FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: LIST OF BULK DRUG SUBSTANCES FOR WHICH THERE IS A CLINICAL NEED UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

WASHINGTON, May 1 -- Food and Drug Administration has issued a notice called: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act.

The notice was published in the Federal Register on May 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for outsourcing facilities to use in compounding (the 503B Bulks List). This notice identifies three bulk drug substances that FDA has considered and propos...