USP–NF General Chapters for Compounding
There are currently five essential compounding General Chapters in the USP–NF. Outlined below, the complete and current text of these chapters is now available in the new electronic publication USP Compounding Compendium.
- <797> Pharmaceutical Compounding—Sterile Preparations—This 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.
- <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).
- <1160> Pharmaceutical Calculations in Prescription Compounding: This General Chapter provides guidance and assistance to pharmacists in performing the necessary calculations when preparing or compounding any pharmaceutical drug.
- <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 prescriptions or in other pharmaceutical compounding.
General Chapters in Development:
- Hazardous Drugs – Handling in Healthcare Settings: This General Chapter will provide guidelines and recommendations to protect healthcare personnel and the environment when handling hazardous drugs. Staff handling hazardous drugs can experience adverse health effects when exposed to such drugs if appropriate precautions are not taken.
- Compounding for Investigational Studies: This General Chapter will provide guidance to compounding pharmacists when preparing investigational new drugs for use in preclinical and early phase 1 studies. Topics in the General Chapter will likely include materials management, standard operating procedures as part of a quality assurance program, assigning beyond-use dates, packaging and labeling, etc.