Chapter 4 - Human Drugs - Sub Chapters 470- 490

Sub Chapter 470 - Post Approval Issues

• CPG Sec. 470.100 Orders for Post-Approval Record Reviews

Sub Chapter 480 - Stability/Expiration

• CPG Sec. 480.100 Requirements for Expiration Dating and Stability Testing
• CPG Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs is obsolete and was withdrawn on 7/30/2020
• CPG Sec. 480.300 Lack of Expiration Date of Stability Data

Sub Chapter 490 - Validation

• CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval
• CPG Sec. 490.200 Parametric Release – Parenteral Drug Products Terminally Sterilized by Moist Heat