FDA Announces List of Bulk Drug Substances for Clinical Need Under Section 503B of the FD&C Act

Summary

The US Food and Drug Administration (FDA) has identified a list of bulk drug substances that have a clinical need for inclusion on the 503B Bulks List, which allows outsourcing facilities to compound drug products with certain exemptions from the FD&C Act, and has also identified substances that are not being included on the list at this time.