856 Ind. Admin. Code 3-4-1

Current through October 23, 2024

Section 856 IAC 3-4-1 - Pedigrees; contents

Authority: IC 25-26-14-8.7; IC 25-26-14-13

Affected: IC 25-26-14

Sec. 1.

A pedigree for each legend drug shall contain the following information:

(1) The legend drug proprietary and established name.

(2) The container size of the legend drug.

(3) The number of containers.

(4) The dosage form.

(5) The dosage strength.

(6) Lot/control numbers with expiration dates.

(7) The name of the manufacturer and repackager, if applicable, of the finished legend drug product.

(8) The name, address, and telephone number of each entity involved in the chain of the legend drug's custody.

(9) The name and address of each person certifying delivery or receipt of the legend drug.

(10) The sales invoice number or other number, unique to the shipping document.

(11) The dates of each transaction, including manufacturer, delivery, and receipt.

(12) A certification that each recipient has authenticated the pedigree, back to the manufacturer.

(13) A certification from the licensed entity that the information contained on the pedigree is true.

856 IAC 3-4-1

Indiana Board of Pharmacy; 856 IAC 3-4-1; filed Mar 10, 2006, 8:37 a.m.: 29 IR 2196; readopted filed Nov 9, 2012, 11:23 a.m.: 20121205-IR-856120389RFA