Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
January 22, 2020
January 7, 2021
bd9edb09-3aaf-4e80-b088-c65aa8949a54
Related Documents
Establishing Impurity Specifications for Antibiotics
Guidance DocumentApril 20, 2026Center for Drug Evaluation and Research
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
Guidance DocumentOctober 6, 2021Center for Drug Evaluation and Research
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance DocumentJune 27, 2023Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.