Proposed Revisions to USP 797 – Overview and Current Status

This article is an overview, including current status, of the proposed revisions to USP 797.

Brief History of USP 797 and the Current, Proposed Revisions:

USP 797 was first published in 2004.

The last official revision to USP 797 became official on June 1, 2008.

The Compounding Expert Committee of USP began a new set of revisions in July 2010, and on September 25, 2015, USP issued a set of proposed revisions to USP 797 for public comment. The public comment period ran through January 31, 2016.

Currently, as of May 14, 2016, USP is evaluating the comments received through the public comment process.

You can download the proposed revisions that were published on September 25, 2015, from the following link:

Key Components of the Proposed Revisions per USP:

According to USP (per, the major revisions of the General Chapter include:

1. Reorganization of existing sections and placement of procedural information in boxes

2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.

3. Removal of information on handling hazardous drugs and added cross-references to Hazardous Drugs—Handling in Healthcare Settings

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