Business · 19/01/2018Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Compounded Drug Products That Are Essentially Copies of Approved Drug Products

The FDA is releasing a guidance document outlining its policies for compounded drug products that are essentially copies of approved drug products under the Federal Food, Drug, and Cosmetic Act. The guidance aims to clarify the conditions for outsourcing facilities to qualify for exemptions under section 503B.