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.

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.

chemotherapy drugs

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.

two-right-left
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.