Revised Guidance on Marketed Unapproved Drugs; Compliance Policy Guide Sec. 440.100; Marketed New Drugs Without Approved NDAs or ANDAs; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Marketed Unapproved Drugs--Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs" (CPG 440.100). CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required FDA approval for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that are being commercially used or sold as of September 19, 2011. All unapproved new drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth in CPG 440.100.