CHAPTER 13. REGULATION OF PHARMACISTS AND PHARMACIES . CREATION OF BOARD
IC 25-26-13
Chapter 13. Regulation of Pharmacists and Pharmacies . Creation
of Board
IC 25-26-13-1
Public interest
Sec. 1. The practice of pharmacy is declared to be a professional
occupation in the state of Indiana, affecting the public health, safety,
and welfare and must be subject to regulation and control in the
public interest by the board of pharmacy. It is further declared to be
a matter of public interest and concern that the practice of pharmacy
merit and receive the confidence of the public and that only qualified
persons 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 through
IC 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 the
body of a person by injection, inhalation, ingestion, or any other
means.
"Board" means the Indiana board of pharmacy.
"Controlled drugs" are those drugs on schedules I through V of
the Federal Controlled Substances Act or on schedules I through V
of IC 35-48-2.
"Counseling" means effective communication between a
pharmacist and a patient concerning the contents, drug to drug
interactions, route, dosage, form, directions for use, precautions, and
effective use of a drug or device to improve the therapeutic outcome
of the patient through the effective use of the drug or device.
"Dispensing" means issuing one (1) or more doses of a drug in a
suitable container with appropriate labeling for subsequent
administration to or use by a patient.
"Drug" means:
(1) articles or substances recognized in the official United
States Pharmacopoeia, official National Formulary, official
Homeopathic Pharmacopoeia of the United States, or any
supplement to any of them;
(2) articles or substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
animals;
(3) articles other than food intended to affect the structure or
any 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 health
care institution for an ultimate user for any drug or device, issued
and signed by a practitioner, or an order transmitted by other means
of communication from a practitioner, which is immediately reduced
to writing by the pharmacist, registered nurse, or other licensed
health care practitioner authorized by the hospital or institution. The
order shall contain the name and bed number of the patient; the name
and strength or size of the drug or device; unless specified by
individual institution policy or guideline, the amount to be dispensed
either in quantity or days; adequate directions for the proper use of
the drug or device when it is administered to the patient; and the
name of the prescriber.
"Drug regimen review" means the retrospective, concurrent, and
prospective review by a pharmacist of a patient's drug related history
that includes the following areas:
(1) Evaluation of prescriptions or drug orders and patient
records for drug allergies, rational therapy contradictions,
appropriate dose and route of administration, appropriate
directions for use, or duplicative therapies.
(2) Evaluation of prescriptions or drug orders and patient
records for drug-drug, drug-food, drug-disease, and
drug-clinical laboratory interactions.
(3) Evaluation of prescriptions or drug orders and patient
records for adverse drug reactions.
(4) Evaluation of prescriptions or drug orders and patient
records for proper utilization and optimal therapeutic outcomes.
"Drug utilization review" means a program designed to measure
and assess on a retrospective and prospective basis the proper use of
drugs.
"Device" means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article 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 other
conditions or the cure, mitigation, treatment, or prevention of
disease in man or other animals; or
(3) intended to affect the structure or any function of the body
of man or other animals and which does not achieve any of its
principal intended purposes through chemical action within or
on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its
principal intended purposes.
"Electronic data intermediary" means an entity that provides the
infrastructure that connects a computer system or another electronic
device used by a prescribing practitioner with a computer system or
another electronic device used by a pharmacy to facilitate the secure
transmission 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, or
process:
(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" means
the transmission of a prescription in electronic form. The term does
not include the transmission of a prescription by facsimile.
"Investigational or new drug" means any drug which is limited by
state or federal law to use under professional supervision of a
practitioner 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 written
certificate from the Indiana board of pharmacy for the practice of
pharmacy or the operation of a pharmacy.
"Nonprescription drug" means a drug that may be sold without a
prescription and that is labeled for use by a patient in accordance
with 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 chapter
expressly 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 pharmacy
while under the personal supervision of a pharmacist and who
is satisfactorily progressing toward meeting the requirements
for licensure as a pharmacist;
(2) a graduate of an approved college of pharmacy or a graduate
who has established educational equivalency by obtaining a
Foreign Pharmacy Graduate Examination Committee Certificate
and who is permitted by the board to obtain practical experience
as a requirement for licensure as a pharmacist;
(3) a qualified applicant awaiting examination for licensure; or
(4) an individual participating in a residency or fellowship
program.
"Pharmacy" means any facility, department, or other place where
prescriptions are filled or compounded and are sold, dispensed,
offered, or displayed for sale and which has as its principal purpose
the dispensing of drug and health supplies intended for the general
health, welfare, and safety of the public, without placing any other
activity on a more important level than the practice of pharmacy.
"The practice of pharmacy" or "the practice of the profession of
pharmacy" means a patient oriented health care profession in which
pharmacists interact with and counsel patients and with other health
care professionals concerning drugs and devices used to enhance
patients' wellness, prevent illness, and optimize the outcome of a
drug or device, by accepting responsibility for performing or
supervising a pharmacist intern or an unlicensed person under
section 18(a)(4) of this chapter to do the following acts, services, and
operations:
(1) The offering of or performing of those acts, service
operations, or transactions incidental to the interpretation,
evaluation, and implementation of prescriptions or drug orders.
(2) The compounding, labeling, administering, dispensing, or
selling of drugs and devices, including radioactive substances,
whether dispensed under a practitioner's prescription or drug
order or sold or given directly to the ultimate consumer.
(3) The proper and safe storage and distribution of drugs and
devices.
(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, as
necessary, as to the contents, therapeutic values, uses,
significant problems, risks, and appropriate manner of use of
drugs and devices.
(6) Assessing, recording, and reporting events related to the use
of drugs or devices.
(7) Provision of the professional acts, professional decisions,
and professional services necessary to maintain all areas of a
patient's pharmacy related care as specifically authorized to a
pharmacist under this article.
"Prescription" means a written order or an order transmitted by
other means of communication from a practitioner to or for an
ultimate 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 or
device;
(4) the amount to be dispensed (unless indicated by directions
and duration of therapy);
(5) adequate directions for the proper use of the drug or device
by 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 the
practitioner.
"Qualifying pharmacist" means the pharmacist who will qualify
the pharmacy by being responsible to the board for the legal
operations of the pharmacy under the permit.
"Record" means all papers, letters, memoranda, notes,
prescriptions, drug orders, invoices, statements, patient medication
charts or files, computerized records, or other written indicia,
documents, or objects which are used in any way in connection with
the 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, or
repackaging;
(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 shall
consist of seven (7) members not more than four (4) of whom may
be from the same political party, appointed by the governor for terms
of four (4) years. One (1) member of the board, to represent the
general public, must be a resident of this state who has never been
associated with pharmacy in any way other than as a consumer.
Except for the member representing the general public, the members
must be pharmacists in good standing of recognized experience and
ability from varied practice settings who hold a current license to
practice pharmacy in Indiana. One (1) member of the board must be
a practicing hospital pharmacist. A person employed as a full-time
staff member or as a professor at a school of pharmacy may not serve
on the board. If a member leaves the board for any reason before the
end of the member's term, the member's successor shall serve for the
unexpired portion of the term.
(b) Not later than ten (10) days after a member's appointment, the
member must subscribe by oath or affirmation to faithfully uphold
the duties of the member's office. If a member fails to qualify as
provided, a new member shall be appointed in the member's place.
(c) At the first meeting of each year the board shall elect from
among its members a president and vice president who shall perform
duties and have powers as the board prescribes.
(d) The board shall meet at least eight (8) times per year at such
times and places as the board selects. At each meeting the board shall
continue in session from day to day, for not more than five (5) days,
until the business of the meeting is complete. Four (4) members of
the board shall constitute a quorum.
(e) Each member of the board is entitled to compensation as
determined by the rules of the budget agency for each day the
member is actually engaged in business of the board, together with
necessary travel and other expenses incurred in the performance of
the member's duties.
(f) Approval by a majority of the quorum is required for any
action 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 for
implementing and enforcing this chapter;
(2) establish requirements and tests to determine the moral,
physical, intellectual, educational, scientific, technical, and
professional qualifications for applicants for pharmacists'
licenses;
(3) refuse to issue, deny, suspend, or revoke a license or permit
or place on probation or fine any licensee or permittee under
this chapter;
(4) regulate the sale of drugs and devices in the state of Indiana;
(5) impound, embargo, confiscate, or otherwise prevent from
disposition any drugs, medicines, chemicals, poisons, or devices
which by inspection are deemed unfit for use or would be
dangerous to the health and welfare of the citizens of the state
of Indiana; the board shall follow those embargo procedures
found in IC 16-42-1-18 through IC 16-42-1-31, and persons may
not refuse to permit or otherwise prevent members of the board
or their representatives from entering such places and making
such inspections;
(6) prescribe minimum standards with respect to physical
characteristics of pharmacies, as may be necessary to the
maintenance of professional surroundings and to the protection
of the safety and welfare of the public;
(7) subject to IC 25-1-7, investigate complaints, subpoena
witnesses, schedule and conduct hearings on behalf of the
public interest on any matter under the jurisdiction of the board;
(8) prescribe the time, place, method, manner, scope, and
subjects of licensing examinations which shall be given at least
twice annually; and
(9) perform such other duties and functions and exercise such
other powers as may be necessary to implement and enforce this
chapter.
(b) The board shall adopt rules under IC 4-22-2 for the following:
(1) Establishing standards for the competent practice of
pharmacy.
(2) Establishing the standards for a pharmacist to counsel
individuals 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 of
expired drugs with; or
(B) is subject to a policy that accepts the return of expired
drugs of;
a wholesaler, manufacturer, or agent of a wholesaler or
manufacturer concerning the return by the pharmacist to the
wholesaler, the manufacturer, or the agent of expired legend
drugs or controlled drugs. In determining the standards and
procedures, the board may not interfere with negotiated terms
related to cost, expenses, or reimbursement charges contained
in contracts between parties, but may consider what is a
reasonable quantity of a drug to be purchased by a pharmacy.
The standards and procedures do not apply to vaccines that
prevent influenza, medicine used for the treatment of malignant
hyperthermia, and other drugs determined by the board to not
be subject to a return policy. An agent of a wholesaler or
manufacturer must be appointed in writing and have policies,
personnel, and facilities to handle properly returns of expired
legend drugs and controlled substances.
(c) The board may grant or deny a temporary variance to a rule it
has adopted if:
(1) the board has adopted rules which set forth the procedures
and standards governing the grant or denial of a temporary
variance; and
(2) the board sets forth in writing the reasons for a grant or
denial of a temporary variance.
(d) The board shall adopt rules and procedures, in consultation
with the medical licensing board, concerning the electronic
transmission of prescriptions. The rules adopted under this
subsection must address the following:
(1) Privacy protection for the practitioner and the practitioner's
patient.
(2) Security of the electronic transmission.
(3) A process for approving electronic data intermediaries for
the electronic transmission of prescriptions.
(4) Use of a practitioner's United States Drug Enforcement
Agency registration number.
(5) Protection of the practitioner from identity theft or
fraudulent use of the practitioner's prescribing authority.
(e) The governor may direct the board to develop:
(1) a prescription drug program that includes the establishment
of criteria to eliminate or significantly reduce prescription
fraud; and
(2) a standard format for an official tamper resistant
prescription drug form for prescriptions (as defined in
IC 16-42-19-7(1)).
The board may adopt rules under IC 4-22-2 necessary to implement
this subsection.
(f) The standard format for a prescription drug form described in
subsection (e)(2) must include the following:
(1) A counterfeit protection bar code with human readable
representation of the data in the bar code.
(2) A thermochromic mark on the front and the back of the
prescription that:
(A) is at least one-fourth (1/4) of one (1) inch in height and
width; and
(B) changes from blue to clear when exposed to heat.
(g) The board may contract with a supplier to implement and
manage the prescription drug program described in subsection (e).
The supplier must:
(1) have been audited by a third party auditor using the SAS 70
audit or an equivalent audit for at least the three (3) previous
years; and
(2) be audited by a third party auditor using the SAS 70 audit or
an 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 substances
advisory committee (IC 35-48-2-1 (before its abolishment)) before
July 1, 2010, shall be treated as rules of the Indiana board of
pharmacy (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 of
information; duties of board designated rehabilitation program
Sec. 4.5. (a) As used in this section, "impaired pharmacist" means
a licensed pharmacist who has been affected by the use or abuse of
alcohol or other drugs.
(b) The board shall assist in the rehabilitation of an impaired or a
licensed pharmacist. The board may:
(1) enter into agreements, provide grants, and make other
arrangements with statewide nonprofit professional
associations, foundations, or entities specifically devoted to the
rehabilitation of impaired health care professionals to identify
and assist impaired pharmacists or licensed pharmacists; and
(2) accept and designate grants, public and private financial
assistance, and licensure fees to fund programs under
subdivision (1).
(c) Except as provided in subsection (e), all:
(1) information furnished to a nonprofit professional
organization or foundation, including interviews, reports,
statements, and memoranda; and
(2) findings, conclusions, or recommendations that result from
a proceeding of a professional organization or foundation;
are privileged and confidential.
(d) The records of a proceeding under subsection (c) may be used
only in the exercise of the proper functions of the board and may not
become public records or be subject to a subpoena or discovery
proceeding.
(e) Information received by the board from the board designated
rehabilitation program for noncompliance by the licensed pharmacist
may be used by the board in any disciplinary or criminal proceedings
instituted against the impaired licensed pharmacist.
(f) The board designated rehabilitation program shall:
(1) immediately report to the board the name and results of any
contact or investigation concerning an impaired licensed
pharmacist that the program believes constitutes an imminent
danger to either the public or the impaired licensed pharmacist;
and
(2) in a timely fashion report to the board an impaired licensed
pharmacist:
(A) who refuses to cooperate with the program;
(B) who refuses to submit to treatment; or
(C) whose impairment is not substantially alleviated through
treatment.
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 the
proceedings of the board. The record shall contain the names and
addresses of all persons who apply to the board for a license or
permit and the action taken on each.
(b) The board shall hire and supervise a sufficient number of
inspector-investigators to enforce the controlled substances law (IC
35-48). Inspector-investigators hired by the board are employees of
the 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 sources
other than the state of Indiana, provided that:
(1) such funds are awarded for the pursuit of a specific
objective which the board is authorized to accomplish by this
chapter, or which the board is qualified to accomplish by reason
of its jurisdiction or professional expertise;
(2) such funds are expended for the pursuit of the objective for
which they are awarded;
(3) activities connected with or occasioned by the expenditures
of such funds do not interfere with or impair the performance
of the board's duties and responsibilities and do not conflict
with the exercise of the board's powers as specified by this
chapter;
(4) such funds are kept in a separate, special account in the state
treasury; and
(5) periodic reports are made to the governor concerning the
board'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, controlled
drugs, legend drugs, and devices and the enforcement of this chapter,
the board shall have the same powers, duties, and functions as
specified 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 pharmacist
intern programs. Such standards shall include, but not be limited to,
the number of hours students must spend in a program, the number
of hours a student must spend in a pharmacy each week, and the
types of duties the student may perform.
(b) The board shall, by regulation, establish standards and
requirements for continuing education and shall endorse those
continuing education programs which meet the standards and
requirements.
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 intern
must furnish proof satisfactory to the board that the applicant:
(1) is actively enrolled in a school of pharmacy accredited by
the American Council of Pharmaceutical Education;
(2) has obtained the Foreign Pharmacy Graduate Examination
Committee Certificate; or
(3) is a qualified applicant awaiting the examination for
licensure 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 the
expiration date established by the Indiana professional licensing
agency under IC 25-1-5-4.
(c) An application for registration or renewal must be
accompanied by the appropriate fee and one (1) of the following:
(1) Proof of having obtained the Foreign Pharmacy Graduate
Examination Committee Certificate.
(2) Proof of active enrollment in a school of pharmacy
accredited by the American Council of Pharmaceutical
Education.
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 of
pharmacy if the activities are under the direct supervision of a
pharmacist. The pharmacist in charge is responsible for the activities
relating to the practice of pharmacy performed by the pharmacy
intern.
(b) A pharmacist shall review in person the prescription drug
order and the dispensed product prepared by a pharmacy intern
before 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, an
individual 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 that
has a direct bearing on the individual's ability to practice
competently;
(3) the individual:
(A) has graduated with a professional degree from a school
of pharmacy accredited by the American Council of
Pharmaceutical Education or the Canadian Council on
Pharmacy Accreditation and approved by the board; or
(B) has:
(i) graduated with a professional degree from a school of
pharmacy located outside the United States and Canada;
and
(ii) met the requirements under subsection (c); and
(4) the individual has satisfactorily completed a pharmacist
intern program approved by the board.
(b) An applicant who has graduated with a professional degree
from a school of pharmacy accredited by the Canadian Council on
Pharmacy Accreditation and approved by the board must obtain the
Foreign Pharmacy Graduate Examination Committee Certificate
administered by the National Association of Boards of Pharmacy
before 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 and
Canada must do the following:
(1) Provide the board with verification of the applicant's
academic record and graduation.
(2) Obtain the Foreign Pharmacy Graduate Examination
Committee Certificate administered by the National Association
of Boards of Pharmacy.
(d) After filing an application on a form provided by the board,
submitting the information required in subsection (a), and
successfully 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 in
another state where the requirements for licensure were not less than
those required in this state at the time of original licensure may be
issued a license in this state if:
(1) the individual has registered with and been approved by the
National Association of Boards of Pharmacy;
(2) the individual has graduated with a professional degree in
pharmacy from a school of pharmacy accredited by the
American Council of Pharmaceutical Education or the Canadian
Council on Pharmacy Accreditation and approved by the board;
and
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes and
regulations and the Indiana statutes and rules governing the
practice of pharmacy.
(b) An individual who has a professional pharmacy degree from
a school of pharmacy located outside the United States and Canada
and who is licensed in another state where the requirements for
licensure are substantially the same as those in this state may be
issued a license under this chapter if:
(1) the individual has registered with and been approved by the
National Association of Boards of Pharmacy;
(2) the individual has provided the board with proof of the
applicant's:
(A) academic record and graduation with a professional
degree from a school of pharmacy; and
(B) completion of the requirements for obtaining a Foreign
Pharmacy Graduate Examination Committee Certificate
administered by the National Association of Boards of
Pharmacy; and
(3) the individual has successfully completed an examination
administered by the board concerning the federal statutes and
regulations and the Indiana statutes and rules governing the
practice 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 be
considered an active pharmacist if his fees are current and he has
complied with all continuing education requirements.
(b) Any active pharmacist either by his own choice or by action
of the board after hearing, may be classified as an inactive
pharmacist. An inactive pharmacist may maintain his license by
paying his license fees. An inactive pharmacist is exempt from the
continuing education requirements. A person may not actively
engage in the practice of pharmacy while classified as an inactive
pharmacist.
(c) A person classified as an inactive pharmacist may reactivate
his license by meeting current continuing education requirements and
successfully demonstrating to the board's satisfaction his ability to
actively 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's
license
Sec. 14. (a) A pharmacist's license expires biennially on the date
established by the licensing agency under IC 25-1-5-4, unless
renewed before that date.
(b) If an application for renewal is not filed and the required fee
paid before the established biennial renewal date, the license expires
and becomes invalid without any action taken by the board.
(c) Subject to IC 25-1-4-3, a statement attesting that the
pharmacist has met the continuing education requirements shall be
submitted with the application for license renewal.
(d) If a pharmacist surrenders the pharmacist's license to practice
pharmacy in Indiana, the board may subsequently consider
reinstatement of the pharmacist's license upon written request of the
pharmacist. The board may impose any conditions it considers
appropriate to the surrender or to the reinstatement of a surrendered
license. The practitioner may not voluntarily surrender the
practitioner's license to the board without the written consent of the
board 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 the
requirements under IC 25-1-8-6(c).
(f) If a license has been expired for more than three (3) years, the
license may be reinstated by the board if the holder of the license
meets the requirements for reinstatement under IC 25-1-8-6(d).
(g) The board may require a person who applies for a license
under subsection (e) to appear before the board and explain the
reason 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 all
prescriptions, drug orders, records, and patient information. He may
divulge such information only when it is in the best interest of the
patient or when requested by the board or its representatives or by a
law enforcement officer charged with the enforcement of laws
pertaining to drugs or devices or the practice of pharmacy.
(b) A person who has knowledge by virtue of his office of any
prescription drug order, record, or patient information may not
divulge such information except in connection with a criminal
prosecution or proceeding or a proceeding before the board, to which
the person to whom the information relates is a party.
(c) A pharmacist or pharmacy is immune from civil liability for
any action based on its good faith release of information under this
section.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-16
Pharmacist's professional judgment; honoring and refusal to honor
prescriptions; immunity
Sec. 16. (a) A pharmacist shall exercise his professional judgment
in the best interest of the patient's health when engaging in the
practice of pharmacy.
(b) A pharmacist has a duty to honor all prescriptions from a
practitioner or from a physician, podiatrist, dentist, or veterinarian
licensed under the laws of another state. Before honoring a
prescription, the pharmacist shall take reasonable steps to determine
whether the prescription has been issued in compliance with the laws
of the state where it originated. The pharmacist is immune from
criminal prosecution or civil liability if he, in good faith, refuses to
honor a prescription because, in his professional judgment, the
honoring 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 prescriptions
of 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 under
IC 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 permits
as follows:
Type I. A retail permit for a pharmacy that provides
pharmaceutical care to the general public by the dispensing of
a drug or device.
Type II. An institutional permit for hospitals, clinics, health
care facilities, sanitariums, nursing homes, or dispensaries that
offer pharmaceutical care by dispensing a drug product to an
inpatient under a drug order or to an outpatient of the institution
under 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 in
an institution or in the patient's home.
Type IV. A permit for a pharmacy not open to the general
public that provides pharmaceutical care by dispensing drugs
and devices to patients exclusively through the United States
Postal Services or other parcel delivery service.
Type V. A permit for a pharmacy that engages exclusively in
the preparation and dispensing of diagnostic or therapeutic
radioactive drugs.
Type VI. A permit for a pharmacy open to the general public
that provides pharmaceutical care by engaging in an activity
under a Type I or Type III permit. A pharmacy that obtains a
Type 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 devices
to an employee, student, or medical staff member or their dependents
for their own use.
(c) Nothing in this section prohibits a pharmacy holding a permit
other than a Type IV permit from delivering drugs or devices through
mail, parcel delivery, or hand delivery.
(d) Hospitals holding a Type II permit may operate remote
locations within a reasonable distance of the licensed area, as
determined 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 in
Indiana 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 drug
inventory
Sec. 18. (a) To be eligible for issuance of a pharmacy permit, an
applicant must show to the satisfaction of the board that:
(1) Persons at the location will engage in the bona fide practice
of pharmacy. The application must show the number of hours
each week, if any, that the pharmacy will be open to the general
public.
(2) The pharmacy will maintain a sufficient stock of emergency
and frequently prescribed drugs and devices as to adequately
serve and protect the public health.
(3) Except as provided in section 19 of this chapter, a registered
pharmacist will be in personal attendance and on duty in the
licensed premises at all times when the practice of pharmacy is
being conducted and that the pharmacist will be responsible for
the lawful conduct of the pharmacy.
(4) One (1) pharmacist will have not more than four (4)
certified pharmacy technicians or pharmacy technicians in
training certified under IC 25-26-19 under the pharmacist's
immediate and personal supervision at any time. As used in this
clause, "immediate and personal supervision" means within
reasonable visual and vocal distance of the pharmacist.
(5) The pharmacy will be located separate and apart from any
area containing merchandise not offered for sale under the
pharmacy permit. The pharmacy will:
(A) be stationary;
(B) be sufficiently secure, either through electronic or
physical means, or a combination of both, to protect the
products contained in the pharmacy and to detect and deter
entry during those times when the pharmacy is closed;
(C) be well lighted and ventilated with clean and sanitary
surroundings;
(D) be equipped with a sink with hot and cold running water
or some means for heating water, a proper sewage outlet,
and refrigeration;
(E) have a prescription filling area of sufficient size to
permit the practice of pharmacy as practiced at that
particular pharmacy; and
(F) have such additional fixtures, facilities, and equipment
as the board requires to enable it to operate properly as a
pharmacy in compliance with federal and state laws and
regulations governing pharmacies.
(b) Prior to opening a pharmacy after receipt of a pharmacy
permit, the permit holder shall submit the premises to a qualifying
inspection by a representative of the board and shall present a
physical inventory of the drug and all other items in the inventory on
the premises.
(c) At all times, the wholesale value of the drug inventory on the
licensed items must be at least ten percent (10%) of the wholesale
value 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 may
be open to the general public without a pharmacist on duty if the
following conditions are met:
(1) Approval is obtained from the board.
(2) All legend drugs and other merchandise that can only be
dispensed by a pharmacist are securely locked or secured by an
alternative system approved by the board when the pharmacist
is absent.
(3) During the pharmacist's absence, a sign at least twenty (20)
inches by thirty (30) inches is prominently displayed in the
prescription department stating: "Prescription Department
Closed, 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 under
this 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, or
maintain a pharmacy shall apply to the board for a pharmacy permit
on 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 the
pharmacy;
(3) the name of the pharmacist who will qualify the pharmacy
by 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 maintain
more than one (1) pharmacy, he must file a separate application for
each. Each pharmacy must be qualified by a different pharmacist.
(c) The board shall permit a pharmacist to serve as a qualifying
pharmacist for more than one (1) pharmacy holding a Type II
pharmacy permit upon the holder of the Type II permit showing
circumstances establishing that:
(1) the permit holder has made a reasonable effort, without
success, to obtain a qualifying pharmacist who is not serving as
a qualifying pharmacist at another Type II pharmacy; and
(2) the single pharmacist could effectively fulfill all duties and
responsibilities of the qualifying pharmacist at both locations.
(d) The board shall grant or deny an application for a permit not
later than one hundred twenty (120) days after the application and
any additional information required by the board are submitted.
(e) The board may not issue a pharmacy permit to a person who
desires 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 location
or ownership.
(b) Not later than ten (10) days after the change of ownership of
a pharmacy, an application shall be submitted for transfer of
ownership accompanied by a signed and dated certificate of sale. The
original permit remains valid until a new permit is issued or the
application is rejected by the board. Not later than ten (10) days after
notice of the board's action, the old permit is void and must be
returned immediately by the new owner.
(c) If the holder of a pharmacy permit desires to change the
location of the pharmacy, he shall file an application on a form
provided by the board for a permit for the new location.
(d) All applications for transfers of ownership or location of a
pharmacy 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 date
established 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 the
requirements 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 under
IC 25-1-8-6(d).
(d) No pharmacy may be open for business after the established
biennial 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 out
this chapter.
(b) All fees are nonrefundable. A receipt shall be issued for all
fees and fines submitted.
(c) All fees collected under this section shall be transferred to the
treasurer of state and deposited in the general fund of the state.
(d) The board shall adopt rules to establish fines for violation of
an 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 the
treasurer of state and deposited in the state general fund.
(f) No fine established under subsection (d) shall be less than
twenty-five dollars ($25).
(g) At the time of license renewal, each licensed pharmacist shall
pay a renewal fee, a part of which shall be used for the rehabilitation
of impaired pharmacists. Notwithstanding subsection (c), the lesser
of the following amounts from fees collected under this subsection
shall be deposited in the impaired pharmacists account of the state
general fund established by section 30 of this chapter:
(1) Sixteen percent (16%) of the license renewal fee for each
license renewed under this section.
(2) The amount per license needed to operate the impaired
pharmacists program, as determined by the Indiana professional
licensing 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 pharmacists
primarily employed in the pharmacy shall be prominently displayed
in an area where customers at the prescription counter can readily see
them.
As added by Acts 1977, P.L.276, SEC.1.
IC 25-26-13-25
Prescriptions; numbering, filing, and inspection; refills; duration
of validity; demise of practitioner or patient; resale or
redistribution of returned medication
Sec. 25. (a) All original prescriptions, whether in written or
electronic format, shall be numbered and maintained in numerical
and chronological order, or in a manner approved by the board and
accessible for at least two (2) years in the pharmacy. A prescription
transmitted from a practitioner by means of communication other
than writing must immediately be reduced to writing or recorded in
an electronic format by the pharmacist. The files shall be open for
inspection to any member of the board or its duly authorized agent
or representative.
(b) A prescription may be electronically transmitted from the
practitioner by computer or another electronic device to a pharmacy
that is licensed under this article or any other state or territory. An
electronic data intermediary that is approved by the board:
(1) may transmit the prescription information between the
prescribing practitioner and the pharmacy;
(2) may archive copies of the electronic information related to
the transmissions as necessary for auditing and security
purposes; and
(3) must maintain patient privacy and confidentiality of all
archived information as required by applicable state and federal
laws.
(c) Except as provided in subsection (d), a prescription for any
drug, the label of which bears either the legend, "Caution: Federal
law prohibits dispensing without prescription" or "Rx Only", may not
be refilled without written, electronically transmitted, or oral
authorization of a licensed practitioner.
(d) A prescription for any drug, the label of which bears either the
legend, "Caution: Federal law prohibits dispensing without
prescription" or "Rx Only", may be refilled by a pharmacist one (1)
time without the written, electronically transmitted, or oral
authorization of a licensed practitioner if all of the following
conditions are met:
(1) The pharmacist has made every reasonable effort to contact
the original prescribing practitioner or the practitioner's
designee for consultation and authorization of the prescription
refill.
(2) The pharmacist believes that, under the circumstances,
failure to provide a refill would be seriously detrimental to the
patient's health.
(3) The original prescription authorized a refill but a refill
would 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 refill
was:
(A) originally filled at the pharmacy where the request for a
refill is received and the prescription has not been
transferred for refills to another pharmacy at any time; or
(B) filled at or transferred to another location of the same
pharmacy or its affiliate owned by the same parent
corporation if the pharmacy filling the prescription has full
access to prescription and patient profile information that is
simultaneously and continuously updated on the parent
corporation's information system.
(5) The drug is prescribed for continuous and uninterrupted use
and the pharmacist determines that the drug is being taken
properly in accordance with IC 25-26-16.
(6) The pharmacist shall document the following information
regarding the refill:
(A) The information required for any refill dispensed under
subsection (e).
&nb