The FDA held a public hearing on November 5, 2018 regarding the future format of the National Drug Code (NDC). An NDC is a unique 10-digit, 3-segment identifier which is assigned to all drugs in U.S. commercial distribution. An NDC is proposed by companies and assigned by FDA through the drug listing process. Current formats for the NDC sequence are 4-4-2, 5-4-1 and 5-3-2.
FDA recognizes the importance of the NDC in many aspects of health care today and is aware that any change to its format or length will have an impact on the health system. Recognizing that a change to NDC length and/or format will be necessary when FDA runs out of 5-digit labeler codes, FDA is holding this public hearing to receive input from stakeholders on how to maximize the benefit and minimize this impact well in advance of any forthcoming change.
Part 1: https://collaboration.fda.gov/pg6htg2g569i/
Part 2: https://collaboration.fda.gov/pe7i49703zsg/
Part 3: https://collaboration.fda.gov/p13roccy3411/
Part 4: https://collaboration.fda.gov/psya690njeov/
See the Federal Register Notice for more information.
Future NDC Format Options and Questions
FDA is proposing the following options and questions to frame the discussion and assist stakeholders in preparing comments for the meeting. These options do not represent an inclusive list of options to address updating the NDC format. The options, or combination of these options, provide a framework of possible solutions, and FDA is seeking stakeholder input on both the general and option-specific questions outlined below. Additionally, stakeholders are encouraged to propose other options. However, FDA requests the same general questions be addressed for any alternative option being proposed.
- What kind of stakeholder are you (payer, patient advocate, drug compendium, retailer, hospital, pharmacy benefits manager, wholesaler, manufacturer, other)?
- Describe how you currently maintain and use NDCs, including:
- Formats (10 digits, 11 digits or both).
- NDC segment separation methods (e.g., hyphens, separate fields).
- A string of digits with no separation.
- For each option below (or any other proposed option):
- What is the value/magnitude for each benefit (clinical practice, safety of products, consistency)?
- What can FDA do to enhance these benefits or mitigate/minimize these costs (e.g. create a grace/transition period)?
- What is the value/magnitude for each cost (efficiencies, public health benefits, monetary, etc.)?
- Would this option present any technical limitations (existing or emerging)?
- Are there any challenges or additional costs if you maintain 10- and/or 11-digit NDCs?
- Would option A, B, C or D be preferred?
Option A: Maintain the current practice without modification. FDA continues assigning the remainder of the 5-digit labeler codes. Whenever the agency runs out of 5-digit combinations, consistent with existing regulations, FDA will start issuing 6-digit labeler codes. This will expand FDA’s NDC inventory to 10 and 11 digits, resulting in five different configurations. FDA would continue to use 10- and 11-digit NDCs. This option is intended to allow stakeholders currently using 10-digit NDCs to continue using them and provide additional flexibility to stakeholders regarding NDC formats. However, as described in the Federal Register Notice, converting a 10-digit NDC into a Health Insurance Portability and Accountability Act (HIPAA) standard 11-digit NDC may result in some 11-digit native NDCs being indistinguishable from HIPAA standard 11-digit NDCs.
Option B: Same as Option A except that FDA will stop issuing 5-digit labeler codes and start issuing 6-digit labeler codes on a specified date in the future, before we anticipate running out of 5-digit labeler codes. This option is intended to provide more certainty to stakeholders by establishing a designated future date on which they will need to have systems in place to accept and process 11-digit NDCs in either 6-4-1 or 6-3-2 format.
Questions for Option A and B
- Does your segment separation method allow you to easily convert an 11-digit HIPAA standard NDC back to a 10-digit NDC, if necessary?
- Have you encountered issues, such as medication errors when converting NDCs, from 10 to 11 digits or 11 to 10 digits? If so, describe the nature, frequency, and outcome of the issue.
- Would having five NDC configurations cause additional confusion or mix-ups? What can FDA do to reduce this confusion?
- How much lead time would be needed to incorporate additional NDC configurations into your system?
- Will you still develop a uniform NDC format for uses other than FDA? If so, what would that look like?
Option C: Adopt the hyphenated NDC 11-digit format (5-4-2 sequenced format) currently used by the payer industry and convert all current 10-digit NDCs to the hyphenated 11-digit format by adding a leading zero to the short segment of the NDC. When supply of 5-digit labeler codes is exhausted, FDA will begin assigning 6-digit labeler codes for use in 6-3-2 and 6-4-1 sequenced formats.
Although this will establish a uniform length for all NDC codes, there will still be additional formats. Additionally, there is the potential for an 11-digit format with a 6-digit labeler code and an 11-digit with a 5-digit labeler code to be identical when the hyphens separating the various segments are removed.
Questions for Option C
- Would using these three new NDC configurations cause confusion or mix-ups? What can FDA do to reduce this confusion (e.g. publish both formats during transition period)?
- How much lead time would be needed to transition to using the new NDC configurations?
Option D: Harmonize NDC assignment at FDA with other stakeholders by moving toward a uniform NDC in a 6-4-2 sequenced format at a future date. Once FDA starts assigning 6-digit labeler codes, all NDCs (new and existing) would be required to be presented in a 6-4-2 sequenced format. Existing NDCs would be converted from their existing format by adding leading zeros to the short segments. This would create one standard configuration for all NDCs and provide the industry with more product or package codes.
FDA understands that an appropriate number of years would be necessary to adapt existing databases and structures to convert to one uniform, 12-digit NDC and implement this proposal. Under this option, FDA would implement a shift to a uniform 12-digit NDC before the current pool of 5-digit labeler codes is exhausted, in order to provide certainty and predictability to industry stakeholders, government payers, and other interested parties.
Questions for Option D
- Would the transition from 10- to 12-digit NDC configurations cause any different confusion or mix-ups? What can FDA do to reduce this confusion (e.g. publish both formats during transition period)?
- How much lead time would be needed to transition to the uniform sequence 6-4-2 NDC configuration?
- Are there any benefits to having additional product and package code combinations for assignment?
- Are there benefits to having a uniform NDC configuration that is harmonized across all stakeholders?
Questions for Options C and D
We recognize that if FDA were to adopt option C or D, labeling for existing products would need to be updated to incorporate the NDC in the updated 11- or 12-digit format.
- Would allowing companies to continue using existing labeling with the 10-digit NDC for a period of time mitigate some of the burdens/costs associated with option C or D? If so, how long of a grace period would be necessary to allow sufficient time for companies to use up existing labeling stocks/retire old labeling because of other non-NDC labeling changes?
- Would allowing companies to continue using existing labeling with the 10-digit NDC for a period of time cause any additional confusion or mix-ups? If so, what could FDA do to reduce this confusion (e.g. publish both formats during transition period)?