Question: : What is the response from the USP on the Appeals to USP <795> and USP <797> that were filed?

Answer:
The following is a brief summary of the USP’s response to the appeals that were filed questioning certain aspects of USP <795> and USP <797>. Please go to the following link and read the response in full.

https://www.usp.org/sites/default/files/usp/document/health-quality-safety/usp-decision-on-appeals-factsheet.pdf

Appeal Topics Summary that Were Addressed

1. Beyond-use Date (BUD) provisions in <795> and <797>
2. Removal of Alternative Technology provision from <797>
3. Applicability of <795> and <797> to veterinary practitioners BUD Provisions

Decisions

1. Beyond-use Date (BUD) provisions in <795> and <797>
   
   The CMP EC decided to:

   Keep BUDs for compounded nonsterile preparations (CNSPs) in <795> as is.
   
   Maintain the BUD provisions for compounded sterile preparations (CSPs) in <797>.

2. Alternative Technology Provision
   
   The CMP EC decided to:

   Reinstate the Alternative Technology Provision from the 2008 Version of <797>.

3. Applicability to Veterinary Practitioners
   
   The CMP EC decided:

   Not to postpone implementation of these chapters for animal drug compounding and to maintain veterinary references in the chapters.

Please take the time to go to the website above and read the response in its entirety. Thank you.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Announcement

At the CompoundingToday.com website, in the section entitled “Download Compliance Documents,� content has been written and updated to cover both those pharmacies in states that do not use USP’s chapters and those that do. Now available are the following:

New Standard Operating Procedures (SOPs) to address the 2019 versions of <795> and <797> have been posted, bringing the total number of SOPs to approximately 700 from which you can choose, modify as needed, and implement.

To see a listing of the new SOP additions to date, go to:

http://compoundingtoday.com/SOP/SearchResults.cfm?txtKeyword=(USP 2019)

Did You Know ...

...that just in case we missed it, $500 is offered to the first pharmacist or pharmacy technician to show where chemical stability and chemical degradation is discussed in detail in USP <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products other than the first mention in the first paragraph of the chapter?

Tip of the Week

The beyond-use dates in USP <795> are largely based on water activity and USP <1112>. However, there appears to be no discussion on this to justify its basis for use in chemical stability and setting beyond-use dates for nonsterile compounded preparations. See our Newsletter published on June 21, 2019, Volume 16, Issue 25 for a more detailed discussion.

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Looking Back

The Burma girls,
In Mandalay,
Dunk bearded lovers,
In the bay,
Who don’t use
     Burma-Shave