Regulatory Focus™ > News Articles > FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

FDA Puts Off Decision on Revoking National Drug Codes for Unapproved Products

Posted 21 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national drug codes (NDCs) for products lacking either a New Drug Application (NDA)or Abbreviated New Drug Application (ANDA) number.

The Citizen Petition was filed in December 2011 by Dr. S. Albert Edwards, RAC, who requested FDA phase out the use of NDCs over a three-year period. Current policy, wrote Edward, "opens the door to allow firms to market their unapproved drug products" and receive reimbursement from insurance companies.

A NDC identifies a product by way of a ten-digit number composed of three segments:

  • The first segment identifies the labeler or vendor.
  • The second segment identifies the product in regards to its strength, dosage form and formulation.
  • The third segment identifies the package size of the product.

Current FDA policy allows companies to file an FDA Form 2657-used to apply for FDA product listing-while leaving the Application Number Field blank if they do not have a NDA or ANDA number.

"With the movement to making the FDA Form 2657 electronic, the Forms WITHOUT a valid entry in the Application Number Field should be easily identified and rejected," wrote Edwards in his 27 December 2011 Citizen Petition to FDA.

Edwards noted at the time that current FDA policy had the potential to endanger public health given the thousands of illegally marketed drug products lacking FDA approval and numerous dangerous products granted NDCs by FDA in the last thirty years.

In its 18 May letter to Edwards, FDA said it "has been unable to reach a decision on [Edwards'] petition due to the need to address other Agency priorities," and will require additional time given the resource shortage.


Read more:

Citizen Petition - Stop Issuing NDC Codes for Unapproved Drug Products When the Application Number Field is Left Blank

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