Other USP–NF General Chapters for Compounding
- <1160> Pharmaceutical Calculations in Prescription Compounding: USP General Chapter <1160> provides guidance for appropriately performing the necessary calculations for compounding and dispensing medications. The chapter provides information for a variety of determinations, including quantities of ingredients, dosages, infusion rates, endotoxin load, stability and expiration dates, and provides illustrative sample calculations.
- <1163> Quality Assurance in Pharmaceutical Compounding: USP General Chapter <1163> describes elements of a quality assurance system that defines the responsibilities and practices that help ensure that compounded preparations are produced with quality attributes to meet the needs of patients and practitioners. The chapter defines integrated components that should comprise a robust quality assurance program, including training; standard operating procedures; documentation; verification; testing; cleaning, disinfecting and safety; containers, packaging, repackaging, labeling and storage; outsourcing (if used); and responsible personnel.
- <1176> Prescription Balances and Volumetric Apparatus Used in Compounding: USP General Chapter <1176> provides information on use of balances and volumetric apparatuses for the measurement of drugs and other substances used in compounding. The chapter describes tests for balances and guidance on selection of volumetric apparatuses (i.e., medicine droppers, dispensing bottles, syringes, pipets and volumetric flasks).
General Chapters in Development:
- <1168> Compounding for Phase 1 Investigational Studies: USP General Chapter <1168> is currently being developed to provide guidance on compounding investigational preparations for phase 1 clinical studies. The chapter will describe considerations such as training, facilities, equipment and components, release testing, quality assurance, quality control and documentation for compounding investigational preparations.
- 2017 UPDATE: General Chapter <1168> was first proposed for public comment in the Pharmacopeial Forum (PF) 39(5) Sept – Oct 2013. The General Chapter remains in a revision process and will be published for another public comment period anticipated beginning May 1, 2017, in PF 43(3) May –June 2017.