Compounding

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The chapters of the United States Pharmacopeia and The National Formulary (USP-NF) on compounding are an enforceable set of standards describing procedures and requirements for the compounding of all sterile and non-sterile products.

Book: "USP on Compounding: A Guide for the Compounding Practitioner”

USP has a guidebook available for purchase on their Web site that contains all of this information together in one book.

Highlights & Features

  • Complete, up-to-date text of all five essential compounding general chapters from USP–NF
    • <795> Pharmaceutical Compounding -- Nonsterile Preparations
    • <797> Pharmaceutical Compounding -- Sterile Preparations
    • <1160> Pharmaceutical Calculations in Prescription Compounding
    • <1163> Quality Assurance in Pharmaceutical Compounding
    • <1176> Prescription Balances and Volumetric Apparatus
  • All supporting general chapters are referenced and hyperlinked in the compounding chapters—more than 40 in all. For example:
    • <71> Sterility Tests
    • <85> Bacterial Endotoxins Test
    • <1151> Pharmaceutical Dosage Forms
    • General Notices and Requirements, providing definitions and important information necessary to correctly interpret and apply compounding standards

Sterile Compounding – USP <797> Pharmaceutical Compounding: Sterile Preparations

USP General Chapter <797> of the United States Pharmacopeia and The National Formulary (USP-NF) is an enforceable set of standards describing procedures and requirements for the compounding of all sterile products.   USP Chapter <797> has been adopted and/or enforced by the Food and Drug Administration (FDA), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and various State Boards of Pharmacy. The purpose of USP <797> is to prevent harm and fatality to patients due to the improper preparation of compounded sterile products.

In May 2006, USP released an in-process revision to Chapter <797>, with some significant changes to the first version.  Public comments on these proposed revisions were accepted by USP until August 15, 2006, and members of the USP Sterile Compounding Committee met in November 2006 to discuss the comments.

In December 2007, USP released the revision of chapter <797>.  The revised became official on June 1, 2008.

The completely revised chapter contains topics including:

  • Introduction and Organization of the Chapter
  • CSP Microbial Contamination Risk Levels
  • Single Dose v. Multiple Dose Containers
  • Hazardous Drugs as CSPs
  • Radiopharmaceuticals as CSPs
  • Allergen Extracts as CSPs
  • Sterilization Methods
  • Environmental Quality and Control
  • Exposure of Critical Sites
  • Placement of Primary Engineering Controls
  • Additional Personnel Requirement
  • Personnel Cleansing and Garbing
  • Disinfectant and Cleaning
  • Appendices

The section on Environmental Monitoring has been deleted. Two subsections anad three appendices were developed from the environmental monitoring section. The two subsections are listed under the Environmental Quality and Control section.

Most state boards of pharmacy have either adopted USP Chapter <797> as their regulations or have crafted their own regulations modeled on these standards.

Additional Resources


Nonsterile Compounding – USP <795> Pharmaceutical Compounding: Nonsterile Preperations

USP General Chapter <795> of the The United States Pharmacopeia and The National Formulary (USP-NF) is an enforceable set of standards describing procedures and requirements for the compounding of all nonsterile products.

USP <795> is published annually in the USP-NF.

Resources regarding compounding and USP General Chapter <795>:

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