2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 3. Uniform Food, Drug, and Cosmetic Act: Adulteration and Misbranding of Drugs or Devices › 16-42-3-6. Drugs Dispensed on Prescription

Sec. 6. (a) This section applies to a drug intended for use by humans that:
(1) is a habit forming drug to which section 4(4) of this chapter applies;
(2) because of:
(A) the drug's toxicity or other potential for harmful effect;
(B) the method of the drug's use; or
(C) the collateral measures necessary to the drug's use;
is not safe for use except under the supervision of a practitioner licensed by law to administer the drug; or
(3) is limited by an approved application under Section 505 of the Federal Act or section 7 or 8 of this chapter to use under the professional supervision of a practitioner licensed by law to administer the drug.
(b) A drug described in subsection (a) may be dispensed only:
(1) upon a written or an electronically transmitted prescription of a practitioner licensed by law to administer the drug;
(2) upon an oral prescription of the practitioner that is reduced promptly to writing and filed by the pharmacist or pharmacist intern (as defined in IC 25-26-13-2); or
(3) by refilling a prescription if the refilling is authorized by the prescriber either in the original prescription, by an electronically transmitted order that is recorded in an electronic format, or by oral order that is reduced promptly to writing or is entered into an electronic format and filed by the pharmacist or pharmacist intern (as defined in IC 25-26-13-2).
(c) If a prescription for a drug described in subsection (a) does not indicate how many times the prescription may be refilled, if any, the prescription may not be refilled unless the pharmacist is subsequently authorized to do so by the practitioner.
(d) The act of dispensing a drug contrary to subsection (a), (b), or (c) is considered to be an act that results in a drug being misbranded while held for sale.
(e) A drug dispensed by filling or refilling a prescription of a practitioner licensed by law to administer the drug is exempt from the requirements of section 4(2), 4(3), 4(4), 4(5), 4(6), 4(7), 4(8), and 4(9) of this chapter if the drug bears a label containing the following:
(1) The name and address of the dispenser.
(2) The serial number and date of the prescription or of the prescription's filling.
(3) The name of the drug's prescriber and, if stated in the prescription, the name of the patient.
(4) The directions for use and cautionary statements, if any, contained in the prescription.
This exemption does not apply to any drugs dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of subsection (a), (b), (c), or (d).
(f) The state department may adopt rules to remove drugs subject to section 4(4) of this chapter, section 7 of this chapter, or section 8 of this chapter from the requirements of subsections (a) through (d) when the requirements are not necessary for the protection of public health. Drugs removed from the prescription requirements of the Federal Act by regulations issued under the Federal Act may also, by rules adopted by the state department, be removed from the requirement of subsections (a) through (d).
(g) A drug that is subject to subsections (a) through (d) is considered to be misbranded if at any time before dispensing the drug's label fails to bear the statement "Caution: Federal Law Prohibits Dispensing Without Prescription" or "Caution: State Law Prohibits Dispensing Without Prescription". A drug to which subsections (a) through (d) do not apply is considered to be misbranded if, at any time before dispensing, the drug's label bears the caution statement described in this subsection.
(h) This section does not relieve a person from a requirement prescribed by or under authority of law with respect to drugs included within the classifications of narcotic drugs or marijuana as defined in the applicable federal and state laws relating to narcotic drugs and marijuana.
(i) A drug may be dispensed under subsection (b) upon an electronically transmitted prescription only to the extent permitted by federal law.
[Pre-1993 Recodification Citation: 16-1-30-15 part.]
As added by P.L.2-1993, SEC.25. Amended by P.L.144-1996, SEC.12; P.L.204-2005, SEC.4.