856 Ind. Admin. Code 3-5-1

Current through November 6, 2024
Section 856 IAC 3-5-1 - Authorized distributor to authorized distributor transaction; pedigree requirement

Authority: IC 25-26-14-8.5; IC 25-26-14-13

Affected: IC 25-26-14-17

Sec. 1.

For purposes of IC 25-26-14 and this article, within the normal distribution chain of custody, an authorized distributor that receives a legend drug directly from the manufacturer, or from the manufacturer's third party logistics provider, may sell the legend drug to a pharmacy, chain drug warehouse, or practitioner or one (1) other authorized distributor of the manufacturer that sells the legend drug directly to a pharmacy, chain drug warehouse, or practitioner without passing a pedigree if the invoice or accompanying document for the transaction includes a statement that the product was purchased directly from:

(1) the manufacturer; or
(2) an authorized distributor of the manufacturer who purchased the product direct from the manufacturer.

856 IAC 3-5-1

Indiana Board of Pharmacy; 856 IAC 3-5-1; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2197; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA