OAR 836-200-0505
Definitions


For purposes of 836-200-0500 (Purpose and Statutory Authority) to 836-200-0560 (Civil Penalties), 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 (Threshold for Reporting Drug Price Increase) to 836-200-0535 (Additional Information Requests).
(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.
(14) “Wholesale acquisition cost” has the meaning given the term in 42 U.S.C. 1395w-3a(c)(6)(B).
836–200–0000
Statutory Authority
836–200–0010
Assessments
836–200–0020
Filing Procedures
836–200–0030
Form 10 K and Other Financial Stability Filings
836–200–0040
Reimbursement Insurance Policy
836–200–0050
Registration Requirements Not Exclusive
836–200–0055
Annual Report
836–200–0060
Service on Registrant
836–200–0100
Notice, Collision Damage Waivers
836–200–0105
Statutory Authority
836–200–0110
Registration Procedures
836–200–0120
Warranty
836–200–0130
Reimbursement Insurance Policy
836–200–0140
Registration Requirements Not Exclusive
836–200–0200
License, Discount Medical Plan Organization
836–200–0210
Renewal of expired license
836–200–0215
One-time processing fee, cancelled application
836–200–0220
License Requirement Not Exclusive
836–200–0250
Purpose and Authority
836–200–0255
Registration of Contracting Entity
836–200–0300
Statement of Purpose
836–200–0305
Retainer Medical Practice Application for Certification
836–200–0310
Retainer Medical Practice Application for Renewal
836–200–0315
Disclosures
836–200–0401
Statement of Purpose
836–200–0406
Application Requirements for Pharmacy Benefit Manager
836–200–0411
Renewal of Pharmacy Benefit Registration
836–200–0416
Registration Requirements Not Exclusive
836–200–0421
Service on Registrant
836–200–0436
Submission of Complaints
836–200–0440
Market Conduct Requirements for Pharmacy Benefit Managers
836–200–0500
Purpose and Statutory Authority
836–200–0505
Definitions
836–200–0510
Account Generation Requirement
836–200–0515
Threshold for Reporting Drug Price Increase
836–200–0520
Threshold for Reporting New Specialty Drug
836–200–0525
Expectations of Reporting Manufacturers
836–200–0530
Form and Manner Requirements for Drug Pricing Reporting
836–200–0535
Additional Information Requests
836–200–0540
Information Claimed to be Trade Secret
836–200–0545
Public Disclosure of Prescription Drug Manufacturer Filings
836–200–0550
Consumer Notices to the Department
836–200–0555
Assessments Against Prescription Drug Manufacturers
836–200–0560
Civil Penalties
Last Updated

Jun. 8, 2021

Rule 836-200-0505’s source at or​.us