Compounding Standards

Contact Information

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
Sterile Preparations Help Promote
Patient Safety and Prevent Harm


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.

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.

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.

Additional USP Standards for Compounding


  • <1160> Pharmaceutical Calculations in Prescription
    Compounding: USP General Chapter
  • <1163> Quality Assurance in Pharmaceutical
    Compounding: USP General Chapter
  • <1176> Prescription Balances and Volumetric
    Apparatus Used in Compounding: USP General Chapter