Indiana § 25-26-14-17.2 For cause authentication

Indiana Statutes

§ 25-26-14-17.2 — For cause authentication

Indiana § 25-26-14-17.2

Title 25PROFESSIONS AND OCCUPATIONS

Art. 26PHARMACISTS, PHARMACIES, DRUG STORES

Ch. 14Wholesale Legend Drug Distributors and Third Party

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Bluebook

Ind. Code § 25-26-14-17.2 (2026).

Text

2.

(a)A wholesale drug distributor that purchases legend drugs from another wholesale drug distributor and has reason to believe that a legend drug purchased from the other wholesale drug distributor is counterfeit, suspected counterfeit, misbranded, or adulterated shall conduct a for cause authentication of each distribution of the legend drug back to the manufacturer.

(b)A wholesale drug distributor that has engaged in the distribution of a legend drug for which a purchasing wholesale drug distributor conducts a for cause authentication under subsection (a) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:

(1)date of purchase of the legend drug;

(2)lot number of the legend drug;

(3)sales invoice number of the legend drug;

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2. (a) A wholesale drug distributor that
purchases legend drugs from another wholesale drug distributor and
has reason to believe that a legend drug purchased from the other
wholesale drug distributor is counterfeit, suspected counterfeit,
misbranded, or adulterated shall conduct a for cause authentication of
each distribution of the legend drug back to the manufacturer.
(b) A wholesale drug distributor that has engaged in the distribution
of a legend drug for which a purchasing wholesale drug distributor
conducts a for cause authentication under subsection (a) shall provide,
upon request, detailed information regarding the distribution of the
legend drug, including the:
(1) date of purchase of the legend drug;
(2) lot number of the legend drug;
(3) sales invoice number of the legend drug; and
(4) contact information, including name, address, telephone
number, and electronic mail address of the wholesale drug
distributor that sold the legend drug.
(c) If a wholesale drug distributor conducts a for cause
authentication under subsection (a) and is unable to authenticate each
distribution of the legend drug, the wholesale drug distributor shall
quarantine the legend drug and report the circumstances to the board
and the federal Food and Drug Administration, if applicable, not more
than ten (10) business days after completing the attempted
authentication.
(d) If a wholesale drug distributor authenticates the distribution of
a legend drug back to the manufacturer under subsection (a), the
wholesale drug distributor shall maintain records of the authentication
for three (3) years and shall produce the records for the board and the
federal Food and Drug Administration upon request.