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  5. Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
  6. Unapproved Drugs Initiative
  1. Enforcement Activities by FDA

Unapproved Drugs Initiative

Unapproved Drugs Initiative

In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)," outlining its enforcement policies aimed at efficiently and rationally bringing all such drugs into the approval process. The FDA uses a risk-based enforcement program in order to concentrate its resources on those products that pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market. For all unapproved drugs, the CPG gives highest enforcement priority to the following:

  • Drugs with potential safety risks
  • Drugs that lack evidence of effectiveness
  • Health fraud drugs
  • Drugs that present direct challenges to the new drug approval and OTC drug monograph systems
  • Unapproved new drugs that are also violative of the Act in other ways
  • Drugs that are reformulated to evade an FDA enforcement action

Summary of Compliance Policy Guide

The Marketed Unapproved Drugs—Compliance Policy Guide (CPG):

  • provides official notice that any illegally marketed product is subject to FDA enforcement at any time
  • clarifies that the FDA intends to use a risk-based approach to enforcement
    • once the risk-based assessment has been made, the FDA can and will take any number of enforcement actions, including but not limited to:
      • requesting voluntary compliance
      • providing notice of action in a Federal register notice
      • issuing an untitled letter
      • issuing a warning letter, or
      • initiating a seizure, injunction, or other proceeding