If you sell a pharmaceutical product in the United States, then you are familiar with using NDC (National Drug Codes) on your products. But the FDA is proposing changes, partly because of the impending possibility of running out of those codes. If you sell one of the many products that must include NDCs on your packaging, then pay attention because the format changes will affect you.
A Refresher on NDCs
The NDCs (National Drug Codes) are ten-digit numbers that follow an FDA standard. They are there to uniquely identify the various drugs sold in the United States. NDCs are commonly used throughout healthcare. Changing the NDCs will affect more than just manufacturers who have to change their packaging. It will also affect:
- Manufacturers of human and animal drugs
- Insurers and payors
- Importers
- Wholesale distributors
- Pharmacies
- Drug databanks
- Small clinics
- Small healthcare practitioners
- Hospitals
- Dental offices
- Nursing care facilities
- Prisons
- Federal agencies
- Local and state governments
- Other supply chain stakeholders
The current format of NDCs includes:
- The labeler code (like the drug company): 4 to 5 digits
- The product code (like the drug name and dosage size): 3 to 4 digits
- The package code (like how many pills are in the package): 1 to 2 digits
Why Change Is Needed
The explanation for the change is simple – the FDA is running out of unique 10-digit codes. This was already an eventual concern, but with the pandemic, even more products needed NDC codes, aggravating the issue.
By proposing a change, the FDA hopes to take action before there are no codes left. The idea is that there will be more predictability, as everyone will know when the change is coming.
A bonus of this change is that everyone will use the same format for NDCs. Currently, various healthcare sectors have different formats, so NDCs have to be converted regularly. If the code were uniform, this wouldn’t be the case, saving time and effort.
The Proposed Changes
For now, the FDA has proposed changes to the NDCs, which haven’t gone into effect yet. The proposal would swap the current format of 10 digits to 12 digits. It would have three distinct segments, which would be consistent across sectors. Thus, there would be a uniform format.
The FDA recognizes that companies aren’t going to be able to switch from 10-digit codes to 12-digit codes overnight. As such, they are proposing that the final rule will have a delayed effective date that can serve as a transition period. This will also allow for any necessary changes to HIPAA standards regarding NDCs. The FDA suggests that the effective date be a full five years after the final rule is published.
The proposed format would change the NDC to the following:
- The labeler code: 6 digits
- The product code: 4 digits
- The package code: 2 digits
Conclusion
If you sell pharmaceuticals in the U.S., you will likely eventually need to change the format for your NDCs. The FDA is still working out the details, and a long transition period will be given for companies to adjust to the change. Even so, it is smart to start planning as early as now.
