FDA Develops List of Bulk Drug Substances for Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Summary

The US Food and Drug Administration (FDA) is creating a list of bulk pharmaceutical ingredients that have a clinical need, which could exempt certain outsourcing facilities from the Federal Food, Drug, and Cosmetic Act. The FDA has identified four substances for inclusion on the list and 19 for exclusion, including Diphenylcyclopropenone, glycolic acid, and trichloroacetic acid, and has also received nominations from the public for additional substances.