibilities of Entities Who Accept Unused or Unwanted Medications › Section 3-2 - Documented policies and procedures

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 2.
Entities that run a take back program must have documented
				  policies and procedures that address all the requirements of IC
				  25-26-23 and this
				  article.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 3 - Responsibilities of Entities Who Accept Unused or Unwanted Medications › Section 3-3 - Management of vendor relationships

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 3.
(a) Entities
				that run a take back program must maintain a documented contract that provides
				for the roles and responsibilities of each party performing services related to
				transportation, destruction, and security, and that is available for review by
				the board. This section does not require that the contract or services be
				approved by the board and does not require a contract where the entity is
				eligible to perform this services
[sic]
independent of a third
				party vendor.
(b) The ultimate
				responsibility for management of the vendor relationship falls to the licensed
				entity that is running the take back program. Any issues of liability,
				indemnification, or responsibility on the vendor's part should be addressed in
				the contractual relationship.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 3 - Responsibilities of Entities Who Accept Unused or Unwanted Medications › Section 3-4 - Prohibition on reuse and resale

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-13-25; IC
				  25-26-23
Sec. 4.
Unused or unwanted medications collected by an entity
				  running a take back program shall not be returned to saleable inventory nor
				  made available for subsequent relabeling and redispensing unless otherwise
				  permitted by law (see IC
				  25-26-13-25).
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 4 - Policy Regarding Record Keeping › Section 4-1 - Requirement to keep records

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 1.
(a) Entities
				that engage in a take back program shall be required to keep a record of the
				following:
(1) Policies and
				procedures;
(2) Personnel involved
				with or who have access to returned medications;
(3) Dates when medications where
[sic, were]
collected by the party responsible for
				destruction; and
(4) Personnel
				responsible for destruction, transportation, and security.
This information may be maintained in conjunction or as part
				  of the policies and procedures being utilized by the entity running the take
				  back program.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 4 - Policy Regarding Record Keeping › Section 4-2 - Access to records

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 2.
Records shall be made available for review to the board,
				  board personnel, and other entities as may be determined by the
				  board.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 4 - Policy Regarding Record Keeping › Section 4-3 - Use of electronic records

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 3.
In instances where an entity that runs a take back program
				  is capable of maintaining records in an electronic format, including any logs,
				  receipts, or other records that might be required under this article, those
				  records may be maintained in an electronic format. However, if maintained
				  electronically, those records must be accessible, readily retrievable, secure
				  (similar to how other pharmacy records are maintained), be backed up in the
				  event of disaster, and available for board inspection upon request. This
				  section is intended to apply to all aspects of this article.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 4 - Policy Regarding Record Keeping › Section 4-4 - Record retention requirements

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 4.
Entities that engage in take back programs are required to
				  maintain the relevant records for a period of two (2) years from the date of
				  destruction or delivery/shipment to the party responsible for
				  destruction.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 5 - Destruction Methods › Section 5-1 - Requirement for destruction

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 1.
Drugs collected by a take back program being implemented
				  under this article are required to be destroyed and may not be resold, reused,
				  redistributed, or otherwise interfered with in any way that might present an
				  opportunity for harm, misuse, or diversion.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 5 - Destruction Methods › Section 5-2 - Required time period for destruction

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 2.
The frequency of drug destruction can be determined by the
				  entity that runs the take back programs as determined by need and volume, but
				  destruction must occur at least on a quarterly basis to ensure drugs are not
				  stored indefinitely and do not pose a threat to public health and
				  safety.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 5 - Destruction Methods › Section 5-3 - Acceptable methods of destruction

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 3.
(a) Entities
				that run take back programs must use a means of destruction that results in
				incineration of the drugs ensuring that those destroyed drugs do not pose a
				risk to public health and safety and ensure that the drugs or drug remains do
				not pose an unacceptable level of risk or harm to water systems or landfills.
				Entities that run take back programs that utilize their own means to destroy
				collected drugs must be able to evidence that their incinerator or destruction
				method is capable of safely destroying drugs and rendering them harmless to the
				public.
(b) Entities that do not
				destroy the collected drugs on site or within their own company must have a
				contract in place with a vendor that will manage the destruction. Such contract
				must include documented policies and procedures that address destruction. Those
				policies and procedures must at least include a discussion of the
				transportation, security, and destruction means which would otherwise comply
				with section 1
[of this rule]
. A system of receipt and/or logs
				that evidence each destruction, the total weight of the drugs destroyed (not
				quantity or type), and the date it occurred must be included as a part of this
				contract.
(c) Entities that wish to
				utilize a different method of destruction not otherwise listed or discussed
				above may petition the board to approve another documented and proven
				destruction process. Such process must include documented policies and
				procedures that at least address the following issues:
(1) Public health and safety;
(2) Diversion; and
(3) Environmental
				hazards.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 6 - Privacy Protocols and Safeguards › Section 6-1 - Privacy generally

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 1.
(a) An entity
				that runs a take back program shall be responsible for ensuring that their take
				back program does not violate the privacy rights of patients and customers, and
				is consistent with what is otherwise required by state and federal law for
				protecting the privacy rights of patients.
(b) If an entity running a take back program
				contracts with vendors to assist in accomplishing components of their programs,
				the entities shall ensure that privacy rights are protected and addressed in
				their contract with appropriate indemnification and liability provisions to
				ensure that those privacy rights are protected.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 6 - Privacy Protocols and Safeguards › Section 6-2 - Privacy protocols and policy

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 2.
(a) An entity
				that runs a take back program shall be responsible for providing documented
				policies and procedures that outline how they protect patient privacy
				consistent with state and federal laws. This policy shall be documented and be
				a part of the larger set of policies and procedures made available for board
				inspection.
(b) An entity shall
				provide privacy training to all staff involved with a take back program and
				have documentation of said training available for board inspection.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 6 - Privacy Protocols and Safeguards › Section 6-3 - Notice to patients or customers

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 3.
An entity that runs a take back program is required to
				  provide a notice to consumers and/or patients a copy of their privacy policy
				  and how they protect consumers' private health information from being
				  disclosed. The notice and policy should include a statement to how the drugs
				  are collected, the security safeguards, and the method of destruction. This
				  notice may be posted or provided in any one (1) of the following ways:
(1) Pamphlets or leaflets that describe the
				policy available to the public upon request;
(2) A notice posted on the box or device
				where the drugs are collected; or
(3) A notice posted in the area where take
				back occurs and is reasonably accessible to view by patients and other
				consumers.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 7 - Securit › Section 7-1 - Storage device or drug return receptacle

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 1.
An acceptable storage device or drug return receptacle will
				  meet the following criteria:
(1) Does
				not allow for the removal of contents except by authorized personnel;
(2) Is secured in a manner that will only
				allow authorized personnel to remove the contents of the container;
				and
(3) Utilizes a design that is
				tamper resistant and will not represent a risk to patient or customer
				safety.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 7 - Securit › Section 7-2 - Location of storage device or drug return receptacle

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 2.
(a) If the
				storage device is movable, the device and/or receptacle must be located in the
				pharmacy department and must be capable of being monitored by whatever security
				features or personnel that pharmacy department utilizes.
(b) If the storage device is stationary and
				secure, than
[sic, then]
the device and/or receptacle may be
				located anywhere in the interior of the building housing the pharmacy, but only
				personnel included within this article and as provided for in the policies and
				procedures of the entity running the take back program may have access to that
				storage device or receptacle.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 7 - Securit › Section 7-3 - Access to contents and secure method of drop off

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 3.
(a) Secure
				method of drop off. It is not required that licensed personnel physically
				facilitate the placement of the drugs by the patient or customer into the
				storage device or receptacle. If done by the patient into a secure device, then
				no other involvement or documentation need occur. If pharmacy staff is involved
				in assisting with the drop off and collection of drugs, the personnel involved
				(one (1) of which shall be licensed) will witness and document that the drop
				off and placement of the drugs into the storage device or receptacle occurred.
				All that needs to be included in this acknowledgement and documentation is the
				date and time the drop off occurred, the names of the personnel that
				facilitated and witnessed the drop off, and that the drugs were placed into the
				appropriate storage device and receptacle for destruction. (The board does not
				intend that this documentation include the name of the patient, the drugs
				accepted, or any physical count or inventory of the product.)
(b) Access to contents. Only personnel
				designated in the policies and procedures governing the take back program for
				each individual entity and program shall have access to remove the storage
				device(s) from the receptacle where the drugs are collected or to transfer the
				device to the party performing the destruction services (be that party internal
				or external). When the device is accessed for removal of the storage device to
				transport or facilitate the contents for destruction, the process will involve
				two (2) personnel for witness and acknowledgment purposes, one (1) of which
				will be a licensed member of the pharmacy staff.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 7 - Securit › Section 7-4 - Requirement for documented policies and procedures

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 4.
Any entity which chooses to run a one (1) time or ongoing
				  take back program is required to maintain documented policies and procedures
				  that will address all the requirements of this article.
Indiana Administrative Code › Title 856 - INDIANA BOARD OF PHARMACY › Article 7 - PRESCRIPTION DRUG TAKE BACK PROGRAMS › Rule 7 - Securit › Section 7-5 - Maintenance, monitoring, and emptying

Current through July 10, 2024
Authority: IC
				  25-26-23-2
Affected: IC
				  25-26-23
Sec. 5.
(a) The drug
				receptacle into which drugs are placed or returned must be maintained in such a
				way as to prevent unintended access, diversion, or harm to the personnel or
				patients/customers that might use or be in the vicinity of the
				receptacle.
(b) The storage device
				and drug receptacle should be monitored in accordance with the security
				provisions discussed in this article. The level of monitoring should correspond
				to the location and permanence of the device and should be focused on
				reasonably preventing diversion, inappropriate access, and harm to patients
				and/or customers. In no instance should the receptacle used to facilitate a
				take back program be located outside the facility or be left in an area
				incapable of being monitored via security cameras or live personnel.
(c) Emptying the device and receptacle shall
				be done in accordance with the provisions provided above and utilize a log or
				receipt schedule capable of being audited and maintained as a part of the
				program's record retention requirements.
(d) In the event that the device being used
				to accept returned medications is full or exceeds capacity, personnel involved
				in managing the take back program may remove the contents to the extent
				necessary to secure the returned medications until such time as personnel can
				arrange for destruction. Whatever contents are removed must be secured in an
				area separate from merchandise or prescriptions available for sale to customers
				or patients. Any additional storage area shall also only be accessible to the
				personnel named in this article and specified in the entity's policies and
				procedures. Additionally, if an entity maintains additional storage space, this
				process and space shall be addressed in their policies and procedures (for
				example, referenced as "Overflow Policy").