News about GMP/cGMP


Intended Revision of mandatory USP chapter <797> “Sterile Compounding”

The Compounding Expert Committee intends a revision of the General Chapter USP <797> Pharmaceutical Compounding – Sterile Compounding. The draft version has been published for public commentation until November 30, 2018.

This is the second revision cycle. The new version contains several major changes, e.g.

  • Definition of the scope of the chapter to include sterile compounding activities and exclude administration of medication (e.g., withdrawing doses for administration).
  • 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).
  • Addition of guidance on use and storage of opened or needle-punctured conventionally manufactured products and CSPs.
  • Addition of information on notification and recall of CSPs that have out-of-specification results.
  • Clarification of requirements for compounding allergenic extract prescription sets.
  • Removal of information related to handling of hazardous drugs and addition of references to Hazardous Drugs—Handling in Healthcare Settings 〈800〉.
  • 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).

More information can be found here.