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 on Compounding: A Guide for the Compounding Practitioner.

• <795>  Pharmaceutical Compounding—Nonsterile Preparations: This chapter provides guidance on applying good compounding practices in the preparation of nonsterile compounded formulations for dispensing and/or administration to humans or animals. <795> was recently revised and the chapter now includes new material; such as categories of compounding (simple, moderate, and complex); new 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). These revisions became official May 1, 2011.

• <797>  Pharmaceutical Compounding—Sterile Preparations: This chapter provides procedures and requirements for compounding sterile preparations. <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.

• <1160> Pharmaceutical Calculations in Prescription Compounding: This chapter provides general guidance and assistance to pharmacists in performing the necessary calculations when preparing or compounding any pharmaceutical drug.

• <1163> Quality Assurance in Pharmaceutical Compounding: This 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 entirely new content with 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 & Volumetric Apparatus: Provides information about acceptable balances and volumetric apparatus (i.e., burets, pipets, cylinders, conical graduates, medicine droppers) used to weigh or measure medicinal and other substances required in prescriptions or in other pharmaceutical compounding.

Potential New Chapters:

• Compounding with Hazardous Drugs: This chapter will provide guidelines and recommendations to reduce the potential harmful effects of hazardous drugs on the well-being of healthcare workers when compounding preparations for patient administration. Pharmacy staff working with hazardous drugs can experience adverse health effects when exposed to such drugs if appropriate precautions are not taken.

• Compounding for Clinical Drug Studies: This chapter will provide guidance to compounding pharmacists when preparing investigational new drugs for use in early clinical trials. Topics in the chapter will likely include materials management, standard operating procedures as part of a quality assurance program, assigning beyond-use dates, packaging and labeling, etc.