CHAPTER 13. REGULATION OF PHARMACISTS AND PHARMACIES . CREATION OF BOARD
IC 25-26-13
Chapter 13. Regulation of Pharmacists and Pharmacies . Creationof Board
IC 25-26-13-1
Public interest
Sec. 1. The practice of pharmacy is declared to be a professionaloccupation in the state of Indiana, affecting the public health, safety,and welfare and must be subject to regulation and control in thepublic interest by the board of pharmacy. It is further declared to bea matter of public interest and concern that the practice of pharmacymerit and receive the confidence of the public and that only qualifiedpersons be permitted to practice pharmacy in the state of Indiana.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-1.5
Continuation of accrued rights or benefits
Sec. 1.5. A right or benefit accrued under IC 25-26-1 throughIC 25-26-12 before July 1, 1977, is continued under this chapter.
As added by P.L.1-1989, SEC.52.
IC 25-26-13-2
Definitions
Sec. 2. As used in this chapter:
"Administering" means the direct application of a drug to thebody of a person by injection, inhalation, ingestion, or any othermeans.
"Board" means the Indiana board of pharmacy.
"Controlled drugs" are those drugs on schedules I through V ofthe Federal Controlled Substances Act or on schedules I through Vof IC 35-48-2.
"Counseling" means effective communication between apharmacist and a patient concerning the contents, drug to druginteractions, route, dosage, form, directions for use, precautions, andeffective use of a drug or device to improve the therapeutic outcomeof the patient through the effective use of the drug or device.
"Dispensing" means issuing one (1) or more doses of a drug in asuitable container with appropriate labeling for subsequentadministration to or use by a patient.
"Drug" means:
(1) articles or substances recognized in the official UnitedStates Pharmacopoeia, official National Formulary, officialHomeopathic Pharmacopoeia of the United States, or anysupplement to any of them;
(2) articles or substances intended for use in the diagnosis, cure,mitigation, treatment, or prevention of disease in man oranimals;
(3) articles other than food intended to affect the structure orany function of the body of man or animals; or
(4) articles intended for use as a component of any article
specified in subdivisions (1) through (3) and devices.
"Drug order" means a written order in a hospital or other healthcare institution for an ultimate user for any drug or device, issuedand signed by a practitioner, or an order transmitted by other meansof communication from a practitioner, which is immediately reducedto writing by the pharmacist, registered nurse, or other licensedhealth care practitioner authorized by the hospital or institution. Theorder shall contain the name and bed number of the patient; the nameand strength or size of the drug or device; unless specified byindividual institution policy or guideline, the amount to be dispensedeither in quantity or days; adequate directions for the proper use ofthe drug or device when it is administered to the patient; and thename of the prescriber.
"Drug regimen review" means the retrospective, concurrent, andprospective review by a pharmacist of a patient's drug related historythat includes the following areas:
(1) Evaluation of prescriptions or drug orders and patientrecords for drug allergies, rational therapy contradictions,appropriate dose and route of administration, appropriatedirections for use, or duplicative therapies.
(2) Evaluation of prescriptions or drug orders and patientrecords for drug-drug, drug-food, drug-disease, anddrug-clinical laboratory interactions.
(3) Evaluation of prescriptions or drug orders and patientrecords for adverse drug reactions.
(4) Evaluation of prescriptions or drug orders and patientrecords for proper utilization and optimal therapeutic outcomes.
"Drug utilization review" means a program designed to measureand assess on a retrospective and prospective basis the proper use ofdrugs.
"Device" means an instrument, apparatus, implement, machine,contrivance, implant, in vitro reagent, or other similar or relatedarticle including any component part or accessory, which is:
(1) recognized in the official United States Pharmacopoeia,official National Formulary, or any supplement to them;
(2) intended for use in the diagnosis of disease or otherconditions or the cure, mitigation, treatment, or prevention ofdisease in man or other animals; or
(3) intended to affect the structure or any function of the bodyof man or other animals and which does not achieve any of itsprincipal intended purposes through chemical action within oron the body of man or other animals and which is not dependentupon being metabolized for the achievement of any of itsprincipal intended purposes.
"Electronic data intermediary" means an entity that provides theinfrastructure that connects a computer system or another electronicdevice used by a prescribing practitioner with a computer system oranother electronic device used by a pharmacy to facilitate the securetransmission of:
(1) an electronic prescription order; (2) a refill authorization request;
(3) a communication; and
(4) other patient care information;
between a practitioner and a pharmacy.
"Electronic signature" means an electronic sound, symbol, orprocess:
(1) attached to or logically associated with a record; and
(2) executed or adopted by a person;
with the intent to sign the record.
"Electronically transmitted" or "electronic transmission" meansthe transmission of a prescription in electronic form. The term doesnot include the transmission of a prescription by facsimile.
"Investigational or new drug" means any drug which is limited bystate or federal law to use under professional supervision of apractitioner authorized by law to prescribe or administer such drug.
"Legend drug" has the meaning set forth in IC 16-18-2-199.
"License" and "permit" are interchangeable and mean a writtencertificate from the Indiana board of pharmacy for the practice ofpharmacy or the operation of a pharmacy.
"Nonprescription drug" means a drug that may be sold without aprescription and that is labeled for use by a patient in accordancewith state and federal laws.
"Person" means any individual, partnership, copartnership, firm,company, corporation, association, joint stock company, trust, estate,or municipality, or a legal representative or agent, unless this chapterexpressly provides otherwise.
"Practitioner" has the meaning set forth in IC 16-42-19-5.
"Pharmacist" means a person licensed under this chapter.
"Pharmacist intern" means a person who is:
(1) permitted by the board to engage in the practice of pharmacywhile under the personal supervision of a pharmacist and whois satisfactorily progressing toward meeting the requirementsfor licensure as a pharmacist;
(2) a graduate of an approved college of pharmacy or a graduatewho has established educational equivalency by obtaining aForeign Pharmacy Graduate Examination Committee Certificateand who is permitted by the board to obtain practical experienceas a requirement for licensure as a pharmacist;
(3) a qualified applicant awaiting examination for licensure; or
(4) an individual participating in a residency or fellowshipprogram.
"Pharmacy" means any facility, department, or other place whereprescriptions are filled or compounded and are sold, dispensed,offered, or displayed for sale and which has as its principal purposethe dispensing of drug and health supplies intended for the generalhealth, welfare, and safety of the public, without placing any otheractivity on a more important level than the practice of pharmacy.
"The practice of pharmacy" or "the practice of the profession ofpharmacy" means a patient oriented health care profession in whichpharmacists interact with and counsel patients and with other health
care professionals concerning drugs and devices used to enhancepatients' wellness, prevent illness, and optimize the outcome of adrug or device, by accepting responsibility for performing orsupervising a pharmacist intern or an unlicensed person undersection 18(a)(4) of this chapter to do the following acts, services, andoperations:
(1) The offering of or performing of those acts, serviceoperations, or transactions incidental to the interpretation,evaluation, and implementation of prescriptions or drug orders.
(2) The compounding, labeling, administering, dispensing, orselling of drugs and devices, including radioactive substances,whether dispensed under a practitioner's prescription or drugorder or sold or given directly to the ultimate consumer.
(3) The proper and safe storage and distribution of drugs anddevices.
(4) The maintenance of proper records of the receipt, storage,sale, and dispensing of drugs and devices.
(5) Counseling, advising, and educating patients, patients'caregivers, and health care providers and professionals, asnecessary, as to the contents, therapeutic values, uses,significant problems, risks, and appropriate manner of use ofdrugs and devices.
(6) Assessing, recording, and reporting events related to the useof drugs or devices.
(7) Provision of the professional acts, professional decisions,and professional services necessary to maintain all areas of apatient's pharmacy related care as specifically authorized to apharmacist under this article.
"Prescription" means a written order or an order transmitted byother means of communication from a practitioner to or for anultimate user for any drug or device containing:
(1) the name and address of the patient;
(2) the date of issue;
(3) the name and strength or size (if applicable) of the drug ordevice;
(4) the amount to be dispensed (unless indicated by directionsand duration of therapy);
(5) adequate directions for the proper use of the drug or deviceby the patient;
(6) the name of the practitioner; and
(7) if the prescription:
(A) is in written form, the signature of the practitioner; or
(B) is in electronic form, the electronic signature of thepractitioner.
"Qualifying pharmacist" means the pharmacist who will qualifythe pharmacy by being responsible to the board for the legaloperations of the pharmacy under the permit.
"Record" means all papers, letters, memoranda, notes,prescriptions, drug orders, invoices, statements, patient medicationcharts or files, computerized records, or other written indicia,
documents, or objects which are used in any way in connection withthe purchase, sale, or handling of any drug or device.
"Sale" means every sale and includes:
(1) manufacturing, processing, transporting, handling,packaging, or any other production, preparation, orrepackaging;
(2) exposure, offer, or any other proffer;
(3) holding, storing, or any other possession;
(4) dispensing, giving, delivering, or any other supplying; and
(5) applying, administering, or any other using.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.149-1987,SEC.72; P.L.2-1993, SEC.144; P.L.187-1999, SEC.1; P.L.270-2001,SEC.2; P.L.288-2001, SEC.1; P.L.1-2002, SEC.97; P.L.204-2005,SEC.14; P.L.98-2006, SEC.2; P.L.94-2007, SEC.1.
IC 25-26-13-3
Board of pharmacy; creation; oath; meetings; compensation;majority approval of actions
Sec. 3. (a) The Indiana board of pharmacy is created. It shallconsist of seven (7) members not more than four (4) of whom maybe from the same political party, appointed by the governor for termsof four (4) years. One (1) member of the board, to represent thegeneral public, must be a resident of this state who has never beenassociated with pharmacy in any way other than as a consumer.Except for the member representing the general public, the membersmust be pharmacists in good standing of recognized experience andability from varied practice settings who hold a current license topractice pharmacy in Indiana. One (1) member of the board must bea practicing hospital pharmacist. A person employed as a full-timestaff member or as a professor at a school of pharmacy may not serveon the board. If a member leaves the board for any reason before theend of the member's term, the member's successor shall serve for theunexpired portion of the term.
(b) Not later than ten (10) days after a member's appointment, themember must subscribe by oath or affirmation to faithfully upholdthe duties of the member's office. If a member fails to qualify asprovided, a new member shall be appointed in the member's place.
(c) At the first meeting of each year the board shall elect fromamong its members a president and vice president who shall performduties and have powers as the board prescribes.
(d) The board shall meet at least eight (8) times per year at suchtimes and places as the board selects. At each meeting the board shallcontinue in session from day to day, for not more than five (5) days,until the business of the meeting is complete. Four (4) members ofthe board shall constitute a quorum.
(e) Each member of the board is entitled to compensation asdetermined by the rules of the budget agency for each day themember is actually engaged in business of the board, together withnecessary travel and other expenses incurred in the performance ofthe member's duties. (f) Approval by a majority of the quorum is required for anyaction to be taken by the board.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.185; P.L.157-1986, SEC.1; P.L.48-1991, SEC.45;P.L.187-1999, SEC.2.
IC 25-26-13-4
Powers and duties of board; prescription drug form program
Sec. 4. (a) The board may:
(1) promulgate rules and regulations under IC 4-22-2 forimplementing and enforcing this chapter;
(2) establish requirements and tests to determine the moral,physical, intellectual, educational, scientific, technical, andprofessional qualifications for applicants for pharmacists'licenses;
(3) refuse to issue, deny, suspend, or revoke a license or permitor place on probation or fine any licensee or permittee underthis chapter;
(4) regulate the sale of drugs and devices in the state of Indiana;
(5) impound, embargo, confiscate, or otherwise prevent fromdisposition any drugs, medicines, chemicals, poisons, or deviceswhich by inspection are deemed unfit for use or would bedangerous to the health and welfare of the citizens of the stateof Indiana; the board shall follow those embargo proceduresfound in IC 16-42-1-18 through IC 16-42-1-31, and persons maynot refuse to permit or otherwise prevent members of the boardor their representatives from entering such places and makingsuch inspections;
(6) prescribe minimum standards with respect to physicalcharacteristics of pharmacies, as may be necessary to themaintenance of professional surroundings and to the protectionof the safety and welfare of the public;
(7) subject to IC 25-1-7, investigate complaints, subpoenawitnesses, schedule and conduct hearings on behalf of thepublic interest on any matter under the jurisdiction of the board;
(8) prescribe the time, place, method, manner, scope, andsubjects of licensing examinations which shall be given at leasttwice annually; and
(9) perform such other duties and functions and exercise suchother powers as may be necessary to implement and enforce thischapter.
(b) The board shall adopt rules under IC 4-22-2 for the following:
(1) Establishing standards for the competent practice ofpharmacy.
(2) Establishing the standards for a pharmacist to counselindividuals regarding the proper use of drugs.
(3) Establishing standards and procedures before January 1,2006, to ensure that a pharmacist:
(A) has entered into a contract that accepts the return ofexpired drugs with; or (B) is subject to a policy that accepts the return of expireddrugs of;
a wholesaler, manufacturer, or agent of a wholesaler ormanufacturer concerning the return by the pharmacist to thewholesaler, the manufacturer, or the agent of expired legenddrugs or controlled drugs. In determining the standards andprocedures, the board may not interfere with negotiated termsrelated to cost, expenses, or reimbursement charges containedin contracts between parties, but may consider what is areasonable quantity of a drug to be purchased by a pharmacy.The standards and procedures do not apply to vaccines thatprevent influenza, medicine used for the treatment of malignanthyperthermia, and other drugs determined by the board to notbe subject to a return policy. An agent of a wholesaler ormanufacturer must be appointed in writing and have policies,personnel, and facilities to handle properly returns of expiredlegend drugs and controlled substances.
(c) The board may grant or deny a temporary variance to a rule ithas adopted if:
(1) the board has adopted rules which set forth the proceduresand standards governing the grant or denial of a temporaryvariance; and
(2) the board sets forth in writing the reasons for a grant ordenial of a temporary variance.
(d) The board shall adopt rules and procedures, in consultationwith the medical licensing board, concerning the electronictransmission of prescriptions. The rules adopted under thissubsection must address the following:
(1) Privacy protection for the practitioner and the practitioner'spatient.
(2) Security of the electronic transmission.
(3) A process for approving electronic data intermediaries forthe electronic transmission of prescriptions.
(4) Use of a practitioner's United States Drug EnforcementAgency registration number.
(5) Protection of the practitioner from identity theft orfraudulent use of the practitioner's prescribing authority.
(e) The governor may direct the board to develop:
(1) a prescription drug program that includes the establishmentof criteria to eliminate or significantly reduce prescriptionfraud; and
(2) a standard format for an official tamper resistantprescription drug form for prescriptions (as defined inIC 16-42-19-7(1)).
The board may adopt rules under IC 4-22-2 necessary to implementthis subsection.
(f) The standard format for a prescription drug form described insubsection (e)(2) must include the following:
(1) A counterfeit protection bar code with human readablerepresentation of the data in the bar code. (2) A thermochromic mark on the front and the back of theprescription that:
(A) is at least one-fourth (1/4) of one (1) inch in height andwidth; and
(B) changes from blue to clear when exposed to heat.
(g) The board may contract with a supplier to implement andmanage the prescription drug program described in subsection (e).The supplier must:
(1) have been audited by a third party auditor using the SAS 70audit or an equivalent audit for at least the three (3) previousyears; and
(2) be audited by a third party auditor using the SAS 70 audit oran equivalent audit throughout the duration of the contract;
in order to be considered to implement and manage the program.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.186; P.L.75-1992, SEC.20; P.L.2-1993, SEC.145;P.L.177-1997, SEC.5; P.L.212-2005, SEC.22; P.L.204-2005,SEC.15; P.L.182-2009(ss), SEC.371.
IC 25-26-13-4.3
Adopted rules
Sec. 4.3. (a) Any rules adopted by the controlled substancesadvisory committee (IC 35-48-2-1 (before its abolishment)) beforeJuly 1, 2010, shall be treated as rules of the Indiana board ofpharmacy (IC 25-26).
(b) This section expires July 1, 2015.
As added by P.L.84-2010, SEC.70.
IC 25-26-13-4.5
Rehabilitation of impaired pharmacists; confidentiality ofinformation; duties of board designated rehabilitation program
Sec. 4.5. (a) As used in this section, "impaired pharmacist" meansa licensed pharmacist who has been affected by the use or abuse ofalcohol or other drugs.
(b) The board shall assist in the rehabilitation of an impaired or alicensed pharmacist. The board may:
(1) enter into agreements, provide grants, and make otherarrangements with statewide nonprofit professionalassociations, foundations, or entities specifically devoted to therehabilitation of impaired health care professionals to identifyand assist impaired pharmacists or licensed pharmacists; and
(2) accept and designate grants, public and private financialassistance, and licensure fees to fund programs undersubdivision (1).
(c) Except as provided in subsection (e), all:
(1) information furnished to a nonprofit professionalorganization or foundation, including interviews, reports,statements, and memoranda; and
(2) findings, conclusions, or recommendations that result froma proceeding of a professional organization or foundation;are privileged and confidential.
(d) The records of a proceeding under subsection (c) may be usedonly in the exercise of the proper functions of the board and may notbecome public records or be subject to a subpoena or discoveryproceeding.
(e) Information received by the board from the board designatedrehabilitation program for noncompliance by the licensed pharmacistmay be used by the board in any disciplinary or criminal proceedingsinstituted against the impaired licensed pharmacist.
(f) The board designated rehabilitation program shall:
(1) immediately report to the board the name and results of anycontact or investigation concerning an impaired licensedpharmacist that the program believes constitutes an imminentdanger to either the public or the impaired licensed pharmacist;and
(2) in a timely fashion report to the board an impaired licensedpharmacist:
(A) who refuses to cooperate with the program;
(B) who refuses to submit to treatment; or
(C) whose impairment is not substantially alleviated throughtreatment.
As added by P.L.188-1995, SEC.4. Amended by P.L.182-2003,SEC.1.
IC 25-26-13-5
Executive director; record of proceedings; inspector-investigators
Sec. 5. (a) The executive director shall keep a record of theproceedings of the board. The record shall contain the names andaddresses of all persons who apply to the board for a license orpermit and the action taken on each.
(b) The board shall hire and supervise a sufficient number ofinspector-investigators to enforce the controlled substances law (IC35-48). Inspector-investigators hired by the board are employees ofthe Indiana professional licensing agency.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.187; Acts 1982, P.L.113, SEC.64; P.L.169-1985,SEC.87; P.L.1-2006, SEC.461.
IC 25-26-13-6
Funds from sources other than state
Sec. 6. The board may accept and expend funds from sourcesother than the state of Indiana, provided that:
(1) such funds are awarded for the pursuit of a specificobjective which the board is authorized to accomplish by thischapter, or which the board is qualified to accomplish by reasonof its jurisdiction or professional expertise;
(2) such funds are expended for the pursuit of the objective forwhich they are awarded;
(3) activities connected with or occasioned by the expendituresof such funds do not interfere with or impair the performance
of the board's duties and responsibilities and do not conflictwith the exercise of the board's powers as specified by thischapter;
(4) such funds are kept in a separate, special account in the statetreasury; and
(5) periodic reports are made to the governor concerning theboard's receipt and expenditure of such funds.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-7
Enforcement of law
Sec. 7. With respect to pharmacists, pharmacies, drugs, controlleddrugs, legend drugs, and devices and the enforcement of this chapter,the board shall have the same powers, duties, and functions asspecified in IC 16-42-20-2.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.2-1993,SEC.146.
IC 25-26-13-8
Repealed
(Repealed by P.L.105-2008, SEC.67.)
IC 25-26-13-9
Pharmacist intern programs; continuing education
Sec. 9. (a) The board shall establish standards for pharmacistintern programs. Such standards shall include, but not be limited to,the number of hours students must spend in a program, the numberof hours a student must spend in a pharmacy each week, and thetypes of duties the student may perform.
(b) The board shall, by regulation, establish standards andrequirements for continuing education and shall endorse thosecontinuing education programs which meet the standards andrequirements.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.98-2006,SEC.3.
IC 25-26-13-10
Pharmacist intern registration
Sec. 10. (a) An applicant for registration as a pharmacist internmust furnish proof satisfactory to the board that the applicant:
(1) is actively enrolled in a school of pharmacy accredited bythe American Council of Pharmaceutical Education;
(2) has obtained the Foreign Pharmacy Graduate ExaminationCommittee Certificate; or
(3) is a qualified applicant awaiting the examination forlicensure as a pharmacist.
(b) A registration issued under subsection (a) is valid for one (1)year and may be renewed by the board for an additional year until theexpiration date established by the Indiana professional licensingagency under IC 25-1-5-4. (c) An application for registration or renewal must beaccompanied by the appropriate fee and one (1) of the following:
(1) Proof of having obtained the Foreign Pharmacy GraduateExamination Committee Certificate.
(2) Proof of active enrollment in a school of pharmacyaccredited by the American Council of PharmaceuticalEducation.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.187-1999,SEC.3; P.L.182-2003, SEC.2; P.L.98-2006, SEC.4; P.L.1-2006,SEC.462; P.L.1-2007, SEC.179.
IC 25-26-13-10.5
Pharmacist intern practice; supervision
Sec. 10.5. (a) A pharmacy intern may engage in the practice ofpharmacy if the activities are under the direct supervision of apharmacist. The pharmacist in charge is responsible for the activitiesrelating to the practice of pharmacy performed by the pharmacyintern.
(b) A pharmacist shall review in person the prescription drugorder and the dispensed product prepared by a pharmacy internbefore the product is dispensed to the patient or the patient's agent.
As added by P.L.98-2006, SEC.5.
IC 25-26-13-11
Pharmacists; licenses; eligibility; examination
Sec. 11. (a) To be eligible for licensure as a pharmacist, anindividual must file such evidence as is required by the board that:
(1) the individual is at least eighteen (18) years of age;
(2) the individual does not have a conviction for a crime thathas a direct bearing on the individual's ability to practicecompetently;
(3) the individual:
(A) has graduated with a professional degree from a schoolof pharmacy accredited by the American Council ofPharmaceutical Education or the Canadian Council onPharmacy Accreditation and approved by the board; or
(B) has:
(i) graduated with a professional degree from a school ofpharmacy located outside the United States and Canada;and
(ii) met the requirements under subsection (c); and
(4) the individual has satisfactorily completed a pharmacistintern program approved by the board.
(b) An applicant who has graduated with a professional degreefrom a school of pharmacy accredited by the Canadian Council onPharmacy Accreditation and approved by the board must obtain theForeign Pharmacy Graduate Examination Committee Certificateadministered by the National Association of Boards of Pharmacybefore taking the examination required under subsection (d).
(c) An applicant who has graduated with a professional degree
from a school of pharmacy located outside the United States andCanada must do the following:
(1) Provide the board with verification of the applicant'sacademic record and graduation.
(2) Obtain the Foreign Pharmacy Graduate ExaminationCommittee Certificate administered by the National Associationof Boards of Pharmacy.
(d) After filing an application on a form provided by the board,submitting the information required in subsection (a), andsuccessfully completing the examination administered by the board,the applicant may be licensed as a pharmacist.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.189; Acts 1982, P.L.113, SEC.65; P.L.169-1985,SEC.88; P.L.149-1987, SEC.73; P.L.152-1988, SEC.21;P.L.48-1991, SEC.46; P.L.33-1993, SEC.44; P.L.242-1995, SEC.2;P.L.98-2006, SEC.6.
IC 25-26-13-12
Persons licensed in another state
Sec. 12. (a) An individual who is licensed as a pharmacist inanother state where the requirements for licensure were not less thanthose required in this state at the time of original licensure may beissued a license in this state if:
(1) the individual has registered with and been approved by theNational Association of Boards of Pharmacy;
(2) the individual has graduated with a professional degree inpharmacy from a school of pharmacy accredited by theAmerican Council of Pharmaceutical Education or the CanadianCouncil on Pharmacy Accreditation and approved by the board;and
(3) the individual has successfully completed an examinationadministered by the board concerning the federal statutes andregulations and the Indiana statutes and rules governing thepractice of pharmacy.
(b) An individual who has a professional pharmacy degree froma school of pharmacy located outside the United States and Canadaand who is licensed in another state where the requirements forlicensure are substantially the same as those in this state may beissued a license under this chapter if:
(1) the individual has registered with and been approved by theNational Association of Boards of Pharmacy;
(2) the individual has provided the board with proof of theapplicant's:
(A) academic record and graduation with a professionaldegree from a school of pharmacy; and
(B) completion of the requirements for obtaining a ForeignPharmacy Graduate Examination Committee Certificateadministered by the National Association of Boards ofPharmacy; and
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes andregulations and the Indiana statutes and rules governing thepractice of pharmacy.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.169-1985,SEC.89; P.L.156-1986, SEC.2; P.L.149-1987, SEC.74; P.L.33-1993,SEC.45; P.L.242-1995, SEC.3; P.L.288-2001, SEC.2; P.L.98-2006,SEC.7.
IC 25-26-13-12.5
Repealed
(Repealed by P.L.98-2006, SEC.29.)
IC 25-26-13-13
Active and inactive pharmacists
Sec. 13. (a) A person holding a pharmacist license shall beconsidered an active pharmacist if his fees are current and he hascomplied with all continuing education requirements.
(b) Any active pharmacist either by his own choice or by actionof the board after hearing, may be classified as an inactivepharmacist. An inactive pharmacist may maintain his license bypaying his license fees. An inactive pharmacist is exempt from thecontinuing education requirements. A person may not activelyengage in the practice of pharmacy while classified as an inactivepharmacist.
(c) A person classified as an inactive pharmacist may reactivatehis license by meeting current continuing education requirements andsuccessfully demonstrating to the board's satisfaction his ability toactively practice as a pharmacist.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-14
Expiration, renewal, surrender, and reinstatement of pharmacist'slicense
Sec. 14. (a) A pharmacist's license expires biennially on the dateestablished by the licensing agency under IC 25-1-5-4, unlessrenewed before that date.
(b) If an application for renewal is not filed and the required feepaid before the established biennial renewal date, the license expiresand becomes invalid without any action taken by the board.
(c) Subject to IC 25-1-4-3, a statement attesting that thepharmacist has met the continuing education requirements shall besubmitted with the application for license renewal.
(d) If a pharmacist surrenders the pharmacist's license to practicepharmacy in Indiana, the board may subsequently considerreinstatement of the pharmacist's license upon written request of thepharmacist. The board may impose any conditions it considersappropriate to the surrender or to the reinstatement of a surrenderedlicense. The practitioner may not voluntarily surrender thepractitioner's license to the board without the written consent of theboard if any disciplinary proceedings are pending against the
practitioner under this chapter or IC 25-1-9.
(e) If a license has been expired for not more than three (3) years,the board may reinstate the license only if the person meets therequirements under IC 25-1-8-6(c).
(f) If a license has been expired for more than three (3) years, thelicense may be reinstated by the board if the holder of the licensemeets the requirements for reinstatement under IC 25-1-8-6(d).
(g) The board may require a person who applies for a licenseunder subsection (e) to appear before the board and explain thereason the person failed to renew the person's license.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.190; P.L.169-1985, SEC.90; P.L.149-1987, SEC.75;P.L.48-1991, SEC.47; P.L.269-2001, SEC.25; P.L.98-2006, SEC.8;P.L.105-2008, SEC.46.
IC 25-26-13-15
Confidentiality of prescriptions, records, and patient information;disclosure; immunity
Sec. 15. (a) A pharmacist shall hold in strictest confidence allprescriptions, drug orders, records, and patient information. He maydivulge such information only when it is in the best interest of thepatient or when requested by the board or its representatives or by alaw enforcement officer charged with the enforcement of lawspertaining to drugs or devices or the practice of pharmacy.
(b) A person who has knowledge by virtue of his office of anyprescription drug order, record, or patient information may notdivulge such information except in connection with a criminalprosecution or proceeding or a proceeding before the board, to whichthe person to whom the information relates is a party.
(c) A pharmacist or pharmacy is immune from civil liability forany action based on its good faith release of information under thissection.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-16
Pharmacist's professional judgment; honoring and refusal to honorprescriptions; immunity
Sec. 16. (a) A pharmacist shall exercise his professional judgmentin the best interest of the patient's health when engaging in thepractice of pharmacy.
(b) A pharmacist has a duty to honor all prescriptions from apractitioner or from a physician, podiatrist, dentist, or veterinarianlicensed under the laws of another state. Before honoring aprescription, the pharmacist shall take reasonable steps to determinewhether the prescription has been issued in compliance with the lawsof the state where it originated. The pharmacist is immune fromcriminal prosecution or civil liability if he, in good faith, refuses tohonor a prescription because, in his professional judgment, thehonoring of the prescription would:
(1) be contrary to law; (2) be against the best interest of the patient;
(3) aid or abet an addiction or habit; or
(4) be contrary to the health and safety of the patient.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.156-1986,SEC.3.
IC 25-26-13-16.5
Optometrists who may have prescriptions filled
Sec. 16.5. Pharmacists licensed by Indiana may fill prescriptionsof optometrists who are:
(1) licensed by Indiana; and
(2) certified under IC 25-24-3;
for a drug that is included in the formulary adopted underIC 25-24-3-10.
As added by P.L.147-1991, SEC.3. Amended by P.L.157-2006,SEC.66.
IC 25-26-13-17
Classes of pharmacy permits
Sec. 17. (a) The board shall establish classes of pharmacy permitsas follows:
Type I. A retail permit for a pharmacy that providespharmaceutical care to the general public by the dispensing ofa drug or device.
Type II. An institutional permit for hospitals, clinics, healthcare facilities, sanitariums, nursing homes, or dispensaries thatoffer pharmaceutical care by dispensing a drug product to aninpatient under a drug order or to an outpatient of the institutionunder a prescription.
Type III. A permit for a pharmacy that is not:
(A) open to the general public; or
(B) located in an institution listed under a Type II permit;
and provides pharmaceutical care to a patient who is located inan institution or in the patient's home.
Type IV. A permit for a pharmacy not open to the generalpublic that provides pharmaceutical care by dispensing drugsand devices to patients exclusively through the United StatesPostal Services or other parcel delivery service.
Type V. A permit for a pharmacy that engages exclusively inthe preparation and dispensing of diagnostic or therapeuticradioactive drugs.
Type VI. A permit for a pharmacy open to the general publicthat provides pharmaceutical care by engaging in an activityunder a Type I or Type III permit. A pharmacy that obtains aType VI permit may provide services to:
(A) a home health care patient;
(B) a long term care facility; or
(C) a member of the general public.
(b) Hospitals holding a Type II permit may offer drugs or devicesto an employee, student, or medical staff member or their dependents
for their own use.
(c) Nothing in this section prohibits a pharmacy holding a permitother than a Type IV permit from delivering drugs or devices throughmail, parcel delivery, or hand delivery.
(d) Hospitals holding a Type II permit may operate remotelocations within a reasonable distance of the licensed area, asdetermined by the board, after:
(1) filing an application on a form prepared by the board;
(2) having each location inspected by the board; and
(3) obtaining approval from the board.
(e) Any applicable rule governing the practice of pharmacy inIndiana shall apply to all permits under this section.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.149-1987,SEC.76; P.L.147-1991, SEC.4; P.L.98-2006, SEC.9.
IC 25-26-13-18
Eligibility for pharmacy permits; inspections; value of druginventory
Sec. 18. (a) To be eligible for issuance of a pharmacy permit, anapplicant must show to the satisfaction of the board that:
(1) Persons at the location will engage in the bona fide practiceof pharmacy. The application must show the number of hourseach week, if any, that the pharmacy will be open to the generalpublic.
(2) The pharmacy will maintain a sufficient stock of emergencyand frequently prescribed drugs and devices as to adequatelyserve and protect the public health.
(3) Except as provided in section 19 of this chapter, a registeredpharmacist will be in personal attendance and on duty in thelicensed premises at all times when the practice of pharmacy isbeing conducted and that the pharmacist will be responsible forthe lawful conduct of the pharmacy.
(4) One (1) pharmacist will have not more than four (4)certified pharmacy technicians or pharmacy technicians intraining certified under IC 25-26-19 under the pharmacist'simmediate and personal supervision at any time. As used in thisclause, "immediate and personal supervision" means withinreasonable visual and vocal distance of the pharmacist.
(5) The pharmacy will be located separate and apart from anyarea containing merchandise not offered for sale under thepharmacy permit. The pharmacy will:
(A) be stationary;
(B) be sufficiently secure, either through electronic orphysical means, or a combination of both, to protect theproducts contained in the pharmacy and to detect and deterentry during those times when the pharmacy is closed;
(C) be well lighted and ventilated with clean and sanitarysurroundings;
(D) be equipped with a sink with hot and cold running wateror some means for heating water, a proper sewage outlet,
and refrigeration;
(E) have a prescription filling area of sufficient size topermit the practice of pharmacy as practiced at thatparticular pharmacy; and
(F) have such additional fixtures, facilities, and equipmentas the board requires to enable it to operate properly as apharmacy in compliance with federal and state laws andregulations governing pharmacies.
(b) Prior to opening a pharmacy after receipt of a pharmacypermit, the permit holder shall submit the premises to a qualifyinginspection by a representative of the board and shall present aphysical inventory of the drug and all other items in the inventory onthe premises.
(c) At all times, the wholesale value of the drug inventory on thelicensed items must be at least ten percent (10%) of the wholesalevalue of the items in the licensed area.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.3-1990,SEC.90; P.L.27-1998, SEC.1; P.L.187-1999, SEC.4; P.L.251-2003,SEC.2; P.L.1-2009, SEC.142.
IC 25-26-13-19
Retail pharmacies; absence of pharmacist; revocation of privilege
Sec. 19. (a) A pharmacy holding a Type I or Type VI permit maybe open to the general public without a pharmacist on duty if thefollowing conditions are met:
(1) Approval is obtained from the board.
(2) All legend drugs and other merchandise that can only bedispensed by a pharmacist are securely locked or secured by analternative system approved by the board when the pharmacistis absent.
(3) During the pharmacist's absence, a sign at least twenty (20)inches by thirty (30) inches is prominently displayed in theprescription department stating: "Prescription DepartmentClosed, No Pharmacist on Duty".
(4) Only a pharmacist has access to the secured area.
(b) The board may revoke or limit a pharmacy's privilege underthis section after a hearing under IC 4-21.5-3.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.7-1987,SEC.125; P.L.147-1991, SEC.5; P.L.288-2001, SEC.3.
IC 25-26-13-20
Applications for pharmacy permits
Sec. 20. (a) A person desiring to open, establish, operate, ormaintain a pharmacy shall apply to the board for a pharmacy permiton a form provided by the board. The applicant shall set forth:
(1) the name and occupation of the persons desiring the permit;
(2) the location, including street address and city, of thepharmacy;
(3) the name of the pharmacist who will qualify the pharmacyby being responsible to the board for the legal operation of the
pharmacy under the permit; and
(4) such other information as the board may require.
(b) If the applicant desires to open, establish, operate, or maintainmore than one (1) pharmacy, he must file a separate application foreach. Each pharmacy must be qualified by a different pharmacist.
(c) The board shall permit a pharmacist to serve as a qualifyingpharmacist for more than one (1) pharmacy holding a Type IIpharmacy permit upon the holder of the Type II permit showingcircumstances establishing that:
(1) the permit holder has made a reasonable effort, withoutsuccess, to obtain a qualifying pharmacist who is not serving asa qualifying pharmacist at another Type II pharmacy; and
(2) the single pharmacist could effectively fulfill all duties andresponsibilities of the qualifying pharmacist at both locations.
(d) The board shall grant or deny an application for a permit notlater than one hundred twenty (120) days after the application andany additional information required by the board are submitted.
(e) The board may not issue a pharmacy permit to a person whodesires to operate the pharmacy out of a residence.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.169-1985,SEC.91; P.L.270-2001, SEC.3; P.L.98-2006, SEC.10.
IC 25-26-13-21
Transfer of ownership or location of pharmacies
Sec. 21. (a) A pharmacy permit is not transferable as to locationor ownership.
(b) Not later than ten (10) days after the change of ownership ofa pharmacy, an application shall be submitted for transfer ofownership accompanied by a signed and dated certificate of sale. Theoriginal permit remains valid until a new permit is issued or theapplication is rejected by the board. Not later than ten (10) days afternotice of the board's action, the old permit is void and must bereturned immediately by the new owner.
(c) If the holder of a pharmacy permit desires to change thelocation of the pharmacy, he shall file an application on a formprovided by the board for a permit for the new location.
(d) All applications for transfers of ownership or location of apharmacy must be accompanied by the appropriate fee.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.191.
IC 25-26-13-22
Expiration and renewal of pharmacy permits
Sec. 22. (a) A pharmacy permit shall expire biennially on a dateestablished by the agency under IC 25-1-5-4.
(b) If a pharmacy permit lapses for not more than three (3) years,it may be reinstated by the board if the holder of the permit meets therequirements established under IC 25-1-8-6(c).
(c) If a pharmacy permit has been expired for more than three (3)years, the permit may be reinstated by the board if the holder of the
permit meets the requirements for reinstatement underIC 25-1-8-6(d).
(d) No pharmacy may be open for business after the establishedbiennial renewal date until the permit is reinstated.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.192; P.L.169-1985, SEC.92; P.L.105-2008, SEC.47.
IC 25-26-13-23
Fees; fines; license renewal
Sec. 23. (a) The board shall establish appropriate fees to carry outthis chapter.
(b) All fees are nonrefundable. A receipt shall be issued for allfees and fines submitted.
(c) All fees collected under this section shall be transferred to thetreasurer of state and deposited in the general fund of the state.
(d) The board shall adopt rules to establish fines for violation ofan article listed in IC 25-26 or a rule adopted under IC 25-26-13-4,IC 25-26-14-13 or IC 35-48-3-1.
(e) A fine collected by the board shall be transferred to thetreasurer of state and deposited in the state general fund.
(f) No fine established under subsection (d) shall be less thantwenty-five dollars ($25).
(g) At the time of license renewal, each licensed pharmacist shallpay a renewal fee, a part of which shall be used for the rehabilitationof impaired pharmacists. Notwithstanding subsection (c), the lesserof the following amounts from fees collected under this subsectionshall be deposited in the impaired pharmacists account of the stategeneral fund established by section 30 of this chapter:
(1) Sixteen percent (16%) of the license renewal fee for eachlicense renewed under this section.
(2) The amount per license needed to operate the impairedpharmacists program, as determined by the Indiana professionallicensing agency.
As added by Acts 1977, P.L.276, SEC.1. Amended by Acts 1981,P.L.222, SEC.193; P.L.169-1985, SEC.93; P.L.152-1988, SEC.22;P.L.188-1995, SEC.5; P.L.1-2003, SEC.76; P.L.182-2003, SEC.3;P.L.1-2006, SEC.463.
IC 25-26-13-24
Display of permits and licenses
Sec. 24. The pharmacy permit and the licenses of the pharmacistsprimarily employed in the pharmacy shall be prominently displayedin an area where customers at the prescription counter can readily seethem.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-25
Prescriptions; numbering, filing, and inspection; refills; durationof validity; demise of practitioner or patient; resale orredistribution of returned medication Sec. 25. (a) All original prescriptions, whether in written orelectronic format, shall be numbered and maintained in numericaland chronological order, or in a manner approved by the board andaccessible for at least two (2) years in the pharmacy. A prescriptiontransmitted from a practitioner by means of communication otherthan writing must immediately be reduced to writing or recorded inan electronic format by the pharmacist. The files shall be open forinspection to any member of the board or its duly authorized agentor representative.
(b) A prescription may be electronically transmitted from thepractitioner by computer or another electronic device to a pharmacythat is licensed under this article or any other state or territory. Anelectronic data intermediary that is approved by the board:
(1) may transmit the prescription information between theprescribing practitioner and the pharmacy;
(2) may archive copies of the electronic information related tothe transmissions as necessary for auditing and securitypurposes; and
(3) must maintain patient privacy and confidentiality of allarchived information as required by applicable state and federallaws.
(c) Except as provided in subsection (d), a prescription for anydrug, the label of which bears either the legend, "Caution: Federallaw prohibits dispensing without prescription" or "Rx Only", may notbe refilled without written, electronically transmitted, or oralauthorization of a licensed practitioner.
(d) A prescription for any drug, the label of which bears either thelegend, "Caution: Federal law prohibits dispensing withoutprescription" or "Rx Only", may be refilled by a pharmacist one (1)time without the written, electronically transmitted, or oralauthorization of a licensed practitioner if all of the followingconditions are met:
(1) The pharmacist has made every reasonable effort to contactthe original prescribing practitioner or the practitioner'sdesignee for consultation and authorization of the prescriptionrefill.
(2) The pharmacist believes that, under the circumstances,failure to provide a refill would be seriously detrimental to thepatient's health.
(3) The original prescription authorized a refill but a refillwould otherwise be invalid for either of the following reasons:
(A) All of the authorized refills have been dispensed.
(B) The prescription has expired under subsection (g).
(4) The prescription for which the patient requests the refillwas:
(A) originally filled at the pharmacy where the request for arefill is received and the prescription has not beentransferred for refills to another pharmacy at any time; or
(B) filled at or transferred to another location of the samepharmacy or its affiliate owned by the same parent
corporation if the pharmacy filling the prescription has fullaccess to prescription and patient profile information that issimultaneously and continuously updated on the parentcorporation's information system.
(5) The drug is prescribed for continuous and uninterrupted useand the pharmacist determines that the drug is being takenproperly in accordance with IC 25-26-16.
(6) The pharmacist shall document the following informationregarding the refill:
(A) The information required for any refill dispensed undersubsection (e).
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