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U.S. Department of Health and Human Services

Drugs

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Notice to Industry: FDA Issues Revised Guidance on Marketed Unapproved Drugs

Newly Marketed Unapproved Drugs Subject to Immediate Enforcement Action
 

FDA today announced a revision to its 2006 guidance titled “Marketed Unapproved Drugs-- Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs” (CPG 440.100).

Revised CPG 440.100 clarifies that any unapproved new drug introduced onto 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.

For unapproved drugs that are being commercially used or sold as of September 19, 2011, FDA will continue to apply the enforcement priorities established in 2006. These give a higher priority to enforcement actions involving drugs in certain high-risk categories, such as drugs that pose a potential safety risk or lack evidence of effectiveness.

The 2006 CPG 440.100 established an orderly approach for removing unapproved new drugs from the market. Unapproved new drugs, however, continue to come onto the market illegally for reasons addressed in FDA’s revised guidance.  Among these reasons are:

  • competition with other unapproved drugs that are already on the market, and not yet subject to a public FDA announcement regarding future enforcement actions.
  • increased market share opportunity is perceived following FDA actions that removed another unapproved drug from the market.

Although revised CPG 440.100 is being issued for immediate implementation, FDA welcomes public input on the revised guidance at any time.  Comments can be submitted electronically to http:/www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  20852.