§ 16-42-19-30 — Investigation of suspected legend drugs; records

Indiana § 16-42-19-30

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 19: Drugs: Indiana Legend Drug Act

Text

(a) Sections 16 and 20 of this chapter do
not apply to the actions of a:
(1) person who is employed or retained as an investigator by a
pharmaceutical manufacturer described in subdivision (3);
(2) practitioner; or
(3) pharmaceutical manufacturer that is approved by the federal
Food and Drug Administration;
performed in an investigation of a pharmaceutical manufacturer's
legend drug that is suspected of being counterfeited, adulterated, or
misbranded.
(b) A drug sample collected during an investigation described in
subsection (a) may only be used for testing or a civil or criminal action.
A drug sample collected during an investigation may not be resold or
provided for human consumption.
(c) A pharmaceutical manufacturer that collects drug samples
during an investigation described in subsection (a) shall:
(1) maintain records of the drug samples; and
(2) make these records available, at a reasonable time, to law
enforcement agencies or the agencies' representatives in the
enforcement of this chapter.

Legislative History

As added by P.L.48-2015, SEC.4.