OAR 855-045-0240
Labeling


In addition to the labeling requirements specified in Division 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 BUD, compliant with current USP standards; and
(7) Handling, storage or drug specific instructions, cautionary information, and warnings as necessary or appropriate for proper use and patient safety.
Last Updated

Jun. 8, 2021

Rule 855-045-0240’s source at or​.us