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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 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 to download the Proposed Revision to USP Chapter <797>

 - Click here to submit comments to USP​ related to the proposed revisions of USP <797>

 - 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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