OAR 855-183-0001. Applicability

(1) All Division 183 rules apply to sterile and non-sterile compounding of a drug for humans and animals. (2) Entities that are located in or outside Oregon that engage in the practice of compounding a drug for dispensing, delivery or distribution in Oregon must register with the board as a Drug Outlet and comply with board regulations. (3) Entities that are registered with the FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act in 21 USC 353b (03/05/2026) must register with the board as a Manufacturer in OAR 855-060. (4) Compounding does not include: (a) Mixing, reconstituting, or other such acts that are performed in accordance with directions contained in FDA-approved labeling or supplemental materials provided by the product’s manufacturer. (b) Preparing a conventionally manufactured sterile product in accordance with the directions in the manufacturer’s FDA-approved labeling when the: (A) Product is prepared as a single dose for an individual patient; and (B) Labeling includes information for the diluent, the resultant strength, the container closure system and Beyond Use Date. (c) Docking and activation of a proprietary bag and vial system in accordance with the FDA-approved labeling for immediate administration to an individual patient. (d) The addition of flavoring to a drug intended for dispensation if the flavoring: (A) Is inert, nonallergenic and has no effect other than imparting a flavor to the drug or modifying the flavor of the drug; and (B) Does not constitute more than five percent of the total volume of the drug. [Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.]