BioPharmaAs a biopharma professional you likely know that if any pharma company manufactures drug products for distribution in the United States, are required to register establishment site(s) annually with FDA in Structured Product Labeling (SPL) format still many manufacturers are unaware,however,that their reporting obligations extend beyond their annual establishment registration.

Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL). Establishment registrations and drug listing data provide the agency with a list of all drug manufacturers currently manufacturing drugs for U.S.commercial distribution and a current inventory of all drugs in the U.S. commercial distribution.

Part of this data is published online in the FDA National Drug Code Directory, FDA Label Repository, FDA Drug Establishment Current Registration Site and NIH’s Daily Med for public, health care professionals, and healthcare industry access.

Drug Listing Requirement:

Requirements for establishment registration and drug listing are outlined in section 510 of the Federal Food, Drug, and Cosmetic Act and part 207 of Title 21 of the Code of Federal Regulations (CFR), which was revised in 2016 and went into effect on November 29 of the same year.

Accuracy and integrity of establishment registration and drug listing data are essential to the FDA’s mission to minimize the exposure of the public to unsafe and ineffective drugs. Several key programs inside and outside the agency such as inspections and reimbursement rely upon registration and listing information. Although FDA has several automated validation rules in place to stop the submission of inaccurate and incomplete data at its entry point, many steps within the process cannot be automated.

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:

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.

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