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

Indiana Statutes

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

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

(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 subse

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(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.

Indiana § 16-42-19-30 (Investigation of suspected legend drugs; records) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.