Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 9, 2023
April 12, 2023
42ece20e-b981-40c7-8486-325a2b13d7dc
Related Documents
Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for Industry
Guidance DocumentOctober 11, 2024Center for Drug Evaluation and Research
Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act
Guidance DocumentNovember 18, 2022Center for Drug Evaluation and Research
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Guidance DocumentMay 8, 2023Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox