Today, the U.S. Food and Drug Administration proposed to include one additional bulk drug substance 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 and Cosmetic Act. The bulk drug substance, quinacrine hydrochloride, is not a component of an FDA-approved drug. The agency nominated quinacrine HCl to compound oral products for the treatment of cutaneous lupus erythematosus (CLE).

The FDA also identified four bulk drug substances—bromfenac sodium, mitomycin–C, nepafenac and hydroxychloroquine sulfate—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 drugs starting from these bulk drug substances, and therefore proposed that the statutory standard for adding these bulk drug substances to the 503B bulks list has not been met.

Read the full FDA In Brief here.

 

For more information, please visit FDA's Human Drug Compounding web site.