USP Compounding Standards & Resources

As part of its commitment to providing public standards for the quality, consistency, purity, identity, and strength of all medicines, USP has developed standards for compounding. These standards help compounding practitioners adhere to widely acknowledged, scientifically sound procedures and practices, and facilitate the delivery of consistent and good-quality prepared medicines to patients. State Boards of Pharmacy may adopt these USP standards into their regulations.

Compounding Information

• Statement on Public Standards for Compounding
• Legal Considerations
• Public Health Webinar
  • Compounding Total Parenteral Nutrition Preparations: A 2011 Investigation of a Bacterial Outbreak
• Collaborative Partnerships
  • American Pharmacists Association (APhA)
  • American Society of Health-System Pharmacists (ASHP)
  • Centers for Disease Control Prevention (CDC)
  • U.S. Food & Drug Administration (FDA)
  • International Academy of Compounding Pharmacists (IACP)
  • National Association of Boards of Pharmacy (NABP)
  • National Home Infusion Association (NHIA)
  • National Community Pharmacists Association (NCPA)
  • Pharmacy Compounding Accreditation Board (PCAB)

USP Standards

USP–NF General Chapters

• <797>  Pharmaceutical Compounding—Sterile Preparations
• <795>  Pharmaceutical Compounding—Nonsterile Preparations
• <1160> Pharmaceutical Calculations in Prescription Compounding
• <1163> Quality Assurance in Pharmaceutical Compounding
• <1176> Prescription Balances & Volumetric Apparatus

Compliance with General Chapter <797> requires the use of other General Chapters, which are available in the publication "USP on Compounding" for purchase.

Monographs

• Monographs for Compounded Preparation
• Veterinary Compounding Monographs

Other Resources

Drug Shortages

• ASHP drug shortage information and list
• FDA drug shortage information and list