836-200-0505 Definitions For purposes of OAR 836-200-0500 to 836-200-0560, the following definitions apply, unless the context requires otherwise: (1) “Course of treatment” means the total dosage of a drug that would be prescribed in a single prescription to a patient taking the drug as recommended by its prescribing label as approved by the United States Food and Drug Administration. If there is more than one such recommended dosage, the largest recommended total dosage will be considered for the purposes of determining a course of treatment. (2) “Developed by the manufacturer” means, for a prescription drug, that its research and development costs were funded by the manufacturer in whole or in part through Phase I, II, or III trials as defined in 21 CFR 312.21. (3) “Dosage” is the highest amount, strength, and frequency that a patient would take the drug as recommended by its prescribing label as approved by the United States Food and Drug Administration (such as one 10mg pill per day or one 5mL injection per week). (4) “Inaccurate or incomplete information” means representations or statements that are false or misleading or that fail to provide all available information required in a report or in response to a request for additional information under OAR 836-200-0515 to 836-200-0535. (5) “Net yearly increase” means an increase in the wholesale acquisition cost of a drug over the course of a calendar year dividing the average wholesale acquisition cost of the drug over the course of a calendar year by the average wholesale acquisition cost over the course of the previous calendar year. (6) "New prescription drug" means a prescription drug that has received initial approval under an original new drug application under 21 U.S.C. 355(b), under an abbreviated new drug application under 21 U.S.C. 355(j), or under a biologics license application under 42 U.S.C. 262. In cases where multiple products are included on an application or approved later, each product with a unique national drug code will be considered a new prescription drug. A new prescription drug’s introduction date is the FDA start marketing date or the date the product is first available for purchase in the United States, whichever is later. A new prescription drug does not include: (a) A product that is only for use under an emergency use authorization (EUA). (b) A product with a change in the national drug code or labeler name that has been previously marketed by the same or a different manufacturer. (c) A vaccine that has been reformulated and replaces a vaccine using the same name, application number, manufacturer, and labeler. (7) “One-month supply” means the total dosage of a prescription drug recommended by its prescribing label as approved by the United States Food and Drug Administration for 30 days or for a course of treatment lasting less than one month. (8) “Price” means the wholesale acquisition cost of a prescription drug. (9) “Price increase” means any increase in the wholesale acquisition cost of a prescription drug. (10) “Public funds” means any funds granted, loaned or otherwise provided by a national, state, local or foreign government entity. (11) “Reporting manufacturer” means an entity meeting all the following characteristics: (a) Required to be registered with the Oregon Board of Pharmacy as a drug manufacturer; (b) Engages in the manufacture, directly or indirectly including through contracts with other entities, of prescription drugs available for sale in this state, as defined by ORS 646A.689(1)(d), that are approved by the United States Food and Drug Administration under: (A) A new drug application; (B) An abbreviated new drug application; or (C) A biologics license application. (c) Sets or changes the wholesale acquisition cost of the drugs it manufactures. (d) Does not only manufacture prescription drugs as a registered 503B facility (section 503B of the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. 353b). (12) "Timely" and "timely manner" mean in compliance with the required deadlines for reporting and providing responses to requests for additional information detailed in OAR 826-200-0515 to 826-200-0535. (13) “Wholesale acquisition cost” or “WAC” has the meaning given to the term in 42 U.S.C. 1395w-3a(c)(6)(B). Statutory/Other Authority: ORS 646A.689 Statutes/Other Implemented: ORS 646A.689 History: ID 2-2025, amend filed 03/26/2025, effective 04/01/2025 ID 2-2019, adopt filed 02/26/2019, effective 03/01/2019