Manufacturers

Registration requirements

Prescription drug manufacturers that meet the definition of a reporting manufacturer are required to register with the Drug Price Transparency Program and pay an annual assessment to cover program expenses. An entity is a reporting manufacturer, if it meets all of the following:

• Required to register with the Oregon Board of Pharmacy as a drug manufacturer
• Engages in the manufacture, directly or indirectly, of FDA approved prescription drugs available for sale in this state as defined by ORS 646A.689(1)(d)
• Sets or changes the wholesale acquisition cost (WAC) of those drugs

When related entities each meet the definition of a reporting manufacturer, registration requirements may differ. See the Manufacturer User guide or contact us for questions about registering related entities.

iReg system access:

iReg is Oregon's system for manufacturers to submit reports, view correspondence related to reports, provide additional reporting information, view labeler names, and view assessments. An iReg account is created when a reporting manufacturer registers with the program.

Due to the large number of companies registered with the program, we ask that manufacturers manage access for users whenever possible. Every company should have at least one registered user who is a company employee with the appropriate permissions to manage users on the manufacturer's account. There should be at least two different company employees as users or contacts. A user is someone who can view the account information in iReg, submit reports, receive trade secret determinations, and view billing information. A contact is someone who receives notices, such as correspondence or billing notices. It is important to mark all the boxes available to registered contacts in iReg to receive all types of notices. The company is responsible for keeping current user and contact information.

Find instructions on user management in our Manufacturer User Guide. If you have questions or need help, email rx.prices@dcbs.oregon.gov.

iReg reporting system

Submitting drug reports

All reporting manufacturers are required to report on prescription drug price increases and on new prescription drugs that meet the threshold reporting requirements. Do not submit reports that are not required. After reviewing the user guide, let us know if you have questions about whether to submit and what information is required. You can email us at rx.prices@dcbs.oregon.gov.

The Manufacturer User Guide is a resource to help reporting manufacturers comply with the requirements in ORS 646A.680 through 646A.692 and OAR 836-200-0500 through OAR 836-200-0560 for Oregon's Drug Price Transparency Program. The Trade Secret Supplement is a resource to help reporting manufacturers making trade secret claims.

New prescription drug reporting:

• A report is required, within 30 days of introduction, for each prescription drug National Drug Code (NDC) for sale in the U.S. when the price of the NDC exceeds the threshold set by the Centers for Medicare and Medicaid Services in Medicare Part D for a 30-day supply or for a course of treatment lasting less than one month. For new drugs introduced on or after Jan. 1, 2025, the reporting threshold is $950 per OAR 836-200-0505. For new drugs introduced before Jan. 1, 2025 the reporting threshold is $670. Note that a new prescription drug does not include a product with a change in the national drug code or labeler name that has been previously marketed by a different manufacturer.
  

Annual price increase reporting:

A report is required by March 15 for each NDC as indicated in DFR Bulletin No. 2024-3 when the following criteria are met:

• The average price for the calendar year that just ended (reporting year) is compared to the average price for the previous calendar year (comparison year) and the price has increased by 10 percent or more. Here, average price means the weighted average of the WAC prices of the drug package from the calendar year, with each price weighted according to how many days it was in effect. Refer to the user guide for more information.
• The price at any point during the reporting year was $100 or more for a one-month supply, or for a course of treatment lasting less than one month.
  
• There was a patient assistance program available in Oregon for the drug during the reporting year, even if there were no Oregon participants.
• Example 1: A package of Drug A contains a three-month supply of the drug; the average price of the package was $700 for 2022 (comparison year) and $850 for 2023 (reporting year), and there was patient assistance available to Oregonians. The price for a one-month supply of Drug A was higher than $100 in 2023, and the increase of the average price comparing the two years is greater than 10 percent, so a report is required for Drug A by the extended due date of May 15, 2024.
  

Sixty-day notice price increase reporting:

• A report is required 60 days before a price increase for each NDC for a brand-name prescription drug when the planned price increase is 10 percent or more OR the increase is $10,000 or more. This includes any drug sold under a brand name, including drugs that are branded generics or biosimilars.
• Example 2: A brand-name prescription drug's WAC is $500 and there is a plan to increase it to $600. This increase is more than 10 percent, so a report is filed at least 60 days before that price increase.
  
• A report is required 60 days before a price increase for each NDC for a generic prescription drug when the planned price increase is 25 percent or more AND the increase is $300 or more.
• Example 3: A generic prescription drug's WAC is $200 and there is a plan to increase it to $300. This increase is more than 25 percent, but the increase is less than $300, so a report is not required.
  
• There are more examples and information on the report filing requirements in Bulletin No. 2020-12.
• Exceptions: No report is required if the prescription drug is manufactured by four or more companies and meets one of the criteria listed in ORS 646A.683(4).

Biscom access:

We use Biscom to securely communicate information claimed as trade secret when necessary. See the Trade Secret Supplement for more information. When we send communication in Biscom, we will also post a message in iReg correspondence. Those listed as contacts for a manufacturer are automatically notified when a message is posted in iReg if they have Reports and Correspondence notices selected on their contact profile. It is important that users and contacts are up to date and the correct people are receiving the notices. Here are instructions about using Biscom to receive a trade secret determination: external user guide

Billings and collections

Manufacturers owe an assessment each year. Demand to pay notices are sent by email 30 days before the assessment is due to the contacts on the account in iReg. Labeler information, billing details, payment vouchers, and fiscal details can be viewed in iReg.

For billing periods starting on or after Aug. 1, 2023, the manufacturer fees are based on size categories. The size categories are small, medium, and large using the count of NDC package codes for the Food and Drug Administration (FDA) approved prescription drugs listed in the FDA NDC directory during the billing period for the manufacturer:

• Small size category: 10 or fewer NDCs
• Medium size category: 11 to 39 NDCs
• Large size category: 40 or more NDCs 

Exception: For reporting manufacturers where all NDCs used for billing purposes on the account have an FDA market category of ANDA (approved under an abbreviated new drug application) or NDA authorized generic (approved as a new drug application for an authorized generic version of a brand name drug), or are products that are biosimilars where the proprietary and nonproprietary name are the same (approved under a BLA, biologics license application), there is no large size category. In these cases, there are two size categories: medium (40 or more NDCs) and small (39 or fewer NDCs).

Before annual assessments are posted, manufacturers have 30 days to review their initial size category for the upcoming billing period and provide information if they do not agree. During the review period, we will post the size categories for all registered manufacturer accounts active during the billing period and email iReg contacts that their size category is available to review. A request for a change in size category must be received within the 30-day review period. If a request for a change to a manufacturer's size category is not received during the 30-day review period, the size category becomes final. Timely requests are reviewed and contacts are notified of the results.

Some accounts include multiple labeler names and those NDCs are also part of the size category for that account. Billings are based on a calendar year and assessments and demand to pay notices are issued in the spring or early summer after the calendar year has ended.

For those registered prior to Mar. 1, 2025, here is the final size categories list for the 2025 assessments.

Manufacturer size categories for 2025 billing

For all manufacturers who owe the 2025 assessment, including those with a late registration, the amount owed by each manufacturer is based on their size category and those amounts are:

• Large size category: $19,505
• Medium size category: $6,525
• Small size category: $725
  

The 2025 assessments were due June 1, 2025.

Contacts on the account are emailed after assessments are posted in iReg and receive a demand to pay notice 30 days before the due date. 

You can download our Form W-9, if needed. Here is our mailing and physical address for sending payments: 

Refer to “Assessment and collections" in our Manufacturer User Guide. Manufacturer accounts with unpaid billings sent to collections will show a banner message in iReg that states “In Collections" on the blue bar near the top of the page.

 

Questions? Email rx.prices@dcbs.oregon.gov.

Webinars

Note: Some of the information from the 2023 webinar has changed. See the webpage above and user guide for the most up to date information.

Previous webinars