§ 25-26-13-4 — Powers and duties of board; prescription drug form program

Indiana § 25-26-13-4

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 26: PHARMACISTS, PHARMACIES, DRUG STORES
• Ch. 13: Regulation of Pharmacists and Pharmacies ─ Creation

Text

(a) The board may:
(1) adopt rules 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.
(h) The board shall adopt rules under IC 4-22-2 concerning:
(1) professional determinations made under IC 35-48-4-14.7(d);
and
(2) the determination of a relationship on record with the
pharmacy under IC 35-48-4-14.7.
(i) The board may:
(1) review professional determinations made by a pharmacist; and
(2) take appropriate disciplinary action against a pharmacist who
violates a rule adopted under subsection (h) concerning a
professional determination made;
under IC 35-48-4-14.7 concerning the sale of ephedrine and
pseudoephedrine.
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; P.L.4-2016, SEC.1; P.L.5-2016, SEC.1;
P.L.93-2024, SEC.186.