USP–NF General Chapters for Compounding

There are currently six essential compounding General Chapters in the USP–NF. Outlined below, the complete and current text of these chapters is available in the electronic publication USP Compounding Compendium.

  • <795> Pharmaceutical Compounding—Nonsterile Preparations: This General Chapter provides guidance on applying good compounding practices in the preparation of nonsterile compounded formulations for dispensing and/or administration to humans or animals. The latest revision which became official May 1, 2011 includes categories of compounding (simple, moderate, and complex); definitions for terms (e.g., beyond-use date, hazardous drug, stability); and criteria for compounding each drug preparation (e.g., suitable compounding environment, use of appropriate equipment).
  • <797> Pharmaceutical Compounding—Sterile PreparationsThis General Chapter provides procedures and requirements for compounding sterile preparations. General Chapter <797> describes conditions and practices to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality in compounded sterile preparations. The chapter was last revised in USP31–NF26 2nd Supplement, which became official on June 1, 2008. A revision to the chapter was proposed in Pharmacopeial Forum (PF) 41(6) Nov-Dec 2015. The chapter is currently being revised based on the comments received. Signup for the Healthcare Quality Standards Newsletter to receive updates on the status of the revisions.
  • <800> Hazardous Drugs – Handling in Healthcare Settings: This General Chapter provides standards for handling hazardous drugs in healthcare settings to protect personnel, patients and the environment. The chapter was published on February 1, 2016 but the official implementation period for the chapter has been extended until July 1, 2018. See the FAQs on <800> to find more information about the chapter. 
  • <1160> Pharmaceutical Calculations in Prescription Compounding: This General Chapter provides guidance and assistance to practitioners in performing the necessary calculations for compounding and dispensing medications.
  • <1163> Quality Assurance in Pharmaceutical Compounding: This General Chapter describes a quality assurance program as a system of steps and actions that must be taken to ensure the maintenance of proper standards in compounded preparations. The latest revision, which became official May 1, 2011, includes sections on training; physical testing of dosage units; weight and volume assessment; cleaning and disinfecting; containers, packaging, repackaging and storage; and outsourcing.
  • <1176> Prescription Balances and Volumetric Apparatus: This General Chapter provides information about acceptable balances and volumetric apparatus (e.g., burets, pipets, cylinders, conical graduates, medicine droppers) used to weigh or measure medicinal and other substances required in compounding.

General Chapters in Development:

  • <1168> Compounding for Investigational Studies: This General Chapter will provide guidance to compounders when preparing investigational new drugs for use in phase 1 clinical studies. The chapter was proposed for public comment in the PF 39(5) Sept-Oct 2013. Based on the public comments received, the chapter is currently undergoing revision for publication for another comment period. The revision is intended to clarify the information that compounders should know when participating in a study on investigational agents and to clarify personnel responsibilities on material management.