Compounding Standards

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.

Timeline of Revisions to General Chapters

General Chapters <795> and <797>
are in the active revision process.
Learn more about opportunities to
engage and provide input on
the proposed revisions.

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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.

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Standards for Compounding Quality
Non-sterile Preparations

USP <795> describes requirements for the compounding
process, facilities, equipment, components, documentation
quality controls and training to promote patient safety.

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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.

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