USP–NF General Chapters for Compounding

USP General Chapters related to compounding establish procedures, methods and practices that help ensure the quality of compounded preparations and also provide criteria for safe handling of medications. Together these General Chapters help safeguard patient and practitioner safety. General Chapters contained in the United States Pharmacopeia and the National Formulary (USPNF) are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in various state laws and regulations. These standards are enforced by regulatory bodies including the U.S. Food and Drug Administration, individual state boards of pharmacy and accreditation organizations (see Legal Considerations for more information). A summary of the six essential compounding General Chapters are provided below.

Status Updates

USP is seeking public feedback from stakeholders on the proposed USP General Chapter <1168> Compounding for Phase I Investigational Studies.

Official General Chapters

  • <795> Pharmaceutical Compounding—Nonsterile Preparations: USP General Chapter <795> provides standards for compounding quality nonsterile preparations to promote patient safety and prevent harm. These standards describe requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. General Chapter <795> also provides guidelines for assigning beyond-use dates to nonsterile preparations.
  • <797> Pharmaceutical Compounding—Sterile PreparationsUSP General Chapter <797> provides quality standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency. This General Chapter describes a number of requirements, including responsibilities of compounding personnel, training, environmental monitoring, storage and testing of finished preparations.
  • <800> Hazardous Drugs – Handling in Healthcare Settings: USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. General Chapter <800> describes requirements for safely handling and preparing both sterile and nonsterile hazardous drugs, including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs.
  • <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) SeptOct 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.

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