FDA's Proposal for a New National Drug Code – What You Need to Know – Healthcare – Food, Drugs, Healthcare, Life Sciences

FDA Proposed New National Drug Code – What You Need to Know

The Food and Drug Administration (FDA) is proposing to change its regulations regarding the format of the National Drug Code (NDC). The NDC is a standard for uniquely identifying drugs marketed in the United States. The current standard has several acceptable formats. When finalized, the proposal will standardize the format of all NDCs.

What is the NDC?

The National Drug Code is a unique, three-segment identifier that the FDA assigns to every drug on the U.S. market. It is a universal product identifier that appears on all prescription and over-the-counter drug packages and inserts.

Current formats:

10-digit identifier

The FDA standard NDC is a 10-digit numeric identifier that includes a labeling code, a product code, and a packaging code.

There are three FDA-assigned formats for the standard NDC:

HIPAA format

The Health Insurance Portability and Accountability Act (HIPAA) established a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized in a 5-4-2 format and is created by adding a leading zero to the labeler, product, or package code.

Upcoming 6-digit format

FDA will run out of 5-digit labeling codes in 10-15 years. According to FDA regulations (21 CFR 207.33), once FDA runs out of 5-digit labeling codes, it will begin issuing 6-digit labeling codes. Without this proposed change, there would be five NDC formats, 3 with 10 digits and 2 with 11 digits. There may be confusion between an FDA-assigned 11-digit NDC and an 11-digit NDC converted to HIPPA.

The proposed rule

The proposed rule amends existing regulations to establish a uniform 12-digit format that can accommodate longer NDCs once FDA begins issuing 6-digit labeler codes.

The change will impact numerous industries and stakeholders, including:

• Manufacturers and distributors of human and veterinary medicinal products




• Pharmaceutical importers




• Federal agencies using the NDC




• Drug databases




• Pharmacies




• Hospitals, clinics, laboratories, medical staff




• Care facilities




• Electronic health record providers




• State and local governments




• Various supply chain stakeholders

The rule change would standardize the NDC format across all sectors and minimize confusion and medication errors.

If adopted, the rule is expected to begin taking effect five years later, in addition to a three-year transition period for preparation and implementation. The proposed changes, whether or not the rule is finally adopted, represent a significant change in NDC formatting to simplify identification and reduce confusion.

The content of this article is intended to provide a general guide to the subject. You should seek professional advice for your specific circumstances.