Oregon Administrative Rules › Chapter 836 - DEPARTMENT OF CONSUMER AND BUSINESS SERVICES, INSURANCE REGULATION › Division 200 - DEPARTMENT REGULATORY PROGRAMS › Section 836-200-0505 - Definitions

Current through Register Vol. 63, No. 7, July 1, 2024
For purposes of 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
			 federal 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) "Inaccurate information" means false or
			 misleading representations or statements.
(4) "Incomplete information" means
			 representations or statements 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,
			 calculated by 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, each product will be considered a new prescription
			 drug. A new prescription drug's introduction date is the date of its market
			 entry.
(7) "One-month supply" means
			 the total daily dosage units of a prescription drug recommended by its
			 prescribing label as approved by the federal Food and Drug Administration for
			 30 days. If there is more than one such recommended daily dosage, the largest
			 recommended daily dosage will be considered for the purposes of determining a
			 one-month supply.
(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:
(a) Required to
			 be registered with the Oregon Board of Pharmacy as a drug
			 manufacturer;
(b) That engages in
			 the manufacture of prescription drugs as defined by 2018 Or Laws ch 7;
			 and
(c) That sets or changes the
			 wholesale acquisition cost of the drugs it manufacturers.