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Drug Compounding

Laws and Rules

​The Oregon Board of Pharmacy Division 045 regulations related to drug compounding are currently under review and revision. Please check back regularly for notifications and updates.

October 2019: The Board discussed the comments received at the 9/24/2019 rulemaking hearing and made revisions to the language. The Board voted to send revised proposed rules to a hearing scheduled for 11/26/2019.

September 2019: 9/24/2019 Rulemaking hearing report​ available.

August 2019: The Board reviewed revisions to Division 045​ and shared pharmacy services. The Board voted to send the proposed rules to the 9/24/19 rulemaking hearing​

June 2019: The Board plans to take a third look at proposed revisions to Division 045 at the August 2019 meeting and will consider sending the proposed rules to September 24, 2019 rulemaking hearing, for potential final adoption in October 2019.

May 2019: The Division 045 – Drug Compounding Rules Advisory Committee met on May 8, 2019. Meeting minutes are available here​

April 2019: Establishes a Rules Advisory Committee to provide input to the Board for rule revision - Agenda. (Updated timeline: rule revision to be complete prior to December 1, 2019 to align with USP)

February 2019: The Board will be taking a first look at proposed revisions to Division 045 at the February 7, 2019 meeting. Agenda and associated documents available here​ (see pg. 5-22 for draft rules).

October 2018: The Board discussed a new timeframe and plan for the Division 045 revision. Rules are to be revised to incorporate policy directives put forth at previous meetings, addressed by the 2014 Work Group, and informed by the survey results. It is expected that the Board will review the revision at the February 2019 and April 2019 meetings, and aims to draft a set of proposed rules for the May 2019 Rulemaking Hearing. The Board may decide to seek input from a Rules Advisory Committee, particularly to be informed about the fiscal impact of compliance. 

This plan aligns with USP Chapter revision publications (see below).

September 2018: The Board sought input related to Div 045 revisions via a Survey Monkey. This survey closed on September 17, 2018 - Thank you for your input!

August 2018: Board discussed the proposed revisions to USP <797> (released on 7/27/2018)

June 2018: Board discussed the comments received at the 5/23/2018 rulemaking hearing. Click here for the rule-making report​.

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USP Resources

The United States Pharmacopeia (USP) develops standards for preparing compounded drugs to help ensure patient benefit and reduce risks, such as contamination, infection, or incorrect dosing.

​ - Click here for USP Chapt​er <800>​ (Note: There are no pending revisions to this chapter; The Board intends to discuss compliance expectations at upcoming meetings)

**UPDATE**: On 9/23/2019, the USP announced it has postponed the intended official dates of Chapters 795, 797, and 825, pending review of additional appeals.

 -  USP intends to publish all three compounding-related Chapters (795, 797, and 800) by June 1, 2019 and has set an 'enforcement' date of December 1, 2019:

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For More Information

Email pharmacy.board@oregon.gov​ for more information related to drug compounding.
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