Millions of prescriptions are compounded by pharmacists, nurses, and doctors each year in the US to meet the unique needs of patients who otherwise may not have access to the required medicine in the right concentration or dosage. Understanding of the risks inherent in compounding and incorporating established USP standards into everyday practice is essential for patient safety.
Standards for Compounding Quality
Nonsterile Preparations
USP <795> describes requirements for the compounding
process, facilities, equipment, components, documentation
quality controls and training to promote patient safety.
Standards for Compounding
Sterile Preparations
USP <797> helps to ensure patients receive
quality preparations that are free from
contaminants and are consistent in intended
identity, strength and potency. It
describes a number of requirements,
including responsibilities of compounding personnel,
training, environmental monitoring,
storage and testing of finished preparations.
Information, Updates and Resources for the
Safe Handling of Hazardous Drugs
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.
USP General Chapter <825> Radiopharmaceuticals – Preparation,
Compounding, Dispensing, and Repackaging
USP<825> provides the minimum standards
for the preparation, compounding, dispensing,
and repackaging of sterile and non-sterile
radiopharmaceuticals for humans and animals
that occur as part of state-licensed activities.
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Donation Program
Compounded Preparations Monographs
USP requests submissions of compounded formulations and supporting scientific information to create Compounded Preparation Monographs that address health needs of vulnerable populations.
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Standards Updates
USP Education courses
Learn about USP standards from the experts at USP. Browse and register for courses and webinars offered around the world.
Mobile App
Know your exposure to hazardous drugs with the <800>HazRx™ Mobile App.
Compounding Compendium
All compounding-related standards from the USP–NF. More than 40 General Chapters and 170 compounding monographs. Available in PDF format.