FDA Proposes Four Bulk Drug Substances for Inclusion on 503B Bulks List for Use by Outsourcing Facilities - Drug Information Update

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-proposes-four-bulk-drug-substances-inclusion-19-not-be-included-503b-bulks-list-use?utm_campaign=FDA%20Proposes%20Four%20Bulk%20Drug%20Substances%20for%20Inclusion%20on%20503B%20Bulks%20List&utm_medium=email&utm_source=Eloqua

FDA Proposes Four Bulk Drug Substances for Inclusion, 19 Not to Be Included on 503B Bulks List for Use by Outsourcing Facilities

Today, the U.S. Food and Drug Administration proposed to include four bulk drug substances on the list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug & Cosmetic Act. The four bulk drug substances are: diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. These substances are not components of FDA-approved drug products. The FDA also identified 19 bulk drug substances that the agency has considered and proposed not to include on the 503B bulks list. Based on the information reviewed, the agency did not find a clinical need for an outsourcing facility to compound drug products starting from these bulk drug substances, and therefore the statutory standard for adding these bulk drug substances to the 503B bulks list has not been met. The FDA is seeking public comment on this proposal before finalizing its decision.

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