Lawmakers To FDA: Speed Review Of Bulk Drug Substances For 503B List

House lawmakers want FDA to expedite its review of drug substances nominated for inclusion on the agency's list of bulk substances that can be compounded based on a clinical need. The lawmakers wrote to FDA Thursday (July 18) that allowing outsourcing facilities to compound products with substances that have been nominated but not yet approved for the list could undermine the traditional drug approval process. There are no drug substances included on FDA’s compounding list, known as the 503B bulks...