Drug Compounding Resources
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.
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.
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.
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.
(Updated timeline: rule revision to be complete prior to December 1, 2019 to align with USP)
The Board will be taking a first look at proposed revisions to Division 045 at the February 7, 2019 meeting.
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.
The Board sought input related to Div 045 revisions via a Survey Monkey. This survey closed on September 17, 2018.
Board discussed the proposed revisions to USP <797> (released on 7/27/2018)
List of potential accreditors
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.
USP intends to publish all three compounding- related Chapters 795, 797 & 800 by June 1,2019 and has set an "enforcement" date of December 1, 2019.