USP Compounding Compendium

Type of Posting: General Announcement
Posting Date: 31–May–2019

The USP Compounding Compendium offers compounding practitioners convenient access to all compounding-related General Chapters and monographs from the United States Pharmacopeia and the National Formulary (USP–NF).  The USP–NF is continuously revised, and the corresponding text in the Compendium is updated accordingly as revisions to the USP–NF are published. For more information about the Compounding Compendium and the Table of Contents, visit: https://www.usp.org/products/usp-compounding-compendium. 

The Compendium includes the following sections:

  • Section 1 contains prefatory sections from the USP-NF including:
    • Mission and Preface
    • General Notices and Requirements
  • Section 2 contains compounding-related General Chapters including
    • <795> Pharmaceutical Compounding—Nonsterile Preparations
    • <797> Pharmaceutical Compounding—Sterile Preparations
    • <800> Hazardous Drugs—Handling in Healthcare Settings
    • <1160> Pharmaceutical Calculations in Pharmacy Practice
    • <1163> Quality Assurance in Pharmaceutical Compounding
    • <1168> Compounding for Phase I Investigational Studies
    • <1176> Prescription Balances and Volumetric Apparatus Used in Compounding
  • Section 3 contains supporting General Chapters.
  • Section 4 contains Compounded Preparation Monographs.

Major new revisions to <795> and <797> will be published in USP 42-NF 37, Second Supplement. As a result, the Compendium will be updated as follows:

  • Section 2
    • New General Chapter <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging will be added.
  • Section 3
    • The following supporting chapters will be added as new cross-references are added to <795>, <797>, and/or <825>
      • <821> Radioactivity
      • <852> Atomic Absorption Spectroscopy
      • <853> Fluorescence Spectroscopy
      • <854> Mid-Infrared Spectroscopy
      • <857> Ultraviolet-Visible Spectroscopy
      • <1085> Guidelines on Endotoxins Test
      • <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products
      • <1113> Microbial Characterization, Identification, and Strain Typing
      • <1207> Package Integrity Evaluation - Sterile Products
      • <1223> Validation of Alternative Microbiological Methods
      • <1228.4> Depyrogenation by Rinsing
      • <1229.14> Sterilization Cycle Development
      • <1229.15> Sterilizing Filtration of Gases
      • <1821> Radioactivity - Theory and Practice
    • The following supporting chapters will be deleted as these cross-references have been removed from <795> and/or <797>
      • <1> Injections and Implanted Drug Products (Parenterals)--Product Quality Tests
      • <31>   Volumetric Apparatus
      • <55>   Biological Indicators---Resistance Performance Tests"
      • <151>   Pyrogen Test
      • <601>   Inhalation and Nasal Drug Products: Aerosols Sprays and Powders---Performance Quality Tests
      • <602>   Propellants 
      • <603>   Topical Aerosols 
      • <604>   Leak Rate 
      • <698>   Deliverable Volume  
      • <789> Particulate Matter in Ophthalmic Solutions
      • <841> Specific Gravity 
      • <905> Uniformity of Dosage Units
      • <1051>  Cleaning Glass Apparatus  
      • <1211>  Sterility Assurance

Should you have any questions, please contact Healthcare Quality and Safety (CompoundingSL@usp.org). 

CN-19-039-00