FDA’s Electronic Drug Listing Requirements for Manufacturers

February 1, 2017 Daniel Henrich

If your company manufactures drug products for distribution in the United States, you probably know that you are required to register your establishment site(s) annually with FDA in Structured Product Labeling (SPL) format. Many manufacturers are unaware, however, that their reporting obligations extend beyond their annual establishment registration.

Drug Listing Requirement

The Federal Food, Drug, and Cosmetic Act (FFDCA) also requires manufacturers to perform drug listings for every finished drug product, Active Pharmaceutical Ingredient (API) or bulk ingredient for distribution or further processing in the U.S. During the electronic drug listing process, products are assigned a National Drug Code (NDC) and associated in FDA’s database with the manufacturer’s labeler code.

FDA relies on drug listing information submitted by manufacturers in order to conduct a number of critical tasks including:

  • Post-marketing surveillance activities
  • Potential user fee assessments
  • Counter-terrorism
  • Monitoring of drug shortages and availability
  • Determining products that are being marketed without an approved application

For companies manufacturing and distributing their own products under their brand, the requirement is fairly straightforward. For contract manufacturing organizations (CMOs), however, things get more complicated. A CMO must file a drug listing with FDA for each product it manufactures under its own NDC labeler code, as well as a separate drug listing using the labeler code of the private label distributor (PLD).


Consequences of Non-compliance

Late last year, our SPL team got a frantic call from a foreign CMO’s U.S. Agent. He told us that the company’s latest shipment to a PLD client in the U.S. was being held at the border. FDA had notified him that the product had not been properly listed and the shipment could not be released until the listing was filed under the PLD’s labeler code, in addition to the CMO’s. The team at Reed Tech was able to explain the requirements and assist in properly drug listing the product to get the shipment released, but the situation delayed the product’s arrival to the PLD, who was anxiously waiting for it.  

When a drug product from outside the U.S. crosses the border, federal customs agents may inspect the shipment and check the FDA’s database to make sure the product has been properly listed. If not, FDA will contact the owner of the shipment and notify them that the product is not properly listed and cannot be delivered to its final destination until the requirements are met. Detainment or even seizure of a drug product shipment can be very expensive and can disrupt relationships with customers inside the U.S. who are waiting to put the product into distribution.

Domestic manufacturers should be equally concerned. Products failing to meet drug listing requirements FFDCA may be regarded as misbranded. Misbranding can carry very serious consequences, including fines, seizure, injunction and even criminal penalties.  

Do you have questions or need help making sure your drug products are properly listed with FDA? Contact the experts at Reed Tech. We’ll be happy to help.  

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