2018 USP Sterile Compounding Revisions

2018 USP Sterile Compounding Revisions

USP Seeks Comment on Proposal Changes to Pharmaceutical Compounding Guidelines

First published in 2004, USP Chapter <797> has undergone new revisions as of July 2018. These revisions are now available for public comment. 

The newest <797> comment period (July 27 – November 30, 2018) includes a 9-point summary (below) for the pharmaceutical compounding sector. Submissions must be made before November 30, 2018 through the online form.

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 fielded a number of inquiries from small-medium sized 797 facilities who found 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. Submit comments using the form available here or view proposed chapter online (USP 797 Revisions Updated PDF Download)

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).

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