On September 19, 2011 the FDA issued a revised guidance on marketing unapproved drugs. Previously under CPG 440.100, unapproved new drugs that were on the market illegally for any number of reasons were removed from the market in an orderly approach.
The revised CPG 440.100 now clarifies that any unapproved drugs entering the market after September 19, 2011 will be “subject to immediate enforcement action, without prior notice and without regard to the enforcement priorities set out in CPG 440.100.” Drugs that are on the market as of September 19, 2011 will continue to have the regulation of the 2006 CPG 440.100 applied which will give a higher priority to high-risk categories.
FDA Revised Guidance If you have further questions about listing your drug product, Registrar Corp is available for discussion by phone at +1-757-224-0177or 24/7 via online Live Help. To receive U.S. FDA regulatory updates, visit: https://www.registrarcorp.com/fda-updates