Business · 27/01/2022Updated: 10/17/2026 · 1 min read
FDA Announces List of Bulk Drug Substances for Clinical Need Under Section 503B of the FD&C Act
Summary
The FDA has identified four bulk drug substances for inclusion on the 503B Bulks List, which can qualify for exemptions from the FD&C Act, and eight substances that will not be included, following public nominations and evaluation
Original source language: Federal Register — Food and Drug AdministrationOpen original release →