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FDA Changes to Drug Listing Process for Contract-Manufactured Products

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The FDA recently introduced two significant changes to its process for drug listing products manufactured by contract manufacturing organizations (CMOs). It is important for CMOs and Private Label Distributors (PLDs) to understand these changes and make sure they update their internal processes in order to ensure successful drug product listing submissions going forward.

Change #1 – Marketing Category

Until recently, the FDA had the following three Marketing Categories under which manufacturers’ listings could be filed:

  • Approved Drug Product Manufactured Exclusively for Private Label Distributor
  • Unapproved Drug Product Manufactured Exclusively for Private Label Distributor
  • OTC Monograph Drug Product Manufactured Exclusively for Private Label Distributor

 
These categories were established for listings performed by a CMO under its own NDC Labeler Code (read more about FDA’s drug listing requirements for CMOs here). Although each category references the CMO’s relationship with the distributor of the product (PLD), the FDA has recognized that the naming of these categories has resulted in confusion within the industry.

To address this problem, the agency has created three new categories, changing the phrase “Manufactured Exclusively for Private Label Distributor” to “Manufactured Under Contract”:

  • Approved Drug Product Manufactured Under Contract
  • Unapproved Drug Product Manufactured Under Contract
  • OTC Monograph Drug Product Manufactured Under Contract

FDA validation procedures have already been updated to reflect this change, so all manufacturer listings must use one of these new categories, effective immediately. Listings submitted under the old categories will fail validation.

Change #2 – Principal Display Panel Image

In addition to the changes in the Marketing Category section, the FDA has given clear feedback to manufacturers regarding the NDC listed in the Principal Display Panel (PDP) section of the drug listing, which contains the packaging image.

Manufacturer listings are performed under the NDC Labeler Code of the CMO, not of the PLD, but use the label image of the actual distributed product, which may show the distributor’s NDC. The FDA has now made it clear that an NDC does not need to appear as part of the image supplied with a manufacturer listing but, if it does, it must match the NDC in the metadata (which will begin with the CMO’s labeler code).

Reed Tech is aware of multiple clients who have received deficiency letters from the agency specifically citing this as an issue. These clients were instructed during correspondence with FDA personnel to fix this by either cropping the NDC out of the PDP image entirely or by replacing the NDC shown in the image with the CMO NDC.

To summarize, if an NDC appears in the label image for a manufacturer listing, it must match the NDC shown in the metadata section. The PLD NDC should not appear in the image. You may simply remove the NDC entirely from the image supplied as part of the manufacturer listing to correct this problem or replace it with the CMO NDC.

Since image text is not part of the automatic validation procedures during the drug listing process, it is possible to submit a drug listing and have it be accepted by the agency with this issue outstanding, then receive a notice (in the form of a deficiency letter) from the FDA later stating that this must be corrected. In that case, you should correct the problem immediately by submitting an updated drug product listing.

Need Help?

We realize this process can be confusing and overwhelming, especially if drug listing is a new part of your responsibilities. The team at Reed Tech can help. Contact us today for help from a drug listing expert. We’ll be happy to speak with you.