Today, the U.S. Food and Drug Administration announced that it issued for public comment a proposed rule, “List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act.” The proposed rule identifies six bulk drug substances that the Agency has evaluated and is proposing for inclusion on a list of bulk drug substances that can be used in compounding under section 503A. It also proposes that four other bulk drug substances that FDA evaluated not be included on the 503A bulks list. In addition, the proposed rule addresses criteria for evaluating bulk drug substances.
The public comment period on the proposed rule closes in 90 days.
The American College for Advancement in Medicine (ACAM) is a not-for-profit organization dedicated to educating physicians and other health care professionals on the safe and effective application of integrative medicine.