Or. Admin. Code § 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).
Notes
Statutory/Other Authority: ORS 646A.689
Statutes/Other Implemented: ORS 646A.689
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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.
(12) "The threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program" means $670, which is the dollar amount specified for minimum Part D specialty tier eligibility in the 2018 Final Call Letter from the Centers for Medicare and Medicaid Services.
(13) "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.
Notes
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7