Federal Register Notice: FDA is making available a guidance, Marketed Unapproved Drugs — Compliance Policy Guide, that describes how the agency intends to exercise its enforcement discretion on drugs marketed in the U.S. that do not have required FDA approval for marketing. The guidance supersedes section 440.100 entitled "Marketed New Drugs Without Approved NDAs or ANDAs" (CPG 7132c.02) of the Compliance Policy Guide. To download this guidance, click here. To view this notice, click here.