OAR 855-183-0005: Definitions

(1) Phrases or definitions used in OAR 855-183 are the same as provided in OAR 855-006, or as included in the USP standard adopted by reference unless otherwise specified. (2) “Compounding Area” means a location designated by the registrant that limits personnel access when activities and items related to compounding may occur. (3) “Compounding” means the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug product or bulk drug substance in accordance with a licensed practitioner’s prescription drug order for a patient specific prescription. Compounding includes the following: (a) Preparation of drug dosage forms for both human and animal patients; (b) Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing or ordering patterns; (c) For sterile preparations, compounding includes repackaging; and (d) Manipulation of commercial products for patient-specific needs beyond FDA-approved labeling. [Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.]