USP Compounding Standards

Compounding standards help improve equitable access to safe, quality medicines for patients

Millions of medicines are compounded each year to meet the unique needs of patients, who otherwise may not have access to their treatment in the right concentration or dosage. Understanding compounding quality risks and incorporating established USP standards into everyday practice is essential to deliver optimal, personalized patient care.

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USP General Chapter <795>

Standards for Compounding Quality Nonsterile Preparations describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training to promote patient safety.

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USP General Chapter <797>

Standards for Compounding Sterile Preparations 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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USP General Chapter <800>

Safe Handling of Hazardous Drugs 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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USP General Chapter <825>

USP develops standards for radiopharmaceuticals including monographs for radioactive drug products and general chapters related to radioactivity and radiopharmaceuticals generally and to certain aspects for the compounding of positron-emitting radiopharmaceuticals.

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Compounded Preparation Monographs

USP Compounded Preparation Monographs provide quality standards for compounding formulations for which there are no suitable commercially available product.

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USP Compendial Notices