Or. Admin. Code § 855-045-0240

Current through Register Vol. 64, No. 1, January 1, 2025

Section 855-045-0240 - Labeling of Compounded Drugs

In addition to the labeling requirements specified in OAR 855-041, the label of a compounded drug dispensed or distributed must contain the following, at a minimum:

(1) The generic or official name of each active ingredient;

(2) The strength or concentration of each active ingredient, to include primary solution for a sterile parenteral preparation;

(3) The dosage form and route of administration;

(4) Rate of infusion, for a sterile parenteral preparation;

(5) The total quantity of the drug product;

(6) A beyond-use date (BUD), compliant with standards required in OAR 855-045-0200(3); and

(7) Handling, storage or drug specific instructions, cautionary information, and warnings as necessary or appropriate for proper use and patient safety.

Or. Admin. Code § 855-045-0240

PB 5-1987, f. & ef. 5-1-87; PB 12-1989, f. & cert. ef. 8-11-89; BP 7-2005, f. 12-14-05, cert. ef. 12-15-05; Renumbered from 855-041-0063, BP 2-2008, f. & cert. ef. 2-20-08; BP 3-2011, f. & cert. ef. 4-18-11; BP 12-2019, amend filed 12/20/2019, effective 12/20/2019; BP 45-2021, amend filed 12/16/2021, effective 12/16/2021

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155