Authority: IC 25-26-13-4

Affected: IC 25-26-13

Sec. 1. (a) This rule establishes the standards and procedures concerning the return of expired legend drugs by an individual or entity licensed to receive legend drugs to either of the following:

1. (1) A drug manufacturer.
2. (2) A designated agent of a drug manufacturer.

(b) This rule does not apply to the following:

1. (1) Vaccines that prevent influenza.
2. (2) Medicine used for the treatment of malignant hyperthermia.
3. (3) Other legend drugs as determined by the board.

(Indiana Board of Pharmacy; 856 IAC 1-38-1; filed Jun 27, 2006, 10:50 a.m.: 20060726-IR-856050138FRA; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA; readopted filed Nov 21, 2018, 8:35 a.m.: 20181219-IR- 856180407RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)