Updated: USP Sterile Compounding 2019

Updated Changes to USP 797 and USP 800 Pharmaceutical Compounding Guidelines and Overview

Revised: 12/28/18

First published in 2004, USP Chapter <797> underwent new revisions as of July 2018. These revisions were previously available for public comment. 

The newest <797> comment period which concluded November 30, 2018 includes a 9-point summary (below) for the pharmaceutical compounding sector. 

For most facilities, USP 797 revisions will not denote outstanding changes and overhauls to current practices. Significant points include changes to the preparation of CSPs based on risk level, packaging environments, and the redaction of USP 800 and 825 references within 797.

Improvements to clarity and readability of documentation are significant for all facilities, but specifically for those compounding both hazardous (800) and non-hazardous (797) drugs, or those administering CSPs.

Production Automation often fields inquiries from small-medium sized 797 facilities who find updates required by USP 800 documentation unclear. New revisions simplify formatting and limit redundancy. General chapter (825) is also proposed for public comment.

Final revisions become official on December 19, 2019, although this date has previously been subject to change. Some sections may have longer adoption dates to allow amicable time for facility changes.

Proposed USP 797 Revisions Changes

  1. Reorganization of the chapter to include section and subsection numbers.
  2. Placement of procedural information in boxes.
  3. Definition of the scope of the chapter to include sterile compounding activities and exclude administration of medication (e.g., withdrawing doses for administration).

Environment Requirements and CSP Categories

  1. Simplified compounded sterile preparation (CSP) microbial risk levels from three (low, medium, and high) to two—Category 1 CSPs and Category 2 CSPs.

    Category 1 and 2 CSPs are distinguished primarily by the facility in which they are made and the time period within which they must be used, i.e., the beyond-use date (BUD).

    • Category 1 CSPs have a shorter BUD and may be prepared in an unclassified segregated compounding area (SCA).
    • Category 2 CSPs have a longer BUD and must be prepared in a cleanroom suite (buffer room with ante-room).

Storage of Opened or Punctured CSP

  1. Addition of guidance on use and storage of opened or needle-punctured conventionally manufactured products and CSPs.
  2. Addition of information on notification and recall of CSPs that have out-of-specification results.
  3. Clarification of requirements for compounding allergenic extract prescription sets.
  4. Removal of information related to the handling of hazardous drugs and addition of references to Hazardous Drugs—Handling in Healthcare Settings 〈800〉.

Removal of Radiopharmaceuticals Section from USP 797

  1. Removal of the section on radiopharmaceuticals as CSPs and addition of a reference to Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging 〈825〉. General chapter 〈825〉 is also proposed for public comment in PF 44(5).

Need Help Upgrading a Cleanroom for USP 800 Standards?

We help industrial, government, and enterprise customers target a specific cleanroom classification or isolate an operation to keep it cleaner. 

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Mitch Walleser

Mitch Walleser

Mitch works with manufacturing engineers and product specialists to examine new technology and products. His background includes 3D printing, electronics and cleanroom manufacturing. Stay up to date with new insights on automated production solutions by following on Twitter. @Go_to_PAC

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