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Update: USP <797>

On Monday, September 23, 2019, the United States Pharmacopeia (USP) released a Notice of Intent to Revise compounding standards. To access the update: https://www.usp.org/news/usp-intent-to-revise-comp-standards

Originally, on June 1, 2019, the United States Pharmacopeia (USP) released updates to the General Chapter USP <797>. The official date for the revised standard was set for December 1, 2019. But this formal appeal to the revision require postponement of the official date until further notice.

On September 25, 2019, Eurofins EMLab P&K’s outreach to USP to request information on scope of the appeal and timeline for a revision received the response below:

In practice, the above provisions mean the following with respect to the compounding chapters currently under appeal:

 Chapters <795>, <797>, and <825> will be postponed until further notice. 

  • None of these chapters will become official on the originally anticipated date of December 1, 2019. 
  • Regardless of the outcome of the appeals process, USP would not reestablish an official date for chapters <795>, <797>, or <825> without granting another six-month implementation period, at a minimum.   
  • USP cannot predict or project a future official date for any of these chapters at this time, as the appeals process remains actively in progress. 

USP cannot predict or project a future official date for any of these chapters at this time, regardless of the decision of the Panel, as the appeals process remains actively in progress

This process may take some time and once the appeals process is completed, the industry will have another 6 months or more for implementation. For now, the 2008 version of General Chapter USP <797> remains official. General Chapter USP <800> Hazardous Drugs – Handling in Healthcare Settings will become official on December 1, 2019.

For more details and questions please contact our client service team or Dr. Michael Berg at (mberg@emlabpk.com).

We are also hosting a Webinar on this USP<797 and <800> on October 23, 2019, presented by Dr. Michael Berg.  To register for this webinar, click here.