Sec. 4. (a) The board may:

(1) adopt rules under IC 4-22-2 for implementing and enforcing this chapter;

Terms Used In Indiana Code 25-26-13-4

  • Board: means the Indiana board of pharmacy. See Indiana Code 25-26-13-2
  • Contract: A legal written agreement that becomes binding when signed.
  • Drug: means :

    Indiana Code 25-26-13-2

  • electronic transmission: means the transmission of a prescription in electronic form. See Indiana Code 25-26-13-2
  • Fraud: Intentional deception resulting in injury to another.
  • in writing: include printing, lithographing, or other mode of representing words and letters. See Indiana Code 1-1-4-5
  • Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
  • Pharmacist: means a person licensed under this chapter. See Indiana Code 25-26-13-2
  • 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. See Indiana Code 25-26-13-2
  • Practitioner: has the meaning set forth in IC 16-42-19-5. See Indiana Code 25-26-13-2
  • 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:

    Indiana Code 25-26-13-2

  • Probation: A sentencing alternative to imprisonment in which the court releases convicted defendants under supervision as long as certain conditions are observed.
  • 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. See Indiana Code 25-26-13-2
  • Sale: means every sale and includes:

    Indiana Code 25-26-13-2

  • Subpoena: A command to a witness to appear and give testimony.
  • United States: includes the District of Columbia and the commonwealths, possessions, states in free association with the United States, and the territories. See Indiana Code 1-1-4-5
(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, or emergency rules in the manner provided under IC 4-22-2-37.1 that take effect on July 1, 2016, 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.