What is USP(797)?
First we must start with defining USP.
The United States Pharmacopeia (USP) is a standard that governs the identification and preparation of drug compounds. As the USP is adopted here in Australia, anyone producing medicines must use this standard in their process.
The USP has specific chapters – Chapter 797, and 800 which govern the preparation of sterile medicines under Good Manufacturing Practice (GMP) in compounding pharmacies.
Chapter (797) covers many aspects of sterile compounding, including:
- Measuring stability of the product
- Measuring sterility of the product
- Assigning correct “Beyond-Use Dates”
- Correct storage of raw materials
- Staff training
- Documentation and evaluation of all processes
- Risk assessment
These features and others make up the standards to which any compounding pharmacy that is producing sterile compounds must now adhere.