FDA Provides Preliminary Assessment on Five Bulk Drug Substances for Use by Outsourcing Facilities - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA In Brief: FDA Provides Preliminary Assessment on Five Bulk Drug Substances for Use by Outsourcing Facilities 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 Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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